Sample records for wait-list controlled trial

  1. The effect of waiting: A meta-analysis of wait-list control groups in trials for tinnitus distress.

    PubMed

    Hesser, Hugo; Weise, Cornelia; Rief, Winfried; Andersson, Gerhard

    2011-04-01

    The response rates and effects of being placed on a wait-list control condition are well documented in psychiatric populations. Despite the usefulness of such estimates and the frequent use of no-treatment controls in clinical trials for tinnitus, the effect of waiting in a tinnitus trial has not been investigated systematically. The aim of the present study was to quantify the overall effect of wait-list control groups on tinnitus distress. Studies were retrieved via a systematic review of randomised controlled trials of cognitive behaviour therapy for tinnitus distress. Outcomes of psychometrically robust tinnitus-specific measures (Tinnitus Handicap Inventory, Tinnitus Questionnaire, Tinnitus Reaction Questionnaire) from wait-list control groups were quantified using meta-analytic techniques. Percentage of change and standard mean difference effect sizes were calculated using the pre and post wait period. Eleven studies involving 314 wait-list subjects with tinnitus were located. The analysis for a waiting period of 6 to 12 weeks revealed a mean decrease in scores on tinnitus-specific measures of 3% to 8%. Across studies, a statically significant small mean within-group effect size was obtained (Hedges' g=.17). The effects were moderated by methodological quality of the trial, sample characteristics (i.e., age, tinnitus duration), time of the wait-list and how diagnosis was established. Subjects in a tinnitus trial improve in tinnitus distress over a short waiting phase. The effects of waiting are highly variable and depend on the characteristics of the sample and of the trial. Copyright © 2011 Elsevier Inc. All rights reserved.

  2. Waiting list randomized controlled trial within a case-finding design: methodological considerations.

    PubMed

    Ronaldson, Sarah; Adamson, Joy; Dyson, Lisa; Torgerson, David

    2014-10-01

    Randomized controlled trials (RCTs) are widely used in health care research to provide high-quality evidence of effectiveness of an intervention. However, sometimes a study does not require an RCT in order to answer its primary objective; a case-finding design may be more appropriate. The aim of this paper was to introduce a new study design that nests a waiting list RCT within a case-finding study. An example of the new study design is the DOC Study, which primarily aims to determine the diagnostic accuracy of lung function tests for chronic obstructive pulmonary disease. It also investigates the impact of lung function tests on smoking behaviour through use of a waiting list design. The first step of the study design is to obtain participants' consent. Individuals are then randomized to one of two groups; either the 'intervention now' group or the 'intervention later' group, that is, participants are placed on a waiting list. All participants receive the same intervention; the only difference between the groups is the timing of the intervention. The design addresses patient preference issues and recruitment issues that can arise in other trial designs. Potential limitations include differential attrition between study groups and potential demoralization for the 'intervention later' group. The 'waiting list case-finding trial' design is a valuable method that could be applied to case-finding studies; the design enables the case-finding component of a study to be maintained while simultaneously exploring additional hypotheses through conducting a trial. © 2014 John Wiley & Sons, Ltd.

  3. A Randomized, Wait-List Controlled Effectiveness Trial Assessing School-Wide Positive Behavior Support in Elementary Schools

    ERIC Educational Resources Information Center

    Horner, Robert H.; Sugai, George; Smolkowski, Keith; Eber, Lucille; Nakasato, Jean; Todd, Anne W.; Esperanza, Jody

    2009-01-01

    We report a randomized, wait-list controlled trial assessing the effects of school-wide positive behavior support (SWPBS). An effectiveness analysis was conducted with elementary schools in Hawaii and Illinois where training and technical assistance in SWPBS was provided by regular state personnel over a 3-year period. Results document that the…

  4. Self-administered acupressure for symptom management among Chinese family caregivers with caregiver stress: a randomized, wait-list controlled trial.

    PubMed

    Tiwari, Agnes; Lao, Lixing; Wang, Amy Xiao-Min; Cheung, Denise Shuk Ting; So, Mike Ka Pui; Yu, Doris Sau Fung; Lum, Terry Yat Sang; Yuk Fung, Helina Yin King; Yeung, Jerry Wing Fai; Zhang, Zhang-Jin

    2016-10-28

    Caregiving can be stressful, potentially creating physical and psychological strain. Substantial evidence has shown that family caregivers suffer from significant health problems arising from the demands of caregiving. Although there are programs supporting caregivers, there is little evidence regarding their effectiveness. Acupressure is an ancient Chinese healing method designed to restore the flow of Qi (vital energy) by applying external pressure to acupoints. A randomized, wait-list controlled trial was developed to evaluate the effectiveness of a self-administered acupressure intervention on caregiver stress (primary objective) and stress-related symptoms of fatigue, insomnia, depression, and health-related quality of life (secondary objectives) in Chinese caregivers of older family members. Two hundred Chinese participants, aged ≥ 21 years, who are the primary caregivers of an older family member and screen positive for caregiver stress and symptoms of fatigue/insomnia/depression will be recruited from a community setting in Hong Kong. Subjects will be randomized to receive either an immediate treatment condition (self-administered acupressure intervention) or a wait-list control condition. The self-administered acupressure intervention will include (i) an individual learning and practice session twice a week for 2 weeks, (ii) a home follow-up visit once a week for 2 weeks, and (iii) 15-min self-practice twice a day for 6 weeks. The wait-list control group will receive the same acupressure training after the intervention group has completed the intervention. We hypothesize that Chinese family caregivers in the intervention group will have lower levels of caregiver stress, fatigue, insomnia, depression, and higher health-related quality of life after completion of the intervention than participants in the wait-list control group. This study will provide evidence for the effectiveness of self-administered acupressure in reducing stress and improving

  5. Effectiveness and cost-effectiveness of web-based treatment for phobic outpatients on a waiting list for psychotherapy: protocol of a randomised controlled trial

    PubMed Central

    2012-01-01

    Background Phobic disorders are highly prevalent and constitute a considerable burden for patients and society. As patients wait for face-to-face psychotherapy for phobic disorders in outpatient clinics, this time can be used for guided self-help interventions. The aim of this study is to investigate a five week internet-based guided self-help programme of exposure therapy in terms of clinical effectiveness and impact on speed of recovery in psychiatric outpatients, as well as the cost-effectiveness of this pre-treatment waiting list intervention. Methods/design A randomised controlled trial will be conducted among 244 Dutch adult patients recruited from waiting lists of outpatient clinics for face-to-face psychotherapy for phobic disorders. Patients suffering from at least one DSM-IV classified phobic disorder (social phobia, agoraphobia or specific phobia) are randomly allocated (at a 1:1 ratio) to either a five-week internet-based guided self-help program followed by face-to-face psychotherapy, or a control group followed by face-to-face psychotherapy. Waiting list status and duration are unchanged and actual need for further treatment is evaluated prior to face-to-face psychotherapy. Clinical and economic self-assessment measurements take place at baseline, post-test (five weeks after baseline) and at 3, 6, 9 and 12 months after baseline. Discussion Offering pre-treatment internet-based guided self-help efficiently uses time otherwise lost on a waiting list and may increase patient satisfaction. Patients are expected to need fewer face-to-face sessions, reducing total treatment cost and increasing speed of recovery. Internet-delivered treatment for phobias may be a valuable addition to psychotherapy as demand for outpatient treatment increases while budgets decrease. Trial registration Netherlands Trial Register NTR2233 PMID:22937959

  6. Effectiveness and cost-effectiveness of web-based treatment for phobic outpatients on a waiting list for psychotherapy: protocol of a randomised controlled trial.

    PubMed

    Kok, Robin N; van Straten, Annemieke; Beekman, Aartjan; Bosmans, Judith; de Neef, Manja; Cuijpers, Pim

    2012-08-31

    Phobic disorders are highly prevalent and constitute a considerable burden for patients and society. As patients wait for face-to-face psychotherapy for phobic disorders in outpatient clinics, this time can be used for guided self-help interventions. The aim of this study is to investigate a five week internet-based guided self-help programme of exposure therapy in terms of clinical effectiveness and impact on speed of recovery in psychiatric outpatients, as well as the cost-effectiveness of this pre-treatment waiting list intervention. A randomised controlled trial will be conducted among 244 Dutch adult patients recruited from waiting lists of outpatient clinics for face-to-face psychotherapy for phobic disorders. Patients suffering from at least one DSM-IV classified phobic disorder (social phobia, agoraphobia or specific phobia) are randomly allocated (at a 1:1 ratio) to either a five-week internet-based guided self-help program followed by face-to-face psychotherapy, or a control group followed by face-to-face psychotherapy. Waiting list status and duration are unchanged and actual need for further treatment is evaluated prior to face-to-face psychotherapy. Clinical and economic self-assessment measurements take place at baseline, post-test (five weeks after baseline) and at 3, 6, 9 and 12 months after baseline. Offering pre-treatment internet-based guided self-help efficiently uses time otherwise lost on a waiting list and may increase patient satisfaction. Patients are expected to need fewer face-to-face sessions, reducing total treatment cost and increasing speed of recovery. Internet-delivered treatment for phobias may be a valuable addition to psychotherapy as demand for outpatient treatment increases while budgets decrease. Netherlands Trial Register NTR2233.

  7. Acceptability of an open-label wait-listed trial design: Experiences from the PROUD PrEP study.

    PubMed

    Gafos, Mitzy; Brodnicki, Elizabeth; Desai, Monica; McCormack, Sheena; Nutland, Will; Wayal, Sonali; White, Ellen; Wood, Gemma; Barber, Tristan; Bell, Gill; Clarke, Amanda; Dolling, David; Dunn, David; Fox, Julie; Haddow, Lewis; Lacey, Charles; Nardone, Anthony; Quinn, Killian; Rae, Caroline; Reeves, Iain; Rayment, Michael; White, David; Apea, Vanessa; Ayap, Wilbert; Dewsnap, Claire; Collaco-Moraes, Yolanda; Schembri, Gabriel; Sowunmi, Yinka; Horne, Rob

    2017-01-01

    PROUD participants were randomly assigned to receive pre-exposure prophylaxis (PrEP) immediately or after a deferred period of one-year. We report on the acceptability of this open-label wait-listed trial design. Participants completed an acceptability questionnaire, which included categorical study acceptability data and free-text data on most and least liked aspects of the study. We also conducted in-depth interviews (IDI) with a purposely selected sub-sample of participants. Acceptability questionnaires were completed by 76% (415/544) of participants. After controlling for age, immediate-group participants were almost twice as likely as deferred-group participants to complete the questionnaire (AOR:1.86;95%CI:1.24,2.81). In quantitative data, the majority of participants in both groups found the wait-listed design acceptable when measured by satisfaction of joining the study, intention to remain in the study, and interest in joining a subsequent study. However, three-quarters thought that the chance of being in the deferred-group might put other volunteers off joining the study. In free-text responses, data collection tools were the most frequently reported least liked aspect of the study. A fifth of deferred participants reported 'being deferred' as the thing they least liked about the study. However, more deferred participants disliked the data collection tools than the fact that they had to wait a year to access PrEP. Participants in the IDIs had a good understanding of the rationale for the open-label wait-listed study design. Most accepted the design but acknowledged they were, or would have been, disappointed to be randomised to the deferred group. Five of the 25 participants interviewed reported some objection to the wait-listed design. The quantitative and qualitative findings suggest that in an environment where PrEP was not available, the rationale for the wait-listed trial design was well understood and generally acceptable to most participants in

  8. Evaluation of wet-cupping therapy for persistent non-specific low back pain: a randomised, waiting-list controlled, open-label, parallel-group pilot trial

    PubMed Central

    2011-01-01

    Background Persistent non-specific low back pain (PNSLBP) is one of the most frequently experienced types of back pain around the world. Wet-cupping is a common intervention for various pain conditions, especially in Korea. In this context, we conducted a pilot study to determine the effectiveness and safety of wet-cupping treatment for PNSLBP. Methods We recruited 32 participants (21 in the wet-cupping group and 11 in the waiting-list group) who had been having PNSLBP for at least 3 months. The participants were recruited at the clinical research centre of the Korea Institute of Oriental Medicine, Korea. Eligible participants were randomly allocated to wet-cupping and waiting-list groups. Following the practice of traditional Korean medicine, the treatment group was provided with wet-cupping treatment at two acupuncture points among the BL23, BL24 and BL25 6 times within 2 weeks. Usual care, including providing brochures for exercise, general advice for PNSLBP and acetaminophen, was allowed in both groups. Separate assessors participated in the outcome assessment. We used the 0 to100 numerical rating scale (NRS) for pain, the McGill Pain Questionnaire for pain intensity (PPI) and the Oswestry Disability Questionnaire (ODQ), and we assessed acetaminophen use and safety issues. Results The results showed that the NRS score for pain decreased (-16.0 [95% CI: -24.4 to -7.7] in the wet-cupping group and -9.1 [-18.1 to -0.1] in the waiting-list group), but there was no statistical difference between the groups (p = 0.52). However, the PPI scores showed significant differences between the two groups (-1.2 [-1.6 to -0.8] for the wet-cupping group and -0.2 [-0.8 to 0.4] for the waiting-list group, p < 0.01). In addition, less acetaminophen was used in the wet-cupping group during 4 weeks (p = 0.09). The ODQ score did not show significant differences between the two groups (-5.60 [-8.90 to -2.30] in the wet-cupping group and -1.8 [-5.8 to 2.2] in the waiting-list group, p

  9. Argentine tango dance compared to mindfulness meditation and a waiting-list control: a randomised trial for treating depression.

    PubMed

    Pinniger, Rosa; Brown, Rhonda F; Thorsteinsson, Einar B; McKinley, Patricia

    2012-12-01

    To determine whether tango dancing is as effective as mindfulness meditation in reducing symptoms of psychological stress, anxiety and depression, and in promoting well-being. This study employed analysis of covariance (ANCOVA) and multiple regression analysis. Ninety-seven people with self-declared depression were randomised into tango dance or mindfulness meditation classes, or to control/waiting-list. classes were conducted in a venue suitable for both activities in the metropolitan area of Sydney, Australia. Participants completed six-week programmes (1½h/week of tango or meditation). The outcome measures were assessed at pre-test and post-test. Depression, Anxiety and Stress Scale; The Self Esteem Scale; Satisfaction with Life Scale, and Mindful Attention Awareness Scale. Sixty-six participants completed the program and were included in the statistical analysis. Depression levels were significantly reduced in the tango (effect size d=0.50, p=.010), and meditation groups (effect size d=0.54, p=.025), relative to waiting-list controls. Stress levels were significantly reduced only in the tango group (effect size d=0.45, p=.022). Attending tango classes was a significant predictor for the increased levels of mindfulness R(2)=.10, adjusted R(2)=.07, F (2,59)=3.42, p=.039. Mindfulness-meditation and tango dance could be effective complementary adjuncts for the treatment of depression and/or inclusion in stress management programmes. Subsequent trials are called to explore the therapeutic mechanisms involved. Crown Copyright © 2012. Published by Elsevier Ltd. All rights reserved.

  10. A randomized wait-list controlled analysis of the implementation integrity of team-initiated problem solving processes.

    PubMed

    Newton, J Stephen; Horner, Robert H; Algozzine, Bob; Todd, Anne W; Algozzine, Kate

    2012-08-01

    Members of Positive Behavior Interventions and Supports (PBIS) teams from 34 elementary schools participated in a Team-Initiated Problem Solving (TIPS) Workshop and follow-up technical assistance. Within the context of a randomized wait-list controlled trial, team members who were the first recipients of the TIPS intervention demonstrated greater implementation integrity in using the problem-solving processes during their team meetings than did members of PBIS Teams in the Wait-List Control group. The success of TIPS at improving implementation integrity of the problem-solving processes is encouraging and suggests the value of conducting additional research focused on determining whether there is a functional relation between use of these problem-solving processes and actual resolution of targeted student academic and social problems. Copyright © 2012 Society for the Study of School Psychology. Published by Elsevier Ltd. All rights reserved.

  11. Wait watchers: the application of a waiting list active management program in ambulatory care.

    PubMed

    de Belvis, Antonio Giulio; Marino, Marta; Avolio, Maria; Pelone, Ferruccio; Basso, Danila; Dei Tos, Gian Antonio; Cinquetti, Sandro; Ricciardi, Walter

    2013-04-01

    This study describes and evaluates the application of a waiting list management program in ambulatory care. Waiting list active management survey (telephone call and further contact); before and after controlled trial. Local Health Trust in Veneto Region (North-East of Italy) in 2008-09. Five hundred and one people on a 554 waiting list for C Class ambulatory care diagnostic and/or clinical investigations (electrocardiography plus cardiology ambulatory consultation, eye ambulatory consultation, carotid vessels Eco-color-Doppler, legs Eco-color-Doppler or colonoscopy, respectively). Active list management program consisting of a telephonic interview on 21 items to evaluate socioeconomic features, self-perceived health status, social support, referral physician, accessibility and patients' satisfaction. A controlled before-and-after study was performed to evaluate anonymously the overall impact on patients' self-perceived quality of care. The rate of patients with deteriorating healthcare conditions; rate of dropout; interviewed degree of satisfaction about the initiative; overall impact on citizens' perceived quality of care. 95.4% patients evaluated the initiative as useful. After the intervention, patients more likely to have been targeted with the program showed a statistically significant increase in self-reported quality of care. Positive impact of the program on some dimensions of ambulatory care quality (health status, satisfaction, willingness to remain in the queue), thus confirming the outstanding value of 'not to leave people alone' and 'not to leave them feeling themselves alone' in healthcare delivery.

  12. The effects and costs of the universal parent group program - all children in focus: a study protocol for a randomized wait-list controlled trial.

    PubMed

    Lindberg, Lene; Ulfsdotter, Malin; Jalling, Camilla; Skärstrand, Eva; Lalouni, Maria; Lönn Rhodin, Kajsa; Månsdotter, Anna; Enebrink, Pia

    2013-07-29

    In recent decades, parents have been involved in programs that aim to improve parenting style and reduce child behavior problems. Research of preventive parenting programs has shown that these interventions generally have a positive influence on both parents and children. However, to our knowledge there is a gap in the scientific literature when it comes to randomized controlled trials of brief, manual-based structured programs which address general parenting among the population, and focus on promoting health. A four-session universal health promotion parent group program named All Children in Focus was developed. It aims at promoting parental competence and children's positive development with the parent-child relationship as the target. There is currently no randomized controlled trial existing of the program. A prospective multicenter randomized wait-list controlled trial is being conducted. Approximately 600 parents with children ranging in age from 3-12 years have been recruited in eleven municipalities and city districts in the County of Stockholm, Sweden. Parents are randomized at baseline to an intervention group, which receives the program directly, or to a waiting-list control group, which participates in the program six months later. Changes in parenting and child health and development are assessed with measures immediately post-intervention and six months after the baseline. Observations of a minor group of parents and children are conducted to explore possible relations between parental reports and observed behaviors, as well as changes in the interaction between parent and child. Further, data collected within the evaluation will also be applied to evaluate the possible cost-effectiveness of the program. This paper describes a study protocol of a randomized controlled trial. Except for the quantitative outcome measures to evaluate the effectiveness of All Children in Focus, this protocol also describes health economic and qualitative analyses to

  13. Feasibility and acceptability of group music therapy vs wait-list control for treatment of patients with long-term depression (the SYNCHRONY trial): study protocol for a randomised controlled trial.

    PubMed

    Carr, Catherine Elizabeth; O'Kelly, Julian; Sandford, Stephen; Priebe, Stefan

    2017-03-29

    Depression is of significant global concern. Despite a range of effective treatment options it is estimated that around one in five diagnosed with an acute depressive episode continue to experience enduring symptoms for more than 2 years. There is evidence for effectiveness of individual music therapy for depression. However, no studies have as yet looked at a group intervention within an NHS context. This study aims to assess the feasibility of conducting a randomised controlled trial of group music therapy for patients with long-term depression (symptom durations of 1 year or longer) within the community. This is a single-centre randomised controlled feasibility trial of group music therapy versus wait-list control with a nested process evaluation. Thirty participants will be randomised with unbalanced allocation (20 to receive the intervention immediately, 10 as wait-list controls). Group music therapy will be offered three times per week in a community centre with a focus on songwriting. Data will be collected post-intervention, 3 and 6 months after the intervention finishes. We will examine the feasibility of recruitment processes including identifying the number of eligible participants, participation and retention rates and the intervention in terms of testing components, measuring adherence and estimation of the likely intervention effect. A nested process evaluation will consist of treatment fidelity analysis, exploratory analysis of process measures and end-of-participation interviews with participants and referring staff. Whilst group music therapy is an option in some community mental health settings, this will be the first study to examine group music therapy for this particular patient group. We will assess symptoms of depression, acceptability of the intervention and quality of life. We anticipate potential challenges in the recruitment and retention of participants. It is unclear whether offering the intervention three times per week will be

  14. The effects and costs of the universal parent group program – all children in focus: a study protocol for a randomized wait-list controlled trial

    PubMed Central

    2013-01-01

    Background In recent decades, parents have been involved in programs that aim to improve parenting style and reduce child behavior problems. Research of preventive parenting programs has shown that these interventions generally have a positive influence on both parents and children. However, to our knowledge there is a gap in the scientific literature when it comes to randomized controlled trials of brief, manual-based structured programs which address general parenting among the population, and focus on promoting health. A four-session universal health promotion parent group program named All Children in Focus was developed. It aims at promoting parental competence and children’s positive development with the parent–child relationship as the target. There is currently no randomized controlled trial existing of the program. Methods/Design A prospective multicenter randomized wait-list controlled trial is being conducted. Approximately 600 parents with children ranging in age from 3–12 years have been recruited in eleven municipalities and city districts in the County of Stockholm, Sweden. Parents are randomized at baseline to an intervention group, which receives the program directly, or to a waiting-list control group, which participates in the program six months later. Changes in parenting and child health and development are assessed with measures immediately post-intervention and six months after the baseline. Observations of a minor group of parents and children are conducted to explore possible relations between parental reports and observed behaviors, as well as changes in the interaction between parent and child. Further, data collected within the evaluation will also be applied to evaluate the possible cost-effectiveness of the program. Discussion This paper describes a study protocol of a randomized controlled trial. Except for the quantitative outcome measures to evaluate the effectiveness of All Children in Focus, this protocol also describes

  15. When Wait Lists Are Not Feasible, Nothing Is a Thing That Does Not Need to Be Done

    ERIC Educational Resources Information Center

    Devilly, Grant J.; McFarlane, Alexander C.

    2009-01-01

    Clinical psychology practices initially grew through the use of case studies, uncontrolled trials, and eventually through randomized controlled trials (RCTs). The use of a wait-list control group is standard practice in such trials of treatment regimens for psychopathological conditions. However, as knowledge advances regarding the successful…

  16. Efficacy of a Mindfulness-Based Mobile Application: a Randomized Waiting-List Controlled Trial.

    PubMed

    van Emmerik, Arnold A P; Berings, Fieke; Lancee, Jaap

    2018-01-01

    Although several hundreds of apps are available that (cl)aim to promote mindfulness, only a few methodologically sound studies have evaluated the efficacy of these apps. This randomized waiting-list controlled trial therefore tested the hypothesis that one such app (the VGZ Mindfulness Coach ) can achieve immediate and long-term improvements of mindfulness, quality of life, general psychiatric symptoms, and self-actualization. One hundred ninety-one experimental participants received the VGZ Mindfulness Coach, which offers 40 mindfulness exercises and background information about mindfulness without any form of therapeutic guidance. Compared to 186 control participants, they reported large (Cohen's d  = 0.77) and statistically significant increases of mindfulness after 8 weeks and small-to-medium increases of the Observing, Describing, Acting with awareness, Nonjudging, and Nonreactivity mindfulness facets as measured with the Five Facet Mindfulness Questionnaire (Cohen's d  = 0.66, 0.26, 0.49, 0.34, and 0.43, respectively). Also, there were large decreases of general psychiatric symptoms (GHQ-12; Cohen's d  = -0.68) and moderate increases of psychological, social, and environmental quality of life (WHOQOL-BREF; Cohen's d  = 0.38, 0.38, and 0.36, respectively). Except for social quality of life, these gains were maintained for at least 3 months. We conclude that it is possible to achieve durable positive effects on mindfulness, general psychiatric symptoms, and several aspects of quality of life at low costs with smartphone apps for mindfulness such as the VGZ Mindfulness Coach.

  17. Evaluation of wet-cupping therapy for persistent non-specific low back pain: a randomised, waiting-list controlled, open-label, parallel-group pilot trial.

    PubMed

    Kim, Jong-In; Kim, Tae-Hun; Lee, Myeong Soo; Kang, Jung Won; Kim, Kun Hyung; Choi, Jun-Yong; Kang, Kyung-Won; Kim, Ae-Ran; Shin, Mi-Suk; Jung, So-Young; Choi, Sun-mi

    2011-06-10

    Persistent non-specific low back pain (PNSLBP) is one of the most frequently experienced types of back pain around the world. Wet-cupping is a common intervention for various pain conditions, especially in Korea. In this context, we conducted a pilot study to determine the effectiveness and safety of wet-cupping treatment for PNSLBP. We recruited 32 participants (21 in the wet-cupping group and 11 in the waiting-list group) who had been having PNSLBP for at least 3 months. The participants were recruited at the clinical research centre of the Korea Institute of Oriental Medicine, Korea. Eligible participants were randomly allocated to wet-cupping and waiting-list groups. Following the practice of traditional Korean medicine, the treatment group was provided with wet-cupping treatment at two acupuncture points among the BL23, BL24 and BL25 6 times within 2 weeks. Usual care, including providing brochures for exercise, general advice for PNSLBP and acetaminophen, was allowed in both groups. Separate assessors participated in the outcome assessment. We used the 0 to 100 numerical rating scale (NRS) for pain, the McGill Pain Questionnaire for pain intensity (PPI) and the Oswestry Disability Questionnaire (ODQ), and we assessed acetaminophen use and safety issues. The results showed that the NRS score for pain decreased (-16.0 [95% CI: -24.4 to -7.7] in the wet-cupping group and -9.1 [-18.1 to -0.1] in the waiting-list group), but there was no statistical difference between the groups (p = 0.52). However, the PPI scores showed significant differences between the two groups (-1.2 [-1.6 to -0.8] for the wet-cupping group and -0.2 [-0.8 to 0.4] for the waiting-list group, p < 0.01). In addition, less acetaminophen was used in the wet-cupping group during 4 weeks (p = 0.09). The ODQ score did not show significant differences between the two groups (-5.60 [-8.90 to -2.30] in the wet-cupping group and -1.8 [-5.8 to 2.2] in the waiting-list group, p = 0.14). There was no

  18. Cost-utility of an internet-based intervention with or without therapist support in comparison with a waiting list for individuals with eating disorder symptoms: a randomized controlled trial.

    PubMed

    Aardoom, J J; Dingemans, A E; van Ginkel, J R; Spinhoven, P; Van Furth, E F; Van den Akker-van Marle, M E

    2016-12-01

    To investigate the cost-utility of the internet-based intervention "Featback" provided with different levels of therapist support, in comparison to a waiting list. This economic evaluation was conducted from a societal perspective and was part of a randomized controlled trial in which participants (N = 354) with self-reported ED symptoms were randomized to: (1) 8 weeks of Featback, consisting of psychoeducation and a fully automated monitoring- and feedback system, (2) Featback with low-intensity (weekly) therapist support, (3) Featback with high-intensity (three times a week) therapist support, and (4) a waiting list. Participants were assessed at baseline, postintervention, and 3-month follow-up. Cost-utility acceptability curves were constructed. No significant differences between the study conditions were found regarding quality-adjusted life-years (P = 0.55) and societal costs (P = 0.45), although the mean costs per participant were lowest in the Featback condition with low-intensity therapist support (€1951), followed by Featback with high-intensity therapist support (€2032), Featback without therapist support (€2102), and the waiting list (€2582). Featback seemed to be cost-effective as compared to the waiting list. No clear preference was found for Featback with or without therapist support. A fully automated Internet-based intervention for ED symptoms with no, low-, or high-intensity therapist support represented good value for money when compared to a waiting list. This finding may have important implications for clinical practice, as both the unguided- and guided intervention could allow for more efficient care and widespread dissemination, potentially increasing the accessibility and availability of mental health care services for individuals with ED symptoms. © 2016 Wiley Periodicals, Inc. (Int J Eat Disord 2016; 49:1068-1076). © 2016 Wiley Periodicals, Inc.

  19. 8 CFR 207.5 - Waiting lists and priority handling.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... REFUGEES § 207.5 Waiting lists and priority handling. Waiting lists are maintained for each designated refugee group of special humanitarian concern. Each applicant whose application is accepted for filing by... filing is the priority date for purposes of case control. Refugees or groups of refugees may be selected...

  20. 24 CFR 982.204 - Waiting list: Administration of waiting list.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ... size (number of bedrooms for which family qualifies under PHA occupancy standards); (3) Date and time... list. (d) Family size. (1) The order of admission from the waiting list may not be based on family size, or on the family unit size for which the family qualifies under the PHA occupancy policy. (2) If the...

  1. Development of an Information Model for Kidney Transplant Wait List.

    PubMed

    Bircan, Hüseyin Yüce; Özçelik, Ümit; Uysal, Nida; Demirağ, Alp; Haberal, Mehmet

    2015-11-01

    Deceased-donor kidney transplant is unique among surgical procedures that are an urgent procedure performed in an elective population. It has not been possible to accurately determine when a given patient will be called for transplant. Patients on the active transplant list can be called for a transplant at any time. As a result, every effort must be made to optimize their health according to best practices and published clinical practice guidelines. Once the patient is placed on the transplant wait list after undergoing an initial extensive evaluation, continued surveillance is required. Therefore, we developed a kidney transplant wait list surveillance software program that alerts organ transplant coordinator on time regarding which patients need a work-up. The new designed software has a database of our waiting patients with their completed and pending controls. The software also has built-in functions to warn the responsible staff with an E-mail. If one of the controls of a recipient delayed, the software sends an automated E-mail to the staff regarding the patients delayed controls. The software is a Web application that works on any platform with a Web browser and Internet connection and allows access by multiple users. The software has been developed with NET platform. The database is SQL server. The software has the following functions: patient communication info, search, alert list, alert E-mail, control entry, and system management. As of January 2014, a total of 21 000 patients were registered on the National Kidney Transplant wait list in Turkey and the kidney transplant wait list had been expanding by 2000 to 3000 patients each year. Therefore computerized wait list programs are crucial to help to transplant centers to keep their patients up-to-date on time.

  2. Clinical effectiveness of patella mobilisation therapy versus a waiting list control for knee osteoarthritis: a protocol for a pragmatic randomised clinical trial.

    PubMed

    Sit, Regina Wing Shan; Chan, Keith Kwok Wai; Yip, Benjamin Hon Kei; Zhang, Daisy Dexing; Reeves, Kenneth Dean; Chan, Ying Ho; Chung, Vincent Chi Ho; Wong, Samuel Yeung Shan

    2018-03-14

    Knee osteoarthritis (KOA) is a common, disabling and costly medical condition. The patellofemoral joint is a critical source of pain in individuals with KOA, and coexistence of patellofemoral osteoarthritis (PFOA) and tibiofemoral osteoarthritis (TFOA) is sometimes observed. The identification of subgroups with PFOA and customised interventions to correct underlying pathomechanics is beneficial for individuals with KOA. This study aims to evaluate whether a clinic-based patella mobilisation therapy (PMT) leads to significant improvement in pain, physical function and quality of life of individuals with KOA. A total of 208 participants with coexistence of PFOA and TFOA will be recruited. A pragmatic randomised clinical trial will be conducted, and participants will be randomised into the PMT and waiting list groups. For the PMT group, three manual mobilisation sessions, along with home-based vastus medialis oblique muscle exercise, will be conducted at 2-month intervals. The waiting list group will continue to receive their usual care, and as an incentive the waiting list group will be offered PMT after the study period is over. The primary outcome is the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) pain subscale, and secondary outcomes include the WOMAC function and stiffness subscales, scores for objective physical function tests (the 30 s chair stand, 40-metre fast-paced walk test, the Timed Up and Go Test), and the EuroQol-5D scores. All outcomes will be evaluated at baseline and 6 months using intention-to-treat and incorporating covariate analysis. Ethics approval has been obtained (CREC no: 2014.379). Results of the trial will be submitted for publication in a peer-reviewed journal. ChiCTR-IPC-15006618; Pre-results. © Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2018. All rights reserved. No commercial use is permitted unless otherwise expressly granted.

  3. Evaluation of the relative efficacy of a couple cognitive-behaviour therapy (CBT) for Premenstrual Disorders (PMDs), in comparison to one-to-one CBT and a wait list control: A randomized controlled trial.

    PubMed

    Ussher, Jane M; Perz, Janette

    2017-01-01

    A randomised control trial (RCT) was conducted to examine the efficacy of couple-based cognitive behaviour therapy (CBT) for Premenstrual Disorders (PMDs), in comparison to one-to-one CBT and a wait-list control. Triangulation of quantitative and qualitative outcome measures evaluated changes pre-post intervention. Eighty three women were randomly allocated across three conditions, with 63 completing post-intervention measures, a retention rate of 76%. Repeated measures analysis of variance found a significant time by group interaction identifying that women in the two CBT conditions reported lower total premenstrual symptoms, emotional reactivity/mood, and premenstrual distress, in comparison to the wait list control. Significantly higher active behavioural coping post-intervention was found in the couple condition than in the one-to-one and wait list control groups. Qualitative analysis provided insight into the subjective experience of PMDs and participation in the intervention study. Across groups, women reported increased awareness and understanding of premenstrual change post-intervention. A larger proportion of women in the CBT conditions reported reduction in intensity and frequency of negative premenstrual emotional reactivity, increased communication and help-seeking, increased understanding and acceptance of embodied change, and the development of coping skills, post-intervention. Increased partner understanding and improved relationship post-intervention was reported by a greater proportion of participants in the CBT conditions, most markedly in the couple condition. These findings suggest that one-to-one and couple CBT interventions can significantly reduce women's premenstrual symptomatology and distress, and improve premenstrual coping. Couple based CBT interventions may have a greater positive impact upon behavioural coping and perceptions of relationship context and support. This suggests that CBT should be available for women reporting moderate

  4. Efficacy of Cognitive Behavioral Therapy for Insomnia in Adolescents: A Randomized Controlled Trial with Internet Therapy, Group Therapy and A Waiting List Condition

    PubMed Central

    de Bruin, Eduard J.; Bögels, Susan M.; Oort, Frans J.; Meijer, Anne Marie

    2015-01-01

    Study Objectives: To investigate the efficacy of cognitive behavioral therapy for insomnia (CBTI) in adolescents. Design: A randomized controlled trial of CBTI in group therapy (GT), guided internet therapy (IT), and a waiting list (WL), with assessments at baseline, directly after treatment (post-test), and at 2 months follow-up. Setting: Diagnostic interviews were held at the laboratory of the Research Institute of Child Development and Education at the University of Amsterdam. Treatment for GT occurred at the mental health care center UvAMinds in Amsterdam, the Netherlands. Participants: One hundred sixteen adolescents (mean age = 15.6 y, SD = 1.6 y, 25% males) meeting DSM-IV criteria for insomnia, were randomized to IT, GT, or WL. Interventions: CBTI of 6 weekly sessions, consisted of psychoeducation, sleep hygiene, restriction of time in bed, stimulus control, cognitive therapy, and relaxation techniques. GT was conducted in groups of 6 to 8 adolescents, guided by 2 trained sleep therapists. IT was applied through an online guided self-help website with programmed instructions and written feedback from a trained sleep therapist. Measurements and Results: Sleep was measured with actigraphy and sleep logs for 7 consecutive days. Symptoms of insomnia and chronic sleep reduction were measured with questionnaires. Results showed that adolescents in both IT and GT, compared to WL, improved significantly on sleep efficiency, sleep onset latency, wake after sleep onset, and total sleep time at post-test, and improvements were maintained at follow-up. Most of these improvements were found in both objective and subjective measures. Furthermore, insomnia complaints and symptoms of chronic sleep reduction also decreased significantly in both treatment conditions compared to WL. Effect sizes for improvements ranged from medium to large. A greater proportion of participants from the treatment conditions showed high end-state functioning and clinically significant

  5. Driving performance in adults with ADHD: results from a randomized, waiting list controlled trial with atomoxetine.

    PubMed

    Sobanski, E; Sabljic, D; Alm, B; Dittmann, R W; Wehmeier, P M; Skopp, G; Strohbeck-Kühner, P

    2013-08-01

    To investigate effects of a 12-week treatment with atomoxetine (ATX) on driving performance in real traffic, driving-related neuropsychological performance tests and self-evaluation of driving in adult patients with ADHD compared to an untreated control group with ADHD. Parallel group design with an ATX and a waiting list group. At baseline and endpoint patients were evaluated with a standardized on-road driving test (SDBO), a driving-related neuropsychological test battery (Act and React Test System [ART2020]), and subjective measures of driving performance (one-week driving diary, Driver Coping Questionnaire). Forty-three of the 64 included patients completed the study (n=22 ATX, n=21 controls). Mean intervention period was 11.9±3.0 weeks, mean daily ATX dosage was 71.6±14.9mg. At endpoint, 60.1% of patients treated with ATX and 0% of waiting list group had reduced ADHD symptoms by greater or equal to 30%. In SDBO, ATX group reduced driving errors in three of four driving performance categories (attention, P<0.05; risk-related self-control, P<0.005; driver skills, P<0.001), number of driving errors remained stable in control group. At endpoint, 47.6% of control group and 18.2% of ATX group (P<0.05) did not fulfil the driving fitness criteria according to German Guidelines (percentile rank less or equal to 16 in one or more subtests in ART2020). Total number of self-reported critical traffic situations decreased from 12.0 to 6.8 per week in ATX group (P<0.05) and remained stable in controls by 9.3 and 9.9 at baseline and endpoint (ns). Coping strategies with stressful traffic situations did not change within both groups. Our study provides first evidence that treatment with ATX improves driving performance in real traffic in adults with ADHD. Copyright © 2012 Elsevier Masson SAS. All rights reserved.

  6. Waiting Lists for Radiation Therapy: A Case Study

    PubMed Central

    2001-01-01

    Background Why waiting lists arise and how to address them remains unclear, and an improved understanding of these waiting list "dynamics" could lead to better management. The purpose of this study is to understand how the current shortage in radiation therapy in Ontario developed; the implications of prolonged waits; who is held accountable for managing such delays; and short, intermediate, and long-term solutions. Methods A case study of the radiation therapy shortage in 1998-99 at Princess Margaret Hospital, Toronto, Ontario, Canada. Relevant documents were collected; semi-structured, face-to-face interviews with ten administrators, health care workers, and patients were conducted, audio-taped and transcribed; and relevant meetings were observed. Results The radiation therapy shortage arose from a complex interplay of factors including: rising cancer incidence rates; broadening indications for radiation therapy; human resources management issues; government funding decisions; and responsiveness to previous planning recommendations. Implications of delays include poorer cancer control rates; patient suffering; and strained doctor-patient relationships. An incompatible relationship exists between moral responsibility, borne by government, and legal liability, borne by physicians. Short-term solutions include re-referral to centers with available resources; long-term solutions include training and recruiting health care workers, improving workload standards, increasing compensation, and making changes to the funding formula. Conclusion Human resource planning plays a critical role in the causes and solutions of waiting lists. Waiting lists have harsh implications for patients. Accountability relationships require realignment. PMID:11319944

  7. Effects of Positive Psychology Interventions on Risk Biomarkers in Coronary Patients: A Randomized, Wait-List Controlled Pilot Trial.

    PubMed

    Nikrahan, Gholam Reza; Laferton, Johannes A C; Asgari, Karim; Kalantari, Mehrdad; Abedi, Mohammad Reza; Etesampour, Ali; Rezaei, Abbas; Suarez, Laura; Huffman, Jeff C

    2016-01-01

    Among cardiac patients, positive psychologic factors are consistently linked with superior clinical outcomes and improvement in key markers of inflammation and hypothalamic-pituitary-adrenal axis functioning. Further, positive psychology interventions (PPI) have effectively increased psychologic well-being in a wide variety of populations. However, there has been minimal study of PPIs in cardiac patients, and no prior study has evaluated their effect on key prognostic biomarkers of cardiac outcome. Accordingly, we investigated the effect of 3 distinct PPIs on risk biomarkers in cardiac patients. In an exploratory trial, 69 patients with recent coronary artery bypass graft surgery or percutaneous intervention were randomized to (1) one of three 6-week in-person PPIs (based on the work of Seligman, Lyubomirsky, or Fordyce) or (2) a wait-list control group. Risk biomarkers were assessed at baseline, postintervention (7 weeks), and at 15-week follow-up. Between-group differences in change from baseline biomarker levels were examined via random effects models. Compared with the control group, participants randomized to the Seligman (B = -2.06; p = 0.02) and Fordyce PPI (B = -1.54; p = 0.04) had significantly lower high-sensitivity C-reactive protein levels at 7 weeks. Further, the Lyubomirsky PPI (B = -245.86; p = 0.04) was associated with a significantly lower cortisol awakening response at 7 weeks when compared with control participants. There were no other significant between-group differences. Despite being an exploratory pilot study with multiple between-group comparisons, this initial trial offers the first suggestion that PPIs might be effective in reducing risk biomarkers in high-risk cardiac patients. Copyright © 2016 The Academy of Psychosomatic Medicine. All rights reserved.

  8. Effects of positive psychology interventions on risk biomarkers in coronary patients: A randomized, wait-list controlled pilot trial

    PubMed Central

    Nikrahan, Gholam Reza; Laferton, Johannes A. C.; Asgari, Karim; Kalantari, Mehrdad; Abedi, Mohammad Reza; Etesampour, Ali; Rezaei, Abbas; Suarez, Laura; Huffman, Jeff C.

    2016-01-01

    Background Among cardiac patients, positive psychological factors are consistently linked with superior clinical outcomes and improvement in key markers of inflammation and hypothalamic-pituitary-adrenal axis functioning. Further, positive psychology interventions (PPI) have effectively increased psychological well-being in a wide variety of populations. However, there has been minimal study of PPIs in cardiac patients, and no prior study has evaluated their effect on key prognostic biomarkers of cardiac outcome. Accordingly, we investigated the effect of three distinct PPIs on risk biomarkers in cardiac patients. Methods In an exploratory trial, 69 patients with recent coronary artery bypass graft surgery or percutaneous intervention were randomized to a) one of three 6-week in-person PPIs (based on the work of Seligman, Lyubomirsky, or Fordyce) or b) a wait-list control group. Risk biomarkers were assessed at baseline, post-intervention (7 weeks), and at 15 week follow-up. Between-group differences in change from baseline biomarker levels were examined via random effects models. Results Compared to the control group, participants randomized to the Seligman (B= −2.06; p= .02) and Fordyce PPI (B= −1.54; p= .04) had significantly lower high-sensitivity C-reactive protein (hs-CRP) levels at 7 weeks. Further, the Lyubomirsky PPI (B= −245.86; p= .04) was associated with a significantly lower cortisol awakening response (CARg) at 7 weeks compared to control participants. There were no other significant between-group differences. Conclusion Despite being an exploratory pilot study with multiple between-group comparisons, this initial trial offers the first suggestion that PPIs might be effective in reducing risk biomarkers in high-risk cardiac patients. PMID:27129358

  9. Cognitive-Behavioral Therapy for Women with Lifelong Vaginismus: A Randomized Waiting-List Controlled Trial of Efficacy

    ERIC Educational Resources Information Center

    Van Lankveld, Jacques J. D. M.; ter Kuile, Moniek M.; de Groot, H. Ellen; Melles, Reinhilde; Nefs, Janneke; Zandbergen, Maartje

    2006-01-01

    Women with lifelong vaginismus (N = 117) were randomly assigned to cognitive-behavioral group therapy, cognitive-behavioral bibliotherapy, or a waiting list. Manualized treatment comprised sexual education, relaxation exercises, gradual exposure, cognitive therapy, and sensate focus therapy. Group therapy consisted of ten 2-hr sessions with 6 to 9…

  10. Virtual-reality-based cognitive behavioural therapy versus waiting list control for paranoid ideation and social avoidance in patients with psychotic disorders: a single-blind randomised controlled trial.

    PubMed

    Pot-Kolder, Roos M C A; Geraets, Chris N W; Veling, Wim; van Beilen, Marije; Staring, Anton B P; Gijsman, Harm J; Delespaul, Philippe A E G; van der Gaag, Mark

    2018-03-01

    Many patients with psychotic disorders have persistent paranoid ideation and avoid social situations because of suspiciousness and anxiety. We investigated the effects of virtual-reality-based cognitive behavioural therapy (VR-CBT) on paranoid thoughts and social participation. In this randomised controlled trial at seven Dutch mental health centres, outpatients aged 18-65 years with a DSM-IV-diagnosed psychotic disorder and paranoid ideation in the past month were randomly assigned (1:1) via block randomisation to VR-CBT (in addition to treatment as usual) or the waiting list control group (treatment as usual). VR-CBT consisted of 16 individual therapy sessions (each 1 h long). Assessments were done at baseline, after treatment (ie, 3 months from baseline), and at a 6 month follow-up visit. The primary outcome was social participation, which we operationalised as the amount of time spent with other people, momentary paranoia, perceived social threat, and momentary anxiety. Analysis was by intention to treat. This trial was retrospectively registered with ISRCTN, number 12929657. Between April 1, 2014, and Dec 31, 2015, 116 patients with a psychotic disorder were randomly assigned, 58 to the VR-CBT group and 58 to the waiting list control group. Compared with the control, VR-CBT did not significantly increase the amount of time spent with other people at the post-treatment assessment. Momentary paranoid ideation (b=-0·331 [95% CI -0·432 to -0·230], p<0·0001; effect size -1·49) and momentary anxiety (-0·288 [-0·438 to -0·1394]; p=0·0002; -0·75) were significantly reduced in the VR-CBT group compared with the control group at the post-treatment assessment, and these improvements were maintained at the follow-up assessment. Safety behaviour and social cognition problems were mediators of change in paranoid ideation. No adverse events were reported relating to the therapy or assessments. Our results suggest that the addition of VR-CBT to standard treatment

  11. Comparison of psychological placebo and waiting list control conditions in the assessment of cognitive behavioral therapy for the treatment of generalized anxiety disorder: a meta-analysis.

    PubMed

    Zhu, Zhipei; Zhang, Li; Jiang, Jiangling; Li, Wei; Cao, Xinyi; Zhou, Zhirui; Zhang, Tiansong; Li, Chunbo

    2014-12-01

    There is ongoing debate about the efficacy of placebos in the treatment of mental disorders. In randomized control trials (RCTs) about the treatment of generalized anxiety disorder, the administration of a psychological placebo or placement on a waiting list are the two most common control conditions. But there has never been a systematic comparison of the clinical effect of these different strategies. Compare the change in symptom severity among individuals treated with cognitive behavioral therapy, provided a psychological placebo, or placed on a waiting list using data from RCTs on generalized anxiety disorder. The following databases were searched for RCTs on generalized anxiety disorder: PubMed, PsycInfo, EMBASE, The Cochrane Library, CNKI, Chongqing VIP, Wanfang, Chinese Biological Medical Literature Database, and Taiwan Electronic Periodical Services. Studies were selected based on pre-defined inclusion and exclusion criteria and the quality of each included study - based on the risk of bias and the level of evidence - was formally assessed. Meta-analysis was conducted using RevMan5.3 and network meta-analyses comparing the three groups were conducted using R. Twelve studies with a combined sample size of 531 were included in the analysis. Compared to either control method (placebo or waiting list), cognitive behavioral therapy was more effective for generalized anxiety disorder. Provision of a psychological placebo was associated with a significantly greater reduction of symptoms than placement on a waiting list. Eight of the studies were classified as 'high risk of bias', and the overall level of evidence was classified as 'moderate', indicating that further research could change the overall results of the meta-analysis. RCTs about the treatment of generalized anxiety disorders are generally of moderate quality; they indicate the superiority of CBT but the results cannot, as yet, be considered robust. There is evidence of a non-negligible treatment effect

  12. Ultrasound waiting lists: rational queue or extended capacity?

    PubMed

    Brasted, Christopher

    2008-06-01

    The features and issues regarding clinical waiting lists in general and general ultrasound waiting lists in particular are reviewed, and operational aspects of providing a general ultrasound service are also discussed. A case study is presented describing a service improvement intervention in a UK NHS hospital's ultrasound department, from which arises requirements for a predictive planning model for an ultrasound waiting list. In the course of this, it becomes apparent that a booking system is a more appropriate way of describing the waiting list than a conventional queue. Distinctive features are identified from the literature and the case study as the basis for a predictive model, and a discrete event simulation model is presented which incorporates the distinctive features.

  13. Protocol: the effect of 12 weeks of Tai Chi practice on anxiety in healthy but stressed people compared to exercise and wait-list comparison groups: a randomized controlled trial.

    PubMed

    Zheng, Shuai; Lal, Sara; Meier, Peter; Sibbritt, David; Zaslawski, Chris

    2014-06-01

    Stress is a major problem in today's fast-paced society and can lead to serious psychosomatic complications. The ancient Chinese mind-body exercise of Tai Chi may provide an alternative and self-sustaining option to pharmaceutical medication for stressed individuals to improve their coping mechanisms. The protocol of this study is designed to evaluate whether Tai Chi practice is equivalent to standard exercise and whether the Tai Chi group is superior to a wait-list control group in improving stress coping levels. This study is a 6-week, three-arm, parallel, randomized, clinical trial designed to evaluate Tai Chi practice against standard exercise and a Tai Chi group against a nonactive control group over a period of 6 weeks with a 6-week follow-up. A total of 72 healthy adult participants (aged 18-60 years) who are either Tai Chi naïve or have not practiced Tai Chi in the past 12 months will be randomized into a Tai Chi group (n = 24), an exercise group (n = 24) or a wait-list group (n = 24). The primary outcome measure will be the State Trait Anxiety Inventory with secondary outcome measures being the Perceived Stress Scale 14, heart rate variability, blood pressure, Short Form 36 and a visual analog scale. The protocol is reported using the appropriate Standard Protocol Items: Recommendations for Interventional Trials (SPIRIT) items. Copyright © 2014. Published by Elsevier B.V.

  14. [Has the time arrived for the management of waiting lists?].

    PubMed

    Bernal, E

    2002-01-01

    Individuals on the waiting list frequently suffer an additional risk caused by the mean time until they receive treatment; however, other individuals do not need the treatment for which they are waiting.Both arguments, which can be contrasted with empirical evidence, would be sufficient to affirm that waiting list management should be implemented, leaving aside policies that are more of less opportunistic. Opportunistic policies are understood as those providing misinformation on waiting lists or their "manipulation", and using programs of auto-coordination with the sole aim of reaching the end of the year without a waiting list of not more than six months, etc. The panorama is not completely bleak. Some management initiatives (and even Politics with a capital P) are opening the way forward and may enter the Agenda in the next few years. In this context, the application of guaranteed times of medical care or the prioritization of waiting lists according to explicit criteria should be highlighted. It is worth remembering that, except for the queues in the waiting rooms of health centers and emergency departments, waiting lists are mediated by the decision of the physician. Therefore, an essential strategy for managing waiting lists consists of attenuating the problems caused by uncertainty (or ignorance) of the patient's diagnosis or prognosis.

  15. [Gender and age differences in waiting time on hospital waiting list.].

    PubMed

    Thornórðardóttir, Steinunn; Halldórsson, Matthías; Guðmundsson, Sigurður

    2002-09-01

    The size of waiting lists has traditionally been viewed as a fairly good measure of the quality of health care services. No statistical analysis exists in Iceland of the length of waiting times and the potential variation between groups of patients. This study was conducted within the office of the Directorate of Health in Iceland. This location was convenient since standardized information on waiting lists is collected by the office three times a year. Variations in waiting times were studied based on gender on the one hand and on age on the other. Data from the largest waiting lists, those amounting to 400 or more patients, were included in the study. The most frequently awaited operations were identified and the groups of people waiting for them analyzed. The departments and prospective operations included in the study were: Dept. of General Surgery at the University Hospital (UH) (laparoscopic gastro-oesophageal antireflux operation), Opthalmology at UH (phakoemulsification with implantation of artificial lens in posterior chamber), Orthopedic Surgery at UH (primary total prosthetic replacement of hip joint using sement), The Rehabilitation Center at Reykjalundur (rehabilitation, not specified), Ear, Nose and Throat (ENT) at UH (tonsillectomy), and Reconstructive Surgery at UH (reduction mammoplasty with transposition of areola). The lists were sorted by gender and age, with the latter consisting of two categories, older and younger patients. Every attempt was made as to ensure similar sample sizes for both age groups within each department. Finally, the median waiting time was determined and a Mann-Whitney test conducted in order to test for significance. The median waiting time for males at the General Surgery Dept. was 73 weeks as compared to 60 weeks for females. This was the only department where the median waiting time was significantly longer for males than for females (p<0.05). At three of the departments the older group had a longer median waiting time

  16. How to report and monitor the performance of waiting list management.

    PubMed

    Torkki, Markus; Linna, Miika; Seitsalo, Seppo; Paavolainen, Pekka

    2002-01-01

    Potential problems concerning waiting list management are often monitored using mean waiting times based on empirical samples. However, the appropriateness of mean waiting time as an indicator of access can be questioned if a waiting list is not managed well, e.g., if the queue discipline is violated. This study was performed to find out about the queue discipline in waiting lists for elective surgery to reveal potential discrepancies in waiting list management. There were 1,774 waiting list patients for hallux valgus or varicose vein surgery or sterilization. The waiting time distributions of patients receiving surgery and of patients still waiting for an operation are presented in column charts. The charts are compared with two model charts. One model chart presents a high queue discipline (first in-first out) and another a poor queue discipline (random) queue. There were significant differences in waiting list management across hospitals and patient categories. Examples of a poor queue discipline were found in queues for hallux valgus and varicose vein operations. A routine waiting list reporting should be used to guarantee the quality of waiting list management and to pinpoint potential problems in access. It is important to monitor not only the number of patients in the waiting list but also the queue discipline and the balance between demand and supply of surgical services. The purpose for this type of reporting is to ensure that the priority setting made at health policy level also works in practise.

  17. Trends in Wait-list Mortality in Children Listed for Heart Transplantation in the United States

    PubMed Central

    Singh, Tajinder P.; Almond, Christopher S.; Piercey, Gary; Gauvreau, Kimberlee

    2014-01-01

    We sought to evaluate trends in overall and race-specific pediatric heart transplant (HT) wait-list mortality in the United States (US) during the last 20 years. We identified all children <18 years old listed for primary HT in the US during 1989–2009 (N=8096, 62% white, 19% black, 13% Hispanic, 6% other) using the Organ Procurement and Transplant Network database. Wait-list mortality was assessed in 4 successive eras (1989–1994, 1995–1999, 2000–2004, and 2005–2009). Overall wait-list mortality declined in successive eras (26%, 23%, 18% and 13%, respectively). The decline across eras remained significant in adjusted analysis (hazard ratio [HR] 0.70 in successive eras, 95% confidence interval [CI] 0.67, 0.74) and was 67% lower for children listed during 2005–2009 vs. those listed during 1989–1994 (HR 0.33, CI 0.28, 0.39). In models stratified by race, wait-list mortality decreased in all racial groups in successive eras. In models stratified by era, minority children were not at higher risk of wait-list mortality in the most recent era. We conclude that the risk of wait-list mortality among US children listed for HT has decreased by two-thirds during the last 20 years. Racial gaps in wait-list mortality present variably in the past are not present in the current era. PMID:21883920

  18. Comparison of psychological placebo and waiting list control conditions in the assessment of cognitive behavioral therapy for the treatment of generalized anxiety disorder: a meta-analysis

    PubMed Central

    ZHU, Zhipei; ZHANG, Li; JIANG, Jiangling; LI, Wei; CAO, Xinyi; ZHOU, Zhirui; ZHANG, Tiansong; LI, Chunbo

    2014-01-01

    Background There is ongoing debate about the efficacy of placebos in the treatment of mental disorders. In randomized control trials (RCTs) about the treatment of generalized anxiety disorder, the administration of a psychological placebo or placement on a waiting list are the two most common control conditions. But there has never been a systematic comparison of the clinical effect of these different strategies. Aim Compare the change in symptom severity among individuals treated with cognitive behavioral therapy, provided a psychological placebo, or placed on a waiting list using data from RCTs on generalized anxiety disorder. Methods The following databases were searched for RCTs on generalized anxiety disorder: PubMed, PsycInfo, EMBASE, The Cochrane Library, CNKI, Chongqing VIP, Wanfang, Chinese Biological Medical Literature Database, and Taiwan Electronic Periodical Services. Studies were selected based on pre-defined inclusion and exclusion criteria and the quality of each included study – based on the risk of bias and the level of evidence – was formally assessed. Meta-analysis was conducted using RevMan5.3 and network meta-analyses comparing the three groups were conducted using R. Results Twelve studies with a combined sample size of 531 were included in the analysis. Compared to either control method (placebo or waiting list), cognitive behavioral therapy was more effective for generalized anxiety disorder. Provision of a psychological placebo was associated with a significantly greater reduction of symptoms than placement on a waiting list. Eight of the studies were classified as ‘high risk of bias’, and the overall level of evidence was classified as ‘moderate’, indicating that further research could change the overall results of the meta-analysis. Conclusions RCTs about the treatment of generalized anxiety disorders are generally of moderate quality; they indicate the superiority of CBT but the results cannot, as yet, be considered robust

  19. Towards decision support for waiting lists: an operations management view.

    PubMed

    Vissers, J M; Van Der Bij, J D; Kusters, R J

    2001-06-01

    This paper considers the phenomenon of waiting lists in a healthcare setting, which is characterised by limitations on the national expenditure, to explore the potentials of an operations management perspective. A reference framework for waiting list management is described, distinguishing different levels of planning in healthcare--national, regional, hospital and process--that each contributes to the existence of waiting lists through managerial decision making. In addition, different underlying mechanisms in demand and supply are distinguished, which together explain the development of waiting lists. It is our contention that within this framework a series of situation specific models should be designed to support communication and decision making. This is illustrated by the modelling of the demand for cataract treatment in a regional setting in the south-eastern part of the Netherlands. An input-output model was developed to support decisions regarding waiting lists. The model projects the demand for treatment at a regional level and makes it possible to evaluate waiting list impacts for different scenarios to meet this demand.

  20. Intention-based therapy for autism spectrum disorder: promising results of a wait-list control study in children.

    PubMed

    Weiner, Robert H; Greene, Roger L

    2014-01-01

    Autism is a complex neurodevelopmental disability that usually manifests during the first three years of life and typically lasts throughout a person's lifetime. The purpose of this study is to investigate the efficacy of NeuroModulation Technique (NMT), a form of intention-based therapy, in improving functioning in children diagnosed with autism. A total of 18 children who met the study criteria were selected to participate. All children completed baseline measures. The children in the experimental group (n = 9) received two sessions a week of NMT for six weeks. Then, children in the wait-list control group (n = 9) received two sessions a week of NMT for six weeks. Primary efficacy outcome measures included the Pervasive Developmental Disorder Behavioral Inventory Autism Composite Index, the Aberrant Behavior Checklist-Community Total Score, and the Autism Treatment Evaluation Checklist Total Score. Our hypotheses were that children in both groups would show significant improvement over their respective baseline scores following NMT treatment, which would reflect an improvement in adaptive behaviors as well as a decrease in maladaptive behaviors. Statistical analysis indicates a significant improvement in both the experimental and wait-list control group on all primary outcome measures following NMT treatment. The wait-list control group demonstrated no significant improvement on test measures over baseline scores during the wait period. No adverse reactions were reported. These findings suggest that NMT is a promising intervention for autism that has the potential to produce a significant reduction in maladaptive behaviors and a significant increase in adaptive behaviors within a relatively short period of time. © 2013 The Authors. Published by Elsevier Inc. All rights reserved.

  1. Low-intensity cognitive-behaviour therapy interventions for obsessive-compulsive disorder compared to waiting list for therapist-led cognitive-behaviour therapy: 3-arm randomised controlled trial of clinical effectiveness

    PubMed Central

    Gellatly, Judith; Byford, Sarah; Bee, Penny; McMillan, Dean; Gilbody, Simon; Gega, Lina; Hardy, Gillian; Reynolds, Shirley; Barkham, Michael; Mottram, Patricia; Molle, Jo; Knopp-Hoffer, Jasmin; Connell, Janice; Heslin, Margaret; Foley, Christopher; Plummer, Faye

    2017-01-01

    Background Obsessive-compulsive disorder (OCD) is prevalent and without adequate treatment usually follows a chronic course. “High-intensity” cognitive-behaviour therapy (CBT) from a specialist therapist is current “best practice.” However, access is difficult because of limited numbers of therapists and because of the disabling effects of OCD symptoms. There is a potential role for “low-intensity” interventions as part of a stepped care model. Low-intensity interventions (written or web-based materials with limited therapist support) can be provided remotely, which has the potential to increase access. However, current evidence concerning low-intensity interventions is insufficient. We aimed to determine the clinical effectiveness of 2 forms of low-intensity CBT prior to high-intensity CBT, in adults meeting the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV) criteria for OCD. Methods and findings This study was approved by the National Research Ethics Service Committee North West–Lancaster (reference number 11/NW/0276). All participants provided informed consent to take part in the trial. We conducted a 3-arm, multicentre randomised controlled trial in primary- and secondary-care United Kingdom mental health services. All patients were on a waiting list for therapist-led CBT (treatment as usual). Four hundred and seventy-three eligible patients were recruited and randomised. Patients had a median age of 33 years, and 60% were female. The majority were experiencing severe OCD. Patients received 1 of 2 low-intensity interventions: computerised CBT (cCBT; web-based CBT materials and limited telephone support) through “OCFighter” or guided self-help (written CBT materials with limited telephone or face-to-face support). Primary comparisons concerned OCD symptoms, measured using the Yale-Brown Obsessive Compulsive Scale–Observer-Rated (Y-BOCS-OR) at 3, 6, and 12 months. Secondary outcomes included health

  2. Turo (qi dance) Program for Parkinson's Disease Patients: Randomized, Assessor Blind, Waiting-List Control, Partial Crossover Study.

    PubMed

    Lee, Hwa-Jin; Kim, Song-Yi; Chae, Younbyoung; Kim, Mi-Young; Yin, Changshik; Jung, Woo-Sang; Cho, Ki-Ho; Kim, Seung-Nam; Park, Hi-Joon; Lee, Hyejung

    2018-03-01

    Qigong, Tai-chi and dancing have all been proven effective for Parkinson's disease (PD); however, no study has yet assessed the efficacy of Turo, a hybrid qigong dancing program developed to relieve symptoms in PD patients. To determine whether Turo may provide benefit in addressing the symptoms of PD patients. Randomized, assessor blind, waiting-list control, partial crossover study. Kyung Hee University Korean Medicine Hospital, Seoul, Republic of Korea. A total of 32 PD patients (mean age 65.7 ± 6.8). Participants were assigned to the Turo group or the waiting-list control group. The Turo group participated in an 8-week Turo training program (60-minute sessions twice a week). The waiting-list control group received no additional treatment during the same period; then underwent the same 8-week Turo training. The primary outcome was a score on the Unified Parkinson's Disease Rating Scale (UPDRS), and the secondary outcomes included the perceived health status assessed using the Parkinson's disease Quality of Life questionnaire (PDQL), balance function as assessed by the Berg Balance Scale (BBS) and the results of the Beck Depression Inventory (BDI). The Turo group showed statistically significant improvements in the UPDRS (P < 0.01) and PDQL (P < 0.05) as compared to the control group. The changes in BBS scores displayed a tendency toward improvement, but was not statistically significant (P = 0.051). These findings suggest that Turo PD training might improve the symptoms of PD patients. Copyright © 2018. Published by Elsevier Inc.

  3. Cognitive-behavioral therapy for women with lifelong vaginismus: a randomized waiting-list controlled trial of efficacy.

    PubMed

    van Lankveld, Jacques J D M; ter Kuile, Moniek M; de Groot, H Ellen; Melles, Reinhilde; Nefs, Janneke; Zandbergen, Maartje

    2006-02-01

    Women with lifelong vaginismus (N=117) were randomly assigned to cognitive-behavioral group therapy, cognitive-behavioral bibliotherapy, or a waiting list. Manualized treatment comprised sexual education, relaxation exercises, gradual exposure, cognitive therapy, and sensate focus therapy. Group therapy consisted of ten 2-hr sessions with 6 to 9 participants per group. Assistance with minimal-contact bibliotherapy consisted of 6 biweekly, 15-min telephone contacts. Twenty-one percent of the participants left the study before posttreatment assessment. Intent-to-treat analysis revealed that successful intercourse at posttreatment was reported by 14% of the treated participants compared with none of the participants in the control condition. At the 12-month follow-up 21% of the group therapy participants and 15% of the bibliotherapy participants, respectively, reported successful intercourse. Cognitive-behavioral treatment of lifelong vaginismus was thus found to be efficacious, but the small effect size of the treatment warrants future efforts to improve the treatment. Copyright (c) 2006 APA, all rights reserved.

  4. Efficacy and Safety of the Traditional Herbal Medicine, Gamiguibi-tang, in Patients With Cancer-Related Sleep Disturbance: A Prospective, Randomized, Wait-List-Controlled, Pilot Study.

    PubMed

    Lee, Jee Young; Oh, Hye Kyung; Ryu, Han Sung; Yoon, Sung Soo; Eo, Wankyu; Yoon, Seong Woo

    2018-06-01

    Sleep disturbance is the second most bothersome symptom in patients with cancer, and it can significantly impair their quality of life. The aim of this study was to investigate the efficacy and safety of the traditional herbal medicine Gamiguibi-tang (GGBT) in patients with cancer-related sleep disturbance. We conducted a prospective, randomized, wait-list-controlled, open-label pilot clinical trial on cancer-related sleep disturbance. Patients with cancer experiencing poor sleep quality with a Pittsburgh Sleep Quality Index of at least 6 were randomly assigned to the GGBT and wait-list groups to receive GGBT and conventional care, respectively, for 2 weeks. The primary endpoint was the Insomnia Severity Index (ISI) score. Fatigue, depression, and cognitive impairment were assessed as the secondary endpoints by using the Brief Fatigue Inventory (BFI), Beck Depression Inventory (BDI), and Montreal Cognitive Assessment (MoCA). Thirty participants who met the eligibility criteria were enrolled. Sleep disturbance assessed using the ISI improved significantly more in the GGBT group than in the wait-list group (-5.5 ± 4.4 vs 0.1 ± 1.1, P < .001). Fatigue level determined using the BFI also improved significantly more in the GGBT group than in the wait-list group (-0.8 ± 0.8 vs 0.0 ± 0.3, P = .002). The BDI and MoCA scores showed no significant changes. Adverse events were reported in two patients in the GGBT group and consisted of mild dyspepsia and mild edema. GGBT may be a potential treatment option for cancer-related sleep disturbance. Further research is needed to investigate the efficacy and safety of GGBT.

  5. Waiting lists and elective surgery: ordering the queue.

    PubMed

    Curtis, Andrea J; Russell, Colin O H; Stoelwinder, Johannes U; McNeil, John J

    2010-02-15

    In the Australian public health system, access to elective surgery is rationed through the use of waiting lists in which patients are assigned to broad urgency categories. Surgeons are principally responsible for referring patients to waiting lists, deciding on the appropriate urgency category, and selecting patients from the waiting list to receive surgery. There are few agreed-upon criteria to help surgeons make these decisions, leading to striking differences between institutions in proportions of patients allocated to urgency categories. In other countries with publicly funded health systems, programs have been developed that aim to make prioritisation more consistent and access to surgery more equitable. As demand for health care increases, similar programs should be established in Australia using relevant clinical and psychosocial factors. Prioritisation methodology adapted for elective surgery may have a role in prioritising high-demand procedures in other areas of health care.

  6. Low-intensity cognitive-behaviour therapy interventions for obsessive-compulsive disorder compared to waiting list for therapist-led cognitive-behaviour therapy: 3-arm randomised controlled trial of clinical effectiveness.

    PubMed

    Lovell, Karina; Bower, Peter; Gellatly, Judith; Byford, Sarah; Bee, Penny; McMillan, Dean; Arundel, Catherine; Gilbody, Simon; Gega, Lina; Hardy, Gillian; Reynolds, Shirley; Barkham, Michael; Mottram, Patricia; Lidbetter, Nicola; Pedley, Rebecca; Molle, Jo; Peckham, Emily; Knopp-Hoffer, Jasmin; Price, Owen; Connell, Janice; Heslin, Margaret; Foley, Christopher; Plummer, Faye; Roberts, Christopher

    2017-06-01

    Obsessive-compulsive disorder (OCD) is prevalent and without adequate treatment usually follows a chronic course. "High-intensity" cognitive-behaviour therapy (CBT) from a specialist therapist is current "best practice." However, access is difficult because of limited numbers of therapists and because of the disabling effects of OCD symptoms. There is a potential role for "low-intensity" interventions as part of a stepped care model. Low-intensity interventions (written or web-based materials with limited therapist support) can be provided remotely, which has the potential to increase access. However, current evidence concerning low-intensity interventions is insufficient. We aimed to determine the clinical effectiveness of 2 forms of low-intensity CBT prior to high-intensity CBT, in adults meeting the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV) criteria for OCD. This study was approved by the National Research Ethics Service Committee North West-Lancaster (reference number 11/NW/0276). All participants provided informed consent to take part in the trial. We conducted a 3-arm, multicentre randomised controlled trial in primary- and secondary-care United Kingdom mental health services. All patients were on a waiting list for therapist-led CBT (treatment as usual). Four hundred and seventy-three eligible patients were recruited and randomised. Patients had a median age of 33 years, and 60% were female. The majority were experiencing severe OCD. Patients received 1 of 2 low-intensity interventions: computerised CBT (cCBT; web-based CBT materials and limited telephone support) through "OCFighter" or guided self-help (written CBT materials with limited telephone or face-to-face support). Primary comparisons concerned OCD symptoms, measured using the Yale-Brown Obsessive Compulsive Scale-Observer-Rated (Y-BOCS-OR) at 3, 6, and 12 months. Secondary outcomes included health-related quality of life, depression, anxiety, and functioning. At

  7. Long-Term Effectiveness of a Stress Management Intervention at Work: A 9-Year Follow-Up Study Based on a Randomized Wait-List Controlled Trial in Male Managers.

    PubMed

    Li, Jian; Riedel, Natalie; Barrech, Amira; Herr, Raphael M; Aust, Birgit; Mörtl, Kathrin; Siegrist, Johannes; Gündel, Harald; Angerer, Peter

    2017-01-01

    Short- and medium-term effectiveness (up to 3 years) of individual level stress management interventions (SMI) at work were demonstrated, yet long-term effectiveness remains unexplored. We therefore aimed to address this research gap. 94 male middle managers participated in a randomized wait-list controlled trial between 2006 and 2008 and in a post-trial-follow-up survey in 2015. During the first two years, all received an 18-hour psychotherapeutic SMI intervention which was based on the Effort-Reward Imbalance (ERI) model: tackling stressor on mismatch between effort and reward and promoting recovery on overcommitment. Work stress (i.e., ERI indicators) was the primary outcome, and the secondary outcome was depressive symptoms. The long-term effectiveness of the SMI was examined by mixed modeling, using an external control group ( n = 94). Effort and reward were substantially improved with significant intervention ⁎ time interaction effects ( p < 0.001) compared to the external control group; effects on overcommitment and depressive symptoms were also significant ( p < 0.05 and p < 0.01, resp.), though their trajectories in the intervention group were less sustainable. The effectiveness of this psychotherapeutic SMI at work based on the ERI model was observed over a 9-year period, particularly on the effort-reward ratio.

  8. [Waiting list in general and digestive surgery: patient expectations, quality of life during waiting time and overall satisfaction].

    PubMed

    Parés, D; Duran, E; Hermoso, J; Comajuncosas, J; Gris, P; Lopez-Negre, J L; Urgellés, J; Orbeal, R; Vallverdú, H; Jimeno, J

    2013-01-01

    The structural resources of the National Health system are limited, and therefore early surgery cannot be performed on all patients. The objective was to analyse the satisfaction perceived by the patient as regards the delay of treatment by waiting list of three types of surgery. The influence of expectations on waiting times, and impaired quality of life due to the clinical symptoms during the delay, were studied. A prospective study was conducted using a postal questionnaire. We compared the expectations (scale of 1 to 5), the impact on quality of life for symptoms (scale of 1 to 5) and the level of patient satisfaction (scale of 1 to 5) with respect to time on the waitng list for cholelithiasis, inguinal hernia and haemorrhoids. The predictors of patient dissatisfaction were analysed. A total of 57 patients were included. When comparing the characteristics of patients with and without satisfaction over time on the waiting list, days on the waiting list (P=.044), the change in the quality of life due to the symptoms (P=.028), and expectations (P<.001) were significantly different between the two groups. In the multivariate analysis, the expectation was associated with patient dissatisfaction as regards the time on waiting list (OR: 3.14 95% CI: 5.91 to 220.73, P<.001). The level of patient dissatisfaction is associated with expectations about time in waiting list. Copyright © 2012 SECA. Published by Elsevier Espana. All rights reserved.

  9. Internet-based treatment of major depression for patients on a waiting list for inpatient psychotherapy: protocol for a multi-centre randomised controlled trial

    PubMed Central

    2013-01-01

    Background Major depressive disorder (MDD) is a prevalent and severe disorder. Although effective treatments for MDD are available, many patients remain untreated, mainly because of insufficient treatment capacities in the health care system. Resulting waiting periods are often associated with prolonged suffering and impairment as well as a higher risk of chronification. Web-based interventions may help to alleviate these problems. Numerous studies provided evidence for the efficacy of web-based interventions for depression. The aim of this study is to evaluate a new web-based guided self-help intervention (GET.ON-Mood Enhancer-WL) specifically developed for patients waiting to commence inpatient therapy for MDD. Methods In a two-armed randomised controlled trial (n = 200), the web-based guided intervention GET.ON-Mood Enhancer-WL in addition to treatment as usual (TAU) will be compared with TAU alone. The intervention contains six modules (psycho education, behavioural activation I & II, problem solving I & II, and preparation for subsequent inpatient depression therapy). The participants will be supported by an e-coach, who will provide written feedback after each module. Inclusion criteria include a diagnosis of MDD assessed with a structured clinical interview [SCID] and a waiting period of at least three weeks before start of inpatient treatment. The primary outcome is observer-rated depressive symptom severity (HRSD24). Further (explorative) questions include whether remission will be achieved earlier and by more patients during inpatient therapy because of the web-based preparatory intervention. Discussion If GET.ON-Mood Enhancer-WL is proven to be effective, patients may start inpatient therapy with reduced depressive symptom severity, ideally leading to higher remission rates, shortened inpatient therapy, reduced costs, and decreased waiting times. Trial registration German Clinical Trial Registration (DRKS): DRKS00004708. PMID:24279841

  10. Web-based stress management for newly diagnosed cancer patients (STREAM-1): a randomized, wait-list controlled intervention study.

    PubMed

    Grossert, Astrid; Urech, Corinne; Alder, Judith; Gaab, Jens; Berger, Thomas; Hess, Viviane

    2016-11-03

    Being diagnosed with cancer causes major psychological distress, yet the majority of newly diagnosed cancer patients lack psychological support. Internet interventions overcome many barriers for seeking face-to-face support and allow for independence in time and place. We assess efficacy and feasibility of the first web-based stress management intervention (STREAM: STREss-Aktiv-Mindern) for newly diagnosed, German-speaking cancer patients. In a prospective, wait-list controlled trial 120 newly diagnosed cancer patients will be included within 12 weeks of starting anti-cancer treatment and randomized between an immediate (intervention group) or delayed (control group) 8-week, web-based intervention. The intervention consists of eight modules with weekly written feedback by a psychologist ("minimal-contact") based on well-established stress management manuals including downloadable audio-files and exercises. The aim of this study is to evaluate efficacy in terms of improvement in quality of life (FACT-F), as well as decrease in anxiety and depression (HADS), as compared to patients in the wait-list control group. A sample size of 120 patients allows demonstrating a clinically relevant difference of nine points in the FACT score after the intervention (T2) with a two-sided alpha of 0.05 and 80 % power. As this is the first online stress management intervention for German-speaking cancer patients, more descriptive outcomes are equally important to further refine the group of patients with the largest potential for benefit who then will be targeted more specifically in future trials. These descriptive endpoints include: patients' characteristics (type of cancer, type of treatment, socio-demographic factors), dropout rate and dropout reasons, adherence and satisfaction with the program. New technologies open new opportunities: minimal-contact psychological interventions are becoming standard of care in several psychological disorders, where their efficacy is often

  11. The Effects of Waiting for Treatment: A Meta-Analysis of Waitlist Control Groups in Randomized Controlled Trials for Social Anxiety Disorder.

    PubMed

    Steinert, Christiane; Stadter, Katja; Stark, Rudolf; Leichsenring, Falk

    2017-05-01

    Social anxiety disorder (SAD) is a highly prevalent mental disorder. However, little is known about how SAD changes in subjects who do not receive treatment. Waitlist control groups (WLCGs) are frequently included in randomized controlled trials (RCTs) on the treatment of mental disorders. Data from WLCGs are of value as they provide information on the untreated short-term course of a disorder and may serve as disorder-specific norms of change (benchmarks) against which treatment outcomes of SAD can be compared. Thus, we performed a meta-analysis focusing on the effects occurring in WLCGs of RCTs for SAD. Our study was conducted along the PRISMA guidelines. Thirty RCTs (total n = 2460) comprising 30 WLCGs and 47 treatment groups were included. Mean waiting time was 10.6 weeks. The pooled effect of waiting on SAD measures was g = 0.128 (95% CI: 0.057-0.199). Effects regarding other forms of anxiety, depression and functioning were of similarly small size. In contrast, change in the treatment groups was large, both within (g = 0.887) and between groups (g = 0.860). Our results show that for SAD, changes occurring in WLCGs of RCTs are small. The findings may serve as benchmarks in pilot studies of a new treatment or as an additional comparison in studies comparing two active treatments. For psychotherapy research in general, the small effect sizes found in WLCGs confirm that testing a treatment against a waiting list is not a very strict test. Further research on WLCGs in specific mental disorders is required, for example examining the expectancies of patients randomized to waiting. Copyright © 2016 John Wiley & Sons, Ltd. In clinical practice, patients suffering from a mental disorder often have to wait for treatment. By analyzing data from waitlist control groups we can gain estimates of symptom change that occur during waiting. It could be seen that waiting for treatment only results in a negligible effect. Thus, in the short-term (i.e., 10.6

  12. Delays in Prior Living Kidney Donors Receiving Priority on the Transplant Waiting List

    PubMed Central

    Klassen, David K.; Kucheryavaya, Anna Y.; Stewart, Darren E.

    2016-01-01

    Background and objectives Prior living donors (PLDs) receive very high priority on the Organ Procurement and Transplantation Network (OPTN) kidney waiting list. Program delays in adding PLDs to the waiting list, setting their status to active, and submitting requests for PLD priority can affect timely access to transplantation. Design, setting, participants, & measurements We used the OPTN and the Centers for Medicare and Medicaid Services data to examine timing of (1) listing relative to start of dialysis, (2) activation on the waiting list, and (3) requests for PLD priority relative to listing date. There were 210 PLDs (221 registrations) added to the OPTN kidney waiting list between January 1, 2010 and July 31, 2015. Results As of September 4, 2015, 167 of the 210 PLDs received deceased donor transplants, six received living donor transplants, two died, five were too sick to transplant, and 29 were still waiting. Median waiting time to deceased donor transplant for PLDs was 98 days. Only 40.7% of 221 PLD registrations (n=90) were listed before they began dialysis; 68.3% were in inactive status for <90 days, 17.6% were in inactive status for 90–365 days, 8.6% were in inactive status for 1–2 years, and 5.4% were in inactive status for >2 years. Median time of PLDs waiting in active status before receiving PLD priority was 2 days (range =0–1450); 67.4% of PLDs received PLD priority within 7 days after activation, but 15.4% waited 8–30 days, 8.1% waited 1–3 months, 4.1% waited 3–12 months, and 5.0% waited >1 year in active status for PLD priority. After receiving priority, most were transplanted quickly. Median time in active status with PLD priority before deceased donor transplant was 23 days. Conclusions Fewer than one half of listed PLDs were listed before starting dialysis. Most listed PLDs are immediately set to active status and receive PLD priority quickly, but a substantial number spends time in active status without PLD priority or a large

  13. Protocol for the End-of-Life Social Action Study (ELSA): a randomised wait-list controlled trial and embedded qualitative case study evaluation assessing the causal impact of social action befriending services on end of life experience.

    PubMed

    Walshe, Catherine; Algorta, Guillermo Perez; Dodd, Steven; Hill, Matthew; Ockenden, Nick; Payne, Sheila; Preston, Nancy

    2016-07-13

    Compassionate support at the end of life should not be the responsibility of health and social care professionals alone and requires a response from the wider community. Volunteers, as community members, are a critical part of many end-of-life care services. The impact of their services on important outcomes such as quality of life is currently poorly understood. The purpose of this study is to evaluate a series of social action initiatives which use volunteers to deliver befriending services to people anticipated to be in their last year of life. The aim is to determine if receiving care from a social action volunteer befriending service plus usual care significantly improves quality of life in the last year of life. The research questions will be addressed through a wait-list randomised controlled trial (WLRCT) and qualitative case study evaluation across 12 sites in England. Participants will be randomly allocated to either receive the social action volunteer befriending service straight away or receive the intervention after a four week wait (wait-list arm). The impact of the intervention on end-of-life experience (quality of life as primary outcome, loneliness, social support) will be measured. Repeated assessments will be carried out at baseline and weeks 4 and 8 for the intervention arm and weeks 4, 8 and 12 for the wait-list arm. For selected sites case study evaluation will include interviews, observation and documentary analysis to understand the mechanisms underpinning any found impact. This study will address the need to both provide services which use social action models to support end-of-life care in community settings, and to robustly evaluate these models to determine if they influence the experience of end-of-life care. Such services could work to reduce isolation, help meet emotional needs and maintain a sense of connectedness to the community. ISRCTN 12929812 Registered 20.5.15.

  14. The Effects of Twelve Weeks of Tai Chi Practice on Anxiety in Stressed But Healthy People Compared to Exercise and Wait-List Groups-A Randomized Controlled Trial.

    PubMed

    Zheng, Shuai; Kim, Christine; Lal, Sara; Meier, Peter; Sibbritt, David; Zaslawski, Chris

    2018-01-01

    This randomized controlled trial was undertaken to determine whether 12 weeks of Tai Chi (TC) practice can reduce anxiety in healthy but stressed people. Fifty participants were randomized into TC (n=17), exercise (n=17), and wait-list (WL) groups (n=16). Outcome measures used were State Trait Anxiety Inventory, Perceived Stress Scale 14 (PSS14), blood pressure and heart rate variability, visual analogue scale (VAS), and Short Form 36. Significant improvements were observed from baseline for both TC and exercise groups for both state (p <0.01) and trait (p <0.01) anxiety, PSS14 (p <0.01), VAS (p <0.01), mental health domain (p <0.01), and vitality domain (p <0.01). Superior outcomes were also observed for TC when compared with WL for state and trait anxiety (p <0.01) and mental health domain (p <0.05). TC reduces stress levels in healthy individuals and provides a safer, cost effective, and less physically vigorous alternative to exercise. © 2017 Wiley Periodicals, Inc.

  15. A brief mindfulness-based cognitive behavioral intervention improves sexual functioning versus wait-list control in women treated for gynecologic cancer

    PubMed Central

    Brotto, Lori A.; Erskine, Yvonne; Carey, Mark; Ehlen, Tom; Finlayson, Sarah; Heywood, Mark; Kwon, Janice; McAlpine, Jessica; Stuart, Gavin; Thomson, Sydney; Miller, Dianne

    2012-01-01

    Goal The goal of this study was to evaluate a mindfulness-based cognitive behavioral intervention for sexual dysfunction in gynecologic cancer survivors compared to a wait-list control group. Methods Thirty-one survivors of endometrial or cervical cancer (mean age 54.0, range 31–64) who self-reported significant and distressing sexual desire and/or sexual arousal concerns were assigned either to three, 90-minute mindfulness-based cognitive behavior therapy sessions or two months of wait-list control prior to entering the treatment arm. Validated measures of sexual response, sexual distress, and mood, as well as laboratory-evoked physiological and subjective sexual arousal were assessed at pre-, one month post-, and 6-months following treatment. Results There were no significant effects of the wait-list condition on any measure. Treatment led to significant improvements in all domains of sexual response, and a trend towards significance for reducing sexual distress. Perception of genital arousal during an erotic film was also significantly increased following the intervention despite no change in physiologically-measured sexual arousal. Conclusions A brief mindfulness-based intervention was effective for improving sexual functioning. Geographic restrictions permitted only a select sample of survivors to participate, thus, the generalizability of the findings is limited. Future studies should aim to develop online modalities for treatment administration to overcome this limitation. PMID:22293042

  16. A brief mindfulness-based cognitive behavioral intervention improves sexual functioning versus wait-list control in women treated for gynecologic cancer.

    PubMed

    Brotto, Lori A; Erskine, Yvonne; Carey, Mark; Ehlen, Tom; Finlayson, Sarah; Heywood, Mark; Kwon, Janice; McAlpine, Jessica; Stuart, Gavin; Thomson, Sydney; Miller, Dianne

    2012-05-01

    The goal of this study was to evaluate a mindfulness-based cognitive behavioral intervention for sexual dysfunction in gynecologic cancer survivors compared to a wait-list control group. Thirty-one survivors of endometrial or cervical cancer (mean age 54.0, range 31-64) who self-reported significant and distressing sexual desire and/or sexual arousal concerns were assigned either to three, 90-minute mindfulness-based cognitive behavior therapy sessions or two months of wait-list control prior to entering the treatment arm. Validated measures of sexual response, sexual distress, and mood, as well as laboratory-evoked physiological and subjective sexual arousal were assessed at pre-, one month post-, and 6-months following treatment. There were no significant effects of the wait-list condition on any measure. Treatment led to significant improvements in all domains of sexual response, and a trend towards significance for reducing sexual distress. Perception of genital arousal during an erotic film was also significantly increased following the intervention despite no change in physiologically-measured sexual arousal. A brief mindfulness-based intervention was effective for improving sexual functioning. Geographic restrictions permitted only a select sample of survivors to participate, thus, the generalizability of the findings is limited. Future studies should aim to develop online modalities for treatment administration to overcome this limitation. Copyright © 2012 Elsevier B.V. All rights reserved.

  17. A comparison of walk-in counselling and the wait list model for delivering counselling services.

    PubMed

    Stalker, Carol A; Riemer, Manuel; Cait, Cheryl-Anne; Horton, Susan; Booton, Jocelyn; Josling, Leslie; Bedggood, Joanna; Zaczek, Margaret

    2016-10-01

    Walk-in counselling has been used to reduce wait times but there are few controlled studies to compare outcomes between walk-in and the traditional model of service delivery. To compare change in psychological distress by clients receiving services from two models of service delivery, a walk-in counselling model and a traditional counselling model involving a wait list. Mixed-methods sequential explanatory design including quantitative comparison of groups with one pre-test and two follow-ups, and qualitative analysis of interviews with a sub-sample. Five-hundred and twenty-four participants ≥16 years were recruited from two Family Counselling Agencies; the General Health Questionnaire-12 assessed change in psychological distress. Hierarchical linear modelling revealed clients of the walk-in model improved faster and were less distressed at the four-week follow-up compared to the traditional service delivery model. Ten weeks later, both groups had improved and were similar. Participants receiving instrumental services prior to baseline improved more slowly. The qualitative data confirmed participants highly valued the accessibility of the walk-in model, and were frustrated by the lengthy waits associated with the traditional model. This study improves methodologically on previous studies of walk-in counselling, an approach to service delivery not conducive to randomized controlled trials.

  18. Therapist-aided exposure for women with lifelong vaginismus: a randomized waiting-list control trial of efficacy.

    PubMed

    Ter Kuile, Moniek M; Melles, Reinhilde; de Groot, H Ellen; Tuijnman-Raasveld, Charlotte C; van Lankveld, Jacques J D M

    2013-12-01

    Vaginismus is commonly described as a persistent difficulty in allowing vaginal entry of a penis or other "objects" (e.g., tampons, fingers, speculum). Lifelong vaginismus is diagnosed when a woman has never been able to have intercourse. The aim of this study was to investigate the efficacy of therapist-aided exposure for lifelong vaginismus. Seventy women and their partners were randomly allocated to exposure or a waiting-list control period of 3 months. The main outcome measure (intercourse ability) was assessed daily during 12 weeks. Secondary outcome measures were complaints about vaginismus, coital pain, coital fear, sexual distress, and sexual functioning. The exposure treatment consisted of a maximum of three 2-hr sessions during 1 week at a university hospital. Each participant performed vaginal penetration exercises herself, in the presence of her partner and a female therapist. Two follow-up sessions were scheduled over a 5-week period. Thirty-one out of 35 (89%; 95% CI [72%, 96%]) participants reported having had sexual intercourse at posttreatment compared with 4 out of 35 (11%; 95% CI [4%, 28%]) participants in the control condition. In most of the successfully treated women (90%), intercourse was possible within the first 2 weeks of treatment. Moreover, treatment resulted in clinical improvement regarding other symptoms related to vaginismus, coital fear, coital pain, and sexual distress. No treatment effects were found regarding other aspects of sexual functioning in women or their partners. This study provides evidence of the efficacy of therapist-aided exposure therapy for women with lifelong vaginismus.

  19. 24 CFR 982.207 - Waiting list: Local preferences in admission to program.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... 24 Housing and Urban Development 4 2011-04-01 2011-04-01 false Waiting list: Local preferences in... Admission to Tenant-Based Program § 982.207 Waiting list: Local preferences in admission to program. (a) Establishment of PHA local preferences. (1) The PHA may establish a system of local preferences for selection of...

  20. 24 CFR 882.513 - Public notice to low-income families; waiting list.

    Code of Federal Regulations, 2010 CFR

    2010-04-01

    ...-income families; waiting list. (a) Public notice to low-income Families. (1) If the PHA does not have a... 24 Housing and Urban Development 4 2010-04-01 2010-04-01 false Public notice to low-income families; waiting list. 882.513 Section 882.513 Housing and Urban Development Regulations Relating to...

  1. 24 CFR 882.513 - Public notice to low-income families; waiting list.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ...-income families; waiting list. (a) Public notice to low-income Families. (1) If the PHA does not have a... 24 Housing and Urban Development 4 2011-04-01 2011-04-01 false Public notice to low-income families; waiting list. 882.513 Section 882.513 Housing and Urban Development REGULATIONS RELATING TO...

  2. 24 CFR 882.513 - Public notice to low-income families; waiting list.

    Code of Federal Regulations, 2013 CFR

    2013-04-01

    ...-income families; waiting list. (a) Public notice to low-income Families. (1) If the PHA does not have a... 24 Housing and Urban Development 4 2013-04-01 2013-04-01 false Public notice to low-income families; waiting list. 882.513 Section 882.513 Housing and Urban Development REGULATIONS RELATING TO...

  3. 24 CFR 882.513 - Public notice to low-income families; waiting list.

    Code of Federal Regulations, 2014 CFR

    2014-04-01

    ...-income families; waiting list. (a) Public notice to low-income Families. (1) If the PHA does not have a... 24 Housing and Urban Development 4 2014-04-01 2014-04-01 false Public notice to low-income families; waiting list. 882.513 Section 882.513 Housing and Urban Development REGULATIONS RELATING TO...

  4. 24 CFR 882.513 - Public notice to low-income families; waiting list.

    Code of Federal Regulations, 2012 CFR

    2012-04-01

    ...-income families; waiting list. (a) Public notice to low-income Families. (1) If the PHA does not have a... 24 Housing and Urban Development 4 2012-04-01 2012-04-01 false Public notice to low-income families; waiting list. 882.513 Section 882.513 Housing and Urban Development REGULATIONS RELATING TO...

  5. Cognitive behaviour therapy for specific phobia of vomiting (Emetophobia): A pilot randomized controlled trial.

    PubMed

    Riddle-Walker, Lori; Veale, David; Chapman, Cynthia; Ogle, Frank; Rosko, Donna; Najmi, Sadia; Walker, Lana M; Maceachern, Pete; Hicks, Thomas

    2016-10-01

    This is the first randomised controlled trial to evaluate a protocol for cognitive behaviour therapy (CBT) for a Specific Phobia of Vomiting (SPOV) compared with a wait list and to use assessment scales that are specific for a SPOV. 24 participants (23 women and 1 man) were randomly allocated to either 12 sessions of CBT or a wait list. At the end of the treatment, CBT was significantly more efficacious than the wait list with a large effect size (Cohen's d=1.53) on the Specific Phobia of Vomiting Inventory between the two groups after 12 sessions. Six (50%) of the participants receiving CBT achieved clinically significant change compared to 2 (16%) participants in the wait list group. Eight (58.3%) participants receiving CBT achieved reliable improvement compared to 2 (16%) participants in the wait list group. A SPOV is a condition treatable by CBT but further developments are required to increase efficacy. Copyright © 2016 Elsevier Ltd. All rights reserved.

  6. Effectiveness of Multimedia for Transplant Preparation for Kidney Transplant Waiting List Patients.

    PubMed

    Charoenthanakit, C; Junchotikul, P; Sittiudomsuk, R; Saiyud, A; Pratumphai, P

    2016-04-01

    A multimedia program could effectively advise patients about preparing for transplantation while on the waiting list for a kidney transplant. This study aimed to compare knowledge about transplant preparation for patients on a kidney transplant waiting list before and after participating in a multimedia program, and to evaluate patient satisfaction with the multimedia program. Research design was quasiexperimental with the use of 1 group. Subjects were 186 patients on the kidney transplant waiting list after HLA matching in Ramathibodi Hospital. The questionnaires were developed by the researchers. The statistical tools used were basic statistics, percentage, average, standard deviation, and the difference of score between before and after participation in the multimedia program (t test). The evaluation knowledge for transplant preparation for kidney transplant waiting list patients after participating in the multimedia program averaged 85.40%, and there was an increased improvement of score by an average 3.27 out of a possible full score of 20 (P < .05). The result of patient satisfaction for the multimedia program had good average, 4.58. Copyright © 2016 Elsevier Inc. All rights reserved.

  7. Characteristics of Older Adults on Waiting Lists for Meals on Wheels: Identifying Areas for Intervention

    PubMed Central

    Thomas, Kali S.; Smego, Raul; Akobundu, Ucheoma; Dosa, David

    2016-01-01

    The purpose of this study was to characterize the population of seniors on Meals on Wheels’ (MOW) waiting lists and identify their rate of depression, anxiety, falls, and fear of falling. Data come from surveys of 626 seniors on waiting lists across the country and the 2013 National Health and Aging Trends Study (NHATS). Results suggest that seniors on waiting lists for MOW were more likely to be widowed, less educated, older, Black, Hispanic, and receive Medicaid than the population of community-dwelling older adults. In addition, 31% of seniors on MOW waiting lists were depressed, compared with 12% of seniors in the national population (p < .001), and 28% exhibited signs and symptoms of anxiety, compared with 10% of the national population of seniors (p < .001). Seniors on waiting lists were significantly more likely to have fallen in the last month and be fearful of falling than the national population of seniors (p < .001). Individuals on MOW waiting lists are a vulnerable and high-risk group. By seeking to better understand clients’ needs, appropriate services can be tailored to promote independent living and improve older adults’ well-being. PMID:26597791

  8. First step in managing bulimia nervosa: controlled trial of therapeutic manual.

    PubMed Central

    Treasure, J.; Schmidt, U.; Troop, N.; Tiller, J.; Todd, G.; Keilen, M.; Dodge, E.

    1994-01-01

    OBJECTIVE--To test the short term efficacy of a self directed treatment manual for bulimia nervosa. DESIGN--Randomised controlled trial of the manual against cognitive behavioural therapy and a waiting list. SETTING--Tertiary referral centre. SUBJECTS--81 consecutive referrals presenting with bulimia nervosa or atypical bulimia nervosa. MAIN OUTCOME MEASURES--Frequency of binge eating, vomiting, and other behaviours to control weight as well as abstinence from these behaviours. RESULTS--Cognitive behavioural treatment produced a significant reduction in the frequency of binge eating, vomiting, and other behaviours to control weight. The manual significantly reduced frequency of binge eating and weight control behaviours other than vomiting, and there was no change in the group on the waiting list. Full remission was achieved in five (24%) of the group assigned to cognitive behavioural treatment, nine (22%) of the group who used the manual, and two (11%) of the group on the waiting list. CONCLUSIONS--A self directed treatment manual may be a useful first intervention in the treatment of bulimia nervosa. PMID:8142791

  9. Therapist-Aided Exposure for Women with Lifelong Vaginismus: Mediators of Treatment Outcome: A Randomized Waiting List Control Trial.

    PubMed

    Ter Kuile, Moniek M; Melles, Reinhilde J; Tuijnman-Raasveld, Charlotte C; de Groot, Helen E; van Lankveld, Jacques J D M

    2015-08-01

    Therapist-aided exposure seems an effective treatment for lifelong vaginismus, but mechanisms of action have not yet been established. The purpose of the present study was to investigate whether treatment outcome of a therapist-aided exposure treatment was mediated by changes in positive and negative penetration beliefs or feelings of sexual disgust. Participants with lifelong vaginismus were allocated at random to a 3-month exposure (n = 35) or a waiting list control condition (n = 35). Full intercourse was assessed daily during 12 weeks. Secondary outcome measures (complaints about vaginismus and coital pain) were assessed at baseline and after 12 weeks. Possible mediators: penetration beliefs (catastrophic pain beliefs, genital incompatibility beliefs, perceived control beliefs) and feelings of sexual disgust were assessed at baseline and 6 weeks. Treatment outcome (coital frequency, symptoms of vaginismus, and coital pain) at 12 weeks was mediated by changes in negative and positive penetration beliefs at 6 weeks, in particular by more pronounced reduction of catastrophic pain penetration beliefs. No evidence was found that changes in feelings of sexual disgust mediated treatment outcome. The results strongly suggest that therapist-aided exposure affects negative penetration beliefs and that these changes in negative penetration beliefs mediate treatment outcome in women with lifelong vaginismus. Implications for treatment are discussed. © 2015 International Society for Sexual Medicine.

  10. Readiness of Wait-Listed Black Patients to Pursue Live Donor Kidney Transplantation

    PubMed Central

    Rodrigue, James R.; Paek, Matthew J.; Egbuna, Ogo; Waterman, Amy D.; Schold, Jesse D.; Pavlakis, Martha; Mandelbrot, Didier A.

    2015-01-01

    Context For adults with end-stage kidney disease, live donor kidney transplantation (LDKT) yields superior outcomes over long-term dialysis and deceased donor kidney transplantation. However, blacks receive LDKT at a much lower rate than adults of any other race or ethnicity. Objective To examine the LDKT readiness stage of blacks on the transplant waiting list and its association with LDKT knowledge, concerns, and willingness. Design Cross-sectional analysis of baseline data from a randomized controlled trial to improve knowledge and reduce concerns about LDKT. Patients and Setting One hundred fifty-two black patients on the kidney transplant waiting list at a single transplant center in the northeastern United States. Main Outcomes LDKT readiness stage, knowledge, concerns, and willingness to talk to others about living donation. Results Sixty percent of patients were not considering or not yet ready to pursue LDKT, while only 11% had taken action to talk to family members or friends about the possibility of living kidney donation. Patients in later stages of LDKT readiness (i.e., had talked to others about donation or were preparing to do so) had significantly more knowledge (p<0.001), fewer concerns (p=0.002), and more willingness (p=0.001) to talk to others about living donation than those in earlier readiness stages. Conclusions The large percentage of blacks who are in the earlier stages of LDKT readiness may account for the low rate of LDKT in this patient population at our transplant center. Innovative and tailored LDKT educational strategies for black patients are needed to help reduce racial disparities in LDKT. PMID:25488559

  11. Addition of long-distance heart procurement promotes changes in heart transplant waiting list status.

    PubMed

    Atik, Fernando Antibas; Couto, Carolina Fatima; Tirado, Freddy Ponce; Moraes, Camila Scatolin; Chaves, Renato Bueno; Vieira, Nubia W; Reis, João Gabbardo

    2014-01-01

    Evaluate the addition of long-distance heart procurement on a heart transplant program and the status of heart transplant recipients waiting list. Between September 2006 and October 2012, 72 patients were listed as heart transplant recipients. Heart transplant was performed in 41 (57%), death on the waiting list occurred in 26 (36%) and heart recovery occurred in 5 (7%). Initially, all transplants were performed with local donors. Long-distance, interstate heart procurement initiated in February 2011. Thirty (73%) transplants were performed with local donors and 11 (27%) with long-distance donors (mean distance=792 km±397). Patients submitted to interstate heart procurement had greater ischemic times (212 min ± 32 versus 90 min±18; P<0.0001). Primary graft dysfunction (distance 9.1% versus local 26.7%; P=0.23) and 1 month and 12 months actuarial survival (distance 90.1% and 90.1% versus local 90% and 86.2%; P=0.65 log rank) were similar among groups. There were marked incremental transplant center volume (64.4% versus 40.7%, P=0.05) with a tendency on less waiting list times (median 1.5 month versus 2.4 months, P=0.18). There was a tendency on reduced waiting list mortality (28.9% versus 48.2%, P=0.09). Incorporation of long-distance heart procurement, despite being associated with longer ischemic times, does not increase morbidity and mortality rates after heart transplant. It enhances viable donor pool, and it may reduce waiting list recipient mortality as well as waiting time.

  12. Efficacy of Cognitive Behavioral Therapy for Insomnia in Adolescents: A Randomized Controlled Trial with Internet Therapy, Group Therapy and A Waiting List Condition.

    PubMed

    de Bruin, Eduard J; Bögels, Susan M; Oort, Frans J; Meijer, Anne Marie

    2015-12-01

    To investigate the efficacy of cognitive behavioral therapy for insomnia (CBTI) in adolescents. A randomized controlled trial of CBTI in group therapy (GT), guided internet therapy (IT), and a waiting list (WL), with assessments at baseline, directly after treatment (post-test), and at 2 months follow-up. Diagnostic interviews were held at the laboratory of the Research Institute of Child Development and Education at the University of Amsterdam. Treatment for GT occurred at the mental health care center UvAMinds in Amsterdam, the Netherlands. One hundred sixteen adolescents (mean age = 15.6 y, SD = 1.6 y, 25% males) meeting DSM-IV criteria for insomnia, were randomized to IT, GT, or WL. CBTI of 6 weekly sessions, consisted of psychoeducation, sleep hygiene, restriction of time in bed, stimulus control, cognitive therapy, and relaxation techniques. GT was conducted in groups of 6 to 8 adolescents, guided by 2 trained sleep therapists. IT was applied through an online guided self-help website with programmed instructions and written feedback from a trained sleep therapist. Sleep was measured with actigraphy and sleep logs for 7 consecutive days. Symptoms of insomnia and chronic sleep reduction were measured with questionnaires. Results showed that adolescents in both IT and GT, compared to WL, improved significantly on sleep efficiency, sleep onset latency, wake after sleep onset, and total sleep time at post-test, and improvements were maintained at follow-up. Most of these improvements were found in both objective and subjective measures. Furthermore, insomnia complaints and symptoms of chronic sleep reduction also decreased significantly in both treatment conditions compared to WL. Effect sizes for improvements ranged from medium to large. A greater proportion of participants from the treatment conditions showed high end-state functioning and clinically significant improvement after treatment and at follow-up compared to WL. This study is the first randomized

  13. Mindfulness and reduced cognitive reactivity to sad mood: evidence from a correlational study and a non-randomized waiting list controlled study.

    PubMed

    Raes, Filip; Dewulf, David; Van Heeringen, Cees; Williams, J Mark G

    2009-07-01

    Cognitive Reactivity (CR) refers to the degree to which a mild dysphoric state reactivates negative thinking patterns, and it has been found to play a key causal role in depressive relapse. Although Mindfulness-Based Cognitive Therapy (MBCT) directly aims to address this mechanism of CR, the relationship between mindfulness and CR has not been tested to date. Using a cross-sectional design (Study 1; n = 164) and a non-randomized waiting list controlled design (Study 2; MBCT [n = 18] vs. waiting list [n = 21]), the authors examined the relationship between naturally occurring levels of mindfulness (Study 1) and MBCT (Study 2) on the one hand, and CR on the other hand. In line with predictions, it was found that (a) trait mindfulness is significantly negatively correlated with CR, even when controlled for current depressive symptoms and prior history of depression (Study 1), and that (b) MBCT, compared to a matched control group, significantly reduces CR, and that this effect of MBCT on reduction of CR is mediated by a positive change in mindfulness skills (Study 2). Results provide first evidence for the claim that mindfulness practices in MBCT are designed to address the process of CR.

  14. A randomized controlled trial of interim methadone maintenance.

    PubMed

    Schwartz, Robert P; Highfield, David A; Jaffe, Jerome H; Brady, Joseph V; Butler, Carol B; Rouse, Charles O; Callaman, Jason M; O'Grady, Kevin E; Battjes, Robert J

    2006-01-01

    Effective alternatives to long waiting lists for entry into methadone hydrochloride maintenance treatment are needed to reduce the complications of continuing heroin dependence and to increase methadone treatment entry. To compare the effectiveness of interim methadone maintenance with that of the usual waiting list condition in facilitating methadone treatment entry and reducing heroin and cocaine use and criminal behavior. Randomized, controlled, clinical trial using 2 conditions, with treatment assignment on a 3:2 basis to interim maintenance-waiting list control. A methadone treatment program in Baltimore. A total of 319 individuals meeting the criteria for current heroin dependence and methadone maintenance treatment. Participants were randomly assigned to either interim methadone maintenance, consisting of an individually determined methadone dose and emergency counseling only for up to 120 days, or referral to community-based methadone treatment programs. Entry into comprehensive methadone maintenance therapy at 4 months from baseline; self-reported days of heroin use, cocaine use, and criminal behavior; and number of urine drug test results positive for heroin and cocaine at the follow-up interview conducted at time of entry into comprehensive methadone treatment (or at 4 months from baseline for participants who did not enter regular treatment). Significantly more participants assigned to the interim methadone maintenance condition entered comprehensive methadone maintenance treatment by the 120th day from baseline (75.9%) than those assigned to the waiting list control condition (20.8%) (P<.001). Overall, in the past 30 days at follow-up, interim participants reported significantly fewer days of heroin use (P<.001), had a significant reduction in heroin-positive drug test results (P<.001), reported spending less money on drugs (P<.001), and received less illegal income (P<.02) than the waiting list participants. Interim methadone maintenance results in a

  15. Can reduce--the effects of chat-counseling and web-based self-help, web-based self-help alone and a waiting list control program on cannabis use in problematic cannabis users: a randomized controlled trial.

    PubMed

    Schaub, Michael P; Haug, Severin; Wenger, Andreas; Berg, Oliver; Sullivan, Robin; Beck, Thilo; Stark, Lars

    2013-11-14

    In European countries, including Switzerland, as well as in many states worldwide, cannabis is the most widely used psychoactive substance after alcohol and tobacco. Although approximately one in ten users develop serious problems of dependency, only a minority attends outpatient addiction counseling centers. The offer of a combined web-based self-help and chat counseling treatment could potentially also reach those users who hesitate to approach such treatment centers and help them to reduce their cannabis use. This paper presents the protocol for a three-armed randomized controlled trial that will test the effectiveness of a web-based self-help intervention in combination with, or independent of, tailored chat counseling compared to a waiting list in reducing or enabling the abstention from cannabis use in problematic users. The primary outcome will be the weekly quantity of cannabis used. Secondary outcome measures will include the number of days per week on which cannabis is used, the severity of cannabis use disorder, the severity of cannabis dependence, cannabis withdrawal symptoms, cannabis craving, the use of alcohol, tobacco, and other non-cannabis illicit drugs, changes in mental health symptoms, and treatment retention. The self-help intervention will consist of 8 modules designed to reduce cannabis use based on the principles of motivational interviewing, self-control practices, and methods of cognitive behavioral therapy. The two additional individual chat-counseling sessions in the additional chat condition will be based on the same therapy approaches and tailored to participants' self-help information data and personal problems. The predictive validity of participants' baseline characteristics on treatment retention and outcomes will be explored. To the best of our knowledge, this will be the first randomized controlled trial to test the effectiveness of online self-help therapy in combination or without chat counseling in reducing or enabling the

  16. Can reduce - the effects of chat-counseling and web-based self-help, web-based self-help alone and a waiting list control program on cannabis use in problematic cannabis users: a randomized controlled trial

    PubMed Central

    2013-01-01

    Background In European countries, including Switzerland, as well as in many states worldwide, cannabis is the most widely used psychoactive substance after alcohol and tobacco. Although approximately one in ten users develop serious problems of dependency, only a minority attends outpatient addiction counseling centers. The offer of a combined web-based self-help and chat counseling treatment could potentially also reach those users who hesitate to approach such treatment centers and help them to reduce their cannabis use. Methods/design This paper presents the protocol for a three-armed randomized controlled trial that will test the effectiveness of a web-based self-help intervention in combination with, or independent of, tailored chat counseling compared to a waiting list in reducing or enabling the abstention from cannabis use in problematic users. The primary outcome will be the weekly quantity of cannabis used. Secondary outcome measures will include the number of days per week on which cannabis is used, the severity of cannabis use disorder, the severity of cannabis dependence, cannabis withdrawal symptoms, cannabis craving, the use of alcohol, tobacco, and other non-cannabis illicit drugs, changes in mental health symptoms, and treatment retention. The self-help intervention will consist of 8 modules designed to reduce cannabis use based on the principles of motivational interviewing, self-control practices, and methods of cognitive behavioral therapy. The two additional individual chat-counseling sessions in the additional chat condition will be based on the same therapy approaches and tailored to participants’ self-help information data and personal problems. The predictive validity of participants’ baseline characteristics on treatment retention and outcomes will be explored. Discussion To the best of our knowledge, this will be the first randomized controlled trial to test the effectiveness of online self-help therapy in combination or without chat

  17. Randomized Control Trial of a CBT Trauma Recovery Program in Palestinian Schools

    ERIC Educational Resources Information Center

    Barron, Ian G.; Abdallah, Ghassan; Smith, Patrick

    2013-01-01

    The current study aimed to assess the Teaching Recovery Techniques (TRT) trauma recovery program within the context of ongoing violence. Utilizing a randomized controlled trial, 11-14-year-old students in Nablus, Palestine, were allocated by class to intervention or wait-list control conditions. Standardized measures assessed trauma exposure,…

  18. Acupuncture for the sequelae of Bell's palsy: a randomized controlled trial.

    PubMed

    Kwon, Hyo-Jung; Choi, Jun-Yong; Lee, Myeong Soo; Kim, Yong-Suk; Shin, Byung-Cheul; Kim, Jong-In

    2015-06-03

    Incomplete recovery from facial palsy results in social and physical disabilities, and the medical options for the sequelae of Bell's palsy are limited. Acupuncture is widely used for Bell's palsy patients in East Asia, but its efficacy is unclear. We performed a randomized controlled trial including participants with the sequelae of Bell's palsy with the following two parallel arms: an acupuncture group (n = 26) and a waiting list group (n = 13). The acupuncture group received acupuncture treatments for 8 weeks, whereas the waiting list group did not receive acupuncture treatments during the 8-week period after randomization. The primary outcome measure was change in the Facial Disability Index (FDI) social and well-being subscale at week 8. We also analyzed changes in the FDI physical function subscale, the House-Brackmann score, the Sunnybrook Facial Nerve Grading system, lip mobility and stiffness at 5 and 8 weeks after randomization. An intention-to-treat analysis was applied. The acupuncture group exhibited greater improvements in the FDI social score (mean difference, 23.54; 95% confidence interval, 12.99 to 34.08) and better results on the FDI physical function subscale (mean difference, 21.54; 95% confidence interval, 7.62 to 35.46), Sunnybrook Facial Nerve Grading score (mean difference, 14.77; 95% confidence interval, 5.05 to 24.49), and stiffness scale (mean difference, -1.58; 95% confidence interval,-2.26 to -0.89) compared with the waiting list group after 8 weeks. No severe adverse event occurred in either group. Compared with the waiting list group, acupuncture had better therapeutic effects on the social and physical aspects of sequelae of Bell's palsy. Current Controlled Trials ISRCTN43104115.

  19. 28 CFR 345.33 - Waiting list hiring exceptions.

    Code of Federal Regulations, 2014 CFR

    2014-07-01

    ... position classification files. (b) Prior FPI work assignment. An inmate with prior FPI work experience during the inmate's current commitment and with no break in custody will ordinarily be placed within the... waiting lists, so there is no break in active duty with FPI. Such actions are also in order where the work...

  20. 28 CFR 345.33 - Waiting list hiring exceptions.

    Code of Federal Regulations, 2012 CFR

    2012-07-01

    ... position classification files. (b) Prior FPI work assignment. An inmate with prior FPI work experience during the inmate's current commitment and with no break in custody will ordinarily be placed within the... waiting lists, so there is no break in active duty with FPI. Such actions are also in order where the work...

  1. 28 CFR 345.33 - Waiting list hiring exceptions.

    Code of Federal Regulations, 2013 CFR

    2013-07-01

    ... position classification files. (b) Prior FPI work assignment. An inmate with prior FPI work experience during the inmate's current commitment and with no break in custody will ordinarily be placed within the... waiting lists, so there is no break in active duty with FPI. Such actions are also in order where the work...

  2. Randomised controlled trial of school-based humanistic counselling for emotional distress in young people: Feasibility study and preliminary indications of efficacy

    PubMed Central

    2010-01-01

    Aims The purpose of this study was to test the feasibility of a randomised controlled trial comparing six weeks of humanistic school-based counselling versus waiting list in the reduction of emotional distress in young people, and to obtain initial indications of efficacy. Methods Following a screening procedure, young people (13 - 15 years old) who experienced emotional distress were randomised to either humanistic counselling or waiting list in this multi-site study. Outcomes were assessed using a range of self-report mental health measures, with the emotional symptoms subscale of the Strengths and Difficulties Questionnaire (SDQ) acting as the primary outcome indicator. Results Recruitment procedures were successful, with 32 young people consenting to participate in the trial and 27 completing endpoint measures. Trial procedures were acceptable to all involved in the research. No significant differences were found between the counselling and waiting list groups in reductions in levels of emotional symptoms (Hedges' g = 0.03), but clients allocated to counselling showed significantly greater improvement in prosocial behaviour (g = 0.89) with an average effect size (g) across the nine outcome measures of 0.25. Participants with higher levels of depressive symptoms showed significantly greater change. Conclusion This study suggested that a randomised controlled trial of counselling in schools is acceptable and feasible, although initial indications of efficacy are mixed. Trial registration Current Controlled Trials ISRCTN68290510. PMID:20412578

  3. Algorithm for prioritization of patients on the waiting list for liver transplantation.

    PubMed

    Gambato, M; Senzolo, M; Canova, D; Germani, G; Tomat, S; Masier, A; Russo, F P; Perissinotto, E; Zanus, G; Cillo, U; Burra, P

    2007-01-01

    Prioritization of patients on the waiting list (WL) for OLT is still a critical issue. Numerous models have been developed to predict mortality before and after OLT. The aim of the study was to prospectively evaluate cirrhotics with and without hepatocellular carcinoma (HCC) undergoing orthotopic liver transplantation (OLT) severity of liver disease on the WL and at transplant, mortality on the WL and after OLT, and their correlations. An algorithm based on seven patient variables (MELD, CTP, UNOS, HCC, BMI, waiting time, age) was created by software dedicated to prioritize patients on the waiting list. We evaluated 118 patients including 75 men and 43 women of age range 19 to 66 years, who underwent OLT from July 2004 to June 2006. Mean CTP and MELD at listing were 8.44 (range 6-12) and 13 (range 2-24), respectively. Overall mortality on the WL at 24 months was 13%, which was significantly higher among patients with MELD > 25 compared to patients with MELD 0 to 15 (P < .0001) or MELD 16 to 25 (P = .0007) at listing. Mean MELD at OLT was 15 (range 7-36), which was significantly lower in patients with than without HCC (MELD 12 vs 16; P = .0003). Six hundred-day patient survival was significantly lower among patients with MELD > 25 compared to patients with MELD < 25 at OLT (P = .017), whereas no difference in survival was observed between patients with and without HCC. The sickest patients are characterized by high mortality both on the waiting list and after liver transplantation. Patients with HCC are transplanted in better condition compared to patients without HCC with the same survival.

  4. Habit Reversal versus Object Manipulation Training for Treating Nail Biting: A Randomized Controlled Clinical Trial

    PubMed Central

    Ghanizadeh, Ahmad; Bazrafshan, Amir; Dehbozorgi, Gholamreza

    2013-01-01

    Objective This is a parallel, three group, randomized, controlled clinical trial, with outcomes evaluated up to three months after randomization for children and adolescents with chronic nail biting. The current study investigates the efficacy of habit reversal training (HRT) and compares its effect with object manipulation training (OMT) considering the limitations of the current literature. Method Ninety one children and adolescents with nail biting were randomly allocated to one of the three groups. The three groups were HRT (n = 30), OMT (n = 30), and wait-list or control group (n = 31). The mean length of nail was considered as the main outcome. Results The mean length of the nails after one month in HRT and OMT groups increased compared to the waiting list group (P < 0.001, P < 0.001, respectively). In long term, both OMT and HRT increased the mean length of nails (P < 0.01), but HRT was more effective than OMT (P < 0.021). The parent-reported frequency of nail biting did show similar results as to the mean length of nails assessment in long term. The number of children who completely stopped nail biting in HRT and OMT groups during three months was 8 and 7, respectively. This number was zero during one month for the wait-list group. Conclusion This trial showed that HRT is more effective than wait-list and OMT in increasing the mean length of nails of children and adolescents in long terms. PMID:24130603

  5. Cumulative incidence for wait-list death in relation to length of queue for coronary-artery bypass grafting: a cohort study.

    PubMed

    Sobolev, Boris G; Kuramoto, Lisa; Levy, Adrian R; Hayden, Robert

    2006-08-24

    In deciding where to undergo coronary-artery bypass grafting, the length of surgical wait lists is often the only information available to cardiologists and their patients. Our objective was to compare the cumulative incidence for death on the wait list according to the length of wait lists at the time of registration for the operation. The study cohort included 8966 patients who registered to undergo isolated coronary-artery bypass grafting (82.4% men; 71.9% semi-urgent; 22.4% non-urgent). The patients were categorized according to wait-list clearance time at registration: either "1 month or less" or "more than 1 month". Cumulative incidence for wait-list death was compared between the groups, and the significance of difference was tested by means of regression models. Urgent patients never registered on a wait list with a clearance time of more than 1 month. Semi-urgent patients registered on shorter wait lists more often than non-urgent patients (79.1% vs. 44.7%). In semi-urgent and non-urgent patients, the observed proportion of wait-list deaths by 52 weeks was lower in category "1 month or less" than in category "more than 1 month" (0.8% [49 deaths] vs. 1.6% [39 deaths], P < 0.005). After adjustment, the odds of death before surgery were 64% higher in patients on longer lists, odds ratio [OR] = 1.64 (95% confidence interval [CI] 1.02-2.63). The observed death rate was higher in category "more than 1 month" than in category "1 month or less", 0.79 (95%CI 0.54-1.04) vs. 0.58 (95% CI 0.42-0.74) per 1000 patient-weeks, the adjusted OR = 1.60 (95%CI 1.01-2.53). Longer wait times (log-rank test = 266.4, P < 0.001) and higher death rates contributed to a higher cumulative incidence for death on the wait list with a clearance time of more than 1 month. Long wait lists for coronary-artery bypass grafting are associated with increased probability that a patient dies before surgery. Physicians who advise patients where to undergo cardiac revascularization should consider

  6. Comparing the clinical-effectiveness and cost-effectiveness of an internet-delivered Acceptance and Commitment Therapy (ACT) intervention with a waiting list control among adults with chronic pain: study protocol for a randomised controlled trial

    PubMed Central

    Hayes, Sara; Hogan, Michael; Dowd, Haulie; Doherty, Edel; O'Higgins, Siobhan; Nic Gabhainn, Saoirse; MacNeela, Padraig; Murphy, Andrew W; Kropmans, Thomas; O'Neill, Ciaran; Newell, John; McGuire, Brian E

    2014-01-01

    Introduction Internet-delivered psychological interventions among people with chronic pain have the potential to overcome environmental and economic barriers to the provision of evidence-based psychological treatment in the Irish health service context. While the use of internet-delivered cognitive–behavioural therapy programmes has been consistently shown to have small-to-moderate effects in the management of chronic pain, there is a paucity in the research regarding the effectiveness of an internet-delivered Acceptance and Commitment Therapy (ACT) programme among people with chronic pain. The current study will compare the clinical-effectiveness and cost-effectiveness of an online ACT intervention with a waitlist control condition in terms of the management of pain-related functional interference among people with chronic pain. Methods and analysis Participants with non-malignant pain that persists for at least 3 months will be randomised to one of two study conditions. The experimental group will undergo an eight-session internet-delivered ACT programme over an 8-week period. The control group will be a waiting list group and will be offered the ACT intervention after the 3-month follow-up period. Participants will be assessed preintervention, postintervention and at a 3-month follow-up. The primary outcome will be pain-related functional interference. Secondary outcomes will include: pain intensity, depression, global impression of change, acceptance of chronic pain and quality of life. A qualitative evaluation of the perspectives of the participants regarding the ACT intervention will be completed after the trial. Ethics and dissemination The study will be performed in agreement with the Declaration of Helsinki and is approved by the National University of Ireland Galway Research Ethics Committee (12/05/05). The results of the trial will be published according to the CONSORT statement and will be presented at conferences and reported in peer

  7. Has the increase in private health insurance uptake affected the Victorian public hospital surgical waiting list?

    PubMed

    Hanning, Brian

    2002-01-01

    It was anticipated that increase uptake of Private Health Insurance (PHI) would reduce demand on public sector surgical waiting lists. The best measure of changed demand is the comparison of the actual cases added to that projected given previous trends in PHI uptake. Detailed Victorian data is available up to 2000-1. The total waiting list has varied little, reflecting significant decreases in both in patients added to and removed. There was a marked increase in private sector elective surgery cases coinciding with the fall in additions to the public sector waiting list and in public sector elective surgical cases. The June 2001 Victorian surgical waiting list would have been 69,599 not 41,838 if the PHI uptake rate had continued to fall in line with pre-1999 trends, and that of June 2002 about 100,000 compared to 40,458 in March 2002. Limited data from other states suggests the Victorian trends are representative of all Australia.

  8. Does Wait-List Size at Registration Influence Time to Surgery? Analysis of a Population-Based Cardiac Surgery Registry

    PubMed Central

    Sobolev, Boris; Levy, Adrian; Hayden, Robert; Kuramoto, Lisa

    2006-01-01

    Objective To determine whether the probability of undergoing coronary bypass surgery within a certain time was related to the number of patients on the wait list at registration for the operation in a publicly funded health system. Methods A prospective cohort study comparing waiting times among patients registered on wait lists at the hospitals delivering adult cardiac surgery. For each calendar week, the list size, the number of new registrations, and the number of direct admissions immediately after angiography characterized the demand for surgery. Results The length of delay in undergoing treatment was associated with list size at registration, with shorter times for shorter lists (log-rank test 1,198.3, p<.0001). When the list size at registration required clearance time over 1 week patients had 42 percent lower odds of undergoing surgery compared with lists with clearance time less than 1 week (odds ratio [OR] 0.58 percent, 95 percent, confidence interval [CI] 0.53–0.63), after adjustment for age, sex, comorbidity, period, and hospital. The weekly number of new registrations exceeding weekly service capacity had an independent effect toward longer service delays when the list size at registration required clearance time less than 1 week (OR 0.56 percent, 95 percent CI 0.45–0.71), but not for longer lists. Every time the operation was performed for a patient requiring surgery without registration on wait lists, the odds of surgery for listed patients were reduced by 6 percent (OR 0.94, CI 0.93–0.95). Conclusion For wait-listed patients, time to surgery depends on the list size at registration, the number of new registrations, as well as on the weekly number of patients who move immediately from angiography to coronary bypass surgery without being registered on a wait list. Hospital managers may use these findings to improve resource planning and to reduce uncertainty when providing advice on expected treatment delays. PMID:16430599

  9. "Every Child Counts": Testing Policy Effectiveness Using a Randomised Controlled Trial, Designed, Conducted and Reported to CONSORT Standards

    ERIC Educational Resources Information Center

    Torgerson, Carole; Wiggins, Andy; Torgerson, David; Ainsworth, Hannah; Hewitt, Catherine

    2013-01-01

    We report a randomised controlled trial evaluation of an intensive one-to-one numeracy programme--"Numbers Count"--which formed part of the previous government's numeracy policy intervention--"Every Child Counts." We rigorously designed and conducted the trial to CONSORT guidelines. We used a pragmatic waiting list design to…

  10. Factors Affecting the Selection of Patients on Waiting List: A Single Center Study.

    PubMed

    Can, Ö; Kasapoğlu, U; Boynueğri, B; Tuğcu, M; Çağlar Ruhi, B; Canbakan, M; Murat Gökçe, A; Ata, P; İzzet Titiz, M; Apaydın, S

    2015-06-01

    There is an increasing gap between organ supply and demand for cadaveric transplantation in our country. Our aim was to evaluate factors affecting selection of patients on waiting list at our hospital. Patients who have been waiting on list and who were transplanted were compared in order to find factors, which affected the selection of patients. Non-parametric Mann-Whitney U test was used for comparison and cox regression analysis was used to find the risk factors that decrease the probability of transplantation in this retrospective case-control study. Patients in the transplanted group were significantly younger, had relatively lower body mass index than the awaiting group. Cardiovascular diseases were more in the awaiting group than the transplanted group. There was no patient with diabetes in transplanted group, despite fifteen diabetic patients were in the awaiting group. Selected patients had lower immunologic risk with regard to peak panel reactive antibody levels. No significant difference was found for gender, hypertension, hyperlipidemia, viral serology, time spent on dialysis and on waiting list between two groups. With cox regression analysis female gender, older age, diabetes mellitus, high body mass index, positive hepatitis B serology and high levels of peak class 1-2 peak panel reactive antibody positivity were found as risk factors that decrease the probability of transplantation. A tendency for selection of low risk patients was found with this study. Time and energy consuming complications and short allograft survival after transplantation in high risk patients and the scarcity of cadaveric pool in our country may contribute to this tendency. Copyright © 2015 Elsevier Inc. All rights reserved.

  11. The People with Asperger syndrome and anxiety disorders (PAsSA) trial: a pilot multicentre, single-blind randomised trial of group cognitive-behavioural therapy.

    PubMed

    Langdon, Peter E; Murphy, Glynis H; Shepstone, Lee; Wilson, Edward C F; Fowler, David; Heavens, David; Malovic, Aida; Russell, Alexandra; Rose, Alice; Mullineaux, Louise

    2016-03-01

    There is a growing interest in using cognitive-behavioural therapy (CBT) with people who have Asperger syndrome and comorbid mental health problems. To examine whether modified group CBT for clinically significant anxiety in an Asperger syndrome population is feasible and likely to be efficacious. Using a randomised assessor-blind trial, 52 individuals with Asperger syndrome were randomised into a treatment arm or a waiting-list control arm. After 24 weeks, those in the waiting-list control arm received treatment, while those initially randomised to treatment were followed up for 24 weeks. The conversion rate for this trial was high (1.6:1), while attrition was 13%. After 24 weeks, there was no significant difference between those randomised to the treatment arm compared with those randomised to the waiting-list control arm on the primary outcome measure, the Hamilton Rating Scale for Anxiety. Trials of psychological therapies with this population are feasible. Larger definitive trials are now needed. None. © The Royal College of Psychiatrists 2016. This is an open access article distributed under the terms of the Creative Commons Attribution (CC BY) licence.

  12. Moderate exercise plus sleep education improves self-reported sleep quality, daytime mood, and vitality in adults with chronic sleep complaints: a waiting list-controlled trial.

    PubMed

    Gebhart, Carmen; Erlacher, Daniel; Schredl, Michael

    2011-01-01

    Research indicates that physical exercise can contribute to better sleep quality. This study investigates the six-week influence of a combined intervention on self-rated sleep quality, daytime mood, and quality of life. A nonclinical sample of 114 adults with chronic initiating and the maintaining of sleep complaints participated in the study. The intervention group of 70 adults underwent moderate physical exercise, conducted weekly, plus sleep education sessions. Improvements among participants assigned to the intervention group relative to the waiting-list control group (n = 44) were noted for subjective sleep quality, daytime mood, depressive symptoms and vitality. Derived from PSQI subscores, the intervention group reported increased sleep duration, shortened sleep latency, fewer awakenings after sleep onset, and overall better sleep efficiency compared to controls. The attained scores were well sustained and enhanced over a time that lasted through to the follow-up 18 weeks later. These findings have implications in treatment programs concerning healthy lifestyle approaches for adults with chronic sleep complaints.

  13. Moderate Exercise Plus Sleep Education Improves Self-Reported Sleep Quality, Daytime Mood, and Vitality in Adults with Chronic Sleep Complaints: A Waiting List-Controlled Trial

    PubMed Central

    Gebhart, Carmen; Erlacher, Daniel; Schredl, Michael

    2011-01-01

    Research indicates that physical exercise can contribute to better sleep quality. This study investigates the six-week influence of a combined intervention on self-rated sleep quality, daytime mood, and quality of life. A nonclinical sample of 114 adults with chronic initiating and the maintaining of sleep complaints participated in the study. The intervention group of 70 adults underwent moderate physical exercise, conducted weekly, plus sleep education sessions. Improvements among participants assigned to the intervention group relative to the waiting-list control group (n = 44) were noted for subjective sleep quality, daytime mood, depressive symptoms and vitality. Derived from PSQI subscores, the intervention group reported increased sleep duration, shortened sleep latency, fewer awakenings after sleep onset, and overall better sleep efficiency compared to controls. The attained scores were well sustained and enhanced over a time that lasted through to the follow-up 18 weeks later. These findings have implications in treatment programs concerning healthy lifestyle approaches for adults with chronic sleep complaints. PMID:23471095

  14. Effect of a family-based cognitive behavioural intervention on body mass index, self-esteem and symptoms of depression in children with obesity (aged 7-13): a randomised waiting list controlled trial.

    PubMed

    Danielsen, Yngvild S; Nordhus, Inger H; Júlíusson, Petur B; Mæhle, Magne; Pallesen, Ståle

    2013-01-01

    We examined the effect of a 12-week family-based cognitive behavioural weight management programme developed for use in primary care settings. The sample consisted of 49 children with obesity (aged 7-13 years; mean ± SD: 10.68 ± 1.24). Families were randomly assigned to immediate start-up of treatment or to a 12-week waiting list condition. Outcome measures were body mass index standard deviation score (BMI SDS), self-esteem, symptoms of depression and blood parameters indicative of cardio-metabolic risk. Assessments were conducted at baseline, post-treatment, post-waiting list and 12 months after treatment termination. The mean reduction for the treatment group was -0.16 BMI SDS units compared with an increase of 0.04 units for the waiting list group (p = .001). For the entire sample, there was a significant post-treatment improvement on BMI SDS (p = .001), all self-esteem measures (p = .001-.041) and symptoms of depression (p = .004). The mean BMI SDS reduction was -0.18 units post-treatment, and it was maintained at 12-month follow-up. Significant reductions were found in blood lipid levels of total cholesterol (p = .03), LDL-cholesterol (p = .005) and HDL-cholesterol (p = .01) at 12-month follow-up. The favourable effect on most of the psychological measures waned from post-treatment to follow-up, but not approaching baseline levels. Boys demonstrated significantly greater reductions in BMI SDS than girls (p = .001), while baseline psychiatric co-morbidity did not influence BMI SDS outcome. The treatment shows significant and favourable effects on BMI SDS, self-esteem and symptoms of depression compared with a waiting list condition. © 2013 Asian Oceanian Association for the Study of Obesity . Published by Elsevier Ltd. All rights reserved.

  15. Is Reducing Uncertain Control the Key to Successful Test Anxiety Intervention for Secondary School Students? Findings from a Randomized Control Trial

    ERIC Educational Resources Information Center

    Putwain, David W.; Pescod, Marc

    2018-01-01

    The aim of the study was to conduct a randomized control trial of a targeted, facilitated, test anxiety intervention for a group of adolescent students, and to examine the mediating role of uncertain control. Fifty-six participants (male = 19, white = 21, mean age = 14.7 years) were randomly allocated to an early intervention or wait-list control…

  16. A randomized controlled trial of internet-based therapy in depression.

    PubMed

    Moritz, Steffen; Schilling, Lisa; Hauschildt, Marit; Schröder, Johanna; Treszl, András

    2012-08-01

    Depression is among the most prevalent disorders worldwide. In view of numerous treatment barriers, internet-based interventions are increasingly adopted to "treat the untreated". The present trial (registered as NCT01401296) was conducted over the internet and aimed to assess the efficacy of an online self-help program for depression (Deprexis). In random order, participants with elevated depression symptoms received program access or were allocated to a wait-list control condition. After eight weeks, participants were invited to take part in an online re-assessment. To compensate for common problems of online studies, such as low completion rates and unclear diagnostic status, reminders and incentives were used, and clinical diagnoses were externally confirmed in a subgroup of 29% of participants. Relative to the wait-list group, program users experienced significant symptom decline on the Beck Depression Inventory (BDI; primary outcome), the Dysfunctional Attitudes Scale (DAS), the Quality of Life scale (WHOQOL-BREF) and the Rosenberg Self-Esteem Scale (RSE). Compared to wait-list participants, symptom decline was especially pronounced among those with moderate symptoms at baseline as well as those not currently consulting a therapist. Completion (82%) and re-test reliability of the instruments (r = .72-.87) were good. The results of this trial suggest that online treatment can be beneficial for people with depression, particularly for those with moderate symptoms. Copyright © 2012 Elsevier Ltd. All rights reserved.

  17. Assessing the performance of centralized waiting lists for patients without a regular family physician using clinical-administrative data.

    PubMed

    Breton, Mylaine; Smithman, Mélanie Ann; Brousselle, Astrid; Loignon, Christine; Touati, Nassera; Dubois, Carl-Ardy; Nour, Kareen; Boivin, Antoine; Berbiche, Djamal; Roberge, Danièle

    2017-01-05

    With 4.6 million patients who do not have a regular family physician, Canada performs poorly compared to other OECD countries in terms of attachment to a family physician. To address this issue, several provinces have implemented centralized waiting lists to coordinate supply and demand for attachment to a family physician. Although significant resources are invested in these centralized waiting lists, no studies have measured their performance. In this article, we present a performance assessment of centralized waiting lists for unattached patients implemented in Quebec, Canada. We based our approach on the Balanced Scorecard method. A committee of decision-makers, managers, healthcare professionals, and researchers selected five indicators for the performance assessment of centralized waiting lists, including both process and outcome indicators. We analyzed and compared clinical-administrative data from 86 centralized waiting lists (GACOs) located in 14 regions in Quebec, from April 1, 2013, to March 31, 2014. During the study period, although over 150,000 patients were attached to a family physician, new requests resulted in a 30% median increase in patients on waiting lists. An inverse correlation of average strength was found between the rates of patients attached to a family physician and the proportion of vulnerable patients attached to a family physician meaning that as more patients became attached to an FP through GACOs, the proportion of vulnerable patients became smaller (r = -0.31, p < 0.005). The results showed very large performance variations both among GACOs of different regions and among those of a same region for all performance indicators. Centralized waiting lists for unattached patients in Quebec seem to be achieving their twofold objective of attaching patients to a family physician and giving priority to vulnerable patients. However, the demand for attachment seems to exceed the supply and there appears to be a tension between giving

  18. A randomized controlled trial examining Iyengar yoga for young adults with rheumatoid arthritis: a study protocol

    PubMed Central

    2011-01-01

    Background Rheumatoid arthritis is a chronic, disabling disease that can compromise mobility, daily functioning, and health-related quality of life, especially in older adolescents and young adults. In this project, we will compare a standardized Iyengar yoga program for young people with rheumatoid arthritis to a standard care wait-list control condition. Methods/Design Seventy rheumatoid arthritis patients aged 16-35 years will be randomized into either the 6-week Iyengar yoga program (12 - 1.5 hour sessions twice weekly) or the 6-week wait-list control condition. A 20% attrition rate is anticipated. The wait-list group will receive the yoga program following completion of the first arm of the study. We will collect data quantitatively, using questionnaires and markers of disease activity, and qualitatively using semi-structured interviews. Assessments include standardized measures of general and arthritis-specific function, pain, mood, and health-related quality of life, as well as qualitative interviews, blood pressure/resting heart rate measurements, a medical exam and the assessment of pro-inflammatory cytokines. Data will be collected three times: before treatment, post-treatment, and two months following the treatment. Discussion Results from this study will provide critical data on non-pharmacologic methods for enhancing function in rheumatoid arthritis patients. In particular, results will shed light on the feasibility and potential efficacy of a novel intervention for rheumatoid arthritis symptoms, paving the way for a larger clinical trial. Trial Registration ClinicalTrials.gov NCT01096823 PMID:21255431

  19. Crisis in the Community: Waiting Lists for MR/DD Services

    ERIC Educational Resources Information Center

    Stasko, Sheila

    2005-01-01

    Waiting lists for people with intellectual disabilities who seek services from Mental Retardation (MR) or Development Disability (DD) systems are a very visible problem across the country and have forced people with disabilities, families and caregivers to respond by pressing their states into action. People living at home with their parents or…

  20. Randomized Controlled Trial in Clinical Settings to Evaluate Effectiveness of Coping Skills Education Used with Progressive Tinnitus Management

    ERIC Educational Resources Information Center

    Henry, James A.; Thielman, Emily J.; Zaugg, Tara L.; Kaelin, Christine; Schmidt, Caroline J.; Griest, Susan; McMillan, Garnett P.; Myers, Paula; Rivera, Izel; Baldwin, Robert; Carlson, Kathleen

    2017-01-01

    Purpose: This randomized controlled trial evaluated, within clinical settings, the effectiveness of coping skills education that is provided with progressive tinnitus management (PTM). Method: At 2 Veterans Affairs medical centers, N = 300 veterans were randomized to either PTM intervention or 6-month wait-list control. The PTM intervention…

  1. A Randomized Controlled Trial of Koru: A Mindfulness Program for College Students and Other Emerging Adults

    PubMed Central

    Greeson, Jeffrey M.; Juberg, Michael K.; Maytan, Margaret; James, Kiera; Rogers, Holly

    2014-01-01

    Objective To evaluate the effectiveness of Koru, a mindfulness training program for college students and other emerging adults. Participants Ninety students (66% female, 62% white, 71% graduate students) participated between Fall 2012 and Spring 2013. Methods Randomized controlled trial. We hypothesized that Koru, compared to a wait-list control group, would reduce perceived stress and sleep problems, and increase mindfulness, self-compassion, and gratitude. Results As hypothesized, results showed significant Group (Koru, wait-list) X Time (pre, post) interactions for improvements in perceived stress (F=4.50, df [1, 76.40], p=.037, d=.45), sleep problems (F= 4.71, df [1,79.49], p=.033, d=.52), mindfulness (F=26.80, df [1, 79.09], p<.001, d=.95), and self-compassion (F=18.08, df [1, 74.77], p<.001, d=.75). All significant effects were replicated in the wait-list group. Significant correlations were observed among changes in perceived stress, sleep problems, mindfulness, and self-compassion. Conclusions Results support the effectiveness of the Koru program for emerging adults in the university setting. PMID:24499130

  2. The People with Asperger syndrome and anxiety disorders (PAsSA) trial: a pilot multicentre, single-blind randomised trial of group cognitive–behavioural therapy

    PubMed Central

    Murphy, Glynis H.; Shepstone, Lee; Wilson, Edward C.F.; Fowler, David; Heavens, David; Malovic, Aida; Russell, Alexandra; Rose, Alice; Mullineaux, Louise

    2016-01-01

    Background There is a growing interest in using cognitive–behavioural therapy (CBT) with people who have Asperger syndrome and comorbid mental health problems. Aims To examine whether modified group CBT for clinically significant anxiety in an Asperger syndrome population is feasible and likely to be efficacious. Method Using a randomised assessor-blind trial, 52 individuals with Asperger syndrome were randomised into a treatment arm or a waiting-list control arm. After 24 weeks, those in the waiting-list control arm received treatment, while those initially randomised to treatment were followed up for 24 weeks. Results The conversion rate for this trial was high (1.6:1), while attrition was 13%. After 24 weeks, there was no significant difference between those randomised to the treatment arm compared with those randomised to the waiting-list control arm on the primary outcome measure, the Hamilton Rating Scale for Anxiety. Conclusions Trials of psychological therapies with this population are feasible. Larger definitive trials are now needed. Declaration of interest None. Copyright and usage © The Royal College of Psychiatrists 2016. This is an open access article distributed under the terms of the Creative Commons Attribution (CC BY) licence. PMID:27703772

  3. A randomized controlled trial of qigong for fibromyalgia

    PubMed Central

    2012-01-01

    Introduction Fibromyalgia is difficult to treat and requires the use of multiple approaches. This study is a randomized controlled trial of qigong compared with a wait-list control group in fibromyalgia. Methods One hundred participants were randomly assigned to immediate or delayed practice groups, with the delayed group receiving training at the end of the control period. Qigong training (level 1 Chaoyi Fanhuan Qigong, CFQ), given over three half-days, was followed by weekly review/practice sessions for eight weeks; participants were also asked to practice at home for 45 to 60 minutes per day for this interval. Outcomes were pain, impact, sleep, physical function and mental function, and these were recorded at baseline, eight weeks, four months and six months. Immediate and delayed practice groups were analyzed individually compared to the control group, and as a combination group. Results In both the immediate and delayed treatment groups, CFQ demonstrated significant improvements in pain, impact, sleep, physical function and mental function when compared to the wait-list/usual care control group at eight weeks, with benefits extending beyond this time. Analysis of combined data indicated significant changes for all measures at all times for six months, with only one exception. Post-hoc analysis based on self-reported practice times indicated greater benefit with the per protocol group compared to minimal practice. Conclusions This study demonstrates that CFQ, a particular form of qigong, provides long-term benefits in several core domains in fibromyalgia. CFQ may be a useful adjuvant self-care treatment for fibromyalgia. Trial registration clinicaltrials.gov NCT00938834. PMID:22863206

  4. A Randomized Controlled Trial of Cognitive-Behavioral Therapy, Light Therapy, and Their Combination for Seasonal Affective Disorder

    ERIC Educational Resources Information Center

    Rohan, Kelly J.; Roecklein, Kathryn A.; Tierney Lindsey, Kathryn; Johnson, Leigh G.; Lippy, Robert D.; Lacy, Timothy J.; Barton, Franca B.

    2007-01-01

    This first controlled psychotherapy trial for seasonal affective disorder (SAD) compared SAD-tailored cognitive-behavioral therapy (CBT), light therapy (LT), and their combination to a concurrent wait-list control. Adults (N = 61) with major depression, recurrent with seasonal pattern, were randomized to one of four 6-week conditions: CBT (1.5-hr…

  5. Randomized control trial: Online parent program and waiting period for unmarried parents in Title IV-D court.

    PubMed

    Rudd, Brittany N; Holtzworth-Munroe, Amy; Reyome, Jason G; Applegate, Amy G; D'Onofrio, Brian M

    2015-10-01

    Despite a lack of research on parent education programs for unmarried parents, many judicial officers mandate participation. We recruited an understudied sample likely at high risk for negative outcomes-182 court cases involving unmarried parents on government assistance in which paternity was contested and then established via genetic testing ordered by the court. This 2 × 2 randomized controlled trial evaluated the impact on initial litigation outcomes of two factors: (a) participation in an online parent education program or not and (b) having a waiting period between the establishment of paternity and the court hearing concerning child-related issues or not. Using an intent-to-treat framework, we found that among cases not assigned to the program, there was no difference in the rate of full agreement on child-related issues (e.g., child support, custody, parenting time) when comparing cases assigned to a waiting period and cases not assigned to a waiting period. In contrast, for cases assigned to the program, cases also assigned a waiting period were less likely to reach a full agreement than cases that had their hearing on the same day. In addition, cases in the "program and waiting period" condition were less likely to return to court for their hearing than cases in the "no program and waiting period" condition. In exploratory analyses of the subsample of cases in which both parents were present at the court hearing, the pattern of results remained the same, although the findings were no longer statistically significant. (c) 2015 APA, all rights reserved).

  6. EMDR for Syrian refugees with posttraumatic stress disorder symptoms: results of a pilot randomized controlled trial

    PubMed Central

    Acarturk, Ceren; Konuk, Emre; Cetinkaya, Mustafa; Senay, Ibrahim; Sijbrandij, Marit; Cuijpers, Pim; Aker, Tamer

    2015-01-01

    Background The most common mental health problems among refugees are depression and posttraumatic stress disorder (PTSD). Eye movement desensitization and reprocessing (EMDR) is an effective treatment for PTSD. However, no previous randomized controlled trial (RCT) has been published on treating PTSD symptoms in a refugee camp population. Objective Examining the effect of EMDR to reduce the PTSD and depression symptoms compared to a wait-list condition among Syrian refugees. Method Twenty-nine adult participants with PTSD symptoms were randomly allocated to either EMDR sessions (n=15) or wait-list control (n=14). The main outcome measures were Impact of Event Scale-Revised (IES-R) and Beck Depression Inventory (BDI-II) at posttreatment and 4-week follow-up. Results Analysis of covariance showed that the EMDR group had significantly lower trauma scores at posttreatment as compared with the wait-list group (d=1.78, 95% CI: 0.92–2.64). The EMDR group also had a lower depression score after treatment as compared with the wait-list group (d=1.14, 95% CI: 0.35–1.92). Conclusion The pilot RCT indicated that EMDR may be effective in reducing PTSD and depression symptoms among Syrian refugees located in a camp. Larger RCTs to verify the (cost-) effectiveness of EMDR in similar populations are needed. PMID:25989952

  7. A comparative analysis of centralized waiting lists for patients without a primary care provider implemented in six Canadian provinces: study protocol.

    PubMed

    Breton, Mylaine; Green, Michael; Kreindler, Sara; Sutherland, Jason; Jbilou, Jalila; Wong, Sabrina T; Shaw, Jay; Crooks, Valorie A; Contandriopoulos, Damien; Smithman, Mélanie Ann; Brousselle, Astrid

    2017-01-21

    Having a regular primary care provider (i.e., family physician or nurse practitioner) is widely considered to be a prerequisite for obtaining healthcare that is timely, accessible, continuous, comprehensive, and well-coordinated with other parts of the healthcare system. Yet, 4.6 million Canadians, approximately 15% of Canada's population, are unattached; that is, they do not have a regular primary care provider. To address the critical need for attachment, especially for more vulnerable patients, six Canadian provinces have implemented centralized waiting lists for unattached patients. These waiting lists centralize unattached patients' requests for a primary care provider in a given territory and match patients with providers. From the little information we have on each province's centralized waiting list, we know the way they work varies significantly from province to province. The main objective of this study is to compare the different models of centralized waiting lists for unattached patients implemented in six provinces of Canada to each other and to available scientific knowledge to make recommendations on ways to improve their design in an effort to increase attachment of patients to a primary care provider. A logic analysis approach developed in three steps will be used. Step 1: build logic models that describe each province's centralized waiting list through interviews with key stakeholders in each province; step 2: develop a conceptual framework, separate from the provincially informed logic models, that identifies key characteristics of centralized waiting lists for unattached patients and factors influencing their implementation through a literature review and interviews with experts; step 3: compare the logic models to the conceptual framework to make recommendations to improve centralized waiting lists in different provinces during a pan Canadian face-to-face exchange with decision-makers, clinicians and researchers. This study is based on an inter

  8. Mortality on the Waiting List for Lung Transplantation in Patients with Idiopathic Pulmonary Fibrosis: A Single-Centre Experience.

    PubMed

    Bennett, David; Fossi, Antonella; Bargagli, Elena; Refini, Rosa Metella; Pieroni, Maria; Luzzi, Luca; Ghiribelli, Claudia; Paladini, Piero; Voltolini, Luca; Rottoli, Paola

    2015-10-01

    Lung transplantation (LTX) is nowadays accepted as a treatment option for selected patients with end-stage pulmonary disease. Idiopathic pulmonary fibrosis (IPF) is characterized by the radiological and histologic appearance of usual interstitial pneumonia. It is associated with a poor prognosis, and LTX is considered an effective treatment to significantly modify the natural history of this disease. The aim of the present study was to analyse mortality during the waiting list in IPF patients at a single institution. A retrospective analysis on IPF patients (n = 90) referred to our Lung Transplant Program in the period 2001-2014 was performed focusing on patients' characteristics and associated risk factors. Diagnosis of IPF was associated with high mortality on the waiting list with respect to other diagnosis (p < 0.05). No differences in demographic, clinical, radiological data and time spent on the waiting list were observed between IPF patients who underwent to LTX or lost on the waiting list. Patients who died showed significant higher levels of pCO2 and needed higher flows of O2-therapy on effort (p < 0.05). Pulmonary function tests failed to predict mortality and no other medical conditions were associated with survival. Patients newly diagnosed with IPF, especially in small to medium lung transplant volume centres and in Countries where a long waiting list is expected, should be immediately referred to transplantation, delay results in increased mortality. Early identification of IPF patients with a rapid progressive phenotype is strongly needed.

  9. How effective are volunteers at supporting people in their last year of life? A pragmatic randomised wait-list trial in palliative care (ELSA).

    PubMed

    Walshe, Catherine; Dodd, Steven; Hill, Matt; Ockenden, Nick; Payne, Sheila; Preston, Nancy; Perez Algorta, Guillermo

    2016-12-09

    Clinical care alone at the end of life is unlikely to meet all needs. Volunteers are a key resource, acceptable to patients, but there is no evidence on care outcomes. This study aimed to determine whether support from a social action volunteer service is better than usual care at improving quality of life for adults in the last year of life. A pragmatic, multi-centre wait-list controlled trial, with participants randomly allocated to receive the volunteer support intervention either immediately or after a 4 week wait. Trained volunteers provided tailored face-to-face support including befriending, practical support and signposting to services, primarily provided within the home, typically for 2-3 hours per week. The primary outcome was rate of change of quality of life at 4 weeks (WHO QOL BREF, a general, culturally sensitive measure). Secondary outcomes included rate of change of quality of life at 8 weeks and Loneliness (De Jong Gierveld Loneliness Scale), social support (mMOS-SS), and reported use of health and social care services at 4 and 8 weeks. In total, 196 adults (61% (n = 109) female; mean age 72 years) were included in the study. No significant difference was found in main or secondary outcomes at 4 weeks. Rate of change of quality of life showed trends in favour of the intervention (physical quality of life domain: b = 3.98, CI, -0.38 to 8.34; psychological domain: b = 2.59, CI, -2.24 to 7.43; environmental domain: b = 3, CI, -4.13 to 4.91). Adjusted analyses to control for hours of volunteer input found significantly less decrease in physical quality of life in the intervention group (slope (b) 4.43, CI, 0.10 to 8.76). While the intervention also favoured the rate of change of emotional (b = -0.08; CI, -0.52 to 0.35) and social loneliness (b = -0.20; CI, -0.58 to 0.18), social support (b = 0.13; CI, -0.13 to 0.39), and reported use of health and social care professionals (b = 0.16; CI, -0.22 to 0.55), these were

  10. Effect Size in Efficacy Trials of Women With Decreased Sexual Desire.

    PubMed

    Pyke, Robert E; Clayton, Anita H

    2018-03-22

    Regarding hypoactive sexual desire disorder (HSDD) in women, some reviewers judge the effect size small for medications vs placebo, but substantial for cognitive behavior therapy (CBT) or mindfulness meditation training (MMT) vs wait list. However, we lack comparisons of the effect sizes for the active intervention itself, for the control treatment, and for the differential between the two. For efficacy trials of HSDD in women, compare effect sizes for medications (testosterone/testosterone transdermal system, flibanserin, and bremelanotide) and placebo vs effect sizes for psychotherapy and wait-list control. We conducted a literature search for mean changes and SD on main measures of sexual desire and associated distress in trials of medications, CBT, or MMT. Effect size was used as it measures the magnitude of the intervention without confounding by sample size. Cohen d was used to determine effect sizes. For medications, mean (SD) effect size was 1.0 (0.34); for CBT and MMT, 1.0 (0.36); for placebo, 0.55 (0.16); and for wait list, 0.05 (0.26). Recommendations of psychotherapy over medication for treatment of HSDD are premature and not supported by data on effect sizes. Active participation in treatment conveys considerable non-specific benefits. Caregivers should attend to biological and psychosocial elements, and patient preference, to optimize response. Few clinical trials of psychotherapies were substantial in size or utilized adequate control paradigms. Medications and psychotherapies had similar, large effect sizes. Effect size of placebo was moderate. Effect size of wait-list control was very small, about one quarter that of placebo. Thus, a substantial non-specific therapeutic effect is associated with receiving placebo plus active care and evaluation. The difference in effect size between placebo and wait-list controls distorts the value of the subtraction of effect of the control paradigms to estimate intervention effectiveness. Pyke RE, Clayton AH

  11. Mental health first aid training by e-learning: a randomized controlled trial.

    PubMed

    Jorm, Anthony F; Kitchener, Betty A; Fischer, Julie-Anne; Cvetkovski, Stefan

    2010-12-01

    Mental Health First Aid training is a course for the public that teaches how to give initial help to a person developing a mental health problem or in a mental health crisis. The present study evaluated the effects of Mental Health First Aid training delivered by e-learning on knowledge about mental disorders, stigmatizing attitudes and helping behaviour. A randomized controlled trial was carried out with 262 members of the Australian public. Participants were randomly assigned to complete an e-learning CD, read a Mental Health First Aid manual or be in a waiting list control group. The effects of the interventions were evaluated using online questionnaires pre- and post-training and at 6-months follow up. The questionnaires covered mental health knowledge, stigmatizing attitudes, confidence in providing help to others, actions taken to implement mental health first aid and participant mental health. Both e-learning and the printed manual increased aspects of knowledge, reduced stigma and increased confidence compared to waiting list. E-learning also improved first aid actions taken more than waiting list, and was superior to the printed manual in reducing stigma and disability due to mental ill health. Mental Health First Aid information received by either e-learning or printed manual had positive effects, but e-learning was better at reducing stigma.

  12. Psychotherapy With Somatosensory Stimulation for Endometriosis-Associated Pain: A Randomized Controlled Trial.

    PubMed

    Meissner, Karin; Schweizer-Arau, Annemarie; Limmer, Anna; Preibisch, Christine; Popovici, Roxana M; Lange, Isabel; de Oriol, Barbara; Beissner, Florian

    2016-11-01

    To evaluate whether psychotherapy with somatosensory stimulation is effective for the treatment of pain and quality of life in patients with endometriosis-related pain. Patients with a history of endometriosis and chronic pelvic pain were randomized to either psychotherapy with somatosensory stimulation (ie, different techniques of acupuncture point stimulation) or wait-list control for 3 months, after which all patients were treated. The primary outcome was brain connectivity assessed by functional magnetic resonance imaging. Prespecified secondary outcomes included pain on 11-point numeric rating scales (maximal and average global pain, pelvic pain, dyschezia, and dyspareunia) and physical and mental quality of life. A sample size of 30 per group was planned to compare outcomes in the treatment group and the wait-list control group. From March 2010 through March 2012, 67 women (mean age 35.6 years) were randomly allocated to intervention (n=35) or wait-list control (n=32). In comparison with wait-list controls, treated patients showed improvements after 3 months in maximal global pain (mean group difference -2.1, 95% confidence interval [CI] -3.4 to -0.8; P=.002), average global pain (-2.5, 95% CI -3.5 to -1.4; P<.001), pelvic pain (-1.4, 95% CI -2.7 to -0.1; P=.036), dyschezia (-3.5, 95% CI -5.8 to -1.3; P=.003), physical quality of life (3.8, 95% CI 0.5-7.1, P=.026), and mental quality of life (5.9, 95% CI 0.6-11.3; P=.031); dyspareunia improved nonsignificantly (-1.8, 95% CI -4.4 to 0.7; P=.150). Improvements in the intervention group remained stable at 6 and 24 months, and control patients showed comparable symptom relief after delayed intervention. Psychotherapy with somatosensory stimulation reduced global pain, pelvic pain, and dyschezia and improved quality of life in patients with endometriosis. After 6 and 24 months, when all patients were treated, both groups showed stable improvements. ClinicalTrials.gov, https://clinicaltrials.gov, NCT01321840.

  13. Effectiveness and acceptance of a web-based depression intervention during waiting time for outpatient psychotherapy: study protocol for a randomized controlled trial.

    PubMed

    Grünzig, Sasha-Denise; Baumeister, Harald; Bengel, Jürgen; Ebert, David; Krämer, Lena

    2018-05-22

    Due to limited resources, waiting periods for psychotherapy are often long and burdening for those in need of treatment and the health care system. In order to bridge the gap between initial contact and the beginning of psychotherapy, web-based interventions can be applied. The implementation of a web-based depression intervention during waiting periods has the potential to reduce depressive symptoms and enhance well-being in depressive individuals waiting for psychotherapy. In a two-arm randomized controlled trial, effectiveness and acceptance of a guided web-based intervention for depressive individuals on a waitlist for psychotherapy are evaluated. Participants are recruited in several German outpatient clinics. All those contacting the outpatient clinics with the wish to enter psychotherapy receive study information and a depression screening. Those adults (age ≥ 18) with depressive symptoms above cut-off (CES-D scale > 22) and internet access are randomized to either intervention condition (treatment as usual and immediate access to the web-based intervention) or waiting control condition (treatment as usual and delayed access to the web-based intervention). At three points of assessment (baseline, post-treatment, 3-months-follow-up) depressive symptoms and secondary outcomes, such as quality of life, attitudes towards psychotherapy and web-based interventions and adverse events are assessed. Additionally, participants' acceptance of the web-based intervention is evaluated, using measures of intervention adherence and satisfaction. This study investigates a relevant setting for the implementation of web-based interventions, potentially improving the provision of psychological health care. The results of this study contribute to the evaluation of innovative and resource-preserving health care models for outpatient psychological treatment. This trial has been registered on 13 February 2017 in the German clinical trials register (DRKS); registration

  14. The natural history of subjective tinnitus in adults: A systematic review and meta-analysis of no-intervention periods in controlled trials.

    PubMed

    Phillips, John S; McFerran, Don J; Hall, Deborah A; Hoare, Derek J

    2018-01-01

    Tinnitus is a prevalent condition, but little has been published regarding the natural history of the condition. One technique for evaluating the long-term progression of the disease is to examine what happens to participants in the no-intervention control arm of a clinical trial. The aim of this study was to examine no-intervention or waiting-list data reported in trials, in which participants on the active arm received any form of tinnitus intervention. CINAHL, PsychINFO, EMBASE, ASSIA, PubMed, Web of Science, Science Direct, EBSCO Host, and Cochrane. Inclusion criteria followed the PICOS principles: Participants, adults with tinnitus; Intervention, none; Control, any intervention for alleviating tinnitus; Outcomes, a measure assessing tinnitus symptoms using a multi-item patient-reported tinnitus questionnaire. Secondary outcome measures included multi-item patient-reported questionnaires of mood and health-related quality of life and measures that quantified change in tinnitus loudness; Study design, randomized controlled trials or observational studies utilizing a no-intervention or waiting-list control group. Data were extracted and standardized mean difference was calculated for each study to enable meta-analysis. The evidence strongly favored a statistically significant decrease in the impact of tinnitus over time, though there was significant heterogeneity and clinical significance cannot be interpreted. Outcome data regarding secondary measures did not demonstrate any clinically significant change. Participants allocated to the no-intervention or waiting-list control arm of clinical trials for a tinnitus intervention show a small but significant improvement in self-reported measures of tinnitus with time; the clinical significance of this finding is unknown. There is, however, considerable variation across individuals. These findings support previous work and can cautiously be used when counseling patients. Laryngoscope, 128:217-227, 2018. © 2017 The

  15. Hypertension analysis of stress reduction using mindfulness meditation and yoga: results from the HARMONY randomized controlled trial.

    PubMed

    Blom, Kimberly; Baker, Brian; How, Maxine; Dai, Monica; Irvine, Jane; Abbey, Susan; Abramson, Beth L; Myers, Martin G; Kiss, Alex; Perkins, Nancy J; Tobe, Sheldon W

    2014-01-01

    The HARMONY study was a randomized, controlled trial examining the efficacy of an 8-week mindfulness-based stress reduction (MBSR) program for blood pressure (BP) lowering among unmedicated stage 1 hypertensive participants. Participants diagnosed with stage 1 hypertension based on ambulatory BP were randomized to either immediate treatment of MBSR for 8 weeks or wait-list control. Primary outcome analysis evaluated whether change in awake and 24-hour ambulatory BP from baseline to week 12 was significantly different between the 2 groups. A within-group before and after MBSR analysis was also performed. The study enrolled 101 adults (38% male) with baseline average 24-hour ambulatory BP of 135±7.9/82±5.8mm Hg and daytime ambulatory BP of 140±7.7/87±6.3 mmHg. At week 12, the change from baseline in 24-hour ambulatory BP was 0.4±6.7/0.0±4.9mm Hg for the immediate intervention and 0.4±7.8/-0.4±4.6mm Hg for the wait-list control. There were no significant differences between intervention and wait-list control for all ambulatory BP parameters. The secondary within-group analysis found a small reduction in BP after MBSR compared with baseline, a finding limited to female subjects in a sex analysis. MBSR did not lower ambulatory BP by a statistically or clinically significant amount in untreated, stage 1 hypertensive patients when compared with a wait-list control group. It leaves untested whether MBSR might be useful for lowering BP by improving adherence in treated hypertensive participants. NCT00825526.

  16. The effects of laughter therapy on mood state and self-esteem in cancer patients undergoing radiation therapy: a randomized controlled trial.

    PubMed

    Kim, So Hee; Kook, Jeong Ran; Kwon, Moonjung; Son, Myeong Ha; Ahn, Seung Do; Kim, Yeon Hee

    2015-04-01

    To investigate whether laughter therapy lowers total mood disturbance scores and improves self-esteem scores in patients with cancer. Randomized controlled trial in a radio-oncology outpatient setting. Sixty-two patients were enrolled and randomly assigned to the experimental group (n=33) or the wait list control group (n=29). Three laughter therapy sessions lasting 60 minutes each. Mood state and self-esteem. The intention-to-treat analysis revealed a significant main effect of group: Experimental group participants reported a 14.12-point reduction in total mood disturbance, while the wait list control group showed a 1.21-point reduction (p=0.001). The per-protocol analysis showed a significant main effect of group: The experimental group reported a 18.86-point decrease in total mood disturbance, while controls showed a 0.19-point reduction (p<0.001). The self-esteem of experimental group was significantly greater than that of the wait list control group (p=0.044). These results indicate that laughter therapy can improve mood state and self-esteem and can be a beneficial, noninvasive intervention for patients with cancer in clinical settings.

  17. The effect of early education on patient anxiety while waiting for elective cardiac catheterization.

    PubMed

    Harkness, Karen; Morrow, Lydia; Smith, Kelly; Kiczula, Michele; Arthur, Heather M

    2003-07-01

    A supply-demand mismatch with respect to cardiac catheterization (CATH) often results in patients experiencing waiting times that vary from a few weeks to several months. Long delays can impose both physical and psychological distress for patients. The purpose of this study was to examine the effect of a psychoeducational nursing intervention at the beginning of the waiting period on patient anxiety during the waiting time for elective CATH. This was a 2-group randomized controlled trial. Intervention patients received a nurse-delivered, detailed information/education session within 2 weeks of being placed on the waiting list for elective CATH. Control group patients received usual care. The mean waiting time for CATH was 13.4+/-7.2 weeks, which did not differ between groups (P=0.509). Anxiety increased in both groups over the waiting time (P=0.028). Health-related quality of life deteriorated over the waiting time in both groups (P<0.05). On a visual analogue scale, there was a significant difference (P=0.002) between the intervention (4.0+/-2.7) and control (5.2+/-3.0) groups in self-reported anxiety 2 weeks prior to CATH. The waiting period prior to elective CATH has a negative impact on patients' perceived anxiety and quality of life and a simple intervention, provided at the beginning of the waiting period, may positively affect the experience of waiting.

  18. Do case-generic measures of queue performance for bypass surgery accurately reflect the waiting-list experiences of those most urgent?

    PubMed

    Burstein, Jason; Lee, Douglas S; Alter, David A

    2006-02-01

    Queue performance is typically assessed using generic measures, which capture the queue in aggregate. The objective of this study was to examine whether case-generic measures of queue performance appropriately reflected the waiting-list experiences of those patients with greatest disease severity. We examined the queue for isolated coronary artery bypass grafting (CABG) in Ontario between April 1993 and March 2000 using data obtained from the Cardiac Care Network. Our primary measure of queue performance was the proportion of patients who received their bypass surgery within their recommended maximum waiting times (%RMWTs) in any given month. We compared case-generic measures of queue performance to case-specific measures of queue performance stratified by urgency level. The queue was largely comprised of elective cases ranging from 73% (1993) to 57%(1999). Urgent patients comprised the minority of the queue ranging from 14% (1993) to 20% (1999). Case-generic month-to-month variations in the percentage of cases completed within RMWTs (an aggregated waiting list measure encompassing the characteristics of all patients in the queue) closely resembled the experiences of elective patients (R2 = 0.81), but conversely, bore little relationship to the waiting-list experiences of those most urgent (R2 = 0.15). Case-generic measures of queue performance for bypass surgery in Ontario were not reflective of the waiting-list experiences of those most urgent. Our results reinforce the concept that urgency-specific waiting list monitoring systems are required to best evaluate and appropriately respond to fluctuations in queue performance.

  19. The Self-help Online against Suicidal thoughts (SOS) trial: study protocol for a randomized controlled trial.

    PubMed

    Mühlmann, Charlotte; Madsen, Trine; Hjorthøj, Carsten; Kerkhof, Ad; Nordentoft, Merete; Erlangsen, Annette

    2017-01-28

    Suicidal thoughts are common, causing distress for millions of people all over the world. However, people with suicidal thoughts might not access support due to financial restraints, stigma or a lack of available treatment offers. Self-help programs provided online could overcome these barriers, and previous efforts show promising results in terms of reducing suicidal thoughts. This study aims to examine the effectiveness of an online self-help intervention in reducing suicidal thoughts among people at risk of suicide. The Danish Self-help Online against Suicidal thoughts (SOS) trial is a partial replication of a previously conducted Dutch trial. A randomized, waiting-list controlled trial with 1:1 allocation ratio will be carried out. A total of 438 people with suicidal thoughts will be recruited from the Danish suicide hotline, The Lifeline's, website and allocated to the intervention condition (N = 219) or the control condition (N = 219). The intervention condition consists of a 6-week, Internet-based self-help therapy intervention. The format of the intervention is self-help, but the participants can be guided by the trial manager. The control condition consists of a waiting-list assignment for 32 weeks. The primary outcomes are frequency and intensity of suicidal thoughts. Secondary outcome measures include depressive symptoms, hopelessness, worrying, quality of life, costs related to health care utilization and production loss. Number of deliberate self-harm episodes, suicides and deaths will, as well as the participant's evaluation of the intervention and the experience of negative effects, be investigated. Assessments will be conducted over the intervention website through self-report questionnaires at baseline, 2 weeks, 4 weeks, 6 weeks and 32 weeks (6 months post intervention). If we find the intervention to be linked to reductions in suicidal thoughts, this will strengthen the evidence that online self-help interventions are relevant tools for

  20. Video-game based exercises for older people with chronic low back pain: a protocol for a feasibility randomised controlled trial (the GAMEBACK trial).

    PubMed

    Zadro, Joshua Robert; Shirley, Debra; Simic, Milena; Mousavi, Seyed Javad; Ceprnja, Dragana; Maka, Katherine; Ferreira, Paulo

    2017-06-01

    To investigate the feasibility of implementing a video-game exercise programme for older people with chronic low back pain (LBP). Single-centred single-blinded randomised controlled trial (RCT). Physiotherapy outpatient department in a public hospital in Western Sydney, Australia. We will recruit 60 participants over 55 years old with chronic LBP from the waiting list. Participants will be randomised to receive video-game exercise (n=30) or to remain on the waiting list (n=30) for 8 weeks, with follow up at 3 and 6 months. Participants engaging in video-game exercises will be unsupervised and will complete video-game exercise for 60minutes, 3 times per week. Participants allocated to remain on the waiting list will be encouraged to maintain their usual levels of physical activity. The primary outcomes for this feasibility study will be study processes (recruitment and response rates, adherence to and experience with the intervention, and incidence of adverse events) relevant to the future design of a large RCT. Estimates of treatment efficacy (point estimates and 95% confidence intervals) on pain self-efficacy, care seeking, physical activity, fear of movement/re-injury, pain, physical function, disability, falls-efficacy, strength, and walking speed, will be our secondary outcome measures. Recruitment for this trial began in November 2015. This study describes the rationale and processes of a feasibility study investigating a video-game exercise programme for older people with chronic LBP. Results from the feasibility study will inform on the design and sample required for a large multicentre RCT. Australian New Zealand Clinical Trials Registry: ACTRN12615000703505. Copyright © 2016 Chartered Society of Physiotherapy. Published by Elsevier Ltd. All rights reserved.

  1. High Emergency Lung Transplantation: dramatic decrease of waiting list death rate without relevant higher post-transplant mortality.

    PubMed

    Roux, Antoine; Beaumont-Azuar, Laurence; Hamid, Abdul Monem; De Miranda, Sandra; Grenet, Dominique; Briend, Guillaume; Bonnette, Pierre; Puyo, Philippe; Parquin, François; Devaquet, Jerome; Trebbia, Gregoire; Cuquemelle, Elise; Douvry, Benoit; Picard, Clément; Le Guen, Morgan; Chapelier, Alain; Stern, Marc; Sage, Edouard

    2015-09-01

    Many candidates for lung transplantation (LT) die on the waiting list, raising the question of graft availability and strategy for organ allocation. We report the experience of the new organ allocation program, "High Emergency Lung Transplantation" (HELT), since its implementation in our center in 2007. Retrospective analysis of 201 lung transplant patients, of whom 37 received HELT from 1st July 2007 to 31th May 2012. HELT candidates had a higher impairment grade on respiratory status and higher Lung Allocation Score (LAS). HELT patients had increased incidence of perioperative complications (e.g., perioperative bleeding) and extracorporeal circulatory assistance (75% vs. 36.6%, P = 0.0005). No significant difference was observed between HELT and non-HELT patients in mechanical ventilation duration (15.5 days vs. 11 days, P = 0.27), intensive care unit length of stay (15 days vs. 10 days, P = 0.22) or survival rate at 12 (81% vs. 80%), and 24 months post-LT (72.9% vs. 75.0%). Lastly, mortality on the waiting list was spectacularly reduced from 19% to 2% when compared to the non-HELT 2004-2007 group. Despite a more severe clinical status of patients on the waiting list, HELT provided similar results to conventional LT. These results were associated with a dramatic reduction in the mortality rate of patients on the waiting list. © 2015 Steunstichting ESOT.

  2. Randomized Controlled Trial of Full and Brief Cognitive-Behaviour Therapy and Wait-List for Paediatric Obsessive-Compulsive Disorder

    ERIC Educational Resources Information Center

    Bolton, Derek; Williams, Tim; Perrin, Sean; Atkinson, Linda; Gallop, Catherine; Waite, Polly; Salkovskis, Paul

    2011-01-01

    Background: Reviews and practice guidelines for paediatric obsessive-compulsive disorder (OCD) recommend cognitive-behaviour therapy (CBT) as the psychological treatment of choice, but note that it has not been sufficiently evaluated for children and adolescents and that more randomized controlled trials are needed. The aim of this trial was to…

  3. Obesity Surgery Score (OSS) for Prioritization in the Bariatric Surgery Waiting List: a Need of Public Health Systems and a Literature Review.

    PubMed

    Casimiro Pérez, José Antonio; Fernández Quesada, Carlos; Del Val Groba Marco, María; Arteaga González, Iván; Cruz Benavides, Francisco; Ponce, Jaime; de Pablos Velasco, Pedro; Marchena Gómez, Joaquín

    2018-04-01

    In the last decades, we have experienced an increase in the prevalence of obesity in western countries with a higher demand for bariatric surgery and consequently prolonged waiting times. Currently, in many public hospitals, the only criterion that establishes priority for bariatric surgery is waiting time regardless of obesity severity. We propose a new, simple, and homogeneous clinical prioritization system, the Obesity Surgery Score (OSS), which takes into account simultaneously and equitably the time on surgical waiting list and the obesity severity based on three variables: body mass index, obesity-related comorbidities, and functional limitations. We have reviewed the current literature related to obesity clinical staging systems, and we have carried out an analysis of our patients in waiting list and divided their characteristics according to their degree of severity (A, B, or C) in the OSS. Patients with OSS grade C have a higher mean BMI, greater severity in comorbidities, and greater socio-labor impact. The current surgery waiting time of our series is of 26 months. Currently, 27 patients (51.9%) with OSS grade B and 15 patients (51.7%) with OSS grade C have been on our waiting list for more than 1 year. Since the obesity severity, the waiting time and its clinical consequences are associated with an increase in morbidity and mortality, it is important to apply a structured prioritization system for bariatric surgery waiting list. This allows prioritization of patients at greater risk, improves patient prognosis, and optimizes costs and available health resources.

  4. Effects of a stress management intervention on absenteeism and return to work--results from a randomized wait-list controlled trial.

    PubMed

    Willert, Morten Vejs; Thulstrup, Ane Marie; Bonde, Jens Peter

    2011-05-01

    High levels of work-related stress are associated with increased absenteeism from work and reduced work ability. In this study, we investigated the effects of a stress management intervention on absenteeism and return to work. We randomized 102 participants into either the intervention or wait-list control (WLC) group. The intervention group received the intervention in weeks 1-16 from baseline, and the WLC group received the intervention in weeks 17-32. Self-reported data on absenteeism (number of days full- or part-time absent from work within the previous three months) were obtained at 16, 32, and 48 weeks follow-up. Register-based data on long-term absence from work were drawn from the Danish public transfer payments (DREAM) database from baseline and 48 weeks onwards. The DREAM database contains weekly information on long-term sickness absence compensation. The threshold to enter DREAM is sick leave for two consecutive weeks. At follow-up in week 16, self-reported absenteeism in the intervention group [median 11 days (range 3-25)] was lower (P=0.02) than in the WLC group [median 45 days (range 19-60)], corresponding to a 29% [95% confidence interval (95% CI) 5-52] reduction. On register-based data (cumulated weeks in DREAM, weeks 1-16), the intervention group median [6 weeks (range 0-11)] was lower than that of the WLC group [median 12 weeks (range 8-16)], though not significantly (P=0.06), corresponding to a 21% (95% CI 0-42) reduction. For return to work, a hazard ratio of 1.58 (95% CI 0.89-2.81) favoring the intervention group was found (P=0.12). The intervention reduces self-reported absenteeism from work. A similar trend was found from register-based records. No conclusive evidence was found for return to work.

  5. Interreality for the management and training of psychological stress: study protocol for a randomized controlled trial

    PubMed Central

    2013-01-01

    Background Psychological stress occurs when an individual perceives that environmental demands tax or exceed his or her adaptive capacity. Its association with severe health and emotional diseases, points out the necessity to find new efficient strategies to treat it. Moreover, psychological stress is a very personal problem and requires training focused on the specific needs of individuals. To overcome the above limitations, the INTERSTRESS project suggests the adoption of a new paradigm for e-health - Interreality - that integrates contextualized assessment and treatment within a hybrid environment, bridging the physical and the virtual worlds. According to this premise, the aim of this study is to investigate the advantages of using advanced technologies, in combination with cognitive behavioral therapy (CBT), based on a protocol for reducing psychological stress. Methods/Design The study is designed as a randomized controlled trial. It includes three groups of approximately 50 subjects each who suffer from psychological stress: (1) the experimental group, (2) the control group, (3) the waiting list group. Participants included in the experimental group will receive a treatment based on cognitive behavioral techniques combined with virtual reality, biofeedback and mobile phone, while the control group will receive traditional stress management CBT-based training, without the use of new technologies. The wait-list group will be reassessed and compared with the two other groups five weeks after the initial evaluation. After the reassessment, the wait-list patients will randomly receive one of the two other treatments. Psychometric and physiological outcomes will serve as quantitative dependent variables, while subjective reports of participants will be used as the qualitative dependent variable. Discussion What we would like to show with the present trial is that bridging virtual experiences, used to learn coping skills and emotional regulation, with real

  6. Computer Enabled Neuroplasticity Treatment: A Clinical Trial of a Novel Design for Neurofeedback Therapy in Adult ADHD

    PubMed Central

    Cowley, Benjamin; Holmström, Édua; Juurmaa, Kristiina; Kovarskis, Levas; Krause, Christina M.

    2016-01-01

    Background: We report a randomized controlled clinical trial of neurofeedback therapy intervention for ADHD/ADD in adults. We focus on internal mechanics of neurofeedback learning, to elucidate the primary role of cortical self-regulation in neurofeedback. We report initial results; more extensive analysis will follow. Methods: Trial has two phases: intervention and follow-up. The intervention consisted of neurofeedback treatment, including intake and outtake measurements, using a waiting-list control group. Treatment involved ~40 h-long sessions 2–5 times per week. Training involved either theta/beta or sensorimotor-rhythm regimes, adapted by adding a novel “inverse-training” condition to promote self-regulation. Follow-up (ongoing) will consist of self-report and executive function tests. Setting: Intake and outtake measurements were conducted at University of Helsinki. Treatment was administered at partner clinic Mental Capital Care, Helsinki. Randomization: We randomly allocated half the sample then adaptively allocated the remainder to minimize baseline differences in prognostic variables. Blinding: Waiting-list control design meant trial was not blinded. Participants: Fifty-four adult Finnish participants (mean age 36 years; 29 females) were recruited after screening by psychiatric review. Forty-four had ADHD diagnoses, 10 had ADD. Measurements: Symptoms were assessed by computerized attention test (T.O.V.A.) and self-report scales, at intake and outtake. Performance during neurofeedback trials was recorded. Results: Participants were recruited and completed intake measurements during summer 2012, before assignment to treatment and control, September 2012. Outtake measurements ran April-August 2013. After dropouts, 23 treatment and 21 waiting-list participants remained for analysis. Initial analysis showed that, compared to waiting-list control, neurofeedback promoted improvement of self-reported ADHD symptoms, but did not show transfer of learning to T

  7. Effects of a manualized short-term treatment of internet and computer game addiction (STICA): study protocol for a randomized controlled trial.

    PubMed

    Jäger, Susanne; Müller, Kai W; Ruckes, Christian; Wittig, Tobias; Batra, Anil; Musalek, Michael; Mann, Karl; Wölfling, Klaus; Beutel, Manfred E

    2012-04-27

    In the last few years, excessive internet use and computer gaming have increased dramatically. Salience, mood modification, tolerance, withdrawal symptoms, conflict, and relapse have been defined as diagnostic criteria for internet addiction (IA) and computer addiction (CA) in the scientific community. Despite a growing number of individuals seeking help, there are no specific treatments of established efficacy. This clinical trial aims to determine the effect of the disorder-specific manualized short-term treatment of IA/CA (STICA). The cognitive behavioural treatment combines individual and group interventions with a total duration of 4 months. Patients will be randomly assigned to STICA treatment or to a wait list control group. Reliable and valid measures of IA/CA and co-morbid mental symptoms (for example social anxiety, depression) will be assessed prior to the beginning, in the middle, at the end, and 6 months after completion of treatment. A treatment of IA/CA will establish efficacy and is desperately needed. As this is the first trial to determine efficacy of a disorder specific treatment, a wait list control group will be implemented. Pros and cons of the design were discussed. ClinicalTrials (NCT01434589).

  8. Teaching in Cyberspace: Online versus Traditional Instruction Using a Waiting-List Experimental Design

    ERIC Educational Resources Information Center

    Poirier, Christopher R.; Feldman, Robert S.

    2004-01-01

    To test the effectiveness of an online introductory psychology course, we randomly assigned students to a large, traditional course or to an online course from a population of students who indicated that either course type was acceptable using a "waiting list" experimental design. Students in the online course performed better on exams and equally…

  9. Effects of a manualized short-term treatment of internet and computer game addiction (STICA): study protocol for a randomized controlled trial

    PubMed Central

    2012-01-01

    Background In the last few years, excessive internet use and computer gaming have increased dramatically. Salience, mood modification, tolerance, withdrawal symptoms, conflict, and relapse have been defined as diagnostic criteria for internet addiction (IA) and computer addiction (CA) in the scientific community. Despite a growing number of individuals seeking help, there are no specific treatments of established efficacy. Methods/design This clinical trial aims to determine the effect of the disorder-specific manualized short-term treatment of IA/CA (STICA). The cognitive behavioural treatment combines individual and group interventions with a total duration of 4 months. Patients will be randomly assigned to STICA treatment or to a wait list control group. Reliable and valid measures of IA/CA and co-morbid mental symptoms (for example social anxiety, depression) will be assessed prior to the beginning, in the middle, at the end, and 6 months after completion of treatment. Discussion A treatment of IA/CA will establish efficacy and is desperately needed. As this is the first trial to determine efficacy of a disorder specific treatment, a wait list control group will be implemented. Pros and cons of the design were discussed. Trial Registration ClinicalTrials (NCT01434589) PMID:22540330

  10. A randomised controlled trial of a web-based educational program in child mental health for schoolteachers.

    PubMed

    Pereira, Celina Andrade; Wen, Chao Lung; Miguel, Eurípedes Constantino; Polanczyk, Guilherme V

    2015-08-01

    Children affected by mental disorders are largely unrecognised and untreated across the world. Community resources, including the school system and teachers, are important elements in actions directed to promoting child mental health and preventing and treating mental disorders, especially in low- and middle-income countries. We developed a web-based program to educate primary school teachers on mental disorders in childhood and conducted a cluster-randomised controlled trial to test the effectiveness of the web-based program intervention in comparison with the same program based on text and video materials only and to a waiting-list control group. All nine schools of a single city in the state of São Paulo, Brazil, were randomised to the three groups, and teachers completed the educational programs during 3 weeks. Data were analysed according to complete cases and intention-to-treat approaches. In terms of gains of knowledge about mental disorders, the web-based program intervention was superior to the intervention with text and video materials, and to the waiting-list control group. In terms of beliefs and attitudes about mental disorders, the web-based program intervention group presented less stigmatised concepts than the text and video group and more non-stigmatised concepts than the waiting-list group. No differences were detected in terms of teachers' attitudes. This study demonstrated initial data on the effectiveness of a web-based program in educating schoolteachers on child mental disorders. Future studies are necessary to replicate and extend the findings.

  11. Thought Field Therapy Compared to Cognitive Behavioral Therapy and Wait-List for Agoraphobia: A Randomized, Controlled Study with a 12-Month Follow-up.

    PubMed

    Irgens, Audun C; Hoffart, Asle; Nysæter, Tor E; Haaland, Vegard Ø; Borge, Finn-Magnus; Pripp, Are H; Martinsen, Egil W; Dammen, Toril

    2017-01-01

    Background: Thought field therapy (TFT) is used for many psychiatric conditions, but its efficacy has not been sufficiently documented. Hence, there is a need for studies comparing TFT to well-established treatments. This study compares the efficacy of TFT and cognitive behavioral therapy (CBT) for patients with agoraphobia. Methods: Seventy-two patients were randomized to CBT ( N = 24), TFT ( N = 24) or a wait-list condition (WLC) ( N = 24) after a diagnostic procedure including the MINI PLUS that was performed before treatment or WLC. Following a 3 months waiting period, the WL patients were randomized to CBT ( n = 12) or TFT ( n = 12), and all patients were reassessed after treatment or waiting period and at 12 months follow-up. At first we compared the three groups CBT, TFT, and WL. After the post WL randomization, we compared CBT ( N = 12 + 24 = 36) to TFT ( N = 12 + 24 = 36), applying the pre-treatment scores as baseline for all patients. The primary outcome measure was a symptom score from the Anxiety Disorders Interview Scale that was performed by an interviewer blinded to the treatment condition. For statistical comparisons, we used the independent sample's t -test, the Fisher's exact test and the ANOVA and ANCOVA tests. Results: Both CBT and TFT showed better results than the WLC ( p < 0.001) at post-treatment. Post-treatment and at the 12-month follow-up, there were not significant differences between CBT and TFT ( p = 0.33 and p = 0.90, respectively). Conclusion: This paper reports the first study comparing TFT to CBT for any disorder. The study indicated that TFT may be an efficient treatment for patients with agoraphobia. Trial Registration: https://clinicaltrials.gov/, identifier NCT00932919.

  12. Thought Field Therapy Compared to Cognitive Behavioral Therapy and Wait-List for Agoraphobia: A Randomized, Controlled Study with a 12-Month Follow-up

    PubMed Central

    Irgens, Audun C.; Hoffart, Asle; Nysæter, Tor E.; Haaland, Vegard Ø.; Borge, Finn-Magnus; Pripp, Are H.; Martinsen, Egil W.; Dammen, Toril

    2017-01-01

    Background: Thought field therapy (TFT) is used for many psychiatric conditions, but its efficacy has not been sufficiently documented. Hence, there is a need for studies comparing TFT to well-established treatments. This study compares the efficacy of TFT and cognitive behavioral therapy (CBT) for patients with agoraphobia. Methods: Seventy-two patients were randomized to CBT (N = 24), TFT (N = 24) or a wait-list condition (WLC) (N = 24) after a diagnostic procedure including the MINI PLUS that was performed before treatment or WLC. Following a 3 months waiting period, the WL patients were randomized to CBT (n = 12) or TFT (n = 12), and all patients were reassessed after treatment or waiting period and at 12 months follow-up. At first we compared the three groups CBT, TFT, and WL. After the post WL randomization, we compared CBT (N = 12 + 24 = 36) to TFT (N = 12 + 24 = 36), applying the pre-treatment scores as baseline for all patients. The primary outcome measure was a symptom score from the Anxiety Disorders Interview Scale that was performed by an interviewer blinded to the treatment condition. For statistical comparisons, we used the independent sample’s t-test, the Fisher’s exact test and the ANOVA and ANCOVA tests. Results: Both CBT and TFT showed better results than the WLC (p < 0.001) at post-treatment. Post-treatment and at the 12-month follow-up, there were not significant differences between CBT and TFT (p = 0.33 and p = 0.90, respectively). Conclusion: This paper reports the first study comparing TFT to CBT for any disorder. The study indicated that TFT may be an efficient treatment for patients with agoraphobia. Trial Registration: https://clinicaltrials.gov/, identifier NCT00932919. PMID:28676782

  13. A Randomized, Controlled Trial of Meditation for Work Stress, Anxiety and Depressed Mood in Full-Time Workers

    PubMed Central

    Manocha, R.; Black, D.; Sarris, J.; Stough, C.

    2011-01-01

    Objective. To assess the effect of meditation on work stress, anxiety and mood in full-time workers. Methods. 178 adult workers participated in an 8-week, 3-arm randomized controlled trial comparing a “mental silence” approach to meditation (n = 59) to a “relaxation” active control (n = 56) and a wait-list control (n = 63). Participants were assessed before and after using Psychological Strain Questionnaire (PSQ), a subscale of the larger Occupational Stress Inventory (OSI), the State component of the State/Trait Anxiety Inventory for Adults (STAI), and the depression-dejection (DD) subscale of the Profile of Mood States (POMS). Results. There was a significant improvement for the meditation group compared to both the relaxation control and the wait-list groups the PSQ (P = .026), and DD (P = .019). Conclusions. Mental silence-orientated meditation, in this case Sahaja Yoga meditation, is a safe and effective strategy for dealing with work stress and depressive feelings. The findings suggest that “thought reduction” or “mental silence” may have specific effects relevant to work stress and hence occupational health. PMID:21716708

  14. Clinical effectiveness, cost-effectiveness and acceptability of low-intensity interventions in the management of obsessive-compulsive disorder: the Obsessive-Compulsive Treatment Efficacy randomised controlled Trial (OCTET).

    PubMed Central

    Lovell, Karina; Bower, Peter; Gellatly, Judith; Byford, Sarah; Bee, Penny; McMillan, Dean; Arundel, Catherine; Gilbody, Simon; Gega, Lina; Hardy, Gillian; Reynolds, Shirley; Barkham, Michael; Mottram, Patricia; Lidbetter, Nicola; Pedley, Rebecca; Molle, Jo; Peckham, Emily; Knopp-Hoffer, Jasmin; Price, Owen; Connell, Janice; Heslin, Margaret; Foley, Christopher; Plummer, Faye; Roberts, Christopher

    2017-01-01

    BACKGROUND The Obsessive-Compulsive Treatment Efficacy randomised controlled Trial emerged from a research recommendation in National Institute for Health and Care Excellence obsessive-compulsive disorder (OCD) guidelines, which specified the need to evaluate cognitive-behavioural therapy (CBT) treatment intensity formats. OBJECTIVES To determine the clinical effectiveness and cost-effectiveness of two low-intensity CBT interventions [supported computerised cognitive-behavioural therapy (cCBT) and guided self-help]: (1) compared with waiting list for high-intensity CBT in adults with OCD at 3 months; and (2) plus high-intensity CBT compared with waiting list plus high-intensity CBT in adults with OCD at 12 months. To determine patient and professional acceptability of low-intensity CBT interventions. DESIGN A three-arm, multicentre, randomised controlled trial. SETTING Improving Access to Psychological Therapies services and primary/secondary care mental health services in 15 NHS trusts. PARTICIPANTS Patients aged ≥ 18 years meeting Diagnostic and Statistical Manual of Mental Disorders-Fourth Edition criteria for OCD, on a waiting list for high-intensity CBT and scoring ≥ 16 on the Yale-Brown Obsessive Compulsive Scale (indicative of at least moderate severity OCD) and able to read English. INTERVENTIONS Participants were randomised to (1) supported cCBT, (2) guided self-help or (3) a waiting list for high-intensity CBT. MAIN OUTCOME MEASURES The primary outcome was OCD symptoms using the Yale-Brown Obsessive Compulsive Scale - Observer Rated. RESULTS Patients were recruited from 14 NHS trusts between February 2011 and May 2014. Follow-up data collection was complete by May 2015. There were 475 patients randomised: supported cCBT (n = 158); guided self-help (n = 158) and waiting list for high-intensity CBT (n = 159). Two patients were excluded post randomisation (one supported cCBT and one waiting list for high-intensity CBT); therefore, data

  15. Rendering hospital budgets volume based and open ended to reduce waiting lists: does it work?

    PubMed

    van de Vijsel, Aart R; Engelfriet, Peter M; Westert, Gert P

    2011-04-01

    In the past decades fixed budgets for hospitals were replaced by reimbursement based on outputs in several countries in order to bring down waiting lists. This was also the case in the Netherlands where fixed global budgets were replaced by budgets that are to a large extent volume based and in practice open-ended. The objective of this study was to examine the effectiveness of this Dutch policy measure, which was implemented in 2001. We carried out a statistical analysis and interpretation of trends in Dutch hospital admission rates. We observed a significant turn in the development of in-patient admission rates after the abolition of budget caps in 2001: decreasing admission rates turned into an internationally exceptional increase of more than 3% per year. Day care admissions had already been rising explosively for two decades, but the pace increased after 2001. The increase in the number of admissions includes a broad range of patient categories that were not in the first place associated with long waiting times. The growth was attributable for a large part to admissions for observation of the patient and the evaluation of symptoms, not resulting in a definite medical diagnosis. We considered several factors, other than the availability of more resources, to explain the growth: the ageing of the population, making up for waiting list arrears, ditto for "under consumption" of unplanned care and, as to the growth of day care, substitution for inpatient care. However, these factors were all found to fall short as an explanation. Although waiting times have dropped since the change in the budget system, they continue to be long for several procedures. Our study indicates that making available more resources to admit patients, or otherwise an increase in hospital activity, do not in itself lead to equilibrium between demand and supply because the volume and composition of demand are partly induced by supply. We conclude that abolishing budget caps to solve waiting

  16. FCET2EC (From controlled experimental trial to = 2 everyday communication): How effective is intensive integrative therapy for stroke-induced chronic aphasia under routine clinical conditions? A study protocol for a randomized controlled trial.

    PubMed

    Baumgaertner, Annette; Grewe, Tanja; Ziegler, Wolfram; Floel, Agnes; Springer, Luise; Martus, Peter; Breitenstein, Caterina

    2013-09-23

    Therapy guidelines recommend speech and language therapy (SLT) as the "gold standard" for aphasia treatment. Treatment intensity (i.e., ≥5 hours of SLT per week) is a key predictor of SLT outcome. The scientific evidence to support the efficacy of SLT is unsatisfactory to date given the lack of randomized controlled trials (RCT), particularly with respect to chronic aphasia (lasting for >6 months after initial stroke). This randomized waiting list-controlled multi-centre trial examines whether intensive integrative language therapy provided in routine in- and outpatient clinical settings is effective in improving everyday communication in chronic post-stroke aphasia. Participants are men and women aged 18 to 70 years, at least 6 months post an ischemic or haemorrhagic stroke resulting in persisting language impairment (i.e., chronic aphasia); 220 patients will be screened for participation, with the goal of including at least 126 patients during the 26-month recruitment period. Basic language production and comprehension abilities need to be preserved (as assessed by the Aachen Aphasia Test).Therapy consists of language-systematic and communicative-pragmatic exercises for at least 2 hours/day and at least 10 hours/week, plus at least 1 hour self-administered training per day, for at least three weeks. Contents of therapy are adapted to patients' individual impairment profiles.Prior to and immediately following the therapy/waiting period, patients' individual language abilities are assessed via primary and secondary outcome measures. The primary (blinded) outcome measure is the A-scale (informational content, or 'understandability', of the message) of the Amsterdam-Nijmegen Everyday Language Test (ANELT), a standardized measure of functional communication ability. Secondary (unblinded) outcome measures are language-systematic and communicative-pragmatic language screenings and questionnaires assessing life quality as viewed by the patient as well as a relative

  17. The Overseas Service Veteran At Home Pilot: How Choice of Care May Affect Use of Nursing Home Beds and Waiting Lists. Brief Report

    ERIC Educational Resources Information Center

    Pedlar, David; Walker, John

    2004-01-01

    In 1999 Veterans Affairs Canada (VAC) implemented the Overseas Service Veterans (OSV) At Home Pilot Project in response to the problem that a growing number of clients were on waiting lists for beds in long-term care facilities. The At Home pilot offered certain clients on waiting lists, who met nursing-level care and military-service…

  18. Interventions to reduce waiting times for elective procedures.

    PubMed

    Ballini, Luciana; Negro, Antonella; Maltoni, Susanna; Vignatelli, Luca; Flodgren, Gerd; Simera, Iveta; Holmes, Jane; Grilli, Roberto

    2015-02-23

    Long waiting times for elective healthcare procedures may cause distress among patients, may have adverse health consequences and may be perceived as inappropriate delivery and planning of health care. To assess the effectiveness of interventions aimed at reducing waiting times for elective care, both diagnostic and therapeutic. We searched the following electronic databases: Cochrane Effective Practice and Organisation of Care (EPOC) Group Specialised Register, the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE (1946-), EMBASE (1947-), the Cumulative Index to Nursing and Allied Health Literature (CINAHL), ABI Inform, the Canadian Research Index, the Science, Social Sciences and Humanities Citation Indexes, a series of databases via Proquest: Dissertations & Theses (including UK & Ireland), EconLit, PAIS (Public Affairs International), Political Science Collection, Nursing Collection, Sociological Abstracts, Social Services Abstracts and Worldwide Political Science Abstracts. We sought related reviews by searching the Cochrane Database of Systematic Reviews and the Database of Abstracts of Reviews of Effectiveness (DARE). We searched trial registries, as well as grey literature sites and reference lists of relevant articles. We considered randomised controlled trials (RCTs), controlled before-after studies (CBAs) and interrupted time series (ITS) designs that met EPOC minimum criteria and evaluated the effectiveness of any intervention aimed at reducing waiting times for any type of elective procedure. We considered studies reporting one or more of the following outcomes: number or proportion of participants whose waiting times were above or below a specific time threshold, or participants' mean or median waiting times. Comparators could include any type of active intervention or standard practice. Two review authors independently extracted data from, and assessed risk of bias of, each included study, using a standardised form and the EPOC 'Risk

  19. Effects of Tailored and ACT-Influenced Internet-Based CBT for Eating Disorders and the Relation Between Knowledge Acquisition and Outcome: A Randomized Controlled Trial.

    PubMed

    Strandskov, Sandra Weineland; Ghaderi, Ata; Andersson, Hedvig; Parmskog, Nicole; Hjort, Emelie; Wärn, Anna Svanberg; Jannert, Maria; Andersson, Gerhard

    2017-09-01

    This is the first trial to investigate the outcome of tailored and ACT-influenced, cognitive behavioral Internet treatment for eating disorder psychopathology, and the relation between knowledge acquisition and outcome. This study utilized a randomized controlled design, with computer-based allocation to treatment or waiting list control group. Participants were recruited via advertisements in social media and newspapers in Sweden. Participants fulfilling the criteria for bulimia nervosa (BN), or Eating Disorder Not Otherwise Specified (EDNOS), with a BMI above 17.5, were enrolled in the study (N = 92). The treatment group received an Internet-based, ACT-influenced CBT intervention, developed by the authors, for eating disorders. The treatment lasted 8 weeks, and was adapted to the participant's individual needs. A clinician provided support. The main outcome measures were eating disorder symptoms and body shape dissatisfaction. Intent-to-treat analysis showed that the treatment group (n = 46) improved significantly on eating disorder symptoms and body dissatisfaction, compared with the waiting list control group (n = 46), with small to moderate effect sizes (between group effects, d = 0.35-0.64). More than a third of the participants in the treatment group (36.6%), compared to 7.1% in the waiting list control condition, made clinically significant improvements. Results showed a significant increase in knowledge in the treatment group compared to the waiting list control group (between group effect, d = 1.12), but we found no significant correlations between knowledge acquisition and outcome (r= -0.27 to -r = 0.23). The results provide preliminary support for Internet-based, tailored, and ACT-influenced treatment, based on CBT for participants with eating disorder psychopathology. Copyright © 2017. Published by Elsevier Ltd.

  20. Evaluation of the COPING parent online universal programme: study protocol for a pilot randomised controlled trial

    PubMed Central

    Owen, Dawn Adele; Griffith, Nia; Hutchings, Judy

    2017-01-01

    Trial sponsor Bangor University, Brigantia Building, College Road, Bangor, LL57 2AS, UK Introduction The COPING parent online universal programme is a web-based parenting intervention for parents of children aged 3-8 years with an interest in positive parenting. The programme focuses on strengthening parent-child relationships and encouraging positive child behaviour. This trial will evaluate whether the intervention is effective in increasing the use of positive parenting strategies outlined in the programme using parent report and blind observation measures. Methods and analysis This is a pilot randomised controlled trial with intervention and wait-list control conditions. The intervention is a 10-week online parenting programme to promote positive parent-child relations by teaching core social learning theory principles that encourage positive child behaviour, primarily through the use of praise and rewards. Health visitors and school nurses will circulate a recruitment poster to parents of children aged 3–8 years on their current caseloads. Recruitment posters will also be distributed via local primary schools and nurseries. Parents recruited to the trial will be randomised on a 2:1 ratio to intervention or wait-list control conditions (stratified according to child gender and age). The primary outcome measure is positive parenting as measured by a behavioural observation of parent-child interactions using the Dyadic Parent-Child Interaction Coding System. Secondary outcomes include parent report of child behaviour, and self-reported parental sense of competence, parenting behaviour and parental mental health. Data will be collected at baseline and 3 months later (postintervention) for all participants and 6 months postbaseline for the intervention group only. Analysis of covariance will be the main statistical method used. Ethics and dissemination The trial has received ethical approval from the NHS Betsi Cadwaladr University Health Board Ethics Committee

  1. Post-listing survival for highly sensitised patients on the UK kidney transplant waiting list: a matched cohort analysis.

    PubMed

    Manook, Miriam; Koeser, Leonardo; Ahmed, Zubir; Robb, Matthew; Johnson, Rachel; Shaw, Olivia; Kessaris, Nicos; Dorling, Anthony; Mamode, Nizam

    2017-02-18

    More than 40% of patients awaiting a kidney transplant in the UK are sensitised with human leucocyte antigen (HLA) antibodies. Median time to transplantation for such patients is double that of unsensitised patients at about 74 months. Removing antibody to perform an HLA-incompatible (HLAi) living donor transplantation is perceived to be high risk, although patient survival data are limited. We compared survival of patients opting for an HLAi kidney transplant with that of similarly sensitised patients awaiting a compatible organ. From the UK adult kidney transplant waiting list, we selected crossmatch positive living donor HLAi kidney transplant recipients who received their transplant between Jan 1, 2007, and Dec 31, 2013, and were followed up to Dec 31, 2014 (end of study). These patients were matched in a 1:4 ratio with similarly sensitised patients cases listed for a deceased-donor transplant during that period. Data were censored both at the time of transplantation (listed only), and at the end of the study period (listed or transplant). We used Kaplan-Meier curves to compare patient survival between HLAi and the matched cohort. Of 25 518 patient listings, 213 (1%) underwent HLAi transplantation during the study period. 852 matched controls were identified, of whom 41% (95% CI 32-50) remained without a transplant at 58 months after matching. We noted no difference in survival between patients who were in the HLAi group compared with the listed only group (log rank p=0·446), or listed or transplant group (log rank p=0·984). Survival of sensitised patients undergoing HLAi in the UK is comparable with those on dialysis awaiting a compatible organ, many of whom are unlikely to be have a transplant. Choosing a direct HLAi transplant has no detrimental effect on survival, but offers no survival benefit, by contrast with similar patients studied in a North American multicentre cohort. UK National Health Service Blood & Transplant and Guy's & St Thomas' National

  2. Bridging and downstaging treatments for hepatocellular carcinoma in patients on the waiting list for liver transplantation

    PubMed Central

    Pompili, Maurizio; Francica, Giampiero; Ponziani, Francesca Romana; Iezzi, Roberto; Avolio, Alfonso Wolfango

    2013-01-01

    Several therapeutic procedures have been proposed as bridging treatments for patients with hepatocellular carcinoma (HCC) awaiting liver transplantation (LT). The most used treatments include transarterial chemoembolization and radiofrequency ablation. Surgical resection has also been successfully used as a bridging procedure, and LT should be considered a rescue treatment in patients with previous HCC resection who experience tumor recurrence or post-treatment severe decompensation of liver function. The aims of bridging treatments include decreasing the waiting list dropout rate before transplantation, reducing HCC recurrence after transplantation, and improving post-transplant overall survival. To date, no data from prospective randomized studies are available; however, for HCC patients listed for LT within the Milan criteria, prolonging the waiting time over 6-12 mo is a risk factor for tumor spread. Bridging treatments are useful in containing tumor progression and decreasing dropout. Furthermore, the response to pre-LT treatments may represent a surrogate marker of tumor biological aggressiveness and could therefore be evaluated to prioritize HCC candidates for LT. Lastly, although a definitive conclusion can not be reached, the experiences reported to date suggest a positive impact of these treatments on both tumor recurrence and post-transplant patient survival. Advanced HCC may be downstaged to achieve and maintain the current conventional criteria for inclusion in the waiting list for LT. Recent studies have demonstrated that successfully downstaged patients can achieve a 5-year survival rate comparable to that of patients meeting the conventional criteria without requiring downstaging. PMID:24282343

  3. Impact of insurance status on heart transplant wait-list mortality for patients with left ventricular assist devices.

    PubMed

    Emani, Sitaramesh; Tumin, Dmitry; Foraker, Randi E; Hayes, Don; Smith, Sakima A

    2017-02-01

    To test the hypotheses that receipt of Medicaid or Medicare (versus private insurance or self-pay) and low socioeconomic status (SES) leads to increased mortality and lower chances of transplantation among heart transplant (HTx) candidates with bridge to transplant left ventricular assist devices (BTT LVADs). Survival while awaiting HTx has improved with the use of BTT LVADs. However, it is unknown whether benefits extend uniformly across patient groups based on insurance status. Data from the United Network of Organ Sharing (UNOS) registry between 2006 and 2015 were examined for first-time HTx candidates ≥18 and <65 years who had LVAD support while wait-listed. Multivariable survival analysis was conducted on competing outcomes of mortality and time to transplant stratified by insurance source at the time of listing. Additional covariates included demographic information and SES. A total of 4626 patients met inclusion criteria, with 3353 being used for multivariable analysis. A majority of patients (68%) underwent HTx during the study period. BTT LVAD wait-list mortality was found to be greater among Medicaid beneficiaries vs. private insurance (SHR 1.57, P<.05) and did not diminish with the inclusion of neighborhood SES. Transplantation as an outcome demonstrated no difference by insurance status. Medicaid insurance status is associated with worse survival on the HTx wait-list among patients with BTT LVADs, although access to transplant was not different among insurance groups. The disparity is not reflective of SES in general and therefore points to other barriers inherent to Medicaid beneficiaries. © 2016 John Wiley & Sons A/S. Published by John Wiley & Sons Ltd.

  4. A randomized, controlled clinical trial of standard, group and brief cognitive-behavioral therapy for panic disorder with agoraphobia: a two-year follow-up.

    PubMed

    Marchand, André; Roberge, Pasquale; Primiano, Sandra; Germain, Vanessa

    2009-12-01

    A randomized controlled clinical trial with a wait-list control group was conducted to examine the effectiveness of three modalities (brief, group, and standard) of cognitive-behavioral treatment (CBT) for panic disorder with agoraphobia. A total of 100 participants meeting DSM-IV criteria were randomly assigned to each treatment condition: a 14-session standard CBT (n=33), a 14-session group CBT (n=35) and a 7-session brief CBT (n=32). Participants received a self-study manual and were assigned weekly readings and exercises. The results indicate that regardless of the treatment condition, CBT for moderate to severe PDA is beneficial in medium and long term. To this effect, all three-treatment conditions significantly reduced the intensity of symptoms, increased participants' quality of life, offered high effect sizes, superior maintenance of gains over time, and lower rates of relapse, compared to the wait-list control.

  5. Pilot study of high-intensity focused ultrasound ablation as a bridging therapy for hepatocellular carcinoma patients wait-listed for liver transplantation.

    PubMed

    Chok, Kenneth S H; Cheung, Tan To; Lo, Regina C L; Chu, Ferdinand S K; Tsang, Simon H Y; Chan, Albert C Y; Sharr, William W; Fung, James Y Y; Dai, Wing Chiu; Chan, See Ching; Fan, Sheung Tat; Lo, Chung Mau

    2014-08-01

    The objective of this study was to investigate the outcomes of high-intensity focused ultrasound (HIFU) ablation as a bridging therapy for patients with hepatocellular carcinoma (HCC) who had been wait-listed for deceased donor liver transplantation (DDLT). Adult patients with unresectable and unablatable HCCs within the University of California San Francisco criteria who had been wait-listed for DDLT were screened for their suitability for HIFU ablation as a bridging therapy if they were not suitable for transarterial chemoembolization (TACE). Treatment outcomes for patients receiving HIFU ablation, TACE, and best medical treatment (BMT) were compared. Fifty-one patients were included in the analysis. Before the introduction of HIFU ablation, only 39.2% of the patients had received bridging therapy (TACE only, n = 20). With HIFU ablation in use, the rate increased dramatically to 80.4% (TACE + HIFU, n = 41). The overall dropout rate was 51% (n = 26). Patients in the BMT group had a significantly higher dropout rate (P = 0.03) and significantly poorer liver function as reflected by higher Model for End-Stage Liver Disease scores and higher Child-Pugh grading. Clinically relevant ascites was found in 5 patients in the HIFU group and 2 patients in the BMT group, but none was found in the TACE group (P = 0.01 and P = 0.03, respectively). The TACE and HIFU groups had comparable percentages of tumor necrosis in excised livers (P = 0.35), and both were significantly higher than that in the BMT group (P = 0.01 and P = 0.02, respectively). In conclusion, HIFU ablation was safe even for HCC patients with Child-Pugh C disease. Its adoption increased the percentage of patients receiving bridging therapy from 39.2% to 80.4%. A randomized controlled trial for further validation of its efficacy is warranted. © 2014 American Association for the Study of Liver Diseases.

  6. Aquatic physical therapy for children with developmental coordination disorder: a pilot randomized controlled trial.

    PubMed

    Hillier, Susan; McIntyre, Auburn; Plummer, Leanne

    2010-05-01

    Aquatic therapy is an intervention for children with Developmental Coordination Disorder (DCD) that has not been investigated formally. This was a pilot randomized controlled trial to investigate the feasibility and preliminary effectiveness of an aquatic therapy program to improve motor skills of children with DCD. Thirteen children (mean age 7 years 1 month; 10 males) with DCD were randomly allocated to receive either six sessions of aquatic therapy (once weekly session of 30 min for 6-8 weeks) or to a wait-list (control group). The intervention and measures were demonstrated to be feasible, but barriers, such as limited appointment times and accessibility, were encountered. Analysis of covariance indicated that at posttest, mean scores on the Movement Assessment Battery were higher for children who received aquatic therapy compared to those on the wait-list (p = .057). Similar trends were noted on the physical competence portion of the Pictorial Scale of Perceived Competence and Social Acceptance (p = .058). Participation levels, as measured by a parent questionnaire, showed improvement for both groups. Potential facilitators and barriers to implementation of an aquatic therapy for children with DCD are discussed.

  7. A randomized controlled trial of the Cool Teens CD-ROM computerized program for adolescent anxiety.

    PubMed

    Wuthrich, Viviana M; Rapee, Ronald M; Cunningham, Michael J; Lyneham, Heidi J; Hudson, Jennifer L; Schniering, Carolyn A

    2012-03-01

    Computerized cognitive behavioral interventions for anxiety disorders in adults have been shown to be efficacious, but limited data are available on the use of computerized interventions with young persons. Adolescents in particular are difficult to engage in treatment and may be especially suited to computerized technologies. This paper describes the results of a small randomized controlled trial of the Cool Teens program for adolescent anxiety, and examines potential barriers to treatment and user preferences of computerized technology in this population. Forty-three adolescents with a primary diagnosis of anxiety were randomly allocated to the Cool Teens program, a 12-week computerized cognitive-behavioral therapy program for anxiety management, or a 12-week wait list. Effects on symptoms, negative thoughts, and life interference were assessed at post-treatment and 3-month follow-up, based on diagnosis as well as self and maternal report. Using mixed-model analyses, at post-treatment and follow-up assessments, adolescents in the Cool Teens condition, compared with those on the wait list, were found to have significant reductions in the total number of anxiety disorders, the severity of the primary anxiety disorder, and the average severity for all disorders. These results were matched by significant reductions in mother and child questionnaire reports of anxiety, internalizing symptoms, automatic thoughts, and life interference. Further few barriers to treatment were found, and user preferences indicated that the computerized treatment was well suited to adolescents with anxiety. The Cool Teens program is efficacious for treatment of adolescent anxiety. Clinical trial registration information-A randomized controlled trial of the Cool Teens computerized program for anxious adolescents compared with waist list; http://www.anzctr.org.au; ACTRN12611000508976. Copyright © 2012 American Academy of Child and Adolescent Psychiatry. Published by Elsevier Inc. All

  8. Randomized control trial follow-up: Online program and waiting period for unmarried parents in Title IV-D Court.

    PubMed

    Rudd, Brittany N; Poladian, Ani R; Holtzworth-Munroe, Amy; Applegate, Amy G; D'Onofrio, Brian M

    2017-04-01

    Despite a lack of research on parent programs for separating unmarried parents, many judicial officers mandate participation. Rudd, Holtzworth-Munroe, Reyome, Applegate, and D'Onofrio (2015) conducted the only randomized controlled trial of any online parent program for separating parents, ProudToParent.org (PTP), and related court processes (e.g., having a waiting period between the establishment of paternity and the court hearing regarding child related issues vs. having the hearing the same day). They recruited a unique sample of 182 cases in a Title IV-D Court (i.e., a court for primarily low income parents) (Authorization of Appropriations, 42 U.S.C. § 651, 2013), in which paternity was previously contested but subsequently established via court-ordered genetic testing. Unexpectedly, cases assigned to PTP and a waiting period were the least likely to reach agreement at their court hearing. In the current study, we extend these results to examine the impact of the study conditions on relitigation in the year following the court hearing; only 11.2% of cases filed a motion, and 7.8% had a hearing. The group that was least likely to reach full initial agreement (i.e., assigned to PTP and the waiting period) were the most likely to relitigate. Further, controlling for study conditions, reaching a full agreement in the Title IV-D court decreased the odds of having a court hearing in the following year. Reaching agreements on the specific issues involved in such cases (e.g., custody, child support) reduced the likelihood of both motions and hearings in the year after the Title IV-D hearings. The implications of these findings are discussed. (PsycINFO Database Record (c) 2017 APA, all rights reserved).

  9. Effectiveness of a web-based solution-focused brief chat treatment for depressed adolescents and young adults: randomized controlled trial.

    PubMed

    Kramer, Jeannet; Conijn, Barbara; Oijevaar, Pien; Riper, Heleen

    2014-05-29

    Up to 9% of young people suffer from depression. Unfortunately, many in need of help remain untreated. The Internet offers anonymous ways to help depressed youth, especially those who are reluctant to search for help because of fear of stigma. Our goal was to evaluate the effectiveness of an individual chat treatment based on Solution-Focused Brief Therapy (SFBT) to young individuals aged 12-22 years with depressive symptoms by comparing it to a waiting list control group. For this study, 263 young people with depressive symptoms were randomized to the Web-based SFBT intervention, PratenOnline, or to a waiting list control condition. The chat treatment was delivered by trained professionals. Groups were compared on depressive complaints as measured by the Center for Epidemiologic Studies Depression Scale (CES-D) after 9 weeks and 4.5 months. For the chat group only, changes in depressive symptoms at 7.5 months after baseline were explored. The experimental SFBT condition (n=131) showed significantly greater improvement than the waiting list condition (n=132) in depressive symptoms at 9 weeks and 4.5 months on the CES-D, with a small between group effect size at 9 weeks (d=0.18, 95% CI -0.10 to 0.47) and a large effect size at 4.5 months (d=0.79, 95% CI 0.45-1.08). The percentage of participants showing a reliable and clinically significant change in depression was significantly larger for the SFBT intervention at 4.5 months only (28.2% vs 11.4% for the waiting list, P<.001, number needed to treat=6). At 7.5 months, the SFBT group showed further improvements. However, results have to be considered carefully because of high attrition rates. The Web-based SFBT chat intervention of PratenOnline was more effective than a waiting list control group in reducing depressive symptoms, and effects were larger at follow-up then at post-treatment. More studies are needed to find out if outcomes will be replicated, especially for those younger than 18 year old. Netherlands Trial

  10. Immune Sensitization and Mortality in Wait-Listed Kidney Transplant Candidates

    PubMed Central

    Sapir-Pichhadze, Ruth; Tinckam, Kathryn J.; Laupacis, Andreas; Logan, Alexander G.; Beyene, Joseph

    2016-01-01

    Cardiovascular mortality is the leading cause of death in ESRD. Whereas innate and adaptive immunity have established roles in cardiovascular disease, the role of humoral immunity is unknown. We conducted a retrospective cohort study in first-time adult kidney transplant candidates (N=161,308) using data from the Scientific Registry of Transplant Recipients and the Centers for Medicare and Medicaid Services to evaluate whether anti–human leukocyte antigen antibodies, measured as panel reactive antibodies (PRAs), are related to mortality in ESRD. Relationships between time-varying PRAs and all-cause or cardiovascular mortality were assessed using Cox proportional hazards models. The analysis was repeated in subcohorts of candidates at lower risk for significant comorbidities, activated on the waiting list after 2007, or unsensitized at activation. Competing risks analyses were also conducted. Fully adjusted models showed increased hazard ratios (HRs [95% confidence intervals]) for all-cause mortality (HR, 1.02 [95% CI, 0.99 to 1.06]; HR, 1.11 [95% CI,1.07 to 1.16]; and HR,1.21 [95% CI,1.15 to 1.27]) and cardiovascular mortality (HR, 1.05 [95% CI,1.00 to 1.10]; HR,1.11 [95% CI,1.05 to 1.18]; and HR,1.21 [95% CI,1.12 to 1.31]) in PRA 1%–19%, PRA 20%–79%, and PRA 80%–100% categories compared with PRA 0%, respectively. Associations between PRA and the study outcomes were accentuated in competing risks models and in lower-risk patients and persisted in other subcohorts. Our findings suggest that PRA is an independent predictor of mortality in wait-listed kidney transplant candidates. The mechanisms by which PRA confers an incremental mortality risk in sensitized patients, and the role of transplantation in modifying this risk, warrant further study. PMID:26054537

  11. The Efficacy of a Group Cognitive Behavioral Therapy for War-Affected Young Migrants Living in Australia: A Cluster Randomized Controlled Trial

    PubMed Central

    Ooi, Chew S.; Rooney, Rosanna M.; Roberts, Clare; Kane, Robert T.; Wright, Bernadette; Chatzisarantis, Nikos

    2016-01-01

    Background: Preventative and treatment programs for people at risk of developing psychological problems after exposure to war trauma have mushroomed in the last decade. However, there is still much contention about evidence-based and culturally sensitive interventions for children. The aim of this study was to examine the efficacy of the Teaching Recovery Techniques in improving the emotional and behavioral outcomes of war-affected children resettled in Australia. Methods and Findings: A cluster randomized controlled trial with pre-test, post-test, and 3-month follow-up design was employed. A total of 82 participants (aged 10–17 years) were randomized by school into the 8-week intervention (n = 45) or the waiting list (WL) control condition (n = 37). Study outcomes included symptoms of post-traumatic stress disorder, depression, internalizing and externalizing problems, as well as psychosocial functioning. A medium intervention effect was found for depression symptoms. Participants in the intervention condition experienced a greater symptom reduction than participants in the WL control condition, F(1, 155) = 5.20, p = 0.024, partial η2 = 0.07. This improvement was maintained at the 3-month follow-up, F(2, 122) = 7.24, p = 0.001, partial η2 = 0.20. Conclusions: These findings suggest the potential benefit of the school and group-based intervention on depression symptoms but not on other outcomes, when compared to a waiting list control group. Trial Registration: Australian New Zealand Clinical Trials Registry ACTRN12611000 948998. PMID:27843435

  12. Exposure to virtual social interactions in the treatment of social anxiety disorder: A randomized controlled trial.

    PubMed

    Kampmann, Isabel L; Emmelkamp, Paul M G; Hartanto, Dwi; Brinkman, Willem-Paul; Zijlstra, Bonne J H; Morina, Nexhmedin

    2016-02-01

    This randomized controlled trial investigated the efficacy of a stand-alone virtual reality exposure intervention comprising verbal interaction with virtual humans to target heterogeneous social fears in participants with social anxiety disorder. Sixty participants (Mage = 36.9 years; 63.3% women) diagnosed with social anxiety disorder were randomly assigned to individual virtual reality exposure therapy (VRET), individual in vivo exposure therapy (iVET), or waiting-list. Multilevel regression analyses revealed that both treatment groups improved from pre-to postassessment on social anxiety symptoms, speech duration, perceived stress, and avoidant personality disorder related beliefs when compared to the waiting-list. Participants receiving iVET, but not VRET, improved on fear of negative evaluation, speech performance, general anxiety, depression, and quality of life relative to those on waiting-list. The iVET condition was further superior to the VRET condition regarding decreases in social anxiety symptoms at post- and follow-up assessments, and avoidant personality disorder related beliefs at follow-up. At follow-up, all improvements were significant for iVET. For VRET, only the effect for perceived stress was significant. VRET containing extensive verbal interaction without any cognitive components can effectively reduce complaints of generalized social anxiety disorder. Future technological and psychological improvements of virtual social interactions might further enhance the efficacy of VRET for social anxiety disorder. Copyright © 2015 Elsevier Ltd. All rights reserved.

  13. [Criteria for prioritising patients on surgical waiting lists in the National Health System].

    PubMed

    Allepuz, A; Espallargues, M; Martínez, O

    2009-01-01

    To survey the importance of previously proposed criteria for prioritising patients on surgical waiting lists and to analyse their use in daily practice. Cross-sectional study through a self-auto-administered postal questionnaire to hospital managers, medical directors, admissions managers, and department heads of general surgery, ophthalmology, orthopaedics and traumatology surgery and vascular surgery from 139 centres. The questionnaire comprised 3 sections: a) 3 to 5 of the most important criteria had to be selected and their use in daily practice had to be assessed; b) new criteria were proposed, c) socio-demographic data. The mean and its standard deviation of each criterion of importance were calculated. The proposed criteria were categorised and their frequency was calculated. The questionnaire was answered by the 22% of those surveyed. Disease severity, speed of progression, waiting time and pain were the criteria considered as most important and were the most used. The current clinical situation and the professional environment were the two most common categories defined from the criteria proposed by those surveyed. The surgical priority should be determined by other criteria related to surgery necessity besides waiting time. Establishing prioritisation criteria could enable current implicit criteria to be used explicitly.

  14. Testing the impact of a social skill training versus waiting list control group for the reduction of disruptive behaviors and stress among preschool children in child care: the study protocol for a cluster randomized trial.

    PubMed

    Côté, Sylvana M; Larose, Marie-Pier; Geoffroy, Marie Claude; Laurin, Julie; Vitaro, Frank; Tremblay, Richard E; Ouellet-Morin, Isabelle

    2017-08-07

    Most preschoolers growing up in western industrialized countries receive child care services (CCS) during the day, while their parents are at work. Meta-analytic data suggest that CCS represent a stressful experience for preschoolers. This may be because preschoolers have not yet developed the social skills necessary to cope with the new and rapidly fluctuating social contexts of CCS. We tested the effectiveness of a child care-based social skill training program aiming to improve children's social behaviors and reduce the stress they experience. We used a cluster randomized control trial (cRCT) to compare children's social behaviors and stress levels in pre- and post-intervention according to whether they received a social skill training intervention or not. Nineteen (n = 19) public CCS (n = 362, 3-years-old preschoolers) of underprivileged neighborhoods (Montreal, Canada) were randomized to one of two conditions: 1) social skills training (n = 10 CCS); or 2) waiting list control group (n = 9 CCS). Educators in the intervention group conducted bi-weekly social skills training sessions over a period of 8 months. The intervention covered four topics: making social contacts, problem solving, emotional self-regulation, as well as emotional expression and recognition. Main outcome measures included preschoolers' disruptive (e.g. aggression, opposition, conflicts) and prosocial behaviors (e.g. sharing toys, helping another child), and stress levels assessed by salivary cortisol sampling at pre and post intervention assessments. Educators' practices will be tested as potential mediators of the expected changes in behaviors and neuroendocrine stress. To our knowledge, this is the first cRCT to test the effectiveness of a child care based social skill training program on the reduction of disruptive behaviors and levels of stress. Significant challenges include the degree of adherence to the intervention protocol as well educators and preschoolers' turnover

  15. Ethics in radiology: wait lists queue jumping.

    PubMed

    Cunningham, Natalie; Reid, Lynette; MacSwain, Sarah; Clarke, James R

    2013-08-01

    Education in ethics is a requirement for all Royal College residency training programs as laid out in the General Standards of Accreditation for residency programs in Canada. The ethical challenges that face radiologists in clinical practice are often different from those that face other physicians, because the nature of the physician-patient interaction is unlike that of many other specialties. Ethics education for radiologists and radiology residents will benefit from the development of teaching materials and resources that focus on the issues that are specific to the specialty. This article is intended to serve as an educational resource for radiology training programs to facilitate teaching ethics to residents and also as a continuing medical education resource for practicing radiologists. In an environment of limited health care resources, radiologists are frequently asked to expedite imaging studies for patients and, in some respects, act as gatekeepers for specialty care. The issues of wait lists, queue jumping, and balancing the needs of individuals and society are explored from the perspective of a radiologist. Copyright © 2013 Canadian Association of Radiologists. Published by Elsevier Inc. All rights reserved.

  16. What factors influence cataract waiting list time?

    PubMed Central

    Churchill, A.; Vize, C.; Stewart, O.; Backhouse, O.

    2000-01-01

    AIMS—To determine whether there were any specific factors that influenced waiting list time (WLT) for patients undergoing cataract surgery.
METHODS—70 preoperative cataract patients were interviewed by one of the authors using a questionnaire to score visual acuity, coexisting ocular pathology and disabilities, threat to independent living/employment, and perceived visual handicap for detailed, gross, and driving vision. Individuals were analysed separately according to whether it was their first or second cataract operation.
RESULTS—The median WLT for first eye surgery was 9 months (n = 31) and 13 months for second eye surgery (n = 36). The WLT ranged from 2 to 25 months for first eyes and 0.25-18 months for second eyes. Where there was a perceived threat to independent living or employment the WLT was found to be significantly shorter than the median. A high overall score correlated with a shorter WLT. Surgical priority was also given to individuals with anisometropia >3 dioptres.
CONCLUSION—This study has demonstrated that there are specific factors that influence clinicians when prioritising patients for cataract surgery.

 PMID:10729304

  17. A randomised controlled trial of the efficacy of the ABCD Parenting Young Adolescents Program: rationale and methodology

    PubMed Central

    2010-01-01

    Background The transition to adolescence is a time of increased vulnerability for risk taking and poor health, social and academic outcomes. Parents have an important role in protecting their children from these potential harms. While the effectiveness of parenting programs in reducing problem behavior has been demonstrated, it is not known if parenting programs that target families prior to the onset of significant behavioral difficulties in early adolescence (9-14 years) improve the wellbeing of adolescents and their parents. This paper describes the rationale and methodology of a randomised controlled trial testing the efficacy of a parenting program for the promotion of factors known to be associated with positive adolescent outcomes, such as positive parenting practices, parent-adolescent relationships and adolescent behavior. Methods/Design One hundred and eighty parents were randomly allocated to an intervention or wait list control group. Parents in the intervention group participated in the ABCD Parenting Young Adolescents Program, a 6-session behavioral family intervention program which also incorporates acceptance-based strategies. Participants in the Wait List control group did not receive the intervention during a six month waiting period. The study was designed to comply with recommendations of the CONSORT statement. The primary outcome measures were reduction in parent-adolescent conflict and improvements in parent-adolescent relationships. Secondary outcomes included improvements in parent psychosocial wellbeing, parenting self-efficacy and perceived effectiveness, parent-adolescent communication and adolescent behavior. Conclusions Despite the effectiveness of parenting programs in reducing child behavioral difficulties, very few parenting programs for preventing problems in adolescents have been described in the peer reviewed literature. This study will provide data which can be used to examine the efficacy of a universal parenting interventions

  18. Effects of group metacognitive training (MCT) on mental capacity and functioning in patients with psychosis in a secure forensic psychiatric hospital: a prospective-cohort waiting list controlled study.

    PubMed

    Naughton, Marie; Nulty, Andrea; Abidin, Zareena; Davoren, Mary; O'Dwyer, Sarah; Kennedy, Harry G

    2012-06-18

    Metacognitive Training (MCT) is a manualised cognitive intervention for psychosis aimed at transferring knowledge of cognitive biases and providing corrective experiences. The aim of MCT is to facilitate symptom reduction and protect against relapse. In a naturalistic audit of clinical effectiveness we examined what effect group MCT has on mental capacity, symptoms of psychosis and global function in patients with a psychotic illness, when compared with a waiting list comparison group. Of 93 patients detained in a forensic mental health hospital under both forensic and civil mental health legislation, 19 were assessed as suitable for MCT and 11 commenced. These were compared with 8 waiting list patients also deemed suitable for group MCT who did not receive it in the study timeframe. The PANSS, GAF, MacArthur Competence Assessment Tool- Treatment (MacCAT-T) and MacArthur Competence Assessment Tool-Fitness to Plead (MacCAT-FP) were recorded at baseline and repeated after group MCT or following treatment as usual in the waiting list group. When baseline functioning was accounted for, patients that attended MCT improved in capacity to consent to treatment as assessed by the MacCAT-T (p = 0.019). The more sessions attended, the greater the improvements in capacity to consent to treatment, mainly due to improvement in MacCAT-T understanding (p = 0.014) and reasoning . The GAF score improved in patients who attended the MCT group when compared to the waiting list group (p = 0.038) but there were no changes in PANSS scores. Measures of functional mental capacity and global function can be used as outcome measures for MCT. MCT can be used successfully even in psychotic patients detained in a forensic setting. The restoration of elements of decision making capacity such as understanding and reasoning may be a hither-to unrecognised advantage of such treatment. Because pharmacotherapy can be optimised and there is likely to be enough time to complete the course

  19. Effects of group metacognitive training (MCT) on mental capacity and functioning in patients with psychosis in a secure forensic psychiatric hospital: a prospective-cohort waiting list controlled study

    PubMed Central

    2012-01-01

    Background Metacognitive Training (MCT) is a manualised cognitive intervention for psychosis aimed at transferring knowledge of cognitive biases and providing corrective experiences. The aim of MCT is to facilitate symptom reduction and protect against relapse. In a naturalistic audit of clinical effectiveness we examined what effect group MCT has on mental capacity, symptoms of psychosis and global function in patients with a psychotic illness, when compared with a waiting list comparison group. Methods Of 93 patients detained in a forensic mental health hospital under both forensic and civil mental health legislation, 19 were assessed as suitable for MCT and 11 commenced. These were compared with 8 waiting list patients also deemed suitable for group MCT who did not receive it in the study timeframe. The PANSS, GAF, MacArthur Competence Assessment Tool- Treatment (MacCAT-T) and MacArthur Competence Assessment Tool-Fitness to Plead (MacCAT-FP) were recorded at baseline and repeated after group MCT or following treatment as usual in the waiting list group. Results When baseline functioning was accounted for, patients that attended MCT improved in capacity to consent to treatment as assessed by the MacCAT-T (p = 0.019). The more sessions attended, the greater the improvements in capacity to consent to treatment, mainly due to improvement in MacCAT-T understanding (p = 0.014) and reasoning . The GAF score improved in patients who attended the MCT group when compared to the waiting list group (p = 0.038) but there were no changes in PANSS scores. Conclusion Measures of functional mental capacity and global function can be used as outcome measures for MCT. MCT can be used successfully even in psychotic patients detained in a forensic setting. The restoration of elements of decision making capacity such as understanding and reasoning may be a hither-to unrecognised advantage of such treatment. Because pharmacotherapy can be optimised and there is likely to

  20. Where does the waiting list begin? A short review of the dynamics and organization of modern waiting lists.

    PubMed

    Rotstein, Dalia L; Alter, David A

    2006-06-01

    Waiting for medical care is the by-product of system rationing, where demand exceeds supply. In this short report we expand on the conventional concept of the queue, by focusing on the regulation of demand and by incorporating a funnel and spout analogy. Real-world examples are used to illustrate the infancy of funnel or demand-side reform initiatives targeting the queue, and the suggestion is made that policy needs to address the concept of 'waiting' much earlier in the treatment cycle.

  1. Post-traumatic stress disorder in the context of terrorism and other civil conflict in Northern Ireland: randomised controlled trial

    PubMed Central

    Gillespie, Kate; Clark, David M

    2007-01-01

    Objective To evaluate the effectiveness of cognitive therapy for post-traumatic stress disorder related to terrorism and other civil conflict in Northern Ireland. Design Randomised controlled trial. Setting Community treatment centre, Northern Ireland. Participants 58 consecutive patients with chronic post-traumatic stress disorder (median 5.2 years, range 3 months to 32 years) mostly resulting from multiple traumas linked to terrorism and other civil conflict. Interventions Immediate cognitive therapy compared with a waiting list control condition for 12 weeks followed by treatment. Treatment comprised a mean of 5.9 sessions during 12 weeks and 2.0 sessions thereafter. Main outcome measures Primary outcome measures were patients' scores for post-traumatic stress disorder (post-traumatic stress diagnostic scale) and depression (Beck depression inventory). The secondary outcome measure was scores for occupational and social functioning (work related disability, social disability, and family related disability) on the Sheehan disability scale. Results At 12 weeks after randomisation, immediate cognitive therapy was associated with significantly greater improvement than the waiting list control group in the symptoms of post-traumatic stress disorder (mean difference 9.6, 95% confidence interval 3.6 to 15.6), depression (mean difference 10.1, 4.8 to 15.3), and self reported occupational and social functioning (mean difference 1.3, 0.3 to 2.5). Effect sizes from before to after treatment were large: post-traumatic stress disorder 1.25, depression 1.05, and occupational and social functioning 1.17. No change was observed in the control group. Conclusion Cognitive therapy is an effective treatment for post-traumatic stress disorder related to terrorism and other civil conflict. Trial registration Current Controlled Trials ISRCTN16228473. PMID:17495988

  2. A pilot effectiveness study of the Enhancing Parenting Skills (EPaS) 2014 programme for parents of children with behaviour problems: study protocol for a randomised controlled trial.

    PubMed

    Williams, Margiad Elen; Hutchings, Judy

    2015-05-20

    The Enhancing Parenting Skills (EPaS) 2014 programme is a home-based, health visitor-delivered parenting support programme for parents of children with identified behaviour problems. This trial aims to evaluate the effectiveness of the EPaS 2014 programme compared to a waiting-list treatment as usual control group. This is a pragmatic, multicentre randomised controlled trial. Sixty health visitors will each be asked to identify two families that have a child scoring above the clinical cut-off for behaviour problems using the Eyberg Child Behaviour Inventory (ECBI). Families recruited to the trial will be randomised in a 1:1 ratio into an intervention or waiting-list control group. Randomisation will occur within health visitor to ensure that each health visitor has one intervention family and one control family. The primary outcome is change in child behaviour problems as measured by the parent-reported ECBI. Secondary outcomes include other measures of child behaviour, parent behaviour, and parental depression as measured by parent-reports and an independent observation of parent and child behaviour. Follow-up measures will be collected 6-months after the collection of baseline measures. This is the first rigorous evaluation of the EPaS 2014 programme. The trial will provide important information on the effectiveness of a one-to-one home-based intervention, delivered by health visitors, for pre-school children with behaviour problems. It will also examine potential mediating (improved parent behaviour and/or improved parental depression) and moderating (single parent, teenage parent, poverty, low education level) factors. Current Controlled Trials ISRCTN06867279 (18 June 2014).

  3. Design of the Resistance and Endurance exercise After ChemoTherapy (REACT) study: a randomized controlled trial to evaluate the effectiveness and cost-effectiveness of exercise interventions after chemotherapy on physical fitness and fatigue.

    PubMed

    Kampshoff, Caroline S; Buffart, Laurien M; Schep, Goof; van Mechelen, Willem; Brug, Johannes; Chinapaw, Mai J M

    2010-11-30

    Preliminary studies suggest that physical exercise interventions can improve physical fitness, fatigue and quality of life in cancer patients after completion of chemotherapy. Additional research is needed to rigorously test the effects of exercise programmes among cancer patients and to determine optimal training intensity accordingly. The present paper presents the design of a randomized controlled trial evaluating the effectiveness and cost-effectiveness of a high intensity exercise programme compared to a low-to-moderate intensity exercise programme and a waiting list control group on physical fitness and fatigue as primary outcomes. After baseline measurements, cancer patients who completed chemotherapy are randomly assigned to either a 12-week high intensity exercise programme or a low-to-moderate intensity exercise programme. Next, patients from both groups are randomly assigned to immediate training or a waiting list (i.e. waiting list control group). After 12 weeks, patients of the waiting list control group start with the exercise programme they have been allocated to.Both interventions consist of equal bouts of resistance and endurance interval exercises with the same frequency and duration, but differ in training intensity. Additionally, patients of both exercise programmes are counselled to improve compliance and achieve and maintain an active lifestyle, tailored to their individual preferences and capabilities.Measurements will be performed at baseline (t = 0), 12 weeks after randomization (t = 1), and 64 weeks after randomization (t = 2). The primary outcome measures are cardiorespiratory fitness and muscle strength assessed by means of objective performance indicators, and self-reported fatigue. Secondary outcome measures include health-related quality of life, self-reported physical activity, daily functioning, body composition, mood and sleep disturbances, and return to work. In addition, compliance and satisfaction with the interventions will be

  4. Effect of pelvic floor muscle training compared with watchful waiting in older women with symptomatic mild pelvic organ prolapse: randomised controlled trial in primary care

    PubMed Central

    Wiegersma, Marian; Panman, Chantal M C R; Kollen, Boudewijn J; Berger, Marjolein Y; Lisman-Van Leeuwen, Yvonne

    2014-01-01

    Objective To compare the effects of pelvic floor muscle training and watchful waiting on pelvic floor symptoms in a primary care population of women aged 55 years and over with symptomatic mild pelvic organ prolapse. Design Randomised controlled trial. Setting Dutch primary care. Participants Women aged 55 years or over with symptomatic mild prolapse (leading edge above the hymen) were identified by screening. Exclusion criteria were current prolapse treatment or treatment in the previous year, malignancy of pelvic organs, current treatment for another gynaecological disorder, severe/terminal illness, impaired mobility, cognitive impairment, and insufficient command of the Dutch language. Interventions Pelvic floor muscle training versus watchful waiting. Main outcome measures The primary outcome was change in bladder, bowel, and pelvic floor symptoms measured with the Pelvic Floor Distress Inventory-20 (PFDI-20), three months after the start of treatment. Secondary outcomes were changes in condition specific and general quality of life, sexual function, degree of prolapse, pelvic floor muscle function, and patients’ perceived change in symptoms. Results Of the 287 women who were randomised to pelvic floor muscle training (n=145) or watchful waiting (n=142), 250 (87%) completed follow-up. Participants in the intervention group improved by (on average) 9.1 (95% confidence interval 2.8 to 15.4) points more on the PFDI-20 than did participants in the watchful waiting group (P=0.005). Of women in the pelvic floor muscle training group, 57% (82/145) reported an improvement in overall symptoms from the start of the study compared with 13% (18/142) in the watchful waiting group (P<0.001). Other secondary outcomes showed no significant difference between the groups. Conclusions Although pelvic floor muscle training led to a significantly greater improvement in PFDI-20 score, the difference between the groups was below the presumed level of clinical relevance (15 points

  5. Effect of pelvic floor muscle training compared with watchful waiting in older women with symptomatic mild pelvic organ prolapse: randomised controlled trial in primary care.

    PubMed

    Wiegersma, Marian; Panman, Chantal M C R; Kollen, Boudewijn J; Berger, Marjolein Y; Lisman-Van Leeuwen, Yvonne; Dekker, Janny H

    2014-12-22

    To compare the effects of pelvic floor muscle training and watchful waiting on pelvic floor symptoms in a primary care population of women aged 55 years and over with symptomatic mild pelvic organ prolapse. Randomised controlled trial. Dutch primary care. Women aged 55 years or over with symptomatic mild prolapse (leading edge above the hymen) were identified by screening. Exclusion criteria were current prolapse treatment or treatment in the previous year, malignancy of pelvic organs, current treatment for another gynaecological disorder, severe/terminal illness, impaired mobility, cognitive impairment, and insufficient command of the Dutch language. Pelvic floor muscle training versus watchful waiting. The primary outcome was change in bladder, bowel, and pelvic floor symptoms measured with the Pelvic Floor Distress Inventory-20 (PFDI-20), three months after the start of treatment. Secondary outcomes were changes in condition specific and general quality of life, sexual function, degree of prolapse, pelvic floor muscle function, and patients' perceived change in symptoms. Of the 287 women who were randomised to pelvic floor muscle training (n=145) or watchful waiting (n=142), 250 (87%) completed follow-up. Participants in the intervention group improved by (on average) 9.1 (95% confidence interval 2.8 to 15.4) points more on the PFDI-20 than did participants in the watchful waiting group (P=0.005). Of women in the pelvic floor muscle training group, 57% (82/145) reported an improvement in overall symptoms from the start of the study compared with 13% (18/142) in the watchful waiting group (P<0.001). Other secondary outcomes showed no significant difference between the groups. Although pelvic floor muscle training led to a significantly greater improvement in PFDI-20 score, the difference between the groups was below the presumed level of clinical relevance (15 points). Nevertheless, 57% of the participants in the intervention group reported an improvement of

  6. Depression in Visual Impairment Trial (DEPVIT): A Randomized Clinical Trial of Depression Treatments in People With Low Vision.

    PubMed

    Nollett, Claire L; Bray, Nathan; Bunce, Catey; Casten, Robin J; Edwards, Rhiannon T; Hegel, Mark T; Janikoun, Sarah; Jumbe, Sandra E; Ryan, Barbara; Shearn, Julia; Smith, Daniel J; Stanford, Miles; Xing, Wen; Margrain, Tom H

    2016-08-01

    The purpose of this study was to compare two interventions for depression, problem solving treatment (PST) and referral to the patient's physician, with a waiting-list control group in people with sight loss and depressive symptoms. This was an assessor-masked, exploratory, multicenter, randomized clinical trial, with concurrent economic analysis. Of 1008 consecutive attendees at 14 low-vision rehabilitation centers in Britain, 43% (n = 430) screened positive for depressive symptoms on the Geriatric Depression Scale and 85 of these attendees participated in the trial. Eligible participants were randomized in the ratio 1:1:1 to PST, referral to their physician, or a waiting-list control arm. PST is a manualized talking intervention delivered by a trained therapist who teaches people over six to eight sessions to implement a seven-step method for solving their problems. Referral to the physician involved sending a referral letter to the person's physician, encouraging him or her to consider treatment according to the stepped care protocol recommended by the U.K.'s National Institute of Health and Care Excellence. The primary outcome was change in depressive symptoms (6 months after baseline) as determined by the Beck Depression Inventory. At 6 months, Beck Depression Inventory scores reduced by 1.05 (SD 8.85), 2.11 (SD 7.60), and 2.68 (SD 7.93) in the waiting-list control, referral, and PST arms, respectively. The cost per patient of the PST intervention was £1176 in Wales and £1296 in London. Depressive symptoms improved most in the PST group and least in the control group. However, the change was small and the uncertainty of the measurements relatively large.

  7. The Prostate cancer Intervention Versus Observation Trial:VA/NCI/AHRQ Cooperative Studies Program #407 (PIVOT): design and baseline results of a randomized controlled trial comparing radical prostatectomy to watchful waiting for men with clinically localized prostate cancer.

    PubMed

    Wilt, Timothy J; Brawer, Michael K; Barry, Michael J; Jones, Karen M; Kwon, Young; Gingrich, Jeffrey R; Aronson, William J; Nsouli, Imad; Iyer, Padmini; Cartagena, Ruben; Snider, Glenn; Roehrborn, Claus; Fox, Steven

    2009-01-01

    Prostate cancer is the most common noncutaneous malignancy and the second leading cause of cancer death in men. Ninety percent of men with prostate cancer are over aged 60 years, diagnosed by early detection with the prostate specific antigen (PSA) blood test and have disease believed confined to the prostate gland (clinically localized). Common treatments for clinically localized prostate cancer include watchful waiting surgery to remove the prostate gland (radical prostatectomy), external beam radiation therapy and interstitial radiation therapy (brachytherapy) and androgen deprivation. Little is known about the relative effectiveness and harms of treatments due to the paucity of randomized controlled trials. The VA/NCI/AHRQ Cooperative Studies Program Study #407: Prostate cancer Intervention Versus Observation Trial (PIVOT), initiated in 1994, is a multicenter randomized controlled trial comparing radical prostatectomy to watchful waiting in men with clinically localized prostate cancer. We describe the study rationale, design, recruitment methods and baseline characteristics of PIVOT enrollees. We provide comparisons with eligible men declining enrollment and men participating in another recently reported randomized trial of radical prostatectomy versus watchful waiting conducted in Scandinavia. We screened 13,022 men with prostate cancer at 52 United States medical centers for potential enrollment. From these, 5023 met initial age, comorbidity and disease eligibility criteria and a total of 731 men agreed to participate and were randomized. The mean age of enrollees was 67 years. Nearly one-third were African-American. Approximately 85% reported they were fully active. The median prostate specific antigen (PSA) was 7.8 ng/mL (mean 10.2 ng/mL). In three-fourths of men the primary reason for biopsy leading to a diagnosis of prostate cancer was a PSA elevation or rise. Using previously developed tumor risk categorizations incorporating PSA levels, Gleason

  8. Parenting Intervention Combined With Acceptance and Commitment Therapy: A Trial With Families of Children With Cerebral Palsy

    PubMed Central

    Sanders, Matthew R.; McKinlay, Lynne; Boyd, Roslyn N.

    2016-01-01

    Objective To examine the effects of Stepping Stones Triple P (SSTP) and Acceptance and Commitment Therapy (ACT) on child functioning, quality of life, and parental adjustment. Method 67 parents (97.0% mothers) of children (64.2% male; mean age 5.3 ± 3.0 years) with cerebral palsy participated in a randomized controlled trial with three groups: wait-list control, SSTP, and SSTP + ACT. This article details the secondary outcomes. Results In comparison with wait-list, the SSTP + ACT group showed increased functional performance and quality of life as well as decreased parental psychological symptoms. No differences were found for parental confidence. No differences were found between SSTP and wait-list or between SSTP and SSTP + ACT. Conclusions ACT-integrated parenting intervention may be an effective way to target child functioning, quality of life, and parental adjustment. PMID:26702629

  9. Specific timely appointments for triage reduced waiting lists in an outpatient physiotherapy service.

    PubMed

    Harding, K E; Bottrell, J

    2016-12-01

    Waiting lists with triage systems are commonly used in outpatient physiotherapy but may not be effective. Could an alternative model of access and triage reduce waiting times over a sustained period with no additional resources? Observational study comparing retrospective data for 11 months prior to the introduction of a new model of access compared with data for the equivalent 11 months afterwards. Patients referred to a physiotherapy outpatient department at an outer metropolitan hospital before (n=721) and after (n=707) the introduction of the new model. A model of access and triage known as 'specific timely appointments for triage' (STAT), in which appointment slots are preserved in advance specifically for new patients based on calculation of average demand. Time from referral to first assessment, number of appointments per patient, occasions of non-attendance and total length of stay in the service. Median time from referral to first appointment was 18 days [interquartile range (IQR) 11 to 33 days] in the pre-intervention group, compared with 14 days (IQR 9 to 21 days) in the post-intervention group (P<0.01). The number of physiotherapy appointments also reduced (IQR 2 to 6 vs IQR 1 to 4; P<0.01). There were no changes in non-attendance rates or total time in the service. Waiting time for outpatient physiotherapy was 22% lower in the year following the introduction of the STAT model. While acknowledging the limitations of a pre- and post-measurement design, this model may have potential for reducing waiting times for outpatient physiotherapy without additional resources. Copyright © 2015 Chartered Society of Physiotherapy. Published by Elsevier Ltd. All rights reserved.

  10. The role of central and peripheral muscle fatigue in postcancer fatigue: a randomized controlled trial.

    PubMed

    Prinsen, Hetty; van Dijk, Johannes P; Zwarts, Machiel J; Leer, Jan Willem H; Bleijenberg, Gijs; van Laarhoven, Hanneke W M

    2015-02-01

    Postcancer fatigue is a frequently occurring problem, impairing quality of life. Little is known about (neuro)physiological factors determining postcancer fatigue. It may be hypothesized that postcancer fatigue is characterized by low peripheral muscle fatigue and high central muscle fatigue. The aims of this study were to examine whether central and peripheral muscle fatigue differ between fatigued and non-fatigued cancer survivors and to examine the effect of cognitive behavioral therapy (CBT) on peripheral and central muscle fatigue of fatigued cancer survivors in a randomized controlled trial. Sixteen fatigued patients in the intervention group (CBT) and eight fatigued patients in the waiting list group were successfully assessed at baseline and six months later. Baseline measurements of 20 fatigued patients were compared with 20 non-fatigued patients. A twitch interpolation technique and surface electromyography were applied, respectively, during sustained contraction of the biceps brachii muscle. Muscle fiber conduction velocity (MFCV) and central activation failure (CAF) were not significantly different between fatigued and non-fatigued patients. Change scores of MFCV and CAF were not significantly different between patients in the CBT and waiting list groups. Patients in the CBT group reported a significantly larger decrease in fatigue scores than patients in the waiting list group. Postcancer fatigue is neither characterized by abnormally high central muscle fatigue nor by low peripheral muscle fatigue. These findings suggest a difference in the underlying physiological mechanism of postcancer fatigue vs. other fatigue syndromes. Copyright © 2015 American Academy of Hospice and Palliative Medicine. Published by Elsevier Inc. All rights reserved.

  11. Randomized Trial of Brief Motivational Treatments for Pathological Gamblers: More Is Not Necessarily Better

    ERIC Educational Resources Information Center

    Hodgins, David C.; Currie, Shawn R.; Currie, Gillian; Fick, Gordon H.

    2009-01-01

    The efficacy of brief treatments for media-recruited pathological gamblers was tested in a randomized clinical trial design (N = 314). Two self-directed motivational interventions were compared with a 6-week waiting list control and a workbook only control. Brief motivational treatment involved a telephone motivational interview and a mailed…

  12. Bibliotherapy for Children with Anxiety Disorders Using Written Materials for Parents: A Randomized Controlled Trial

    ERIC Educational Resources Information Center

    Rapee, Ronald M.; Abbott, Maree J.; Lyneham, Heidi J.

    2006-01-01

    The current trial examined the value of modifying empirically validated treatment for childhood anxiety for application via written materials for parents of anxious children. Two hundred sixty-seven clinically anxious children ages 6-12 years and their parents were randomly allocated to standard group treatment, wait list, or a bibliotherapy…

  13. A Randomized Controlled Trial on The Beneficial Effects of Training Letter-Speech Sound Integration on Reading Fluency in Children with Dyslexia

    PubMed Central

    Fraga González, Gorka; Žarić, Gojko; Tijms, Jurgen; Bonte, Milene; van der Molen, Maurits W.

    2015-01-01

    A recent account of dyslexia assumes that a failure to develop automated letter-speech sound integration might be responsible for the observed lack of reading fluency. This study uses a pre-test-training-post-test design to evaluate the effects of a training program based on letter-speech sound associations with a special focus on gains in reading fluency. A sample of 44 children with dyslexia and 23 typical readers, aged 8 to 9, was recruited. Children with dyslexia were randomly allocated to either the training program group (n = 23) or a waiting-list control group (n = 21). The training intensively focused on letter-speech sound mapping and consisted of 34 individual sessions of 45 minutes over a five month period. The children with dyslexia showed substantial reading gains for the main word reading and spelling measures after training, improving at a faster rate than typical readers and waiting-list controls. The results are interpreted within the conceptual framework assuming a multisensory integration deficit as the most proximal cause of dysfluent reading in dyslexia. Trial Registration: ISRCTN register ISRCTN12783279 PMID:26629707

  14. A randomized controlled trial to promote volunteering in older adults.

    PubMed

    Warner, Lisa M; Wolff, Julia K; Ziegelmann, Jochen P; Wurm, Susanne

    2014-12-01

    Volunteering is presumed to confer health benefits, but interventions to encourage older adults to volunteer are sparse. Therefore, a randomized controlled trial with 280 community-dwelling older German adults was conducted to test the effects of a theory-based social-cognitive intervention against a passive waiting-list control group and an active control intervention designed to motivate physical activity. Self-reports of weekly volunteering minutes were assessed at baseline (5 weeks before the intervention) as well as 2 and 6 weeks after the intervention. Participants in the treatment group increased their weekly volunteering minutes to a greater extent than participants in the control groups 6 weeks after the intervention. We conclude that a single, face-to-face group session can increase volunteering among older community-dwelling adults. However, the effects need some time to unfold because changes in volunteering were not apparent 2 weeks after the intervention. (PsycINFO Database Record (c) 2014 APA, all rights reserved).

  15. Effects of a multidisciplinary stress treatment programme on patient return to work rate and symptom reduction: results from a randomised, wait-list controlled trial.

    PubMed

    Netterstrøm, Bo; Friebel, Lene; Ladegaard, Yun

    2013-01-01

    To evaluate the efficacy of a multidisciplinary stress treatment programme. General practitioners referred 198 employed patients on sick leave with symptoms of persistent work-related stress. Using a waitlisted randomised controlled trial design, the participants were randomly divided into the following three groups: the intervention group (IG, 69 participants); treatment-as-usual control group (TAUCG, 71 participants), which received 12 consultations with a psychologist, and the waitlisted control group (WLCG, 58 participants). The stress treatment intervention consisted of nine 1-hour sessions conducted over 3 months. The goals of the sessions were the following: (1) identifying relevant stressors; (2) changing the participant's coping strategies; (3) adjusting the participant's workload and tasks, and (4) improving workplace dialogue. Each participant also attended a mindfulness-based stress reduction (MBSR) course for 2 h a week over 8 weeks. The IG and TAUCG showed significantly greater symptom level (Symptom Check List 92) reductions compared to the WLCG. Regarding the return to work (RTW) rate, 67% of participants in the IG returned to full-time work after treatment, which was a significantly higher rate than in the TAUCG (36%) and WLCG (24%). Significantly more participants in the IG (97%) increased their working hours during treatment compared with the participants in the control groups, TAUCG (71%) and WLCG (64%). The stress treatment programme--a combination of work place-focused psychotherapy and MBSR--significantly reduced stress symptom levels and increased RTW rates compared with the WLCG and TAUCG. Copyright © 2013 S. Karger AG, Basel.

  16. The Feasibility, Acceptability, and Efficacy of Delivering Internet-Based Self-Help and Guided Self-Help Interventions for Generalized Anxiety Disorder to Indian University Students: Design of a Randomized Controlled Trial.

    PubMed

    Kanuri, Nitya; Newman, Michelle G; Ruzek, Josef I; Kuhn, Eric; Manjula, M; Jones, Megan; Thomas, Neil; Abbott, Jo-Anne M; Sharma, Smita; Taylor, C Barr

    2015-12-11

    Generalized anxiety disorder (GAD) is one of the most common mental disorders among university students; however, many students go untreated due to treatment costs, stigma concerns, and limited access to trained mental health professionals. These barriers are heightened in universities in India, where there are scant mental health care services and severe stigma surrounding help seeking. To evaluate the feasibility, acceptability, and efficacy of Internet-based, or "online," cognitive behavioral therapy (CBT)-based unguided and guided self-help interventions (using the programs GAD Online and Lantern, respectively) to reduce GAD symptoms in students with clinical and subthreshold GAD and, ultimately, reduce the prevalence and incidence of GAD among the student population. Students will be recruited via 3 colleges in Hyderabad, India, and referred for a campus-wide online screening. Self-report data will be collected entirely online. A total of 300 qualifying students will be randomized in a 1:1:1 ratio to receive GAD Online, Lantern, or to be in a wait-list control condition, stratified by clinical and subthreshold GAD symptomatology. Students will complete a postintervention assessment after 3 months and a follow-up assessment 6 months later, at which point students in the wait-list control condition will receive one of the programs. The primary outcome is GAD symptom severity at 3 months postintervention. Secondary outcomes include GAD caseness at 9 months, other anxiety and depression symptoms, self-efficacy, and functional measures (eg, sleep, social functioning) at 3 and 9 months, respectively. Primary analyses will be differences between each of the intervention groups and the wait-list control group, analyzed on an intention-to-treat (ITT) basis using mixed-design ANOVA. The study commenced in February 2015. The sample was recruited over a 3-week period at each college. The trial is expected to end in December 2015. This trial will be the first to evaluate

  17. Parenting Intervention Combined With Acceptance and Commitment Therapy: A Trial With Families of Children With Cerebral Palsy.

    PubMed

    Whittingham, Koa; Sanders, Matthew R; McKinlay, Lynne; Boyd, Roslyn N

    2016-06-01

    To examine the effects of Stepping Stones Triple P (SSTP) and Acceptance and Commitment Therapy (ACT) on child functioning, quality of life, and parental adjustment. 67 parents (97.0% mothers) of children (64.2% male; mean age 5.3 ± 3.0 years) with cerebral palsy participated in a randomized controlled trial with three groups: wait-list control, SSTP, and SSTP + ACT. This article details the secondary outcomes. In comparison with wait-list, the SSTP + ACT group showed increased functional performance and quality of life as well as decreased parental psychological symptoms. No differences were found for parental confidence. No differences were found between SSTP and wait-list or between SSTP and SSTP + ACT. ACT-integrated parenting intervention may be an effective way to target child functioning, quality of life, and parental adjustment. © The Author 2015. Published by Oxford University Press on behalf of the Society of Pediatric Psychology. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com.

  18. The Feasibility, Acceptability, and Efficacy of Delivering Internet-Based Self-Help and Guided Self-Help Interventions for Generalized Anxiety Disorder to Indian University Students: Design of a Randomized Controlled Trial

    PubMed Central

    Newman, Michelle G; Ruzek, Josef I; Kuhn, Eric; Manjula, M; Jones, Megan; Thomas, Neil; Abbott, Jo-Anne M; Sharma, Smita; Taylor, C. Barr

    2015-01-01

    Background Generalized anxiety disorder (GAD) is one of the most common mental disorders among university students; however, many students go untreated due to treatment costs, stigma concerns, and limited access to trained mental health professionals. These barriers are heightened in universities in India, where there are scant mental health care services and severe stigma surrounding help seeking. Objective To evaluate the feasibility, acceptability, and efficacy of Internet-based, or “online,” cognitive behavioral therapy (CBT)-based unguided and guided self-help interventions (using the programs GAD Online and Lantern, respectively) to reduce GAD symptoms in students with clinical and subthreshold GAD and, ultimately, reduce the prevalence and incidence of GAD among the student population. Methods Students will be recruited via 3 colleges in Hyderabad, India, and referred for a campus-wide online screening. Self-report data will be collected entirely online. A total of 300 qualifying students will be randomized in a 1:1:1 ratio to receive GAD Online, Lantern, or to be in a wait-list control condition, stratified by clinical and subthreshold GAD symptomatology. Students will complete a postintervention assessment after 3 months and a follow-up assessment 6 months later, at which point students in the wait-list control condition will receive one of the programs. The primary outcome is GAD symptom severity at 3 months postintervention. Secondary outcomes include GAD caseness at 9 months, other anxiety and depression symptoms, self-efficacy, and functional measures (eg, sleep, social functioning) at 3 and 9 months, respectively. Primary analyses will be differences between each of the intervention groups and the wait-list control group, analyzed on an intention-to-treat (ITT) basis using mixed-design ANOVA. Results The study commenced in February 2015. The sample was recruited over a 3-week period at each college. The trial is expected to end in December 2015

  19. Reduction in liver transplant wait-listing in the era of direct-acting antiviral therapy.

    PubMed

    Flemming, Jennifer A; Kim, W Ray; Brosgart, Carol L; Terrault, Norah A

    2017-03-01

    Direct-acting antiviral (DAA) therapy, recently approved for patients with decompensated cirrhosis (DC) secondary to hepatitis C virus (HCV), is associated with improved hepatic function. We analyzed trends in liver transplant (LT) wait-listing (WL) to explore potential impact of effective medical therapy on WL registration. This is a cohort study using the Scientific Registry of Transplant Recipients database from 2003 to 2015. A total of 47,591 adults wait-listed for LT from HCV, hepatitis B virus (HBV), and nonalcoholic steatohepatitis (NASH) were identified. LT indication was defined as DC if the Model for End-Stage Liver Disease (MELD) at WL was ≥15 or hepatocellular carcinoma (HCC). Era of listing was divided into interferon (IFN; 2003-2010), protease inhibitor (PI; 2011-2013), and direct-acting antiviral (DAA; 2014-2015). Annual standardized incidence rates of WL were analyzed using Poisson regression. Adjusted incidences of LT WL for DC in HCV patients decreased by 5% in the PI era (P = 0.004) and 32% in the DAA era (P < 0.001) compared to the IFN era. Listing for DC in HBV also decreased in the PI (-17%; P = 0.002) and DAA eras (-24%; P < 0.001). Conversely, WL for DC in NASH increased by 41% in the PI era (P < 0.001) and 81% in the DAA era (P < 0.001). WL for HCC in both the HCV and NASH populations increased in both the PI and DAA eras (P < 0.001 for all) whereas HCC WL in HBV remained stable (P > 0.05 for all). The rate of LT WL for HCV complicated by DC has decreased by over 30% in the era of DAA therapy. Further reductions in WL are anticipated with increased testing, linkage to care, and access to DAA therapy. (Hepatology 2017;65:804-812). © 2016 by the American Association for the Study of Liver Diseases.

  20. Attitudes and perceptions of patients on the kidney transplant waiting list toward mobile health-delivered physical activity programs.

    PubMed

    Sieverdes, John C; Raynor, Phyllis A; Armstrong, Tracy; Jenkins, Carolyn H; Sox, Luke R; Treiber, Frank A

    2015-03-01

    Dialysis patients' lifestyles are associated with low levels of physical activity, increasing the chances of being removed from kidney waiting lists or dying while awaiting transplant because of increased cardiovascular risk factors and deteriorating health conditions. Personalized mobile health (mHealth) delivered programs may support their engagement in healthier lifestyles, maintain transplant eligibility, and reduce premature mortality. To explore barriers and perceptions of physical activity behaviors and gauge interest in using mHealth in a physical activity wellness program for dialysis patients on the kidney transplant waiting list. In-depth key informant interviews were conducted with 22 randomly selected dialysis patients during dialysis treatment in an urban Southeastern coastal city. A theory-guided community-based participatory research approach was used to develop the interview content. Constructivist grounded theory guided the data analysis using NVIVO 10 (QSR Int). The 32-item checklist from the Consolidated Criteria for Reporting Qualitative Studies was used in the qualitative reporting. Dialysis patients had a mean age of 46 (SD, 10.7) years, 45% were female, and 82% were African American. Their mean duration on transplant waiting lists was 6.7 (SD 4.3) years, and 73% owned smartphones. After saturation was reached, predominant themes included (1) physical activity was perceived as optional, (2) social support both encouraged and limited physical activity, (3) chronic stress and coping influenced physical activity, (4) spirituality provided strength to engage in physical activity, (5) self-care management practices varied considerably, and (6) high interest (95%) for using mHealth to promote physical activity was found. Patients preferred their home and neighborhood environments to intradialytic settings for engaging in physical activity.

  1. Efficacy of an internet-based intervention for burnout: a randomized controlled trial in the German working population.

    PubMed

    Jonas, Benjamin; Leuschner, Fabian; Tossmann, Peter

    2017-03-01

    Internet-based interventions are a viable treatment option for various mental problems. However, their effects on the burnout syndrome yielded mixed results. In this paper, we examine the efficacy of a structured and therapist-guided internet intervention, based on solution-focused and cognitive-behavioral therapy, for individuals with symptoms of burnout. Two-arm, Internet-based, randomized, wait-list controlled trial (RCT). Participants were recruited through in-house events and online advertising. They were randomly assigned to the intervention or a wait-list. Group comparison was conducted three months after randomization. Outcomes were the burnout level according to the Maslach Burnout Inventory (MBI-GS) and the levels of depression, anxiety and stress according to the DASS-21. Thirty-nine participants were included in the trial; 36 (92.3%) took part at the 3-months-follow-up. Intention-to-treat analyses revealed significant group differences in favor of the intervention group in depression (d = 0.66), cynicism (d = 0.87) and personal accomplishment (d = 0.75). The intervention helped ameliorate symptoms of work-related stress and burnout. Although limited by a small sample size, the study suggests that the program provides effective support for affected individuals. However, further studies with bigger sample sizes should be conducted to examine the effects of such programs more precisely.

  2. Refining paracervical block techniques for pain control in first trimester surgical abortion: a randomized controlled noninferiority trial.

    PubMed

    Renner, Regina-Maria; Edelman, Alison B; Nichols, Mark D; Jensen, Jeffrey T; Lim, Jeong Y; Bednarek, Paula H

    2016-11-01

    Our objective was to evaluate two different aspects of the paracervical block (PCB) technique for first trimester surgical abortion, to compare a 3-min wait prior to cervical dilation to no wait and to compare four-site with two-site injection. We conducted two consecutive randomized, single-blinded noninferiority trials. In the first trial, women <11 weeks gestational age received a 20-mL 1% buffered lidocaine four-site PCB with either a 3-min wait between PCB injection and dilation or no wait. In the second trial, we compared a four-site with a two-site PCB. We evaluated dilation pain [100-mm visual analogue scale (VAS)] as the primary outcome. Secondary outcomes included pain at additional time points, anxiety, satisfaction and adverse events. Both trials fully enrolled (total n=332). Results were inconclusive as to whether no wait was noninferior to waiting 3-min prior to cervical dilation for dilation pain [VAS: 63 mm (SD, 24 mm) vs. 56 mm (SD, 32mm)] and as to whether a two-site PCB was noninferior to a four-site block [VAS: 68 mm (SD, 21 mm) vs. 60 mm (SD, 30 mm)]. Noninferiority analysis was inconclusive because the confidence interval of the mean pain score difference between groups included the predefined inferiority margin of 13-mm pain difference. Superiority analysis showed the four-site PCB to be superior to the two-site PCB. It remained inconclusive whether a 3-min wait time between PCB and cervical dilation provides noninferior pain control for first trimester surgical abortion. However, a four-site PCB appeared to be superior to a two-site PCB. It remained inconclusive whether a 3-min wait time between PCB and cervical dilation or using a two-site instead of a four-site PCB provided noninferior pain control for first trimester surgical abortion. This study did not assess whether the combination of the two separate factors provides additive benefit. Copyright © 2016 Elsevier Inc. All rights reserved.

  3. Efficacy of group psychotherapy for social anxiety disorder: A meta-analysis of randomized-controlled trials.

    PubMed

    Barkowski, Sarah; Schwartze, Dominique; Strauss, Bernhard; Burlingame, Gary M; Barth, Jürgen; Rosendahl, Jenny

    2016-04-01

    Group psychotherapy for social anxiety disorder (SAD) is an established treatment supported by findings from primary studies and earlier meta-analyses. However, a comprehensive summary of the recent evidence is still pending. This meta-analysis investigates the efficacy of group psychotherapy for adult patients with SAD. A literature search identified 36 randomized-controlled trials examining 2171 patients. Available studies used mainly cognitive-behavioral group therapies (CBGT); therefore, quantitative analyses were done for CBGT. Medium to large positive effects emerged for wait list-controlled trials for specific symptomatology: g=0.84, 95% CI [0.72; 0.97] and general psychopathology: g=0.62, 95% CI [0.36; 0.89]. Group psychotherapy was also superior to common factor control conditions in alleviating symptoms of SAD, but not in improving general psychopathology. No differences appeared for direct comparisons of group psychotherapy and individual psychotherapy or pharmacotherapy. Hence, group psychotherapy for SAD is an efficacious treatment, equivalent to other treatment formats. Copyright © 2016 Elsevier Ltd. All rights reserved.

  4. Internet-based cognitive-behavior therapy for procrastination: A randomized controlled trial.

    PubMed

    Rozental, Alexander; Forsell, Erik; Svensson, Andreas; Andersson, Gerhard; Carlbring, Per

    2015-08-01

    Procrastination can be a persistent behavior pattern associated with personal distress. However, research investigating different treatment interventions is scarce, and no randomized controlled trial has examined the efficacy of cognitive-behavior therapy (CBT). Meanwhile, Internet-based CBT has been found promising for several conditions, but has not yet been used for procrastination. Participants (N = 150) were randomized to guided self-help, unguided self-help, and wait-list control. Outcome measures were administered before and after treatment, or weekly throughout the treatment period. They included the Pure Procrastination Scale, the Irrational Procrastination Scale, the Susceptibility to Temptation Scale, the Montgomery Åsberg Depression Rating Scale-Self-report version, the Generalized Anxiety Disorder Assessment, and the Quality of Life Inventory. The intention-to-treat principle was used for all statistical analyses. Mixed-effects models revealed moderate between-groups effect sizes comparing guided and unguided self-help with wait-list control; the Pure Procrastination Scale, Cohen's d = 0.70, 95% confidence interval (CI) [0.29, 1.10], and d = 0.50, 95% CI [0.10, 0.90], and the Irrational Procrastination Scale, d = 0.81 95% CI [0.40, 1.22], and d = 0.69 95% CI [0.29, 1.09]. Clinically significant change was achieved among 31.3-40.0% for guided self-help, compared with 24.0-36.0% for unguided self-help. Neither of the treatment conditions was found to be superior on any of the outcome measures, Fs(98, 65.17-72.55) < 1.70, p > .19. Internet-based CBT could be useful for managing self-reported difficulties due to procrastination, both with and without the guidance of a therapist. (c) 2015 APA, all rights reserved).

  5. Early failure of total hip replacements implanted at distant hospitals to reduce waiting lists.

    PubMed Central

    Ciampolini, Jac; Hubble, Matthew J. W.

    2005-01-01

    AIM: In the years 1990-1993, in an effort to reduce waiting-list time, a small number of patients were sent from Exeter to hospitals in London to undergo elective total hip replacement. No medium- or long-term follow-up was arranged. Our aim was to audit the outcome of these hip replacements. PATIENTS AND METHODS: Review of the records of the referring medical practices, Regional Health Authority, local orthopaedic hospital and the distant centres at which the surgery was performed identified 31 cases. A total of 27 hip replacements in 24 patients were available for clinical and radiological review. RESULTS: 12 (44%) hips have so far required revision surgery, at a mean of 6.5 years. Of these, three (11%) have been for deep infection. A further three hips (11%) are radiologically loose and are being closely monitored. Two patients (7%) suffered permanent sciatic nerve palsy. CONCLUSIONS: Patients whose surgery was performed locally over a similar time period have a published failure rate of only 4.9%. This difference is highly statistically significant (P < 0.001). The causes for such a difference in outcome were analysed and include surgical technique, implant selection and absence of follow-up. In the light of this evidence, we would like to urge the government to address waiting list problems by investing in the local infrastructure. Expanding those facilities where properly audited and fully accountable surgeons operate must be the way forward. PMID:15720905

  6. Physiological and neurophysiological determinants of postcancer fatigue: design of a randomized controlled trial

    PubMed Central

    2012-01-01

    Background Postcancer fatigue is a frequently occurring, severe, and invalidating problem, impairing quality of life. Although it is possible to effectively treat postcancer fatigue with cognitive behaviour therapy, the nature of the underlying (neuro)physiology of postcancer fatigue remains unclear. Physiological aspects of fatigue include peripheral fatigue, originating in muscle or the neuromuscular junction; central fatigue, originating in nerves, spinal cord, and brain; and physical deconditioning, resulting from a decreased cardiopulmonary function. Studies on physiological aspects of postcancer fatigue mainly concentrate on deconditioning. Peripheral and central fatigue and brain morphology and function have been studied for patients with fatigue in the context of chronic fatigue syndrome and neuromuscular diseases and show several characteristic differences with healthy controls. Methods/design Fifty seven severely fatigued and 21 non-fatigued cancer survivors will be recruited from the Radboud University Nijmegen Medical Centre. Participants should have completed treatment of a malignant, solid tumour minimal one year earlier and should have no evidence of disease recurrence. Severely fatigued patients are randomly assigned to either the intervention condition (cognitive behaviour therapy) or the waiting list condition (start cognitive behaviour therapy after 6 months). All participants are assessed at baseline and the severely fatigued patients also after 6 months follow-up (at the end of cognitive behaviour therapy or waiting list). Primary outcome measures are fatigue severity, central and peripheral fatigue, brain morphology and function, and physical condition and activity. Discussion This study will be the first randomized controlled trial that characterizes (neuro)physiological factors of fatigue in disease-free cancer survivors and evaluates to which extent these factors can be influenced by cognitive behaviour therapy. The results of this

  7. A multi-site single blind clinical study to compare the effects of prolonged exposure, eye movement desensitization and reprocessing and waiting list on patients with a current diagnosis of psychosis and co morbid post traumatic stress disorder: study protocol for the randomized controlled trial Treating Trauma in Psychosis

    PubMed Central

    2013-01-01

    Background Trauma contributes to psychosis and in psychotic disorders post-traumatic stress disorder (PTSD) is often a comorbid disorder. A problem is that PTSD is underdiagnosed and undertreated in people with psychotic disorders. This study’s primary goal is to examine the efficacy and safety of prolonged exposure and eye movement desensitization and reprocessing (EMDR) for PTSD in patients with both psychotic disorders and PTSD, as compared to a waiting list. Secondly, the effects of both treatments are determined on (a) symptoms of psychosis, in particular verbal hallucinations, (b) depression and social performance, and (c) economic costs. Thirdly, goals concern links between trauma exposure and psychotic symptomatology and the prevalence of exposure to traumatic events, and of PTSD. Fourthly predictors, moderators, and mediators for treatment success will be explored. These include cognitions and experiences concerning treatment harm, credibility and burden in both participants and therapists. Methods/Design A short PTSD-screener assesses the possible presence of PTSD in adult patients (21- to 65- years old) with psychotic disorders, while the Clinician Administered PTSD Scale interview will be used for the diagnosis of current PTSD. The M.I.N.I. Plus interview will be used for diagnosing lifetime psychotic disorders and mood disorders with psychotic features. The purpose is to include consenting participants (N = 240) in a multi-site single blind randomized clinical trial. Patients will be allocated to one of three treatment conditions (N = 80 each): prolonged exposure or EMDR (both consisting of eight weekly sessions of 90 minutes each) or a six-month waiting list. All participants are subjected to blind assessments at pre-treatment, twomonths post treatment, and six monthspost treatment. In addition, participants in the experimental conditions will have assessments at mid treatment and at 12 months follow-up. Discussion The results from the post

  8. Sleep-Related Safety Behaviors and Dysfunctional Beliefs Mediate the Efficacy of Online CBT for Insomnia: A Randomized Controlled Trial.

    PubMed

    Lancee, Jaap; Eisma, Maarten C; van Straten, Annemieke; Kamphuis, Jan H

    2015-01-01

    Several trials have demonstrated the efficacy of online cognitive behavioral therapy (CBT) for insomnia. However, few studies have examined putative mechanisms of change based on the cognitive model of insomnia. Identification of modifiable mechanisms by which the treatment works may guide efforts to further improve the efficacy of insomnia treatment. The current study therefore has two aims: (1) to replicate the finding that online CBT is effective for insomnia and (2) to test putative mechanism of change (i.e., safety behaviors and dysfunctional beliefs). Accordingly, we conducted a randomized controlled trial in which individuals with insomnia were randomized to either online CBT for insomnia (n = 36) or a waiting-list control group (n = 27). Baseline and posttest assessments included questionnaires assessing insomnia severity, safety behaviors, dysfunctional beliefs, anxiety and depression, and a sleep diary. Three- and six-month assessments were administered to the CBT group only. Results show moderate to large statistically significant effects of the online treatment compared to the waiting list on insomnia severity, sleep measures, sleep safety behaviors, and dysfunctional beliefs. Furthermore, dysfunctional beliefs and safety behaviors mediated the effects of treatment on insomnia severity and sleep efficiency. Together, these findings corroborate the efficacy of online CBT for insomnia, and suggest that these effects were produced by changing maladaptive beliefs, as well as safety behaviors. Treatment protocols for insomnia may specifically be enhanced by more focused attention on the comprehensive fading of sleep safety behaviors, for instance through behavioral experiments.

  9. Internet-Delivered Cognitive-Behavioral Therapy for Social Anxiety Disorder in Romania: A Randomized Controlled Trial

    PubMed Central

    Tulbure, Bogdan Tudor; Szentagotai, Aurora; David, Oana; Ștefan, Simona; Månsson, Kristoffer N. T.; David, Daniel; Andersson, Gerhard

    2015-01-01

    Background and Aims Internet-based cognitive-behavioral therapy (iCBT) for social anxiety disorder has been found effective, as attested by independently conducted randomized controlled trials in four languages. The study aim is to test the efficacy of an iCBT program in a culture where it was not tested before (i.e. Romania). Methods Participants (n = 76) were recruited, screened and randomized to either a nine-week guided iCBT or a wait-list control group in April and May 2012. Self-report measures were collected before (April 2012) and after the intervention (July 2012), as well as six months later (January 2013). Although social anxiety was assessed with multiple measures, the Liebowitz Social Anxiety Scale - Self Report version (LSAS-SR) and Social Phobia Inventory (SPIN) were used as the primary outcome measures. Results A significant difference with a large between-group effect size in favor of iCBT was found (Cohen´s d = 1.19 for LSAS-SR and d = 1.27 for SPIN). Recovery rates show that 36.8% (n = 14) in the treatment group score below the SPIN clinical cut-off compared to only 2.6% (n = 1) in the wait-list control group. Post-intervention clinical interviews also revealed that 34.2% (n = 13) of the treatment group was completely recovered (full remission) while additionally 36.8% (n = 14) retained some social anxiety symptoms (partial remission). However, an important study limitation is that post-intervention interviewers were not blinded to the study conditions. The program also effectively reduced depression and dysfunctional thinking (between-group Cohen´s d = 0.84 for depression and d = 0.63 for dysfunctional thinking). Moreover, the iCBT intervention appears to have a long-term impact for participants’ functioning, as the treatment gains were maintained six months later. Conclusions Internet-delivered interventions display a high potential to quickly and widely disseminate effective evidence-based programs around the world. This study provides

  10. Cognitive-Behavioral Therapy for Intermittent Explosive Disorder: A Pilot Randomized Clinical Trial

    ERIC Educational Resources Information Center

    McCloskey, Michael S.; Noblett, Kurtis L.; Deffenbacher, Jerry L.; Gollan, Jackie K.; Coccaro, Emil F.

    2008-01-01

    No randomized clinical trials have evaluated the efficacy of psychotherapy for intermittent explosive disorder (IED). In the present study, the authors tested the efficacy of 12-week group and individual cognitive-behavioral therapies (adapted from J. L. Deffenbacher & M. McKay, 2000) by comparing them with a wait-list control in a randomized…

  11. Clinical characteristics of Japanese candidates for lung transplant for interstitial lung disease and risk factors for early death while on the waiting list.

    PubMed

    Higo, Hisao; Kurosaki, Takeshi; Ichihara, Eiki; Kubo, Toshio; Miyoshi, Kentaroh; Otani, Shinji; Sugimoto, Seiichiro; Yamane, Masaomi; Miyahara, Nobuaki; Kiura, Katsuyuki; Miyoshi, Shinichiro; Oto, Takahiro

    2017-07-01

    Lung transplants have produced very favorable outcomes for patients with interstitial lung disease (ILD) in Japan. However, because of the severe donor lung shortage, patients must wait approximately 2.5 years before they can undergo transplantation and many candidates die before allocation. We reveal the clinical characteristics of Japanese patients with ILD who are candidates for lung transplants and the risk factors for early death while on the waiting list. We retrospectively reviewed the clinical data of patients registered in the Japan Organ Transplant Network from Okayama University Hospital who are candidates for cadaveric lung transplants for ILD between 1999 and 2015. Fifty-three patients with ILD were included (24 patients with idiopathic pulmonary fibrosis and 29 others). They had severe pulmonary dysfunction and low exercise tolerability. The median waiting time for transplantation was 462 days, and 22 patients died before allocation. Patients who died before 462 days without undergoing transplantation had more severe dyspnea, shorter 6-minute walk distance (6MWD), and lower performance status than those who waited ≥462 days. Japanese candidates for cadaveric lung transplants for ILD have severe pulmonary dysfunction. Severe dyspnea, short 6MWD, and low performance status are risk factors for early death while on the waiting list. Copyright © 2017 The Japanese Respiratory Society. Published by Elsevier B.V. All rights reserved.

  12. Efficacy of the resilience and adjustment intervention after traumatic brain injury: a randomized controlled trial.

    PubMed

    Kreutzer, Jeffrey S; Marwitz, Jennifer H; Sima, Adam P; Mills, Ana; Hsu, Nancy H; Lukow, Herman R

    2018-05-24

    Examine a psychoeducational and skill-building intervention's effectiveness for individuals after traumatic brain injury (TBI), using a two-arm, parallel, randomized, controlled trial with wait-listed control. The Resilience and Adjustment Intervention (RAI) targets adjustment challenges and emphasizes education, skill-building and psychological support. Overall, 160 outpatients were randomly assigned to a treatment or wait-list control (WLC) group. The manualized treatment was delivered in seven 1-h sessions. The Connor-Davidson Resilience Scale (CD-RISC) was the primary outcome measure. Secondary measures included the Mayo Portland Adaptability Inventory-4 (MPAI-4), Brief Symptom Inventory-18 (BSI-18) and 13-Item Stress Test. After adjusting for injury severity, education and time postinjury, the RAI group (N = 75) demonstrated a significantly greater increase in resilience (effect size = 1.03) compared to the WLC group (N = 73). Participants in the RAI group demonstrated more favourable scores on the MPAI-4 Adjustment and Ability Indices, BSI-18 and the 13-item Stress Test. However, only the CD-RISC and BSI-18 demonstrated a clinically significant difference. In addition, RAI participants demonstrated maintenance of gains from pre-treatment to 3-month follow-up; however, only the BSI-18 maintained a clinically significant difference. Investigation provided evidence that a resilience-focused intervention can improve psychological health and adjustment after TBI. Additional research is needed to ascertain the longer term benefits of intervention and the efficacy of alternative delivery methods (e.g., via telephone, Internet).

  13. Evaluation of mindfulness-based cognitive therapy for life and a cognitive behavioural therapy stress-management workshop to improve healthcare staff stress: study protocol for two randomised controlled trials.

    PubMed

    Strauss, Clara; Gu, Jenny; Pitman, Nikki; Chapman, Cavita; Kuyken, Willem; Whittington, Adrian

    2018-04-02

    Healthcare workers experience higher levels of work-related stress and higher rates of sickness absence than workers in other sectors. Psychological approaches have potential in providing healthcare workers with the knowledge and skills to recognise stress and to manage stress effectively. The strongest evidence for effectiveness in reducing stress in the workplace is for stress-management courses based on cognitive behavioural therapy (CBT) principles and mindfulness-based interventions (MBIs). However, research examining effects of these interventions on sickness absence (an objective indicator of stress) and compassion for others (an indicator of patient care) is limited, as is research on brief CBT stress-management courses (which may be more widely accessible) and on MBIs adapted for workplace settings. This protocol is for two randomised controlled trials with participant preference between the two trials and 1:1 allocation to intervention or wait-list within the preferred choice. The first trial is examining a one-day CBT stress-management workshop and the second trial an 8-session Mindfulness-Based Cognitive Therapy for Life (MBCT-L) course, with both trials comparing intervention to wait-list. The primary outcome for both trials is stress post-intervention with secondary outcomes being sickness absence, compassion for others, depression symptoms, anxiety symptoms, wellbeing, work-related burnout, self-compassion, presenteeism, and mindfulness (MBCT-L only). Both trials aim to recruit 234 staff working in the National Health Service in the UK. This trial will examine whether a one-day CBT stress-management workshop and an 8-session MBCT-L course are effective at reducing healthcare staff stress and other mental health outcomes compared to wait-list, and, whether these interventions are effective at reducing sickness absence and presenteeism and at enhancing wellbeing, self-compassion, mindfulness and compassion for others. Findings will help inform

  14. Using Social Media While Waiting in Pain: A Clinical 12-Week Longitudinal Pilot Study.

    PubMed

    Merolli, Mark; Gray, Kathleen; Martin-Sanchez, Fernando; Mantopoulos, Steven; Hogg, Malcolm

    2015-08-07

    completed questionnaires. Low specificity of the resources to one's condition and time poorness may have been barriers to engagement. Results suggest that with refinements, this study design can be implemented successfully when conducting a larger social media study. At present, comment cannot be made on what effect using social media can have on patients on hospital waiting lists, nor whether those who use social media while waiting in pain achieve better outcomes from eventual participation in a chronic pain program. Long-term follow-up should be included in future studies to answer this. Future research should focus on multicenter randomized controlled trials, involving patients in the intervention design for improved participation and outcomes and for evidence to be sound.

  15. Breathe Easier Online: Evaluation of a Randomized Controlled Pilot Trial of an Internet-Based Intervention to Improve Well-being in Children and Adolescents With a Chronic Respiratory Condition

    PubMed Central

    Dunn, Tamara L; Casey, Leanne M; Sheffield, Jeanie K; Petsky, Helen; Anderson-James, Sophie; Chang, Anne B

    2012-01-01

    Background Chronic respiratory illnesses are the most common group of childhood chronic health conditions and are overrepresented in socially isolated groups. Objective To conduct a randomized controlled pilot trial to evaluate the efficacy of Breathe Easier Online (BEO), an Internet-based problem-solving program with minimal facilitator involvement to improve psychosocial well-being in children and adolescents with a chronic respiratory condition. Methods We randomly assigned 42 socially isolated children and adolescents (18 males), aged between 10 and 17 years to either a BEO (final n = 19) or a wait-list control (final n = 20) condition. In total, 3 participants (2 from BEO and 1 from control) did not complete the intervention. Psychosocial well-being was operationalized through self-reported scores on depression symptoms and social problem solving. Secondary outcome measures included self-reported attitudes toward their illness and spirometry results. Paper-and-pencil questionnaires were completed at the hospital when participants attended a briefing session at baseline (time 1) and in their homes after the intervention for the BEO group or a matched 9-week time period for the wait-list group (time 2). Results The two groups were comparable at baseline across all demographic measures (all F < 1). For the primary outcome measures, there were no significant group differences on depression (P = .17) or social problem solving (P = .61). However, following the online intervention, those in the BEO group reported significantly lower depression (P = .04), less impulsive/careless problem solving (P = .01), and an improvement in positive attitude toward their illness (P = .04) compared with baseline. The wait-list group did not show these differences. Children in the BEO group and their parents rated the online modules very favorably. Conclusions Although there were no significant group differences on primary outcome measures, our pilot data provide tentative support

  16. Effects of Assertiveness Training and Expressive Writing on Acculturative Stress in International Students: A Randomized Trial

    ERIC Educational Resources Information Center

    Tavakoli, Shedeh; Lumley, Mark A.; Hijazi, Alaa M.; Slavin-Spenny, Olga M.; Parris, George P.

    2009-01-01

    International university students often experience acculturative stress, and culturally appropriate techniques to manage stress are needed. This randomized trial tested the effects of group assertiveness training, private expressive writing, their combination, and a wait-list control on the acculturative stress, affect, and health of 118…

  17. Effects of online cognitive treatment for problematic anger: a randomized controlled trial.

    PubMed

    Howie, Amanda J; Malouff, John M

    2014-01-01

    Problematic anger, which is common, has been associated with a wide range of negative interpersonal and intrapersonal consequences, including violent behaviour, relationship damage, health problems and low self-esteem. This article reports the results of the first randomized controlled trial of brief online cognitive treatment for anger. The sample included 75 adults who were randomly assigned to cognitive treatment or a waiting list control. The analyses with the 59 participants who completed the post-intervention assessment at four weeks after the beginning of the intervention showed that individuals who received the intervention reported significantly lower anger levels than the control group at post-assessment. The treatment group showed a substantial decrease in anger from pre to post. The results suggest that brief online cognitive treatment can be effective for reducing problematic anger in adults. These findings provide an initial support for the development of internet-based cognitive treatment for problematic anger.

  18. Motivational Interviewing Versus Cognitive Behavioral Group Therapy in the Treatment of Problem and Pathological Gambling: A Randomized Controlled Trial

    PubMed Central

    Carlbring, Per; Jonsson, Jakob; Josephson, Henrik; Forsberg, Lars

    2009-01-01

    Pathological gambling is a widespread problem with major implications for society and the individual. There are effective treatments, but little is known about the relative effectiveness of different treatments. The aim of this study was to test the effectiveness of motivational interviewing, cognitive behavioral group therapy, and a no-treatment control (wait-list) in the treatment of pathological gambling. This was done in a randomized controlled trial at an outpatient dependency clinic at Karolinska Institute (Stockholm, Sweden). A total of 150 primarily self-recruited patients with current gambling problems or pathological gambling according to an NORC DSM-IV screen for gambling problems were randomized to four individual sessions of motivational interviewing (MI), eight sessions of cognitive behavioral group therapy (CBGT), or a no-treatment wait-list control. Gambling-related measures derived from timeline follow-back as well as general levels of anxiety and depression were administered at baseline, termination, and 6 and 12 months posttermination. Treatment showed superiority in some areas over the no-treatment control in the short term, including the primary outcome measure. No differences were found between MI and CBGT at any point in time. Instead, both MI and CBGT produced significant within-group decreases on most outcome measures up to the 12-month follow-up. Both forms of intervention are promising treatments, but there is room for improvement in terms of both outcome and compliance. PMID:19967577

  19. Randomized Trial of Internet-Delivered Self-Help with Telephone Support for Pathological Gamblers

    ERIC Educational Resources Information Center

    Carlbring, Per; Smit, Filip

    2008-01-01

    Although effective therapies for pathological gambling exist, their uptake is limited to 10% of the target population. To lower the barriers for help seeking, the authors tested an online alternative in a randomized trial (N = 66). The participants were pathological gamblers not presenting with severe comorbid depression. A wait-list control was…

  20. Designs for Testing Group-Based Interventions with Limited Numbers of Social Units: The Dynamic Wait-Listed and Regression Point Displacement Designs.

    PubMed

    Wyman, Peter A; Henry, David; Knoblauch, Shannon; Brown, C Hendricks

    2015-10-01

    The dynamic wait-listed design (DWLD) and regression point displacement design (RPDD) address several challenges in evaluating group-based interventions when there is a limited number of groups. Both DWLD and RPDD utilize efficiencies that increase statistical power and can enhance balance between community needs and research priorities. The DWLD blocks on more time units than traditional wait-listed designs, thereby increasing the proportion of a study period during which intervention and control conditions can be compared, and can also improve logistics of implementing intervention across multiple sites and strengthen fidelity. We discuss DWLDs in the larger context of roll-out randomized designs and compare it with its cousin the Stepped Wedge design. The RPDD uses archival data on the population of settings from which intervention unit(s) are selected to create expected posttest scores for units receiving intervention, to which actual posttest scores are compared. High pretest-posttest correlations give the RPDD statistical power for assessing intervention impact even when one or a few settings receive intervention. RPDD works best when archival data are available over a number of years prior to and following intervention. If intervention units were not randomly selected, propensity scores can be used to control for non-random selection factors. Examples are provided of the DWLD and RPDD used to evaluate, respectively, suicide prevention training (QPR) in 32 schools and a violence prevention program (CeaseFire) in two Chicago police districts over a 10-year period. How DWLD and RPDD address common threats to internal and external validity, as well as their limitations, are discussed.

  1. Designs for testing group-based interventions with limited numbers of social units: The dynamic wait-listed and regression point displacement designs

    PubMed Central

    Wyman, Peter A.; Brown, C. Hendricks

    2015-01-01

    The dynamic wait-listed design (DWLD) and regression point displacement design (RPDD) address several challenges in evaluating group-based interventions when there is a limited number of groups. Both DWLD and RPDD utilize efficiencies that increase statistical power and can enhance balance between community needs and research priorities. The DWLD blocks on more time units than traditional wait-listed designs, thereby increasing the proportion of a study period during which intervention and control conditions can be compared, and can also improve logistics of implementing intervention across multiple sites and strengthen fidelity. We discuss DWLDs in the larger context of roll-out randomized designs and compare it with its cousin the Stepped Wedge design. The RPDD uses archival data on the population of settings from which intervention unit(s) are selected to create expected posttest scores for units receiving intervention, to which actual posttest scores are compared. High pretest-posttest correlations give the RPDD statistical power for assessing intervention impact even when one or a few settings receive intervention. RPDD works best when archival data are available over a number of years prior to and following intervention. If intervention units were not randomly selected, propensity scores can be used to control for nonrandom selection factors. Examples are provided of the DWLD and RPDD used to evaluate, respectively, suicide prevention training (QPR) in 32 schools and a violence prevention program (CeaseFire) in 2 Chicago police districts over a 10-year period. How DWLD and RPDD address common threats to internal and external validity, as well as their limitations, are discussed. PMID:25481512

  2. Treatment of child anxiety disorders via guided parent-delivered cognitive-behavioural therapy: randomised controlled trial.

    PubMed

    Thirlwall, Kerstin; Cooper, Peter J; Karalus, Jessica; Voysey, Merryn; Willetts, Lucy; Creswell, Cathy

    2013-12-01

    Promising evidence has emerged of clinical gains using guided self-help cognitive-behavioural therapy (CBT) for child anxiety and by involving parents in treatment; however, the efficacy of guided parent-delivered CBT has not been systematically evaluated in UK primary and secondary settings. To evaluate the efficacy of low-intensity guided parent-delivered CBT treatments for children with anxiety disorders. A total of 194 children presenting with a current anxiety disorder, whose primary carer did not meet criteria for a current anxiety disorder, were randomly allocated to full guided parent-delivered CBT (four face-to-face and four telephone sessions) or brief guided parent-delivered CBT (two face-to-face and two telephone sessions), or a wait-list control group (trial registration: ISRCTN92977593). Presence and severity of child primary anxiety disorder (Anxiety Disorders Interview Schedule for DSM-IV, child/parent versions), improvement in child presentation of anxiety (Clinical Global Impression - Improvement scale), and change in child anxiety symptoms (Spence Children's Anxiety Scale, child/parent version and Child Anxiety Impact scale, parent version) were assessed at post-treatment and for those in the two active treatment groups, 6 months post-treatment. Full guided parent-delivered CBT produced superior diagnostic outcomes compared with wait-list at post-treatment, whereas brief guided parent-delivered CBT did not: at post-treatment, 25 (50%) of those in the full guided CBT group had recovered from their primary diagnosis, compared with 16 (25%) of those on the wait-list (relative risk (RR) 1.85, 95% CI 1.14-2.99); and in the brief guided CBT group, 18 participants (39%) had recovered from their primary diagnosis post-treatment (RR = 1.56, 95% CI 0.89-2.74). Level of therapist training and experience was unrelated to child outcome. Full guided parent-delivered CBT is an effective and inexpensive first-line treatment for child anxiety.

  3. Promoting deceased organ and tissue donation registration in family physician waiting rooms (RegisterNow-1 trial): study protocol for a pragmatic, stepped-wedge, cluster randomized controlled registry.

    PubMed

    Li, Alvin H; Garg, Amit X; Prakash, Versha; Grimshaw, Jeremy M; Taljaard, Monica; Mitchell, Joanna; Matti, Danny; Linklater, Stefanie; Naylor, Kyla L; Dixon, Stephanie; Faulds, Cathy; Bevan, Rachel; Getchell, Leah; Knoll, Greg; Kim, S Joseph; Sontrop, Jessica; Bjerre, Lise M; Tong, Allison; Presseau, Justin

    2017-12-21

    There is a worldwide shortage of organs available for transplant, leading to preventable mortality associated with end-stage organ disease. While most citizens in many countries with an intent-to-donate "opt-in" system support organ donation, registration rates remain low. In Canada, most Canadians support organ donation but less than 25% in most provinces have registered their desire to donate their organs when they die. The family physician office is a promising yet underused setting in which to promote organ donor registration and address known barriers and enablers to registering for deceased organ and tissue donation. We developed a protocol to evaluate an intervention to promote registration for organ and tissue donation in family physician waiting rooms. This protocol describes a planned, stepped-wedge, cluster randomized registry trial in six family physician offices in Ontario, Canada to evaluate the effectiveness of reception staff providing patients with a pamphlet that addresses barriers and enablers to registration including a description of how to register for organ donation. An Internet-enabled tablet will also be provided in waiting rooms so that interested patients can register while waiting for their appointments. Family physicians and reception staff will be provided with training and/or materials to support any conversations about organ donation with their patients. Following a 2-week control period, the six offices will cross sequentially into the intervention arm in randomized sequence at 2-week intervals until all offices deliver the intervention. The primary outcome will be the proportion of patients visiting the office who are registered organ donors 7 days following their office visit. We will evaluate this outcome using routinely collected registry data from provincial administrative databases. A post-trial qualitative evaluation process will assess the experiences of reception staff and family physicians with the intervention and the

  4. Does a fall prevention educational programme improve knowledge and change exercise prescribing behaviour in health and exercise professionals? A study protocol for a randomised controlled trial.

    PubMed

    Tiedemann, A; Sturnieks, D L; Hill, A-M; Lovitt, L; Clemson, L; Lord, S R; Harvey, L; Sherrington, C

    2014-11-19

    Falling in older age is a serious and costly problem. At least one in three older people fall annually. Although exercise is recognised as an effective fall prevention intervention, low numbers of older people engage in suitable programmes. Health and exercise professionals play a crucial role in addressing fall risk in older adults. This trial aims to evaluate the effect of participation in a fall prevention educational programme, compared with a wait-list control group, on health and exercise professionals' knowledge about fall prevention and the effect on fall prevention exercise prescription behaviour and confidence to prescribe the exercises to older people. A randomised controlled trial involving 220 consenting health and exercise professionals will be conducted. Participants will be individually randomised to an intervention group (n=110) to receive an educational workshop plus access to internet-based support resources, or a wait-list control group (n=110). The two primary outcomes, measured 3 months after randomisation, are: (1) knowledge about fall prevention and (2) self-perceived change in fall prevention exercise prescription behaviour. Secondary outcomes include: (1) participants' confidence to prescribe fall prevention exercises; (2) the proportion of people aged 60+ years seen by trial participants in the past month who were prescribed fall prevention exercise; and (3) the proportion of fall prevention exercises prescribed by participants to older people in the past month that comply with evidence-based guidelines. Outcomes will be measured with a self-report questionnaire designed specifically for the trial. The trial protocol was approved by the Human Research Ethics Committee, The University of Sydney, Australia. Trial results will be disseminated via peer reviewed journals, presentations at international conferences and participants' newsletters. Trial protocol was registered with the Australian and New Zealand Clinical Trials Registry (Number

  5. The efficacy of direct anti-HCV drugs improves early post-liver transplant survival and induces significant changes in waiting list composition.

    PubMed

    Crespo, Gonzalo; Trota, Núria; Londoño, Maria-Carlota; Mauro, Ezequiel; Baliellas, Carme; Castells, Lluís; Castellote, Jose; Tort, Jaume; Forns, Xavier; Navasa, Miquel

    2018-07-01

    The efficacy of direct-acting antivirals (DAAs) has dramatically changed the prognosis of patients with chronic hepatitis C. We aimed to evaluate the impact of DAA therapy on the composition of the liver transplant (LT) waiting list and the early post-transplant survival. We evaluated all patients admitted to the waiting list for a primary LT between 1st January 2008 and 31st of December 2016 in Catalonia, Spain. Time span was divided into two periods according to the availability of different antiviral therapies: 2008-2013 (interferon-based therapies) and 2014-2016 (DAA). Changes in the indications of LT and the aetiology of liver disease, as well as post-LT patient survival, were evaluated according to the year of inclusion and transplantation, respectively. We included 1,483 patients. Admissions in the waiting list for hepatitis C virus (HCV)-related liver disease decreased significantly, from 47% in 2008-2013 to 35% in 2014-2016 (p <0.001), particularly because of a reduction in patients with decompensated cirrhosis. In contrast, NASH-related inclusions increased from 4% to 7% (p = 0.003). Three-year post-LT patient survival increased significantly in the second period in the whole cohort (82% vs. 91%, p = 0.002), because of better survival in anti-HCV positive patients (76% vs. 91%, p = 0.001), but not in anti-HCV negative patients (88% vs. 91% p = 0.359). Anti-HCV positive serology, the time period of 2008-2013 and higher donor age were independently associated with post-LT mortality in the whole cohort; while time period and donor age were independently associated with post-LT mortality in anti-HCV positive recipients. The high efficacy of DAAs is associated with significant changes in the composition of the LT waiting list and, more importantly, results in improved post-transplant survival. The efficacy of the new direct-acting antivirals is associated with a significant improvement in survival of patients undergoing liver transplantation

  6. Impact of a board-game approach on current smokers: a randomized controlled trial

    PubMed Central

    2013-01-01

    Background The main objective of our study was to assess the impact of a board game on smoking status and smoking-related variables in current smokers. To accomplish this objective, we conducted a randomized controlled trial comparing the game group with a psychoeducation group and a waiting-list control group. Methods The following measures were performed at participant inclusion, as well as after a 2-week and a 3-month follow-up period: “Attitudes Towards Smoking Scale” (ATS-18), “Smoking Self-Efficacy Questionnaire” (SEQ-12), “Attitudes Towards Nicotine Replacement Therapy” scale (ANRT-12), number of cigarettes smoked per day, stages of change, quit attempts, and smoking status. Furthermore, participants were assessed for concurrent psychiatric disorders and for the severity of nicotine dependence with the Fagerström Test for Nicotine Dependence (FTND). Results A time × group effect was observed for subscales of the ANRT-12, ATS-18 and SEQ-12, as well as for the number of cigarettes smoked per day. At three months follow-up, compared to the participants allocated to the waiting list group, those on Pick-Klop group were less likely to remain smoker. Outcomes at 3 months were not predicted by gender, age, FTND, stage of change, or psychiatric disorders at inclusion. Conclusions The board game seems to be a good option for smokers. The game led to improvements in variables known to predict quitting in smokers. Furthermore, it increased smoking-cessation rates at 3-months follow-up. The game is also an interesting alternative for smokers in the precontemplation stage. PMID:23327643

  7. Contribution of spontaneous improvement to placebo response in depression: a meta-analytic review.

    PubMed

    Rutherford, Bret R; Mori, Shoko; Sneed, Joel R; Pimontel, Monique A; Roose, Steven P

    2012-06-01

    It is unknown to what degree spontaneous improvement accounts for the large placebo response observed in antidepressant trials for Major Depressive Disorder (MDD). The purpose of this study was to estimate the spontaneous improvement observed in treatment-seeking individuals with acute MDD by determining the symptom change in depressed patients assigned to wait-list controls in psychotherapy studies. The databases PubMed and PsycINFO were searched to identify randomized, prospective studies randomizing outpatients to psychotherapy or a wait-list control condition for the treatment of acute MDD. Standardized effect sizes calculated from each identified study were aggregated in a meta-analysis to obtain a summary statistic for the change in depression scores during participation in a wait-list control. Ten trials enrolling 340 participants in wait-list control conditions were identified. The estimated effect size for the change in depression scores during wait-list control was 0.505 (95% CI 0.271-0.739, p < 0.001), representing an average improvement of 4 points on the Hamilton Rating Scale for Depression. Depressed patients acutely experience improvement even without treatment, but spontaneous improvement is unlikely to account for the magnitude of placebo response typically observed in antidepressant trials. These findings must be interpreted in light of the small number wait-list control participants available for analysis as well as certain methodological heterogeneity in the psychotherapy studies analyzed. Copyright © 2012 Elsevier Ltd. All rights reserved.

  8. Consumer behaviour in the waiting area.

    PubMed

    Mobach, Mark P

    2007-02-01

    To determine consumer behaviour in the pharmacy waiting area. The applied methods for data-collection were direct observations. Three Dutch community pharmacies were selected for the study. The topics in the observation list were based on available services at each waiting area (brochures, books, illuminated new trailer, children's play area, etc.). Per patient each activity was registered, and at each pharmacy the behaviour was studied for 2 weeks. Most patients only waited during the waiting time at the studied pharmacies. Few consumers obtained written information during their wait. The waiting area may have latent possibilities to expand the information function of the pharmacy and combine this with other activities that distract the consumer from the wait. Transdisciplinary research, combining knowledge from pharmacy practice research with consumer research, has been a useful approach to add information on queueing behaviour of consumers.

  9. Virtual reality exposure therapy for social anxiety disorder: a randomized controlled trial.

    PubMed

    Anderson, Page L; Price, Matthew; Edwards, Shannan M; Obasaju, Mayowa A; Schmertz, Stefan K; Zimand, Elana; Calamaras, Martha R

    2013-10-01

    This is the first randomized trial comparing virtual reality exposure therapy to in vivo exposure for social anxiety disorder. Participants with a principal diagnosis of social anxiety disorder who identified public speaking as their primary fear (N = 97) were recruited from the community, resulting in an ethnically diverse sample (M age = 39 years) of mostly women (62%). Participants were randomly assigned to and completed 8 sessions of manualized virtual reality exposure therapy, exposure group therapy, or wait list. Standardized self-report measures were collected at pretreatment, posttreatment, and 12-month follow-up, and process measures were collected during treatment. A standardized speech task was delivered at pre- and posttreatment, and diagnostic status was reassessed at 3-month follow-up. Analysis of covariance showed that, relative to wait list, people completing either active treatment significantly improved on all but one measure (length of speech for exposure group therapy and self-reported fear of negative evaluation for virtual reality exposure therapy). At 12-month follow-up, people showed significant improvement from pretreatment on all measures. There were no differences between the active treatments on any process or outcome measure at any time, nor differences on achieving partial or full remission. Virtual reality exposure therapy is effective for treating social fears, and improvement is maintained for 1 year. Virtual reality exposure therapy is equally effective as exposure group therapy; further research with a larger sample is needed, however, to better control and statistically test differences between the treatments.

  10. Implementation of Organ Culture storage of donor corneas: a 3 year study of its impact on the corneal transplant wait list at the Lions New South Wales Eye Bank.

    PubMed

    Devasahayam, Raj; Georges, Pierre; Hodge, Christopher; Treloggen, Jane; Cooper, Simon; Petsoglou, Con; Sutton, Gerard; Zhu, Meidong

    2016-09-01

    Organ Culture corneal storage offers an extended storage time and increased donor pool and tissue assessment opportunities. In September 2011, the Lions New South Wales Eye Bank (LNSWEB) moved from hypothermic storage to Organ Culture corneal storage. This study evaluates the impact of implementation of Organ Culture on donor eye retrieval and the corneal transplant waiting list over a 3 year period in NSW, Australia. Retrospective review of the LNSWEB data from September 2011 to August 2014. Tissue collection, waiting list and tissue utilization data were recorded. The data from September 2008 to August 2011 for Optisol-GS storage was used for comparison. The annual donor and cornea collection rate increased 35 % and 44 % respectively with Organ Culture compared to Optisol-GS storage. The utilization rate of corneal tissue increased from 73.4 % with hypothermic storage to 77.2 % with Organ Culture storage. The transplant wait list decreased by 77.3 % from September 2011 to August 2014 and correlated with the increased rate of corneal transplantation (r = -0.9381, p < 0.0001). No other factors impacting the wait list changed over this period. Corneas not used from either storage method were due to unacceptable endothelial cell density/viability. The contamination rate of corneas stored in Organ Culture medium was low at 1.74 %. The Organ Culture storage method increases the corneal donor pool available to Eye banks. The practical benefits of the extended storage time and increased donor assessment opportunities have directly led to an increase in corneal utilization rate and a significant decrease in recipient wait list time.

  11. A national analysis of dental waiting lists and point-in-time geographic access to subsidised dental care: can geographic access be improved by offering public dental care through private dental clinics?

    PubMed

    Dudko, Yevgeni; Kruger, Estie; Tennant, Marc

    2017-01-01

    Australia is one of the least densely populated countries in the world, with a population concentrated on or around coastal areas. Up to 33% of the Australian population are likely to have untreated dental decay, while people with inadequate dentition (fewer than 21 teeth) account for up to 34% of Australian adults. Historically, inadequate access to public dental care has resulted in long waiting lists, received much media coverage and been the subject of a new federal and state initiative. The objective of this research was to gauge the potential for reducing the national dental waiting list through geographical advantage, which could arise from subcontracting the delivery of subsidised dental care to the existing network of private dental clinics across Australia. Eligible population data were collected from the Australian Bureau of Statistics website. Waiting list data from across Australia were collected from publicly available sources and confirmed through direct communication with each individual state or territory dental health body. Quantum geographic information system software was used to map distribution of the eligible population across Australia by statistical area, and to plot locations of government and private dental clinics. Catchment areas of 5 km for metropolitan clinics and 5 km and 50 km for rural clinics were defined. The number of people on the waiting list and those eligible for subsidised dental care covered by each of the catchment areas was calculated. Percentage of the eligible population and those on the waiting list that could benefit from the potential improvement in geographic access was ascertained for metropolitan and rural residents. Fifty three percent of people on the waiting list resided within metropolitan areas. Rural and remote residents made up 47% of the population waiting to receive care. The utilisation of both government and private dental clinics for the delivery of subsidised dental care to the eligible population

  12. Improving Patient Satisfaction with Waiting Time

    ERIC Educational Resources Information Center

    Eilers, Gayleen M.

    2004-01-01

    Waiting times are a significant component of patient satisfaction. A patient satisfaction survey performed in the author's health center showed that students rated waiting time lowest of the listed categories--A ratings of 58% overall, 63% for scheduled appointments, and 41% for the walk-in clinic. The center used a quality improvement process and…

  13. Parent Training with High-Risk Immigrant Chinese Families: A Pilot Group Randomized Trial Yielding Practice-Based Evidence

    ERIC Educational Resources Information Center

    Lau, Anna S.; Fung, Joey J.; Ho, Lorinda Y.; Liu, Lisa L.; Gudino, Omar G.

    2011-01-01

    We studied the efficacy and implementation outcomes of a culturally responsive parent training (PT) program. Fifty-four Chinese American parents participated in a wait-list controlled group randomized trial (32 immediate treatment, 22 delayed treatment) of a 14-week intervention designed to address the needs of high-risk immigrant families.…

  14. Cognitive Behavioral Therapy for 4- to 7-Year-Old Children with Anxiety Disorders: A Randomized Clinical Trial

    ERIC Educational Resources Information Center

    Hirshfeld-Becker, Dina R.; Masek, Bruce; Henin, Aude; Blakely, Lauren Raezer; Pollock-Wurman, Rachel A.; McQuade, Julia; DePetrillo, Lillian; Briesch, Jacquelyn; Ollendick, Thomas H.; Rosenbaum, Jerrold F.; Biederman, Joseph

    2010-01-01

    Objective: To examine the efficacy of a developmentally appropriate parent-child cognitive behavioral therapy (CBT) protocol for anxiety disorders in children ages 4-7 years. Method: Design: Randomized wait-list controlled trial. Conduct: Sixty-four children (53% female, mean age 5.4 years, 80% European American) with anxiety disorders were…

  15. A randomized clinical trial of cognitive behavioural therapy versus short-term psychodynamic psychotherapy versus no intervention for patients with hypochondriasis.

    PubMed

    Sørensen, P; Birket-Smith, M; Wattar, U; Buemann, I; Salkovskis, P

    2011-02-01

    Hypochondriasis is common in the clinic and in the community. Cognitive behavioural therapy (CBT) has been found to be effective in previous trials. Psychodynamic psychotherapy is a treatment routinely offered to patients with hypochondriasis in many countries, including Denmark. The aim of this study was to test CBT for hypochondriasis in a centre that was not involved in its development and compare both CBT and short-term psychodynamic psychotherapy (STPP) to a waiting-list control and to each other. CBT was modified by including mindfulness and group therapy sessions, reducing the therapist time required. STPP consisted of individual sessions. Eighty patients randomized to CBT, STPP and the waiting list were assessed on measures of health anxiety and general psychopathology before and after a 6-month treatment period. Waiting-list patients were subsequently offered one of the two active treatments on the basis of re-randomization, and assessed on the same measures post-treatment. Patients were again assessed at 6- and 12-month follow-up points. Patients who received CBT did significantly better on all measures relative to the waiting-list control group, and on a specific measure of health anxiety compared with STPP. The STPP group did not significantly differ from the waiting-list group on any outcome measures. Similar differences were observed between CBT and STPP during follow-up, although some of the significant differences between groups were lost. A modified and time-saving CBT programme is effective in the treatment of hypochondriasis, although the two psychotherapeutic interventions differed in structure.

  16. The Sources of Strength Australia Project: study protocol for a cluster randomised controlled trial.

    PubMed

    Calear, Alison L; Brewer, Jacqueline L; Batterham, Philip J; Mackinnon, Andrew; Wyman, Peter A; LoMurray, Mark; Shand, Fiona; Kazan, Dominique; Christensen, Helen

    2016-07-26

    The school system has been identified as an ideal setting for the implementation of prevention and early intervention programs for suicide. However, in Australia, suicide-prevention programs that are routinely delivered in the schools are lacking. Internationally, evidence exists for the effectiveness of peer-led interventions that take a social connectedness approach to improve help-seeking for suicide. The aim of the current trial is to test the effectiveness of the Sources of Strength program to promote help-seeking for suicide in adolescents in Australian high schools. This study is a two-arm, cluster-randomised, controlled trial that will compare the evidence-based Sources of Strength program to a wait-list control condition. Sixteen Australian high schools will be recruited to the trial, with all adolescents in years 7 to 10 (12-16 years of age) invited to participate. Peer leaders from intervention-condition schools will receive training in the Sources of Strength program and will integrate positive messages, across 3 months, with the support of adult advisors. Activities may take the form of class presentations, posters, videos, and messages on social media sites and will aim to change help-seeking norms, strengthen youth-adult connections, and promote positive coping. The primary outcome measure for the study is help-seeking intentions, whereas secondary outcomes include help-seeking behaviour, help-seeking attitudes and norms, referral of distressed peers, availability of adult help, positive coping, and suicidal behaviour. Data will be collected pre-intervention, post-intervention (after the initial 3 months of messaging), and at the end of the first (6-month follow-up) and the second year after implementation (18-month follow-up). Primary analyses will compare changes in help-seeking intentions for the intervention condition relative to the wait-list control condition using mixed-effect repeated-measures analyses to account for clustering within

  17. The Effects of Tai Chi and Neck Exercises in the Treatment of Chronic Nonspecific Neck Pain: A Randomized Controlled Trial.

    PubMed

    Lauche, Romy; Stumpe, Christoph; Fehr, Johannes; Cramer, Holger; Cheng, Ying Wu; Wayne, Peter M; Rampp, Thomas; Langhorst, Jost; Dobos, Gustav

    2016-09-01

    This study aimed to test the efficacy of Tai Chi for treating chronic neck pain. Subjects with chronic nonspecific neck pain were randomly assigned to 12 weeks of group Tai Chi or conventional neck exercises with weekly sessions of 75 to 90 minutes, or a wait-list control. The primary outcome measure was pain intensity (visual analogue scale). Secondary outcomes included pain on movement, functional disability, quality of life, well-being and perceived stress, postural and interoceptive awareness, satisfaction, and safety. Altogether, 114 participants were included (91 women, 49.4 ± 11.7 years of age). After 12 weeks Tai Chi participants reported significantly less pain compared with the wait list group (average difference in mm on the visual analogue scale: -10.5; 95% confidence interval, -20.3 to -.9; P = .033). Group differences were also found for pain on movement, functional disability, and quality of life compared with the wait list group. No differences were found for Tai Chi compared with neck exercises. Patients' satisfaction with both exercise interventions was high, and only minor side effects were observed. Tai Chi was more effective than no treatment in improving pain in subjects with chronic nonspecific neck pain. Because Tai Chi is probably as effective as neck exercises it may be considered a suitable alternative to conventional exercises for those with a preference toward Tai Chi. This article presents results of a randomized controlled trial comparing Tai Chi, conventional neck exercises, and no treatment for chronic nonspecific neck pain. Results indicate that Tai Chi exercises and conventional neck exercises are equally effective in improving pain and quality of life therefore representing beneficial interventions for neck pain. Copyright © 2016 American Pain Society. Published by Elsevier Inc. All rights reserved.

  18. The evaluation of a formalized queue management system for coronary angiography waiting lists.

    PubMed

    Alter, D A; Newman, Alice M; Cohen, Eric A; Sykora, Kathy; Tu, Jack V

    2005-11-01

    Lengthy waiting lists for coronary angiography have been described in many health care systems worldwide. The extent to which formal queue management systems may improve the prioritization and survival of patients in the angiography queue is unknown. To prospectively evaluate the performance of a formal queue management system for patients awaiting coronary angiography in Ontario. The coronary angiography urgency scale, a formal queue management system developed in 1993 using a modified Delphi panel, allocates recommended maximum waiting times (RMWTs) in accordance with clinical necessity. By using a provincial clinical registry, 35,617 consecutive patients referred into the coronary angiography queue between April 1, 2001, and March 31, 2002, were prospectively tracked. Cox proportional hazards models were used to examined mortality risk across urgency after adjusting for additional clinical and comorbid factors. Good agreement was determined in urgency ratings between scores from the coronary angiography urgency scale and implicit physician judgement, which was obtained independently at the time of the index referral (weighted kappa = 0.49). The overall mortality in the queue was 0.3% (0.47%, 0.26% and 0.13% for urgent, semiurgent and elective patients, respectively). Urgency, as specified by the coronary angiography urgency scale, was the strongest predictor of death in the queue (P<0.001). However, when patients were censored according to their RMWTs, mortality was similar across different levels of urgency. Consequently, up to 18.5 deaths per 10,000 patients could have potentially been averted had patients been triaged and undergone coronary angiography within the RMWT as specified by the coronary angiography urgency scale. The incorporation of the coronary angiography urgency scale as a formal queue management system may decrease mortality in the coronary angiography queue. The authors recommend its implementation in health care systems where patients

  19. Using Social Media While Waiting in Pain: A Clinical 12-Week Longitudinal Pilot Study

    PubMed Central

    Gray, Kathleen; Martin-Sanchez, Fernando; Mantopoulos, Steven; Hogg, Malcolm

    2015-01-01

    -up 9 out of 17 (53%) patients completed questionnaires. Low specificity of the resources to one’s condition and time poorness may have been barriers to engagement. Conclusions Results suggest that with refinements, this study design can be implemented successfully when conducting a larger social media study. At present, comment cannot be made on what effect using social media can have on patients on hospital waiting lists, nor whether those who use social media while waiting in pain achieve better outcomes from eventual participation in a chronic pain program. Long-term follow-up should be included in future studies to answer this. Future research should focus on multicenter randomized controlled trials, involving patients in the intervention design for improved participation and outcomes and for evidence to be sound. PMID:26254245

  20. Beneficial effects of reading aloud and solving simple arithmetic calculations (learning therapy) on a wide range of cognitive functions in the healthy elderly: study protocol for a randomized controlled trial

    PubMed Central

    2012-01-01

    Background Almost all cognitive functions decline with age. Results of previous studies have shown that cognitive training related to everyday life (reading aloud and solving simple arithmetic calculations), namely learning therapy, can improve two cognitive function (executive functions and processing speed) in elderly people. However, it remains unclear whether learning therapy engenders improvement of various cognitive functions or not. We investigate the impact of learning therapy on various cognitive functions (executive functions, episodic memory, short-term memory, working memory, attention, reading ability, and processing speed) in healthy older adults. Methods We use a single-blinded intervention with two parallel groups (a learning therapy group and a waiting list control group). Testers are blind to the study hypothesis and the group membership of participants. Through an advertisement in local newspaper, 64 healthy older adults are recruited. They will be assigned randomly to a learning therapy group or a waiting list control group. In the learning therapy group, participants are required to perform two cognitive tasks for 6 months: reading Japanese aloud and solving simple calculations. The waiting list group does not participate in the intervention. The primary outcome measure is the Stroop test score: a measure of executive function. Secondary outcome measures are assessments including the following: verbal fluency task, logical memory, first and second names, digit span forward, digit span backward, Japanese reading test, digit cancellation task, digit symbol coding, and symbol search. We assess these outcome measures before and after the intervention. Discussion This report is the first study which investigates the beneficial effects of learning therapy on a wide range of cognitive functions of elderly people. Our study provides sufficient evidence of learning therapy effectiveness. Most cognitive functions, which are correlated strongly with daily

  1. Educational program for middle-level public health nurses to develop new health services regarding community health needs: protocol for a randomized controlled trial.

    PubMed

    Yoshioka-Maeda, Kyoko; Katayama, Takafumi; Shiomi, Misa; Hosoya, Noriko

    2018-01-01

    Developing health services is a key strategy for improving the community health provided by public health nurses. However, an effective educational program for improving their skills in planning such services has not been developed. To describe our program and its evaluation protocol for the education of middle-level public health nurses to improve their skills in developing new health services to fulfil community health needs in Japan. In this randomized control trial, eligible participants in Japan will be randomly allocated to an intervention group and a control wait-list group. We will provide 8 modules of web-based learning for public health nurses from July to October 2018. To ensure fairness of educational opportunity, the wait-list group will participate in the same program as the intervention group after collection of follow-up data of the intervention group. The primary outcomes will be evaluated using the scale of competency measurement of creativity for public health nurses at baseline, immediately after the intervention. Secondary outcomes will be knowledge and performance regarding program development of public health nurses. This study will enable the analysis of the effects of the educational program on public health nurses for improving their competency to develop new health services for fulfilling community health needs and enriching health care systems. We registered our study protocol to the University hospital Medical Information Network- Clinical Trials Registry approved by International Committee of Medical Journal Editors (No. UMIN000032176, April, 2018).

  2. Maintained physical activity and physiotherapy in the management of distal upper limb pain – a protocol for a randomised controlled trial (the arm pain trial)

    PubMed Central

    2014-01-01

    Background Distal upper limb pain (pain affecting the elbow, forearm, wrist, or hand) can be non-specific, or can arise from specific musculoskeletal disorders. It is clinically important and costly, the best approach to clinical management is unclear. Physiotherapy is the standard treatment and, while awaiting treatment, advice is often given to rest and avoid strenuous activities, but there is no evidence base to support these strategies. This paper describes the protocol of a randomised controlled trial to determine, among patients awaiting physiotherapy for distal arm pain, (a) whether advice to remain active and maintain usual activities results in a long-term reduction in arm pain and disability, compared with advice to rest; and (b) whether immediate physiotherapy results in a long-term reduction in arm pain and disability, compared with physiotherapy delivered after a seven week waiting list period. Methods/Design Between January 2012 and January 2014, new referrals to 14 out-patient physiotherapy departments were screened for potential eligibility. Eligible and consenting patients were randomly allocated to one of the following three groups in equal numbers: 1) advice to remain active, 2) advice to rest, 3) immediate physiotherapy. Patients were and followed up at 6, 13, and 26 weeks post-randomisation by self-complete postal questionnaire and, at six weeks, patients who had not received physiotherapy were offered it at this time. The primary outcome is the proportion of patients free of disability at 26 weeks, as determined by the modified DASH (Disabilities of the Arm, Shoulder and Hand) questionnaire. We hypothesise (a) that advice to maintain usual activities while awaiting physiotherapy will be superior than advice to rest the arm; and (b) that fast-track physiotherapy will be superior to normal (waiting list) physiotherapy. These hypotheses will be examined using an intention-to-treat analysis. Discussion Results from this trial will contribute to

  3. Cholelithiasis in patients on the kidney transplant waiting list

    PubMed Central

    Brito, André Thiago Scandiuzzi; Azevedo, Luiz Sergio; Nahas, Willian Carlos; Matheus, André Siqueira; Jukemura, José

    2010-01-01

    OBJECTIVES To evaluate the prevalence of cholecystopathy in chronic renal patients awaiting kidney transplants. INTRODUCTION The prevalence and management of cholelithiasis in renal transplant patients is not well established. METHODS A total of 342 chronic renal failure patients on the waiting list for a kidney transplant were studied. Patients were evaluated for the presence of cholelithiasis and related symptoms, previous cholecystectomies and other abdominal surgeries, time on dialysis, and general data (gender, age, number of pregnancies, and body mass index). RESULTS Cholelithiasis was found in 41 out of 342 patients (12%). Twelve of these patients, all symptomatic, had previously undergone cholecystectomies. Five out of 29 patients who had not undergone surgery were symptomatic. Overall, 17 patients (41.5%) were symptomatic. Their mean age was 54 (range 32–74) years old; 61% were female, and their mean body mass index was 25.4. Nineteen (76%) out of 25 women had previously been pregnant, with an average of 3.6 pregnancies per woman. CONCLUSIONS The frequency of cholelithiasis was similar to that reported in the literature for the general population. However, the high frequency of symptomatic patients points toward an indication of routine pre-transplant cholecystectomy to avoid serious post-transplant complications. PMID:20454496

  4. Attrition after Intake at a University Counseling Center: Relationship among Client Race, Problem Type, and Time on a Waiting List

    ERIC Educational Resources Information Center

    Levy, Jacob J.; Thompson-Leonardelli, Kenya; Smith, Nathan Grant; Coleman, M. Nicole

    2005-01-01

    The present study examined the relationship between attrition after intake and the length of time that clients spent on a waiting list by client race and problem type. Participants were 1,461 clients who completed an initial intake evaluation at a large, Mid-Atlantic counseling center over a 6-year period. Fullfactorial hierarchical logistic…

  5. Trial of CBT for impulse control behaviors affecting Parkinson patients and their caregivers

    PubMed Central

    Okai, David; Askey-Jones, Sally; Samuel, Michael; O’Sullivan, Sean S.; Chaudhuri, K. Ray; Martin, Anne; Mack, Joel; Brown, Richard G.

    2013-01-01

    Objective: To test the effects of a novel cognitive-behavioral therapy (CBT)–based intervention delivered by a nurse therapist to patients with Parkinson disease (PD) with clinically significant impulse control behaviors (ICB). Methods: This was a randomized controlled trial comparing up to 12 sessions of a CBT-based intervention compared to a waiting list control condition with standard medical care (SMC). A total of 27 patients were randomized to the intervention and 17 to the waiting list. Patients with a Mini-Mental State Examination score of <24 were excluded. The coprimary outcomes were overall symptom severity and neuropsychiatric disturbances in the patients and carer burden and distress after 6 months. Secondary outcome measures included depression and anxiety, marital satisfaction, and work and social adjustment in patients plus general psychiatric morbidity and marital satisfaction in carers. Results: There was a significant improvement in global symptom severity in the CBT intervention group vs controls, from a mean score consistent with moderate to one of mild illness-related symptoms (χ2 = 16.46, p < 0.001). Neuropsychiatric disturbances also improved significantly (p = 0.03), as did levels of anxiety and depression and adjustment. Measures of carer burden and distress showed changes in the desired direction in the intervention group but did not change significantly. General psychiatric morbidity did improve significantly in the carers of patients given CBT. Conclusions: This CBT-based intervention is the first to show efficacy in ICB related to PD in terms of patient outcomes. The hoped-for alleviation of carer burden was not observed. The study demonstrates the feasibility and potential benefit of a psychosocial treatment approach for these disturbances at least in the short term, and encourages further larger-scale clinical trials. Classification of evidence: The study provides Class IV evidence that CBT plus SMC is more effective than SMC alone

  6. Randomized, Controlled Trial of CBT Training for PTSD Providers

    DTIC Science & Technology

    2013-10-01

    Statistician and Co- Investigator), Michelle Pucillo, MPH (Project Manager ), Gayatri Ranganathan , MS (Statistician), Julia Coleman (Research Associate...Journal of Consulting and Clinical Psychology, 74, 898-907. Ruzek, J. I., Friedman, M. J., & Murray, S. (2005). Toward a knowledge management system...result in superior CBT skills than wait-list control. Secondary Aim #1: To compare improvements in knowledge and attitudes following internet- based

  7. Effects of a tele-prehabilitation program or an in-person prehabilitation program in surgical candidates awaiting total hip or knee arthroplasty: Protocol of a pilot single blind randomized controlled trial.

    PubMed

    Doiron-Cadrin, Patrick; Kairy, Dahlia; Vendittoli, Pascal-André; Lowry, Véronique; Poitras, Stéphane; Desmeules, François

    2016-12-15

    The accessibility for total joint arthroplasty often comes up against long wait lists, and may lead to deleterious effects for the awaiting patients. This pilot single blind randomized controlled trial aims to evaluate the impact of a telerehabilitation prehabilitation program before a hip or knee arthroplasty compared to in-person prehabilitation or to usual wait for surgery. Thirty-six patients on a wait list for a total hip or knee arthroplasty will be recruited and randomly assigned to one of three groups. The in-person prehabilitation group (n = 12) will receive a 12-week rehabilitation program (2 sessions/week) including education, exercises of the lower limb and cardiovascular training. Patients in the tele-prehabilitation group (n = 12) will receive the same intervention using a telecommunication software. The control group (n = 12) will be provided with the hospital's usual documentation before surgery. The Lower Extremity Functional Scale (LEFS) will be the primary outcome measure taken at baseline and at 12 weeks. Secondary measures will include self-reported function and quality of life as well as performance tests. A mixed-model, 2-way repeated-measure ANOVA will be used to analyse the effects of the rehabilitation programs. This pilot study is the first to evaluate the feasibility and the impact of a telerehabilitation prehabilitation program for patients awaiting a total joint arthroplasty. The results of this pilot-RCT will set the foundations for further research in the fields of rehabilitation and tele-medicine for patients suffering from lower limb osteoarthritis. ClinicalTrials.gov: NCT02636751.

  8. A multi-site single blind clinical study to compare the effects of prolonged exposure, eye movement desensitization and reprocessing and waiting list on patients with a current diagnosis of psychosis and co morbid post traumatic stress disorder: study protocol for the randomized controlled trial Treating Trauma in Psychosis.

    PubMed

    de Bont, Paul A J M; van den Berg, David P G; van der Vleugel, Berber M; de Roos, Carlijn; Mulder, Cornelis L; Becker, Eni S; de Jongh, Ad; van der Gaag, Mark; van Minnen, Agnes

    2013-05-23

    Trauma contributes to psychosis and in psychotic disorders post-traumatic stress disorder (PTSD) is often a comorbid disorder. A problem is that PTSD is underdiagnosed and undertreated in people with psychotic disorders. This study's primary goal is to examine the efficacy and safety of prolonged exposure and eye movement desensitization and reprocessing (EMDR) for PTSD in patients with both psychotic disorders and PTSD, as compared to a waiting list. Secondly, the effects of both treatments are determined on (a) symptoms of psychosis, in particular verbal hallucinations, (b) depression and social performance, and (c) economic costs. Thirdly, goals concern links between trauma exposure and psychotic symptomatology and the prevalence of exposure to traumatic events, and of PTSD. Fourthly predictors, moderators, and mediators for treatment success will be explored. These include cognitions and experiences concerning treatment harm, credibility and burden in both participants and therapists. A short PTSD-screener assesses the possible presence of PTSD in adult patients (21- to 65- years old) with psychotic disorders, while the Clinician Administered PTSD Scale interview will be used for the diagnosis of current PTSD. The M.I.N.I. Plus interview will be used for diagnosing lifetime psychotic disorders and mood disorders with psychotic features. The purpose is to include consenting participants (N = 240) in a multi-site single blind randomized clinical trial. Patients will be allocated to one of three treatment conditions (N = 80 each): prolonged exposure or EMDR (both consisting of eight weekly sessions of 90 minutes each) or a six-month waiting list. All participants are subjected to blind assessments at pre-treatment, two months post treatment, and six months post treatment. In addition, participants in the experimental conditions will have assessments at mid treatment and at 12 months follow-up. The results from the post treatment measurement can be considered

  9. Waiting Narratives of Lung Transplant Candidates

    PubMed Central

    Yelle, Maria T.; Stevens, Patricia E.; Lanuza, Dorothy M.

    2013-01-01

    Before 2005, time accrued on the lung transplant waiting list counted towards who was next in line for a donor lung. Then in 2005 the lung allocation scoring system was implemented, which meant the higher the illness severity scores, the higher the priority on the transplant list. Little is known of the lung transplant candidates who were listed before 2005 and were caught in the transition when the lung allocation scoring system was implemented. A narrative analysis was conducted to explore the illness narratives of seven lung transplant candidates between 2006 and 2007. Arthur Kleinman's concept of illness narratives was used as a conceptual framework for this study to give voice to the illness narratives of lung transplant candidates. Results of this study illustrate that lung transplant candidates expressed a need to tell their personal story of waiting and to be heard. Recommendation from this study calls for healthcare providers to create the time to enable illness narratives of the suffering of waiting to be told. Narrative skills of listening to stories of emotional suffering would enhance how healthcare providers could attend to patients' stories and hear what is most meaningful in their lives. PMID:23476760

  10. Waiting narratives of lung transplant candidates.

    PubMed

    Yelle, Maria T; Stevens, Patricia E; Lanuza, Dorothy M

    2013-01-01

    Before 2005, time accrued on the lung transplant waiting list counted towards who was next in line for a donor lung. Then in 2005 the lung allocation scoring system was implemented, which meant the higher the illness severity scores, the higher the priority on the transplant list. Little is known of the lung transplant candidates who were listed before 2005 and were caught in the transition when the lung allocation scoring system was implemented. A narrative analysis was conducted to explore the illness narratives of seven lung transplant candidates between 2006 and 2007. Arthur Kleinman's concept of illness narratives was used as a conceptual framework for this study to give voice to the illness narratives of lung transplant candidates. Results of this study illustrate that lung transplant candidates expressed a need to tell their personal story of waiting and to be heard. Recommendation from this study calls for healthcare providers to create the time to enable illness narratives of the suffering of waiting to be told. Narrative skills of listening to stories of emotional suffering would enhance how healthcare providers could attend to patients' stories and hear what is most meaningful in their lives.

  11. Using Acceptance and Commitment Therapy to Increase Self-Compassion: A Randomized Controlled Trial.

    PubMed

    Yadavaia, James E; Hayes, Steven C; Vilardaga, Roger

    2014-10-01

    Self-compassion has been shown to be related to several types of psychopathology, including traumatic stress, and has been shown to improve in response to various kinds of interventions. Current conceptualizations of self-compassion fit well with the psychological flexibility model, which underlies acceptance and commitment therapy (ACT). However, there has been no research on ACT interventions specifically aimed at self-compassion. This randomized trial therefore compared a 6-hour ACT-based workshop targeting self-compassion to a wait-list control. From pretreatment to 2-month follow-up, ACT was significantly superior to the control condition in self-compassion, general psychological distress, and anxiety. Process analyses revealed psychological flexibility to be a significant mediator of changes in self-compassion, general psychological distress, depression, anxiety, and stress. Exploratory moderation analyses revealed the intervention to be of more benefit in terms of depression, anxiety, and stress to those with greater trauma history.

  12. Internet-delivered cognitive-behavioral therapy for social anxiety disorder in Romania: a randomized controlled trial.

    PubMed

    Tulbure, Bogdan Tudor; Szentagotai, Aurora; David, Oana; Ștefan, Simona; Månsson, Kristoffer N T; David, Daniel; Andersson, Gerhard

    2015-01-01

    Internet-based cognitive-behavioral therapy (iCBT) for social anxiety disorder has been found effective, as attested by independently conducted randomized controlled trials in four languages. The study aim is to test the efficacy of an iCBT program in a culture where it was not tested before (i.e. Romania). Participants (n = 76) were recruited, screened and randomized to either a nine-week guided iCBT or a wait-list control group in April and May 2012. Self-report measures were collected before (April 2012) and after the intervention (July 2012), as well as six months later (January 2013). Although social anxiety was assessed with multiple measures, the Liebowitz Social Anxiety Scale - Self Report version (LSAS-SR) and Social Phobia Inventory (SPIN) were used as the primary outcome measures. A significant difference with a large between-group effect size in favor of iCBT was found (Cohen's d = 1.19 for LSAS-SR and d = 1.27 for SPIN). Recovery rates show that 36.8% (n = 14) in the treatment group score below the SPIN clinical cut-off compared to only 2.6% (n = 1) in the wait-list control group. Post-intervention clinical interviews also revealed that 34.2% (n = 13) of the treatment group was completely recovered (full remission) while additionally 36.8% (n = 14) retained some social anxiety symptoms (partial remission). However, an important study limitation is that post-intervention interviewers were not blinded to the study conditions. The program also effectively reduced depression and dysfunctional thinking (between-group Cohen's d = 0.84 for depression and d = 0.63 for dysfunctional thinking). Moreover, the iCBT intervention appears to have a long-term impact for participants' functioning, as the treatment gains were maintained six months later. Internet-delivered interventions display a high potential to quickly and widely disseminate effective evidence-based programs around the world. This study provides support for guided iCBT as a promising treatment

  13. Effects of mindfulness meditation on chronic pain: a randomized controlled trial.

    PubMed

    la Cour, Peter; Petersen, Marian

    2015-04-01

    This randomized controlled clinical trial investigated the effects of mindfulness meditation on chronic pain. A total of 109 patients with nonspecific chronic pain were randomized to either a standardized mindfulness meditation program (mindfulness-based stress reduction [MBSR]) or to a wait list control. Pain, physical function, mental function, pain acceptance, and health-related quality of life were measured. The SF36 vitality scale was chosen as the primary outcome measure; the primary end point was after completing the MBSR course. Within a 2.5-year period, 43 of the 109 randomized patients completed the mindfulness program, while 47 remained in the control group. Data were compared at three time points: at baseline, after completion of the course/waiting period, and at the 6-month follow-up. Significant effect (Cohen's d = 0.39) was found on the primary outcome measure, the SF36 vitality scale. On the secondary variables, significant medium to large size effects (Cohen's d = 0.37-0.71) were found for lower general anxiety and depression, better mental quality of life (psychological well-being), feeling in control of the pain, and higher pain acceptance. Small (nonsignificant) effect sizes were found for pain measures. There were no significant differences in the measures just after the intervention vs the 6-month follow-up. A standardized mindfulness program (MBSR) contributes positively to pain management and can exert clinically relevant effects on several important dimensions in patients with long-lasting chronic pain. © 2014 American Academy of Pain Medicine.

  14. Silence is deadly: a cluster-randomised controlled trial of a mental health help-seeking intervention for young men.

    PubMed

    Calear, Alison L; Banfield, Michelle; Batterham, Philip J; Morse, Alyssa R; Forbes, Owen; Carron-Arthur, Bradley; Fisk, Martin

    2017-10-23

    Young men are consistently less likely to seek help for mental health problems than their female peers. This is particularly concerning given the high rates of suicide among male adolescents. The school system has been identified as an ideal setting for the implementation of prevention and early intervention programs for young people. The current trial aims to determine the effectiveness of the Silence is Deadly program in increasing positive help-seeking intentions for mental health problems and suicide among male secondary school students. This study is a two-arm, cluster-randomised, controlled trial that will compare the Silence is Deadly program to a wait-list control condition. Eight Australian high schools will be recruited to the trial, with male students in grades 11 and 12 (16 to 18 years of age) targeted for participation. The program is an innovative male-tailored suicide prevention intervention, comprising a presentation that emphasises role-modelling and legitimises help-seeking for personal and emotional problems, and a brief video that features celebrity athletes who counter existing male norms around help-seeking and encourage communication about personal and emotional issues. The program also includes a discussion of how to help a friend in distress and ends with a question and answer session. The primary outcome measure for the current study is help-seeking intentions. Secondary outcomes include help-seeking behaviour, help-seeking attitudes, help-seeking stigma, mental health symptoms, and suicidal ideation. Data will be collected pre-intervention, post-intervention, and at 3-month follow-up. Primary analyses will compare changes in help-seeking intentions for the intervention condition relative to the wait-list control condition using mixed-effects repeated-measures analyses that account for clustering within schools. If proven to be effective, this targeted help-seeking intervention for adolescent males, which is currently only delivered in

  15. Movement-Pattern Training to Improve Function in People With Chronic Hip Joint Pain: A Feasibility Randomized Clinical Trial.

    PubMed

    Harris-Hayes, Marcie; Czuppon, Sylvia; Van Dillen, Linda R; Steger-May, Karen; Sahrmann, Shirley; Schootman, Mario; Salsich, Gretchen B; Clohisy, John C; Mueller, Michael J

    2016-06-01

    Study Design Feasibility randomized clinical trial. Background Rehabilitation may be an appropriate treatment strategy for patients with chronic hip joint pain; however, the evidence related to the effectiveness of rehabilitation is limited. Objectives To assess feasibility of performing a randomized clinical trial to investigate the effectiveness of movement-pattern training (MPT) to improve function in people with chronic hip joint pain. Methods Thirty-five patients with chronic hip joint pain were randomized into a treatment (MPT) group or a control (wait-list) group. The MPT program included 6 one-hour supervised sessions and incorporated (1) task-specific training for basic functional tasks and symptom-provoking tasks, and (2) strengthening of hip musculature. The wait-list group received no treatment. Primary outcomes for feasibility were patient retention and adherence. Secondary outcomes to assess treatment effects were patient-reported function (Hip disability and Osteoarthritis Outcome Score), lower extremity kinematics, and hip muscle strength. Results Retention rates did not differ between the MPT (89%) and wait-list groups (94%, P = 1.0). Sixteen of the 18 patients (89%) in the MPT group attended at least 80% of the treatment sessions. For the home exercise program, 89% of patients reported performing their home program at least once per day. Secondary outcomes support the rationale for conduct of a superiority randomized clinical trial. Conclusion Based on retention and adherence rates, a larger randomized clinical trial appears feasible and warranted to assess treatment effects more precisely. Data from this feasibility study will inform our future clinical trial. Level of Evidence Therapy, level 2b-. J Orthop Sports Phys Ther 2016;46(6):452-461. Epub 26 Apr 2016. doi:10.2519/jospt.2016.6279.

  16. Internet-based affect-focused psychodynamic therapy for social anxiety disorder: A randomized controlled trial with 2-year follow-up.

    PubMed

    Johansson, Robert; Hesslow, Thomas; Ljótsson, Brjánn; Jansson, Angelica; Jonsson, Lina; Färdig, Smilla; Karlsson, Josefine; Hesser, Hugo; Frederick, Ronald J; Lilliengren, Peter; Carlbring, Per; Andersson, Gerhard

    2017-12-01

    Social anxiety disorder (SAD) is associated with considerable individual suffering and societal costs. Although there is ample evidence for the efficacy of cognitive behavior therapy, recent studies suggest psychodynamic therapy may also be effective in treating SAD. Furthermore, Internet-based psychodynamic therapy (IPDT) has shown promising results for addressing mixed depression and anxiety disorders. However, no study has yet investigated the effects of IPDT specifically for SAD. This paper describes a randomized controlled trial testing the efficacy of a 10-week, affect-focused IPDT protocol for SAD, compared with a wait-list control group. Long-term effects were also estimated by collecting follow-up data, 6, 12, and 24 months after the end of therapy. A total of 72 individuals meeting diagnostic criteria for DSM-IV social anxiety disorder were included. The primary outcome was the self-report version of Liebowitz Social Anxiety Scale. Mixed model analyses using the full intention-to-treat sample revealed a significant interaction effect of group and time, suggesting a larger effect in the treatment group than in the wait-list control. A between-group effect size Cohen's d = 1.05 (95% [CI]: [0.62, 1.53]) was observed at termination. Treatment gains were maintained at the 2-year follow-up, as symptom levels in the treated group continued to decrease significantly. The findings suggest that Internet-based affect-focused psychodynamic therapy is a promising treatment for social anxiety disorder. (PsycINFO Database Record (c) 2017 APA, all rights reserved).

  17. Randomized controlled trial of a cognitive-behavioral intervention for HIV-positive persons: an investigation of treatment effects on psychosocial adjustment.

    PubMed

    Carrico, Adam W; Chesney, Margaret A; Johnson, Mallory O; Morin, Stephen F; Neilands, Torsten B; Remien, Robert H; Rotheram-Borus, Mary Jane; Lennie Wong, F

    2009-06-01

    Questions remain regarding the clinical utility of psychological interventions for HIV-positive persons because randomized controlled trials have utilized stringent inclusion criteria and focused extensively on gay men. The present randomized controlled trial examined the efficacy of a 15-session, individually delivered cognitive-behavioral intervention (n = 467) compared to a wait-list control (n = 469) in a diverse sample of HIV-positive persons who reported HIV transmission risk behavior. Five intervention sessions that dealt with executing effective coping responses were delivered between baseline and the 5 months post-randomization. Additional assessments were completed through 25 months post-randomization. Despite previously documented reductions in HIV transmission risk, no intervention-related changes in psychosocial adjustment were observed across the 25-month investigation period. In addition, there were no intervention effects on psychosocial adjustment among individuals who presented with mild to moderate depressive symptoms. More intensive mental health interventions may be necessary to improve psychosocial adjustment among HIV-positive individuals.

  18. Cost-effectiveness of a workplace intervention for sick-listed employees with common mental disorders: design of a randomized controlled trial

    PubMed Central

    van Oostrom, Sandra H; Anema, Johannes R; Terluin, Berend; de Vet, Henrica CW; Knol, Dirk L; van Mechelen, Willem

    2008-01-01

    Background Considering the high costs of sick leave and the consequences of sick leave for employees, an early return-to-work of employees with mental disorders is very important. Therefore, a workplace intervention is developed based on a successful return-to-work intervention for employees with low back pain. The objective of this paper is to present the design of a randomized controlled trial evaluating the cost-effectiveness of the workplace intervention compared with usual care for sick-listed employees with common mental disorders. Methods The study is designed as a randomized controlled trial with a follow-up of one year. Employees eligible for this study are on sick leave for 2 to 8 weeks with common mental disorders. The workplace intervention will be compared with usual care. The workplace intervention is a stepwise approach that aims to reach consensus about a return-to-work plan by active participation and strong commitment of both the sick-listed employee and the supervisor. Outcomes will be assessed at baseline, 3, 6, 9 and 12 months. The primary outcome of this study is lasting return-to-work, which will be acquired from continuous registration systems of the companies after the follow-up. Secondary outcomes are total number of days of sick leave during the follow-up, severity of common mental disorders, coping style, job content, and attitude, social influence, and self-efficacy determinants. Cost-effectiveness will be evaluated from the societal perspective. A process evaluation will also be conducted. Discussion Return-to-work is difficult to discuss in the workplace for sick-listed employees with mental disorders and their supervisors. Therefore, this intervention offers a unique opportunity for the sick-listed employee and the supervisor to discuss barriers for return-to-work. Results of this study will possibly contribute to improvement of disability management for sick-listed employees with common mental disorders. Results will become

  19. Attitude of kidney patients on the transplant waiting list toward related-living donation. A reason for the scarce development of living donation in Spain.

    PubMed

    Martínez-Alarcón, L; Ríos, A; Conesa, C; Alcaraz, J; González, M J; Ramírez, P; Parrilla, P

    2006-01-01

    Most Spanish transplant centers have on-going living kidney transplant programs. However, such transplants are not increasing as a proportion of the total number of kidney transplants. The objective of this study is to analyze the attitude of kidney patients on the kidney transplant waiting list toward living kidney donation. The patients studied were selected from those included on the kidney transplant waiting list from November 2003 until September 2005 (n = 221). Attitude toward living donation was evaluated using a psychosocial questionnaire. It was completed in a direct personal interview with an independent health-care worker from the Transplant Unit. Student's t-test and the chi-squared test were applied. Two hundred and fourteen patients completed the questionnaire (97%), of which 35% would accept a related living kidney if it were offered to them, 60% would prefer to wait on the waiting list and the remaining 5% are undecided. Up to 66% (n = 134) of patients report that a member of their family or a friend have offered them an organ for donation. Eighty-nine percentage believe that there is some risk involved in living kidney donation, although it is not a factor that affects whether an organ would be accepted or not (p = 0.767). The psychosocial variables that affect attitude toward accepting a related living kidney are: (i) age: the youngest are those who are most likely to accept (40 vs. 45-yr-old; p = 0.010); (ii) descendents: patients without descendents are more likely to accept a living organ (56% vs. 27%; p < 0.000); (iii) marital status: a greater percentage of single respondents would be prepared to receive this type of transplant compared to the group of married respondents (55% vs. 30%. p = 0.007); and (iv) level of education: those with a higher level of education are more likely to accept a living organ (43% have secondary or university studies vs. 28% who only have primary education; p = 0.040). Patients on the waiting list for a kidney

  20. Mindfulness-based intervention for teenagers with cancer: study protocol for a randomized controlled trial

    PubMed Central

    2013-01-01

    Background Individuals living with cancer must learn to face not only the physical symptoms of their condition, but also the anxiety and uncertainty related to the progression of the disease, the anticipation of physical and emotional pain related to illness and treatment, the significant changes implied in living with cancer, as well as the fear of recurrence after remission. Mindfulness-based meditation constitutes a promising option to alleviate these manifestations. Methods/Design This article presents the rationale and protocol development for a research project aimed at evaluating the effects of a mindfulness-based meditation intervention on quality of life, sleep, and mood in adolescents with cancer compared to a control group. A prospective, longitudinal, experimental design involving three time points (baseline, post-intervention, and follow-up) and two groups (experimental and control) was developed for this project. Participants will be assigned randomly to either group. Eligible participants are adolescents aged 11 to 18 years with a diagnosis of cancer, with no specific selection/exclusion based on type, stage, or trajectory of cancer. A final sample size of 28 participants is targeted. Adolescents in the experimental group will be completing the mindfulness meditation intervention, taught by two trained therapists. The intervention will comprise of eight weekly sessions, lasting 90 min each. Once the follow-up assessment is completed by the experimental group, wait-list controls will be offered to complete the mindfulness-based program. Intra-group analyses will serve to evaluate the impact of the mindfulness-based meditation intervention on quality of life, sleep, and mood pre-post intervention, as well as follow-up. Analyses will also be used to carry out inter-group comparisons between the experimental group and the wait-list controls. Voluntary participation, risk of attrition, and the small sample size are potential limitations of this project

  1. Meditation awareness training for the treatment of workaholism: A controlled trial.

    PubMed

    Van Gordon, William; Shonin, Edo; Dunn, Thomas J; Garcia-Campayo, Javier; Demarzo, Marcelo M P; Griffiths, Mark D

    2017-06-01

    Background and aims Workaholism is a form of behavioral addiction that can lead to reduced life and job satisfaction, anxiety, depression, burnout, work-family conflict, and impaired productivity. Given the number of people affected, there is a need for more targeted workaholism treatments. Findings from previous case studies successfully utilizing second-generation mindfulness-based interventions (SG-MBIs) for treating behavioral addiction suggest that SG-MBIs may be suitable for treating workaholism. This study conducted a controlled trial to investigate the effects of an SG-MBI known as meditation awareness training (MAT) on workaholism. Methods Male and female adults suffering from workaholism (n = 73) were allocated to MAT or a waiting-list control group. Assessments were performed at pre-, post-, and 3-month follow-up phases. Results MAT participants demonstrated significant and sustained improvements over control-group participants in workaholism symptomatology, job satisfaction, work engagement, work duration, and psychological distress. Furthermore, compared to the control group, MAT participants demonstrated a significant reduction in hours spent working but without a decline in job performance. Discussion and conclusions MAT may be a suitable intervention for treating workaholism. Further controlled intervention studies investigating the effects of SG-MBIs on workaholism are warranted.

  2. Parallel multicentre randomised trial of a clinical trial question prompt list in patients considering participation in phase 3 cancer treatment trials.

    PubMed

    Tattersall, Martin H N; Jefford, Michael; Martin, Andrew; Olver, Ian; Thompson, John F; Brown, Richard F; Butow, Phyllis N

    2017-03-01

    To evaluate the effect of a clinical trial question prompt list in patients considering enrolment in cancer treatment trials. Tertiary cancer referral hospitals in three state capital cities in Australia. 88 patients with cancer attending three cancer centres in Australia, who were considering enrolment in phase 3 treatment trials, were invited to enrol in an unblinded randomised trial of provision of a clinical trial question prompt list (QPL) before consenting to enrol in the treatment trial. We developed and pilot tested a targeted QPL for patients with cancer considering clinical trial participation (the clinical trial QPL). Consenting patients were randomised to receive the clinical trial QPL or not before further discussion with their oncologist and/or trial nurse about the treatment trial. Questionnaires were completed at baseline and within 3 weeks of deciding on treatment trial participation. scores on the Quality of Informed Consent questionnaire (QuIC). 88 patients of 130 sought for the study were enrolled (43 males), and 45 received the clinical trial QPL. 49% of trials were chemotherapy interventions for patients with advanced disease, 35% and 16% were surgical adjuvant and radiation adjuvant trials respectively. 70 patients completed all relevant questionnaires. 28 of 43 patients in the control arm compared with 39 of 45 patients receiving the clinical trial QPL completed the QuIC (p=0.0124). There were no significant differences in the QuIC scores between the randomised groups (QuIC part A p=0.08 and QuIC part B p=0.92). There were no differences in patient satisfaction with decisions or in anxiety levels between the randomised groups. Use of a question prompt list did not significantly change the QuIC scores in this randomised trial. ANZCTR 12606000214538 prospectively registered 31/5/2006. Results, ACTRN12606000214538. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to

  3. [The status of domestic PET/CT attendance in the light of the waiting list data].

    PubMed

    Galuska, László; Balkay, László

    2010-06-01

    The aim of the study is to demonstrate the diagnostic and geographical distribution of the domestic PET/CT examinations financed by the OEP based on the data from the waiting list of the past 4 years. The analysis of the demonstrated data can support the rational usage of PET/CT examination contingents in the domestic oncological attendance, which has growing importance. PET examinations with oncological aims have started in Debrecen more than 10 years ago. In 2005 already 1500 PET examinations have been carried out. According to the governmental regulation accepted in 2006, OEP ensures the financing of the three PET/CT centers until 2012, which means 12,000 examinations in 2012. However, the number of domestic oncological patients requiring PET/CT examinations can reach the number of 20,000-30,000 patients. The study summarizes the number of patients who applied for PET/CT examinations for the first time and later again between 2006 and 2010, based on the data of the waiting list, and the change of the patient assigning diagnosis and the number of examinations carried out with 18F-FDG and with 11C-methionine. The study demonstrates the number of examinations by counties which characterize the population's access to PET/CT. The assigning diagnosis in 2007 was already widespread and focused on problems. After the regulation came in to force in 2008 the possibilities significantly decreased. Clinical cases which were efficiently examined with PET/CT earlier were left out from the indication list. The distribution by county is uneven, although the number of examinations increases year by year. The number of repeated examinations increases as well. As a conclusion, the annual PET/CT examination contingents are constantly exploited. This might seem sufficient, because the method has not become a part of the oncological routine in all counties. Although the current indication list includes the most frequent oncological cases requiring PET/CT, the abandoning of the less

  4. Training Parents of Youth with Autism Spectrum Disorder to Advocate for Adult Disability Services: Results from a Pilot Randomized Controlled Trial

    PubMed Central

    Taylor, Julie Lounds; Hodapp, Robert M.; Burke, Meghan M.; Waitz-Kudla, Sydney N.; Rabideau, Carol

    2017-01-01

    This study presents findings from a pilot randomized controlled trial, testing a 12-week intervention to train parents of youth with autism spectrum disorder (ASD) to advocate for adult disability services—the Volunteer Advocacy Project-Transition (VAP-T). Participants included 41 parents of youth with ASD within two years of high school exit, randomly assigned to a treatment (N = 20) or wait-list control (N = 21) group. Outcomes, collected before and after the intervention, included parental knowledge about adult services, advocacy skills-comfort, and empowerment. The VAP-T had acceptable feasibility, treatment fidelity, and acceptability. After participating in the VAP-T, intervention parents (compared to controls) knew more about the adult service system, were more skilled/comfortable advocating, and felt more empowered. PMID:28070786

  5. Maintained physical activity and physiotherapy in the management of distal upper limb pain - a protocol for a randomised controlled trial (the arm pain trial).

    PubMed

    Jones, Gareth T; Mertens, Kathrin; Macfarlane, Gary J; Palmer, Keith T; Coggon, David; Walker-Bone, Karen; Burton, Kim; Heine, Peter J; McCabe, Candy; McNamee, Paul; McConnachie, Alex

    2014-03-10

    Distal upper limb pain (pain affecting the elbow, forearm, wrist, or hand) can be non-specific, or can arise from specific musculoskeletal disorders. It is clinically important and costly, the best approach to clinical management is unclear. Physiotherapy is the standard treatment and, while awaiting treatment, advice is often given to rest and avoid strenuous activities, but there is no evidence base to support these strategies. This paper describes the protocol of a randomised controlled trial to determine, among patients awaiting physiotherapy for distal arm pain, (a) whether advice to remain active and maintain usual activities results in a long-term reduction in arm pain and disability, compared with advice to rest; and (b) whether immediate physiotherapy results in a long-term reduction in arm pain and disability, compared with physiotherapy delivered after a seven week waiting list period. Between January 2012 and January 2014, new referrals to 14 out-patient physiotherapy departments were screened for potential eligibility. Eligible and consenting patients were randomly allocated to one of the following three groups in equal numbers: 1) advice to remain active, 2) advice to rest, 3) immediate physiotherapy. Patients were and followed up at 6, 13, and 26 weeks post-randomisation by self-complete postal questionnaire and, at six weeks, patients who had not received physiotherapy were offered it at this time. The primary outcome is the proportion of patients free of disability at 26 weeks, as determined by the modified DASH (Disabilities of the Arm, Shoulder and Hand) questionnaire.We hypothesise (a) that advice to maintain usual activities while awaiting physiotherapy will be superior than advice to rest the arm; and (b) that fast-track physiotherapy will be superior to normal (waiting list) physiotherapy. These hypotheses will be examined using an intention-to-treat analysis. Results from this trial will contribute to the evidence base underpinning the

  6. Guided self-help interventions for mental health disorders in children with neurological conditions: study protocol for a pilot randomised controlled trial.

    PubMed

    Bennett, Sophie; Heyman, Isobel; Coughtrey, Anna; Simmonds, Jess; Varadkar, Sophia; Stephenson, Terence; DeJong, Margaret; Shafran, Roz

    2016-11-04

    Rates of mental health disorders are significantly greater in children with physical illnesses than in physically well children. Children with neurological conditions, such as epilepsy, are known to have particularly high rates of mental health disorders. Despite this, mental health problems in children with neurological conditions have remained under-recognised and under-treated in clinical settings. Evidence-based guided self-help interventions are efficacious in reducing symptoms of mental health disorders in children, but their efficacy in reducing symptoms of common mental health disorders in children with neurological conditions has not been investigated. We aim to pilot a guided self-help intervention for the treatment of mental health disorders in children with neurological conditions. A pilot randomised controlled trial with 18 patients with neurological conditions and mental health disorders will be conducted. Participants attending specialist neurology clinics at a National UK Children's Hospital will be randomised to receive guided self-help for common mental health disorders or to a 12-week waiting list control. Participants in the treatment group will receive 10 sessions of guided self-help delivered over the telephone. The waiting list control group will receive the intervention after a waiting period of 12 weeks. The primary outcome measure is reduction in symptoms of mental health disorders. Exclusion criteria are limited to those at significant risk of harm to self or others, the presence of primary mental health disorder other than anxiety, depression or disruptive behaviour (e.g. psychosis, eating disorder, obsessive-compulsive disorder) or intellectual disability at a level meaning potential participants would be unable to access the intervention. The study has ethical approval from the Camden and Islington NHS Research Ethics Committee, registration number 14.LO.1353. Results will be disseminated to patients, the wider public, clinicians and

  7. Effects of digital Cognitive Behavioural Therapy for Insomnia on cognitive function: study protocol for a randomised controlled trial.

    PubMed

    Kyle, Simon D; Hurry, Madeleine E D; Emsley, Richard; Luik, Annemarie I; Omlin, Ximena; Spiegelhalder, Kai; Espie, Colin A; Sexton, Claire E

    2017-06-17

    The daytime effects of insomnia pose a significant burden to patients and drive treatment seeking. In addition to subjective deficits, meta-analytic data show that patients experience reliable objective impairments across several cognitive domains. While Cognitive Behavioural Therapy for Insomnia (CBT-I) is an effective and scalable treatment, we know little about its impact upon cognitive function. Trials of CBT-I have typically used proxy measures for cognitive functioning, such as fatigue or work performance scales, and no study has assessed self-reported impairment in cognitive function as a primary outcome. Moreover, only a small number of studies have assessed objective cognitive performance, pre-to-post CBT-I, with mixed results. This study specifically aims to (1) investigate the impact of CBT-I on cognitive functioning, assessed through both self-reported impairment and objective performance measures, and (2) examine whether change in sleep mediates this impact. We propose a randomised controlled trial of 404 community participants meeting criteria for Insomnia Disorder. In the DISCO trial (D efining the I mpact of improved S leep on CO gnitive function (DISCO)) participants will be randomised to digital automated CBT-I delivered by a web and/or mobile platform (in addition to treatment as usual (TAU)) or to a wait-list control (in addition to TAU). Online assessments will take place at 0 (baseline), 10 (post-treatment), and 24 (follow-up) weeks. At week 25, all participants allocated to the wait-list group will be offered digital CBT-I, at which point the controlled element of the trial will be complete. The primary outcome is self-reported cognitive impairment at post-treatment (10 weeks). Secondary outcomes include objective cognitive performance, insomnia severity, sleepiness, fatigue, and self-reported cognitive failures and emotional distress. All main analyses will be carried out on completion of follow-up assessments and will be based on the

  8. Revealing List-Level Control in the Stroop Task by Uncovering Its Benefits and a Cost

    PubMed Central

    Bugg, Julie M.; McDaniel, Mark A.; Scullin, Michael K.; Braver, Todd S.

    2012-01-01

    Interference is reduced in mostly incongruent relative to mostly congruent lists. Classic accounts of this list-wide proportion congruence effect assume that list-level control processes strategically modulate word reading. Contemporary accounts posit that reliance on the word is modulated poststimulus onset by item-specific information (e.g., proportion congruency of the word). To adjudicate between these accounts, we used novel designs featuring neutral trials. In two experiments, we showed that the list-wide proportion congruence effect is accompanied by a change in neutral trial color-naming performance. Because neutral words have no item-specific bias, this pattern can be attributed to list-level control. Additionally, we showed that list-level attenuation of word reading led to a cost to performance on a secondary prospective memory task but only when that task required processing of the irrelevant, neutral word. These findings indicate that the list-wide proportion congruence effect at least partially reflects list-level control and challenge purely item-specific accounts of this effect. PMID:21767049

  9. Randomized Controlled Trial of Group Cognitive Behavioural Therapy for Post-Traumatic Stress Disorder in Children and Adolescents Exposed to Tsunami in Thailand.

    PubMed

    Pityaratstian, Nuttorn; Piyasil, Vinadda; Ketumarn, Panom; Sitdhiraksa, Nanthawat; Ularntinon, Sirirat; Pariwatcharakul, Pornjira

    2015-09-01

    Post-traumatic stress disorder (PTSD) is a common and debilitating consequence of natural disaster in children and adolescents. Accumulating data show that cognitive behavioural therapy (CBT) is an effective treatment for PTSD. However, application of CBT in a large-scale disaster in a setting with limited resources, such as when the tsunami hit several Asian countries in 2004, poses a major problem. This randomized controlled trial aimed to test for the efficacy of the modified version of CBT for children and adolescents with PSTD. Thirty-six children (aged 10-15 years) who had been diagnosed with PSTD 4 years after the tsunami were randomly allocated to either CBT or wait list. CBT was delivered in 3-day, 2-hour-daily, group format followed by 1-month posttreatment self-monitoring and daily homework. Compared to the wait list, participants who received CBT demonstrated significantly greater improvement in symptoms of PTSD at 1-month follow-up, although no significant improvement was observed when the measures were done immediately posttreatment. Brief, group CBT is an effective treatment for PTSD in children and adolescents when delivered in conjunction with posttreatment self-monitoring and daily homework.

  10. Weight loss with a modified Mediterranean-type diet using fat modification: a randomized controlled trial.

    PubMed

    Austel, A; Ranke, C; Wagner, N; Görge, J; Ellrott, T

    2015-08-01

    There is evidence that Mediterranean diets with a high proportion of olive oil and nuts can be effective for weight management and prevention of cardiovascular disease. It might be difficult for populations with other eating habits to follow such diets. Therefore, a modified Mediterranean-type diet using fat modification through neutral and butter-flavored canola oil, walnuts and walnut oil with two portion-controlled sweet daily snacks was tested in Germany. Randomized waiting-list control study with overweight/grade 1 obese subjects: 12-week self-help modified Mediterranean-type diet, 6 weeks of diet plans and 6 weeks of weight loss maintenance training. Trial duration was 12 months. Intervention group (IG) included 100 participants (average age of 52.4 years, weight 85.1 kg and body mass index (BMI) 30.1 kg/m(2)), waiting-list control group (CG) included 112 participants (52.6 years, 84.1 kg and 30.1 kg/m(2)). Per-protocol weight loss after 12 weeks was 5.2 kg in IG vs 0.4 kg in CG (P ⩽ 0.0001), BMI -1.8 vs -0.1 kg/m(2) (P ⩽ 0.0001), waist circumference -4.7 vs -0.9 cm (P ⩽ 0.0001). Triglycerides, total cholesterol and LDL cholesterol improved significantly in IG but not in CG. One-year dropouts: 44% in IG and 53% in CG. Weight loss after 12 months: 4.2 kg (pooled data). A five-meal modified Mediterranean-type diet with two daily portion-controlled sweet snacks was effective for weight management in a self-help setting for overweight and grade 1 obese subjects. Fat modification through canola oil, walnuts and walnut oil improved blood lipids even at 12 months.

  11. Cognitive Mediation of Treatment Change in Social Phobia

    ERIC Educational Resources Information Center

    Hofmann, Stefan G.

    2004-01-01

    Ninety individuals with social phobia (social anxiety disorder) participated in a randomized controlled trial and completed cognitive-behavioral group therapy, exposure group therapy without explicit cognitive interventions, or a wait-list control condition. Both treatments were superior to the wait-list group in reducing social anxiety but did…

  12. Using Acceptance and Commitment Therapy to Increase Self-Compassion: A Randomized Controlled Trial

    PubMed Central

    Yadavaia, James E.; Hayes, Steven C.; Vilardaga, Roger

    2014-01-01

    Self-compassion has been shown to be related to several types of psychopathology, including traumatic stress, and has been shown to improve in response to various kinds of interventions. Current conceptualizations of self-compassion fit well with the psychological flexibility model, which underlies acceptance and commitment therapy (ACT). However, there has been no research on ACT interventions specifically aimed at self-compassion. This randomized trial therefore compared a 6-hour ACT-based workshop targeting self-compassion to a wait-list control. From pretreatment to 2-month follow-up, ACT was significantly superior to the control condition in self-compassion, general psychological distress, and anxiety. Process analyses revealed psychological flexibility to be a significant mediator of changes in self-compassion, general psychological distress, depression, anxiety, and stress. Exploratory moderation analyses revealed the intervention to be of more benefit in terms of depression, anxiety, and stress to those with greater trauma history. PMID:25506545

  13. Act-and-wait time-delayed feedback control of autonomous systems

    NASA Astrophysics Data System (ADS)

    Pyragas, Viktoras; Pyragas, Kestutis

    2018-02-01

    Recently an act-and-wait modification of time-delayed feedback control has been proposed for the stabilization of unstable periodic orbits in nonautonomous dynamical systems (Pyragas and Pyragas, 2016 [30]). The modification implies a periodic switching of the feedback gain and makes the closed-loop system finite-dimensional. Here we extend this modification to autonomous systems. In order to keep constant the phase difference between the controlled orbit and the act-and-wait switching function an additional small-amplitude periodic perturbation is introduced. The algorithm can stabilize periodic orbits with an odd number of real unstable Floquet exponents using a simple single-input single-output constraint control.

  14. Can We Predict Patient Wait Time?

    PubMed

    Pianykh, Oleg S; Rosenthal, Daniel I

    2015-10-01

    The importance of patient wait-time management and predictability can hardly be overestimated: For most hospitals, it is the patient queues that drive and define every bit of clinical workflow. The objective of this work was to study the predictability of patient wait time and identify its most influential predictors. To solve this problem, we developed a comprehensive list of 25 wait-related parameters, suggested in earlier work and observed in our own experiments. All parameters were chosen as derivable from a typical Hospital Information System dataset. The parameters were fed into several time-predicting models, and the best parameter subsets, discovered through exhaustive model search, were applied to a large sample of actual patient wait data. We were able to discover the most efficient wait-time prediction factors and models, such as the line-size models introduced in this work. Moreover, these models proved to be equally accurate and computationally efficient. Finally, the selected models were implemented in our patient waiting areas, displaying predicted wait times on the monitors located at the front desks. The limitations of these models are also discussed. Optimal regression models based on wait-line sizes can provide accurate and efficient predictions for patient wait time. Copyright © 2015 American College of Radiology. Published by Elsevier Inc. All rights reserved.

  15. A randomized controlled trial of tai chi for long-term low back pain (TAI CHI): study rationale, design, and methods.

    PubMed

    Hall, Amanda M; Maher, Chris G; Latimer, Jane; Ferreira, Manuela L; Lam, Paul

    2009-05-28

    Low back pain persisting for longer than 3 months is a common and costly condition for which many current treatments have low-moderate success rates at best. Exercise is among the more successful treatments for this condition, however, the type and dosage of exercise that elicits the best results is not clearly defined. Tai chi is a gentle form of low intensity exercise that uses controlled movements in combination with relaxation techniques and is currently used as a safe form of exercise for people suffering from other chronic pain conditions such as arthritis. To date, there has been no scientific evaluation of tai chi as an intervention for people with back pain. Thus the aim of this study will be to examine the effects of a tai chi exercise program on pain and disability in people with long-term low back pain. The study will recruit 160 healthy individuals from the community setting to be randomised to either a tai chi intervention group or a wait-list control group. Individuals in the tai chi group will attend 2 tai chi sessions (40 minutes)/week for 8 weeks followed by 1 tai chi session/week for 2 weeks. The wait-list control will continue their usual health care practices and have the opportunity to participate in the tai chi program once they have completed the follow-up assessments. The primary outcome will be bothersomeness of back symptoms measured with a 0-10 numerical rating scale. Secondary outcomes include, self-reports of pain-related disability, health-related quality of life and global perceived effect of treatment. Statistical analysis of primary and secondary outcomes will be based on the intention to treat principle. Linear mixed models will be used to test for the effect of treatment on outcome at 10 weeks follow up. This trial has received ethics approval from The University of Sydney Human Research Ethics Committee. HREC Approval No.10452 This study will be the first trial in this area and the information on its effectiveness will allow

  16. Cognitive behavioural therapy and mindfulness for stress and burnout: a waiting list controlled pilot study comparing treatments for parents of children with chronic conditions.

    PubMed

    Anclair, Malin; Lappalainen, Raimo; Muotka, Joona; Hiltunen, Arto J

    2018-03-01

    Parents of children with chronic conditions often experience a crisis with serious mental health problems for themselves as a consequence. The healthcare focus is on the children; however, the parents often worry about their children's health and future but are seldom offered any counselling or guidance. The aim of this study was to investigate the effectiveness of two group-based behavioural interventions on stress and burnout among parents of children with chronic conditions. After a waiting list control period (n = 28), parents were offered either a cognitive behavioural (CBT, n = 10) or a mindfulness program (MF, n = 9). Both interventions decreased significantly stress and burnout. The within-group effect sizes were large in both interventions (CBT, g = 1.28-1.64; MF, g = 1.25-2.20). Hence, the results of this pilot study show that treating a group using either CBT or mindfulness can be an efficient intervention for reducing stress levels and burnout in parents of children with chronic conditions. © 2017 The Authors Scandinavian Journal of Caring Sciences published by John Wiley & Sons Ltd on behalf of Nordic College of Caring Science.

  17. Guided and unguided Acceptance and Commitment Therapy for social anxiety disorder and/or panic disorder provided via the Internet and a smartphone application: A randomized controlled trial.

    PubMed

    Ivanova, Ekaterina; Lindner, Philip; Ly, Kien Hoa; Dahlin, Mats; Vernmark, Kristofer; Andersson, Gerhard; Carlbring, Per

    2016-12-01

    Acceptance and Commitment Therapy (ACT) can be effective in treating anxiety disorders, yet there has been no study on Internet-delivered ACT for social anxiety disorder (SAD) and panic disorder (PD), nor any study investigating whether therapist guidance is superior to unguided self-help when supplemented with a smartphone application. In the current trial, n=152 participants diagnosed with SAD and/or PD were randomized to therapist-guided or unguided treatment, or a waiting-list control group. Both treatment groups used an Internet-delivered ACT-based treatment program and a smartphone application. Outcome measures were self-rated general and social anxiety and panic symptoms. Treatment groups saw reduced general (d=0.39) and social anxiety (d=0.70), but not panic symptoms (d=0.05) compared to the waiting-list group, yet no differences in outcomes were observed between guided and unguided interventions. We conclude that Internet-delivered ACT is appropriate for treating SAD and potentially PD. Smartphone applications may partially compensate for lack of therapist support. Copyright © 2016. Published by Elsevier Ltd.

  18. Social Stories in mainstream schools for children with autism spectrum disorder: a feasibility randomised controlled trial.

    PubMed

    Marshall, David; Wright, Barry; Allgar, Victoria; Adamson, Joy; Williams, Christine; Ainsworth, Hannah; Cook, Liz; Varley, Danielle; Hackney, Lisa; Dempster, Paul; Ali, Shehzad; Trepel, Dominic; Collingridge Moore, Danielle; Littlewood, Elizabeth; McMillan, Dean

    2016-08-11

    To assess the feasibility of recruitment, retention, outcome measures and intervention training/delivery among teachers, parents and children. To calculate a sample size estimation for full trial. A single-centre, unblinded, cluster feasibility randomised controlled trial examining Social Stories delivered within a school environment compared with an attentional control. 37 primary schools in York, UK. 50 participants were recruited and a cluster randomisation approach by school was examined. Participants were randomised into the treatment group (n=23) or a waiting list control group (n=27). Acceptability and feasibility of the trial, intervention and of measurements required to assess outcomes in a definitive trial. An assessment of the questionnaire completion rates indicated teachers would be most appropriate to complete the primary outcome measure. 2 outcome measures: the Social Responsiveness Scale (SRS)-2 and a goal-based measure showed both the highest levels of completion rates (above 80%) at the primary follow-up point (6 weeks postintervention) and captured relevant social and behaviour outcomes. Power calculations were based on these 2 outcome measures leading to a total proposed sample size of 180 participant groups. Results suggest that a future trial would be feasible to conduct and could inform the policy and practice of using Social Stories in mainstream schools. ISRCTN96286707; Results. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/

  19. Complaint-Directed Mini-Interventions for Depressive Complaints: A Randomized Controlled Trial of Unguided Web-Based Self-Help Interventions.

    PubMed

    Lokman, Suzanne; Leone, Stephanie S; Sommers-Spijkerman, Marion; van der Poel, Agnes; Smit, Filip; Boon, Brigitte

    2017-01-04

    Prevention of depression is important due to the substantial burden of disease associated with it. To this end, we developed a novel, brief, and low-threshold Web-based self-help approach for depressive complaints called complaint-directed mini-interventions (CDMIs). These CDMIs focus on highly prevalent complaints that are demonstrably associated with depression and have a substantial economic impact: stress, sleep problems, and worry. The aim was to evaluate the effectiveness of the Web-based self-help CDMIs in a sample of adults with mild-to-moderate depressive symptoms compared to a wait-list control group. A two-armed randomized controlled trial was conducted. An open recruitment strategy was used. Participants were randomized to either the Web-based CDMIs or the no-intervention wait-list control group. The CDMIs are online, unguided, self-help interventions, largely based on cognitive behavioral techniques, which consist of 3 to 4 modules with up to 6 exercises per module. Participants are free to choose between the modules and exercises. Assessments, using self-report questionnaires, took place at baseline and at 3 and 6 months after baseline. The control group was given access to the intervention following the 3-month assessment. The primary goal of the CDMIs is to reduce depressive complaints. The primary outcome of the study was a reduction in depressive complaints as measured by the Inventory of Depressive Symptomatology Self-Report (IDS-SR). Secondary outcomes included reductions in stress, worry, sleep problems, and anxiety complaints, and improvements in well-being. Data were analyzed using linear mixed models. In total, 329 participants enrolled in the trial, of which 165 were randomized to the intervention group and 164 to the control group. Approximately three-quarters of the intervention group actually created an account. Of these participants, 91.3% (116/127) logged into their chosen CDMI at least once during the 3-month intervention period

  20. Comparison of eye movement desensitization and reprocessing therapy, cognitive behavioral writing therapy, and wait-list in pediatric posttraumatic stress disorder following single-incident trauma: a multicenter randomized clinical trial.

    PubMed

    de Roos, Carlijn; van der Oord, Saskia; Zijlstra, Bonne; Lucassen, Sacha; Perrin, Sean; Emmelkamp, Paul; de Jongh, Ad

    2017-11-01

    Practice guidelines for childhood posttraumatic stress disorder (PTSD) recommend trauma-focused psychotherapies, mainly cognitive behavioral therapy (CBT). Eye movement desensitization and reprocessing (EMDR) therapy is a brief trauma-focused, evidence-based treatment for PTSD in adults, but with few well-designed trials involving children and adolescents. We conducted a single-blind, randomized trial with three arms (n = 103): EMDR (n = 43), Cognitive Behavior Writing Therapy (CBWT; n = 42), and wait-list (WL; n = 18). WL participants were randomly reallocated to CBWT or EMDR after 6 weeks; follow-ups were conducted at 3 and 12 months posttreatment. Participants were treatment-seeking youth (aged 8-18 years) with a DSM-IV diagnosis of PTSD (or subthreshold PTSD) tied to a single trauma, who received up to six sessions of EMDR or CBWT lasting maximally 45 min each. Both treatments were well-tolerated and relative to WL yielded large, intent-to-treat effect sizes for the primary outcomes at posttreatment: PTSD symptoms (EMDR: d = 1.27; CBWT: d = 1.24). At posttreatment 92.5% of EMDR, and 90.2% of CBWT no longer met the diagnostic criteria for PTSD. All gains were maintained at follow-up. Compared to WL, small to large (range d = 0.39-1.03) intent-to-treat effect sizes were obtained at posttreatment for negative trauma-related appraisals, anxiety, depression, and behavior problems with these gains being maintained at follow-up. Gains were attained with significantly less therapist contact time for EMDR than CBWT (mean = 4.1 sessions/140 min vs. 5.4 sessions/227 min). EMDR and CBWT are brief, trauma-focused treatments that yielded equally large remission rates for PTSD and reductions in the severity of PTSD and comorbid difficulties in children and adolescents seeking treatment for PTSD tied to a single event. Further trials of both treatments with PTSD tied to multiple traumas are warranted. © 2017 Association for Child and Adolescent Mental

  1. The TALKS study to improve communication, logistical, and financial barriers to live donor kidney transplantation in African Americans: protocol of a randomized clinical trial.

    PubMed

    Strigo, Tara S; Ephraim, Patti L; Pounds, Iris; Hill-Briggs, Felicia; Darrell, Linda; Ellis, Matthew; Sudan, Debra; Rabb, Hamid; Segev, Dorry; Wang, Nae-Yuh; Kaiser, Mary; Falkovic, Margaret; Lebov, Jill F; Boulware, L Ebony

    2015-10-09

    Live donor kidney transplantation (LDKT), an optimal therapy for many patients with end-stage kidney disease, is underutilized, particularly by African Americans. Potential recipient difficulties initiating and sustaining conversations about LDKT, identifying willing and medically eligible donors, and potential donors' logistical and financial hurdles have been cited as potential contributors to race disparities in LDKT. Few interventions specifically targeting these factors have been tested. We report the protocol of the Talking about Living Kidney Donation Support (TALKS) study, a study designed to evaluate the effectiveness of behavioral, educational and financial assistance interventions to improve access to LDKT among African Americans on the deceased donor kidney transplant recipient waiting list. We adapted a previously tested educational and social worker intervention shown to improve consideration and pursuit of LDKT among patients and their family members for its use among patients on the kidney transplant waiting list. We also developed a financial assistance intervention to help potential donors overcome logistical and financial challenges they might face during the pursuit of live kidney donation. We will evaluate the effectiveness of these interventions by conducting a randomized controlled trial in which patients on the deceased donor waiting list receive 1) usual care while on the transplant waiting list, 2) the educational and social worker intervention, or 3) the educational and social worker intervention plus the option of participating in the financial assistance program. The primary outcome of the randomized controlled trial will measure potential recipients' live kidney donor activation (a composite rate of live donor inquiries, completed new live donor evaluations, or live kidney donation) at 1 year. The TALKS study will rigorously assess the effectiveness of promising interventions to reduce race disparities in LDKT. NCT02369354.

  2. PREPARE: presurgery physiotherapy for patients with degenerative lumbar spine disorder: a randomized controlled trial.

    PubMed

    Lindbäck, Yvonne; Tropp, Hans; Enthoven, Paul; Abbott, Allan; Öberg, Birgitta

    2017-12-15

    Surgery because of disc herniation or spinal stenosis results mostly in large improvement in the short-term, but mild to moderate improvements for pain and disability at long-term follow-up. Prehabilitation has been defined as augmenting functional capacity before surgery, which may have beneficial effect on outcome after surgery. The aim was to study if presurgery physiotherapy improves function, pain, and health in patients with degenerative lumbar spine disorder scheduled for surgery. A single-blinded, two-arm, randomized controlled trial (RCT). A total of 197 patients were consecutively included at a spine clinic. The inclusion criteria were patients scheduled for surgery because of disc herniation, spinal stenosis, spondylolisthesis, or degenerative disc disease (DDD), 25-80 years of age. Primary outcome was Oswestry Disability Index (ODI). Secondary outcomes were pain intensity, anxiety, depression, self-efficacy, fear avoidance, physical activity, and treatment effect. Patients were randomized to either presurgery physiotherapy or standardized information, with follow-up after the presurgery intervention as well as 3 and 12 months post surgery. The study was funded by regional research funds for US$77,342. No conflict of interest is declared. The presurgery physiotherapy group had better ODI, visual analog scale (VAS) back pain, EuroQol-5D (EQ-5D), EQ-VAS, Fear Avoidance Belief Questionnaire-Physical Activity (FABQ-PA), Self-Efficacy Scale (SES), and Hospital Anxiety and Depression Scale (HADS) depression scores and activity level compared with the waiting-list group after the presurgery intervention. The improvements were small, but larger than the study-specific minimal clinical important change (MCIC) in VAS back and leg pain, EQ-5D, and FABQ-PA, and almost in line with MCIC in ODI and Physical Component Summary (PCS) in the physiotherapy group. Post surgery, the only difference between the groups was higher activity level in the physiotherapy group

  3. Beneficial effects of reading aloud and solving simple arithmetic calculations (learning therapy) on a wide range of cognitive functions in the healthy elderly: study protocol for a randomized controlled trial.

    PubMed

    Nouchi, Rui; Taki, Yasuyuki; Takeuchi, Hikaru; Hashizume, Hiroshi; Nozawa, Takayuki; Sekiguchi, Atsushi; Nouchi, Haruka; Kawashima, Ryuta

    2012-04-06

    Almost all cognitive functions decline with age. Results of previous studies have shown that cognitive training related to everyday life (reading aloud and solving simple arithmetic calculations), namely learning therapy, can improve two cognitive function (executive functions and processing speed) in elderly people. However, it remains unclear whether learning therapy engenders improvement of various cognitive functions or not. We investigate the impact of learning therapy on various cognitive functions (executive functions, episodic memory, short-term memory, working memory, attention, reading ability, and processing speed) in healthy older adults. We use a single-blinded intervention with two parallel groups (a learning therapy group and a waiting list control group). Testers are blind to the study hypothesis and the group membership of participants. Through an advertisement in local newspaper, 64 healthy older adults are recruited. They will be assigned randomly to a learning therapy group or a waiting list control group. In the learning therapy group, participants are required to perform two cognitive tasks for 6 months: reading Japanese aloud and solving simple calculations. The waiting list group does not participate in the intervention. The primary outcome measure is the Stroop test score: a measure of executive function. Secondary outcome measures are assessments including the following: verbal fluency task, logical memory, first and second names, digit span forward, digit span backward, Japanese reading test, digit cancellation task, digit symbol coding, and symbol search. We assess these outcome measures before and after the intervention. This report is the first study which investigates the beneficial effects of learning therapy on a wide range of cognitive functions of elderly people. Our study provides sufficient evidence of learning therapy effectiveness. Most cognitive functions, which are correlated strongly with daily life activities, decrease

  4. Internet treatment for social anxiety disorder in Romania: study protocol for a randomized controlled trial

    PubMed Central

    2012-01-01

    Background Social anxiety disorder (SAD) is one of the most common anxiety disorders and is associated with marked impairments. However, a small proportion of individuals with SAD seek and receive treatment. Internet-administrated cognitive behavior therapy (iCBT) has been found to be an effective treatment for SAD. This trial will be the first Internet-delivered guided self-help intervention for SAD in Romania. Methods Participants with social anxiety disorder (N = 96) will be recruited via newspapers, online banners and Facebook. Participants will be randomized to either: a) an active treatment, or b) a waiting list control group. The treatment will have a guided iCBT format and will last for nine weeks. Self-report questionnaires on social phobia, anxiety, depression, treatment credibility and irrational thinking will be used. All assessments will be collected pre, post and at follow-up (six months after intervention). Liebowitz Social Anxiety Scale – Self-Report version (LSAS-SR) will be the primary outcome measure and will be administrated on a weekly basis in both conditions. Discussion The present randomized controlled trial investigates the efficacy of an Internet-administered intervention in reducing social anxiety symptoms in a culture where this form of treatment has not been tested. This trial will add to the body of knowledge on the efficacy of iCBT, and the results might lead to an increase of the accessibility of evidence-based psychological treatment in Romania. Trial registration ClinicalTrials.gov: NCT01557894 PMID:23111108

  5. Differences in Waiting List Prioritization Preferences of Occupational Therapists, Elderly People, and Persons With Disabilities: A Discrete Choice Experiment.

    PubMed

    Raymond, Marie-Hélène; Demers, Louise; Feldman, Debbie Ehrmann

    2018-01-01

    To compare the preferences of occupational therapists, elderly people, and adults with disabilities regarding prioritization criteria for occupational therapy waiting lists in home care. Discrete choice experiment survey. Survey mailed to occupational therapists working in home care and community-dwelling elderly or disabled persons. A sample (N=714) of home-based occupational therapists (n=241), elderly persons from a bank of research participants (n=226), and adults with physical disabilities recruited through community organizations (n=247). Not applicable. The dependent variable was whether the referral scenario was prioritized or not in each question. The results were analyzed through logistic regression using conditional logit models. Prioritization preferences differed between groups (P<.001). Occupational therapists most strongly prioritized people who had a few falls (odds ratio vs no falls, 48.7), whereas elderly people and adults with disabilities most strongly prioritized people who were unable to enter and exit the home (odds ratio vs no difficulty entering and exiting the home, 30.8 for elderly people and 16.8 for persons with disabilities.) CONCLUSIONS: Our results highlight the gap between the priorities of home-based occupational therapists and their target clientele. Although further inquiry is needed to inform priority setting, the findings emphasize the importance of public or patient involvement in decisions on waiting list prioritization. Copyright © 2017 American Congress of Rehabilitation Medicine. Published by Elsevier Inc. All rights reserved.

  6. Space, place and (waiting) time: reflections on health policy and politics.

    PubMed

    Sheard, Sally

    2018-02-19

    Health systems have repeatedly addressed concerns about efficiency and equity by employing trans-national comparisons to draw out the strengths and weaknesses of specific policy initiatives. This paper demonstrates the potential for explicit historical analysis of waiting times for hospital treatment to add value to spatial comparative methodologies. Waiting times and the size of the lists of waiting patients have become key operational indicators. In the United Kingdom, as National Health Service (NHS) financial pressures intensified from the 1970s, waiting times have become a topic for regular public and political debate. Various explanations for waiting times include the following: hospital consultants manipulate NHS waiting lists to maintain their private practice; there is under-investment in the NHS; and available (and adequate) resources are being used inefficiently. Other countries have also experienced ongoing tensions between the public and private delivery of universal health care in which national and trans-national comparisons of waiting times have been regularly used. The paper discusses the development of key UK policies, and provides a limited Canadian comparative perspective, to explore wider issues, including whether 'waiting crises' were consciously used by policymakers, especially those brought into government to implement new economic and managerial strategies, to diminish the autonomy and authority of the medical professional in the hospital environment.

  7. Getting on the List

    MedlinePlus

    ... on the list Getting on the list First step For most people, the first step in receiving ... Langhorne, explains how the national waiting list works: Steps you need to take Here are the necessary ...

  8. Taking Healthy Steps: rationale, design and baseline characteristics of a randomized trial of a pedometer-based internet-mediated walking program in veterans with chronic obstructive pulmonary disease

    PubMed Central

    2014-01-01

    Background Low levels of physical activity are common in patients with chronic obstructive pulmonary disease (COPD), and a sedentary lifestyle is associated with poor outcomes including increased mortality, frequent hospitalizations, and poor health-related quality of life. Internet-mediated physical activity interventions may increase physical activity and improve health outcomes in persons with COPD. Methods/Design This manuscript describes the design and rationale of a randomized controlled trial that tests the effectiveness of Taking Healthy Steps, an Internet-mediated walking program for Veterans with COPD. Taking Healthy Steps includes an uploading pedometer, a website, and an online community. Eligible and consented patients wear a pedometer to obtain one week of baseline data and then are randomized on a 2:1 ratio to Taking Healthy Steps or to a wait list control. The intervention arm receives iterative step-count feedback; individualized step-count goals, motivational and informational messages, and access to an online community. Wait list controls are notified that they are enrolled, but that their intervention will start in one year; however, they keep the pedometer and have access to a static webpage. Discussion Participants include 239 Veterans (mean age 66.7 years, 93.7% male) with 155 randomized to Taking Healthy Steps and 84 to the wait list control arm; rural-living (45.2%); ever-smokers (93.3%); and current smokers (25.1%). Baseline mean St. George’s Respiratory Questionnaire Total Score was 46.0; 30.5% reported severe dyspnea; and the average number of comorbid conditions was 4.9. Mean baseline daily step counts was 3497 (+/- 2220). Veterans with COPD can be recruited to participate in an online walking program. We successfully recruited a cohort of older Veterans with a significant level of disability including Veterans who live in rural areas using a remote national recruitment strategy. Trial registration Clinical Trials.gov NCT01102777

  9. PREPARE: Pre-surgery physiotherapy for patients with degenerative lumbar spine disorder: a randomized controlled trial protocol.

    PubMed

    Lindbäck, Yvonne; Tropp, Hans; Enthoven, Paul; Abbott, Allan; Öberg, Birgitta

    2016-07-11

    Current guidelines for the management of patients with specific low back pain pathology suggest non-surgical intervention as first-line treatment, but there is insufficient evidence to make recommendations of the content in the non-surgical intervention. Opinions regarding the dose of non-surgical intervention that should be trialled prior to decision making about surgery intervention vary. The aim of the present study is to investigate if physiotherapy administrated before surgery improves function, pain and health in patients with degenerative lumbar spine disorder scheduled for surgery. The patients are followed over two years. A secondary aim is to study what factors predict short and long term outcomes. This study is a single blinded, 2-arm, randomized controlled trial with follow-up after the completion of pre-surgery intervention as well as 3, 12 and 24 months post-surgery. The study will recruit men and women, 25 to 80 years of age, scheduled for surgery due to; disc herniation, spinal stenosis, spondylolisthesis or degenerative disc disease. A total of 202 patients will be randomly allocated to a pre-surgery physiotherapy intervention or a waiting list group for 9 weeks. The waiting-list group will receive standardized information about surgery, post-surgical rehabilitation and advice to stay active. The pre-surgery physiotherapy group will receive physiotherapy 2 times per week, consisting of a stratified classification treatment, based on assessment findings. One of the following treatments will be selected; a) Specific exercises and mobilization, b) Motor control exercises or c) Traction. The pre-surgery physiotherapy group will also be prescribed a tailor-made general supervised exercise program. The physiotherapist will use a behavioral approach aimed at reducing patient fear avoidance and increasing activity levels. They will also receive standardized information about surgery, post-surgical rehabilitation and advice to stay active. Primary

  10. Meditation awareness training for the treatment of workaholism: A controlled trial

    PubMed Central

    Van Gordon, William; Shonin, Edo; Dunn, Thomas J.; Garcia-Campayo, Javier; Demarzo, Marcelo M. P.; Griffiths, Mark D.

    2017-01-01

    Background and aims Workaholism is a form of behavioral addiction that can lead to reduced life and job satisfaction, anxiety, depression, burnout, work–family conflict, and impaired productivity. Given the number of people affected, there is a need for more targeted workaholism treatments. Findings from previous case studies successfully utilizing second-generation mindfulness-based interventions (SG-MBIs) for treating behavioral addiction suggest that SG-MBIs may be suitable for treating workaholism. This study conducted a controlled trial to investigate the effects of an SG-MBI known as meditation awareness training (MAT) on workaholism. Methods Male and female adults suffering from workaholism (n = 73) were allocated to MAT or a waiting-list control group. Assessments were performed at pre-, post-, and 3-month follow-up phases. Results MAT participants demonstrated significant and sustained improvements over control-group participants in workaholism symptomatology, job satisfaction, work engagement, work duration, and psychological distress. Furthermore, compared to the control group, MAT participants demonstrated a significant reduction in hours spent working but without a decline in job performance. Discussion and conclusions MAT may be a suitable intervention for treating workaholism. Further controlled intervention studies investigating the effects of SG-MBIs on workaholism are warranted. PMID:28425778

  11. Evaluating the effectiveness and efficacy of unguided internet-based self-help intervention for the prevention of depression: a randomized controlled trial.

    PubMed

    Lintvedt, Ove K; Griffiths, Kathleen M; Sørensen, Kristian; Østvik, Andreas R; Wang, Catharina E A; Eisemann, Martin; Waterloo, Knut

    2013-01-01

    The Internet has the potential to increase the capacity and accessibility of mental health services. This study aimed to investigate whether an unguided Internet-based self-help intervention delivered without human support or guidance can reduce symptoms of depression in young people at risk of depression. The study also aimed to explore the usage of such sites in a real-life setting, to estimate the effects of the intervention for those who received a meaningful intervention dose and to evaluate user satisfaction. Young adults were recruited by means of a screening survey sent to all students at the University of Tromsø. Of those responding to the survey, 163 students (mean age 28.2 years) with elevated psychological distress were recruited to the trial and randomized to an Internet intervention condition or the waiting list control group. The Internet condition comprised a depression information website and a self-help Web application delivering automated cognitive behavioural therapy. The participants in the waiting list condition were free to access formal or informal help as usual. Two-thirds of the users who completed the trial initially reported an unmet need for help. The findings demonstrated that an unguided intervention was effective in reducing symptoms of depression and negative thoughts and in increasing depression literacy in young adults. Significant improvements were found at 2-month follow up. Internet-based interventions can be effective without tracking and thus constitute a minimal cost intervention for reaching a large number of people. User satisfaction among participants was high. Copyright © 2011 John Wiley & Sons, Ltd.

  12. An internet-based intervention for adjustment disorder (TAO): study protocol for a randomized controlled trial.

    PubMed

    Rachyla, Iryna; Pérez-Ara, Marian; Molés, Mar; Campos, Daniel; Mira, Adriana; Botella, Cristina; Quero, Soledad

    2018-05-31

    Adjustment Disorder (AjD) is a common and disabling mental health problem. The lack of research on this disorder has led to the absence of evidence-based interventions for its treatment. Moreover, because the available data indicate that a high percentage of people with mental illness are not treated, it is necessary to develop new ways to provide psychological assistance. The present study describes a Randomized Controlled Trial (RCT) aimed at assessing the effectiveness and acceptance of a linear internet-delivered cognitive-behavioral therapy (ICBT) intervention for AjD. A two-armed RCT was designed to compare an intervention group to a waiting list control group. Participants from the intervention group will receive TAO, an internet-based program for AjD composed of seven modules. TAO combines CBT and Positive Psychology strategies in order to provide patients with complete support, reducing their clinical symptoms and enhancing their capacity to overcome everyday adversity. Participants will also receive short weekly telephone support. Participants in the control group will be assessed before and after a seven-week waiting period, and then they will be offered the same intervention. Participants will be randomly assigned to one of the 2 groups. Measurements will be taken at five different moments: baseline, post-intervention, and three follow-up periods (3-, 6- and 12-month). BDI-II and BAI will be used as primary outcome measures. Secondary outcomes will be symptoms of AjD, posttraumatic growth, positive and negative affect, and quality of life. The development of ICBT programs like TAO responds to a need for evidence-based interventions that can reach most of the people who need them, reducing the burden and cost of mental disorders. More specifically, TAO targets AjD and will entail a step forward in the treatment of this prevalent but under-researched disorder. Finally, it should be noted that this is the first RCT focusing on an internet

  13. Prioritisation of patients on waiting lists for hip and knee arthroplasties and cataract surgery: Instruments validation

    PubMed Central

    Allepuz, Alejandro; Espallargues, Mireia; Moharra, Montse; Comas, Mercè; Pons, Joan MV

    2008-01-01

    Background Prioritisation instruments were developed for patients on waiting list for hip and knee arthroplasties (AI) and cataract surgery (CI). The aim of the study was to assess their convergent and discriminant validity and inter-observer reliability. Methods Multicentre validation study which included orthopaedic surgeons and ophthalmologists from 10 hospitals. Participating doctors were asked to include all eligible patients placed in the waiting list for the procedures under study during the medical visit. Doctors assessed patients' priority through a visual analogue scale (VAS) and administered the prioritisation instrument. Information on socio-demographic data and health-related quality of life (HRQOL) (HUI3, EQ-5D, WOMAC and VF-14) was obtained through a telephone interview with patients. The correlation coefficients between the prioritisation instrument score and VAS and HRQOL were calculated. For the reliability study a self-administered questionnaire, which included hypothetic patients' scenarios, was sent via postal mail to the doctors. The priority of these scenarios was assessed through the prioritisation instrument. The intraclass correlation coefficient (ICC) between doctors was calculated. Results Correlations with VAS were strong for the AI (0.64, CI95%: 0.59–0.68) and for the CI (0.65, CI95%: 0.62–0.69), and moderate between the WOMAC and the AI (0.39, CI95%: 0.33–0.45) and the VF-14 and the CI (0.38, IC95%: 0.33–0.43). The results of the discriminant analysis were in general as expected. Inter-observer reliability was 0.79 (CI95%: 0.64–0.94) for the AI, and 0.79 (CI95%: 0.63–0.95) for the CI. Conclusion The results show acceptable validity and reliability of the prioritisation instruments in establishing priority for surgery. PMID:18397519

  14. Waiting time of inpatients before elective surgical procedures at a State Government Teaching Hospital in India.

    PubMed

    Ray, Shreyasi; Kirtania, Jyotirmay

    2017-01-01

    Abundant published literature exists addressing the issues of outpatient waiting lists before surgery. However, there is no published literature on inpatient waiting time before elective surgical procedures. This study aims to measure the inpatient waiting time, identify the factors that affect the inpatient waiting time, and recommend the ways of reducing the waiting time of inpatients before elective surgical procedures, at a state government teaching hospital in India. Descriptive research methods and quality control tools were used for this prospective observational study. Descriptive statistics, Shapiro-Wilk test of normality, Wilcoxon-Mann-Whitney Test, and Kruskal-Wallis test were used. Pareto charts were used to highlight the most important modifiable factors among the set of factors causing increased waiting time. We also applied the M/M/c model (Erlang - A model) of queue theory to analyze the traffic intensity and system congestion. The median waiting time of inpatients before elective surgery was 12 days (interquartile range = 11.5 days). The waiting time was influenced significantly (P < 0.05) by the patient's age, physical status, and the financial status. The surgical specialty, blood product booking and procurement, cross-specialty consultation before surgery, and Intensive Care Unit booking were the other important factors. Modifiable and nonmodifiable factors affecting the inpatient waiting time of surgical patients were identified. Control measures that can reduce the waiting time of inpatients before elective surgery were identified.

  15. Return to work of workers without a permanent employment contract, sick-listed due to a common mental disorder: design of a randomised controlled trial

    PubMed Central

    2014-01-01

    Background Workers without a permanent employment contract represent a vulnerable group within the working population. Mental disorders are a major cause of sickness absence within this group. Common mental disorders are stress-related, depressive and anxiety disorders. To date, little attention has been paid to effective return to work interventions for this type of sick-listed workers. Therefore, a participatory supportive return to work program has been developed. It combines elements of a participatory return to work program, integrated care and direct placement in a competitive job. The objective of this paper is to describe the design of a randomised controlled trial to evaluate the cost-effectiveness of this program compared to care as usual. Methods/Design The cost-effectiveness of the participatory supportive return to work program will be examined in a randomised controlled trial with a follow-up of twelve months. The program strongly involves the sick-listed worker in the identification of obstacles for return to work and possible solutions, resulting in a consensus based action plan. This plan will be used as a starting point for the search of suitable competitive employment with support of a rehabilitation agency. During this process the insurance physician of the sick-listed worker contacts other caregivers to promote integrated care. Workers eligible to participate in this study have no permanent employment contract, have applied for a sickness benefit at the Dutch Social Security Agency and are sick-listed between two and fourteen weeks due to mental health problems. The primary outcome measure is the duration until first sustainable return to work in a competitive job. Outcomes are measured at baseline and after three, six, nine and twelve months. Discussion If the participatory supportive return to work program proves to be cost-effective, the social security system, the sick-listed worker and society as a whole will benefit. A cost

  16. The effect of acupuncture on psychosocial outcomes for women experiencing infertility: a pilot randomized controlled trial.

    PubMed

    Smith, Caroline A; Ussher, Jane M; Perz, Janette; Carmady, Bridget; de Lacey, Sheryl

    2011-10-01

    The study objectives were to examine the effectiveness of acupuncture for reducing infertility-related stress. The study design was a randomized controlled trial of acupuncture compared with a wait-list control. The study was conducted at The University of Western Sydney. Thirty-two (32) women aged 20-45 years, with a diagnosis of infertility, or a history of unsuccessfully trying to conceive for 12 months or more, were the subjects of the study. Women received six sessions of acupuncture over 8 weeks. The primary outcomes were infertility self-efficacy, anxiety, and infertility-related stress. The women's experience of infertility and acupuncture is also reported. At the end of the 8-week intervention, women in the acupuncture group reported significant changes on two domains on the Fertility Problem Inventory with less social concern (mean difference [MD] -3.75, 95% confidence interval [CI] -7.58 to 0.84, p=0.05), and less relationship concern (MD -3.66, 95% CI -6.80 to -0.052, p=0.02). There were also trends toward a reduction of infertility stress on other domains, and a trend toward improved self-efficacy (MD 11.9, 95% CI -2.20 to 26.0, p=0.09) and less anxiety (MD -2.54, 95% CI -5.95 to 0.86, p=0.08) in the acupuncture group compared with the wait-list control. Women described the experience and impact of acupuncture as positive relating to a sense of relaxation and time out, the engagement with the practitioner, and an intervention that had very few negative side-effects. Changes were also perceived after treatment with women describing a physical and psychologic sense of relaxation and calmness, and a changed perspective in relation to coping. Acupuncture may be a useful intervention to assist with the reduction of infertility-related stress. Further research is justified.

  17. Myofascial trigger point-focused head and neck massage for recurrent tension-type headache: A randomized, placebo-controlled clinical trial

    PubMed Central

    Moraska, Albert F.; Stenerson, Lea; Butryn, Nathan; Krutsch, Jason P.; Schmiege, Sarah J.; Mann, J. Douglas

    2014-01-01

    Objective Myofascial trigger points (MTrPs) are focal disruptions in skeletal muscle that can refer pain to the head and reproduce the pain patterns of tension-type headache (TTH). The present study applied massage focused on MTrPs of subjects with TTH in a placebo-controlled, clinical trial to assess efficacy on reducing headache pain. Methods Fifty-six subjects with TTH were randomized to receive 12 massage or placebo (detuned ultrasound) sessions over six weeks, or to wait-list. Trigger point release (TPR) massage focused on MTrPs in cervical musculature. Headache pain (frequency, intensity and duration) was recorded in a daily headache diary. Additional outcome measures included self-report of perceived clinical change in headache pain and pressure-pain threshold (PPT) at MTrPs in the upper trapezius and sub-occipital muscles. Results From diary recordings, group differences across time were detected in headache frequency (p=0.026), but not for intensity or duration. Post hoc analysis indicated headache frequency decreased from baseline for both massage (p<0.0003) and placebo (p=0.013), but no difference was detected between massage and placebo. Subject report of perceived clinical change was a greater reduction in headache pain for massage than placebo or wait-list groups (p=0.002). PPT improved in all muscles tested for massage only (all p's<0.002). Discussion Two findings from this study are apparent: 1) MTrPs are important components in the treatment of TTH, and 2) TTH, like other chronic conditions, is responsive to placebo. Clinical trials on headache that do not include a placebo group are at risk for overestimating the specific contribution from the active intervention. PMID:25329141

  18. Myofascial trigger point-focused head and neck massage for recurrent tension-type headache: a randomized, placebo-controlled clinical trial.

    PubMed

    Moraska, Albert F; Stenerson, Lea; Butryn, Nathan; Krutsch, Jason P; Schmiege, Sarah J; Mann, John D

    2015-02-01

    Myofascial trigger points (MTrPs) are focal disruptions in the skeletal muscle that can refer pain to the head and reproduce the pain patterns of tension-type HA (TTH). The present study applied massage focused on MTrPs of patients with TTH in a placebo-controlled, clinical trial to assess efficacy on reducing headache (HA) pain. Fifty-six patients with TTH were randomized to receive 12 massage or placebo (detuned ultrasound) sessions over 6 weeks, or to wait-list. Trigger point release massage focused on MTrPs in cervical musculature. HA pain (frequency, intensity, and duration) was recorded in a daily HA diary. Additional outcome measures included self-report of perceived clinical change in HA pain and pressure-pain threshold at MTrPs in the upper trapezius and suboccipital muscles. From diary recordings, group differences across time were detected in HA frequency (P=0.026), but not for intensity or duration. Post hoc analysis indicated that HA frequency decreased from baseline for both massage (P<0.0003) and placebo (P=0.013), but no difference was detected between massage and placebo. Patient report of perceived clinical change was greater reduction in HA pain for massage than placebo or wait-list groups (P=0.002). Pressure-pain threshold improved in all muscles tested for massage only (all P's<0.002). Two findings from this study are apparent: (1) MTrPs are important components in the treatment of TTH, and (2) TTH, like other chronic conditions, is responsive to placebo. Clinical trials on HA that do not include a placebo group are at risk for overestimating the specific contribution from the active intervention.

  19. The surgical waiting time initiative: A review of the Nigerian situation

    PubMed Central

    Abdulkareem, Imran Haruna

    2014-01-01

    SUMMARY The concept of surgical waiting time initiative (SWAT) was introduced in developed countries to reduce elective surgery waiting lists and increase efficiency of care. It was supplemented by increasing popularity of day surgery, which shortens elective waiting lists and minimises cancellations. It is established in Western countries, but not in developing countries like Nigeria where it is still evolving. A search was carried out in Pub Med, Google, African journals online (AJOL), Athens and Ovid for relevant publications on elective surgery waiting list in Nigeria, published in English language. Words include waiting/wait time, waiting time initiative, time to surgery, waiting for operations, waiting for intervention, waiting for procedures and time before surgery in Nigeria. A total of 37 articles published from Nigeria in relation to various waiting times were found from the search and fulfilled the inclusion criteria. Among them, 11 publications (29.7%) were related to emergency surgery waiting times, 10 (27%) were related to clinic waiting times, 9 (24.3%) were related to day case surgery, 2 (5.5%) were related to investigation waiting times and only 5 (13.5%) articles were specifically published on elective surgery waiting times. A total of 9 articles (24.5%) were published from obstetrics and gynaecology (OG), 7 (19%) from general surgery, 5 (13.5%) from public health, 3 (8%) from orthopaedics, 3 (8%) from general practice (GP), 3 (8%) from paediatrics/paediatric surgery, 2 (5.5%) from ophthalmology, 1 (2.7%) from ear, nose and throat (ENT), 1 (2.7%) from plastic surgery, 1 (2.7%) from urology and only 1 (2.7%) article was published from dental/maxillofacial surgery. Waiting times mean different things to different health practitioners in Nigeria. There were only 5/37 articles (13.5%) specifically related to elective surgery waiting times in Nigerian hospitals, which show that the concept of the SWAT is still evolving in Nigeria. Of the 37, 11 (24

  20. The surgical waiting time initiative: A review of the Nigerian situation.

    PubMed

    Abdulkareem, Imran Haruna

    2014-11-01

    The concept of surgical waiting time initiative (SWAT) was introduced in developed countries to reduce elective surgery waiting lists and increase efficiency of care. It was supplemented by increasing popularity of day surgery, which shortens elective waiting lists and minimises cancellations. It is established in Western countries, but not in developing countries like Nigeria where it is still evolving. A search was carried out in Pub Med, Google, African journals online (AJOL), Athens and Ovid for relevant publications on elective surgery waiting list in Nigeria, published in English language. Words include waiting/wait time, waiting time initiative, time to surgery, waiting for operations, waiting for intervention, waiting for procedures and time before surgery in Nigeria. A total of 37 articles published from Nigeria in relation to various waiting times were found from the search and fulfilled the inclusion criteria. Among them, 11 publications (29.7%) were related to emergency surgery waiting times, 10 (27%) were related to clinic waiting times, 9 (24.3%) were related to day case surgery, 2 (5.5%) were related to investigation waiting times and only 5 (13.5%) articles were specifically published on elective surgery waiting times. A total of 9 articles (24.5%) were published from obstetrics and gynaecology (OG), 7 (19%) from general surgery, 5 (13.5%) from public health, 3 (8%) from orthopaedics, 3 (8%) from general practice (GP), 3 (8%) from paediatrics/paediatric surgery, 2 (5.5%) from ophthalmology, 1 (2.7%) from ear, nose and throat (ENT), 1 (2.7%) from plastic surgery, 1 (2.7%) from urology and only 1 (2.7%) article was published from dental/maxillofacial surgery. Waiting times mean different things to different health practitioners in Nigeria. There were only 5/37 articles (13.5%) specifically related to elective surgery waiting times in Nigerian hospitals, which show that the concept of the SWAT is still evolving in Nigeria. Of the 37, 11 (24

  1. AIDE-Acute Illness and Depression in Elderly Patients. Cognitive Behavioral Group Psychotherapy in Geriatric Patients With Comorbid Depression: A Randomized, Controlled Trial.

    PubMed

    Hummel, Jana; Weisbrod, Cecilia; Boesch, Leila; Himpler, Katharina; Hauer, Klaus; Hautzinger, Martin; Gaebel, Andrea; Zieschang, Tania; Fickelscherer, Andrea; Diener, Slawomira; Dutzi, Ilona; Krumm, Bertram; Oster, Peter; Kopf, Daniel

    2017-04-01

    Comorbid depression is highly prevalent in geriatric patients and associated with functional loss, frequent hospital re-admissions, and a higher mortality rate. Cognitive behavioral psychotherapy (CBT) has shown to be effective in older depressive patients living in the community. To date, CBT has not been applied to older patients with acute physical illness and comorbid depression. To evaluate the effectiveness of CBT in depressed geriatric patients, hospitalized for acute somatic illness. Randomized controlled trial with waiting list control group. Postdischarge intervention in a geriatric day clinic; follow-up evaluations at the patients' homes. A total of 155 randomized patients, hospitalized for acute somatic illness, aged 82 ± 6 years and suffering from depression [Hospital Anxiety and Depression Scale (HADS) scores >7]. Exclusion criteria were dementia, delirium, and terminal state of medical illness. Fifteen, weekly group sessions based on a CBT manual. Commencement of psychotherapy immediately after discharge in the intervention group and a 4-month waiting list interval with usual care in the control group. HADS depression total score after 4 months. Secondary endpoints were functional, cognitive, psychosocial and physical status, resource utilization, caregiver burden, and amount of contact with physician. The intervention group improved significantly in depression scores (HADS baseline 18.8; after 4 months 11.4), whereas the control group deteriorated (HADS baseline 18.1; after 4 months 21.6). Significant improvement in the intervention group, but not in the control group, was observed for most secondary outcome parameters such as the Barthel and Karnofsky indexes. Intervention effects were less pronounced in patients with cognitive impairment or acute fractures. CBT is feasible and highly effective in geriatric patients. The benefits extend beyond effective recovery and include improvement in physical and functional parameters. Early diagnosis

  2. A home-based intervention to reduce depressive symptoms and improve quality of life in older African Americans: a randomized trial.

    PubMed

    Gitlin, Laura N; Harris, Lynn Fields; McCoy, Megan C; Chernett, Nancy L; Pizzi, Laura T; Jutkowitz, Eric; Hess, Edward; Hauck, Walter W

    2013-08-20

    Effective care models for treating older African Americans with depressive symptoms are needed. To determine whether a home-based intervention alleviates depressive symptoms and improves quality of life in older African Americans. Parallel, randomized trial stratified by recruitment site. Interviewers assessing outcomes were blinded to treatment assignment. (ClinicalTrials.gov: NCT00511680). A senior center and participants' homes from 2008 to 2010. African Americans aged 55 years or older with depressive symptoms. A multicomponent, home-based intervention delivered by social workers or a wait-list control group that received the intervention at 4 months. Self-reported depression severity at 4 months (primary outcome) and depression knowledge, quality of life, behavioral activation, anxiety, function, and remission at 4 and 8 months. Of 208 participants (106 and 102 in the intervention and wait-list groups, respectively), 182 (89 and 93, respectively) completed 4 months and 160 (79 and 81, respectively) completed 8 months. At 4 months, participants in the intervention group showed reduced depression severity (difference in mean change in Patient Health Questionnaire-9 score from baseline, -2.9 [95% CI, -4.6 to -1.2]; difference in mean change in Center for Epidemiologic Studies Depression Scale score from baseline, -3.7 [CI, -5.4 to -2.1]); improved depression knowledge, quality of life, behavioral activation, and anxiety (P < 0.001); and improved function (P = 0.014) compared with wait-list participants. More intervention than wait-list participants entered remission at 4 months (43.8% vs. 26.9%). After treatment, control participants showed benefits similar in magnitude to those of participants in the initial intervention group. Those in the initial intervention group maintained benefits at 8 months. The study had a small sample, short duration, and differential withdrawal rate. A home-based intervention delivered by social workers could reduce depressive

  3. Effects of the FITKids physical activity randomized controlled trial on conflict monitoring in youth.

    PubMed

    Drollette, Eric S; Pontifex, Matthew B; Raine, Lauren B; Scudder, Mark R; Moore, R Davis; Kao, Shih-Chun; Westfall, Daniel R; Wu, Chien-Ting; Kamijo, Keita; Castelli, Darla M; Khan, Naiman A; Kramer, Arthur F; Hillman, Charles H

    2018-03-01

    The present study investigated the effect of a 9-month physical activity (PA) intervention on children's cardiorespiratory fitness levels and neuroelectric indices of conflict monitoring (i.e., error-related negativity, ERN). Four hundred twenty-eight preadolescent children (8-9 years old) were randomized into a PA intervention or wait-list control group, and completed a fitness and cognitive control assessment (i.e., modified flanker task) at pre- and posttest. Following exclusion criterion, 308 children were included in the analyses (PA intervention: n = 139; wait-list control: n = 169). Children in the intervention displayed greater improvements in fitness and response accuracy, which were accompanied by stability of ERN amplitude from pre- to posttest. In contrast, the control group revealed increased ERN amplitude at posttest compared to pretest, despite no change in fitness or task performance. These findings demonstrate the efficacy of daily PA for promoting children's fitness and underlying neural processes associated with effective conflict monitoring. Such findings have significant implications for promoting organized PA programs intended to foster overall physical and brain health in school age children. © 2017 Society for Psychophysiological Research.

  4. Pinocchio testing in the forensic analysis of waiting lists: using public waiting list data from Finland and Spain for testing Newcomb-Benford’s Law

    PubMed Central

    López-Valcárcel, Beatriz G; González-Martel, Christian; Peiro, Salvador

    2018-01-01

    Objective Newcomb-Benford’s Law (NBL) proposes a regular distribution for first digits, second digits and digit combinations applicable to many different naturally occurring sources of data. Testing deviations from NBL is used in many datasets as a screening tool for identifying data trustworthiness problems. This study aims to compare public available waiting lists (WL) data from Finland and Spain for testing NBL as an instrument to flag up potential manipulation in WLs. Design Analysis of the frequency of Finnish and Spanish WLs first digits to determine if their distribution is similar to the pattern documented by NBL. Deviations from the expected first digit frequency were analysed using Pearson’s χ2, mean absolute deviation and Kuiper tests. Setting/participants Publicly available WL data from Finland and Spain, two countries with universal health insurance and National Health Systems but characterised by different levels of transparency and good governance standards. Main outcome measures Adjustment of the observed distribution of the numbers reported in Finnish and Spanish WL data to the expected distribution according to NBL. Results WL data reported by the Finnish health system fits first digit NBL according to all statistical tests used (p=0.6519 in χ2 test). For Spanish data, this hypothesis was rejected in all tests (p<0.0001 in χ2 test). Conclusions Testing deviations from NBL distribution can be a useful tool to identify problems with WL data trustworthiness and signalling the need for further testing. PMID:29743333

  5. Pinocchio testing in the forensic analysis of waiting lists: using public waiting list data from Finland and Spain for testing Newcomb-Benford's Law.

    PubMed

    Pinilla, Jaime; López-Valcárcel, Beatriz G; González-Martel, Christian; Peiro, Salvador

    2018-05-09

    Newcomb-Benford's Law (NBL) proposes a regular distribution for first digits, second digits and digit combinations applicable to many different naturally occurring sources of data. Testing deviations from NBL is used in many datasets as a screening tool for identifying data trustworthiness problems. This study aims to compare public available waiting lists (WL) data from Finland and Spain for testing NBL as an instrument to flag up potential manipulation in WLs. Analysis of the frequency of Finnish and Spanish WLs first digits to determine if their distribution is similar to the pattern documented by NBL. Deviations from the expected first digit frequency were analysed using Pearson's χ 2 , mean absolute deviation and Kuiper tests. Publicly available WL data from Finland and Spain, two countries with universal health insurance and National Health Systems but characterised by different levels of transparency and good governance standards. Adjustment of the observed distribution of the numbers reported in Finnish and Spanish WL data to the expected distribution according to NBL. WL data reported by the Finnish health system fits first digit NBL according to all statistical tests used (p=0.6519 in χ 2 test). For Spanish data, this hypothesis was rejected in all tests (p<0.0001 in χ 2 test). Testing deviations from NBL distribution can be a useful tool to identify problems with WL data trustworthiness and signalling the need for further testing. © Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2018. All rights reserved. No commercial use is permitted unless otherwise expressly granted.

  6. Randomised controlled trial of online continuing education for health professionals to improve the management of chronic fatigue syndrome: a study protocol.

    PubMed

    Li, Sophie H; Sandler, Carolina X; Casson, Sally M; Cassar, Joanne; Bogg, Tina; Lloyd, Andrew R; Barry, Benjamin K

    2017-05-10

    Chronic fatigue syndrome (CFS) is a serious and debilitating illness that affects between 0.2%-2.6% of the world's population. Although there is level 1 evidence of the benefit of cognitive behaviour therapy (CBT) and graded exercise therapy (GET) for some people with CFS, uptake of these interventions is low or at best untimely. This can be partly attributed to poor clinician awareness and knowledge of CFS and related CBT and GET interventions. This trial aims to evaluate the effect of participation in an online education programme, compared with a wait-list control group, on allied health professionals' knowledge about evidence-based CFS interventions and their levels of confidence to engage in the dissemination of these interventions. A randomised controlled trial consisting of 180 consenting allied health professionals will be conducted. Participants will be randomised into an intervention group (n=90) that will receive access to the online education programme, or a wait-list control group (n=90). The primary outcomes will be: 1) knowledge and clinical reasoning skills regarding CFS and its management, measured at baseline, postintervention and follow-up, and 2) self-reported confidence in knowledge and clinical reasoning skills related to CFS. Secondary outcomes include retention of knowledge and satisfaction with the online education programme. The influence of the education programme on clinical practice behaviour, and self-reported success in the management of people with CFS, will also be assessed in a cohort study design with participants from the intervention and control groups combined. The study protocol has been approved by the Human Research Ethics Committee at The University of New South Wales (approval number HC16419). Results will be disseminated via peer-reviewed journal articles and presentations at scientific conferences and meetings. ACTRN12616000296437. © Article author(s) (or their employer(s) unless otherwise stated in the text of the

  7. Effects of the FITKids randomized controlled trial on executive control and brain function.

    PubMed

    Hillman, Charles H; Pontifex, Matthew B; Castelli, Darla M; Khan, Naiman A; Raine, Lauren B; Scudder, Mark R; Drollette, Eric S; Moore, Robert D; Wu, Chien-Ting; Kamijo, Keita

    2014-10-01

    To assess the effect of a physical activity (PA) intervention on brain and behavioral indices of executive control in preadolescent children. Two hundred twenty-one children (7-9 years) were randomly assigned to a 9-month afterschool PA program or a wait-list control. In addition to changes in fitness (maximal oxygen consumption), electrical activity in the brain (P3-ERP) and behavioral measures (accuracy, reaction time) of executive control were collected by using tasks that modulated attentional inhibition and cognitive flexibility. Fitness improved more among intervention participants from pretest to posttest compared with the wait-list control (1.3 mL/kg per minute, 95% confidence interval [CI]: 0.3 to 2.4; d = 0.34 for group difference in pre-to-post change score). Intervention participants exhibited greater improvements from pretest to posttest in inhibition (3.2%, 95% CI: 0.0 to 6.5; d = 0.27) and cognitive flexibility (4.8%, 95% CI: 1.1 to 8.4; d = 0.35 for group difference in pre-to-post change score) compared with control. Only the intervention group increased attentional resources from pretest to posttest during tasks requiring increased inhibition (1.4 µV, 95% CI: 0.3 to 2.6; d = 0.34) and cognitive flexibility (1.5 µV, 95% CI: 0.6 to 2.5; d = 0.43). Finally, improvements in brain function on the inhibition task (r = 0.22) and performance on the flexibility task correlated with intervention attendance (r = 0.24). The intervention enhanced cognitive performance and brain function during tasks requiring greater executive control. These findings demonstrate a causal effect of a PA program on executive control, and provide support for PA for improving childhood cognition and brain health. Copyright © 2014 by the American Academy of Pediatrics.

  8. Waiting for coronary angiography: is there a clinically ordered queue?

    PubMed

    Hemingway, H; Crook, A M; Feder, G; Dawson, J R; Timmis, A

    2000-03-18

    Among over 3000 patients undergoing coronary angiography in the absence of a formal queue-management system, we found that a-priori urgency scores were strongly associated with waiting times, prevalence of coronary-artery disease, rate of revascularisation, and mortality. These data challenge the widely held assumption that such waiting lists are not clinically ordered; however, the wide variation in waiting times within urgency categories suggests the need for further improvements in clinical queueing.

  9. Short-Term Effectiveness of Web-Based Guided Self-Help for Phobic Outpatients: Randomized Controlled Trial

    PubMed Central

    van Straten, Annemieke; Beekman, Aartjan T F; Cuijpers, Pim

    2014-01-01

    Background Internet-based guided self-help has been successfully used in the general population, but it is unknown whether this method can be effectively used in outpatient clinics for patients waiting for face-to-face psychotherapy for phobias. Objective The aim was to assess the clinical effectiveness of Phobias Under Control, an Internet-based intervention based on exposure therapy with weekly guidance. Methods We conducted a randomized controlled trial, recruiting 212 outpatients scheduled to receive face-to-face psychotherapy for any type of phobia at an outpatient clinic. Participants suffering from at least 1 DSM-IV or ICD-10 classified phobia (social phobia, agoraphobia with or without panic disorder, and/or specific phobia as ascertained by a telephone interview at baseline) were randomly allocated to either a 5-week Internet-based guided self-help program based on exposure therapy with weekly student support followed by face-to-face psychotherapy (n=105) or a wait-list control group followed by face-to-face psychotherapy (n=107). Primary outcome was the Fear Questionnaire (FQ). Secondary outcomes were the Beck Anxiety Inventory (BAI) and Center of Epidemiological Studies-Depression scale (CES-D). Assessments took place by telephone at baseline (T0) and on the Internet at posttest (T1, self-assessment at 5 weeks after baseline). Missing data at T1 were imputed. Results At posttest, analysis of covariance on the intention-to-treat sample showed significant but small effect sizes between intervention and control groups on the FQ (d=0.35, P=.02), CES-D (d=0.34, P=.03), and a nonsignificant effect size on the BAI (d=0.28. P=.05). Although initial acceptance was good, high nonresponse was observed, with 86 of 212 participants (40.5%) lost to follow-up at T1 and only 14 of 105 (13.3%) intervention participants finishing all 5 weeks. Conclusions Phobias Under Control is modestly effective in lowering phobic and depressive symptoms in a relatively short period and

  10. Effectiveness of Parent-Child Mediation in Improving Family Functioning and Reducing Adolescent Problem Behavior: Results from a Pilot Randomized Controlled Trial.

    PubMed

    Tucker, Joan S; Edelen, Maria Orlando; Huang, Wenjing

    2017-03-01

    Parent-child mediation programs are intended to resolve or manage disputes and improve family functioning, but rigorous evaluations of their effectiveness are lacking. Families referred to a community-based mediation program (N = 111) were randomized to an intervention or wait-list control group, and completed three surveys over a 12-week period. With the exception of parent-reported child delinquency (which decreased more in the intervention group), this evaluation provides little support for the short-term effectiveness of parent-child mediation for improving family functioning and reducing child problem behaviors in general. Given that this is the first randomized controlled trial of a parent-child mediation program, additional evaluations involving larger samples and longer follow-ups are needed before firm conclusions can be drawn about the effectiveness of this intervention.

  11. Effectiveness of Parent-Child Mediation in Improving Family Functioning and Reducing Adolescent Problem Behavior: Results from a Pilot Randomized Controlled Trial

    PubMed Central

    Tucker, Joan S.; Edelen, Maria Orlando; Huang, Wenjing

    2016-01-01

    Parent-child mediation programs are intended to resolve or manage disputes and improve family functioning, but rigorous evaluations of their effectiveness are lacking. Families referred to a community-based mediation program (N=111) were randomized to an intervention or wait-list control group, and completed three surveys over a 12-week period. With the exception of parent-reported child delinquency (which decreased more in the intervention group), this evaluation provides little support for the short-term effectiveness of parent-child mediation for improving family functioning and reducing child problem behaviors in general. Given that this is the first randomized controlled trial of a parent-child mediation program, additional evaluations involving larger samples and longer follow-ups are needed before firm conclusions can be drawn about the effectiveness of this intervention. PMID:26762375

  12. A novel bio-psycho-social approach for rehabilitation of traumatized victims of torture and war in the post-conflict context: a pilot randomized controlled trial in Kosovo.

    PubMed

    Wang, Shr-Jie; Bytyçi, Ardiana; Izeti, Selvi; Kallaba, Melita; Rushiti, Feride; Montgomery, Edith; Modvig, Jens

    2016-01-01

    Some evidence showed that multidisciplinary rehabilitation in Western countries is effective for treating war-related trauma, but it remains unclear whether this approach is applicable to civilians living in resource-poor countries affected by war. In 2012-14, Danish Institute against Torture (DIGNITY) conducted a randomized controlled trial (RCT), in partnership with Kosova Rehabilitation Centre for Torture Victims (KRCT), to examine the effects of multidisciplinary intervention among victims of torture and war in Kosovo. A single-center, randomized, parallel-arm, single-masked, waiting-list controlled trial was implemented in northern Kosovo. Thirty-four participants meeting the recruiting criteria were randomized to either intervention group, which received integrated treatments plus a once-daily multivitamin, or the waiting list group, which received multivitamin alone. The integrated treatments consisted of 10 weekly individual 60-min sessions of cognitive behavioral therapy (CBT), based on an adapted prolonged exposure therapy manual, an individual 20-min breathing exercise with an emWave biofeedback device, and 90-min group physiotherapy. The waiting list group also received the same treatment after the intervention group had completed their sessions. Outcome assessments were conducted at 3, 6 and 9 months after baseline assessment. Outcomes measures consisted of 4 subtypes: mental, emotional, physical health, functioning and social outcomes, i.e. PTSD, depression, anxiety, chronic pain, anger and hatred expression, body mass index, handgrip strength, standing balance, income, employment rate and disability score. Over 1/3 of PTSD cases were successfully treated. Inconsistent patterns with mental health and chronic pain outcomes were observed while there was a definite impact of intervention on functioning and social outcomes, i.e. the employment rate, which increased nearly 15 %, and the monthly wage, which rose 45-137 %. There was also a noticeable

  13. Psychological skills training and a mindfulness-based intervention to enhance functional athletic performance: design of a randomized controlled trial using ambulatory assessment.

    PubMed

    Röthlin, Philipp; Birrer, Daniel; Horvath, Stephan; Grosse Holtforth, Martin

    2016-07-26

    Struggling to deliver performance in competitions is one of the main reasons why athletes seek the advice of sport psychologists. Psychologists apply a variety of intervention techniques, many of which are not evidence-based. Evidence-based techniques promote quality management and could help athletes, for example, to increase and maintain functional athletic behavior in competitions/games (i.e., being focused on task relevant cues and executing movements and actions in high quality). However, well-designed trials investigating the effectiveness of sport psychological interventions for performance enhancement are scarce. The planed study is founded by the Swiss National Science Foundation and examines the effectiveness of two interventions with elite and sub-elite athletes. A psychological skills training (PST) and a mindfulness-based intervention (MI), administered as group-program, will be compared to a waiting-list control group concerning how they enhance functional athletic behavior - which is a prerequisite for optimal performance. Furthermore, we will investigate underlying mechanisms (mediators) and moderators (e.g., task difficulty, individual characteristics, intervention-expectancy and intervention-integrity). The presented trial uses a randomized controlled design with three groups, comparing PST, MI and a waiting list control condition. Both group interventions will last 5 weeks, consist of four 2 h sessions and will be administered by a trained sport psychologist. Primary outcome is functional athletic behavior assessed using ambulatory assessment in a competition/game. As secondary outcomes competition anxiety, cognitive interference and negative outcome expectations will be assessed. Assessments are held at pre- and post-intervention as well as at 2 months follow up. The study has been approved by the ethical committee of the Swiss Federal Institute of Sport. Both PST and MI are expected to help improve functional behavior in athletes. By

  14. Mime therapy improves facial symmetry in people with long-term facial nerve paresis: a randomised controlled trial.

    PubMed

    Beurskens, Carien H G; Heymans, Peter G

    2006-01-01

    What is the effect of mime therapy on facial symmetry and severity of paresis in people with facial nerve paresis? Randomised controlled trial. 50 people recruited from the Outpatient department of two metropolitan hospitals with facial nerve paresis for more than nine months. The experimental group received three months of mime therapy consisting of massage, relaxation, inhibition of synkinesis, and co-ordination and emotional expression exercises. The control group was placed on a waiting list. Assessments were made on admission to the trial and three months later by a measurer blinded to group allocation. Facial symmetry was measured using the Sunnybrook Facial Grading System. Severity of paresis was measured using the House-Brackmann Facial Grading System. After three months of mime therapy, the experimental group had improved their facial symmetry by 20.4 points (95% CI 10.4 to 30.4) on the Sunnybrook Facial Grading System compared with the control group. In addition, the experimental group had reduced the severity of their paresis by 0.6 grade (95% CI 0.1 to 1.1) on the House-Brackmann Facial Grading System compared with the control group. These effects were independent of age, sex, and duration of paresis. Mime therapy improves facial symmetry and reduces the severity of paresis in people with facial nerve paresis.

  15. A randomized controlled trial of a manual-based psychosocial group intervention for young people with epilepsy [PIE].

    PubMed

    Dorris, Liam; Broome, Helen; Wilson, Margaret; Grant, Cathy; Young, David; Baker, Gus; Balloo, Selina; Bruce, Susan; Campbell, Jo; Concannon, Bernie; Conway, Nadia; Cook, Lisa; Davis, Cheryl; Downey, Bruce; Evans, Jon; Flower, Diane; Garlovsky, Jack; Kearney, Shauna; Lewis, Susan; Stephens, Victoria; Turton, Stuart; Wright, Ingram

    2017-07-01

    We conducted an exploratory RCT to examine feasibility and preliminary efficacy for a manual-based psychosocial group intervention aimed at improving epilepsy knowledge, self-management skills, and quality of life in young people with epilepsy. Eighty-three participants (33:50m/f; age range 12-17years) were randomized to either the treatment or control group in seven tertiary paediatric neuroscience centres in the UK, using a wait-list control design. Participants were excluded if they reported suicidal ideation and/or scored above the cut off on mental health screening measures, or if they had a learning disability or other neurological disorder. The intervention consisted of six weekly 2-hour sessions using guided discussion, group exercises and role-plays facilitated by an epilepsy nurse and a clinical psychologist. At three month follow up the treatment group (n=40) was compared with a wait-list control group (n=43) on a range of standardized measures. There was a significant increase in epilepsy knowledge in the treatment group (p=0.02). Participants receiving the intervention were also significantly more confident in speaking to others about their epilepsy (p=0.04). Quality of life measures did not show significant change. Participants reported the greatest value of attending the group was: Learning about their epilepsy (46%); Learning to cope with difficult feelings (29%); and Meeting others with epilepsy (22%). Caregiver and facilitator feedback was positive, and 92% of participants would recommend the group to others. This brief psychosocial group intervention was effective in increasing participants' knowledge of epilepsy and improved confidence in discussing their epilepsy with others. We discuss the qualitative feedback, feasibility, strengths and limitations of the PIE trial. Copyright © 2017 Elsevier Inc. All rights reserved.

  16. Computerised CBT for depressed adolescents: Randomised controlled trial.

    PubMed

    Smith, Patrick; Scott, Rebecca; Eshkevari, Ertimiss; Jatta, Fatoumata; Leigh, Eleanor; Harris, Victoria; Robinson, Alex; Abeles, Paul; Proudfoot, Judy; Verduyn, Chrissie; Yule, William

    2015-10-01

    Depression in adolescents is a common and impairing problem. Effective psychological therapies for depression are not accessed by most adolescents. Computerised therapy offers huge potential for improving access to treatment. To test the efficacy of Stressbusters, a Computerised-CBT (C-CBT) programme for depression in young people. Multi-site, schools-based, RCT of C-CBT compared to Waiting List, for young people (N = 112; aged 12-16) with significant symptoms of depression, using multiple-informants (adolescents, parents, teachers), with follow-up at 3 and 6 months. Relative to being on a Waiting List, C-CBT was associated with statistically significant and clinically meaningful improvements in symptoms of depression and anxiety according to adolescent self-report; and with a trend towards improvements in depression and anxiety according to parent-report. Improvements were maintained at follow-up. Treatment gains were similar for boys and girls across the participating age range. Treatment effect was partially mediated by changes in ruminative thinking. Teachers rated adolescents as having few emotional or behavioural problems, both before and after intervention. C-CBT had no detectable effect on academic attainment. In the month after intervention, young people who received C-CBT had significantly fewer absences from school than those on the Waiting List. C-CBT shows considerable promise for the treatment of mild-moderate depression in adolescents. Copyright © 2015 Elsevier Ltd. All rights reserved.

  17. Effects of group songwriting on motivation and readiness for treatment on patients in detoxification: a randomized wait-list effectiveness study.

    PubMed

    Silverman, Michael J

    2012-01-01

    Songwriting is a commonly utilized music therapy technique for clients in substance abuse rehabilitation. For these patients, motivation and readiness for treatment remain two key treatment areas. Moreover, there is a lack of randomized and controlled music therapy studies systematically investigating how group songwrit-ing can affect patients on a detoxification unit. The purposes of this study were to measure the effects of a single group songwriting session on motivation and readiness for treatment and determine emerging themes from patient-composed songs with patients on a detoxification unit. Participants (N = 99) were randomized to experimental (posttest only) or wait-list control (pretest only) conditions to provide treatment to all participants in an inclusive single-session design. There were significant between-group differences in motivation and readiness for treatment, with experimental participants having higher means than control participants. Code categorizations from patients' composed song lyrics concerned "action," "emotions and feelings," "change," "reflection," "admission," and "responsibility." From the results of this study, it seems that a single group songwriting session can be an effective intervention concerning motivation and readiness for treatment in patients on a detoxification unit. Implications for clinical practice, suggestions for future research, and limitations are provided.

  18. Cognitive Processing Therapy for Veterans with Military-Related Posttraumatic Stress Disorder

    ERIC Educational Resources Information Center

    Monson, Candice M.; Schnurr, Paula P.; Resick, Patricia A.; Friedman, Matthew J.; Young-Xu, Yinong; Stevens, Susan P.

    2006-01-01

    Sixty veterans (54 men, 6 women) with chronic military-related posttraumatic stress disorder (PTSD) participated in a wait-list controlled trial of cognitive processing therapy (CPT). The overall dropout rate was 16.6% (20% from CPT, 13% from waiting list). Random regression analyses of the intention-to-treat sample revealed significant…

  19. Efficacy of a behavioral self-help treatment with or without therapist guidance for co-morbid and primary insomnia--a randomized controlled trial.

    PubMed

    Jernelöv, Susanna; Lekander, Mats; Blom, Kerstin; Rydh, Sara; Ljótsson, Brjánn; Axelsson, John; Kaldo, Viktor

    2012-01-22

    Cognitive behavioral therapy is treatment of choice for insomnia, but availability is scarce. Self-help can increase availability at low cost, but evidence for its efficacy is limited, especially for the typical insomnia patient with co-morbid problems. We hypothesized that a cognitive behaviorally based self-help book is effective to treat insomnia in individuals, also with co-morbid problems, and that the effect is enhanced by adding brief therapist telephone support. Volunteer sample; 133 media-recruited adults with insomnia. History of sleep difficulties (mean [SD]) 11.8 [12.0] years. 92.5% had co-morbid problems (e.g. allergy, pain, and depression). Parallel randomized (block-randomization, n ≥ 21) controlled "open label" trial; three groups-bibliotherapy with (n = 44) and without (n = 45) therapist support, and waiting list control (n = 44). Assessments before and after treatment, and at three-month follow-up. Intervention was six weeks of bibliotherapeutic self-help, with established cognitive behavioral methods including sleep restriction, stimulus control, and cognitive restructuring. Therapist support was a 15-minute structured telephone call scheduled weekly. Main outcome measures were sleep diary data, and the Insomnia Severity Index. Intention-to-treat analyses of 133 participants showed significant improvements in both self-help groups from pre to post treatment compared to waiting list. For example, treatment with and without support gave shorter sleep onset latency (improvement minutes [95% Confidence Interval], 35.4 [24.2 to 46.6], and 20.6 [10.6 to 30.6] respectively), and support gave a higher remission rate (defined as ISI score below 8; 61.4%), than bibliotherapy alone (24.4%, p's < .001). Improvements were not seen in the control group (sleep onset latency 4.6 minutes shorter [-1.5 to 10.7], and remission rate 2.3%). Self-help groups maintained gains at three-month follow-up. Participants receiving self-help for insomnia benefited markedly

  20. Aromatherapy massage affects menopausal symptoms in korean climacteric women: a pilot-controlled clinical trial.

    PubMed

    Hur, Myung-Haeng; Yang, Yun Seok; Lee, Myeong Soo

    2008-09-01

    This study investigated the effects of aromatherapy massage on menopausal symptoms in Korean climacteric women. Kupperman's menopausal index was used to compare an experimental group of 25 climacteric women with a wait-listed control group of 27 climacteric women. Aromatherapy was applied topically to subjects in the experimental group in the form of massage on the abdomen, back and arms using lavender, rose geranium, rose and jasmine in almond and primrose oils once a week for 8 weeks (eight times in total). The experimental group reported a significantly lower total menopausal index than wait-listed controls (P < 0.05). There were also significant intergroup differences in subcategories such as vasomotor, melancholia, arthralgia and myalgia (all P < 0.05). These findings suggest that aromatherapy massage may be an effective treatment of menopausal symptoms such as hot flushes, depression and pain in climacteric women. However, it could not be verified whether the positive effects were from the aromatherapy, the massage or both. Further rigorous studies should be done with more objective measures.

  1. Aromatherapy Massage Affects Menopausal Symptoms in Korean Climacteric Women: A Pilot-Controlled Clinical Trial

    PubMed Central

    Hur, Myung-Haeng; Yang, Yun Seok

    2008-01-01

    This study investigated the effects of aromatherapy massage on menopausal symptoms in Korean climacteric women. Kupperman's menopausal index was used to compare an experimental group of 25 climacteric women with a wait-listed control group of 27 climacteric women. Aromatherapy was applied topically to subjects in the experimental group in the form of massage on the abdomen, back and arms using lavender, rose geranium, rose and jasmine in almond and primrose oils once a week for 8 weeks (eight times in total). The experimental group reported a significantly lower total menopausal index than wait-listed controls (P < 0.05). There were also significant intergroup differences in subcategories such as vasomotor, melancholia, arthralgia and myalgia (all P < 0.05). These findings suggest that aromatherapy massage may be an effective treatment of menopausal symptoms such as hot flushes, depression and pain in climacteric women. However, it could not be verified whether the positive effects were from the aromatherapy, the massage or both. Further rigorous studies should be done with more objective measures. PMID:18830459

  2. Investigation of the effectiveness of the "Girls on the Go!" program for building self-esteem in young women: trial protocol.

    PubMed

    Tirlea, Loredana; Truby, Helen; Haines, Terry P

    2013-01-01

    Body Image is a major factor affecting health in a range of age groups, but has particular significance for adolescents. The aim of this research is to evaluate the efficacy of the "Girls on the Go!" program delivered outside of the school environment by health professionals to girls at risk of developing poor self-esteem on the outcomes of self-esteem, impairment induced by eating disorders, body satisfaction, self-efficacy, and dieting behaviour. A stepped wedge, cluster randomised controlled trial that was conducted in two phases on the basis of student population (Study 1 = secondary school age participants; Study 2 = primary school age participants). The waiting list for the "Girls on the Go!" program was used to generate the control periods. A total of 12 schools that requested the program were separated into study 1 or 2 on the basis of student population (Study 1 = secondary, Study 2 = primary). Schools were matched on the basis of number of students and were allocated to receiving the intervention immediately or having a waiting list period. Study 1 had one waiting list period of one school term, creating two steps in the stepped-wedge design (i.e. 3 schools were provided with "Girls on the Go!" each term over 2 terms). Study 2 had two waiting list periods of one and two school terms, creating three steps in the stepped-wedge design (i.e. 2 schools were provided with "Girls on the Go!" each term over 3 terms). Primary outcome measures were self-esteem and impairment inducted by eating disorders. There is a lack of preventative interventions currently available that address low self-esteem, low self-efficacy and body dissatisfaction in young women. This project will be the first group-based, professional-led, targeted program conducted outside the school environment amongst school age young women to be evaluated via a randomised control trial. These findings will indicate if the "Girls on the Go!" program may be successfully used and applied

  3. Efficacy of web-based cognitive-behavioural therapy for chronic fatigue syndrome: randomised controlled trial.

    PubMed

    Janse, A; Worm-Smeitink, M; Bleijenberg, G; Donders, R; Knoop, H

    2018-02-01

    Face-to-face cognitive-behavioural therapy (CBT) leads to a reduction of fatigue in chronic fatigue syndrome (CFS). Aims To test the efficacy of internet-based CBT (iCBT) for adults with CFS. A total of 240 patients with CFS were randomised to either iCBT with protocol-driven therapist feedback or with therapist feedback on demand, or a waiting list. Primary outcome was fatigue severity assessed with the Checklist Individual Strength (Netherlands Trial Register: NTR4013). Compared with a waiting list, intention-to-treat (ITT) analysis showed a significant reduction of fatigue for both iCBT conditions (protocol-driven feedback: B = -8.3, 97.5% CI -12.7 to -3.9, P < 0.0001; feedback on demand: B = -7.2, 97.5% CI -11.3 to -3.1, P < 0.0001). No significant differences were found between both iCBT conditions on all outcome measures (P = 0.3-0.9). An exploratory analysis revealed that feedback-on-demand iCBT required less therapist time (mean 4 h 37 min) than iCBT with protocol-driven feedback (mean 6 h 9 min, P < 0.001) and also less than face-to-face CBT as reported in the literature. Both iCBT conditions are efficacious and time efficient. Declaration of interest None.

  4. Effect of virtual reality exposure therapy on social participation in people with a psychotic disorder (VRETp): study protocol for a randomized controlled trial.

    PubMed

    Pot-Kolder, Roos; Veling, Wim; Geraets, Chris; van der Gaag, Mark

    2016-01-13

    Many patients with a psychotic disorder participate poorly in society. When psychotic disorders are in partial remission, feelings of paranoia, delusions of reference, social anxiety and self-stigmatization often remain at diminished severity and may lead to avoidance of places and people. Virtual reality exposure therapy (VRET) is an evidence-based treatment for several anxiety disorders. For patients with a psychotic disorder, the VRETp was developed to help them experience exposure to feared social situations. The present study aims to investigate the effects of VRETp on social participation in real life among patients with a psychotic disorder. The study is a single-blind randomized controlled trial with two conditions: the active condition, in which participants receive the virtual reality treatment together with treatment as usual (TAU), and the waiting list condition, in which participants receive TAU only. The two groups are compared at baseline, at 3 months posttreatment and at 6 months follow-up. All participants on the waiting list are also offered the virtual reality treatment after the follow-up measurements are completed. The primary outcome is social participation. Secondary outcomes are quality of life, interaction anxiety, depression and social functioning in general. Moderator and mediator analyses are conducted with stigma, cognitive schemata, cognitive biases, medication adherence, simulator sickness and presence in virtual reality. If effective, a cost-effectiveness analysis will be conducted. Results from the posttreatment measurement can be considered strong empirical indicators of the effectiveness of VRETp. The 6-month follow-up data may provide reliable documentation of the long-term effects of the treatment on the outcome variables. Data from pre-treatment and mid-treatment can be used to reveal possible pathways of change. Current Controlled Trials: ISRCTN12929657 . Date of registration: 8 September 2015.

  5. Informant-related effects of neurofeedback and cognitive training in children with ADHD including a waiting control phase: a randomized-controlled trial.

    PubMed

    Minder, Franziska; Zuberer, Agnieszka; Brandeis, Daniel; Drechsler, Renate

    2018-02-02

    There is controversy regarding the clinical efficacy of neurofeedback (NF) and computerized cognitive training (CogT) as treatments for ADHD. Meta-analyses claim that probably blinded teachers observe smaller effects than parents, because they are less biased. We investigated informant-specific effects by manipulating the involvement of informants, by controlling for waiting time effects, and by adding a blinded outcome measure. Seventy-seven children with ADHD were randomly allocated to slow cortical potential NF or to individualized CogT (of attention, working memory or inhibition). The training was conducted in schools (NF: n = 19, CogT: n = 19) or in outpatient clinics (NF: n = 19, CogT: n = 20). Three assessments were scheduled: baseline, followed by a waiting period, pre-training, and post-training. Multivariate Analyses of Variance were conducted to assess parent- and teacher-rated changes in ADHD symptoms and executive functions (EF), and changes according to standardized classroom observations. Both treatments resulted in significant improvements according to informants, with larger effects for parents (ADHD symptoms: parent η p 2  = .32; teacher η p 2  = .10), and according to observations (η p 2  = .19). The setting had no effect on outcome. Considerable waiting time effects were revealed for ADHD symptom ratings by both informants, for EF ratings only by teachers. Changed classroom behavior was uncorrelated with teacher-rated changes. Overall, the results do not support the notion that teachers are more objective while being as sensitive to change as parents. The three sources seem to contribute differential and mostly unrelated pieces of information to the evaluation of treatments.

  6. Common issues in the management of patients in the waiting list and after liver transplantation.

    PubMed

    Burra, Patrizia; Belli, Luca Saverio; Ginanni Corradini, Stefano; Volpes, Riccardo; Marzioni, Marco; Giannini, Edoardo; Toniutto, Pierluigi

    2017-03-01

    The present document contains the recommendations of an expert panel of transplant hepatologists, appointed by the Italian Association for the Study of the Liver (AISF), on how to manage the most common aspects of liver transplantation: the topics covered include: new treatments for HCV in patients on the waiting list for liver transplantation; antiviral treatments in patients with HCV recurrence after liver transplantation; prophylaxis for HBV recurrence after liver transplantation; indications for liver transplantation in alcoholic liver disease; and Immunosuppressive therapy. The statements on each topic were approved by participants at the AISF Transplant Hepatologist Expert Meeting (organized by the Permanent Committee on Liver Transplantation in Mondello on 4-5 October 2015), and are graded according to the Oxford classification of levels of evidence. Copyright © 2016 Editrice Gastroenterologica Italiana S.r.l. Published by Elsevier Ltd. All rights reserved.

  7. The PRCI study: design of a randomized clinical trial to evaluate a coping intervention for medical waiting periods used by women undergoing a fertility treatment.

    PubMed

    Ockhuijsen, Henrietta D L; van den Hoogen, Agnes; Macklon, Nickolas S; Boivin, Jacky

    2013-09-03

    Many medical situations necessitate a stressful period of waiting for potentially threatening test results. The medical waiting period is often associated with negative anticipatory anxiety and rumination about the outcome of treatment. Few evidence-based self-help coping interventions are available to assist individuals manage these periods. Theory and research suggest that positive reappraisal coping strategies may be particularly useful for this type of unpredictable and uncontrollable stressful context. The objective of this study is to investigate the effects of a Positive Reappraisal Coping Intervention (PRCI) on psychological well-being of women waiting for the outcome of their fertility treatment cycle. In a three-armed randomized controlled trial, the effectiveness of the PRCI will be tested. Consecutive patients undergoing in vitro fertilisation in a Dutch university hospital and meeting selection criteria will be invited to participate. Those who agree will be randomized to one of three experimental groups (N=372). The PRCI Intervention group will receive the intervention that comprises an explanatory leaflet and the 10 statements designed to promote positive reappraisal coping, to be read at least once in the morning, once in the evening. To capture the general impact of PRCI on psychological wellbeing patients will complete questionnaires before the waiting period (pre-intervention), on day ten of the 14-day waiting period (intervention) and six weeks after the start of the waiting period (post-intervention). To capture the specific effects of the PRCI during the waiting period, patients will also be asked to monitor daily their emotions and reactions during the 14-day waiting period. The primary outcome is general anxiety, measured by the Hospital Anxiety and Depression Scale. Secondary outcomes are positive and negative emotions during the waiting period, depression, quality of life, coping and treatment outcome. During recruitment for the RCT it was

  8. Hypertension Analysis of stress Reduction using Mindfulness meditatiON and Yoga (The HARMONY Study): study protocol of a randomised control trial

    PubMed Central

    How, Maxine; Dai, Monica; Baker, Brian; Irvine, Jane; Abbey, Susan; Abramson, Beth L; Myers, Martin; Perkins, Nancy; Tobe, Sheldon W

    2012-01-01

    Introduction Hypertension (HTN) is a leading risk factor for preventable cardiovascular disease, with over one in five adults affected worldwide. Lifestyle modification is a key strategy for the prevention and treatment of HTN. Stress has been associated with greater cardiovascular risk, and stress management is a recommended intervention for hypertensives. Stress reduction through relaxation therapies has been shown to have an effect on human physiology, including lowering blood pressure (BP). However, individualised behavioural interventions are resource intensive, and group stress management approaches have not been validated for reducing HTN. The HARMONY Study is a pilot randomised controlled trial designed to determine if mindfulness-based stress reduction (MBSR), a standardised group therapy, is an effective intervention for lowering BP in stage 1 unmedicated hypertensives. Methods and analysis Men and women unmedicated for HTN with mean daytime ambulatory blood pressure (ABP) ≥135/85 mm Hg or 24 h ABP ≥130/80 mm Hg are included in the study. Subjects are randomised to receive MBSR immediately or after a wait-list control period. The primary outcome measure is mean awake and 24 h ABP. The primary objective of the HARMONY Study is to compare ABP between the treatment and wait-list control arm at the 12-week primary assessment period. Results from this study will determine if MBSR is an effective intervention for lowering BP in early unmedicated hypertensives. Ethics and dissemination This research project was approved by the Sunnybrook Research Ethics Board and the University Health Network Research Ethics Board (Toronto, Canada). Planned analyses are in full compliance with the principles of the Declaration of Helsinki. Data collection will be completed by early spring 2012. Primary and secondary analysis will commence immediately after data monitoring is completed; dissemination plans include preparing publications for submission during the

  9. Effectiveness of a Web-based Intervention for Problem Drinkers and Reasons for Dropout: Randomized Controlled Trial

    PubMed Central

    de Haan, Hein A; ter Huurne, Elke D; Becker, Eni S; de Jong, Cor AJ

    2010-01-01

    Background Online self-help interventions for problem drinkers show promising results, but the effectiveness of online therapy with active involvement of a therapist via the Internet only has not been examined. Objective The objective of our study was to evaluate an e-therapy program with active therapeutic involvement for problem drinkers, with the hypotheses that e-therapy would (1) reduce weekly alcohol consumption, and (2) improve health status. Reasons for dropout were also systematically investigated. Method In an open randomized controlled trial, Dutch-speaking problem drinkers in the general population were randomly assigned (in blocks of 8, according to a computer-generated random list) to the 3-month e-therapy program (n = 78) or the waiting list control group (n = 78). The e-therapy program consisted of a structured 2-part online treatment program in which the participant and the therapist communicated asynchronously, via the Internet only. Participants in the waiting list control group received “no-reply” email messages once every 2 weeks. The primary outcome measures were (1) the difference in the score on weekly alcohol consumption, and (2) the proportion of participants drinking under the problem drinking limit. Intention-to-treat analyses were performed using multiple imputations to deal with loss to follow-up. A dropout questionnaire was sent to anyone who did not complete the 3-month assessment. Reasons for dropout were independently assessed by the first and third author. Results Of the 156 individuals who were randomly assigned, 102 (65%) completed assessment at 3 months. In the intention-to-treat analyses, the e-therapy group (n = 78) showed a significantly greater decrease in alcohol consumption than those in the control group (n = 78) at 3 months. The e-therapy group decreased their mean weekly alcohol consumption by 28.8 units compared with 3.1 units in the control group, a difference in means of 25.6 units on a weekly basis (95

  10. The psoas muscle transversal diameter predicts mortality in patients with cirrhosis on a waiting list for liver transplantation: A retrospective cohort study.

    PubMed

    Huguet, Audrey; Latournerie, Marianne; Debry, Pauline Houssel; Jezequel, Caroline; Legros, Ludivine; Rayar, Michel; Boudjema, Karim; Guyader, Dominique; Jacquet, Edouard Bardou; Thibault, Ronan

    2018-02-09

    Malnutrition impairs prognosis in liver cirrhosis. Our aims were to determine (1) if transversal (TPTI) and axial (APTI) psoas thickness indices predict mortality in cirrhotic patients and (2) the feasibility and reproducibility of transversal (TDPM) and axial (ADPM) diameters of the psoas muscle measurements. This was a retrospective study. Inclusion criteria included cirrhosis diagnosis, on liver transplantation waiting list, and abdominal computed tomography (CT) scan within the 3 mo preceding list inscription. TDPM and ADPM were measured on a single umbilicus-targeted CT image by non-expert and expert operators. TPTI or APTI (mm/m) were calculated as TDPM or ADPM/height (m). Area under the receiver operating characteristic curve (AUC) and Cox proportional hazard models were assessed. TPTI and APTI interobserver agreement: κ correlation test. A total of 173 patients were included. Low TPTI was associated with increased mortality: AUC = 0.66 (95% confidence interval, 0.51-0.80). TPTI was the only factor associated with mortality (hazard ratio = 0.87, 95% confidence interval 0.76-0.99, P = 0.034). There was an almost perfect interobserver agreement between the two operators: TDPM, κ = 0.97; ADPM, κ = 0.94; P <0.0001. TPTI measured on umbilicus-targeted CT scan before inscription on the waiting list for liver transplantation predicts mortality of cirrhotic patients. TPTI measurement is easy and reliable, even by a non-trained operator, and this is highly feasible in daily clinical practice. Copyright © 2018 Elsevier Inc. All rights reserved.

  11. Global lessons in graft type and pediatric liver allocation: A path toward improving outcomes and eliminating wait-list mortality.

    PubMed

    Hsu, Evelyn K; Mazariegos, George V

    2017-01-01

    Current literature and policy in pediatric liver allocation and organ procurement are reviewed here in narrative fashion, highlighting historical context, ethical framework, technical/procurement considerations, and support for a logical way forward to an equitable pediatric liver allocation system that will improve pediatric wait-list and posttransplant outcomes without adversely affecting adults. Where available, varying examples of successful international pediatric liver allocation and split-liver policy will be compared to current US policy to highlight potential strategies that can be considered globally. Liver Transplantation 23:86-95 2017 AASLD. © 2016 by the American Association for the Study of Liver Diseases.

  12. Return to work of workers without a permanent employment contract, sick-listed due to a common mental disorder: design of a randomised controlled trial.

    PubMed

    Lammerts, Lieke; Vermeulen, Sylvia J; Schaafsma, Frederieke G; van Mechelen, Willem; Anema, Johannes R

    2014-06-12

    Workers without a permanent employment contract represent a vulnerable group within the working population. Mental disorders are a major cause of sickness absence within this group. Common mental disorders are stress-related, depressive and anxiety disorders. To date, little attention has been paid to effective return to work interventions for this type of sick-listed workers. Therefore, a participatory supportive return to work program has been developed. It combines elements of a participatory return to work program, integrated care and direct placement in a competitive job.The objective of this paper is to describe the design of a randomised controlled trial to evaluate the cost-effectiveness of this program compared to care as usual. The cost-effectiveness of the participatory supportive return to work program will be examined in a randomised controlled trial with a follow-up of twelve months.The program strongly involves the sick-listed worker in the identification of obstacles for return to work and possible solutions, resulting in a consensus based action plan. This plan will be used as a starting point for the search of suitable competitive employment with support of a rehabilitation agency. During this process the insurance physician of the sick-listed worker contacts other caregivers to promote integrated care.Workers eligible to participate in this study have no permanent employment contract, have applied for a sickness benefit at the Dutch Social Security Agency and are sick-listed between two and fourteen weeks due to mental health problems.The primary outcome measure is the duration until first sustainable return to work in a competitive job. Outcomes are measured at baseline and after three, six, nine and twelve months. If the participatory supportive return to work program proves to be cost-effective, the social security system, the sick-listed worker and society as a whole will benefit. A cost-effective return to work program will lead to a

  13. Effects of a depression-focused internet intervention in slot machine gamblers: A randomized controlled trial.

    PubMed

    Bücker, Lara; Bierbrodt, Julia; Hand, Iver; Wittekind, Charlotte; Moritz, Steffen

    2018-01-01

    Problematic and pathological gambling have been linked to depression. Despite a high demand for treatment and negative financial consequences, only a small fraction of problematic and pathological gamblers seek professional help. The existing treatment gap could be narrowed by providing low-threshold, anonymous internet-based interventions. The aim of the present study was to examine the acceptance and efficacy of an online-intervention for depression ("Deprexis") in a sample of problematic and pathological slot-machine gamblers. We hypothesized that the intervention group would show a greater reduction in both depressive and gambling-related symptoms compared to a wait-list control group. A total of 140 individuals with self-reported gambling and mood problems were randomly allocated either to the intervention group or to a wait-list control group. After 8 weeks, all participants were invited for re-assessment. The Patient Health Questionnaire - 9 (PHQ-9) served as the primary outcome assessment. Problematic gambling was measured with the Pathological Gambling Adaptation of Yale-Brown Obsessive Compulsive Scale (PG-YBOCS) and the South Oaks Gambling Screen (SOGS). The trial is registered with the German Registry for Clinical Studies (DRKS00013888). ITT analyses showed that the intervention led to a significant reduction in depressive symptoms as well as gambling-related symptoms compared to the control group, with moderate to strong effect sizes. PP analyses failed to yield significant results due to high rates of non-completion and limited statistical power. Moderator analyses indicated that Deprexis was particularly beneficial in reducing problematic gambling for those scoring high on baseline gambling-related symptoms and for those who gamble due to loneliness. Results of the present study suggest that Deprexis might be a useful adjunct to traditional interventions for the treatment of problematic gambling. The potential of internet-based interventions that are

  14. Effectiveness of a web-based treatment program using intensive therapeutic support for female patients with bulimia nervosa, binge eating disorder and eating disorders not otherwise specified: study protocol of a randomized controlled trial

    PubMed Central

    2013-01-01

    Background Disordered eating behavior and body dissatisfaction affect a large proportion of the Dutch population and account for severe psychological, physical and social morbidity. Yet, the threshold for seeking professional care is still high. In the Netherlands, only 7.5% of patients with bulimia nervosa and 33% of patients with anorexia nervosa are treated within the mental health care system. Easily accessible and low-threshold interventions, therefore, are needed urgently. The internet has great potential to offer such interventions. The aim of this study is to determine whether a web-based treatment program for patients with eating disorders can improve eating disorder psychopathology among female patients with bulimia nervosa, binge eating disorder and eating disorders not otherwise specified. Methods/design This randomized controlled trial will compare the outcomes of an experimental treatment group to a waiting list control group. In the web-based treatment program, participants will communicate personally and asynchronously with their therapists exclusively via the internet. The first part of the program will focus on analyzing eating attitudes and behaviors. In the second part of the program participants will learn how to change their attitudes and behaviors. Participants assigned to the waiting list control group will receive no-reply email messages once every two weeks during the waiting period of 15 weeks, after which they can start the program. The primary outcome measure is an improvement in eating disorder psychopathology as determined by the Eating Disorder Examination Questionnaire. Secondary outcomes include improvements in body image, physical and mental health, body weight, self-esteem, quality of life, and social contacts. In addition, the participants’ motivation for treatment and their acceptability of the program and the therapeutic alliance will be measured. The study will follow the recommendations in the CONSORT statement relating

  15. Hockey Fans in Training: A Pilot Pragmatic Randomized Controlled Trial.

    PubMed

    Petrella, Robert J; Gill, Dawn P; Zou, Guangyong; DE Cruz, Ashleigh; Riggin, Brendan; Bartol, Cassandra; Danylchuk, Karen; Hunt, Kate; Wyke, Sally; Gray, Cindy M; Bunn, Christopher; Zwarenstein, Merrick

    2017-12-01

    Hockey Fans in Training (Hockey FIT) is a gender-sensitized weight loss and healthy lifestyle program. We investigated 1) feasibility of recruiting and retaining overweight and obese men into a pilot pragmatic randomized controlled trial and 2) potential for Hockey FIT to lead to weight loss and improvements in other outcomes at 12 wk and 12 months. Male fans of two ice hockey teams (35-65 yr; body mass index ≥28 kg·m) located in Ontario (Canada) were randomized to intervention (Hockey FIT) or comparator (wait-list control). Hockey FIT includes a 12-wk active phase (weekly, coach-led group meetings including provision of dietary information, practice of behavior change techniques, and safe exercise sessions plus incremental pedometer walking) and a 40-wk minimally supported phase (smartphone app for sustaining physical activity, private online social network, standardized e-mails, booster session/reunion). Measurement at baseline and 12 wk (both groups) and 12 months (intervention group only) included clinical outcomes (e.g., weight) and self-reported physical activity, diet, and self-rated health. Eighty men were recruited in 4 wk; trial retention was >80% at 12 wk and >75% at 12 months. At 12 wk, the intervention group lost 3.6 kg (95% confidence interval, -5.26 to -1.90 kg) more than the comparator group (P < 0.001) and maintained this weight loss to 12 months. The intervention group also demonstrated greater improvements in other clinical measures, physical activity, diet, and self-rated health at 12 wk; most sustained to 12 months. Results suggest feasible recruitment/retention of overweight and obese men in the Hockey FIT program. Results provide evidence for the potential effectiveness of Hockey FIT for weight loss and improved health in at-risk men and, thus, evidence to proceed with a definitive trial.

  16. Hockey Fans in Training: A Pilot Pragmatic Randomized Controlled Trial

    PubMed Central

    PETRELLA, ROBERT J.; GILL, DAWN P.; ZOU, GUANGYONG; DE CRUZ, ASHLEIGH; RIGGIN, BRENDAN; BARTOL, CASSANDRA; DANYLCHUK, KAREN; HUNT, KATE; WYKE, SALLY; GRAY, CINDY M.; BUNN, CHRISTOPHER; ZWARENSTEIN, MERRICK

    2017-01-01

    ABSTRACT Introduction Hockey Fans in Training (Hockey FIT) is a gender-sensitized weight loss and healthy lifestyle program. We investigated 1) feasibility of recruiting and retaining overweight and obese men into a pilot pragmatic randomized controlled trial and 2) potential for Hockey FIT to lead to weight loss and improvements in other outcomes at 12 wk and 12 months. Methods Male fans of two ice hockey teams (35–65 yr; body mass index ≥28 kg·m−2) located in Ontario (Canada) were randomized to intervention (Hockey FIT) or comparator (wait-list control). Hockey FIT includes a 12-wk active phase (weekly, coach-led group meetings including provision of dietary information, practice of behavior change techniques, and safe exercise sessions plus incremental pedometer walking) and a 40-wk minimally supported phase (smartphone app for sustaining physical activity, private online social network, standardized e-mails, booster session/reunion). Measurement at baseline and 12 wk (both groups) and 12 months (intervention group only) included clinical outcomes (e.g., weight) and self-reported physical activity, diet, and self-rated health. Results Eighty men were recruited in 4 wk; trial retention was >80% at 12 wk and >75% at 12 months. At 12 wk, the intervention group lost 3.6 kg (95% confidence interval, −5.26 to −1.90 kg) more than the comparator group (P < 0.001) and maintained this weight loss to 12 months. The intervention group also demonstrated greater improvements in other clinical measures, physical activity, diet, and self-rated health at 12 wk; most sustained to 12 months. Conclusions Results suggest feasible recruitment/retention of overweight and obese men in the Hockey FIT program. Results provide evidence for the potential effectiveness of Hockey FIT for weight loss and improved health in at-risk men and, thus, evidence to proceed with a definitive trial. PMID:28719494

  17. An Internet-based self-help treatment for fear of public speaking: a controlled trial.

    PubMed

    Botella, C; Gallego, M J; Garcia-Palacios, A; Guillen, V; Baños, R M; Quero, S; Alcañiz, M

    2010-08-01

    This study offers data about the efficacy of "Talk to Me," an Internet-based telepsychology program for the treatment of fear of public speaking that includes the most active components in cognitive-behavior therapy (CBT) for social phobia (exposure and cognitive therapies). One hundred twenty-seven participants with social phobia were randomly assigned to three experimental conditions: (a) an Internet-based self-administered program; (b) the same program applied by a therapist; (c) a waiting-list control group. Results showed that both treatment conditions were equally efficacious. In addition, Talk to Me and the same treatment applied by a therapist were more efficacious than the waiting-list condition. Treatment gains were maintained at 1-year follow-up. The results from this study support the utility of Internet-delivered CBT programs in order to reach a higher number of people who could benefit from CBT. Internet-delivered CBT programs could also play a valuable role in the dissemination of CBT.

  18. Waiting time for cataract surgery and its influence on patient attitudes.

    PubMed

    Chan, Frank Wan-kin; Fan, Alex Hoi; Wong, Fiona Yan-yan; Lam, Philip Tsze-ho; Yeoh, Eng-kiong; Yam, Carrie Ho-kwan; Griffiths, Sian; Lam, Dennis Shun-chiu; Congdon, Nathan

    2009-08-01

    To characterize willingness to pay for private operations and preferred waiting time among patients awaiting cataract surgery in Hong Kong. This was a cross-sectional survey. Subjects randomly selected from cataract surgical waiting lists in Hong Kong (n = 467) underwent a telephone interview based on a structured, validated questionnaire. Data were collected on private insurance coverage, preferred waiting time, amount willing to pay for surgery, and self-reported visual function and health status. Among 300 subjects completing the interview, 144 (48.2%) were 76 years of age or older, 177 (59%) were women, and mean time waiting for surgery was 17 +/- 15 months. Among 220 subjects (73.3%) willing to pay anything for surgery, the mean amount was US$552 +/- 443. With adjustment for age, education, and monthly household income, subjects willing to pay anything were less willing to wait 12 months for surgery (OR = 4.34; P = 0.002), more likely to know someone having had cataract surgery (OR = 2.20; P = 0.03), and more likely to use their own savings to pay for the surgery (OR = 2.21; P = 0.04). Subjects considering private cataract surgery, knowing people who have had cataract surgery, using nongovernment sources to pay for surgery, and having lower visual function were willing to pay more. Many patients wait significant periods for cataract surgery in Hong Kong, and are willing to pay substantial amounts for private operations. These results may have implications for other countries with cataract waiting lists.

  19. Implementation of treat-to-target in rheumatoid arthritis through a Learning Collaborative: Rationale and design of the TRACTION trial.

    PubMed

    Solomon, Daniel H; Lee, Sara B; Zak, Agnes; Corrigan, Cassandra; Agosti, Jenifer; Bitton, Asaf; Harrold, Leslie; Losina, Elena; Lu, Bing; Pincus, Ted; Radner, Helga; Smolen, Josef; Katz, Jeffrey N; Fraenkel, Liana

    2016-08-01

    Treat-to-target (TTT) is a recommended strategy in the management of rheumatoid arthritis (RA), but various data sources suggest that its uptake in routine care in the US is suboptimal. Herein, we describe the design of a randomized controlled trial of a Learning Collaborative to facilitate implementation of TTT. We recruited 11 rheumatology sites from across the US and randomized them into the following two groups: one received the Learning Collaborative intervention in Phase 1 (month 1-9) and the second formed a wait-list control group to receive the intervention in Phase 2 (months 10-18). The Learning Collaborative intervention was designed using the Model for Improvement, consisting of a Change Package with corresponding principles and action phases. Phase 1 intervention practices had nine learning sessions, collaborated using a web-based tool, and shared results of plan-do-study-act cycles and monthly improvement metrics collected at each practice. The wait-list control group sites had no intervention during Phase 1. The primary trial outcome is the implementation of TTT as measured by chart review, comparing the differences from baseline to end of Phase 1, between intervention and control sites. All intervention sites remained engaged in the Learning Collaborative throughout Phase 1, with a total of 38 providers participating. The primary trial outcome measures are currently being collected by the study team through medical record review. If the Learning Collaborative is an effective means for improving implementation of TTT, this strategy could serve as a way of implementing disseminating TTT more widely. Copyright © 2016 Elsevier Inc. All rights reserved.

  20. [Dealing with Waiting Times in Health Systems - An International Comparative Overview].

    PubMed

    Finkenstädt, V

    2015-10-01

    Waiting times in the health system are a form of rationing that exists in many countries. Previous studies on this topic are mainly related to the problem of international comparability of waiting times or on the presentation of national strategies as to how they should be reduced. This review adds to this analysis and examines how the OECD countries deal with waiting times in the health-care system and investigates which information is published about waiting for what purpose. Furthermore, waiting times and the type of health system financing are compared. A systematic internet research on waiting times in the health-care system was conducted on the websites of the competent authorities (Ministry of Health or other authorities and institutions). The identified publications were then examined for the purpose of their deployment. Finally, the OECD Health Data were analysed to determine the relationship between tax and contribution financing of public health care expenditure. The primary form of financing was compared with the results of the waiting time analysis. 16 OECD countries are identified which officially collect and publish administrative data on waiting times on the Internet. The data are processed differently depending on the country. By providing this information, two main objectives are pursued: a public monitoring of waiting times in the health system (14 countries) and information for patients on waiting times (9 countries). Official statistics on waiting times exist mainly in countries with tax-financed health systems, whereas this is not the case in the majority of OECD countries with health systems that are funded through contributions. The publication of administrative waiting times data is primarily intended to inform the patient and as a performance indicator in terms of access to health care. Even if data on waiting times are published, the publication of indicators and the management of waiting lists alone will not solve the problem. Rather

  1. Efficacy of a Reading and Language Intervention for Children with Down Syndrome: A Randomized Controlled Trial

    ERIC Educational Resources Information Center

    Burgoyne, Kelly; Duff, Fiona J.; Clarke, Paula J.; Buckley, Sue; Snowling, Margaret J.; Hulme, Charles

    2012-01-01

    Background: This study evaluates the effects of a language and literacy intervention for children with Down syndrome. Methods: Teaching assistants (TAs) were trained to deliver a reading and language intervention to children in individual daily 40-min sessions. We used a waiting list control design, in which half the sample received the…

  2. How effective are cognitive behavior therapies for major depression and anxiety disorders? A meta‐analytic update of the evidence

    PubMed Central

    Cuijpers, Pim; Cristea, Ioana A.; Karyotaki, Eirini; Reijnders, Mirjam; Huibers, Marcus J.H.

    2016-01-01

    We report the current best estimate of the effects of cognitive behavior therapy (CBT) in the treatment of major depression (MDD), generalized anxiety disorder (GAD), panic disorder (PAD) and social anxiety disorder (SAD), taking into account publication bias, the quality of trials, and the influence of waiting list control groups on the outcomes. In our meta‐analyses, we included randomized trials comparing CBT with a control condition (waiting list, care‐as‐usual or pill placebo) in the acute treatment of MDD, GAD, PAD or SAD, diagnosed on the basis of a structured interview. We found that the overall effects in the 144 included trials (184 comparisons) for all four disorders were large, ranging from g=0.75 for MDD to g=0.80 for GAD, g=0.81 for PAD, and g=0.88 for SAD. Publication bias mostly affected the outcomes of CBT in GAD (adjusted g=0.59) and MDD (adjusted g=0.65), but not those in PAD and SAD. Only 17.4% of the included trials were considered to be high‐quality, and this mostly affected the outcomes for PAD (g=0.61) and SAD (g=0.76). More than 80% of trials in anxiety disorders used waiting list control groups, and the few studies using other control groups pointed at much smaller effect sizes for CBT. We conclude that CBT is probably effective in the treatment of MDD, GAD, PAD and SAD; that the effects are large when the control condition is waiting list, but small to moderate when it is care‐as‐usual or pill placebo; and that, because of the small number of high‐quality trials, these effects are still uncertain and should be considered with caution. PMID:27717254

  3. Dual sensory loss: development of a dual sensory loss protocol and design of a randomized controlled trial

    PubMed Central

    2013-01-01

    Background Dual sensory loss (DSL) has a negative impact on health and wellbeing and its prevalence is expected to increase due to demographic aging. However, specialized care or rehabilitation programs for DSL are scarce. Until now, low vision rehabilitation does not sufficiently target concurrent impairments in vision and hearing. This study aims to 1) develop a DSL protocol (for occupational therapists working in low vision rehabilitation) which focuses on optimal use of the senses and teaches DSL patients and their communication partners to use effective communication strategies, and 2) describe the multicenter parallel randomized controlled trial (RCT) designed to test the effectiveness and cost-effectiveness of the DSL protocol. Methods/design To develop a DSL protocol, literature was reviewed and content was discussed with professionals in eye/ear care (interviews/focus groups) and DSL patients (interviews). A pilot study was conducted to test and confirm the DSL protocol. In addition, a two-armed international multi-center RCT will evaluate the effectiveness and cost-effectiveness of the DSL protocol compared to waiting list controls, in 124 patients in low vision rehabilitation centers in the Netherlands and Belgium. Discussion This study provides a treatment protocol for rehabilitation of DSL within low vision rehabilitation, which aims to be a valuable addition to the general low vision rehabilitation care. Trial registration Netherlands Trial Register (NTR) identifier: NTR2843 PMID:23941667

  4. Exposure therapy changes dysfunctional evaluations of somatic symptoms in patients with hypochondriasis (health anxiety). A randomized controlled trial.

    PubMed

    Weck, Florian; Neng, Julia M B; Schwind, Julia; Höfling, Volkmar

    2015-08-01

    Dysfunctional evaluations of somatic symptoms are considered a central factor in maintaining hypochondriasis. The aim of the current study was to investigate whether exposure therapy (ET) without cognitive restructuring is sufficient to change dysfunctional evaluations of somatic symptoms. The current study was based on a randomized controlled trial and compared patients with hypochondriasis (N=73) receiving ET or cognitive therapy (CT) to a wait list (WL) control group. In both the ET and CT groups, dysfunctional symptom evaluations changed significantly compared with the WL group. No differences between the ET and CT groups emerged. The relationship between the treatment condition (active treatment vs. WL) and reductions in health anxiety was mediated by changes in somatic symptom evaluations only in a specific card sorting procedure. We conclude that addressing dysfunctional symptom evaluations is a necessary precondition for the effective treatment of hypochondriasis. However, the results indicate that ET and CT appear to change those processes to a similar degree. Copyright © 2015 Elsevier Ltd. All rights reserved.

  5. A Randomized, Controlled Trial of Wholistic Hybrid Derived From Eye Movement Desensitization and Reprocessing and Emotional Freedom Technique (WHEE) for Self-Treatment of Pain, Depression, and Anxiety in Chronic Pain Patients

    PubMed Central

    Benor, Daniel; Rossiter-Thornton, John; Toussaint, Loren

    2016-01-01

    In this pilot study, a convenience sample of 24 chronic pain patients (17 with chronic fatigue syndrome/fibromyalgia) were randomized into WHEE treatment and wait-list control groups for 6 weeks. Assessments of depression, anxiety, and pain were completed before, during, and at 1 and 3 months after treatment. Wait-listed patients then received an identical course of WHEE and assessments. WHEE decreased anxiety (P < .5) and depression (P < .05) compared with the control group. The wait-list-turned-WHEE assessments demonstrated decreased pain severity (P < .05) and depression (P < .04) but not pain interference or anxiety. WHEE appears a promising method for pain, anxiety, and depression in patients with chronic pain, compared to standard medical care alone. Though a small pilot study, the present results suggest that further research appears warranted. An incidental finding was that a majority of patients with chronic pain had suffered psychological trauma in childhood and/or adulthood. PMID:27432773

  6. Why do some diabetic patients on the kidney transplant waiting list not receive a transplant?

    PubMed

    Kyllönen, Lauri; Salmela, Kaija

    2004-10-01

    The waiting list (WL) history of 405 diabetic patients placed on the kidney transplantation WL for the years 1993-2000 was examined. By 31 December 2000, 295 (73 %) patients had received a transplant. Of the remaining 110 patients 53 (13 %) were still on the WL; 27 of these were temporarily withdrawn, i.e. non-active, 46 others (11 %) had died and 11 (3 %) had been permanently removed. Patient follow-up continued until the end of 2002. Although the mean total time on the WL of the non-transplanted was twice that of the transplanted patients there were no significant differences in the mean active times on the WL. The mean cumulative withdrawal time of the transplanted and those on the active WL was less than 10 % of their total time on the list, but for the patients who had died or were withdrawn on 31 December 2000 it exceeded 50 %, usually because of diabetic complications. The 5-year survival of the transplanted patients was greatly superior to that of the non-transplanted, as expected. However, the better survival of the transplanted patients is not necessarily proof of a better treatment modality but rather a consequence of the exclusion from transplantation of patients suffering from diabetic complications. It is not justified to compare the survival of transplantable and non-transplantable WL patients.

  7. Efficacy of Mobile Serious Games in Increasing HIV Risk Perception in Swaziland: A Randomized Control Trial (SGprev Trial) Research Protocol

    PubMed Central

    Musumari, Patou; El-Saaidi, Christina; Techasrivichien, Teeranee; Suguimoto, S. Pilar; Ono Kihara, Masako; Kihara, Masahiro

    2016-01-01

    Background The human immunodeficiency virus (HIV) and acquired immune deficiency syndrome (AIDS) continue to be a major public health problem in Sub-Saharan Africa (SSA), particularly in Swaziland, which has the highest HIV prevalence in this region. A wide range of strategies and interventions have been used to promote behavior change, though almost all such interventions have involved mass media. Therefore, innovative behavior change strategies beyond mass media communication are urgently needed. Serious games have demonstrated effectiveness in advancing health in the developed world; however, no rigorous serious games interventions have been implemented in HIV prevention in SSA. Objective We plan to test whether a serious game intervention delivered on mobile phones to increase HIV risk perception, increase intention to reduce sexual partnerships, and increase intention to know own and partners HIV status will be more effective compared with current prevention efforts. Methods This is a two-arm randomized intervention trial. We will recruit 380 participants who meet the following eligibility criteria: 18-29 years of age, own a smartphone running an Android-based operating system, have the WhatsApp messaging app, live in Swaziland, and can adequately grant informed consent. Participants will be allocated into a smartphone interactive, educational story game, and a wait-list control group in a 1:1 allocation ratio. Subsequently, a self-administered Web-based questionnaire will be issued at baseline and after 4 weeks of exposure to the game. We hypothesize that the change in HIV risk perception between pre- and post-intervention assessment is greater in the intervention group compared with the change in the control group. Our primary hypothesis is based on the assumption that increased perceived risk of HIV provides cues to engage in protective behavior. Our primary outcome measure is HIV risk perceived mean change between pre- and post-intervention compared with

  8. 'PhysioDirect' telephone assessment and advice services for physiotherapy: protocol for a pragmatic randomised controlled trial

    PubMed Central

    Salisbury, Chris; Foster, Nadine E; Bishop, Annette; Calnan, Michael; Coast, Jo; Hall, Jeanette; Hay, Elaine; Hollinghurst, Sandra; Hopper, Cherida; Grove, Sean; Kaur, Surinder; Montgomery, Alan

    2009-01-01

    Background Providing timely access to physiotherapy has long been a problem for the National Health Service in the United Kingdom. In an attempt to improve access some physiotherapy services have introduced a new treatment pathway known as PhysioDirect. Physiotherapists offer initial assessment and advice by telephone, supported by computerised algorithms, and patients are sent written self-management and exercise advice by post. They are invited for face-to-face treatment only when necessary. Although several such services have been developed, there is no robust evidence regarding clinical and cost-effectiveness, nor the acceptability of PhysioDirect. Methods/Design This protocol describes a multi-centre pragmatic individually randomised trial, with nested qualitative research. The aim is to determine the effectiveness, cost-effectiveness, and acceptability of PhysioDirect compared with usual models of physiotherapy based on patients going onto a waiting list and receiving face-to-face care. PhysioDirect services will be established in four areas in England. Adult patients in these areas with musculoskeletal problems who refer themselves or are referred by a primary care practitioner for physiotherapy will be invited to participate in the trial. About 1875 consenting patients will be randomised in a 2:1 ratio to PhysioDirect or usual care. Data about outcome measures will be collected at baseline and 6 weeks and 6 months after randomisation. The primary outcome is clinical improvement at 6 months; secondary outcomes include cost, waiting times, time lost from work and usual activities, patient satisfaction and preference. The impact of PhysioDirect on patients in different age-groups and with different conditions will also be examined. Incremental cost-effectiveness will be assessed in terms of quality adjusted life years in relation to cost. Qualitative methods will be used to explore factors associated with the success or failure of the service, the

  9. Internet-delivered treatment: its potential as a low-intensity community intervention for adults with symptoms of depression: protocol for a randomized controlled trial

    PubMed Central

    2014-01-01

    Background Depression is a high prevalence disorder, displaying high rates of lifetime incidence, early age onset, high chronicity, and role impairment. In Ireland 12-month prevalence of depression has been reported to be 10.3%. A large percentage of affected individuals have no medical diagnosis nor seek treatment. Cognitive Behavior Therapy (CBT) has established itself as an option for the treatment of depression. Many Irish adults with depression find it difficult to access evidence-based CBT, this is due to several factors, like stigma and costs. However, systematic factors including the shortage of trained professionals and the relative underdevelopment of services also make access difficult. Stepped-care can increase access to evidence-based CBT. One option is tailored internet-delivered treatment programs. Preliminary research from Ireland needs now to include large-scale studies on effectiveness. Thus the current study seeks to examine the potential of an internet-delivered low-intensity treatment for symptoms of depression in an Irish adult community sample. Method/Design The study is a randomized controlled trial of an online CBT (iCBT) program for the treatment of adults with depressive symptoms. The trial will include an active treatment group and a waiting-list control group. The active condition will consist of 8 weekly modules of iCBT, with post-session feedback support. Participants in the waiting list will receive access to the treatment at week 8. Participants will complete the Beck Depression Inventory (BDI-II) and eligibility criteria will also apply. Primary outcomes are depressive symptoms. Secondary outcomes include quality of life indicators, significant events and satisfaction with online treatment. Data will be collected at baseline and at post-treatment, week 8, and at follow-up week 20 (3-months) and week 32 (6-months). Analysis will be conducted on the intention-to-treat basis. Discussion The study seeks to evaluate the effectiveness of

  10. Chronic pain self-management support with pain science education and exercise (COMMENCE): study protocol for a randomized controlled trial.

    PubMed

    Miller, Jordan; MacDermid, Joy C; Walton, David M; Richardson, Julie

    2015-10-14

    Previous research suggests that self-management programs for people with chronic pain improve knowledge and self-efficacy but result in negligible effects on function. This study will investigate the effectiveness self-management support with pain science education and exercise on improving function for people with chronic pain in comparison to a wait-list control. A secondary objective is to determine which variables help to predict response to the intervention. This study will be an unblinded, randomized controlled trial with 110 participants comparing a 6-week program that includes self-management support, pain science education and exercise to a wait-list control. The primary outcome will be function measured by the Short Musculoskeletal Function Assessment - Dysfunction Index. Secondary outcomes will include pain intensity measured by a numeric pain rating scale, pain interference measured by the eight-item PROMIS pain interference item-bank, how much patients are bothered by functional problems measured by the Short Musculoskeletal Function Assessment - Bother Index, catastrophic thinking measured by the Pain Catastrophizing Scale, fear of movement/re-injury measured by the 11-item Tampa Scale of Kinesiophobia, sense of perceived injustice measured by the Injustice Experience Questionnaire, self-efficacy measured by the Pain Self-Efficacy Questionnaire, pain sensitivity measured by pressure pain threshold and cold sensitivity testing, fatigue measured by a numeric fatigue rating scale, pain neurophysiology knowledge measured by the Neurophysiology of Pain Questionnaire, healthcare utilization measured by number of visits to a healthcare provider, and work status. Assessments will be completed at baseline, 7 and 18 weeks. After the 18-week assessment, the groups will crossover; however, we anticipate carry-over effects with the treatment. Therefore, data from after the crossover will be used to estimate within-group changes and to determine predictors of

  11. Efficacy of cognitive behavioral internet-based therapy in parents after the loss of a child during pregnancy: pilot data from a randomized controlled trial.

    PubMed

    Kersting, Anette; Kroker, Kristin; Schlicht, Sarah; Baust, Katja; Wagner, Birgit

    2011-12-01

    The loss of a child during pregnancy can be a traumatic event associated with long-lasting grief and psychological distress. This study examined the efficacy of an internet-based cognitive behavioral therapy program for mothers after pregnancy loss. In a randomized controlled trial with a waiting list control group, 83 participants who had lost a child during pregnancy were randomly allocated either to 5 weeks of internet therapy or to a 5-week waiting condition. Within a manualized cognitive behavioral treatment program, participants wrote ten essays on loss-specific topics. Posttraumatic stress, grief, and general psychopathology, especially depression, were assessed pretreatment, posttreatment, and at 3-month follow-up. Intention-to-treat analyses and completer analyses were performed. Relative to controls, participants in the treatment group showed significant improvements in posttraumatic stress, grief, depression, and overall mental health, but not in anxiety or somatization. Medium to large effect sizes were observed, and the improvement was maintained at 3-month follow-up. This internet-based cognitive behavioral therapy program represents an effective treatment approach with stable effects for women after pregnancy loss. Implementation of the program can thus help to improve the health care provision for mothers in this traumatic loss situation.

  12. BRACAVENIR - impact of a psychoeducational intervention on expectations and coping in young women (aged 18-30 years) exposed to a high familial breast/ovarian cancer risk: study protocol for a randomized controlled trial.

    PubMed

    Kwiatkowski, Fabrice; Dessenne, Pascal; Laquet, Claire; Daures, Jean-Pierre; Gay-Bellile, Mathilde; Bignon, Yves-Jean

    2016-10-21

    Young women exposed to a high hereditary breast and ovarian cancer (HBOC) risk are particularly vulnerable. They are ignored by health prevention measures but exposed to a stream of contradictory information (medicine, media, Internet). They may feel concerned about surgical prevention issues at a key moment of their identity construction (self, relationship, sexuality). We designed a special psychoeducational intervention to help these women cope better with these difficulties. The BRACAVENIR study consists of a prospective, randomized superiority phase II trial with a wait list control group. Participants are childless young female counselees (aged 18-30 years) seen at the oncogenetics department of the Centre Jean Perrin and belonging to HBOC families either with or without BRCA mutations. They will be invited to attend a weekend group session at a spa resort and to participate in short expert conferences and focus group activities (group sharing, Moreno role game) supervised by a psychotherapist. Two sessions separated by a 6-month delay (wait list) will enable us to evaluate the intervention's effect by comparing questionnaire scores between the 6-month time points. The main endpoint is an increase of the Herth Hope Index by at least 1 SD. Secondary endpoints are self-esteem, anxiety trait, anxiety state, coping, and quality of life. With a one-sided α = 0.05 and β = 0.20, 12 participants will be needed by group, plus an additional 2 in anticipation of dropouts. Participants will be randomized 1:1 to the first or the second session so that the groups will be comparable. The intent of this trial is to bridge the gap on a psychosocial level in these young women with HBOC. A particularity of the design is the use of a waiting list, which should allow for avoiding major bias. The intervention consists of a short session that could be proposed to other young counselees if successful. The results may bring complementary information to facilitate the

  13. Transplantation of A2 and A2B kidneys from deceased donors into B waiting list candidates increases their transplantation rate.

    PubMed

    Bryan, Christopher F; Nelson, Paul W; Shield, Charles F; Ross, Gilbert; Warady, Bradley; Murillo, Daniel; Winklhofer, Franz T

    2004-01-01

    Transplant centers in the Midwest Transplant Network began transplanting kidneys from A2 or A2B donors into blood group B and O patients in 1986. Since 1991, an OPTN/UNOS variance has permitted us to allocate these kidneys preferentially into B and O waiting list patients. With more than 10 years of experience we have noted the following: 1. Thirty-one percent more blood group B patients were transplanted by allocating them A2 or A2B kidneys from our deceased donors. 2. Ten-year graft survival for B recipients of an A2 or A2B kidney (72%) was equivalent to that for B recipients of a B kidney (69%). 3. Type B recipients of simultaneous pancreas-kidney transplants (n=4) also did well with A2 or A2B organs. 4. Non-A recipients were transplanted only when their anti-A IgG titer history was consistently low (< or =4). 5. Most (90%) blood group B patients had a low anti-A IgG titer history; whereas, only one-third of blood group O patients had a low titer history. 6. Neither ethnicity nor HLA class I sensitization level influenced the anti-A IgG titer history. 7. In an OPO with mostly (87%) white donors, nearly 20% of blood group A donors were A2. 8. Waiting time until transplantation was lower for B patients who received an A2 or A2B kidney than for those who received a B or O kidney. 9. Our OPO blood group B waiting list was reduced from 25 low PRA (<40%) B candidates in 1994 to 4 in July, 2004. 10. Blood group A candidates received 6.4% fewer transplants with our A2/A2B--> B allocation algorithm. 11. Minority patients were transplanted at the same rate when using the A2/A2B--> B allocation algorithm as when using the standard UNOS algorithm for allocating B and O kidneys--> B patients.

  14. Enhancing outpatient clinics management software by reducing patients' waiting time.

    PubMed

    Almomani, Iman; AlSarheed, Ahlam

    The Kingdom of Saudi Arabia (KSA) gives great attention to improving the quality of services provided by health care sectors including outpatient clinics. One of the main drawbacks in outpatient clinics is long waiting time for patients-which affects the level of patient satisfaction and the quality of services. This article addresses this problem by studying the Outpatient Management Software (OMS) and proposing solutions to reduce waiting times. Many hospitals around the world apply solutions to overcome the problem of long waiting times in outpatient clinics such as hospitals in the USA, China, Sri Lanka, and Taiwan. These clinics have succeeded in reducing wait times by 15%, 78%, 60% and 50%, respectively. Such solutions depend mainly on adding more human resources or changing some business or management policies. The solutions presented in this article reduce waiting times by enhancing the software used to manage outpatient clinics services. Both quantitative and qualitative methods have been used to understand current OMS and examine level of patient's satisfaction. Five main problems that may cause high or unmeasured waiting time have been identified: appointment type, ticket numbering, doctor late arrival, early arriving patient and patients' distribution list. These problems have been mapped to the corresponding OMS components. Solutions to the above problems have been introduced and evaluated analytically or by simulation experiments. Evaluation of the results shows a reduction in patient waiting time. When late doctor arrival issues are solved, this can reduce the clinic service time by up to 20%. However, solutions for early arriving patients reduces 53.3% of vital time, 20% of the clinic time and overall 30.3% of the total waiting time. Finally, well patient-distribution lists make improvements by 54.2%. Improvements introduced to the patients' waiting time will consequently affect patients' satisfaction and improve the quality of health care services

  15. Developing a placebo-controlled trial in surgery: Issues of design, acceptability and feasibility

    PubMed Central

    2011-01-01

    Background Surgical placebos are controversial. This in-depth study explored the design, acceptability, and feasibility issues relevant to designing a surgical placebo-controlled trial for the evaluation of the clinical and cost effectiveness of arthroscopic lavage for the management of people with osteoarthritis of the knee in the UK. Methods Two surgeon focus groups at a UK national meeting for orthopaedic surgeons and one regional surgeon focus group (41 surgeons); plenary discussion at a UK national meeting for orthopaedic anaesthetists (130 anaesthetists); three focus groups with anaesthetists (one national, two regional; 58 anaesthetists); two focus groups with members of the patient organisation Arthritis Care (7 participants); telephone interviews with people on consultant waiting lists from two UK regional centres (15 participants); interviews with Chairs of UK ethics committees (6 individuals); postal surveys of members of the British Association of Surgeons of the Knee (382 surgeons) and members of the British Society of Orthopaedic Anaesthetists (398 anaesthetists); two centre pilot (49 patients assessed). Results There was widespread acceptance that evaluation of arthroscopic lavage had to be conducted with a placebo control if scientific rigour was not to be compromised. The choice of placebo surgical procedure (three small incisions) proved easier than the method of anaesthesia (general anaesthesia). General anaesthesia, while an excellent mimic, was more intrusive and raised concerns among some stakeholders and caused extensive discussion with local decision-makers when seeking formal approval for the pilot. Patients were willing to participate in a pilot with a placebo arm; although some patients when allocated to surgery became apprehensive about the possibility of receiving placebo, and withdrew. Placebo surgery was undertaken successfully. Conclusions Our study illustrated the opposing and often strongly held opinions about surgical placebos

  16. Treatment of posttraumatic stress disorder in postwar Kosovar adolescents using mind-body skills groups: a randomized controlled trial.

    PubMed

    Gordon, James S; Staples, Julie K; Blyta, Afrim; Bytyqi, Murat; Wilson, Amy T

    2008-09-01

    To determine whether participation in a mind-body skills group program based on psychological self-care, mind-body techniques, and self-expression decreases symptoms of posttraumatic stress disorder (PTSD). Eighty-two adolescents meeting criteria for PTSD according to the Harvard Trauma Questionnaire (which corresponds with 16 of the 17 diagnostic criteria for PTSD in DSM-IV) were randomly assigned to a 12-session mind-body group program or a wait-list control group. The program was conducted by high school teachers in consultation with psychiatrists and psychologists and included meditation, guided imagery, and breathing techniques; self-expression through words, drawings, and movement; autogenic training and biofeedback; and genograms. Changes in PTSD symptoms were measured using the Harvard Trauma Questionnaire. The study was conducted from September 2004 to May 2005 by The Center for Mind-Body Medicine at a high school in the Suhareka region of Kosovo. Students in the immediate intervention group had significantly lower PTSD symptom scores following the intervention than those in the wait-list control group (F = 29.8, df = 1,76; p < .001). Preintervention and postintervention scores (mean [SD]) for the intervention group were 2.5 (0.3) and 2.0 (0.3), respectively, and for the control group, 2.5 (0.3) and 2.4 (0.4), respectively. The decreased PTSD symptom scores were maintained in the initial intervention group at 3-month follow-up. After the wait-list control group received the intervention, there was a significant decrease (p < .001) in PTSD symptom scores compared to the preintervention scores. Mind-body skills groups can reduce PTSD symptoms in war-traumatized high school students and can be effectively led by trained and supervised schoolteachers. Copyright 2008 Physicians Postgraduate Press, Inc.

  17. Prevention of depression and anxiety in adolescents: a randomized controlled trial testing the efficacy and mechanisms of Internet-based self-help problem-solving therapy.

    PubMed

    Hoek, Willemijn; Schuurmans, Josien; Koot, Hans M; Cuijpers, Pim

    2009-10-12

    Even though depression and anxiety are highly prevalent in adolescence, youngsters are not inclined to seek help in regular healthcare. Therapy through the Internet, however, has been found to appeal strongly to young people. The main aim of the present study is to examine the efficacy of preventive Internet-based guided self-help problem-solving therapy with adolescents reporting depressive and anxiety symptoms. A secondary objective is to test potential mediating and moderating variables in order to gain insight into how the intervention works and for whom it works best. This study is a randomized controlled trial with an intervention condition group and a wait-list control group. The intervention condition group receives Internet-based self-help problem-solving therapy. Support is provided by a professional and delivered through email. Participants in the wait-list control group receive the intervention four months later. The study population consists of adolescents (12-18-year-olds) from the general population who report mild to moderate depressive and/or anxiety symptoms and are willing to complete a self-help course. Primary outcomes are symptoms of depression and anxiety. Secondary outcomes are quality of life, social anxiety, and cost-effectiveness. The following variables are examined for their moderating role: demographics, motivation, treatment credibility and expectancy, externalizing behaviour, perceived social support from parents and friends, substance use, the experience of important life events, physical activity, the quality of the therapeutic alliance, and satisfaction. Mediator variables include problem-solving skills, worrying, mastery, and self-esteem. Data are collected at baseline and at 3 weeks, 5 weeks, 4 months, 8 months, and 12 months after baseline. Both intention-to-treat and completer analyses will be conducted. This study evaluates the efficacy and mechanisms of Internet-based problem-solving therapy for adolescents. If Internet

  18. Feasibility and Efficacy of a Parent-Focused, Text Message–Delivered Intervention to Reduce Sedentary Behavior in 2- to 4-Year-Old Children (Mini Movers): Pilot Randomized Controlled Trial

    PubMed Central

    Salmon, Jo; Hinkley, Trina; Hnatiuk, Jill A; Hesketh, Kylie D

    2018-01-01

    Background Despite public health guidelines to limit sedentary behavior, many young children spend large amounts of time sedentary (eg, screen and sitting time) during waking hours. Objective The objective of this study was to test the feasibility and efficacy of a parent-focused, predominantly text message–delivered intervention to support parents to reduce the amount of time their children spend in sedentary behavior. Methods Mini Movers was a pilot randomized controlled trial delivered to parents of 2- to 4-year-old children in Melbourne, Australia. Participants were recruited through playgroups, social media, and snowball sampling. Eligibility criteria were having an ambulatory child (2-4 years), English literacy, and smartphone ownership. Participants were randomized to intervention or wait-list control on a 1:1 ratio after baseline data collection. The 6-week intervention was predominantly delivered via text messages, using a Web-based bulk text message platform managed by the interventionist. Intervention strategies focused on increasing parental knowledge, building self-efficacy, setting goals, and providing reinforcement, and were underpinned by the Coventry, Aberdeen & London-Refined taxonomy of behavior change techniques and social cognitive theory. The primary outcome was intervention feasibility, measured by recruitment, retention, intervention delivery, and fidelity; process evaluation questionnaires; and qualitative interviews with a subsample of participants. Secondary outcomes were children’s screen and restraint time (parent report), sitting time (parent report, activPAL), and potential mediators (parent report). Linear regression models were used to determine intervention effects on secondary outcomes, controlling for the child’s sex and age and clustering by playgroup; effect sizes (Cohen's d) were calculated. Results A total of 57 participants (30 intervention; 27 wait-list control) were recruited, and retention was high (93%). Process

  19. Changes of attachment characteristics during psychotherapy of patients with social anxiety disorder: Results from the SOPHO-Net trial

    PubMed Central

    Strauß, Bernhard; Altmann, Uwe; Manes, Susanne; Tholl, Anne; Koranyi, Susan; Nolte, Tobias; Beutel, Manfred E.; Wiltink, Jörg; Herpertz, Stephan; Hiller, Wolfgang; Hoyer, Jürgen; Joraschky, Peter; Nolting, Björn; Ritter, Viktoria; Stangier, Ulrich; Willutzki, Ulrike; Salzer, Simone; Leibing, Eric; Leichsenring, Falk; Kirchmann, Helmut

    2018-01-01

    Objectives Within a randomized controlled trial contrasting the outcome of manualized cognitive-behavioral (CBT) and short term psychodynamic therapy (PDT) compared to a waiting list condition (the SOPHO-Net trial), we set out to test whether self-reported attachment characteristics change during the treatments and if these changes differ between treatments. Research design and methods 495 patients from the SOPHO-Net trial (54.5% female, mean age 35.2 years) who were randomized to either CBT, PDT or waiting list (WL) completed the partner-related revised Experiences in Close Relationships Questionnaire (ECR-R) before and after treatment and at 6 and 12 months follow-up. The Liebowitz Social Anxiety Scale (LSAS) was administered at pre-treatment, post-treatment, and at 6-month and 1-year follow-up. ECR-R scores were first compared to a representative healthy sample (n = 2508) in order to demonstrate that the clinical sample differed significantly from the non-clinical sample with respect to attachment anxiety and avoidance. Results LSAS scores correlated significantly with both ECR-R subscales. Post-therapy, patients treated with CBT revealed significant changes in attachment anxiety and avoidance whereas patients treated with PDT showed no significant changes. Changes between post-treatment and the two follow-ups were significant in both conditions, with minimal (insignificant) differences between treatments at the 12- month follow-up. Conclusions The current study supports recent reviews of mostly naturalistic studies indicating changes in attachment as a result of psychotherapy. Although there were differences between conditions at the end of treatment, these largely disappeared during the follow-up period which is line with the other results of the SOPHO-NET trial. Trial registration Controlled-trials.com ISRCTN53517394 PMID:29518077

  20. The impact of waiting for intervention on costs and effectiveness: the case of transcatheter aortic valve replacement.

    PubMed

    Ribera, Aida; Slof, John; Ferreira-González, Ignacio; Serra, Vicente; García-Del Blanco, Bruno; Cascant, Purificació; Andrea, Rut; Falces, Carlos; Gutiérrez, Enrique; Del Valle-Fernández, Raquel; Morís-de laTassa, César; Mota, Pedro; Oteo, Juan Francisco; Tornos, Pilar; García-Dorado, David

    2017-11-23

    The economic crisis in Europe might have limited access to some innovative technologies implying an increase of waiting time. The purpose of the study is to evaluate the impact of waiting time on the costs and benefits of transcatheter aortic valve replacement (TAVR) for the treatment of severe aortic stenosis. This is a cost-utility analysis from the perspective of the Spanish National Health Service. Results of two prospective hospital registries (158 and 273 consecutive patients) were incorporated into a probabilistic Markov model to compare quality adjusted life years (QALYs) and costs for TAVR after waiting for 3-12 months, relative to immediate TAVR. We simulated a cohort of 1000 patients, male, and 80 years old; other patient profiles were assessed in sensitivity analyses. As waiting time increased, costs decreased at the expense of lower survival and loss of QALYs, leading to incremental cost-effectiveness ratios for eliminating waiting lists of about 12,500 € per QALY. In subgroup analyses prioritization of patients for whom higher benefit was expected led to a smaller loss of QALYs. Concerning budget impact, long waiting lists reduced spending considerably and permanently. A shorter waiting time is likely to be cost-effective (considering commonly accepted willingness-to-pay thresholds in Europe) relative to 3 months or longer waiting periods. If waiting lists are nevertheless seen as unavoidable due to severe but temporary budgetary restrictions, prioritizing patients for whom higher benefit is expected appears to be a way of postponing spending without utterly sacrificing patients' survival and quality of life.

  1. Effect of a mobile app intervention on vegetable consumption in overweight adults: a randomized controlled trial.

    PubMed

    Mummah, Sarah; Robinson, Thomas N; Mathur, Maya; Farzinkhou, Sarah; Sutton, Stephen; Gardner, Christopher D

    2017-09-15

    Mobile applications (apps) have been heralded as transformative tools to deliver behavioral health interventions at scale, but few have been tested in rigorous randomized controlled trials. We tested the effect of a mobile app to increase vegetable consumption among overweight adults attempting weight loss maintenance. Overweight adults (n=135) aged 18-50 years with BMI=28-40 kg/m 2 near Stanford, CA were recruited from an ongoing 12-month weight loss trial (parent trial) and randomly assigned to either the stand-alone, theory-based Vegethon mobile app (enabling goal setting, self-monitoring, and feedback and using "process motivators" including fun, surprise, choice, control, social comparison, and competition) or a wait-listed control condition. The primary outcome was daily vegetables servings, measured by an adapted Harvard food frequency questionnaire (FFQ) 8 weeks post-randomization. Daily vegetable servings from 24-hour dietary recalls, administered by trained, certified, and blinded interviewers 5 weeks post-randomization, was included as a secondary outcome. All analyses were conducted according to principles of intention-to-treat. Daily vegetable consumption was significantly greater in the intervention versus control condition for both measures (adjusted mean difference: 2.0 servings; 95% CI: 0.1, 3.8, p=0.04 for FFQ; and 1.0 servings; 95% CI: 0.2, 1.9; p=0.02 for 24-hour recalls). Baseline vegetable consumption was a significant moderator of intervention effects (p=0.002) in which effects increased as baseline consumption increased. These results demonstrate the efficacy of a mobile app to increase vegetable consumption among overweight adults. Theory-based mobile interventions may present a low-cost, scalable, and effective approach to improving dietary behaviors and preventing associated chronic diseases. ClinicalTrials.gov NCT01826591. Registered 27 March 2013.

  2. Thought Field Therapy (TFT) as a treatment for anxiety symptoms: a randomized controlled trial.

    PubMed

    Irgens, Audun; Dammen, Toril; Nysæter, Tor Erik; Hoffart, Asle

    2012-01-01

    To investigate whether thought field therapy (TFT) has an impact on anxiety symptoms in patients with a variety of anxiety disorders. Forty-five patients were randomized to either TFT (n = 23) or a waiting list (n = 22) condition. The wait-list group was reassessed and compared with the TFT group two and a half months after the initial evaluation. After the reassessment, the wait-list patients received treatment with TFT. All 45 patients were followed up one to two weeks after TFT treatment, as well as at three and 12 months after treatment. Patients with an anxiety disorder, mostly outpatients. TFT aims to influence the body's bioenergy field by tapping on specific points along energy meridians, thereby relieving anxiety and other symptoms. Symptom Checklist 90-Revised, Hospital Anxiety and Depression Scale, the Sheehan Disability Scale. Repeated-measures analysis of variance was used to compare the TFT and the wait-list group. The TFT group had a significantly better outcome on two measures of anxiety and one measure of function. Follow-up data for all patients taken together showed a significant decrease in all symptoms during the one to two weeks between the pretreatment and the post-treatment assessments. The significant improvement seen after treatment was maintained at the three- and 12-month assessments. The results suggest that TFT may have an enduring anxiety-reducing effect. Copyright © 2012 Elsevier Inc. All rights reserved.

  3. Improving chronic disease prevention and screening in primary care: results of the BETTER pragmatic cluster randomized controlled trial.

    PubMed

    Grunfeld, Eva; Manca, Donna; Moineddin, Rahim; Thorpe, Kevin E; Hoch, Jeffrey S; Campbell-Scherer, Denise; Meaney, Christopher; Rogers, Jess; Beca, Jaclyn; Krueger, Paul; Mamdani, Muhammad

    2013-11-20

    Primary care provides most of the evidence-based chronic disease prevention and screening services offered by the healthcare system. However, there remains a gap between recommended preventive services and actual practice. This trial (the BETTER Trial) aimed to improve preventive care of heart disease, diabetes, colorectal, breast and cervical cancers, and relevant lifestyle factors through a practice facilitation intervention set in primary care. Pragmatic two-way factorial cluster RCT with Primary Care Physicians' practices as the unit of allocation and individual patients as the unit of analysis. The setting was urban Primary Care Team practices in two Canadian provinces. Eight Primary Care Team practices were randomly assigned to receive the practice-level intervention or wait-list control; 4 physicians in each team (32 physicians) were randomly assigned to receive the patient-level intervention or wait-list control. Patients randomly selected from physicians' rosters were stratified into two groups: 1) general and 2) moderate mental illness. The interventions involved a multifaceted, evidence-based, tailored practice-level intervention with a Practice Facilitator, and a patient-level intervention involving a one-hour visit with a Prevention Practitioner where patients received a tailored 'prevention prescription'. The primary outcome was a composite Summary Quality Index of 28 evidence-based chronic disease prevention and screening actions with pre-defined targets, expressed as the ratio of eligible actions at baseline that were met at follow-up. A cost-effectiveness analysis was conducted. 789 of 1,260 (63%) eligible patients participated. On average, patients were eligible for 8.96 (SD 3.2) actions at baseline. In the adjusted analysis, control patients met 23.1% (95% CI: 19.2% to 27.1%) of target actions, compared to 28.5% (95% CI: 20.9% to 36.0%) receiving the practice-level intervention, 55.6% (95% CI: 49.0% to 62.1%) receiving the patient

  4. Children, parents, and pets exercising together (CPET) randomised controlled trial: study rationale, design, and methods

    PubMed Central

    2012-01-01

    Background Objectively measured physical activity is low in British children, and declines as childhood progresses. Observational studies suggest that dog-walking might be a useful approach to physical activity promotion in children and adults, but there are no published public health interventions based on dog-walking with children. The Children, Parents, and Pets Exercising Together Study aims to develop and evaluate a theory driven, generalisable, family-based, dog walking intervention for 9-11 year olds. Methods/design The Children, Parents, and Pets Exercising Together Study is an exploratory, assessor-blinded, randomised controlled trial as defined in the UK MRC Framework on the development and evaluation of complex interventions in public health. The trial will follow CONSORT guidance. Approximately 40 dog-owning families will be allocated randomly in a ratio of 1.5:1 to receive a simple behavioural intervention lasting for 10 weeks or to a 'waiting list' control group. The primary outcome is change in objectively measured child physical activity using Actigraph accelerometry. Secondary outcomes in the child, included in part to shape a future more definitive randomised controlled trial, are: total time spent sedentary and patterning of sedentary behaviour (Actigraph accelerometry); body composition and bone health from dual energy x-ray absorptiometry; body weight, height and BMI; and finally, health-related quality of life using the PedsQL. Secondary outcomes in parents and dogs are: changes in body weight; changes in Actigraph accelerometry measured physical activity and sedentary behaviour. Process evaluation will consist of assessment of simultaneous child, parent, and dog accelerometry data and brief interviews with participating families. Discussion The Children, Parents, and Pets Exercising Together trial should be the first randomised controlled study to establish and evaluate an intervention aimed at dog-based physical activity promotion in

  5. Short-term effectiveness of web-based guided self-help for phobic outpatients: randomized controlled trial.

    PubMed

    Kok, Robin N; van Straten, Annemieke; Beekman, Aartjan T F; Cuijpers, Pim

    2014-09-29

    Internet-based guided self-help has been successfully used in the general population, but it is unknown whether this method can be effectively used in outpatient clinics for patients waiting for face-to-face psychotherapy for phobias. The aim was to assess the clinical effectiveness of Phobias Under Control, an Internet-based intervention based on exposure therapy with weekly guidance. We conducted a randomized controlled trial, recruiting 212 outpatients scheduled to receive face-to-face psychotherapy for any type of phobia at an outpatient clinic. Participants suffering from at least 1 DSM-IV or ICD-10 classified phobia (social phobia, agoraphobia with or without panic disorder, and/or specific phobia as ascertained by a telephone interview at baseline) were randomly allocated to either a 5-week Internet-based guided self-help program based on exposure therapy with weekly student support followed by face-to-face psychotherapy (n=105) or a wait-list control group followed by face-to-face psychotherapy (n=107). Primary outcome was the Fear Questionnaire (FQ). Secondary outcomes were the Beck Anxiety Inventory (BAI) and Center of Epidemiological Studies-Depression scale (CES-D). Assessments took place by telephone at baseline (T0) and on the Internet at posttest (T1, self-assessment at 5 weeks after baseline). Missing data at T1 were imputed. At posttest, analysis of covariance on the intention-to-treat sample showed significant but small effect sizes between intervention and control groups on the FQ (d=0.35, P=.02), CES-D (d=0.34, P=.03), and a nonsignificant effect size on the BAI (d=0.28. P=.05). Although initial acceptance was good, high nonresponse was observed, with 86 of 212 participants (40.5%) lost to follow-up at T1 and only 14 of 105 (13.3%) intervention participants finishing all 5 weeks. Phobias Under Control is modestly effective in lowering phobic and depressive symptoms in a relatively short period and may be clinically beneficial when implemented in

  6. Hypertension Analysis of stress Reduction using Mindfulness meditatiON and Yoga (The HARMONY Study): study protocol of a randomised control trial.

    PubMed

    Blom, Kimberly; How, Maxine; Dai, Monica; Baker, Brian; Irvine, Jane; Abbey, Susan; Abramson, Beth L; Myers, Martin; Perkins, Nancy; Tobe, Sheldon W

    2012-01-01

    Hypertension (HTN) is a leading risk factor for preventable cardiovascular disease, with over one in five adults affected worldwide. Lifestyle modification is a key strategy for the prevention and treatment of HTN. Stress has been associated with greater cardiovascular risk, and stress management is a recommended intervention for hypertensives. Stress reduction through relaxation therapies has been shown to have an effect on human physiology, including lowering blood pressure (BP). However, individualised behavioural interventions are resource intensive, and group stress management approaches have not been validated for reducing HTN. The HARMONY Study is a pilot randomised controlled trial designed to determine if mindfulness-based stress reduction (MBSR), a standardised group therapy, is an effective intervention for lowering BP in stage 1 unmedicated hypertensives. Men and women unmedicated for HTN with mean daytime ambulatory blood pressure (ABP) ≥135/85 mm Hg or 24 h ABP ≥130/80 mm Hg are included in the study. Subjects are randomised to receive MBSR immediately or after a wait-list control period. The primary outcome measure is mean awake and 24 h ABP. The primary objective of the HARMONY Study is to compare ABP between the treatment and wait-list control arm at the 12-week primary assessment period. Results from this study will determine if MBSR is an effective intervention for lowering BP in early unmedicated hypertensives. This research project was approved by the Sunnybrook Research Ethics Board and the University Health Network Research Ethics Board (Toronto, Canada). Planned analyses are in full compliance with the principles of the Declaration of Helsinki. Data collection will be completed by early spring 2012. Primary and secondary analysis will commence immediately after data monitoring is completed; dissemination plans include preparing publications for submission during the summer of 2012. This study is registered with http

  7. A pilot randomized controlled trial of the Yoga of Awareness program in the management of fibromyalgia

    PubMed Central

    Carson, James W.; Carson, Kimberly M.; Jones, Kim D.; Bennett, Robert M.; Wright, Cheryl L.; Mist, Scott D.

    2017-01-01

    A mounting body of literature recommends that treatment for fibromyalgia (FM) encompass medications, exercise and improvement of coping skills. However, there is a significant gap in determining an effective counterpart to pharmacotherapy that incorporates both exercise and coping. The aim of this randomized controlled trial was to evaluate the effects of a comprehensive yoga intervention on FM symptoms and coping. A sample of 53 female FM patients were randomized to the 8-week Yoga of Awareness program (gentle poses, meditation, breathing exercises, yoga-based coping instructions, group discussions) or to wait-listed standard care. Data were analyzed by intention to treat. At post-treatment, women assigned to the yoga program showed significantly greater improvements on standardized measures of FM symptoms and functioning, including pain, fatigue, and mood, and in pain catastrophizing, acceptance, and other coping strategies. This pilot study provides promising support for the potential benefits of a yoga program for women with FM. PMID:20946990

  8. Guided self-help cognitive behavioral intervention for VoicEs (GiVE): study protocol for a pilot randomized controlled trial.

    PubMed

    Hazell, Cassie M; Hayward, Mark; Cavanagh, Kate; Jones, Anna-Marie; Strauss, Clara

    2016-07-26

    Cognitive behavior therapy for psychosis (CBTp) is an effective intervention for people who hear distressing voices (auditory hallucinations). However, there continues to be a problem of poor access to CBTp. Constraints on health care funding require this problem to be addressed without a substantial increase in funding. One solution is to develop guided self-help forms of CBTp to improve access, and a symptom-specific focus on, for example, distressing voices (auditory verbal hallucinations) has the potential to enhance effectiveness. We term this cognitive behavior therapy for distressing voices (CBTv). This trial is an external pilot randomized controlled trial comparing the effects of 12-week guided self-help CBTv (with eight therapist support sessions) with a wait list control condition. Informed consent will be obtained from each participant. Half of the 30 participants will be randomized to receive guided self-help CBTv immediately; the remaining half will receive the intervention after a 12-week delay. All participants will continue with their usual treatment throughout the study. Outcomes will be assessed using questionnaires completed at baseline and 12 weeks postrandomization. Interviews will be offered to all those who receive therapy immediately to explore their experiences with the intervention. The outcomes of this trial, both quantitative and qualitative, will inform the design of a definitive randomized controlled trial of guided self-help CBTv. If this intervention is effective, it could help to increase access to CBT for those who hear distressing voices. ISRCTN registration number  ISRCTN77762753 . Registered on 23 July 2015.

  9. Cognitive Therapy Versus Exposure and Applied Relaxation in Social Phobia: A Randomized Controlled Trial

    ERIC Educational Resources Information Center

    Clark, David M.; Ehlers, Anke; Hackmann, Ann; McManus, Freda; Fennell, Melanie; Grey, Nick; Waddington, Louise; Wild, Jennifer

    2006-01-01

    A new cognitive therapy (CT) program was compared with an established behavioral treatment. Sixty-two patients meeting Diagnostic and Statistical Manual of Mental Disorders (4th ed.; American Psychiatric Association, 1994) criteria for social phobia were randomly assigned to CT, exposure plus applied relaxation (EXP = AR), or wait-list (WAIT). CT…

  10. Danger ideation reduction therapy (DIRT) for obsessive-compulsive washers. A controlled trial.

    PubMed

    Jones, M K; Menzies, R G

    1998-10-01

    Twenty-one OCD sufferers with washing/contamination concerns took part in a controlled treatment trial at the Anxiety Disorders Clinic, University of Sydney. Eleven of the subjects received danger ideation reduction therapy (DIRT) over eight, 1 h weekly group sessions conducted by the second author. Ten subjects were placed on a wait list and did not receive DIRT or any other treatment. DIRT procedures were solely directed at decreasing danger-related expectancies concerning contamination and did not include exposure, response prevention or behavioral experiments. Components of DIRT include attentional focusing, filmed interviews, corrective information, cognitive restructuring, expert testimony, microbiological experiments and a probability of catastrophe assessment task. All subjects were assessed at pre-treatment, post-treatment and three-month follow-up using the Maudsley Obsessional-Compulsive Inventory, Leyton Obsessionality Inventory, Beck Depression Inventory and a Self Rating of Severity Scale. Changes from pre-treatment to after treatment (post-treatment and follow-up scores averaged) were significantly greater in the DIRT condition than in the control condition for all measures. No significant differences were obtained between groups on post-treatment to follow-up change on any measure. The implications of these findings for theoretical models of OCD and its management are discussed.

  11. Internet-based treatment for Romanian adults with panic disorder: protocol of a randomized controlled trial comparing a Skype-guided with an unguided self-help intervention (the PAXPD study).

    PubMed

    Ciuca, Amalia Maria; Berger, Thomas; Crişan, Liviu George; Miclea, Mircea

    2016-01-14

    Efficacy of self-help internet-based cognitive behavior therapy (ICBT) for anxiety disorders has been confirmed in several randomized controlled trials. However, the amount and type of therapist guidance needed in ICBT are still under debate. Previous studies have shown divergent results regarding the role of therapist guidance and its impact on treatment outcome. This issue is central to the development of ICBT programs and needs to be addressed directly. The present study aims to compare the benefits of regular therapist guidance via online real-time audio-video communication (i.e. Skype) to no therapist guidance during a 12-week Romanian self-help ICBT program for Panic Disorder. Both treatments are compared to a waiting-list control group. A parallel group randomized controlled trial is proposed. The participants, 192 Romanian adults fulfilling diagnostic criteria for panic disorder according to a diagnostic interview, conducted via secured Skype or telephone, are randomly assigned to one of the three conditions: independent use of the internet-based self-help program PAXonline, the same self-help treatment with regular therapist support via secured Skype, and waiting-list control group. The primary outcomes are severity of self-report panic symptoms (PDSS-SR) and diagnostic status (assessors are blind to group assignment), at the end of the intervention (12 weeks) and at follow-up (months 3 and 6). The secondary measures address symptoms of comorbid anxiety disorders, depression, quality of life, adherence and satisfaction with ICBT. Additional measures of socio-demographic characteristics, personality traits, treatment expectancies, catastrophic cognitions, body vigilance and working alliance are considered as potential moderators and/ or mediators of treatment outcome. To the best of our knowledge, the present study is the first effort to investigate the efficacy of a self-help internet-based intervention with therapist guidance via real-time video

  12. The effectiveness of self-help mindfulness-based cognitive therapy in a student sample: a randomised controlled trial.

    PubMed

    Lever Taylor, Billie; Strauss, Clara; Cavanagh, Kate; Jones, Fergal

    2014-12-01

    Mindfulness-based cognitive therapy (MBCT) involves approximately twenty hours of therapist contact time and is not universally available. MBCT self-help (MBCT-SH) may widen access but little is known about its effectiveness. This paper presents a randomised controlled trial (RCT) of MBCT-SH for students. Eighty students were randomly assigned to an eight-week MBCT-SH condition or a wait-list control. ANOVAs showed significant group by time interactions in favour of MBCT-SH on measures of depression, anxiety, stress, satisfaction with life, mindfulness and self-compassion. Post-intervention between-group effect sizes ranged from Cohen's d = 0.22 to 1.07. Engagement with MBCT-SH was high: participants engaged in mindfulness practice a median of two to three times a week and 85% read at least half the intervention book. Only 5% of participants dropped out. This is the first published RCT of MBCT-SH and benefits were found relative to a control group. MBCT-SH has the potential to be a low-cost, readily available and highly acceptable intervention. Future research should include an active control condition and explore whether findings extend to clinical populations. Copyright © 2014 Elsevier Ltd. All rights reserved.

  13. A training programme involving automatic self-transcending meditation in late-life depression: preliminary analysis of an ongoing randomised controlled trial.

    PubMed

    Vasudev, Akshya; Arena, Amanda; Burhan, Amer M; Ionson, Emily; Hirjee, Hussein; Maldeniya, Pramudith; Wetmore, Stephen; Newman, Ronnie I

    2016-03-01

    Late-life depression affects 2-6% of seniors aged 60 years and above. Patients are increasingly embracing non-pharmacological therapies, many of which have not been scientifically evaluated. This study aimed to evaluate a category of meditation, automatic self-transcending meditation (ASTM), in alleviating symptoms of depression when augmenting treatment as usual (NCT02149810). The preliminary results of an ongoing single-blind randomised controlled trial comparing a training programme involving ASTM with a wait-list control indicate that a 12-week ASTM programme may lead to significantly greater reductions in depression and anxiety severity. As such, ASTM may be an effective adjunctive therapy in the treatment of late-life depression. R.I.N. is Director of Research and Health Promotion for the Art of Living Foundation, Canada and supervised the staff providing ASTM training. © The Royal College of Psychiatrists 2016. This is an open access article distributed under the terms of the Creative Commons Non-Commercial, No Derivatives (CC BY-NC-ND) licence.

  14. Guided self-help on the Internet for Turkish migrants with depression: the design of a randomized controlled trial.

    PubMed

    Unlü, Burçin; Riper, Heleen; van Straten, Annemieke; Cuijpers, Pim

    2010-11-04

    The Turkish population living in The Netherlands has a high prevalence of psychological complaints and has a high threshold for seeking professional help for these problems. Seeking help through the Internet can overcome these barriers. This project aims to evaluate the effectiveness of a guided self-help problem-solving intervention for depressed Turkish migrants that is culturally adapted and web-based. This study is a randomized controlled trial with two arms: an experimental condition group and a wait list control group. The experimental condition obtains direct access to the guided web-based self-help intervention, which is based on Problem Solving Treatment (PST) and takes 6 weeks to complete. Turkish adults with mild to moderate depressive symptoms will be recruited from the general population and the participants can choose between a Turkish and a Dutch version. The primary outcome measure is the reduction of depressive symptoms, the secondary outcome measures are somatic symptoms, anxiety, acculturation, quality of life and satisfaction. Participants are assessed at baseline, post-test (6 weeks), and 4 months after baseline. Analysis will be conducted on the intention-to-treat sample. This study evaluates the effectiveness of a guided problem-solving intervention for Turkish adults living in The Netherlands that is culturally adapted and web-based. Nederlands Trial Register: NTR2303.

  15. Developing a placebo-controlled trial in surgery: issues of design, acceptability and feasibility.

    PubMed

    Campbell, M K; Entwistle, V A; Cuthbertson, B H; Skea, Z C; Sutherland, A G; McDonald, A M; Norrie, J D; Carlson, R V; Bridgman, S

    2011-02-21

    Surgical placebos are controversial. This in-depth study explored the design, acceptability, and feasibility issues relevant to designing a surgical placebo-controlled trial for the evaluation of the clinical and cost effectiveness of arthroscopic lavage for the management of people with osteoarthritis of the knee in the UK. Two surgeon focus groups at a UK national meeting for orthopaedic surgeons and one regional surgeon focus group (41 surgeons); plenary discussion at a UK national meeting for orthopaedic anaesthetists (130 anaesthetists); three focus groups with anaesthetists (one national, two regional; 58 anaesthetists); two focus groups with members of the patient organisation Arthritis Care (7 participants); telephone interviews with people on consultant waiting lists from two UK regional centres (15 participants); interviews with Chairs of UK ethics committees (6 individuals); postal surveys of members of the British Association of Surgeons of the Knee (382 surgeons) and members of the British Society of Orthopaedic Anaesthetists (398 anaesthetists); two centre pilot (49 patients assessed). There was widespread acceptance that evaluation of arthroscopic lavage had to be conducted with a placebo control if scientific rigour was not to be compromised. The choice of placebo surgical procedure (three small incisions) proved easier than the method of anaesthesia (general anaesthesia). General anaesthesia, while an excellent mimic, was more intrusive and raised concerns among some stakeholders and caused extensive discussion with local decision-makers when seeking formal approval for the pilot.Patients were willing to participate in a pilot with a placebo arm; although some patients when allocated to surgery became apprehensive about the possibility of receiving placebo, and withdrew. Placebo surgery was undertaken successfully. Our study illustrated the opposing and often strongly held opinions about surgical placebos, the ethical issues underpinning this

  16. Healthy eating and obesity prevention for preschoolers: a randomised controlled trial

    PubMed Central

    2010-01-01

    Background Developing effective prevention and intervention programs for the formative preschool years is seen as an essential step in combating the obesity epidemic across the lifespan. The overall goal of the current project is to measure the effectiveness of a healthy eating and childhood obesity prevention intervention, the MEND (Mind Exercise Nutrition Do It!) program that is delivered to parents of children aged 2-4 years. Methods/Design This randomised controlled trial will be conducted with 200 parents and their 2-4 year old children who attend the MEND 2-4 program in metropolitan and regional Victoria. Parent-child dyads will attend ten 90-minute group workshops. These workshops focus on general nutrition, as well as physical activity and behaviours. They are typically held at community or maternal and child health centres and run by a MEND 2-4 trained program leader. Child eating habits, physical activity levels and parental behaviours and cognitions pertaining to nutrition and physical activity will be assessed at baseline, the end of the intervention, and at 6 and 12 months post the intervention. Informed consent will be obtained from all parents, who will then be randomly allocated to the intervention or wait-list control group. Discussion Our study is the first RCT of a healthy eating and childhood obesity prevention intervention targeted specifically to Australian parents and their preschool children aged 2-4 years. It responds to the call by experts in the area of childhood obesity and child health that prevention of overweight in the formative preschool years should focus on parents, given that parental beliefs, attitudes, perceptions and behaviours appear to impact significantly on the development of early overweight. This is 'solution-oriented' rather than 'problem-oriented' research, with its focus being on prevention rather than intervention. If this is a positive trial, the MEND2-4 program can be implemented as a national program. Trial

  17. Cognitive-behavioral therapy for sleep disturbances in treating posttraumatic stress disorder symptoms: A meta-analysis of randomized controlled trials.

    PubMed

    Ho, Fiona Yan-Yee; Chan, Christian S; Tang, Kristen Nga-Sze

    2016-02-01

    Sleep disturbances are frequently reported in patients with posttraumatic stress disorder (PTSD). There is evidence that sleep disturbance is not only a secondary symptom but also a risk factor for PTSD. Sleep-specific psychological treatments provide an alternative to conventional trauma-focused psychological treatments. The current meta-analysis evaluated the efficacy of sleep-specific cognitive-behavioral therapy (CBT) in mitigating PTSD, sleep, and depressive symptoms. A total of 11 randomized controlled trials were included in the meta-analytic comparisons between sleep-specific CBT and waiting-list control groups at posttreatment. Random effects models showed significant reduction in self-report PTSD and depressive symptoms and insomnia severity in the sleep-specific CBT group. The corresponding effect sizes, measured in Hedges' g, were 0.58, 0.44, and 1.15, respectively. The effect sizes for sleep diary-derived sleep onset latency, wake after sleep onset, and sleep efficiency were 0.83, 1.02 and 1.15, respectively. The average study attrition rate of sleep-specific CBT was relatively low (12.8%), with no significant difference from the control group (9.4%). In conclusion, sleep-specific CBT appears to be efficacious and feasible in treating PTSD symptoms. Due to the relatively small number of randomized controlled trials available, further research is warranted to confirm its efficacy and acceptability, especially in comparison to trauma-specific psychological treatments. Copyright © 2015 Elsevier Ltd. All rights reserved.

  18. Quasi-experimental trial of diabetes Self-Management Automated and Real-Time Telephonic Support (SMARTSteps) in a Medicaid managed care plan: study protocol.

    PubMed

    Ratanawongsa, Neda; Handley, Margaret A; Quan, Judy; Sarkar, Urmimala; Pfeifer, Kelly; Soria, Catalina; Schillinger, Dean

    2012-01-26

    Health information technology can enhance self-management and quality of life for patients with chronic disease and overcome healthcare barriers for patients with limited English proficiency. After a randomized controlled trial of a multilingual automated telephone self-management support program (ATSM) improved patient-centered dimensions of diabetes care in safety net clinics, we collaborated with a nonprofit Medicaid managed care plan to translate research into practice, offering ATSM as a covered benefit and augmenting ATSM to promote medication activation. This paper describes the protocol of the Self-Management Automated and Real-Time Telephonic Support Project (SMARTSteps). This controlled quasi-experimental trial used a wait-list variant of a stepped wedge design to enroll 362 adult health plan members with diabetes who speak English, Cantonese, or Spanish and receive care at 4 publicly-funded clinics. Through language-stratified randomization, participants were assigned to four intervention statuses: SMARTSteps-ONLY, SMARTSteps-PLUS, or wait-list for either intervention. In addition to usual primary care, intervention participants received 27 weekly calls in their preferred language with rotating queries and response-triggered education about self-care, medication adherence, safety concerns, psychological issues, and preventive services. Health coaches from the health plan called patients with out-of-range responses for collaborative goal setting and action planning. SMARTSteps-PLUS also included health coach calls to promote medication activation, adherence and intensification, if triggered by ATSM-reported non-adherence, refill non-adherence from pharmacy claims, or suboptimal cardiometabolic indicators. Wait-list patients crossed-over to SMARTSteps-ONLY or -PLUS at 6 months. For participants who agreed to structured telephone interviews at baseline and 6 months (n = 252), primary outcomes will be changes in quality of life and functional status with

  19. Patient satisfaction with wait times at an emergency ophthalmology on-call service.

    PubMed

    Chan, Brian J; Barbosa, Joshua; Moinul, Prima; Sivachandran, Nirojini; Donaldson, Laura; Zhao, Lily; Mullen, Sarah J; McLaughlin, Christopher R; Chaudhary, Varun

    2018-04-01

    To assess patient satisfaction with emergency ophthalmology care and determine the effect provision of anticipated appointment wait time has on scores. Single-centre, randomized control trial. Fifty patients triaged at the Hamilton Regional Eye Institute (HREI) from November 2015 to July 2016. Fifty patients triaged for next-day appointments at the HREI were randomly assigned to receive standard-of-care preappointment information or standard-of-care information in addition to an estimated appointment wait time. Patient satisfaction with care was assessed postvisit using the modified Judgements of Hospital Quality Questionnaire (JHQQ). In determining how informing patients of typical wait times influenced satisfaction, the Mann-Whitney U test was performed. As secondary study outcomes, we sought to determine patient satisfaction with the intervention material using the Fisher exact test and the effect that wait time, age, sex, education, mobility, and number of health care providers seen had on satisfaction scores using logistic regression analysis. The median JHQQ response was "very good" (4/5) and between "very good" and "excellent" (4.5/5) in the intervention and control arms, respectively. There was no difference in patient satisfaction between the cohorts (Mann-Whitney U = 297.00, p = 0.964). Logistic regression analysis demonstrated that wait times influenced patient satisfaction (OR = 0.919, 95% CI 0.864-0.978, p = 0.008). Of the intervention arm patients, 92.0% (N = 23) found the preappointment information useful, whereas only 12.5% (N = 3) of the control cohort patients noted the same (p < 0.001). Provision of anticipated wait time information to patients in an emergency on-call ophthalmology clinic did not influence satisfaction with care as captured by the JHQQ. Copyright © 2018 Canadian Ophthalmological Society. Published by Elsevier Inc. All rights reserved.

  20. Reducing postpartum weight retention and improving breastfeeding outcomes in overweight women: a pilot randomised controlled trial.

    PubMed

    Martin, Julia; MacDonald-Wicks, Lesley; Hure, Alexis; Smith, Roger; Collins, Clare E

    2015-02-25

    Overweight and obesity is prevalent among women of reproductive age (42% BMI > 25 kg/m2) and parity is associated with risk of weight gain. Weight gain greater than that recommended by the Institute of Medicine (IOM )is also associated with lower rates of breastfeeding initiation and duration in women. The aim of this pilot randomised controlled trial is to examine the feasibility of recruiting and maintaining a cohort of pregnant women with the view of reducing postpartum weight retention and improving breastfeeding outcomes. Women (BMI of 25-35 kg/m2 (n = 36)) were recruited from the John Hunter Hospital antenatal clinic in New South Wales, Australia. Participants were stratified by BMI and randomised to one of three groups with follow-up to six months postpartum. Women received a dietary intervention with or without breastfeeding support from a lactation consultant, or were assigned to a wait-list control group where the dietary intervention was issued at three months postpartum. Feasibility and acceptability was assessed by participation rates and questionnaire. Analysis of variance and covariance was conducted to determine any differences between groups. Sixty-nine per cent of the participants were still enrolled at six months postpartum. This pilot demonstrated some difficulties in recruiting women from antenatal clinics and retaining them in the trial. Although underpowered; the results on weight; biomarkers and breastfeeding outcomes indicated improved metabolic health.

  1. Children, parents, and pets exercising together (CPET) randomised controlled trial: study rationale, design, and methods.

    PubMed

    Yam, Philippa S; Morrison, Ryan; Penpraze, Viki; Westgarth, Carri; Ward, Dianne S; Mutrie, Nanette; Hutchison, Pippa; Young, David; Reilly, John J

    2012-03-19

    Objectively measured physical activity is low in British children, and declines as childhood progresses. Observational studies suggest that dog-walking might be a useful approach to physical activity promotion in children and adults, but there are no published public health interventions based on dog-walking with children. The Children, Parents, and Pets Exercising Together Study aims to develop and evaluate a theory driven, generalisable, family-based, dog walking intervention for 9-11 year olds. The Children, Parents, and Pets Exercising Together Study is an exploratory, assessor-blinded, randomised controlled trial as defined in the UK MRC Framework on the development and evaluation of complex interventions in public health. The trial will follow CONSORT guidance. Approximately 40 dog-owning families will be allocated randomly in a ratio of 1.5:1 to receive a simple behavioural intervention lasting for 10 weeks or to a 'waiting list' control group. The primary outcome is change in objectively measured child physical activity using Actigraph accelerometry. Secondary outcomes in the child, included in part to shape a future more definitive randomised controlled trial, are: total time spent sedentary and patterning of sedentary behaviour (Actigraph accelerometry); body composition and bone health from dual energy x-ray absorptiometry; body weight, height and BMI; and finally, health-related quality of life using the PedsQL. Secondary outcomes in parents and dogs are: changes in body weight; changes in Actigraph accelerometry measured physical activity and sedentary behaviour. Process evaluation will consist of assessment of simultaneous child, parent, and dog accelerometry data and brief interviews with participating families. The Children, Parents, and Pets Exercising Together trial should be the first randomised controlled study to establish and evaluate an intervention aimed at dog-based physical activity promotion in families. It should advance our

  2. We cannot change the past, but we can change its meaning. A randomized controlled trial on the effects of self-help imagery rescripting on depression.

    PubMed

    Moritz, Steffen; Ahlf-Schumacher, Jana; Hottenrott, Birgit; Peter, Ulrike; Franck, Stephanie; Schnell, Thomas; Peter, Helmut; Schneider, Brooke C; Jelinek, Lena

    2018-05-01

    Imagery rescripting is a psychotherapeutic technique that aims to ameliorate negative emotions by altering (i.e., rescripting) inner representations of negative memories and images. Although the treatment was initially developed for traumatized individuals, face-to-face interventions have yielded promising results for patients with other diagnoses as well. The present study explored the feasibility and efficacy of the approach when used as a self-help intervention for depression. A total of 127 individuals with diagnosed depression were randomly allocated to either a wait-list control condition or received a brief or long version of a manual teaching imagery rescripting. Six weeks after inclusion, patients were invited to participate in the post assessment. The Beck Depression Inventory (BDI-II) served as the primary outcome (registered at ClinicalTrials.gov (NCT03299127). The long version was superior to the wait-list control condition on the BDI-II, self-esteem, and quality of life at a medium effect size. No effects emerged for anxiety. No significant between-group differences were found for the brief version. Moderation analyses indicated that the self-help approach seems particularly beneficial for those scoring high on symptoms, willingness to change, and expectancy (baseline). Most patients indicated they would use the technique in the future. The efficacy of imagery rescripting was confirmed when applied via self-help. Use of the long form of the manual is recommended. Future studies are needed to ascertain whether treatment effects are sustained over time. Copyright © 2018. Published by Elsevier Ltd.

  3. Efficacy of metacognitive therapy for prolonged grief disorder: protocol for a randomised controlled trial

    PubMed Central

    Wenn, Jenine; O'Connor, Moira; Breen, Lauren J; Kane, Robert T; Rees, Clare S

    2015-01-01

    Introduction Studies of effective psychotherapy for individuals suffering from the effects of prolonged grief disorder (PGD) are scarce. This paper describes the protocol for an evaluation of a metacognitive therapy programme designed specifically for PGD, to reduce the psychological distress and loss of functioning resulting from bereavement. Methods and analysis The proposed trial comprises three phases. Phase 1 consists of a review of the literature and semistructured interviews with key members of the target population to inform the development of a metacognitive therapy programme for Prolonged Grief. Phase 2 involves a randomised controlled trial to implement and evaluate the programme. Male and female adults (N=34) will be randomly assigned to either a wait list or an intervention group. Measures of PGD, anxiety, depression, rumination, metacognitions and quality of life will be taken pretreatment and posttreatment and at the 3-month and 6-month follow-up. The generalised linear mixed model will be used to assess treatment efficacy. Phase 3 will test the social validity of the programme. Discussion This study is the first empirical investigation of the efficacy of a targeted metacognitive treatment programme for PGD. A focus on identifying and changing the metacognitive mechanisms underpinning the development and maintenance of prolonged grief is likely to be beneficial to theory and practice. Ethics Ethics approval was obtained from Curtin University Human Research Ethics Committee (Approval number HR 41/2013.) Trial registration number ACTRN12613001270707. PMID:26646828

  4. The effects of the Make a Wish intervention on psychiatric symptoms and health-related quality of life of children with cancer: a randomised controlled trial.

    PubMed

    Shoshani, Anat; Mifano, Keren; Czamanski-Cohen, Johanna

    2016-05-01

    Children with life-threatening medical conditions frequently undergo invasive medical procedures that may elicit anxiety and distress. However, there are few empirically validated interventions that reduce mental health symptoms and increase the resilience of children during the acute stages of illness. This study aimed to evaluate the efficacy of the Make a Wish intervention for children with life-threatening cancer. The design was a wait-list-controlled trial with two parallel groups. Sixty-six children aged 5-12 with an initial diagnosis of life-threatening cancer were identified and randomly assigned to the Make a Wish intervention (n = 32) or a wait-list control group (n = 34). Children completed measures of psychiatric and health-related symptoms, positive and negative affect, hope, and optimism pre-intervention and post-intervention. After baseline data collection, children were interviewed and made an authentic wish that they wanted to come true. These wishes were made possible 5-6 months after baseline data collection, to fuel anticipation and excitement over the wish-fulfillment event. The post-intervention assessment point was 5 weeks after wish fulfillment (approximately 7 months after baseline data collection). Children in the intervention group exhibited a significant reduction in general distress (d = 0.54), depression (d = 0.70), and anxiety symptoms (d = 0.41), improved health-related quality of life (d = 0.59), hope (d = 0.71), and positive affect (d = 0.80) compared to decrease in positive affect and no significant changes in the other measures in the control group. These findings emphasize the role of hope and positive emotions in fostering the well-being of children who suffer from serious illnesses.

  5. Pelvic floor muscle training versus watchful waiting or pessary treatment for pelvic organ prolapse (POPPS): design and participant baseline characteristics of two parallel pragmatic randomized controlled trials in primary care.

    PubMed

    Wiegersma, Marian; Panman, Chantal M C R; Kollen, Boudewijn J; Vermeulen, Karin M; Schram, Aaltje J; Messelink, Embert J; Berger, Marjolein Y; Lisman-Van Leeuwen, Yvonne; Dekker, Janny H

    2014-02-01

    Pelvic floor muscle training (PFMT) and pessaries are commonly used in the conservative treatment of pelvic organ prolapse (POP). Because there is a lack of evidence regarding the optimal choice between these two interventions, we designed the "Pelvic Organ prolapse in primary care: effects of Pelvic floor muscle training and Pessary treatment Study" (POPPS). POPPS consists of two parallel open label randomized controlled trials performed in primary care, in women aged ≥55 years, recruited through a postal questionnaire. In POPPS trial 1, women with mild POP receive either PFMT or watchful waiting. In POPPS trial 2, women with advanced POP receive either PFMT or pessary treatment. Patient recruitment started in 2009 and was finished in December 2012. Primary outcome of both POPPS trials is improvement in POP-related symptoms. Secondary outcomes are quality of life, sexual function, POP-Q stage, pelvic floor muscle function, post-void residual volume, patients' perception of improvement, and costs. All outcomes are measured 3, 12, and 24 months after the start of treatment. Cost-effectiveness will be calculated based on societal costs, using the PFDI-20 and the EQ-5D as outcomes. In this paper the POPPS design, the encountered challenges and our solutions, and participant baseline characteristics are presented. For both trials the target numbers of patients in each treatment group are achieved, giving this study sufficient power to lead to promising results. Copyright © 2013 Elsevier Ireland Ltd. All rights reserved.

  6. Promoting gross motor skills and physical activity in childcare: A translational randomized controlled trial.

    PubMed

    Jones, Rachel A; Okely, Anthony D; Hinkley, Trina; Batterham, Marijka; Burke, Claire

    2016-09-01

    Educator-led programs for physical activity and motor skill development show potential but few have been implemented and evaluated using a randomized controlled design. Furthermore, few educator-led programs have evaluated both gross motor skills and physical activity. Therefore, the aim of this study was to evaluate a gross motor skill and physical activity program for preschool children which was facilitated solely by childcare educators. A six-month 2-arm randomized controlled trial was implemented between April and September 2012 in four early childhood centers in Tasmania, Australia. Educators participated in ongoing professional development sessions and children participated in structured physical activity lessons and unstructured physical activity sessions. In total, 150 children were recruited from four centers which were randomized to intervention or wait-list control group. Six early childhood educators from the intervention centers were trained to deliver the intervention. Gross motor skills were assessed using the Test of Gross Motor Development (2nd edition) and physical activity was measured objectively using GT3X+ Actigraph accelerometers. No statistically significant differences were identified. However, small to medium effect sizes, in favor of the intervention group, were evident for four of the five gross motor skills and the total gross motor skill score and small to medium effect sizes were reported for all physical activity outcomes. This study highlights the potential of educator-led physical activity interventions and supports the need for further translational trials within the early childhood sector. Copyright © 2015 Sports Medicine Australia. Published by Elsevier Ltd. All rights reserved.

  7. The placebo effect and its determinants in fibromyalgia: meta-analysis of randomised controlled trials.

    PubMed

    Chen, Xi; Zou, Kun; Abdullah, Natasya; Whiteside, Nicola; Sarmanova, Aliya; Doherty, Michael; Zhang, Weiya

    2017-07-01

    The aims of this study were to determine whether placebo treatment in randomised controlled trials (RCTs) is effective for fibromyalgia and to identify possible determinants of the magnitude of any such placebo effect. A systematic literature search was undertaken for RCTs in people with fibromyalgia that included a placebo and/or a no-treatment (observation only or waiting list) control group. Placebo effect size (ES) for pain and other outcomes was measured as the improvement of each outcome from baseline divided by the standard deviation of the change from baseline. This effect was compared with changes in the no-treatment control groups. Meta-analysis was undertaken to combine data from different studies. Subgroup analysis was conducted to identify possible determinants of the placebo ES. A total of 3912 studies were identified from the literature search. After scrutiny, 229 trials met the inclusion criteria. Participants who received placebo in the RCTs experienced significantly better improvements in pain, fatigue, sleep quality, physical function, and other main outcomes than those receiving no treatment. The ES of placebo for pain relief was clinically moderate (0.53, 95%CI 0.48 to 0.57). The ES increased with increasing strength of the active treatment, increasing participant age and higher baseline pain severity, but decreased in RCTS with more women and with longer duration of fibromyalgia. In addition, placebo treatment in RCTs is effective in fibromyalgia. A number of factors (expected strength of treatment, age, gender, disease duration) appear to influence the magnitude of the placebo effect in this condition.

  8. Internet Delivered Support for Tobacco Control in Dental Practice: Randomized Controlled Trial

    PubMed Central

    Richman, Joshua S; Ray, Midge N; Allison, Jeroan J; Gilbert, Gregg H; Shewchuk, Richard M; Kohler, Connie L; Kiefe, Catarina I

    2008-01-01

    Background The dental visit is a unique opportunity for tobacco control. Despite evidence of effectiveness in dental settings, brief provider-delivered cessation advice is underutilized. Objective To evaluate an Internet-delivered intervention designed to increase implementation of brief provider advice for tobacco cessation in dental practice settings. Methods Dental practices (N = 190) were randomized to the intervention website or wait-list control. Pre-intervention and after 8 months of follow-up, each practice distributed exit cards (brief patient surveys assessing provider performance, completed immediately after the dental visit) to 100 patients. Based on these exit cards, we assessed: whether patients were asked about tobacco use (ASK) and, among tobacco users, whether they were advised to quit tobacco (ADVISE). All intervention practices with follow-up exit card data were analyzed as randomized regardless of whether they participated in the Internet-delivered intervention. Results Of the 190 practices randomized, 143 (75%) dental practices provided follow-up data. Intervention practices’ mean performance improved post-intervention by 4% on ASK (29% baseline, adjusted odds ratio = 1.29 [95% CI 1.17-1.42]), and by 11% on ADVISE (44% baseline, OR = 1.55 [95% CI 1.28-1.87]). Control practices improved by 3% on ASK (Adj. OR 1.18 [95% CI 1.07-1.29]) and did not significantly improve in ADVISE. A significant group-by-time interaction effect indicated that intervention practices improved more over the study period than control practices for ADVISE (P = 0.042) but not for ASK. Conclusion This low-intensity, easily disseminated intervention was successful in improving provider performance on advice to quit. Trial Registration clinicaltrials.gov NCT00627185; http://clinicaltrials.gov/ct2/show/NCT00627185 (Archived by WebCite at http://www.webcitation.org/5c5Kugvzj) PMID:18984559

  9. The influence of parametric and external noise in act-and-wait control with delayed feedback.

    PubMed

    Wang, Jiaxing; Kuske, Rachel

    2017-11-01

    We apply several novel semi-analytic approaches for characterizing and calculating the effects of noise in a system with act-and-wait control. For concrete illustration, we apply these to a canonical balance model for an inverted pendulum to study the combined effect of delay and noise within the act-and-wait setting. While the act-and-wait control facilitates strong stabilization through deadbeat control, a comparison of different models with continuous vs. discrete updating of the control strategy in the active period illustrates how delays combined with the imprecise application of the control can seriously degrade the performance. We give several novel analyses of a generalized act-and-wait control strategy, allowing flexibility in the updating of the control strategy, in order to understand the sensitivities to delays and random fluctuations. In both the deterministic and stochastic settings, we give analytical and semi-analytical results that characterize and quantify the dynamics of the system. These results include the size and shape of stability regions, densities for the critical eigenvalues that capture the rate of reaching the desired stable equilibrium, and amplification factors for sustained fluctuations in the context of external noise. They also provide the dependence of these quantities on the length of the delay and the active period. In particular, we see that the combined influence of delay, parametric error, or external noise and on-off control can qualitatively change the dynamics, thus reducing the robustness of the control strategy. We also capture the dependence on how frequently the control is updated, allowing an interpolation between continuous and frequent updating. In addition to providing insights for these specific models, the methods we propose are generalizable to other settings with noise, delay, and on-off control, where analytical techniques are otherwise severely scarce.

  10. Individual differences in the efficacy of a short theory of mind intervention for children with autism spectrum disorder: a randomized controlled trial.

    PubMed

    Hoddenbach, Elske; Koot, Hans M; Clifford, Pamela; Gevers, Carolien; Clauser, Cassandra; Boer, Frits; Begeer, Sander

    2012-11-09

    Having a 'theory of mind', or having the ability to attribute mental states to oneself or others, is considered one of the most central domains of impairment among children with an autism spectrum disorder (ASD). Many interventions focus on improving theory of mind skills in children with ASD. Nonetheless, the empirical evidence for the effect of these interventions is limited. The main goal of this study is to examine the effectiveness of a short theory of mind intervention for children with ASD. A second objective is to determine which subgroups within the autism spectrum profit most from the intervention. This study is a randomized controlled trial. One hundred children with ASD, aged 7 to 12 years will be randomly assigned to an intervention or a waiting list control group. Outcome measures include the completion of theory of mind and emotion understanding tasks, and parent and teacher questionnaires on children's social skills. Follow-up data for the intervention group will be collected 6 months after the interventions. This study evaluates the efficacy of a theory of mind intervention for children with ASD. Hypotheses, strengths, and limitations of the study are discussed. Netherlands Trial Register NTR2327.

  11. Financial cost to institutions on patients waiting for gall bladder disease surgery.

    PubMed

    Waqas, Ahmed; Qasmi, Shahzad Ahmed; Kiani, Faran; Raza, Ahmed; Khan, Khizar Ishtiaque; Manzoor, Shazia

    2014-01-01

    The aim of this study was to determine the financial costs to institution on patients waiting for gall bladder disease surgery and suggest measures to reduce them. This multi-centre prospective descriptive survey was performed on all patients who underwent an elective cholecystectomy by three consultants at secondary care hospitals in Pakistan between Jan 2010 to Jan 2012. Data was collected on demographics, the duration of mean waiting time, specific indications and nature of disease for including the patients in the waiting list, details of emergency re-admissions while awaiting surgery, investigations done, treatment given and expenditures incurred on them during these episodes. A total of 185 patients underwent elective open cholecystectomy. The indications for listing the patients for surgery were biliary colic in 128 patients (69%), acute cholecystitis in 43 patients (23%), obstructive jaundice in 8 patients (4.5%) and acute pancreatitis in 6 patients (3.2%). 146 (78.9%) and 39 (21.1%) of patients were listed as outdoor electives and indoor emergencies respectively. Of the 185 patients, 54 patients (29.2%) were re-admitted. Financial costs in Pakistani rupees per episode of readmission were 23050 per episode in total and total money spent on all readmissions was Rs. 17,05,700/-. Financial costs on health care institutions due to readmissions in patients waiting for gall bladder disease surgery are high. Identifying patients at risk for these readmissions and offering them early laparoscopic cholecystectomy is very important.

  12. Workstyle Intervention for the Prevention of Work-Related Upper Extremity Problems: A Randomized Controlled Trial

    DTIC Science & Technology

    2005-01-01

    questions are about how you feel and how things have been with you during the past 4 weeks. For each question, please give the one answer that...better overall treatment gains because a focus on workstyle may simultaneously address multiple risk factors for WRUEDs. This study compared treatment...alone. Symptomatic workers were recruited to participate in one of the three intervention conditions or in a wait-list control condition, where

  13. A Randomized Controlled Trial of Koru: A Mindfulness Program for College Students and Other Emerging Adults

    ERIC Educational Resources Information Center

    Greeson, Jeffrey M.; Juberg, Michael K.; Maytan, Margaret; James, Kiera; Rogers, Holly

    2014-01-01

    Objective: To evaluate the effectiveness of Koru, a mindfulness training program for college students and other emerging adults. Participants: Ninety students (66% female, 62% white, 71% graduate students) participated between Fall 2012 and Spring 2013. Methods: Randomized controlled trial. It was hypothesized that Koru, compared with a wait-list…

  14. The effects of the Bali Yoga Program (BYP-BC) on reducing psychological symptoms in breast cancer patients receiving chemotherapy: results of a randomized, partially blinded, controlled trial.

    PubMed

    Lanctôt, Dominique; Dupuis, Gilles; Marcaurell, Roger; Anestin, Annélie S; Bali, Madan

    2016-12-01

    Background Several cognitive behavioral interventions have been reported to reduce psychological symptoms in breast cancer (BC) patients. The goal of this study was to evaluate the effects of a yoga intervention in reducing depression and anxiety symptoms in BC patients. Methods This study was a randomized, partially blinded, controlled trial comparing a standardized yoga intervention to standard care. It was conducted at three medical centers in Montreal, Canada. Eligible patients were women diagnosed with stage I-III BC receiving chemotherapy. Participants were randomly assigned to receive yoga intervention immediately (experimental group, n=58) or after a waiting period (n=43 control group). The Bali Yoga Program for Breast Cancer Patients (BYP-BC) consisted of 23 gentle Hatha asanas (poses), 2 prayanamas (breathing techniques), shavasanas (relaxation corpse poses) and psychoeducational themes. Participants attended eight weekly sessions lasting 90 min each and received a DVD for home practice with 20- and 40-min sessions. Participants in the wait list control group received standard care during the 8-week waiting period. Results A total of 101 participants took part in the final intention-to-treat analyses. The repeated measures analyses demonstrated that depression symptoms increased in the control group (p=0.007), while no change was reported in the BYP-BC group (p=0.29). Also, depression symptoms decreased in the WL control group after receiving the BYP-BC intervention (p=0.03). Finally, there was no statistical significance in terms of anxiety symptoms (p=0.10). Conclusions Results support the BYP-BC intervention as a beneficial means of reducing and preventing the worsening of depression symptoms during chemotherapy treatment.

  15. The efficacy of Life Review Therapy combined with Memory Specificity Training (LRT-MST) targeting cancer patients in palliative care: A randomized controlled trial.

    PubMed

    Kleijn, Gitta; Lissenberg-Witte, Birgit I; Bohlmeijer, Ernst T; Steunenberg, Bas; Knipscheer-Kuijpers, Kitty; Willemsen, Vincent; Becker, Annemarie; Smit, Egbert F; Eeltink, Corien M; Bruynzeel, Anna M E; van der Vorst, Maurice; de Bree, Remco; Leemans, C René; van den Brekel, Michiel W M; Cuijpers, Pim; Verdonck-de Leeuw, Irma M

    2018-01-01

    The aim of this study was to evaluate the efficacy of an intervention combining Life Review Therapy (LRT) and Memory Specificity Training (MST) (LRT-MST) to improve ego-integrity and despair among cancer patients in palliative care. In this multicentre randomized controlled trial, cancer patients in palliative care were randomized to the intervention group (LRT-MST; n = 55) or waiting-list control group (n = 52). LRT-MST is a 4-session home-based psychological intervention that aims to retrieve specific positive memories, to re-evaluate life events and to reconstruct the story of a patient's life, including the diagnosis of incurable cancer. Outcome measures were ego-integrity and despair (NEIS), psychological distress, anxiety and depression (HADS), quality of life (EORTC QLQ-C15-PAL), and specificity of the autobiographical memory (AMT). NEIS, HADS and EORTC QLQ-C15-PAL were assessed at baseline (T0), 1 month later (post-treatment; T1), and at 1 month follow-up (T2). AMT was assessed at T0 and T1. Linear mixed models (intention to treat) were used to assess group differences in changes over time. Independent samples t-tests were used to assess group differences at T0, T1, and T2, and effect sizes (ES) were calculated at T1 and T2. The course of ego-integrity (not despair) improved significantly over time (p = .007) in the intervention group compared to the waiting-list control group, with moderate, but insignificant, effect sizes at T1 (ES = .42) and T2 (ES = .48). Compliance rate was 69% and total dropout rate was 28%, both primarily related to disease progression and death. LRT-MST seems effective among cancer patients in palliative care to improve the course of ego-integrity.

  16. Skills Training via Smartphone App for University Students with Excessive Alcohol Consumption: a Randomized Controlled Trial.

    PubMed

    Gajecki, Mikael; Andersson, Claes; Rosendahl, Ingvar; Sinadinovic, Kristina; Fredriksson, Morgan; Berman, Anne H

    2017-10-01

    University students in a study on estimated blood alcohol concentration (eBAC) feedback apps were offered participation in a second study, if reporting continued excessive consumption at 6-week follow-up. This study evaluated the effects on excessive alcohol consumption of offering access to an additional skills training app. A total of 186 students with excessive alcohol consumption were randomized to an intervention group or a wait list group. Both groups completed online follow-ups regarding alcohol consumption after 6 and 12 weeks. Wait list participants were given access to the intervention at 6-week follow-up. Assessment-only controls (n = 144) with excessive alcohol consumption from the ongoing study were used for comparison. The proportion of participants with excessive alcohol consumption declined in both intervention and wait list groups compared to controls at first (p < 0.001) and second follow-ups (p = 0.054). Secondary analyses showed reductions for the intervention group in quantity of drinking at first follow-up (-4.76, 95% CI [-6.67, -2.85], Z = -2.09, p = 0.037) and in frequency of drinking at both follow-ups (-0.83, 95% CI [-1.14, -0.52], Z = -2.04, p = 0.041; -0.89, 95% CI [-1.16, -0.62], Z = -2.12, p = 0.034). The odds ratio for not having excessive alcohol consumption among men in the intervention group compared to male controls was 2.68, 95% CI [1.37, 5.25] (Z = 2.88, p = 0.004); the figure for women was 1.71, 95% CI [1.11, 2.64] (Z = 2.41, p = 0.016). Skills training apps have potential for reducing excessive alcohol use among university students. Future research is still needed to disentangle effects of app use from emailed feedback on excessive alcohol consumption and study participation. NCT02064998.

  17. Randomized Clinical Trial Replication of a Psychosocial Treatment for Children with High-Functioning Autism Spectrum Disorders

    ERIC Educational Resources Information Center

    Thomeer, Marcus L.; Lopata, Christopher; Volker, Martin A.; Toomey, Jennifer A.; Lee, Gloria K.; Smerbeck, Audrey M.; Rodgers, Jonathan D.; McDonald, Christin A.; Smith, Rachael A.

    2012-01-01

    This replication randomized clinical trial examined the efficacy of a comprehensive psychosocial intervention for children aged 7 to 12 years with high-functioning autism spectrum disorders (HFASDs). Participants were randomly assigned to treatment or wait-list conditions. Treatment included instruction and therapeutic activities targeting social…

  18. The study protocol of a cluster-randomised controlled trial of family-mediated personalised activities for nursing home residents with dementia

    PubMed Central

    2012-01-01

    Background Following admission to a nursing home, the feelings of depression and burden that family carers may experience do not necessarily diminish. Additionally, they may experience feelings of guilt and grief for the loss of a previously close relationship. At the same time, individuals with dementia may develop symptoms of depression and agitation (BPSD) that may be related to changes in family relationships, social interaction and stimulation. Until now, interventions to alleviate carer stress and BPSD have treated carers and relatives separately rather than focusing on maintaining or enhancing their relationships. One-to-one structured activities have been shown to reduce BPSD and also improve the caring experience, but barriers such as a lack of resources impede the implementation of activities in aged care facilities. The current study will investigate the effect of individualised activities based on the Montessori methodology administered by family carers in residential care. Methods/Design We will conduct a cluster-randomised trial to train family carers in conducting personalised one-to-one activities based on the Montessori methodology with their relatives. Montessori activities derive from the principles espoused by Maria Montessori and subsequent educational theorists to promote engagement in learning, namely task breakdown, guided repetition, progression in difficulty from simple to complex, and the careful matching of demands to levels of competence. Persons with dementia living in aged care facilities and frequently visiting family carers will be included in the study. Consented, willing participants will be randomly assigned by facility to a treatment condition using the Montessori approach or a control waiting list condition. We hypothesise that family carers conducting Montessori-based activities will experience improvements in quality of visits and overall relationship with the resident as well as higher self-rated mastery, fewer depressive

  19. Internet-Based Self-Help with Therapist Feedback and in Vivo Group Exposure for Social Phobia: A Randomized Controlled Trial

    ERIC Educational Resources Information Center

    Andersson, Gerhard; Carlbring, Per; Holmstrom, Annelie; Sparthan, Elisabeth; Furmark, Tomas; Nilsson-Ihrfelt, Elisabeth; Buhrman, Monica; Ekselius, Lisa

    2006-01-01

    Sixty-four individuals with social phobia (social anxiety disorder) were assigned to a multimodal cognitive-behavioral treatment package or to a waiting list control group. Treatment consisted of a 9-week, Internet-delivered, self-help program that was combined with 2 group exposure sessions in real life and minimal therapist contact via e-mail.…

  20. Effectiveness of a web-based treatment program using intensive therapeutic support for female patients with bulimia nervosa, binge eating disorder and eating disorders not otherwise specified: study protocol of a randomized controlled trial.

    PubMed

    ter Huurne, Elke D; Postel, Marloes G; de Haan, Hein A; DeJong, Cor A J

    2013-11-16

    Disordered eating behavior and body dissatisfaction affect a large proportion of the Dutch population and account for severe psychological, physical and social morbidity. Yet, the threshold for seeking professional care is still high. In the Netherlands, only 7.5% of patients with bulimia nervosa and 33% of patients with anorexia nervosa are treated within the mental health care system. Easily accessible and low-threshold interventions, therefore, are needed urgently. The internet has great potential to offer such interventions. The aim of this study is to determine whether a web-based treatment program for patients with eating disorders can improve eating disorder psychopathology among female patients with bulimia nervosa, binge eating disorder and eating disorders not otherwise specified. This randomized controlled trial will compare the outcomes of an experimental treatment group to a waiting list control group. In the web-based treatment program, participants will communicate personally and asynchronously with their therapists exclusively via the internet. The first part of the program will focus on analyzing eating attitudes and behaviors. In the second part of the program participants will learn how to change their attitudes and behaviors. Participants assigned to the waiting list control group will receive no-reply email messages once every two weeks during the waiting period of 15 weeks, after which they can start the program. The primary outcome measure is an improvement in eating disorder psychopathology as determined by the Eating Disorder Examination Questionnaire. Secondary outcomes include improvements in body image, physical and mental health, body weight, self-esteem, quality of life, and social contacts. In addition, the participants' motivation for treatment and their acceptability of the program and the therapeutic alliance will be measured. The study will follow the recommendations in the CONSORT statement relating to designing and reporting on

  1. Quasi-experimental trial of diabetes Self-Management Automated and Real-Time Telephonic Support (SMARTSteps) in a Medicaid managed care plan: study protocol

    PubMed Central

    2012-01-01

    Background Health information technology can enhance self-management and quality of life for patients with chronic disease and overcome healthcare barriers for patients with limited English proficiency. After a randomized controlled trial of a multilingual automated telephone self-management support program (ATSM) improved patient-centered dimensions of diabetes care in safety net clinics, we collaborated with a nonprofit Medicaid managed care plan to translate research into practice, offering ATSM as a covered benefit and augmenting ATSM to promote medication activation. This paper describes the protocol of the Self-Management Automated and Real-Time Telephonic Support Project (SMARTSteps). Methods/Design This controlled quasi-experimental trial used a wait-list variant of a stepped wedge design to enroll 362 adult health plan members with diabetes who speak English, Cantonese, or Spanish and receive care at 4 publicly-funded clinics. Through language-stratified randomization, participants were assigned to four intervention statuses: SMARTSteps-ONLY, SMARTSteps-PLUS, or wait-list for either intervention. In addition to usual primary care, intervention participants received 27 weekly calls in their preferred language with rotating queries and response-triggered education about self-care, medication adherence, safety concerns, psychological issues, and preventive services. Health coaches from the health plan called patients with out-of-range responses for collaborative goal setting and action planning. SMARTSteps-PLUS also included health coach calls to promote medication activation, adherence and intensification, if triggered by ATSM-reported non-adherence, refill non-adherence from pharmacy claims, or suboptimal cardiometabolic indicators. Wait-list patients crossed-over to SMARTSteps-ONLY or -PLUS at 6 months. For participants who agreed to structured telephone interviews at baseline and 6 months (n = 252), primary outcomes will be changes in quality of life and

  2. Feasibility and Acceptability of a Web-Based Treatment with Telephone Support for Postpartum Women With Anxiety: Randomized Controlled Trial.

    PubMed

    Ashford, Miriam T; Olander, Ellinor K; Rowe, Heather; Fisher, Jane Rw; Ayers, Susan

    2018-04-20

    Postpartum anxiety can have adverse effects on the mother and child if left untreated. Time constraints and stigma are common barriers to postpartum treatment. Web-based treatments offer potential flexibility and anonymity. What Am I Worried About (WaWa) is a self-guided treatment based on cognitive-behavioral and mindfulness principles for women experiencing postpartum anxiety. WaWa was developed in Australia and consists of 9 modules with optional weekly telephone support. WaWa was adapted to a Web-based version for use in England (Internet-based What Am I Worried About, iWaWa). This study aimed to investigate the feasibility (engagement and usability) and acceptability (usefulness, satisfaction, and helpfulness) of iWaWa among English postpartum women with anxiety. Postpartum (<12 months) women with mild-to-severe anxiety were recruited anonymously via social media during an 8-week period. Participants were randomized to the iWaWa treatment (8 weeks) or wait-list control group. Treatment and study feasibility and acceptability were assessed after the treatment, and anxiety symptoms were assessed at baseline, 8 weeks postrandomization, and 12 weeks postrandomization (treatment group only) using Web-based questionnaires. Semistructured telephone interviews were carried out after the treatment period for a more in-depth exploration of treatment acceptability and feasibility. A total of 89 eligible women were recruited through social media and randomized into the treatment (n=46) or wait-list control group (n=43). Women were predominantly Caucasian, well-educated, married, on maternity leave, first-time mothers and reported moderate levels of anxiety. Dropout rates were high, especially in the treatment group (treatment: 82%, 38/46; wait-list control: 51%, 22/43). A total of 26 women started iWaWa with only 2 women completing all 9 modules. Quantitative and qualitative data suggest iWaWa was experienced as generally useful and helpful. Participants enjoyed i

  3. Home-based exercise program and fall-risk reduction in older adults with multiple sclerosis: phase 1 randomized controlled trial.

    PubMed

    Sosnoff, Jacob J; Finlayson, Marcia; McAuley, Edward; Morrison, Steve; Motl, Robert W

    2014-03-01

    To determine the feasibility, safety, and efficacy of a home-based exercise intervention targeting fall risk in older adults with multiple sclerosis. A randomized controlled pilot trial. A home-based exercise program. Participants were randomly allocated to either a home-based exercise intervention group (n = 13) or a waiting list control group (n = 14). The exercise group completed exercises targeting lower muscle strength and balance three times a week for 12 weeks. The control group continued normal activity. Fall risk (Physiological Profile Assessment scores), balance (Berg Balance Scale), and walking testing prior to and immediately following the 12-week intervention. Each outcome measure was placed in an analysis of covariance with group as the between-subject factor and baseline values as the covariate. Effect sizes were calculated. Twelve participants from the control group and ten from the exercise group completed the study. There were no related adverse events. Fall risk was found to decrease in the exercise group following the intervention (1.1 SD 1.0 vs. 0.6 SD 0.6) while there was an increase in fall risk in the control group (1.9 SD 1.5 vs. 2.2 SD 1.9). Effect sizes for most outcomes were large (η(2) > 0.15). Home-based exercise was found to be feasible, safe, and effective for reducing physiological fall risk in older adults with multiple sclerosis. Our findings support the implementation of a larger trial to reduce fall risk in persons with multiple sclerosis.

  4. Brief hypnotherapeutic-behavioral intervention for functional abdominal pain and irritable bowel syndrome in childhood: a randomized controlled trial.

    PubMed

    Gulewitsch, Marco Daniel; Müller, Judith; Hautzinger, Martin; Schlarb, Angelika Anita

    2013-08-01

    Functional abdominal pain and irritable bowel syndrome are two prevalent disorders in childhood which are associated with recurrent or chronic abdominal pain, disabilities in daily functioning, and reduced quality of life. This study aimed to evaluate a brief hypnotherapeutic-behavioral intervention program in a prospective randomized controlled design. Thirty-eight children, 6 to 12 years of age, and their parents were randomly assigned to a standardized hypnotherapeutic-behavioral treatment (n = 20) or to a waiting list condition (n = 18). Both groups were reassessed 3 months after beginning. Primary outcome variables were child-completed pain measures and pain-related disability. Secondary outcome variables were parent-completed measures of their children's pain and pain-related disability. Health-related quality of life from both perspectives also served as a secondary outcome. In the treatment group, 11 of 20 children (55.0%) showed clinical remission (>80% improvement), whereas only one child (5.6%) in the waiting list condition was classified as responder. Children in the treatment group reported a significantly greater reduction of pain scores and pain-related disability than children of the waiting list condition. Parental ratings also showed a greater reduction of children's abdominal pain and pain-related disability. Health-related quality of life did not increase significantly. Hypnotherapeutic and behavioral interventions are effective in treating children with long-standing AP. Treatment success of this brief program should be further evaluated against active interventions with a longer follow-up.

  5. Goal management training of executive functions in patients with spina bifida: a randomized controlled trial.

    PubMed

    Stubberud, Jan; Langenbahn, Donna; Levine, Brian; Stanghelle, Johan; Schanke, Anne-Kristine

    2013-07-01

    Executive dysfunction causes significant real-life disability for patients with spina bifida (SB). However, no previous research has been directed toward the amelioration of executive functioning deficits amongst persons with SB. Goal Management Training (GMT) is a compensatory cognitive rehabilitation approach, addressing underlying deficits in sustained attention to improve executive function. GMT has received empirical support in studies of other patient groups. The purpose of the present study was to determine the efficacy of GMT in treating subjects with SB, using inpatient intervention periods. We hypothesized post-intervention changes in scores on neuropsychological measures to reflect improved attentional control, including sustained attention and inhibitory control. Thirty-eight adult subjects with SB were included in this randomized controlled trial. Inclusion was based upon the presence of executive functioning complaints. Experimental subjects (n = 24) received 21 hr of GMT, with efficacy of GMT being compared to results of subjects in a wait-list condition (n = 14). All subjects were assessed at baseline, post-intervention, and at 6-month follow-up. Findings indicated superior effects of GMT on domain-specific neuropsychological measures and on a functional "real-life" measure, all lasting at least 6 months post-treatment. These results show that deficits in executive functioning can be ameliorated in patients with congenital brain dysfunction.

  6. Managing stress and anxiety through qigong exercise in healthy adults: a systematic review and meta-analysis of randomized controlled trials

    PubMed Central

    2014-01-01

    Background An increasing number of studies have documented the effectiveness of qigong exercise in helping people reduce psychological stress and anxiety, but there is a scarcity of systematic reviews evaluating evidence from randomized controlled trials (RCTs) conducted among healthy subjects. Methods Thirteen databases were searched for RCTs from their inception through June 2013. Effects of qigong exercise were pooled across trials. Standardized mean differences (SMDs) were calculated for the pooled effects. Heterogeneity was assessed using the I 2 test. The risk of bias was assessed using the Cochrane criteria. Results Seven RCTs met the inclusion criteria. Two RCTs suggested that qigong exercise immediately relieved anxiety among healthy adults, compared to lecture attendance and structured movements only. Four RCTs suggested qigong exercise relieved anxiety (pooled SMD = -0.75; 95% CI, -1.11 to -0.40), and three RCTs suggested that qigong exercise reduced stress (pooled SMD = -0.88; 95% CI, -1.22 to -0.55) among healthy subjects following one to three months of qigong practice, compared to wait-list controls. Conclusions The available evidence suggests that qigong exercise reduces stress and anxiety in healthy adults. However, given the limited number of RCTs and their methodological flaws, further rigorously designed RCTs are needed. PMID:24400778

  7. Evaluating the (cost-)effectiveness of guided and unguided Internet-based self-help for problematic alcohol use in employees--a three arm randomized controlled trial.

    PubMed

    Boß, Leif; Lehr, Dirk; Berking, Matthias; Riper, Heleen; Schaub, Michael Patrick; Ebert, David Daniel

    2015-10-12

    Problematic alcohol consumption is associated with a high disease burden for affected individuals and has a detrimental impact on companies and society due to direct and indirect health costs. This protocol describes a study design to evaluate the (cost)-effectiveness of a guided and unguided Internet-based self-help intervention for employees called "GET.ON Clever weniger trinken" (be smart - drink less) compared to a waiting list control group. In a three-arm randomized controlled trial, 528 German adults who are currently members of the workforce will be recruited by occupational health departments of major health insurance companies. Employees aged 18 and older displaying problematic drinking patterns (>21/14 drinks per week and an AUDIT score > 8/6 for men/women) will be randomly assigned to one of three following study conditions: 1. unguided web-based self-help for problematic drinking, 2. adherence-focused guided self-help, and 3. waiting list control. Self-report data will be collected at baseline (T1), 6 weeks (T2), and 6 months (T3) after randomization. The primary outcome will be the reduction of alcohol standard units during the 7 days prior to T2, using the Timeline Followback method. Cost-effectiveness analyses to determine direct and indirect costs will be conducted from the perspectives of employers and the society. Data will be analyzed on an intention-to-treat basis and per protocol. There is a need to identify effective low-threshold solutions to improve ill-health and reduce the negative economic consequences due to problematic alcohol drinking in workforces. If the proposed web-based intervention proves both to be efficacious and cost-effective, it may be a useful tool to increase utilization rates of interventions for problematic drinking in occupational settings. German Register of Clinical Studies (DRKS): DRKS00006105 , date of registration: 2014-07-07.

  8. Cognitive rehabilitation in patients with gliomas: a randomized, controlled trial.

    PubMed

    Gehring, Karin; Sitskoorn, Margriet M; Gundy, Chad M; Sikkes, Sietske A M; Klein, Martin; Postma, Tjeerd J; van den Bent, Martin J; Beute, Guus N; Enting, Roelien H; Kappelle, Arnoud C; Boogerd, Willem; Veninga, Theo; Twijnstra, Albert; Boerman, Dolf H; Taphoorn, Martin J B; Aaronson, Neil K

    2009-08-01

    Patients with gliomas often experience cognitive deficits, including problems with attention and memory. This randomized, controlled trial evaluated the effects of a multifaceted cognitive rehabilitation program (CRP) on cognitive functioning and selected quality-of-life domains in patients with gliomas. One hundred forty adult patients with low-grade and anaplastic gliomas, favorable prognostic factors, and both subjective cognitive symptoms and objective cognitive deficits were recruited from 11 hospitals in the Netherlands. Patients were randomly assigned to an intervention group or to a waiting-list control group. The intervention incorporated both computer-based attention retraining and compensatory skills training of attention, memory, and executive functioning. Participants completed a battery of neuropsychological (NP) tests and self-report questionnaires on cognitive functioning, fatigue, mental health-related quality of life, and community integration at baseline, after completion of the CRP, and at 6-month follow-up. At the immediate post-treatment evaluation, statistically significant intervention effects were observed for measures of subjective cognitive functioning and its perceived burden but not for the objective NP outcomes or for any of the other self-report measures. At the 6-month follow-up, the CRP group performed significantly better than the control group on NP tests of attention and verbal memory and reported less mental fatigue. Group differences in other subjective outcomes were not significant at 6 months. The CRP has a salutary effect on short-term cognitive complaints and on longer-term cognitive performance and mental fatigue. Additional research is needed to identify which elements of the intervention are most effective.

  9. The efficacy of eye movement desensitization and reprocessing for post-traumatic stress disorder and depression among Syrian refugees: results of a randomized controlled trial.

    PubMed

    Acarturk, C; Konuk, E; Cetinkaya, M; Senay, I; Sijbrandij, M; Gulen, B; Cuijpers, P

    2016-09-01

    Previous research indicates a high prevalence of post-traumatic stress disorder (PTSD) and depression among refugees. Eye movement desensitization and reprocessing (EMDR) is an effective treatment for PTSD for victims of natural disasters, car accidents or other traumatic events. The current study examined the effect of EMDR on symptoms of PTSD and depression by comparing the treatment with a wait-list control condition in Syrian refugees. Adult refugees located in Kilis Refugee Camp at the Turkish-Syrian border with a PTSD diagnosis were randomly allocated to either EMDR (n = 37) or wait-list control (n = 33) conditions. All participants were assessed with the Mini-International Neuropsychiatric Interview Plus at pre-intervention, at 1 week after finishing the intervention and at 5 weeks after finishing the intervention. The main outcome measures were the Harvard Trauma Questionnaire (HTQ) and the Impact of Event Scale-Revised. The Beck Depression Inventory and the Hopkins Symptoms Checklist-25 were included as secondary outcome measures. The Trial Registration no. is NCT01847742. Mixed-model analyses adjusted for the baseline scores indicated a significant effect of group at post-treatment indicating that the EMDR therapy group showed a significantly larger reduction of PTSD symptoms as assessed with the HTQ. Similar findings were found on the other outcome measures. There was no effect of time or group × time interaction on any measure, showing that the difference between the groups at the post-treatment was maintained to the 5-week follow-up. EMDR may be effective in reducing PTSD and depression symptoms among Syrian refugees with PTSD located in a refugee camp.

  10. Effect of volunteering on risk factors for cardiovascular disease in adolescents: a randomized controlled trial.

    PubMed

    Schreier, Hannah M C; Schonert-Reichl, Kimberly A; Chen, Edith

    2013-04-01

    The idea that individuals who help others incur health benefits themselves suggests a novel approach to improving health while simultaneously promoting greater civic orientation in our society. The present study is the first experimental trial, to our knowledge, of whether regular volunteering can reduce cardiovascular risk factors in adolescents. To test a novel intervention that assigned adolescents to volunteer with elementary school-aged children as a means of improving adolescents' cardiovascular risk profiles. Randomized controlled trial, with measurements taken at baseline and 4 months later (postintervention). Urban public high school in western Canada. One hundred six 10th-grade high school students who were fluent in English and free of chronic illnesses. Weekly volunteering with elementary school-aged children for 2 months vs wait-list control group. Cardiovascular risk markers of C-reactive protein level, interleukin 6 level, total cholesterol level, and body mass index. No statistically significant group differences were found at baseline. Postintervention, adolescents in the intervention group showed significantly lower interleukin 6 levels (log10 mean difference, 0.13; 95% CI, 0.004 to 0.251), cholesterol levels (log10 mean difference, 0.03; 95% CI, 0.003 to 0.059), and body mass index (mean difference, 0.39; 95% CI, 0.07 to 0.71) compared with adolescents in the control group. Effects for C-reactive protein level were marginal (log10 mean difference, 0.13; 95% CI, -0.011 to 0.275). Preliminary analyses within the intervention group suggest that those who increased the most in empathy and altruistic behaviors, and who decreased the most in negative mood, also showed the greatest decreases in cardiovascular risk over time. Adolescents who volunteer to help others also benefit themselves, suggesting a novel way to improve health. TRIAL REGISTRATION clinicaltrials.gov Identifier: NCT01698034.

  11. A protocol for a pragmatic randomized controlled trial evaluating outcomes of emergency nurse practitioner service.

    PubMed

    Jennings, Natasha; Gardner, Glenn; O'Reilly, Gerard

    2014-09-01

    To evaluate emergency nurse practitioner service effectiveness on outcomes related to quality of care and service responsiveness. Increasing service pressures in the emergency setting have resulted in the adoption of service innovation models; the most common and rapidly expanding of these is the emergency nurse practitioner. The delivery of high quality patient care in the emergency department is one of the most important service indicators to be measured in health services today. The rapid uptake of emergency nurse practitioner service in Australia has outpaced the capacity to evaluate this model in outcomes related to safety and quality of patient care. Pragmatic randomized controlled trial at one site with 260 participants. This protocol describes a definitive prospective randomized controlled trial, which will examine the impact of emergency nurse practitioner service on key patient care and service indicators. The study control will be standard emergency department care. The intervention will be emergency nurse practitioner service. The primary outcome measure is pain score reduction and time to analgesia. Secondary outcome measures are waiting time, number of patients who did not wait, length of stay in the emergency department and representations within 48 hours. Scant research enquiry evaluating emergency nurse practitioner service on patient effectiveness and service responsiveness exists currently. This study is a unique trial that will test the effectiveness of the emergency nurse practitioner service on patients who present to the emergency department with pain. The research will provide an opportunity to further evaluate emergency nurse practitioner models of care and build research capacity into the workforce. Trial registration details: Australian and New Zealand Clinical Trials Registry dated 18th August 2013, ACTRN12613000933752. © 2014 John Wiley & Sons Ltd.

  12. Internet-based treatment for adults with depressive symptoms: randomized controlled trial.

    PubMed

    Warmerdam, Lisanne; van Straten, Annemieke; Twisk, Jos; Riper, Heleen; Cuijpers, Pim

    2008-11-20

    Many depressed people do not receive help for their symptoms, and there are various barriers that impede help-seeking. The Internet may offer interesting alternatives for reaching and helping people with depression. Depression can be treated effectively with Internet-based cognitive behavioral therapy (CBT), but a short intervention based on problem solving therapy (PST) could constitute a worthwhile alternative to CBT. In this study we evaluated the effectiveness of Internet-based CBT and Internet-based PST in comparison to a waiting list control group (WL), and we determined the differences between the two treatments. We conducted a 3-arm randomized controlled trial to compare CBT, PST, and WL. The main inclusion criterion was presence of depressive symptoms (>or= 16 on the Center for Epidemiological Studies Depression scale). CBT and PST consisted of eight and five weekly lessons respectively. Participants were supported by email. Self-report measures of depression, anxiety, and quality of life were completed at pretest and after 5, 8, and 12 weeks. A total of 263 participants were randomized to the three conditions (CBT: n=88; PST: n=88; WL: n=87). Of the 263 participants, 184 (70%) completed questionnaires after 5 weeks, 173 (66%) after 8 weeks, and 151 (57%) after 12 weeks. Between-group effect sizes for depressive symptoms were 0.54 for CBT after 8 weeks (95% confidence interval (CI): 0.25 - 0.84) and 0.47 for PST after 5 weeks (95% CI: 0.17 - 0.77). These effects were further improved at 12 weeks (CBT: 0.69, 95% CI: 0.41 - 0.98; PST: 0.65, 95% CI: 0.36 - 0.95). For anxiety, effect sizes were also at a medium level. Effect sizes for quality of life were low. The number of participants showing clinically significant change at 12 weeks was significantly higher for CBT (n = 34, 38.6%) and PST (n = 30, 34.1%), compared to WL (n = 0). Both Internet-based treatments are effective in reducing depressive symptoms, although the effect of PST is realized more quickly

  13. Effect of socioeconomic deprivation on waiting time for cardiac surgery: retrospective cohort study

    PubMed Central

    Pell, Jill P; Pell, Alastair C H; Norrie, John; Ford, Ian; Cobbe, Stuart M

    2000-01-01

    Objective To determine whether the priority given to patients referred for cardiac surgery is associated with socioeconomic status. Design Retrospective study with multivariate logistic regression analysis of the association between deprivation and classification of urgency with allowance for age, sex, and type of operation. Multivariate linear regression analysis was used to determine association between deprivation and waiting time within each category of urgency, with allowance for age, sex, and type of operation. Setting NHS waiting lists in Scotland. Participants 26 642 patients waiting for cardiac surgery, 1 January 1986 to 31 December 1997. Main outcome measures Deprivation as measured by Carstairs deprivation category. Time spent on NHS waiting list. Results Patients who were most deprived tended to be younger and were more likely to be female. Patients in deprivation categories 6 and 7 (most deprived) waited about three weeks longer for surgery than those in category 1 (mean difference 24 days, 95% confidence interval 15 to 32). Deprived patients had an odds ratio of 0.5 (0.46 to 0.61) for having their operations classified as urgent compared with the least deprived, after allowance for age, sex, and type of operation. When urgent and routine cases were considered separately, there was no significant difference in waiting times between the most and least deprived categories. Conclusions Socioeconomically deprived patients are thought to be more likely to develop coronary heart disease but are less likely to be investigated and offered surgery once it has developed. Such patients may be further disadvantaged by having to wait longer for surgery because of being given lower priority. PMID:10617517

  14. The effectiveness of interventions aimed at reducing anxiety in health care waiting spaces: a systematic review of randomized and nonrandomized trials.

    PubMed

    Biddiss, Elaine; Knibbe, Tara Joy; McPherson, Amy

    2014-08-01

    Reducing waiting anxiety is an important objective of patient-centered care. Anxiety is linked to negative health outcomes, including longer recovery periods, lowered pain thresholds, and for children in particular, resistance to treatment, nightmares, and separation anxiety. The goals of this study were (1) to systematically review published research aimed at reducing preprocedural waiting anxiety, and (2) to provide directions for future research and development of strategies to manage preprocedural waiting anxiety in health care environments. We performed a systematic review of the literature via ISI Web of Knowledge, PubMed, PsycINFO, EMBASE, CINAHL, and Medline. Included in this review were studies describing measurable outcomes in response to interventions specifically intended to improve the waiting experience of patients in health care settings. Primary outcomes of interest were stress and anxiety. Exclusion criteria included (a) studies aimed at reducing wait times and management of waiting lists only, (b) waiting in non-health care settings, (c) design of health care facilities with nonspecific strategies pertaining to waiting spaces, (d) strategies to reduce pain or anxiety during the course of medical procedures, and (e) interventions such as massage, acupuncture, or hypnosis that require dedicated staff and/or private waiting environments to administer. We identified 8690 studies. Forty-one articles met the inclusion criteria. In adult populations, 33 studies were identified, wherein the effects of music (n = 25), aromatherapy (n = 6), and interior design features (n = 2) were examined. Eight pediatric studies were identified investigating play opportunities (n = 2), media distractions (n = 2), combined play opportunities and media distractions (n = 3), and music (n = 1). Based on results from 1129 adult participants in the 14 studies that evaluated music and permitted meta-analysis, patients who listened to music before a medical procedure exhibited a

  15. Effects of a Cognitive Behavioral Self-Help Program on Emotional Problems for People with Acquired Hearing Loss: A Randomized Controlled Trial

    ERIC Educational Resources Information Center

    Garnefski, Nadia; Kraaij, Vivian

    2012-01-01

    The aim of the study was to examine whether a cognitive-behavioral self-help program was effective in improving depressed mood and anxiety in people with acquired deafness. Participants were 45 persons with acquired deafness, randomly allocated to the Cognitive-Behavioral Self-help (CBS) group or the Waiting List Control (WLC) group. Depression…

  16. Randomized controlled trial of cognitive behavioral therapy and acceptance and commitment therapy for social phobia: outcomes and moderators.

    PubMed

    Craske, Michelle G; Niles, Andrea N; Burklund, Lisa J; Wolitzky-Taylor, Kate B; Vilardaga, Jennifer C Plumb; Arch, Joanna J; Saxbe, Darby E; Lieberman, Matthew D

    2014-12-01

    Cognitive behavioral therapy (CBT) is an empirically supported treatment for social phobia. However, not all individuals respond to treatment and many who show improvement do not maintain their gains over the long-term. Thus, alternative treatments are needed. The current study (N = 87) was a 3-arm randomized clinical trial comparing CBT, acceptance and commitment therapy (ACT), and a wait-list control group (WL) in participants with a diagnosis of social phobia based on criteria of the Diagnostic and Statistical Manual of Mental Disorders (4th ed.; American Psychiatric Association, 1994). Participants completed 12 sessions of CBT or ACT or a 12-week waiting period. All participants completed assessments at baseline and posttreatment, and participants assigned to CBT and ACT also completed assessments 6 and 12 months following baseline. Assessments consisted of self-report measures, a public-speaking task, and clinician ratings. Multilevel modeling was used to examine between-group differences on outcomes measures. Both treatment groups outperformed WL, with no differences observed between CBT and ACT on self-report, independent clinician, or public-speaking outcomes. Lower self-reported psychological flexibility at baseline was associated with greater improvement by the 12-month follow-up in CBT compared with ACT. Self-reported fear of negative evaluation significantly moderated outcomes as well, with trends for both extremes to be associated with superior outcomes from CBT and inferior outcomes from ACT. Across treatment groups, higher perceived control and extraversion were associated with greater improvement, whereas comorbid depression was associated with poorer outcomes. Implications for clinical practice and future research are discussed.

  17. Internet-based intervention programme for obese adolescents and their families (Next.Step): research protocol of a controlled trial.

    PubMed

    Sousa, Pedro; Fonseca, Helena; Gaspar, Pedro; Gaspar, Filomena

    2014-04-01

    This paper describes the design and rationale of a controlled trial that aims to determine the effectiveness of an intervention programme in which the internet is used. Adolescent obesity is a major health problem, there being urgency to find effective interventions that induce behavioural change. The inclusion of the internet in the intervention may improve adolescents' adherence to the weight management programme and lead to adoption of healthier lifestyles. A clinical trial with a control group (non-randomized). Participants are adolescents with appointments at a paediatric obesity clinic (Portugal). Sample size was calculated according to the power analysis. The experimental group will follow the standard treatment protocol and receive free access to the e-therapeutic platform. The control group will follow the standard treatment protocol and join a waiting list. Intervention length will be 36 weeks (24 weeks of direct intervention with a follow-up for 12 weeks). This study was approved by the Ethical Committee for Health (Lisbon, Portugal) in January 2012 and funded by the Foundation for Science and Technology (Portugal) in December 2012. The results of this research will promote reflection on new approaches directed to treat adolescent obesity and on the promotion of healthy behaviours. We expect to gather empirical evidence of the intervention programme effectiveness. The expectations lie on the population health gains, empowerment in decision-making and adoption of healthier lifestyles. © 2013 John Wiley & Sons Ltd.

  18. A telephonic mindfulness-based intervention for persons with sickle cell disease: study protocol for a randomized controlled trial.

    PubMed

    Williams, Hants; Silva, Susan; Simmons, Leigh Ann; Tanabe, Paula

    2017-05-15

    One of the most difficult symptoms for persons with sickle cell disease (SCD) to manage is chronic pain. Chronic pain impacts approximately one-third of persons with SCD and is associated with increased pain intensity, pain behavior, and frequency and duration of hospital visits. A promising category of nonpharmacological interventions for managing both physical and affective components of pain are mindfulness-based interventions (MBIs). The primary aim of this study is to conduct a randomized controlled study to evaluate the acceptability and feasibility, as well as to determine the preliminary efficacy, of a telephonic MBI for adults with SCD who have chronic pain. We will enroll 60 adult patients with SCD and chronic pain at an outpatient comprehensive SCD center in the southeastern United States. Patients will be randomized to either an MBI or a wait-listed control group. The MBI group will complete a six-session (60 minutes), telephonically delivered, group-based MBI program. The feasibility, acceptability, and efficacy of the MBI regarding pain catastrophizing will be assessed by administering questionnaires at baseline and weeks 1, 3, and 6. In addition, ten randomly selected MBI participants will complete semistructured interviews to help determine intervention acceptability. In this study protocol, we report detailed methods of the randomized controlled trial. Findings of this study will be useful to determine the acceptability, feasibility, and efficacy of an MBI for persons with SCD and chronic pain. ClinicalTrials.gov identifier: NCT02394587 . Registered on 9 February 2015.

  19. Randomized Controlled Trial of an Internet-Based Cognitive-Behavioral Treatment Program for Binge-Eating Disorder.

    PubMed

    Wagner, Birgit; Nagl, Michaela; Dölemeyer, Ruth; Klinitzke, Grit; Steinig, Jana; Hilbert, Anja; Kersting, Anette

    2016-07-01

    Binge-eating disorder (BED) is a prevalent health condition associated with obesity. Few people with BED receive appropriate treatment. Personal barriers include shame, fear of stigma, geographic distance to mental health services, and long wait-lists. The aims of this study were to examine the efficacy of an Internet-based cognitive-behavioral intervention for adults with threshold BED (DSM-IV) and to examine the stability of treatment effects over 12months. Participants were randomly assigned to a 16-week Internet-based cognitive-behavioral intervention (n=69) or a wait-list condition (n=70). Binge-eating frequency and eating disorder psychopathology were measured with the Eating Disorder Examination-Questionnaire and the Eating Disorder Examination administered over the telephone. Additionally, body weight and body mass index, depression, and anxiety were assessed before and immediately after treatment. Three-, 6-, and 12-month follow-up data were recorded in the treatment group. Immediately after the treatment the number of binge-eating episodes showed significant improvement (d=1.02, between group) in the treatment group relative to the wait-list condition. The treatment group had also significantly reduced symptoms of all eating psychopathology outcomes relative to the wait-list condition (0.82≤d≤1.11). In the treatment group significant improvement was still observed for all measures 1year after the intervention relative to pretreatment levels. The Internet-based intervention proved to be efficacious, significantly reducing the number of binge-eating episodes and eating disorder pathology long term. Low-threshold e-health interventions should be further evaluated to improve treatment access for patients suffering from BED. Copyright © 2016. Published by Elsevier Ltd.

  20. Cost-effectiveness of a participatory return-to-work intervention for temporary agency workers and unemployed workers sick-listed due to musculoskeletal disorders: design of a randomised controlled trial

    PubMed Central

    2010-01-01

    Background Within the working population there is a vulnerable group: workers without an employment contract and workers with a flexible labour market arrangement, e.g. temporary agency workers. In most cases, when sick-listed, these workers have no workplace/employer to return to. Also, for these workers access to occupational health care is limited or even absent in many countries. For this vulnerable working population there is a need for tailor-made occupational health care, including the presence of an actual return-to-work perspective. Therefore, a participatory return-to-work program has been developed based on a successful return-to-work intervention for workers, sick-listed due to low back pain. The objective of this paper is to describe the design of a randomised controlled trial to study the (cost-)effectiveness of this newly developed participatory return-to-work program adapted for temporary agency workers and unemployed workers, sick-listed due to musculoskeletal disorders, compared to usual care. Methods/Design The design of this study is a randomised controlled trial with one year of follow-up. The study population consists of temporary agency workers and unemployed workers sick-listed between 2 and 8 weeks due to musculoskeletal disorders. The new return-to-work program is a stepwise program aimed at making a consensus-based return-to-work implementation plan with the possibility of a (therapeutic) workplace to return-to-work. Outcomes are measured at baseline, 3, 6, 9 and 12 months. The primary outcome measure is duration of the sickness benefit period after the first day of reporting sick. Secondary outcome measures are: time until first return-to-work, total number of days of sickness benefit during follow-up; functional status; intensity of musculoskeletal pain; pain coping; and attitude, social influence and self-efficacy determinants. Cost-benefit is evaluated from an insurer's perspective. A process evaluation is part of this study

  1. Web-Based Psychotherapy for Posttraumatic Stress Disorder in War-Traumatized Arab Patients: Randomized Controlled Trial

    PubMed Central

    Brand, Janine; Lange, Alfred; Ruwaard, Jeroen; Wagner, Birgit

    2015-01-01

    Background In recent years, armed conflicts in the Middle East have resulted in high rates of exposure to traumatic events. Despite the increasing demand of mental health care provision, ongoing violence limits conventional approaches of mental health care provision. Internet-based interventions for posttraumatic stress disorder (PTSD) have proved feasible and effective in Western countries, but their applicability and efficacy in war and conflict regions remains unknown. Objective This study investigated the efficacy of a cognitive behavioral Internet-based intervention for war-traumatized Arab patients, with focus on Iraq. Methods A total of 159 individuals with PTSD participated in a parallel group randomized trial. Participants were randomly allocated by a computer-generated sequence to a treatment group (n=79) or a waiting list control group (n=80). The treatment group received 2 weekly 45-minute cognitive behavioral interventions via Internet over a 5-week period (10 sessions in total). The primary outcome was recovery from posttraumatic stress symptoms. Results Posttraumatic stress symptoms were significantly reduced from baseline to posttreatment (intention-to-treat analysis) in the treatment group relative to the control group (F1,157=44.29, P<.001, d=0.92). Treatment effects were sustained at 3-month follow-up. Completer analysis indicated that 29 of 47 patients (62%) in the treatment group had recovered from posttraumatic stress symptoms at posttreatment (reliable change and Posttraumatic Stress Diagnostic Scale score <20) versus 1 patient (2%) in the control group (OR 74.19, 95% CI 9.93-585.8, P<.001) indicating that the chance of recovering was 74.19 times higher in the treatment than in the control group. Conclusions The results indicate, even in unstable and insecure settings with ongoing exposure to human rights violations through war and dictatorships, people with posttraumatic stress symptoms benefit from a cognitive behavioral treatment provided

  2. A training programme involving automatic self-transcending meditation in late-life depression: preliminary analysis of an ongoing randomised controlled trial

    PubMed Central

    Arena, Amanda; Burhan, Amer M.; Ionson, Emily; Hirjee, Hussein; Maldeniya, Pramudith; Wetmore, Stephen; Newman, Ronnie I.

    2016-01-01

    Late-life depression affects 2–6% of seniors aged 60 years and above. Patients are increasingly embracing non-pharmacological therapies, many of which have not been scientifically evaluated. This study aimed to evaluate a category of meditation, automatic self-transcending meditation (ASTM), in alleviating symptoms of depression when augmenting treatment as usual (NCT02149810). The preliminary results of an ongoing single-blind randomised controlled trial comparing a training programme involving ASTM with a wait-list control indicate that a 12-week ASTM programme may lead to significantly greater reductions in depression and anxiety severity. As such, ASTM may be an effective adjunctive therapy in the treatment of late-life depression. Declaration of interest R.I.N. is Director of Research and Health Promotion for the Art of Living Foundation, Canada and supervised the staff providing ASTM training. Copyright and usage © The Royal College of Psychiatrists 2016. This is an open access article distributed under the terms of the Creative Commons Non-Commercial, No Derivatives (CC BY-NC-ND) licence. PMID:27703774

  3. Sailing for Rehabilitation of Patients with Severe Mental Disorders: Results of a Cross Over Randomized Controlled Trial

    PubMed Central

    Carta, Mauro G; Maggiani, Federica; Pilutzu, Laura; Moro, Maria F; Mura, Gioia; Cadoni, Federica; Sancassiani, Federica; Vellante, Marcello; Machado, Sergio; Preti, Antonio

    2014-01-01

    This study set out to evaluate the effectiveness of a sailing and learning-to-sail rehabilitation protocol in a sample of patients diagnosed with severe mental disorders. The study was a randomized, crossover, waiting-list controlled trial, following recruitment in the Departments of Mental Health of South Sardinia. Participants were outpatients diagnosed with severe mental disorders, recruited through announcements to the directors of the Departments of Mental Health of South Sardinia. Out of the 40 patients enrolled in the study, those exposed to rehabilitation with sailing during a series of guided and supervised sea expeditions near the beach of Cagliari (Sardinia), where the aim to explore the marine environment while sailing was emphasized, showed a statistically significant improvement of their clinical status (measured by BPRS) and, as well, of their general functioning (measured by HoNOS Scale) against the control group. The improvement was maintained at follow-up for some months only: after 12 months, the patients returned to their baseline values on the measures of psychopathology and showed a worsening trend of their quality of life. Sailing can represent a substitute of important experiences that the patients with severe mental disorders miss because of their illness. PMID:25191520

  4. Parenting for Autism, Language, And Communication Evaluation Study (PALACES): protocol for a pilot randomised controlled trial

    PubMed Central

    Williams, Margiad Elen; Hastings, Richard; Charles, Joanna Mary; Evans, Sue; Hutchings, Judy

    2017-01-01

    Introduction Children with autistic spectrum disorder (ASD) often have associated behavioural difficulties that can present a challenge for parents and parenting. There are several effective social learning theory-based parenting programmes for dealing with behavioural difficulties, including the Incredible Years (IY) parent programmes. However, these programmes typically do not specifically target parents of children with ASD. Recently, a new addition to the IY suite of programmes known as the IY Autistic Spectrum and Language Delays (IY-ASLD) parent programme was developed. The main aims of the present study are to examine the feasibility of delivering this programme within child health services and to provide initial evidence for effectiveness and economic costs. Methods and analysis The Parenting for Autism, Language, And Communication Evaluation Study (PALACES) trial is a pragmatic, multicentre, pilot randomised controlled trial comparing the IY-ASLD programme with a wait-list control condition. 72 parents of children with ASD (aged 3–8 years) will be randomly allocated to either the intervention or control condition. Data will be collected prior to randomisation and 6 months postrandomisation for all families. Families in the intervention condition only will also be followed up at 12 and 18 months postrandomisation. This study will provide initial evidence of effectiveness for the newly developed IY-ASLD parenting programme. It will also add to the limited economic evidence for an intervention targeting parents of children with ASD and provide longer term data, an important component for evaluations of parenting programmes. Ethics and dissemination Approval for the study was granted by the Research Ethics Committee at the School of Psychology, Bangor University (reference number: 2016–15768) and the North Wales Research Ethics Committee, UK (reference number: 16/WA/0224). The findings will be disseminated through research conferences and peer

  5. Study protocol: a randomized controlled trial investigating the effects of a psychosexual training program for adolescents with autism spectrum disorder.

    PubMed

    Visser, Kirsten; Greaves-Lord, Kirstin; Tick, Nouchka T; Verhulst, Frank C; Maras, Athanasios; van der Vegt, Esther J M

    2015-08-28

    Previous research shows that adolescents with autism spectrum disorder (ASD) run several risks in their psychosexual development and that these adolescents can have limited access to reliable information on puberty and sexuality, emphasizing the need for specific guidance of adolescents with ASD in their psychosexual development. Few studies have investigated the effects of psychosexual training programs for adolescents with ASD and to date no randomized controlled trials are available to study the effects of psychosexual interventions for this target group. The randomized controlled trial (RCT) described in this study protocol aims to investigate the effects of the Tackling Teenage Training (TTT) program on the psychosexual development of adolescents with ASD. This parallel clinical trial, conducted in the South-West of the Netherlands, has a simple equal randomization design with an intervention and a waiting-list control condition. Two hundred adolescents and their parents participate in this study. We assess the participants in both conditions using self-report as well as parent-report questionnaires at three time points during 1 year: at baseline (T1), post-treatment (T2), and for follow-up (T3). To our knowledge, the current study is the first that uses a randomized controlled design to study the effects of a psychosexual training program for adolescents with ASD. It has a number of methodological strengths, namely a large sample size, a wide range of functionally relevant outcome measures, the use of multiple informants, and a standardized research and intervention protocol. Also some limitations of the described study are identified, for instance not making a comparison between two treatment conditions, and no use of blinded observational measures to investigate the ecological validity of the research results. Dutch Trial Register NTR2860. Registered on 20 April 2011.

  6. Online CBT life skills programme for low mood and anxiety: study protocol for a pilot randomized controlled trial.

    PubMed

    Williams, Christopher; McClay, Carrie-Anne; Martinez, Rebeca; Morrison, Jill; Haig, Caroline; Jones, Ray; Farrand, Paul

    2016-04-27

    Low mood is a common mental health problem with significant health consequences. Studies have shown that cognitive behavioural therapy (CBT) is an effective treatment for low mood and anxiety when delivered one-to-one by an expert practitioner. However, access to this talking therapy is often limited and waiting lists can be long, although a range of low-intensity interventions that can increase access to services are available. These include guided self-help materials delivered via books, classes and online packages. This project aims to pilot a randomized controlled trial of an online CBT-based life skills course with community-based individuals experiencing low mood and anxiety. Individuals with elevated symptoms of depression will be recruited directly from the community via online and newspaper advertisements. Participants will be remotely randomized to receive either immediate access or delayed access to the Living Life to the Full guided online CBT-based life skills package, with telephone or email support provided whilst they use the online intervention. The primary end point will be at 3 months post-randomization, at which point the delayed-access group will be offered the intervention. Levels of depression, anxiety, social functioning and satisfaction will be assessed. This pilot study will test the trial design, and ability to recruit and deliver the intervention. Drop-out rates will be assessed and the completion and acceptability of the package will be investigated. The study will also inform a sample size power calculation for a subsequent substantive randomized controlled trial. ISRCTN ISRCTN12890709.

  7. A self-help coping intervention can reduce anxiety and avoidant health behaviours whilst waiting for cancer genetic risk information: results of a phase III randomised trial.

    PubMed

    Phelps, Ceri; Bennett, Paul; Hood, Kerenza; Brain, Kate; Murray, Alexandra

    2013-04-01

    The objective of this study is to evaluate the effectiveness of a self-help coping intervention in reducing intrusive negative thoughts while waiting for cancer genetic risk information. Between August 2007 and November 2008, 1958 new referrals for cancer genetic risk assessment were invited to participate in a randomised trial. The control group received standard information. The intervention group received this information plus a written self-help coping leaflet. The primary outcome measure was the intrusion subscale of the Impact of Event Scale. The intervention significantly reduced intrusive thoughts during the waiting period in those reporting moderate baseline levels of intrusion (p = 0.03). Following risk provision, those in the intervention group reporting low and moderate intrusive worries at baseline reported less intrusive thoughts than those in the control group (p = 0.04 and p = 0.03, respectively). The intervention had no adverse impact in the sample as a whole. Participants in the intervention group with high baseline avoidance and negative affect scores were significantly more likely to remain in the study than those in the control group (p = 0.05 and p = 0.004). Findings that the intervention both reduced distress in those with moderate levels of distress and had no adverse effects following notification of cancer genetic risk suggest that this simple intervention can be implemented across a range of oncology settings involving periods of waiting and uncertainty. The intervention may also reduce the number of individuals dropping out of cancer genetic risk assessment or screening. However, those with clinically high levels of psychological distress are likely to require a more intensive psychological intervention. Copyright © 2012 John Wiley & Sons, Ltd.

  8. A pilot randomized controlled trial using EEG-based brain-computer interface training for a Chinese-speaking group of healthy elderly.

    PubMed

    Lee, Tih-Shih; Quek, Shin Yi; Goh, Siau Juinn Alexa; Phillips, Rachel; Guan, Cuntai; Cheung, Yin Bun; Feng, Lei; Wang, Chuan Chu; Chin, Zheng Yang; Zhang, Haihong; Lee, Jimmy; Ng, Tze Pin; Krishnan, K Ranga Rama

    2015-01-01

    There is growing evidence that cognitive training (CT) can improve the cognitive functioning of the elderly. CT may be influenced by cultural and linguistic factors, but research examining CT programs has mostly been conducted on Western populations. We have developed an innovative electroencephalography (EEG)-based brain-computer interface (BCI) CT program that has shown preliminary efficacy in improving cognition in 32 healthy English-speaking elderly adults in Singapore. In this second pilot trial, we examine the acceptability, safety, and preliminary efficacy of our BCI CT program in healthy Chinese-speaking Singaporean elderly. Thirty-nine elderly participants were randomized into intervention (n=21) and wait-list control (n=18) arms. Intervention consisted of 24 half-hour sessions with our BCI-based CT training system to be completed in 8 weeks; the control arm received the same intervention after an initial 8-week waiting period. At the end of the training, a usability and acceptability questionnaire was administered. Efficacy was measured using the Repeatable Battery for the Assessment of Neuropsychological Status (RBANS), which was translated and culturally adapted for the Chinese-speaking local population. Users were asked about any adverse events experienced after each session as a safety measure. The training was deemed easily usable and acceptable by senior users. The median difference in the change scores pre- and post-training of the modified RBANS total score was 8.0 (95% confidence interval [CI]: 0.0-16.0, P=0.042) higher in the intervention arm than waitlist control, while the mean difference was 9.0 (95% CI: 1.7-16.2, P=0.017). Ten (30.3%) participants reported a total of 16 adverse events - all of which were graded "mild" except for one graded "moderate". Our BCI training system shows potential in improving cognition in both English- and Chinese-speaking elderly, and deserves further evaluation in a Phase III trial. Overall, participants

  9. Effectiveness and cost-effectiveness of a universal parenting skills programme in deprived communities: multicentre randomised controlled trial

    PubMed Central

    Simkiss, D E; Snooks, H A; Stallard, N; Kimani, P K; Sewell, B; Fitzsimmons, D; Anthony, R; Winstanley, S; Wilson, L; Phillips, C J; Stewart-Brown, S

    2013-01-01

    Objective To evaluate the effectiveness and cost utility of a universally provided early years parenting programme. Design Multicentre randomised controlled trial with cost-effectiveness analysis. Setting Early years centres in four deprived areas of South Wales. Participants Families with children aged between 2 and 4 years. 286 families were recruited and randomly allocated to the intervention or waiting list control. Intervention The Family Links Nurturing Programme (FLNP), a 10-week course with weekly 2 h facilitated group sessions. Main outcome measures Negative and supportive parenting, child and parental well-being and costs assessed before the intervention, following the course (3 months) and at 9 months using standardised measures. Results There were no significant differences in primary or secondary outcomes between trial arms at 3 or 9 months. With ‘+’ indicating improvement, difference in change in negative parenting score at 9 months was +0.90 (95%CI −1.90 to 3.69); in supportive parenting, +0.17 (95%CI −0.61 to 0.94); and 12 of the 17 secondary outcomes showed a non-significant positive effect in the FLNP arm. Based on changes in parental well-being (SF-12), the cost per quality-adjusted life year (QALY) gained was estimated to be £34 913 (range 21 485–46 578) over 5 years and £18 954 (range 11 664–25 287) over 10 years. Probability of cost per QALY gained below £30 000 was 47% at 5 years and 57% at 10 years. Attendance was low: 34% of intervention families attended no sessions (n=48); only 47% completed the course (n=68). Also, 19% of control families attended a parenting programme before 9-month follow-up. Conclusions Our trial has not found evidence of clinical or cost utility for the FLNP in a universal setting. However, low levels of exposure and contamination mean that uncertainty remains. Trial registration The trial is registered with Current Controlled Trials ISRCTN13919732. PMID:23906953

  10. Internet-based guided self-help for glioma patients with depressive symptoms: design of a randomized controlled trial

    PubMed Central

    2014-01-01

    Background Among glioma patients, depression is estimated to be more prevalent than in both the general population and the cancer patient population. This can have negative consequences for both patients and their primary informal caregivers (e.g., a spouse, family member or close friend). At present, there is no evidence from randomized controlled trials for the effectiveness of psychological treatment for depression in glioma patients. Furthermore, the possibility of delivering mental health care through the internet has not yet been explored in this population. Therefore, a randomized controlled trial is warranted to evaluate the effects of an internet-based, guided self-help intervention for depressive symptoms in glioma patients. Methods/design The intervention is based on problem-solving therapy. An existing 5-week course is adapted for use by adult glioma patients with mild to moderate depressive symptoms (Center for Epidemiology Studies Depression Scale score ≥12). Sample size calculations yield 126 glioma patients to be included, who are randomly assigned to either the intervention group or a waiting list control group. In addition, we aim to include 63 patients with haematological cancer in a non-central nervous system malignancy control group. Assessments take place at baseline, after 6 and 12 weeks, and after 6 and 12 months. Primary outcome measure is the change in depressive symptoms. Secondary outcome measures include health-related quality of life, fatigue, costs and patient satisfaction. In addition, all patients are asked to assign a primary informal caregiver, who does not participate in the intervention but who is asked to complete similar assessments. Their mood, health-related quality of life and fatigue is evaluated as well. Discussion This is the first study to evaluate the effects of problem-solving therapy delivered through the internet as treatment for depressive symptoms in glioma patients. If proven effective, this treatment will

  11. Stress Management and Resiliency Training (SMART) program among Department of Radiology faculty: a pilot randomized clinical trial.

    PubMed

    Sood, Amit; Sharma, Varun; Schroeder, Darrell R; Gorman, Brian

    2014-01-01

    To test the efficacy of a Stress Management and Resiliency Training (SMART) program for decreasing stress and anxiety and improving resilience and quality of life among Department of Radiology physicians. The study was approved by the institutional review board. A total of 26 Department of Radiology physicians were randomized in a single-blind trial to either the SMART program or a wait-list control arm for 12 weeks. The program involved a single 90-min group session in the SMART training with two follow-up phone calls. Primary outcomes measured at baseline and week 12 included the Perceived Stress Scale, Linear Analog Self-Assessment Scale, Mindful Attention Awareness Scale, and Connor-Davidson Resilience Scale. A total of 22 physicians completed the study. A statistically significant improvement in perceived stress, anxiety, quality of life, and mindfulness at 12 weeks was observed in the study arm compared to the wait-list control arm; resilience also improved in the active arm, but the changes were not statistically significant when compared to the control arm. A single session to decrease stress among radiologists using the SMART program is feasible. Furthermore, the intervention afforded statistically significant and clinically meaningful improvement in anxiety, stress, quality of life, and mindful attention. Further studies including larger sample size and longer follow-up are warranted. Copyright © 2014. Published by Elsevier Inc.

  12. Intervention for children with word-finding difficulties: a parallel group randomised control trial.

    PubMed

    Best, Wendy; Hughes, Lucy Mari; Masterson, Jackie; Thomas, Michael; Fedor, Anna; Roncoli, Silvia; Fern-Pollak, Liory; Shepherd, Donna-Lynn; Howard, David; Shobbrook, Kate; Kapikian, Anna

    2017-07-31

    The study investigated the outcome of a word-web intervention for children diagnosed with word-finding difficulties (WFDs). Twenty children age 6-8 years with WFDs confirmed by a discrepancy between comprehension and production on the Test of Word Finding-2, were randomly assigned to intervention (n = 11) and waiting control (n = 9) groups. The intervention group had six sessions of intervention which used word-webs and targeted children's meta-cognitive awareness and word-retrieval. On the treated experimental set (n = 25 items) the intervention group gained on average four times as many items as the waiting control group (d = 2.30). There were also gains on personally chosen items for the intervention group. There was little change on untreated items for either group. The study is the first randomised control trial to demonstrate an effect of word-finding therapy with children with language difficulties in mainstream school. The improvement in word-finding for treated items was obtained following a clinically realistic intervention in terms of approach, intensity and duration.

  13. Efficacy of 'Tailored Physical Activity' or 'Chronic Pain Self-Management Program' on return to work for sick-listed citizens: design of a randomised controlled trial.

    PubMed

    Andersen, Lotte Nygaard; Juul-Kristensen, Birgit; Roessler, Kirsten Kaya; Herborg, Lene Gram; Sørensen, Thomas Lund; Søgaard, Karen

    2013-01-23

    Pain affects quality of life and can result in absence from work. Treatment and/or prevention strategies for musculoskeletal pain-related long-term sick leave are currently undertaken in several health sectors. Moreover, there are few evidence-based guidelines for such treatment and prevention. The aim of this study is to evaluate the efficacy of 'Tailored Physical Activity' or 'Chronic Pain Self-Management Program' for sick-listed citizens with pain in the back and/or the upper body. This protocol describes the design of a parallel randomised controlled trial on the efficacy of 'Tailored Physical Activity' or a 'Chronic Pain Self-management Program' versus a reference group for sick-listed citizens with complaints of pain in the back or upper body. Participants will have been absent from work due to sick-listing for 3 to 9 weeks at the time of recruitment. All interventions will be performed at the 'Health Care Center' in the Sonderborg Municipality, and a minimum of 138 participants will be randomised into one of the three groups.All participants will receive 'Health Guidance', a (1.5-hour) individualised dialogue focusing on improving ways of living, based on assessments of risk behavior, motivation for change, level of self-care and personal resources. In addition, the experimental groups will receive either 'Tailored Physical Activity' (three 50-minute sessions/week over 10 weeks) or 'Chronic Pain Self-Management Program' (2.5-hours per week over 6 weeks). The reference group will receive only 'Health Guidance'.The primary outcome is the participants' sick-listed status at 3 and 12 months after baseline. The co-primary outcome is the time it takes to return to work. In addition, secondary outcomes include anthropometric measurements, functional capacity and self-reported number of sick days, musculoskeletal symptoms, general health, work ability, physical capacity, kinesiophobia, physical functional status, interpersonal problems and mental disorders. There

  14. ShopSmart 4 Health – Protocol of a skills-based randomised controlled trial promoting fruit and vegetable consumption among socioeconomically disadvantaged women

    PubMed Central

    2013-01-01

    Background There is a need for evidence on the most effective and cost-effective approaches for promoting healthy eating among groups that do not meet dietary recommendations for good health, such as those with low incomes or experiencing socioeconomic disadvantage. This paper describes the ShopSmart 4 Health study, a randomised controlled trial conducted by Deakin University, Coles Supermarkets and the Heart Foundation, to investigate the effectiveness and cost-effectiveness of a skill-building intervention for promoting increased purchasing and consumption of fruits and vegetables amongst women of low socioeconomic position (SEP). Methods/design ShopSmart 4 Health employed a randomised controlled trial design. Women aged 18–60 years, holding a Coles store loyalty card, who shopped at Coles stores within socioeconomically disadvantaged neighbourhoods and met low-income eligibility criteria were invited to participate. Consenting women completed a baseline survey assessing food shopping and eating habits and food-related behaviours and attitudes. On receipt of their completed survey, women were randomised to either a skill-building intervention or a wait-list control condition. Intervention effects will be evaluated via self-completion surveys and using supermarket transaction sales data, collected at pre- and post-intervention and 6-month follow-up. An economic evaluation from a societal perspective using a cost-consequences approach will compare the costs and outcomes between intervention and control groups. Process evaluation will be undertaken to identify perceived value and effects of intervention components. Discussion This study will provide data to address the currently limited evidence base regarding the effectiveness and cost-effectiveness of skill-building intervention strategies aimed at increasing fruit and vegetable consumption among socioeconomically disadvantaged women, a target group at high risk of poor diets. Trial registration Current

  15. Effectiveness of a healthy lifestyle intervention for chronic low back pain: a randomised controlled trial.

    PubMed

    Williams, Amanda; Wiggers, John; OʼBrien, Kate M; Wolfenden, Luke; Yoong, Sze Lin; Hodder, Rebecca K; Lee, Hopin; Robson, Emma K; McAuley, James H; Haskins, Robin; Kamper, Steven J; Rissel, Chris; Williams, Christopher M

    2018-06-01

    We assessed the effectiveness of a 6-month healthy lifestyle intervention, on pain intensity in patients with chronic low back pain who were overweight or obese. We conducted a pragmatic randomised controlled trial, embedded within a cohort multiple randomised controlled trial of patients on a waiting list for outpatient orthopaedic consultation at a tertiary hospital in NSW, Australia. Eligible patients with chronic low back pain (>3 months in duration) and body mass index ≥27 kg/m and <40 kg/m were randomly allocated, using a central concealed random allocation process, to receive advice and education and referral to a 6-month telephone-based healthy lifestyle coaching service, or usual care. The primary outcome was pain intensity measured using an 11-point numerical rating scale, at baseline, 2 weeks, and monthly for 6 months. Data analysis was by intention-to-treat according to a prepublished analysis plan. Between May 13, 2015, and October 27, 2015, 160 patients were randomly assigned in a 1:1 ratio to the intervention or usual care. We found no difference between groups for pain intensity over 6 months (area under the curve, mean difference = 6.5, 95% confidence interval -8.0 to 21.0; P = 0.38) or any secondary outcome. In the intervention group, 41% (n = 32) of participants reported an adverse event compared with 56% (n = 45) in the control group. Our findings show that providing education and advice and telephone-based healthy lifestyle coaching did not benefit patients with low back pain who were overweight or obese, compared with usual care. The intervention did not influence the targeted healthy lifestyle behaviours proposed to improve pain in this patient group.

  16. The Good Schools Toolkit to prevent violence against children in Ugandan primary schools: study protocol for a cluster randomised controlled trial

    PubMed Central

    2013-01-01

    Background We aim to evaluate the effectiveness of the Good School Toolkit, developed by Raising Voices, in preventing violence against children attending school and in improving child mental health and educational outcomes. Methods/design We are conducting a two-arm cluster randomised controlled trial with parallel assignment in Luwero District, Uganda. We will also conduct a qualitative study, a process evaluation and an economic evaluation. A total of 42 schools, representative of Luwero District, Uganda, were allocated to receive the Toolkit plus implementation support, or were allocated to a wait-list control condition. Our main analysis will involve a cross-sectional comparison of the prevalence of past-week violence from school staff as reported by children in intervention and control primary schools at follow-up. At least 60 children per school and all school staff members will be interviewed at follow-up. Data collection involves a combination of mobile phone-based, interviewer-completed questionnaires and paper-and-pen educational tests. Survey instruments include the ISPCAN Child Abuse Screening Tools to assess experiences of violence; the Strengths and Difficulties Questionnaire to measure symptoms of common childhood mental disorders; and word recognition, reading comprehension, spelling, arithmetic and sustained attention tests adapted from an intervention trial in Kenya. Discussion To our knowledge, this is the first study to rigorously investigate the effects of any intervention to prevent violence from school staff to children in primary school in a low-income setting. We hope the results will be informative across the African region and in other settings. Trial registration clinicaltrials.gov NCT01678846 PMID:23883138

  17. Individual and system influences on waiting time for substance abuse treatment.

    PubMed

    Carr, Carey J A; Xu, Jiangmin; Redko, Cristina; Lane, D Timothy; Rapp, Richard C; Goris, John; Carlson, Robert G

    2008-03-01

    Waiting time is a contemporary reality of many drug abuse treatment programs, resulting in substantial problems for substance users and society. Individual and system factors that influence waiting time are diverse and may vary at different points in the treatment continuum. This study assessed waiting time preceding clinical assessment at a centralized intake unit and during the period after the assessment but before treatment entry. The present study included 577 substance abusers who were enrolled in a large clinical trial of two brief treatment interventions in a midsize metropolitan area in Ohio. Bivariate analyses identified individual and system factors that influenced preassessment and postassessment waiting time, as well as total wait to treatment services. Multivariate analyses demonstrated that longer wait time for an assessment is influenced by being court referred, less belief in having a substance abuse problem, and less desire for change. A shorter wait to actually enter treatment is predicted by having a case manager, being more ready for treatment, and having less severe employment and alcohol problems. The different influences present during the two waiting periods suggest that assessment and treatment programs need to implement system changes and entry enhancement interventions that are specific to the needs of substance abusers at each waiting period.

  18. The clinical impact and cost-effectiveness of essential oils and aromatherapy for the treatment of acne vulgaris: a protocol for a randomized controlled trial.

    PubMed

    Agnew, Tamara; Leach, Matthew; Segal, Leonie

    2014-05-01

    Acne is a prevalent, chronic, and sometimes severe skin disorder affecting an estimated 85% of adolescents and 50% of adults older than age 20 years. The psychosocial implications of acne can be considerable, often continuing long after physical symptoms resolve. Although effective acne medications are available, most exhibit adverse-effect profiles that can leave the patient with few effective treatment options. Emerging evidence indicates that plant-derived essential oils may be a biologically plausible treatment for acne, although high-quality evidence of effectiveness and safety is lacking. To examine the clinical effectiveness and cost-effectiveness of essential oils and aromatherapy for the treatment of acne. This randomized, wait-list controlled trial will have three parallel groups; 192 participants with acne vulgaris, aged 16-45 years, will be recruited primarily through eight Technical and Further Education campuses across Adelaide, South Australia. Participants will be randomly assigned to standard essential oil blend, customized aromatherapy treatment, or wait-list control. Changes in the physical and psychosocial symptoms of acne will be assessed at baseline and 6 and 12 weeks by using the Leeds Acne Grading System, Assessment of Quality of Life-8 Dimension instrument, and Acne-Specific Quality of Life instrument. Costs of treatment will be measured on the basis of resource inputs and unit costs and will be limited to acne treatment. The clinical effectiveness and cost-effectiveness will be compared between each intervention and against usual care, using standard health economic techniques. The provision of high-quality evidence of the effectiveness of essential oils and aromatherapy in the treatment of acne may help consumers make better-informed choices about acne management. Insights gained from this research will also contribute to the academic field of complementary medicine, specifically aromatherapy, for which the evidence base is extremely

  19. What happened to the no-wait hospital? A case study of implementation of operational plans for reduced waits.

    PubMed

    Hansson, Johan; Tolf, Sara; Øvretveit, John; Carlsson, Jan; Brommels, Mats

    2012-01-01

    Both research and practice show that waiting lists are hard to reduce. Implementing complex interventions for reduced waits is an intricate and challenging process that requires special attention for surrounding factors helping and hindering the implementation. This article reports a case study of a hospital implementation of operational plans for reduced waits, with an emphasis on the process of change. A case study research design, theoretically informed by the Pettigrew and Whipp model of strategic change, was applied. Data were gathered from individual and focus group interviews with informants from different organizational levels at different times and from documents and plans. The findings revealed arrangements both helping and hindering the implementation work. Helping factors were the hospital's contemporary savings requirements and experiences from similar change initiatives. Those hindering the actions to plan and agree the changes were unclear support functions and unclear task prioritization. One contribution of this study is to demonstrate the advantages, disadvantages, and challenges of a contextualized case study for increased understanding of factors influencing organizational change implementation. One lesson for current policy is to regard context factors that are critical for successful implementation.

  20. A Randomised Controlled Trial of a Play-Based Intervention to Improve the Social Play Skills of Children with Attention Deficit Hyperactivity Disorder (ADHD)

    PubMed Central

    Wilkes-Gillan, Sarah; Lincoln, Michelle; Chen, Yu-Wei

    2016-01-01

    There is a need for effective interventions to address the social difficulties of children with ADHD. This randomised controlled trial examined the effectiveness of a play-based intervention for improving the social play skills of children with ADHD in peer-to-peer interactions. Children with ADHD (5 to 11 years) were randomised to an intervention-first (n = 15) or waitlist control-first group (n = 14). Participants allocated to the control-first group received the intervention after a 10-week wait period. Children invited a typically-developing playmate and parents of children with ADHD participated. The intervention involved: six clinic play-sessions, weekly home-modules and a one-month home follow up. The Test of Playfulness (ToP) was scored by a blinded rater. Parent reported treatment adherence was used to assess treatment fidelity. Between group statistics were used to compare the change of the intervention-first (10-week intervention period) and control-first (10-week wait period) groups. Once all children had received the intervention, repeated measures ANOVA, post hoc Least Significance Difference tests and Cohen’s-d were used to measure effect. Changes in ToP social items were analysed using Friedman’s ANOVA. Linear regression analyses were used to identify variables that predicted change. The control-first group did not change during the wait period. The change in the intervention-first group was significantly greater than the change in the control-first group (during the wait period). When the data from the two groups were combined, the mean ToP scores of the children with ADHD (n = 29) improved significantly following the intervention, with a large effect from pre to post intervention and from pre intervention to follow up. Children maintained treatment gains at follow up. All ToP social items improved significantly following the intervention. The findings support the use of play involving parent and peer mediated components to enhance the social

  1. Increasing students' physical activity during school physical education: rationale and protocol for the SELF-FIT cluster randomized controlled trial.

    PubMed

    Ha, Amy S; Lonsdale, Chris; Lubans, David R; Ng, Johan Y Y

    2017-07-11

    The Self-determined Exercise and Learning For FITness (SELF-FIT) is a multi-component school-based intervention based on tenets of self-determination theory. SELF-FIT aims to increase students' moderate-to-vigorous physical activity (MVPA) during physical education lessons, and enhance their autonomous motivation towards fitness activities. Using a cluster randomized controlled trial, we aim to examine the effects of the intervention on students' MVPA during school physical education. Secondary 2 students (approximately aged 14 years) from 26 classes in 26 different schools will be recruited. After baseline assessments, students will be randomized into either the experimental group or wait-list control group using a matched-pair randomization. Teachers allocated to the experimental group will attend two half-day workshops and deliver the SELF-FIT intervention for 8 weeks. The main intervention components include training teachers to teach in more need supportive ways, and conducting fitness exercises using a fitness dice with interchangeable faces. Other motivational components, such as playing music during classes, are also included. The primary outcome of the trial is students' MVPA during PE lessons. Secondary outcomes include students' leisure-time MVPA, perceived need support from teachers, need satisfaction, autonomous motivation towards physical education, intention to engage in physical activity, psychological well-being, and health-related fitness (cardiorespiratory and muscular fitness). Quantitative data will be analyzed using multilevel modeling approaches. Focus group interviews will also be conducted to assess students' perceptions of the intervention. The SELF-FIT intervention has been designed to improve students' health and well-being by using high-intensity activities in classes delivered by teachers who have been trained to be autonomy needs supportive. If successful, scalable interventions based on SELF-FIT could be applied in physical

  2. Relaxation therapy and anxiety, self-esteem, and emotional regulation among adults with intellectual disabilities: A randomized controlled trial.

    PubMed

    Bouvet, Cyrille; Coulet, Aurélie

    2016-09-01

    This pilot study is a randomized controlled trial on the effects of relaxation on anxiety, self-esteem, and emotional regulation in adults with intellectual disabilities (ID) working in a center of supported employment in France. We studied 30 adults with mild or moderate ID who were split at random into a relaxation group (RG, 15 subjects), who completed 10 sessions of relaxation therapy, and a control group (CG, 15 subjects), who were on a waiting list. The method used is the pretest and posttest. Variables were assessed by the State-Trait Anxiety Inventory form Y scale, the Rosenberg Self-Esteem scale, and the Emotion Regulation Questionnaire. We found that in the RG, relaxation significantly reduced state anxiety, t(14, 15) = 17.8***, d = -0.72, and improved self-esteem, t(14, 15) = -7.7***, d = 1.03, and cognitive reappraisal, t(14, 15) = -6.3***, d = 1.3, while the CG showed no change for these variables. We conclude that relaxation seems to be an interesting therapeutic option for reducing anxiety in people with ID in a supported employment setting. © The Author(s) 2015.

  3. DUNDRUM-2: Prospective validation of a structured professional judgment instrument assessing priority for admission from the waiting list for a forensic mental health hospital

    PubMed Central

    2011-01-01

    Background The criteria for deciding who should be admitted first from a waiting list to a forensic secure hospital are not necessarily the same as those for assessing need. Criteria were drafted qualitatively and tested in a prospective 'real life' observational study over a 6-month period. Methods A researcher rated all those presented at the weekly referrals meeting using the DUNDRUM-1 triage security scale and the DUNDRUM-2 triage urgency scale. The key outcome measure was whether or not the individual was admitted. Results Inter-rater reliability and internal consistency for the DUNDRUM-2 were acceptable. The DUNDRUM-1 triage security score and the DUNDRUM-2 triage urgency score correlated r = 0.663. At the time of admission, after a mean of 23.9 (SD35.9) days on the waiting list, those admitted had higher scores on the DUNDRUM-2 triage urgency scale than those not admitted, with no significant difference between locations (remand or sentenced prisoners, less secure hospitals) at the time of admission. Those admitted also had higher DUNDRUM-1 triage security scores. At baseline the receiver operating characteristic area under the curve for a combined score was the best predictor of admission while at the time of admission the DUNDRUM-2 triage urgency score had the largest AUC (0.912, 95% CI 0.838 to 0.986). Conclusions The triage urgency items and scale add predictive power to the decision to admit. This is particularly true in maintaining equitability between those referred from different locations. PMID:21722397

  4. A goal management intervention for polyarthritis patients: rationale and design of a randomized controlled trial

    PubMed Central

    2013-01-01

    Background A health promotion intervention was developed for inflammatory arthritis patients, based on goal management. Elevated levels of depression and anxiety symptoms, which indicate maladjustment, are found in such patients. Other indicators of adaptation to chronic disease are positive affect, purpose in life and social participation. The new intervention focuses on to improving adaptation by increasing psychological and social well-being and decreasing symptoms of affective disorders. Content includes how patients can cope with activities and life goals that are threatened or have become impossible to attain due to arthritis. The four goal management strategies used are: goal maintenance, goal adjustment, goal disengagement and reengagement. Ability to use various goal management strategies, coping versatility and self-efficacy are hypothesized to mediate the intervention’s effect on primary and secondary outcomes. The primary outcome is depressive symptoms. Secondary outcomes are anxiety symptoms, positive affect, purpose in life, social participation, pain, fatigue and physical functioning. A cost-effectiveness analysis and stakeholders’ analysis are planned. Methods/design The protocol-based psycho-educational program consists of six group-based meetings and homework assignments, led by a trained nurse. Participants are introduced to goal management strategies and learn to use these strategies to cope with threatened personal goals. Four general hospitals participate in a randomized controlled trial with one intervention group and a waiting list control condition. Discussion The purpose of this study is to evaluate the effectiveness of a goal management intervention. The study has a holistic focus as both the absence of psychological distress and presence of well-being are assessed. In the intervention, applicable goal management competencies are learned that assist people in their choice of behaviors to sustain and enhance their quality of life

  5. Fall risk and incidence reduction in high risk individuals with multiple sclerosis: a pilot randomized control trial.

    PubMed

    Sosnoff, Jacob J; Moon, Yaejin; Wajda, Douglas A; Finlayson, Marcia L; McAuley, Edward; Peterson, Elizabeth W; Morrison, Steve; Motl, Robert W

    2015-10-01

    To determine the feasibility of three fall prevention programs delivered over 12 weeks among individuals with multiple sclerosis: (A) a home-based exercise program targeting physiological risk factors; (B) an educational program targeting behavioral risk factors; and (C) a combined exercise-and-education program targeting both factors. Randomized controlled trial. Home-based training with assessments at research laboratory. A total of 103 individuals inquired about the investigation. After screening, 37 individuals with multiple sclerosis who had fallen in the last year and ranged in age from 45-75 years volunteered for the investigation. A total of 34 participants completed postassessment following the 12-week intervention. Participants were randomly assigned into one of four conditions: (1) wait-list control (n = 9); (2) home-based exercise (n = 11); (3) education (n = 9); or (4) a combined exercise and education (n = 8) group. Before and after the 12-week interventions, participants underwent a fall risk assessment as determined by the physiological profile assessment and provided information on their fall prevention behaviors as indexed by the Falls Prevention Strategy Survey. Participants completed falls diaries during the three-months postintervention. A total of 34 participants completed postintervention testing. Procedures and processes were found to be feasible. Overall, fall risk scores were lower in the exercise groups (1.15 SD 1.31) compared with the non-exercise groups (2.04 SD 1.04) following the intervention (p < 0.01). There was no group difference in fall prevention behaviors (p > 0.05). Further examination of home-based exercise/education programs for reducing falls in individuals with multiple sclerosis is warranted. A total of 108 participants would be needed in a larger randomized controlled trial.ClinicalTrials.org #NCT01956227. © The Author(s) 2014.

  6. Electroacupuncture plus standard of care for managing refractory functional dyspepsia: protocol of a pragmatic trial with economic evaluation

    PubMed Central

    Chung, Vincent C H; Wong, Charlene H L; Ching, Jessica Y L; Wong, Samuel Y S; Wu, Justin C Y

    2018-01-01

    Introduction This trial proposes to compare the effectiveness and cost-effectiveness of electroacupuncture (EA) plus on-demand gastrocaine with waiting list for EA plus on-demand gastrocaine in providing symptom relief and quality-of-life improvement among patients with functional dyspepsia (FD). Methods and analysis This is a single-centre, pragmatic, randomised parallel-group, superiority trial comparing the outcomes of (1) EA plus on-demand gastrocaine group and (2) waiting list to EA plus on-demand gastrocaine group. 132 (66/arm) endoscopically confirmed, Helicobacter pylori-negative patients with FD will be recruited. Enrolled patients will respectively be receiving (1) 20 sessions of EA over 10 weeks plus on-demand gastrocaine; or (2) on-demand gastrocaine and being nominated on to a waiting list for EA, which entitles them 20 sessions of EA over 10 weeks after 12 weeks of waiting. The primary outcome will be the between-group difference in proportion of patients achieving adequate relief of symptoms over 12 weeks. The secondary outcomes will include patient-reported change in global symptoms and individual symptoms, Nepean Dyspepsia Index, Nutrient Drink Test, 9-item Patient Health Questionnaire (PHQ9), and 7-item Generalised Anxiety Disorder Scale (GAD7). Adverse events will be assessed formally. Results on direct medical costs and on the EuroQol (EQ-5D) questionnaire will also be used to assess cost-effectiveness. Analysis will follow the intention-to-treat principle using appropriate univariate and multivariate methods. A mixed model analysis taking into account missing data of these outcomes will be performed. Cost-effectiveness analysis will be performed using established approach. Ethics and dissemination The study is supported by the Health and Medical Research Fund, Government of the Hong Kong Special Administrative Region of China. It has been approved by the Joint Chinese University of Hong Kong – New Territories East Cluster Clinical Research

  7. Cognitive behavioral therapy for compulsive buying disorder.

    PubMed

    Mitchell, James E; Burgard, Melissa; Faber, Ron; Crosby, Ross D; de Zwaan, Martina

    2006-12-01

    To our knowledge, no psychotherapy treatment studies for compulsive buying have been published. The authors conducted a pilot trial comparing the efficacy of a group cognitive behavioral intervention designed for the treatment of compulsive buying to a waiting list control. Twenty-eight subjects were assigned to receive active treatment and 11 to the waiting list control group. The results at the end of treatment showed significant advantages for cognitive behavioral therapy (CBT) over the waiting list in reductions in the number of compulsive buying episodes and time spent buying, as well as scores on the Yale-Brown Obsessive Compulsive Scale--Shopping Version and the Compulsive Buying Scale. Improvement was well-maintained at 6-month follow-up. The pilot data suggests that a cognitive behavioral intervention can be quite effective in the treatment of compulsive buying disorder. This model requires further testing.

  8. The PLUNGE randomized controlled trial: evaluation of a games-based physical activity professional learning program in primary school physical education.

    PubMed

    Miller, Andrew; Christensen, Erin M; Eather, Narelle; Sproule, John; Annis-Brown, Laura; Lubans, David Revalds

    2015-05-01

    To evaluate the efficacy of the Professional Learning for Understanding Games Education (PLUNGE) program on fundamental movement skills (FMS), in-class physical activity and perceived sporting competence. A cluster-randomized controlled trial involving one year six class each from seven primary schools (n=168; mean age=11.2 years, SD=1.0) in the Hunter Region, NSW, Australia. In September (2013) participants were randomized by school into the PLUNGE intervention (n=97 students) or the 7-week wait-list control (n=71) condition. PLUNGE involved the use of Game Centered curriculum delivered via an in-class teacher mentoring program. Students were assessed at baseline and 8-week follow-up for three object control FMS (Test of Gross Motor Development 2), in-class physical activity (pedometer steps/min) and perceived sporting competence (Self-perception Profile for Children). Linear mixed models revealed significant group-by-time intervention effects (all p<0.05) for object control competency (effect size: d=0.9), and in-class pedometer steps/min (d=1.0). No significant intervention effects (p>0.05) were observed for perceived sporting competence. The PLUNGE intervention simultaneously improved object control FMS proficiency and in-class PA in stage three students. Copyright © 2015 Elsevier Inc. All rights reserved.

  9. Telephone-delivered cognitive behavioral therapy for high anxiety sensitivity: a randomized controlled trial.

    PubMed

    Olthuis, Janine V; Watt, Margo C; Mackinnon, Sean P; Stewart, Sherry H

    2014-12-01

    High anxiety sensitivity (AS) is associated with the development and maintenance of anxiety and depressive symptoms and is theorized to be a mediator of treatment outcomes for anxiety and depression. The present study tested the efficacy of a telephone-delivered cognitive behavioral therapy (CBT) intervention in reducing high AS and its associated anxiety and depressive symptoms. Treatment-seeking participants with high AS were recruited from the community (N = 80; M age = 36 years; 79% women; 76% Caucasian) and were randomly assigned to an 8-week telephone-delivered CBT program or a waiting list control. Participants completed anxiety and depression symptom and diagnostic measures at pre- and posttreatment, after a subsequent 4 weeks of continued interoceptive exposure, and 8 weeks later. Multilevel modeling showed the treatment was successful in reducing AS, as well as panic, social phobia, posttraumatic stress symptoms, and number of Diagnostic and Statistical Manual of Mental Disorders (4th ed.; American Psychiatric Association, 1994) diagnoses per participant when compared to a waiting list control. These gains were maintained at follow-up. Generalized anxiety and depressive symptoms, however, did not improve as a result of treatment. Mediated moderation analyses suggested that treatment-related changes in AS may mediate anxiety symptom changes. RESULTS of the present study provide promising evidence for this transdiagnostic treatment approach. Reductions in anxiety symptoms across diagnostic categories stemming from this AS-targeted intervention may have implications for helping a broad array of clients with various anxiety disorders that share AS as a common risk or maintenance factor.

  10. Dismantling Multicomponent Behavioral Treatment for Insomnia in Older Adults: A Randomized Controlled Trial

    PubMed Central

    Epstein, Dana R.; Sidani, Souraya; Bootzin, Richard R.; Belyea, Michael J.

    2012-01-01

    Study Objective: Recently, the use of multicomponent insomnia treatment has increased. This study compares the effect of single component and multicomponent behavioral treatments for insomnia in older adults after intervention and at 3 months and 1 yr posttreatment. Design: A randomized, controlled study. Setting: Veterans Affairs medical center. Participants: 179 older adults (mean age, 68.9 yr ± 8.0; 115 women [64.2%]) with chronic primary insomnia. Interventions: Participants were randomly assigned to 6 wk of stimulus control therapy (SCT), sleep restriction therapy (SRT), the 2 therapies combined into a multicomponent intervention (MCI), or a wait-list control group. Measurements and Results: Primary outcomes were subjective (daily sleep diary) and objective (actigraphy) measures of sleep-onset latency (SOL), wake after sleep onset (WASO), total sleep time (TST), time in bed (TIB), and sleep efficiency (SE). Secondary outcomes were clinical measures including response and remission rates. There were no differences between the single and multicomponent interventions on primary sleep outcomes measured by diary and actigraphy. All treatments produced significant improvement in diary-reported sleep in comparison with the control group. Effect sizes for sleep diary outcomes were medium to large. Treatment gains were maintained at follow-up for diary and actigraph measured SOL, WASO, and SE. The MCI group had the largest proportion of treatment remitters. Conclusions: For older adults with chronic primary insomnia, the findings provide initial evidence that SCT, SRT, and MCI are equally efficacious and produce sustainable treatment gains on diary, actigraphy, and clinical outcomes. From a clinical perspective, MCI may be a preferred treatment due to its higher remission rate. Clinical Trial Information: Behavioral Intervention for Insomnia in Older Adults. NCT01154023. URL: http://clinicaltrials.gov/ct2/show/NCT01154023?term

  11. Testing the efficacy of web-based cognitive behavioural therapy for adult patients with chronic fatigue syndrome (CBIT): study protocol for a randomized controlled trial.

    PubMed

    Janse, Anthonie; Worm-Smeitink, Margreet; Bussel-Lagarde, José; Bleijenberg, Gijs; Nikolaus, Stephanie; Knoop, Hans

    2015-08-12

    Cognitive behavioural therapy (CBT) is an effective treatment for fatigue and disabilities in patients with chronic fatigue syndrome (CFS). However, treatment capacity is limited. Providing web-based CBT and tailoring the amount of contact with the therapist to the individual needs of the patient may increase the efficiency of the intervention. Web-based CBT for adolescents with CFS has proven to be effective in reducing fatigue and increasing school attendance. In the proposed study the efficacy of a web-based CBT intervention for adult patients with CFS will be explored. Two different formats of web-based CBT will be tested. In the first format named protocol driven feedback, patients report on their progress and receive feedback from a therapist according to a preset schedule. In the second format named support on demand, feedback and support of the therapist is only given when patients ask for it. The primary objective of the study is to determine the efficacy of a web-based CBT intervention on fatigue severity. A randomized clinical trial will be conducted. Two-hundred-forty adults who have been diagnosed with CFS according to the US Centers for Disease Control and Prevention (CDC) consensus criteria will be recruited and randomized to one of three conditions: web-based CBT with protocol driven feedback, web-based CBT with support on demand, or wait list. Feedback will be delivered by therapists specialized in CBT for CFS. Each of the web-based CBT interventions will be compared to a wait list condition with respect to its effect on the primary outcome measure; fatigue severity. Secondary outcome measures are level of disability, physical functioning, psychological distress, and the proportion of patients with clinical significant improvement in fatigue severity. Outcomes will be assessed at baseline and six months post randomization. The web-based CBT formats will be compared with respect to the time therapists need to deliver the intervention. As far as we

  12. The effect of chiropractic treatment on the reaction and response times of special operation forces military personnel: study protocol for a randomized controlled trial.

    PubMed

    DeVocht, James W; Smith, Dean L; Long, Cynthia R; Corber, Lance; Kane, Bridget; Jones, Thomas M; Goertz, Christine M

    2016-09-20

    Chiropractic care is commonly used to treat musculoskeletal conditions and has been endorsed by clinical practice guidelines as being evidence-based and cost-effective for the treatment of patients with low back pain. Gaps in the literature exist regarding the physiological outcomes of chiropractic treatment. Previous pilot work has indicated the possibility of improvements in response time following the application of chiropractic treatment. However, it is unknown whether or not chiropractic treatment is able to improve reaction and response times in specific populations of interest. One such population is the U.S. military special operation forces' (SOF) personnel. This study is a randomized controlled trial of 120 asymptomatic volunteer SOF personnel. All participants are examined by a study doctor of chiropractic (DC) for eligibility prior to randomization. The participants are randomly allocated to either a treatment group receiving four treatments of chiropractic manipulative therapy (CMT) over 2 weeks or to a wait-list control group. The wait-list group does not receive any treatment but has assessments at the same time interval as the treatment group. The outcome measures are simple reaction times for dominant hand and dominant foot, choice reaction time with prompts calling for either hand or either foot, response time using Fitts' law tasks for small movements involving eye-hand coordination, and brief whole body movements using the t-wall, a commercially available product. At the first visit, all five tests are completed so that participants can familiarize themselves with the equipment and protocol. Assessments at the second and the final visits are used for data analysis. SOF personnel are highly motivated and extremely physically fit individuals whose occupation requires reaction times that are as quick as possible during the course of their assigned duties. A goal of CMT is to maximize the functionality and integration of the neuromusculoskeletal

  13. Efficacy of Mobile Serious Games in Increasing HIV Risk Perception in Swaziland: A Randomized Control Trial (SGprev Trial) Research Protocol.

    PubMed

    Lukhele, Bhekumusa Wellington; Musumari, Patou; El-Saaidi, Christina; Techasrivichien, Teeranee; Suguimoto, S Pilar; Ono Kihara, Masako; Kihara, Masahiro

    2016-11-22

    The human immunodeficiency virus (HIV) and acquired immune deficiency syndrome (AIDS) continue to be a major public health problem in Sub-Saharan Africa (SSA), particularly in Swaziland, which has the highest HIV prevalence in this region. A wide range of strategies and interventions have been used to promote behavior change, though almost all such interventions have involved mass media. Therefore, innovative behavior change strategies beyond mass media communication are urgently needed. Serious games have demonstrated effectiveness in advancing health in the developed world; however, no rigorous serious games interventions have been implemented in HIV prevention in SSA. We plan to test whether a serious game intervention delivered on mobile phones to increase HIV risk perception, increase intention to reduce sexual partnerships, and increase intention to know own and partners HIV status will be more effective compared with current prevention efforts. This is a two-arm randomized intervention trial. We will recruit 380 participants who meet the following eligibility criteria: 18-29 years of age, own a smartphone running an Android-based operating system, have the WhatsApp messaging app, live in Swaziland, and can adequately grant informed consent. Participants will be allocated into a smartphone interactive, educational story game, and a wait-list control group in a 1:1 allocation ratio. Subsequently, a self-administered Web-based questionnaire will be issued at baseline and after 4 weeks of exposure to the game. We hypothesize that the change in HIV risk perception between pre- and post-intervention assessment is greater in the intervention group compared with the change in the control group. Our primary hypothesis is based on the assumption that increased perceived risk of HIV provides cues to engage in protective behavior. Our primary outcome measure is HIV risk perceived mean change between pre- and post-intervention compared with the mean change in the wait-list

  14. Randomized Trial of Cognitive-Behavioral Therapy for Chronic Posttraumatic Stress Disorder in Adult Female Survivors of Childhood Sexual Abuse

    ERIC Educational Resources Information Center

    McDonagh, Annmarie; Friedman, Matthew; McHugo, Gregory; Ford, Julian; Sengupta, Anjana; Mueser, Kim; Demment, Christine Carney; Fournier, Debra; Schnurr, Paula P.

    2005-01-01

    The authors conducted a randomized clinical trial of individual psychotherapy for women with posttraumatic stress disorder (PTSD) related to childhood sexual abuse (n = 74), comparing cognitive-behavioral therapy (CBT) with a problem-solving therapy (present-centered therapy; PCT) and to a wait-list (WL). The authors hypothesized that CBT would be…

  15. Virtual reality compared with in vivo exposure in the treatment of social anxiety disorder: a three-arm randomised controlled trial.

    PubMed

    Bouchard, Stéphane; Dumoulin, Stéphanie; Robillard, Geneviève; Guitard, Tanya; Klinger, Évelyne; Forget, Hélène; Loranger, Claudie; Roucaut, François Xavier

    2017-04-01

    Background People with social anxiety disorder (SAD) fear social interactions and may be reluctant to seek treatments involving exposure to social situations. Social exposure conducted in virtual reality (VR), embedded in individual cognitive-behavioural therapy (CBT), could be an answer. Aims To show that conducting VR exposure in CBT for SAD is effective and is more practical for therapists than conducting exposure in vivo Method Participants were randomly assigned to either VR exposure ( n = 17), in vivo exposure ( n = 22) or waiting list ( n = 20). Participants in the active arms received individual CBT for 14 weekly sessions and outcome was assessed with questionnaires and a behaviour avoidance test. (Trial registration number ISRCTN99747069) Results Improvements were found on the primary (Liebowitz Social Anxiety Scale) and all five secondary outcome measures in both CBT groups compared with the waiting list. Conducting exposure in VR was more effective at post-treatment than in vivo on the primary outcome measure and on one secondary measure. Improvements were maintained at the 6-month follow-up. VR was significantly more practical for therapists than in vivo exposure. Conclusions Using VR can be advantageous over standard CBT as a potential solution for treatment avoidance and as an efficient, cost-effective and practical medium of exposure. © The Royal College of Psychiatrists 2017.

  16. Web-based psychotherapy for posttraumatic stress disorder in war-traumatized Arab patients: randomized controlled trial.

    PubMed

    Knaevelsrud, Christine; Brand, Janine; Lange, Alfred; Ruwaard, Jeroen; Wagner, Birgit

    2015-03-20

    In recent years, armed conflicts in the Middle East have resulted in high rates of exposure to traumatic events. Despite the increasing demand of mental health care provision, ongoing violence limits conventional approaches of mental health care provision. Internet-based interventions for posttraumatic stress disorder (PTSD) have proved feasible and effective in Western countries, but their applicability and efficacy in war and conflict regions remains unknown. This study investigated the efficacy of a cognitive behavioral Internet-based intervention for war-traumatized Arab patients, with focus on Iraq. A total of 159 individuals with PTSD participated in a parallel group randomized trial. Participants were randomly allocated by a computer-generated sequence to a treatment group (n=79) or a waiting list control group (n=80). The treatment group received 2 weekly 45-minute cognitive behavioral interventions via Internet over a 5-week period (10 sessions in total). The primary outcome was recovery from posttraumatic stress symptoms. Posttraumatic stress symptoms were significantly reduced from baseline to posttreatment (intention-to-treat analysis) in the treatment group relative to the control group (F1,157=44.29, P<.001, d=0.92). Treatment effects were sustained at 3-month follow-up. Completer analysis indicated that 29 of 47 patients (62%) in the treatment group had recovered from posttraumatic stress symptoms at posttreatment (reliable change and Posttraumatic Stress Diagnostic Scale score <20) versus 1 patient (2%) in the control group (OR 74.19, 95% CI 9.93-585.8, P<.001) indicating that the chance of recovering was 74.19 times higher in the treatment than in the control group. The results indicate, even in unstable and insecure settings with ongoing exposure to human rights violations through war and dictatorships, people with posttraumatic stress symptoms benefit from a cognitive behavioral treatment provided entirely through the Internet. This method of

  17. Randomized controlled trial of physical activity, cognition, and walking in multiple sclerosis.

    PubMed

    Sandroff, Brian M; Klaren, Rachel E; Pilutti, Lara A; Dlugonski, Deirdre; Benedict, Ralph H B; Motl, Robert W

    2014-02-01

    The present study adopted a randomized controlled trial design and examined the effect of a physical activity behavioral intervention on cognitive and walking performance among persons with MS who have mild or moderate disability status. A total of 82 MS patients were randomly allocated into intervention or wait-list control conditions. The intervention condition received a theory-based program for increasing physical activity behavior that was delivered via the Internet, and one-on-one video chat sessions with a behavior-change coach. Participants completed self-report measures of physical activity and disability status, and underwent the oral Symbol Digit Modalities Test (SDMT) and 6-minute walk (6MW) test before and after the 6-month period. Analysis using mixed-model ANOVA indicated a significant time × condition × disability group interaction on SDMT scores (p = 0.02, partial-η (2) = 0.08), such that persons with mild disability in the intervention condition demonstrated a clinically meaningful improvement in SDMT scores (~6 point change). There was a further significant time × condition interaction on 6MW distance (p = 0.02, partial-η (2) = 0.07), such that those in the intervention condition demonstrated an increase in 6MW distance relative to those in the control group. The current study supports physical activity as a promising tool for managing cognitive impairment and impaired walking performance in persons with MS, and suggests that physical activity might have specific effects on cognition and non-specific effects on walking performance in this population.

  18. Cognitive Therapy and Task Concentration Training Applied as Intensified Group Therapies for Social Anxiety Disorder with Fear of Blushing-A Randomized Controlled Trial.

    PubMed

    Härtling, Samia; Klotsche, Jens; Heinrich, Anke; Hoyer, Jürgen

    2016-11-01

    The current study examines the efficacy of intensified group therapy for social anxiety disorder with fear of blushing. Task concentration training (TCT) and cognitive therapy (CT) were applied during one weekend and compared with a waiting list condition in a randomized controlled trial including 82 patients. On a second weekend, another intervention was added (resulting in TCT-CT and CT-TCT sequences) to examine order effects. Task concentration training and CT were both superior to the waiting list and equally effective after the first therapy weekend. Also, no differences were found between the sequences TCT-CT and CT-TCT at post-assessment. At 6- and 12-month follow-up, effects remained stable or further improved. At the 6-month follow-up, remission rates in completers, established by diagnostic status, were between 69% and 73%. Intensified group therapy is highly effective in treating social anxiety disorder with fear of blushing. Group formats for patients sharing a common primary concern may contribute to the dissemination of cognitive-behavioural therapy. Copyright © 2015 John Wiley & Sons, Ltd. Key Practitioner Message: This study focuses on blushing from fearful individuals within the SAD spectrum to improve evidence for treatment efficacy in those whose social fears are centred around observable bodily sensations. This study integrates task concentration training into the SAD model of Clark and Wells to combine two evidence-based treatments for SAD under one treatment model. This study uses an innovative format of brief, intensified group therapy, conducted on two full-day weekend group sessions delivered over two weekends, with strong observed effect sizes. Copyright © 2015 John Wiley & Sons, Ltd.

  19. Effect of YH0618 soup on chemotherapy-induced toxicity in patients with cancer who have completed chemotherapy: study protocol for a randomized controlled trial.

    PubMed

    You, Jie-Shu; Chen, Jian-Ping; Chan, Jessie S M; Lee, Ho-Fun; Wong, Mei-Kuen; Yeung, Wing-Fai; Lao, Li-Xing

    2016-07-26

    The incidence of cancer has been staying at a high level worldwide in recent years. With advances in cancer diagnosis and therapy strategy, the survival rate of patients with cancer has been increasing, but the side effects of these treatments, especially chemotherapy, are obvious even when the chemotherapy ceases. YH0618, a prescription, has showed efficacy in reducing chemotherapy-induced toxicity through long clinical practice. However, there is no scientific research exploring the effects of YH0618 in patients with cancer. Therefore, using a randomized controlled trial, this study will explore the efficacy of YH0618 on ameliorating chemotherapy-induced toxicity including dermatologic toxicity, myelosuppression, hepatotoxicity and nephrotoxicity and improving fatigue in cancer patients who have completed chemotherapy. This is a prospective assessor-blinded, parallel, randomized controlled trial. Patients with cancer at any stage who have completed chemotherapy within two weeks will be randomly divided into group A (YH0618) and group B (wait-list) using a 1:1 allocation ratio. The chemotherapeutic agents include taxanes or anthracyclines. Subjects assigned to group A will receive YH0618 soup 6 days a week for 6 weeks and uncontrolled follow-up for 6 weeks, while group B are required to wait for 6 weeks before receiving YH0618 intervention. The primary outcome of this study is the incidence of protocol-specified grade ≥2 dermatologic toxicities graded by NCI CTCAE Chinese version 4.0 and changes of fingernail color, face skin color and tongue color evaluated by the L*a*b system within 6 weeks. There are some secondary outcomes associated with dermatologic toxicity including fatigue and clinical objective examination. There are few scientific and safe methods in ameliorating chemotherapy-induced toxicity. The proposed study may provide direct and convincing evidence to support YH0618 as an adjuvant treatment for reducing chemotherapy-induced toxicity, which

  20. The study protocol of a cluster-randomised controlled trial of family-mediated personalised activities for nursing home residents with dementia.

    PubMed

    van der Ploeg, Eva S; Camp, Cameron J; Eppingstall, Barbara; Runci, Susannah J; O'Connor, Daniel W

    2012-01-12

    Following admission to a nursing home, the feelings of depression and burden that family carers may experience do not necessarily diminish. Additionally, they may experience feelings of guilt and grief for the loss of a previously close relationship. At the same time, individuals with dementia may develop symptoms of depression and agitation (BPSD) that may be related to changes in family relationships, social interaction and stimulation. Until now, interventions to alleviate carer stress and BPSD have treated carers and relatives separately rather than focusing on maintaining or enhancing their relationships. One-to-one structured activities have been shown to reduce BPSD and also improve the caring experience, but barriers such as a lack of resources impede the implementation of activities in aged care facilities. The current study will investigate the effect of individualised activities based on the Montessori methodology administered by family carers in residential care. We will conduct a cluster-randomised trial to train family carers in conducting personalised one-to-one activities based on the Montessori methodology with their relatives. Montessori activities derive from the principles espoused by Maria Montessori and subsequent educational theorists to promote engagement in learning, namely task breakdown, guided repetition, progression in difficulty from simple to complex, and the careful matching of demands to levels of competence. Persons with dementia living in aged care facilities and frequently visiting family carers will be included in the study. Consented, willing participants will be randomly assigned by facility to a treatment condition using the Montessori approach or a control waiting list condition. We hypothesise that family carers conducting Montessori-based activities will experience improvements in quality of visits and overall relationship with the resident as well as higher self-rated mastery, fewer depressive symptoms, and a better

  1. One-session treatment of specific phobias in youth: a randomized clinical trial in the United States and Sweden.

    PubMed

    Ollendick, Thomas H; Ost, Lars-Göran; Reuterskiöld, Lena; Costa, Natalie; Cederlund, Rio; Sirbu, Cristian; Davis, Thompson E; Jarrett, Matthew A

    2009-06-01

    One hundred and ninety-six youth, ages 7-16, who fulfilled Diagnostic and Statistical Manual of Mental Disorders (4th ed.) criteria for various specific phobias were randomized to a one-session exposure treatment, education support treatment, or a wait list control group. After the waiting period, the wait list participants were offered treatment and, if interested, rerandomized to 1 of the 2 active treatments. The phobias were assessed with semistructured diagnostic interviews, clinician severity ratings, and behavioral avoidance tests, whereas fears, general anxiety, depression, and behavior problems were assessed with self- and parent report measures. Assessments were completed pretreatment, posttreatment, and at 6 months following treatment. Results showed that both treatment conditions were superior to the wait list control condition and that 1-session exposure treatment was superior to education support treatment on clinician ratings of phobic severity, percentage of participants who were diagnosis free, child ratings of anxiety during the behavioral avoidance test, and treatment satisfaction as reported by the youth and their parents. There were no differences on self-report measures. Treatment effects were maintained at follow-up. Implications of these findings are discussed. Copyright 2009 APA

  2. Cluster randomised controlled trial of 'whole school' child maltreatment prevention programme in primary schools in Northern Ireland: study protocol for Keeping Safe.

    PubMed

    McElearney, Aisling; Brennan-Wilson, Aoibheann; Murphy, Christina; Stephenson, Phyllis; Bunting, Brendan

    2018-05-03

    Child maltreatment has a pervasive, detrimental impact on children's wellbeing. Despite a growing focus on prevention through school based education, few programmes adopt a whole- school approach, are multi-component, seek to address all forms of maltreatment, or indeed have been robustly evaluated. This paper describes a cluster randomised controlled trial designed to evaluate a school based child maltreatment prevention programme: 'Keeping Safe' in primary schools in Northern Ireland. The intervention has been designed by a non-profit agency. Programme resources include 63 lessons taught incrementally to children between four and 11 years old, and is premised on three core themes: healthy relationships, my body, and being safe. There are programme resources to engage parents and to build the capacity and skills of school staff. A cluster Randomised Controlled Trial (RCT) will be conducted with children in 80 schools over a two-year period. The unit of randomisation is the school. Schools will be allocated to intervention or wait-list control groups using a computer-generated list. Data will be collected at three time points: baseline, end of year one, and end of year two of programme implementation. Primary outcomes will include: children's understanding of key programme concepts, self-efficacy to keep safe in situations of maltreatment, anxiety arising from programme participation, and disclosure of maltreatment. Secondary outcomes include teachers' comfort and confidence in teaching the programme and parents' confidence in talking to their children about programme concepts. This RCT will address gaps in current practice and evidence regarding school based child maltreatment prevention programmes. This includes the use of a whole- school approach and multi-component programme that addresses all maltreatment concepts, a two-year period of programme implementation, and the tracking of outcomes for children, parents, and teachers. Methodologically, it will extend

  3. The effects of computer-based mindfulness training on Self-control and Mindfulness within Ambulatorily assessed network Systems across Health-related domains in a healthy student population (SMASH): study protocol for a randomized controlled trial.

    PubMed

    Rowland, Zarah; Wenzel, Mario; Kubiak, Thomas

    2016-12-01

    Self-control is an important ability in everyday life, showing associations with health-related outcomes. The aim of the Self-control and Mindfulness within Ambulatorily assessed network Systems across Health-related domains (SMASH) study is twofold: first, the effectiveness of a computer-based mindfulness training will be evaluated in a randomized controlled trial. Second, the SMASH study implements a novel network approach in order to investigate complex temporal interdependencies of self-control networks across several domains. The SMASH study is a two-armed, 6-week, non-blinded randomized controlled trial that combines seven weekly laboratory meetings and 40 days of electronic diary assessments with six prompts per day in a healthy undergraduate student population at the Johannes Gutenberg University Mainz, Germany. Participants will be randomly assigned to (1) receive a computer-based mindfulness intervention or (2) to a wait-list control condition. Primary outcomes are self-reported momentary mindfulness and self-control assessed via electronic diaries. Secondary outcomes are habitual mindfulness and habitual self-control. Further measures include self-reported behaviors in specific self-control domains: emotion regulation, alcohol consumption and eating behaviors. The effects of mindfulness training on primary and secondary outcomes are explored using three-level mixed models. Furthermore, networks will be computed with vector autoregressive mixed models to investigate the dynamics at participant and group level. This study was approved by the local ethics committee (reference code 2015_JGU_psychEK_011) and follows the standards laid down in the Declaration of Helsinki (2013). This randomized controlled trial combines an intensive Ambulatory Assessment of 40 consecutive days and seven laboratory meetings. By implementing a novel network approach, underlying processes of self-control within different health domains will be identified. These results will

  4. Usefulness of a fast track list for anxious patients in a upper GI endoscopy.

    PubMed

    Cardin, Fabrizio; Andreotti, Alessandra; Zorzi, Manuel; Terranova, Claudio; Martella, Bruno; Amato, Bruno; Militello, Carmelo

    2012-01-01

    To determine whether patients with no alarm signs who ask the endoscopist to shorten their waiting time due to test result anxiety, represent a risk category for a major organic pathology. At our open-access endoscopy service, we set up an expedite list for six months for outpatients who complained that the waiting time for gastroscopy was too long. Over this period we studied 373 gastroscopy patients. In addition to personal details, we collected information on the presence of Hp infection and compliance with dyspepsia guideline indications for gastroscopy. Average waiting time was 38.2 days (SD 12.7). The 66 patients who considered the waiting time too long underwent gastroscopy within 15 days. We made 5 diagnoses of esophageal and gastric tumour and gastric ulcer (7.6%) among the expedite list patients and 14 (4.6%) among those on the normal list (p=0.31). On including duodenal peptic disease in the analysis, the total prevalence rate rose to 19.7% in the short-wait group and to 10.4% (p=0.036) in the longer-wait group. Our data suggests that asking to be fast-tracked does not have prognostic impact on the diagnosis of a major (gastric ulcer and cancer) pathology.

  5. ShopSmart 4 Health - protocol of a skills-based randomised controlled trial promoting fruit and vegetable consumption among socioeconomically disadvantaged women.

    PubMed

    Ball, Kylie; McNaughton, Sarah A; Le, Ha; Andrianopoulos, Nick; Inglis, Victoria; McNeilly, Briohny; Lichomets, Irene; Granados, Alba; Crawford, David

    2013-05-14

    There is a need for evidence on the most effective and cost-effective approaches for promoting healthy eating among groups that do not meet dietary recommendations for good health, such as those with low incomes or experiencing socioeconomic disadvantage. This paper describes the ShopSmart 4 Health study, a randomised controlled trial conducted by Deakin University, Coles Supermarkets and the Heart Foundation, to investigate the effectiveness and cost-effectiveness of a skill-building intervention for promoting increased purchasing and consumption of fruits and vegetables amongst women of low socioeconomic position (SEP). ShopSmart 4 Health employed a randomised controlled trial design. Women aged 18-60 years, holding a Coles store loyalty card, who shopped at Coles stores within socioeconomically disadvantaged neighbourhoods and met low-income eligibility criteria were invited to participate. Consenting women completed a baseline survey assessing food shopping and eating habits and food-related behaviours and attitudes. On receipt of their completed survey, women were randomised to either a skill-building intervention or a wait-list control condition. Intervention effects will be evaluated via self-completion surveys and using supermarket transaction sales data, collected at pre- and post-intervention and 6-month follow-up. An economic evaluation from a societal perspective using a cost-consequences approach will compare the costs and outcomes between intervention and control groups. Process evaluation will be undertaken to identify perceived value and effects of intervention components. This study will provide data to address the currently limited evidence base regarding the effectiveness and cost-effectiveness of skill-building intervention strategies aimed at increasing fruit and vegetable consumption among socioeconomically disadvantaged women, a target group at high risk of poor diets. Current Controlled Trials ISRCTN48771770.

  6. Protocol for the 'Virtual Traveller' cluster-randomised controlled trial: a behaviour change intervention to increase physical activity in primary-school Maths and English lessons.

    PubMed

    Norris, E; Dunsmuir, S; Duke-Williams, O; Stamatakis, E; Shelton, N

    2016-06-27

    Physical activity (PA) has been shown to be an important factor for health and educational outcomes in children. However, a large proportion of children's school day is spent in sedentary lesson-time. There is emerging evidence about the effectiveness of physically active lessons: integrating physical movements and educational content in the classroom. 'Virtual Traveller' is a novel 6-week intervention of 10-min sessions performed 3 days per week, using classroom interactive whiteboards to integrate movement into primary-school Maths and English teaching. The primary aim of this project is to evaluate the effect of the Virtual Traveller intervention on children's PA, on-task behaviour and student engagement. This study will be a cluster-randomised controlled trial with a waiting-list control group. Ten year 4 (aged 8-9 years) classes across 10 primary schools will be randomised by class to either the 6-week Virtual Traveller intervention or the waiting-list control group. Data will be collected 5 times: at baseline, at weeks 2 and 4 of the intervention, and 1 week and 3 months postintervention. At baseline, anthropometric measures, 4-day objective PA monitoring (including 2 weekend days; Actigraph accelerometer), PA and on-task behaviour observations and student engagement questionnaires will be performed. All but anthropometric measures will be repeated at all other data collection points. Changes in overall PA levels and levels during different time-periods (eg, lesson-time) will be examined. Changes in on-task behaviour and student engagement between intervention groups will also be examined. Multilevel regression modelling will be used to analyse the data. Process evaluation will be carried out during the intervention period. The results of this study will be disseminated through peer-review publications and conference presentations. Ethical approval was obtained through the University College London Research Ethics Committee (reference number: 3500

  7. Promising effects of treatment with flotation-REST (restricted environmental stimulation technique) as an intervention for generalized anxiety disorder (GAD): a randomized controlled pilot trial.

    PubMed

    Jonsson, Kristoffer; Kjellgren, Anette

    2016-03-25

    During Flotation-REST a person is floating inside a quiet and dark tank, filled with heated salt saturated water. Deep relaxation and beneficial effects on e.g. stress, sleep difficulties, anxiety and depression have been documented in earlier research. Despite that treatments for generalized anxiety disorder (GAD) are effective; it is till the least successfully treated anxiety disorder, indicating that treatment protocols can be enhanced. The use of Flotation-REST as a treatment of GAD has not been researched. The aim of the present study was to conduct an initial evaluation of the effects in a self-diagnosed GAD sample. This study was a randomized, parallel group, non-blinded trial with 1:1 allocation ratio to waiting list control group (n = 25) or to a twelve session treatment with flotation-REST (n = 25). Inclusion criteria's were: 18-65 years and GAD (as defined by self-report measures). The primary outcome was GAD-symptomatology, and secondary outcomes were depression, sleep difficulties, emotion regulation difficulties and mindfulness. Assessments were made at three time points (baseline, four weeks in treatment, post-treatment), and at six-month follow-up. The main data analyses were conducted with a two-way MANOVA and additional t-tests. Forty-six participants (treatment, n = 24; control, n = 22) were included in the analyses. A significant Time x Group interaction effect for GAD-symptomatology [F (2,88) = 2.93, p < .001, η p (2)  = .062] was found. Further analyses showed that the GAD-symptomatology was significantly reduced for the treatment group (t (23) = 4.47, p < .001), but not for the waiting list control group (t(21) = 0.98, p > .05), when comparing baseline to post-treatment scoring. Regarding clinical significant change, 37 % in the treatment group reached full remission at post-treatment. Significant beneficial effects were also found for sleep difficulties, difficulties in emotional regulation, and depression, while the treatment had

  8. Who Benefits and How Does It Work? Moderators and Mediators of Outcome in an Effectiveness Trial of a Parenting Intervention

    ERIC Educational Resources Information Center

    Gardner, Frances; Hutchings, Judy; Bywater, Tracey; Whitaker, Chris

    2010-01-01

    We examined mediators and moderators of change in conduct problems, in a multiagency randomized trial of the Incredible Years parenting program. Preschoolers (n = 153) at risk for conduct problems were randomly assigned to intervention (n = 104) and wait-list (n = 49) groups. Boys and younger children, and those with more depressed mothers, tended…

  9. A video-based transdiagnostic REBT universal prevention program for internalizing problems in adolescents: study protocol of a cluster randomized controlled trial.

    PubMed

    Păsărelu, Costina Ruxandra; Dobrean, Anca

    2018-04-13

    Internalizing problems are the most prevalent mental health problems in adolescents. Transdiagnostic programs are promising manners to treat multiple problems within the same protocol, however, there is limited research regarding the efficacy of such programs delivered as universal prevention programs in school settings. Therefore, the present study aims to investigate the efficacy of a video-based transdiagnostic rational emotive behavioral therapy (REBT) universal prevention program, for internalizing problems. The second objective of the present paper will be to investigate the subsequent mechanisms of change, namely maladaptive cognitions. A two-arm parallel randomized controlled trial will be conducted, with two groups: a video-based transdiagnostic REBT universal prevention program and a wait list control. Power analysis indicated that the study will involve 338 participants. Adolescents with ages between 12 and 17 years old, from several middle schools and high schools, will be invited to participate. Assessments will be conducted at four time points: baseline (T 1 ), post-intervention (T 2 ), 3 months follow-up (T 3 ) and 12 months follow-up (T 4 ). Intent-to-treat analysis will be used in order to investigate significant differences between the two groups in both primary and secondary outcomes. This is the first randomized controlled trial that aims to investigate the efficacy and mechanisms of change of a video-based transdiagnostic REBT universal prevention program, delivered in a school context. The present study has important implications for developing efficient prevention programs, interactive, that will aim to target within the same protocol both anxiety and depressive symptoms. ClinicalTrials.gov: NCT02756507 . Registered on 25 April 2016.

  10. Online cognitive-behavioural treatment of bulimic symptoms: a randomized controlled trial.

    PubMed

    Ruwaard, Jeroen; Lange, Alfred; Broeksteeg, Janneke; Renteria-Agirre, Aitziber; Schrieken, Bart; Dolan, Conor V; Emmelkamp, Paul

    2013-01-01

    Manualized cognitive-behavioural treatment (CBT) is underutilized in the treatment of bulimic symptoms. Internet-delivered treatment may reduce current barriers. This study aimed to assess the efficacy of a new online CBT of bulimic symptoms. Participants with bulimic symptoms (n = 105) were randomly allocated to online CBT, bibliotherapy or waiting list/delayed treatment condition. Data were gathered at pre-treatment, post-treatment and 1-year follow-up. The primary outcome measures were the Eating Disorder Examination Questionnaire (EDE-Q) and the frequency of binge eating and purging episodes. The secondary outcome measure was the Body Attitude Test. Dropout from Internet treatment was 26%. Intention-to-treat ANCOVAs of post-test data revealed that the EDE-Q scores and the frequency of binging and purging reduced more in the online CBT group compared with the bibliotherapy and waiting list groups (pooled between-group effect size: d = 0.9). At 1-year follow-up, improvements in the online CBT group had sustained. This study identifies online CBT as a viable alternative in the treatment of bulimic symptoms. Copyright © 2012 John Wiley & Sons, Ltd.

  11. 76 FR 81793 - The Commerce Control List

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-12-29

    ... DEPARTMENT OF COMMERCE Bureau of Industry and Security 15 CFR Part 774 The Commerce Control List... Commerce Control List), Category 9 Aerospace and Propulsion, Product Group E is amended by revising the...'' ``technology'' for repair, rebuild and overhaul. Excluded from 9E001 to 9E003 control are: technical data...

  12. Walk well: a randomised controlled trial of a walking intervention for adults with intellectual disabilities: study protocol

    PubMed Central

    2013-01-01

    Background Walking interventions have been shown to have a positive impact on physical activity (PA) levels, health and wellbeing for adult and older adult populations. There has been very little work carried out to explore the effectiveness of walking interventions for adults with intellectual disabilities. This paper will provide details of the Walk Well intervention, designed for adults with intellectual disabilities, and a randomised controlled trial (RCT) to test its effectiveness. Methods/design This study will adopt a RCT design, with participants allocated to the walking intervention group or a waiting list control group. The intervention consists of three PA consultations (baseline, six weeks and 12 weeks) and an individualised 12 week walking programme. A range of measures will be completed by participants at baseline, post intervention (three months from baseline) and at follow up (three months post intervention and six months from baseline). All outcome measures will be collected by a researcher who will be blinded to the study groups. The primary outcome will be steps walked per day, measured using accelerometers. Secondary outcome measures will include time spent in PA per day (across various intensity levels), time spent in sedentary behaviour per day, quality of life, self-efficacy and anthropometric measures to monitor weight change. Discussion Since there are currently no published RCTs of walking interventions for adults with intellectual disabilities, this RCT will examine if a walking intervention can successfully increase PA, health and wellbeing of adults with intellectual disabilities. Trial registration ISRCTN: ISRCTN50494254 PMID:23816316

  13. Treating Acute Insomnia: A Randomized Controlled Trial of a “Single-Shot” of Cognitive Behavioral Therapy for Insomnia

    PubMed Central

    Ellis, Jason G.; Cushing, Toby; Germain, Anne

    2015-01-01

    Study Objectives: Despite considerable evidence supporting cognitive behavioral therapy for insomnia (CBT-I) for chronic insomnia, it remains untested within the context of acute insomnia. This study examined the efficacy of a single session of CBT-I, with an accompanying self-help pamphlet, for individuals with acute insomnia. Design: A pragmatic parallel group randomized controlled trial. Setting: Community. Participants: Forty adults (mean age 32.9 ± 13.72 y) with Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) defined insomnia disorder, except a self-reported duration of less than 3 mo (i.e., acute insomnia), who reported no previous exposure to CBT-I and were not currently taking medication for sleep. Interventions: A single 60- to 70-min session of CBT-I (n = 20), with an accompanying self-help pamphlet, or wait list control group (n = 20). All subjects were offered a full individual course of CBT-I on completion of the study, regardless of group allocation. Measurements and Results: Subjects completed sleep diaries and the Insomnia Severity Index (ISI) pretreatment and 1 mo following treatment. There were no between-group differences on baseline ISI scores or subjective sleep continuity. The intervention group reported significantly lower ISI scores than controls (t(38) 2.24, P < 0.05) at follow-up. Further, using proposed ISI scores for identifying insomnia caseness (i.e., ≥ 10), 60% of those in the CBT-I group had remitted by 1 mo compared to 15% of those in the control group. Conclusions: This single session of cognitive behavioral therapy for insomnia (CBT-I) is sufficiently efficacious for a significant proportion of those with acute insomnia. The results are discussed in terms of integrating this brief form of CBT-I into the “stepped care” model of insomnia. Trial Registration: Testing the efficacy of an early intervention for acute insomnia (SRCTN05891695) http://www.controlled-trials.com/ISRCTN05891695. Citation

  14. Efficacy of a reading and language intervention for children with Down syndrome: a randomized controlled trial

    PubMed Central

    Burgoyne, Kelly; Duff, Fiona J; Clarke, Paula J; Buckley, Sue; Snowling, Margaret J; Hulme, Charles

    2012-01-01

    Background This study evaluates the effects of a language and literacy intervention for children with Down syndrome. Methods Teaching assistants (TAs) were trained to deliver a reading and language intervention to children in individual daily 40-min sessions. We used a waiting list control design, in which half the sample received the intervention immediately, whereas the remaining children received the treatment after a 20-week delay. Fifty-seven children with Down syndrome in mainstream primary schools in two UK locations (Yorkshire and Hampshire) were randomly allocated to intervention (40 weeks of intervention) and waiting control (20 weeks of intervention) groups. Assessments were conducted at three time points: pre-intervention, after 20 weeks of intervention, and after 40 weeks of intervention. Results After 20 weeks of intervention, the intervention group showed significantly greater progress than the waiting control group on measures of single word reading, letter-sound knowledge, phoneme blending and taught expressive vocabulary. Effects did not transfer to other skills (nonword reading, spelling, standardised expressive and receptive vocabulary, expressive information and grammar). After 40 weeks of intervention, the intervention group remained numerically ahead of the control group on most key outcome measures; but these differences were not significant. Children who were younger, attended more intervention sessions, and had better initial receptive language skills made greater progress during the course of the intervention. Conclusions A TA-delivered intervention produced improvements in the reading and language skills of children with Down syndrome. Gains were largest in skills directly taught with little evidence of generalization to skills not directly taught in the intervention. PMID:22533801

  15. Parent training for preschool ADHD: A randomized controlled trial of specialized and generic programs

    PubMed Central

    Abikoff, Howard B.; Thompson, Margaret; Laver-Bradbury, Cathy; Long, Nicholas; Forehand, Rex L.; Brotman, Laurie Miller; Klein, Rachel G.; Reiss, Philip; Huo, Lan; Sonuga-Barke, Edmund

    2014-01-01

    Background The ‘New Forest Parenting Package’ (NFPP), an 8-week home-based intervention for parents of preschoolers with ADHD, fosters constructive parenting to target ADHD-related dysfunctions in attention and impulse control.Although NFPP has improved parent and laboratory measures of ADHD in community samples of children with ADHD-like problems, its efficacy in a clinical sample, and relative to an active treatment comparator, is unknown. The aims are to evaluate the short and long-term efficacy and generalization effects of NFPP compared to an established clinic-based parenting intervention for treating noncompliant behavior (‘Helping the Noncompliant Child’ [HNC]) in young children with ADHD. Methods A randomized controlled trial with three parallel arms was the design for this study. 164 3-4-year-olds, 73.8% male, meeting DSM-IV ADHD diagnostic criteria were randomized to NFPP (N = 67), HNC (N = 63), or wait-list control (WL, N = 34). All participants were assessed at post-treatment. NFPP and HNC participants were assessed at follow-up in the next school year. Primary outcomes were ADHD ratings by teachers blind to and uninvolved in treatment, and by parents. Secondary ADHD outcomes included clinician assessments, and laboratory measures of on-task behavior and delay of gratification. Other outcomes included parent and teacher ratings of oppositional behavior, and parenting measures. (Trial name: Home-Based Parent Training in ADHD Preschoolers; Registry: ClinicalTrials.gov Identifier: NCT01320098; URL: http://www/clinicaltrials.gov/ct2/show/NCT01320098). Results In both treatment groups, children's ADHD and ODD behaviors, as well as aspects of parenting, were rated improved by parents at the end of treatment compared to controls. Most of these gains in the children's behavior and in some parenting practices were sustained at follow-up. However, these parent-reported improvements were not corroborated by teacher ratings or objective observations. NFPP

  16. Relationship of cravings with weight loss and hunger: results from a 6 month worksite weight loss intervention

    USDA-ARS?s Scientific Manuscript database

    We examined the association of food cravings with weight loss and eating behaviors in a 6 month worksite lifestyle weight loss program. This randomized controlled trial of the intervention versus a wait-listed control was conducted at 4 worksites, and 95 participants completed outcome assessments ...

  17. Protocol for the ‘Virtual Traveller’ cluster-randomised controlled trial: a behaviour change intervention to increase physical activity in primary-school Maths and English lessons

    PubMed Central

    Norris, E; Dunsmuir, S; Duke-Williams, O; Stamatakis, E; Shelton, N

    2016-01-01

    Introduction Physical activity (PA) has been shown to be an important factor for health and educational outcomes in children. However, a large proportion of children's school day is spent in sedentary lesson-time. There is emerging evidence about the effectiveness of physically active lessons: integrating physical movements and educational content in the classroom. ‘Virtual Traveller’ is a novel 6-week intervention of 10-min sessions performed 3 days per week, using classroom interactive whiteboards to integrate movement into primary-school Maths and English teaching. The primary aim of this project is to evaluate the effect of the Virtual Traveller intervention on children's PA, on-task behaviour and student engagement. Methods and analysis This study will be a cluster-randomised controlled trial with a waiting-list control group. Ten year 4 (aged 8–9 years) classes across 10 primary schools will be randomised by class to either the 6-week Virtual Traveller intervention or the waiting-list control group. Data will be collected 5 times: at baseline, at weeks 2 and 4 of the intervention, and 1 week and 3 months postintervention. At baseline, anthropometric measures, 4-day objective PA monitoring (including 2 weekend days; Actigraph accelerometer), PA and on-task behaviour observations and student engagement questionnaires will be performed. All but anthropometric measures will be repeated at all other data collection points. Changes in overall PA levels and levels during different time-periods (eg, lesson-time) will be examined. Changes in on-task behaviour and student engagement between intervention groups will also be examined. Multilevel regression modelling will be used to analyse the data. Process evaluation will be carried out during the intervention period. Ethics and dissemination The results of this study will be disseminated through peer-review publications and conference presentations. Ethical approval was obtained through the University

  18. A Randomized Controlled Trial on Effects of the Transcendental Meditation Program on Blood Pressure, Psychological Distress, and Coping in Young Adults

    PubMed Central

    Nidich, Sanford I.; Rainforth, Maxwell V.; Haaga, David A.F.; Hagelin, John; Salerno, John W.; Travis, Fred; Tanner, Melissa; Gaylord-King, Carolyn; Grosswald, Sarina; Schneider, Robert H.

    2009-01-01

    Background Psychological distress contributes to the development of hypertension in young adults. This trial assessed the effects of a mind–body intervention on blood pressure (BP), psychological distress, and coping in college students. Methods This was a randomized controlled trial (RCT) of 298 university students randomly allocated to either the Transcendental Meditation (TM) program or wait-list control. At baseline and after 3 months, BP, psychological distress, and coping ability were assessed. A subgroup of 159 subjects at risk for hypertension was analyzed similarly. Results Changes in systolic BP (SBP)/diastolic BP (DBP) for the overall sample were −2.0/−1.2 mm Hg for the TM group compared to +0.4/+0.5 mm Hg for controls (P = 0.15, P = 0.15, respectively). Changes in SBP/DBP for the hypertension risk subgroup were −5.0/−2.8 mm Hg for the TM group compared to +1.3/+1.2 mm Hg for controls (P = 0.014, P = 0.028, respectively). Significant improvements were found in total psychological distress, anxiety, depression, anger/hostility, and coping (P values < 0.05). Changes in psychological distress and coping correlated with changes in SBP (P values < 0.05) and DBP (P values < 0.08). Conclusions This is the first RCT to demonstrate that a selected mind–body intervention, the TM program, decreased BP in association with decreased psychological distress, and increased coping in young adults at risk for hypertension. This mind–body program may reduce the risk for future development of hypertension in young adults. PMID:19798037

  19. A randomized controlled trial on effects of the Transcendental Meditation program on blood pressure, psychological distress, and coping in young adults.

    PubMed

    Nidich, Sanford I; Rainforth, Maxwell V; Haaga, David A F; Hagelin, John; Salerno, John W; Travis, Fred; Tanner, Melissa; Gaylord-King, Carolyn; Grosswald, Sarina; Schneider, Robert H

    2009-12-01

    Psychological distress contributes to the development of hypertension in young adults. This trial assessed the effects of a mind-body intervention on blood pressure (BP), psychological distress, and coping in college students. This was a randomized controlled trial (RCT) of 298 university students randomly allocated to either the Transcendental Meditation (TM) program or wait-list control. At baseline and after 3 months, BP, psychological distress, and coping ability were assessed. A subgroup of 159 subjects at risk for hypertension was analyzed similarly. Changes in systolic BP (SBP)/diastolic BP (DBP) for the overall sample were -2.0/-1.2 mm Hg for the TM group compared to +0.4/+0.5 mm Hg for controls (P = 0.15, P = 0.15, respectively). Changes in SBP/DBP for the hypertension risk subgroup were -5.0/-2.8 mm Hg for the TM group compared to +1.3/+1.2 mm Hg for controls (P = 0.014, P = 0.028, respectively). Significant improvements were found in total psychological distress, anxiety, depression, anger/hostility, and coping (P values < 0.05). Changes in psychological distress and coping correlated with changes in SBP (P values < 0.05) and DBP (P values < 0.08). This is the first RCT to demonstrate that a selected mind-body intervention, the TM program, decreased BP in association with decreased psychological distress, and increased coping in young adults at risk for hypertension. This mind-body program may reduce the risk for future development of hypertension in young adults.

  20. Passage Meditation Reduces Perceived Stress in Health Professionals: A Randomized, Controlled Trial

    ERIC Educational Resources Information Center

    Oman, Doug; Hedberg, John; Thoresen, Carl E.

    2006-01-01

    The authors evaluated an 8-week, 2-hr per week training for physicians, nurses, chaplains, and other health professionals using nonsectarian, spiritually based self-management tools based on passage meditation (E. Easwaran, 1978/1991). Participants were randomized to intervention (n = 27) or waiting list (n = 31). Pretest, posttest, and 8-and…

  1. Outcomes of videotape instruction in clinic waiting area.

    PubMed

    Oermann, Marilyn H; Webb, Sue A; Ashare, Jo Ann

    2003-01-01

    The purpose of our study was to examine the effectiveness of general health-promotion teaching for patients in the waiting room of a clinic, using focused videotape instruction. An experimental design was used. Subjects were patients (N = 215) in the waiting rooms of clinics in a university medical center in the Midwest. Patients were randomly assigned to two groups: focused videotape instruction in the clinic (n = 106) and control (no instruction in the clinic waiting area) (n = 109). The outcome measures included patient learning about a health education topic and patient satisfaction with overall care, explanations by the provider, and education received during the clinic visit. There was a significant gain in knowledge for patients who viewed the videotape in the waiting room (t = 5.43, df = 213, p < .0001), and they were more satisfied with their education compared with the control group (t = 4.73, df = 213, p < .0001). This study supports focused video instruction as an effective and efficient teaching intervention for disseminating health information in the waiting area.

  2. A Randomized Controlled Trial of Acupuncture for Osteoarthritis of the Knee: Effects of Patient-Provider Communication

    PubMed Central

    Suarez-Almazor, Maria E.; Looney, Carol; Liu, YanFang; Cox, Vanessa; Pietz, Kenneth; Marcus, Donald M.; Street, Richard L.

    2012-01-01

    Objectives There is conflicting evidence on the efficacy of Traditional Chinese Acupuncture (TCA), and the role of placebo effects elicited by acupuncturists’ behavior has not been elucidated. We conducted a 3-month randomized clinical trial in patients with knee osteoarthritis to compare the efficacy of TCA to sham acupuncture, and examine the effects of acupuncturists’ communication style. Methods Acupuncturists were trained to interact in one of two communication styles: ‘high’ or ‘neutral’ expectations. Patients were randomized to one of 3 groups: waiting list, ‘high’ or ‘neutral’, and nested within style, TCA or sham acupuncture over 6 weeks. Sham acupuncture was performed in non-meridian points, with shallow needles and minimal stimulation. Primary outcome measures were: Joint-specific Multidimensional Assessment of Pain (J-MAP), Western Ontario McMaster Osteoarthritis Index (WOMAC), and satisfaction. Results 455 patients who received treatment (TCA or sham) and 72 controls were included. No statistically significant differences were observed between TCA or sham acupuncture, but both groups had significant reductions in J-MAP and WOMAC pain compared to the waiting group (-1.1, -1.0, and -0.1, p<0.001; -13.7, -14, -1.7, p<0.001). Statistically significant differences were observed in J-MAP pain reduction and satisfaction, favoring the ‘high’ expectations group. Fifty-two percent and 43% in the TCA and sham groups thought they had received TCA (kappa=0.05), suggesting successful blinding. Conclusion TCA was not superior to sham acupuncture. However, acupuncturists’ style had significant effects on pain reduction and satisfaction, suggesting that the analgesic benefits of acupuncture can be partially mediated through placebo effects related to the acupuncturist's behavior. PMID:20506122

  3. Melodic Intonation Therapy in Chronic Aphasia: Evidence from a Pilot Randomized Controlled Trial

    PubMed Central

    Van Der Meulen, Ineke; Van De Sandt-Koenderman, Mieke W. M. E.; Heijenbrok, Majanka H.; Visch-Brink, Evy; Ribbers, Gerard M.

    2016-01-01

    Melodic Intonation Therapy (MIT) is a language production therapy for severely non-fluent aphasic patients using melodic intoning and rhythm to restore language. Although many studies have reported its beneficial effects on language production, randomized controlled trials (RCT) examining the efficacy of MIT are rare. In an earlier publication, we presented the results of an RCT on MIT in subacute aphasia and found that MIT was effective on trained and untrained items. Further, we observed a clear trend in improved functional language use after MIT: subacute aphasic patients receiving MIT improved considerably on language tasks measuring connected speech and daily life verbal communication. Here, we present the results of a pilot RCT on MIT in chronic aphasia and compare these to the results observed in subacute aphasia. We used a multicenter waiting-list RCT design. Patients with chronic (>1 year) post-stroke aphasia were randomly allocated to the experimental group (6 weeks MIT) or to the control group (6 weeks no intervention followed by 6 weeks MIT). Assessments were done at baseline (T1), after 6 weeks (T2), and 6 weeks later (T3). Efficacy was evaluated at T2 using univariable linear regression analyses. Outcome measures were chosen to examine several levels of therapy success: improvement on trained items, generalization to untrained items, and generalization to verbal communication. Of 17 included patients, 10 were allocated to the experimental condition and 7 to the control condition. MIT significantly improved repetition of trained items (β = 13.32, p = 0.02). This effect did not remain stable at follow-up assessment. In contrast to earlier studies, we found only a limited and temporary effect of MIT, without generalization to untrained material or to functional communication. The results further suggest that the effect of MIT in chronic aphasia is more restricted than its effect in earlier stages post stroke. This is in line with studies showing larger

  4. 77 FR 46948 - The Commerce Control List

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-08-07

    ... DEPARTMENT OF COMMERCE Bureau of Industry and Security 15 CFR Part 774 The Commerce Control List... to 7A005. 0 C. On page 840, in 7A008, add ``License Requirements'' above ``Reason for Control''. 0 D... text to be added is set forth below: Supplement No. 1 to Part 774--The Commerce Control List...

  5. Implementation and quantitative evaluation of chronic disease self-management programme in Shanghai, China: randomized controlled trial.

    PubMed Central

    Fu, Dongbo; Fu, Hua; McGowan, Patrick; Shen, Yi-e; Zhu, Lizhen; Yang, Huiqin; Mao, Jianguo; Zhu, Shitai; Ding, Yongming; Wei, Zhihua

    2003-01-01

    OBJECTIVE: To evaluate the effectiveness of the Shanghai Chronic Disease Self-Management Program (CDSMP). METHODS: A randomized controlled trial with six-month follow-up compared patients who received treatment with those who did not receive treatment (waiting-list controls) in five urban communities in Shanghai, China. Participants in the treatment group received education from a lay-led CDSMP course and one copy of a help book immediately; those in the control group received the same education and book six months later. FINDINGS: In total, 954 volunteer patients with a medical record that confirmed a diagnosis of hypertension, heart disease, chronic lung disease, arthritis, stroke, or diabetes who lived in communities were assigned randomly to treatment (n = 526) and control (n = 428) groups. Overall, 430 (81.7%) and 349 (81.5%) patients in the treatment and control groups completed the six-month study. Patients who received treatment had significant improvements in weekly minutes of aerobic exercise, practice of cognitive symptom management, self-efficacy to manage own symptoms, and self-efficacy to manage own disease in general compared with controls. They also had significant improvements in eight indices of health status and, on average, fewer hospitalizations. CONCLUSION: When implemented in Shanghai, the CDSMP was acceptable culturally to Chinese patients. The programme improved participants' health behaviour, self-efficacy, and health status and reduced the number of hospitalizations six months after the course. The locally based delivery model was integrated into the routine of community government organizations and community health services. Chinese lay leaders taught the CDSMP courses as successfully as professionals. PMID:12764513

  6. A mental health intervention for schoolchildren exposed to violence: a randomized controlled trial.

    PubMed

    Stein, Bradley D; Jaycox, Lisa H; Kataoka, Sheryl H; Wong, Marleen; Tu, Wenli; Elliott, Marc N; Fink, Arlene

    2003-08-06

    No randomized controlled studies have been conducted to date on the effectiveness of psychological interventions for children with symptoms of posttraumatic stress disorder (PTSD) that has resulted from personally witnessing or being personally exposed to violence. To evaluate the effectiveness of a collaboratively designed school-based intervention for reducing children's symptoms of PTSD and depression that has resulted from exposure to violence. A randomized controlled trial conducted during the 2001-2002 academic year. Sixth-grade students at 2 large middle schools in Los Angeles who reported exposure to violence and had clinical levels of symptoms of PTSD. Students were randomly assigned to a 10-session standardized cognitive-behavioral therapy (the Cognitive-Behavioral Intervention for Trauma in Schools) early intervention group (n = 61) or to a wait-list delayed intervention comparison group (n = 65) conducted by trained school mental health clinicians. Students were assessed before the intervention and 3 months after the intervention on measures assessing child-reported symptoms of PTSD (Child PTSD Symptom Scale; range, 0-51 points) and depression (Child Depression Inventory; range, 0-52 points), parent-reported psychosocial dysfunction (Pediatric Symptom Checklist; range, 0-70 points), and teacher-reported classroom problems using the Teacher-Child Rating Scale (acting out, shyness/anxiousness, and learning problems; range of subscales, 6-30 points). Compared with the wait-list delayed intervention group (no intervention), after 3 months of intervention students who were randomly assigned to the early intervention group had significantly lower scores on symptoms of PTSD (8.9 vs 15.5, adjusted mean difference, - 7.0; 95% confidence interval [CI], - 10.8 to - 3.2), depression (9.4 vs 12.7, adjusted mean difference, - 3.4; 95% CI, - 6.5 to - 0.4), and psychosocial dysfunction (12.5 vs 16.5, adjusted mean difference, - 6.4; 95% CI, -10.4 to -2.3). Adjusted

  7. Impact of the Cognitive-Functional (Cog-Fun) Intervention on Executive Functions and Participation Among Children With Attention Deficit Hyperactivity Disorder: A Randomized Controlled Trial.

    PubMed

    Hahn-Markowitz, Jeri; Berger, Itai; Manor, Iris; Maeir, Adina

    We examined the effect of the Cognitive-Functional (Cog-Fun) occupational therapy intervention on executive functions and participation among children with attention deficit hyperactivity disorder (ADHD). We used a randomized, controlled study with a crossover design. One hundred and seven children age 7-10 yr diagnosed with ADHD were allocated to treatment or wait-list control group. The control group received treatment after a 3-mo wait. Outcome measures included the Behavior Rating Inventory of Executive Function (BRIEF) and the Canadian Occupational Performance Measure (COPM). Significant improvements were found on both the BRIEF and COPM after intervention with large treatment effects. Before crossover, significant Time × Group interactions were found on the BRIEF. This study supports the effectiveness of the Cog-Fun intervention in improving executive functions and participation among children with ADHD. Copyright © 2017 by the American Occupational Therapy Association, Inc.

  8. Low-fat, plant-based diet in multiple sclerosis: A randomized controlled trial.

    PubMed

    Yadav, Vijayshree; Marracci, Gail; Kim, Edward; Spain, Rebecca; Cameron, Michelle; Overs, Shannon; Riddehough, Andrew; Li, David K B; McDougall, John; Lovera, Jesus; Murchison, Charles; Bourdette, Dennis

    2016-09-01

    The role that dietary interventions can play in multiple sclerosis (MS) management is of huge interest amongst patients and researchers but data evaluating this is limited. Possible effects of a very-low-fat, plant-based dietary intervention on MS related progression and disease activity as measured by brain imaging and MS related symptoms have not been evaluated in a randomized-controlled trial. Despite use of disease modifying therapies (DMT), poor quality of life (QOL) in MS patients can be a significant problem with fatigue being one of the common disabling symptoms. Effective treatment options for fatigue remain limited. Emerging evidence suggests diet and vascular risk factors including obesity and hyperlipidemia may influence MS disease progression and improve QOL. To evaluate adherence, safety and effects of a very-low-fat, plant-based diet (Diet) on brain MRI, clinical [MS relapses and disability, body mass index (BMI)] and metabolic (blood lipids and insulin) outcomes, QOL [Short Form-36 (SF-36)], and fatigue [Fatigue Severity Scale (FSS) and Modified Fatigue Impact Scale (MFIS)], in relapsing-remitting MS (RRMS). This was a randomized-controlled, assessor-blinded, one-year long study with 61 participants assigned to either Diet (N=32) or wait-listed (Control, N=29) group. The mean age (years) [Control-40.9±8.48; Diet-40.8±8.86] and the mean disease duration (years) [Control -5.3±3.86; Diet-5.33±3.63] were comparable between the two groups. There was a slight difference between the two study groups in the baseline mean expanded disability status scale (EDSS) score [Control-2.22±0.90; Diet-2.72±1.05]. Eight subjects withdrew (Diet, N=6; Control, N=2). Adherence to the study diet based on monthly Food Frequency Questionnaire (FFQ) was excellent with the diet group showing significant difference in the total fat caloric intake compared to the control group [total fat intake/total calories averaged ~15% (Diet) versus ~40% (Control)]. The two groups

  9. 41 CFR 102-36.435 - How do we identify Munitions List Items (MLIs)/Commerce Control List Items (CCLIs) requiring...

    Code of Federal Regulations, 2013 CFR

    2013-07-01

    ... Munitions List Items (MLIs)/Commerce Control List Items (CCLIs) requiring demilitarization? 102-36.435... Personal Property Whose Disposal Requires Special Handling Munitions List Items/commerce Control List Items (mlis/cclis) § 102-36.435 How do we identify Munitions List Items (MLIs)/Commerce Control List Items...

  10. 41 CFR 102-36.435 - How do we identify Munitions List Items (MLIs)/Commerce Control List Items (CCLIs) requiring...

    Code of Federal Regulations, 2012 CFR

    2012-01-01

    ... Munitions List Items (MLIs)/Commerce Control List Items (CCLIs) requiring demilitarization? 102-36.435... Personal Property Whose Disposal Requires Special Handling Munitions List Items/commerce Control List Items (mlis/cclis) § 102-36.435 How do we identify Munitions List Items (MLIs)/Commerce Control List Items...

  11. 41 CFR 102-36.435 - How do we identify Munitions List Items (MLIs)/Commerce Control List Items (CCLIs) requiring...

    Code of Federal Regulations, 2011 CFR

    2011-01-01

    ... Munitions List Items (MLIs)/Commerce Control List Items (CCLIs) requiring demilitarization? 102-36.435... Personal Property Whose Disposal Requires Special Handling Munitions List Items/commerce Control List Items (mlis/cclis) § 102-36.435 How do we identify Munitions List Items (MLIs)/Commerce Control List Items...

  12. 41 CFR 102-36.435 - How do we identify Munitions List Items (MLIs)/Commerce Control List Items (CCLIs) requiring...

    Code of Federal Regulations, 2014 CFR

    2014-01-01

    ... Munitions List Items (MLIs)/Commerce Control List Items (CCLIs) requiring demilitarization? 102-36.435... Personal Property Whose Disposal Requires Special Handling Munitions List Items/commerce Control List Items (mlis/cclis) § 102-36.435 How do we identify Munitions List Items (MLIs)/Commerce Control List Items...

  13. 41 CFR 102-36.435 - How do we identify Munitions List Items (MLIs)/Commerce Control List Items (CCLIs) requiring...

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... Munitions List Items (MLIs)/Commerce Control List Items (CCLIs) requiring demilitarization? 102-36.435... Personal Property Whose Disposal Requires Special Handling Munitions List Items/commerce Control List Items (mlis/cclis) § 102-36.435 How do we identify Munitions List Items (MLIs)/Commerce Control List Items...

  14. Chinese proprietary herbal medicine listed in 'China national essential drug list' for common cold: a systematic literature review.

    PubMed

    Chen, Wei; Lewith, George; Wang, Li-qiong; Ren, Jun; Xiong, Wen-jing; Lu, Fang; Liu, Jian-ping

    2014-01-01

    Chinese proprietary herbal medicines (CPHMs) have long history in China for the treatment of common cold, and lots of them have been listed in the 'China national essential drug list' by the Chinese Ministry of Health. The aim of this review is to provide a well-round clinical evidence assessment on the potential benefits and harms of CPHMs for common cold based on a systematic literature search to justify their clinical use and recommendation. We searched CENTRAL, MEDLINE, EMBASE, SinoMed, CNKI, VIP, China Important Conference Papers Database, China Dissertation Database, and online clinical trial registry websites from their inception to 31 March 2013 for clinical studies of CPHMs listed in the 'China national essential drug list' for common cold. There was no restriction on study design. A total of 33 CPHMs were listed in 'China national essential drug list 2012' for the treatment of common cold but only 7 had supportive clinical evidences. A total of 6 randomised controlled trials (RCTs) and 7 case series (CSs) were included; no other study design was identified. All studies were conducted in China and published in Chinese between 1995 and 2012. All included studies had poor study design and methodological quality, and were graded as very low quality. The use of CPHMs for common cold is not supported by robust evidence. Further rigorous well designed placebo-controlled, randomized trials are needed to substantiate the clinical claims made for CPHMs.

  15. Effectiveness and cost-effectiveness of a group-based pain self-management intervention for patients undergoing total hip replacement: feasibility study for a randomized controlled trial.

    PubMed

    Wylde, Vikki; Marques, Elsa; Artz, Neil; Blom, Ashley; Gooberman-Hill, Rachael

    2014-05-20

    Total hip replacement (THR) is a common elective surgical procedure and can be effective for reducing chronic pain. However, waiting times can be considerable. A pain self-management intervention may provide patients with skills to more effectively manage their pain and its impact during their wait for surgery. This study aimed to evaluate the feasibility of conducting a randomized controlled trial to assess the effectiveness and cost-effectiveness of a group-based pain self-management course for patients undergoing THR. Patients listed for a THR at one orthopedic center were posted a study invitation pack. Participants were randomized to attend a pain self-management course plus standard care or standard care only. The lay-led course was delivered by Arthritis Care and consisted of two half-day sessions prior to surgery and one full-day session after surgery. Participants provided outcome and resource-use data using a diary and postal questionnaires prior to surgery and one month, three months and six months after surgery. Brief telephone interviews were conducted with non-participants to explore barriers to participation. Invitations were sent to 385 eligible patients and 88 patients (23%) consented to participate. Interviews with 57 non-participants revealed the most common reasons for non-participation were views about the course and transport difficulties. Of the 43 patients randomized to the intervention group, 28 attended the pre-operative pain self-management sessions and 11 attended the post-operative sessions. Participant satisfaction with the course was high, and feedback highlighted that patients enjoyed the group format. Retention of participants was acceptable (83% of recruited patients completed follow-up) and questionnaire return rates were high (72% to 93%), with the exception of the pre-operative resource-use diary (35% return rate). Resource-use completion rates allowed for an economic evaluation from the health and social care payer perspective

  16. A Support Group for Parents of Children on a Waiting List for an Assessment for Autism Spectrum Disorder

    ERIC Educational Resources Information Center

    Connolly, Micaela; Gersch, Irvine

    2013-01-01

    Parents of children waiting for a diagnostic assessment for autism spectrum disorder (ASD) experience distress and anxiety while they wait. The present small-scale study took place in a multi-disciplinary therapeutic service in Ireland for children with ASD and was run between April and September 2011. The first author, an educational psychologist…

  17. 41 CFR 102-36.430 - May we dispose of excess Munitions List Items (MLIs)/Commerce Control List Items (CCLIs)?

    Code of Federal Regulations, 2013 CFR

    2013-07-01

    ... Munitions List Items (MLIs)/Commerce Control List Items (CCLIs)? 102-36.430 Section 102-36.430 Public... Disposal Requires Special Handling Munitions List Items/commerce Control List Items (mlis/cclis) § 102-36.430 May we dispose of excess Munitions List Items (MLIs)/Commerce Control List Items (CCLIs)? You may...

  18. 41 CFR 102-36.430 - May we dispose of excess Munitions List Items (MLIs)/Commerce Control List Items (CCLIs)?

    Code of Federal Regulations, 2012 CFR

    2012-01-01

    ... Munitions List Items (MLIs)/Commerce Control List Items (CCLIs)? 102-36.430 Section 102-36.430 Public... Disposal Requires Special Handling Munitions List Items/commerce Control List Items (mlis/cclis) § 102-36.430 May we dispose of excess Munitions List Items (MLIs)/Commerce Control List Items (CCLIs)? You may...

  19. 41 CFR 102-36.430 - May we dispose of excess Munitions List Items (MLIs)/Commerce Control List Items (CCLIs)?

    Code of Federal Regulations, 2014 CFR

    2014-01-01

    ... Munitions List Items (MLIs)/Commerce Control List Items (CCLIs)? 102-36.430 Section 102-36.430 Public... Disposal Requires Special Handling Munitions List Items/commerce Control List Items (mlis/cclis) § 102-36.430 May we dispose of excess Munitions List Items (MLIs)/Commerce Control List Items (CCLIs)? You may...

  20. 41 CFR 102-36.430 - May we dispose of excess Munitions List Items (MLIs)/Commerce Control List Items (CCLIs)?

    Code of Federal Regulations, 2011 CFR

    2011-01-01

    ... Munitions List Items (MLIs)/Commerce Control List Items (CCLIs)? 102-36.430 Section 102-36.430 Public... Disposal Requires Special Handling Munitions List Items/commerce Control List Items (mlis/cclis) § 102-36.430 May we dispose of excess Munitions List Items (MLIs)/Commerce Control List Items (CCLIs)? You may...

  1. 41 CFR 102-36.430 - May we dispose of excess Munitions List Items (MLIs)/Commerce Control List Items (CCLIs)?

    Code of Federal Regulations, 2010 CFR

    2010-07-01

    ... Munitions List Items (MLIs)/Commerce Control List Items (CCLIs)? 102-36.430 Section 102-36.430 Public... Disposal Requires Special Handling Munitions List Items/commerce Control List Items (mlis/cclis) § 102-36.430 May we dispose of excess Munitions List Items (MLIs)/Commerce Control List Items (CCLIs)? You may...

  2. The effectiveness of a suicide prevention app for indigenous Australian youths: study protocol for a randomized controlled trial.

    PubMed

    Shand, Fiona L; Ridani, Rebecca; Tighe, Joe; Christensen, Helen

    2013-11-20

    Indigenous Australian youth (aged 15 to 34) have up to four times the risk of suicide compared with their non-Indigenous counterparts. Barriers to help-seeking include shame, feared loss of autonomy and negative attitudes towards healthcare providers. The use of mobile devices and apps continues to rise amongst young people, thus presenting opportunities to utilize these aids in overcoming help-seeking barriers. Apps have been shown to assist in several health-related areas, including weight loss and smoking cessation, although no apps have as yet been evaluated for suicide prevention. Moreover, there is a lack of research that scientifically evaluates suicide prevention interventions within Indigenous communities. In this study, a recently developed self-help app will be evaluated in a randomized controlled trial. The intervention is based on acceptance and commitment therapy and mindfulness-based cognitive behavioural therapy. It is aimed at participants who have suicidal thoughts but who are not actively suicidal. In total, 150 participants will be randomly allocated to the intervention-condition (N = 75) or to the wait-list control condition (N = 75). Questionnaires will be completed at baseline, post-test and 6 weeks follow-up. The primary outcome measure is a reduction in frequency and intensity of suicidal thoughts. Secondary outcome measures are the reduction of depression, anxiety and impulsivity. This study is the first to evaluate the effectiveness of a self-help app for suicidal thoughts amongst young Indigenous people. Several limitations and strengths of the design are discussed. Australian New Zealand Clinical Trials Registry (ANZCTR): ACTRN12613000104752.

  3. Internet-Based Exposure and Behavioral Activation for Complicated Grief and Rumination: A Randomized Controlled Trial.

    PubMed

    Eisma, Maarten C; Boelen, Paul A; van den Bout, Jan; Stroebe, Wolfgang; Schut, Henk A W; Lancee, Jaap; Stroebe, Margaret S

    2015-11-01

    This study examined the effectiveness and feasibility of therapist-guided Internet-delivered exposure (EX) and behavioral activation (BA) for complicated grief and rumination. Forty-seven bereaved individuals with elevated levels of complicated grief and grief rumination were randomly assigned to three conditions: EX (N=18), BA (N=17), or a waiting-list (N=12). Treatment groups received 6 homework assignments over 6 to 8weeks. Intention-to-treat analyses showed that EX reduced complicated grief, posttraumatic stress, depression, grief rumination, and brooding levels relative to the control group at posttreatment (d=0.7-1.2). BA lowered complicated grief, posttraumatic stress, and grief rumination levels at posttreatment (d=0.8-0.9). At 3-month follow-up, effects of EX were maintained on complicated grief and grief rumination (d=0.6-1.2), and for BA on complicated grief, posttraumatic stress, and grief rumination (d=0.8-0.9). EX reduced depression more strongly than BA (d=0.6). Completers analyses corroborated results for EX, and partially those for BA, but no group differences were detected. BA suffered from high dropout (59%), relative to EX (33%) and the waiting-list (17%). Feasibility appeared higher for EX than BA. Results supported potential applicability of online exposure but not behavioral activation to decrease complicated grief and rumination. Copyright © 2015. Published by Elsevier Ltd.

  4. Suicide prevention after traumatic brain injury: a randomized controlled trial of a program for the psychological treatment of hopelessness.

    PubMed

    Simpson, Grahame K; Tate, Robyn L; Whiting, Diane L; Cotter, Rachel E

    2011-01-01

    To evaluate the efficacy of a psychological treatment to reduce moderate to severe hopelessness after severe traumatic brain injury (TBI). Randomized controlled trial. Participants were aged between 18 and 65 years, experienced posttraumatic amnesia more than 1day and moderate to severe hopelessness (Beck Hopelessness Scale [BHS]) and/or suicide ideation. Intervention comprised a 20-hour manualized group cognitive behavior therapy program. Participants were randomly allocated using concealed allocation (treatment n = 8; wait-list n = 9); all remained in their allocated group. Outcome variables were collected by assessors blind to group allocation. No between-groups differences were observed on demographic, injury, cognitive, and psychosocial variables at baseline (time 1). A significant group-by-time interaction was found for BHS in the treatment group (F1,15 = 13.20, P = .002), reflecting a reduction in mean BHS scores between time 1 and time 2 (posttreatment) with no main effects for group or time. At 3-month follow-up (time 3), the treatment gains were maintained or improved for 75% (6/8) of participants. Secondary outcome variables (suicide ideation, depression, social problem solving, self-esteem, hopefulness) displayed no significant group-by-time interactions or main effects. This trial provides initial evidence for the efficacy of a psychological intervention in reducing hopelessness among long-term survivors with severe TBI.

  5. Heart Surgery Waiting Time: Assessing the Effectiveness of an Action.

    PubMed

    Badakhshan, Abbas; Arab, Mohammad; Gholipour, Mahin; Behnampour, Naser; Saleki, Saeid

    2015-08-01

    Waiting time is an index assessing patient satisfaction, managerial effectiveness and horizontal equity in providing health care. Although heart surgery centers establishment is attractive for politicians. They are always faced with the question of to what extent they solve patient's problems. The objective of this study was to evaluate factors influencing waiting time in patients of heart surgery centers, and to make recommendations for health-care policy-makers for reducing waiting time and increasing the quality of services from this perspective. This cross-sectional study was performed in 2013. After searching articles on PubMed, Elsevier, Google Scholar, Ovid, Magiran, IranMedex, and SID, a list of several criteria, which relate to waiting time, was provided. Afterwards, the data on waiting time were collected by a researcher-structured checklist from 156 hospitalized patients. The data were analyzed by SPSS 16. The Kolmogorov Smirnov and Shapiro tests were used for determination of normality. Due to the non-normal distribution, non-parametric tests, such as Kruskal-Wallis and Mann-Whitney were chosen for reporting significance. Parametric tests also used reporting medians. Among the studied variables, just economic status had a significant relation with waiting time (P = 0.37). Fifty percent of participants had diabetes, whereas this estimate was 43.58% for high blood pressure. As the cause of delay, 28.2% of patients reported financial problems, 18.6% personal problem and 13.5% a delay in providing equipment by the hospital. It seems the studied hospital should review its waiting time arrangements and detach them, as far as possible, from subjective and personal (specialists) decisions. On the other hand, ministries of health and insurance companies should consider more financial support. It is also recommend that hospitals should arrange preoperational psychiatric consultation for increasing patients' emotionally readiness.

  6. Reducing sexual victimization among adolescent girls: a randomized controlled pilot trial of my voice, my choice.

    PubMed

    Rowe, Lorelei Simpson; Jouriles, Ernest N; McDonald, Renee

    2015-05-01

    Despite extensive efforts to develop and implement programs to prevent sexual violence, few programs have empirically-demonstrated efficacy. The primary exceptions are programs that emphasize risk-reduction skills; yet even these programs are not consistently effective. This study seeks to add to the literature by evaluating the effects of My Voice, My Choice (MVMC), a 90-minute assertive resistance training program that emphasizes skill practice in an immersive virtual environment (IVE). We hypothesized that MVMC would reduce male-to-female sexual victimization among adolescent girls over a 3-month follow-up period. We also examined whether these results would generalize to other forms of male-to-female relationship violence and to girls' psychological distress. Eighty-three female students from an urban public high school were randomized to MVMC (n=47) or to a wait-list control condition (n=36); 78 provided data over the 3-month follow-up period. Participants assigned to MVMC were less likely than control participants to report sexual victimization during the follow-up period. Our results also suggest that MVMC reduced risk for psychological victimization and for psychological distress among participants with greater prior victimization at baseline. The promising results of this pilot trial suggest that MVMC may help girls evade male-to-female relationship violence. Copyright © 2014. Published by Elsevier Ltd.

  7. Internet-based information and support program for parents of children with burns: A randomized controlled trial.

    PubMed

    Sveen, Josefin; Andersson, Gerhard; Buhrman, Bo; Sjöberg, Folke; Willebrand, Mimmie

    2017-05-01

    The aim of the study was to evaluate the feasibility and effects of an internet-based information and self-help program with therapist contact for parents of children and adolescents with burns. The program aimed to reduce parents' symptoms of general and posttraumatic stress. Participants were parents of children treated for burns between 2009-2013 at either of the two specialized Swedish Burn centers. Sixty-two parents were included in a two-armed, randomized controlled trial with a six-week intervention group and a wait-list control group, including a pre and post-assessment, as well as a 3 and 12-month follow-up. The intervention contained psychoeducation, exercises and homework assignments, and the intervention group received weekly written feedback from a therapist. The main outcome was stress (post-traumatic stress, general stress and parental stress). The program had a beneficial effect on posttraumatic stress in the short term, but did not affect general stress or parental stress. The parents rated the program as being informative and meaningful, but some of them thought it was time-consuming. The program has the potential to support parents of children with burns. The intervention is easily accessible, cost-effective and could be implemented in burn care rehabilitation. Copyright © 2016 The Author(s). Published by Elsevier Ltd.. All rights reserved.

  8. Effectiveness of a psycho-oncology training program for oncology nurses: a randomized controlled trial.

    PubMed

    Kubota, Yosuke; Okuyama, Toru; Uchida, Megumi; Umezawa, Shino; Nakaguchi, Tomohiro; Sugano, Koji; Ito, Yoshinori; Katsuki, Fujika; Nakano, Yumi; Nishiyama, Takeshi; Katayama, Yoshiko; Akechi, Tatsuo

    2016-06-01

    Oncology nurses are expected to play an important role in psychosocial care for cancer patients. The aim of this study was to examine whether a novel training program aimed at enhancing oncology nurses' ability to assess and manage common psychological problems in cancer patients would improve participants' self-reported confidence, knowledge, and attitudes regarding care of patients with common psychological problems (trial register: UMIN000008559). Oncology nurses were assigned randomly to either the intervention group (N = 50) or the waiting list control group (N = 46). The intervention group received a 16-h program, the content of which focused on four psychological issues: normal reactions, clinically significant distress, suicidal thoughts, and delirium. Each session included a role-play exercise, group work, and didactic lecture regarding assessment and management of each problem. Primary outcomes were changes in self-reported confidence, knowledge, and attitudes toward the common psychological problems between pre-intervention and 3 months post-intervention. Secondary outcomes were job-related stress and burnout. Intervention acceptability to participants was also assessed. In the intervention group, confidence and knowledge but not attitudes were significantly improved relative to the control group. No significant intervention effects were found for job- related stress and burnout. A high percentage (98%) of participants considered the program useful in clinical practice. This psycho-oncology training program improved oncology nurses' confidence and knowledge regarding care for patients with psychological problems. Copyright © 2015 John Wiley & Sons, Ltd. Copyright © 2015 John Wiley & Sons, Ltd.

  9. Depression treatment for impoverished mothers by point-of-care providers: A randomized controlled trial.

    PubMed

    Segre, Lisa S; Brock, Rebecca L; O'Hara, Michael W

    2015-04-01

    Depression in low-income, ethnic-minority women of childbearing age is prevalent and compromises infant and child development. Yet numerous barriers prevent treatment delivery. Listening Visits (LV), an empirically supported intervention developed for delivery by British home-visiting nurses, could address this unmet mental health need. This randomized controlled trial (RCT) evaluated the effectiveness of LV delivered at a woman's usual point-of-care, including home visits or an ob-gyn office. Listening Visits were delivered to depressed pregnant women or mothers of young children by their point-of-care provider (e.g., home visitor or physician's assistant), all of whom had low levels of prior counseling experience. Three quarters of the study's participants were low-income. Of those who reported ethnicity, all identified themselves as minorities. Participants from 4 study sites (N = 66) were randomized in a 2:1 ratio, to LV or a wait-list control group (WLC). Assessments, conducted at baseline and 8 weeks, evaluated depression, quality of life, and treatment satisfaction. Depressive severity, depressive symptoms, and quality of life significantly improved among LV recipients as compared with women receiving standard social/health services. Women valued LV as evidenced by their high attendance rates and treatment satisfaction ratings. In a stepped model of depression care, LV can provide an accessible, acceptable, and effective first-line treatment option for at-risk women who otherwise are unlikely to receive treatment. (PsycINFO Database Record (c) 2015 APA, all rights reserved).

  10. The Prostate Cancer Intervention Versus Observation Trial: VA/NCI/AHRQ Cooperative Studies Program #407 (PIVOT): design and baseline results of a randomized controlled trial comparing radical prostatectomy with watchful waiting for men with clinically localized prostate cancer.

    PubMed

    Wilt, Timothy J

    2012-12-01

    Prostate cancer is the most common noncutaneous malignancy and the second leading cause of cancer death in men. In the United States, 90% of men with prostate cancer are more than age 60 years, diagnosed by early detection with the prostate-specific antigen (PSA) blood test, and have disease believed confined to the prostate gland (clinically localized). Common treatments for clinically localized prostate cancer include watchful waiting (WW), surgery to remove the prostate gland (radical prostatectomy), external-beam radiation therapy and interstitial radiation therapy (brachytherapy), and androgen deprivation. Little is known about the relative effectiveness and harms of treatments because of the paucity of randomized controlled trials. The Department of Veterans Affairs/National Cancer Institute/Agency for Healthcare Research and Quality Cooperative Studies Program Study #407:Prostate Cancer Intervention Versus Observation Trial (PIVOT), initiated in 1994, is a multicenter randomized controlled trial comparing radical prostatectomy with WW in men with clinically localized prostate cancer. We describe the study rationale, design, recruitment methods, and baseline characteristics of PIVOT enrollees. We provide comparisons with eligible men declining enrollment and men participating in another recently reported randomized trial of radical prostatectomy vs WW conducted in Scandinavia. We screened 13 022 men with prostate cancer at 52 US medical centers for potential enrollment. From these, 5023 met initial age, comorbidity, and disease eligibility criteria, and a total of 731 men agreed to participate and were randomized. The mean age of enrollees was 67 years. Nearly one-third were African American. Approximately 85% reported that they were fully active. The median PSA was 7.8ng/mL (mean 10.2ng/mL). In three-fourths of men, the primary reason for biopsy leading to a diagnosis of prostate cancer was a PSA elevation or rise. Using previously developed tumor risk

  11. Two Effective Ways to Implement Wait Time. A Symposium on Wait Time.

    ERIC Educational Resources Information Center

    Swift, J. Nathan; And Others

    The effects of instructional guides and a wait time feedback device (called a "Wait Timer") on the classroom interaction of middle school science teachers are examined. The Wait Timer, an unobtrusive indicator of wait time, is an automatic device that activates a light when a person speaks. The duration of the light at the end of a…

  12. Reward Sensitivity and Waiting Impulsivity: Shift towards Reward Valuation away from Action Control

    PubMed Central

    Mechelmans, Daisy J; Strelchuk, Daniela; Doñamayor, Nuria; Banca, Paula; Robbins, Trevor W; Baek, Kwangyeol

    2017-01-01

    Abstract Background Impulsivity and reward expectancy are commonly interrelated. Waiting impulsivity, measured using the rodent 5-Choice Serial Reaction Time task, predicts compulsive cocaine seeking and sign (or cue) tracking. Here, we assess human waiting impulsivity using a novel translational task, the 4-Choice Serial Reaction Time task, and the relationship with reward cues. Methods Healthy volunteers (n=29) performed the monetary incentive delay task as a functional MRI study where subjects observe a cue predicting reward (cue) and wait to respond for high (£5), low (£1), or no reward. Waiting impulsivity was tested with the 4-Choice Serial Reaction Time task. Results For high reward prospects (£5, no reward), greater waiting impulsivity on the 4-CSRT correlated with greater medial orbitofrontal cortex and lower supplementary motor area activity to cues. In response to high reward cues, greater waiting impulsivity was associated with greater subthalamic nucleus connectivity with orbitofrontal cortex and greater subgenual cingulate connectivity with anterior insula, but decreased connectivity with regions implicated in action selection and preparation. Conclusion These findings highlight a shift towards regions implicated in reward valuation and a shift towards compulsivity away from higher level motor preparation and action selection and response. We highlight the role of reward sensitivity and impulsivity, mechanisms potentially linking human waiting impulsivity with incentive approach and compulsivity, theories highly relevant to disorders of addiction. PMID:29020291

  13. Waiting time distribution in public health care: empirics and theory.

    PubMed

    Dimakou, Sofia; Dimakou, Ourania; Basso, Henrique S

    2015-12-01

    Excessive waiting times for elective surgery have been a long-standing concern in many national healthcare systems in the OECD. How do the hospital admission patterns that generate waiting lists affect different patients? What are the hospitals characteristics that determine waiting times? By developing a model of healthcare provision and analysing empirically the entire waiting time distribution we attempt to shed some light on those issues. We first build a theoretical model that describes the optimal waiting time distribution for capacity constraint hospitals. Secondly, employing duration analysis, we obtain empirical representations of that distribution across hospitals in the UK from 1997-2005. We observe important differences on the 'scale' and on the 'shape' of admission rates. Scale refers to how quickly patients are treated and shape represents trade-offs across duration-treatment profiles. By fitting the theoretical to the empirical distributions we estimate the main structural parameters of the model and are able to closely identify the main drivers of these empirical differences. We find that the level of resources allocated to elective surgery (budget and physical capacity), which determines how constrained the hospital is, explains differences in scale. Changes in benefits and costs structures of healthcare provision, which relate, respectively, to the desire to prioritise patients by duration and the reduction in costs due to delayed treatment, determine the shape, affecting short and long duration patients differently. JEL Classification I11; I18; H51.

  14. 76 FR 66181 - The Commerce Control List

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-10-26

    ... DEPARTMENT OF COMMERCE Bureau of Industry and Security 15 CFR Part 774 The Commerce Control List CFR Correction In Title 15 of the Code of Federal Regulations, Parts 300-799, revised as of January 1... to read as follows: Supplement No. 1 to PART 774--THE COMMERCE CONTROL LIST * * * * * 1C118 Titanium...

  15. 76 FR 66181 - The Commerce Control List

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-10-26

    ... DEPARTMENT OF COMMERCE Bureau of Industry and Security 15 CFR Part 774 The Commerce Control List CFR Correction In Title 15 of the Code of Federal Regulations, Parts 300-799, revised as of January 1... read as follows: Supplement No. 1 to PART 774--THE COMMERCE CONTROL LIST * * * * * 2B008 Assemblies or...

  16. Interventions for vaginismus.

    PubMed

    Melnik, Tamara; Hawton, Keith; McGuire, Hugh

    2012-12-12

    Vaginismus is an involuntary contraction of the vaginal muscles which makes sexual intercourse difficult or impossible. It is one of the more common female psychosexual problems. Various therapeutic strategies for vaginismus, such as sex therapy and desensitisation, have been proposed, and uncontrolled case series appear promising. To assess the effects of different interventions for vaginismus. We searched the Cochrane Depression, Anxiety and Neurosis Group's Specialised Register (CCDANCTR-Studies and CCDANCTR-References) to August 2012. This register contains relevant randomised controlled trials from: The Cochrane Library (all years), EMBASE (1974 to date), MEDLINE (1950 to date) and PsycINFO (1967 to date). We searched reference lists and conference abstracts. We contacted experts in the field regarding unpublished material. Controlled trials comparing treatments for vaginismus with another treatment, a placebo treatment, treatment as usual or waiting list control. The review authors extracted data which we verified with the trial investigator where possible. Five studies were included, of which four with a total of 282 participants provided data. No meta-analysis was possible due to heterogeneity of comparisons within included studies as well as inadequate reporting of data. All studies were considered to be at either moderate or high risk of bias. The results of this systematic review indicate that there is no clinical or statistical difference between systematic desensitisation and any of the control interventions (either waiting list control, systematic desensitisation combined with group therapy or in vitro (with women under instruction by the therapist) desensitisation) for the treatment of vaginismus. The drop-out rates were higher in the waiting list groups. A clinically relevant effect of systematic desensitisation when compared with any of the control interventions cannot be ruled out. None of the included trials compared other behaviour therapies (e

  17. The Good Schools Toolkit to prevent violence against children in Ugandan primary schools: study protocol for a cluster randomised controlled trial.

    PubMed

    Devries, Karen M; Allen, Elizabeth; Child, Jennifer C; Walakira, Eddy; Parkes, Jenny; Elbourne, Diana; Watts, Charlotte; Naker, Dipak

    2013-07-24

    We aim to evaluate the effectiveness of the Good School Toolkit, developed by Raising Voices, in preventing violence against children attending school and in improving child mental health and educational outcomes. We are conducting a two-arm cluster randomised controlled trial with parallel assignment in Luwero District, Uganda. We will also conduct a qualitative study, a process evaluation and an economic evaluation. A total of 42 schools, representative of Luwero District, Uganda, were allocated to receive the Toolkit plus implementation support, or were allocated to a wait-list control condition. Our main analysis will involve a cross-sectional comparison of the prevalence of past-week violence from school staff as reported by children in intervention and control primary schools at follow-up.At least 60 children per school and all school staff members will be interviewed at follow-up. Data collection involves a combination of mobile phone-based, interviewer-completed questionnaires and paper-and-pen educational tests. Survey instruments include the ISPCAN Child Abuse Screening Tools to assess experiences of violence; the Strengths and Difficulties Questionnaire to measure symptoms of common childhood mental disorders; and word recognition, reading comprehension, spelling, arithmetic and sustained attention tests adapted from an intervention trial in Kenya. To our knowledge, this is the first study to rigorously investigate the effects of any intervention to prevent violence from school staff to children in primary school in a low-income setting. We hope the results will be informative across the African region and in other settings. clinicaltrials.gov NCT01678846.

  18. Evaluation and treatment of low and anxious mood in Chinese-speaking international students studying in Scotland: study protocol of a pilot randomised controlled trial.

    PubMed

    Zheng, Mengyi; McClay, Carrie-Anne; Wilson, Sarah; Williams, Christopher

    2015-01-01

    Low mood is a common mental health problem affecting up to 121 million people worldwide and is common in students, particularly international students. Cognitive behavioural therapy (CBT) is known to be effective as a treatment for low mood and anxiety when delivered one to one by an expert practitioner, however this can be expensive and many services have waiting lists and delayed access. A range of additional ways of increasing access to services includes the offer of online courses such as computerised CBT as a possible additional pathway for care. This project aims to test the feasibility of a pilot randomised controlled trial of an online CBT-based life skills course with Chinese-speaking international students experiencing low mood and anxiety. Chinese-speaking international students with symptoms of low mood and/or anxiety will be recruited from the University of Glasgow, Scotland. Participants will be remotely randomised to receive either immediate access (IA) or delayed access (DA) to a guided/supported online CBT-based life skills package, the "Living Life" package (Chinese version). Participants will be randomly assigned to IA or DA to the intervention. The primary end point will be at 3 months when the delayed group will be offered the intervention. Levels of depression, anxiety, social functioning and satisfaction will be assessed. This pilot study will test the trial design, ability to recruit, gather completed questionnaires, test drop-out rates and investigate completion and acceptability of the package. The study aims to reduce uncertainties about the delivery of a future substantive study and will also inform a sample size calculation for that subsequent substantive randomised controlled trial (RCT) which will be carried out to determine the effectiveness of the online package in improving low mood and anxiety in the Chinese-speaking student population. Current Controlled Trials ISRCTN30816908.

  19. A Randomised Controlled Trial of a Play-Based Intervention to Improve the Social Play Skills of Children with Attention Deficit Hyperactivity Disorder (ADHD).

    PubMed

    Wilkes-Gillan, Sarah; Bundy, Anita; Cordier, Reinie; Lincoln, Michelle; Chen, Yu-Wei

    2016-01-01

    There is a need for effective interventions to address the social difficulties of children with ADHD. This randomised controlled trial examined the effectiveness of a play-based intervention for improving the social play skills of children with ADHD in peer-to-peer interactions. Children with ADHD (5 to 11 years) were randomised to an intervention-first (n = 15) or waitlist control-first group (n = 14). Participants allocated to the control-first group received the intervention after a 10-week wait period. Children invited a typically-developing playmate and parents of children with ADHD participated. The intervention involved: six clinic play-sessions, weekly home-modules and a one-month home follow up. The Test of Playfulness (ToP) was scored by a blinded rater. Parent reported treatment adherence was used to assess treatment fidelity. Between group statistics were used to compare the change of the intervention-first (10-week intervention period) and control-first (10-week wait period) groups. Once all children had received the intervention, repeated measures ANOVA, post hoc Least Significance Difference tests and Cohen's-d were used to measure effect. Changes in ToP social items were analysed using Friedman's ANOVA. Linear regression analyses were used to identify variables that predicted change. The control-first group did not change during the wait period. The change in the intervention-first group was significantly greater than the change in the control-first group (during the wait period). When the data from the two groups were combined, the mean ToP scores of the children with ADHD (n = 29) improved significantly following the intervention, with a large effect from pre to post intervention and from pre intervention to follow up. Children maintained treatment gains at follow up. All ToP social items improved significantly following the intervention. The findings support the use of play involving parent and peer mediated components to enhance the social play

  20. A goal management intervention for polyarthritis patients: rationale and design of a randomized controlled trial.

    PubMed

    Arends, Roos Y; Bode, Christina; Taal, Erik; Van de Laar, Mart A F J

    2013-08-13

    A health promotion intervention was developed for inflammatory arthritis patients, based on goal management. Elevated levels of depression and anxiety symptoms, which indicate maladjustment, are found in such patients. Other indicators of adaptation to chronic disease are positive affect, purpose in life and social participation. The new intervention focuses on to improving adaptation by increasing psychological and social well-being and decreasing symptoms of affective disorders. Content includes how patients can cope with activities and life goals that are threatened or have become impossible to attain due to arthritis. The four goal management strategies used are: goal maintenance, goal adjustment, goal disengagement and reengagement. Ability to use various goal management strategies, coping versatility and self-efficacy are hypothesized to mediate the intervention's effect on primary and secondary outcomes. The primary outcome is depressive symptoms. Secondary outcomes are anxiety symptoms, positive affect, purpose in life, social participation, pain, fatigue and physical functioning. A cost-effectiveness analysis and stakeholders' analysis are planned. The protocol-based psycho-educational program consists of six group-based meetings and homework assignments, led by a trained nurse. Participants are introduced to goal management strategies and learn to use these strategies to cope with threatened personal goals. Four general hospitals participate in a randomized controlled trial with one intervention group and a waiting list control condition. The purpose of this study is to evaluate the effectiveness of a goal management intervention. The study has a holistic focus as both the absence of psychological distress and presence of well-being are assessed. In the intervention, applicable goal management competencies are learned that assist people in their choice of behaviors to sustain and enhance their quality of life. Nederlands Trial Register = NTR3606