Quantitative assessment of barriers to the clinical development and adoption of cellular therapies: A pilot study.

PubMed

Davies, Benjamin M; Rikabi, Sarah; French, Anna; Pinedo-Villanueva, Rafael; Morrey, Mark E; Wartolowska, Karolina; Judge, Andrew; MacLaren, Robert E; Mathur, Anthony; Williams, David J; Wall, Ivan; Birchall, Martin; Reeve, Brock; Atala, Anthony; Barker, Richard W; Cui, Zhanfeng; Furniss, Dominic; Bure, Kim; Snyder, Evan Y; Karp, Jeffrey M; Price, Andrew; Carr, Andrew; Brindley, David A

2014-01-01

There has been a large increase in basic science activity in cell therapy and a growing portfolio of cell therapy trials. However, the number of industry products available for widespread clinical use does not match this magnitude of activity. We hypothesize that the paucity of engagement with the clinical community is a key contributor to the lack of commercially successful cell therapy products. To investigate this, we launched a pilot study to survey clinicians from five specialities and to determine what they believe to be the most significant barriers to cellular therapy clinical development and adoption. Our study shows that the main concerns among this group are cost-effectiveness, efficacy, reimbursement, and regulation. Addressing these concerns can best be achieved by ensuring that future clinical trials are conducted to adequately answer the questions of both regulators and the broader clinical community.

The effects of interactive music therapy on hospitalized children with cancer: a pilot study.

PubMed

Barrera, Maru E; Rykov, Mary H; Doyle, Sandra L

2002-01-01

The use of music therapy with children in health settings has been documented, but its effectiveness has not yet been well established. This pilot study is a preliminary exploration of the effectiveness of interactive music therapy in reducing anxiety and increasing the comfort of hospitalized children with cancer. Pre- and post-music therapy measures were obtained from children (N = 65) and parents. The measures consisted of children's ratings of mood using schematic faces, parental ratings of the child's play performance, and satisfaction questionnaires completed by parents, children and staff. There was a significant improvement in children's ratings of their feelings from pre- to post-music therapy. Parents perceived an improved play performance after music therapy in pre-schoolers and adolescents but not in school-aged children. Qualitative analyses of children's and parents' comments suggested a positive impact of music therapy on the child's well-being. These preliminary findings are encouraging and suggest beneficial effects of interactive music therapy with hospitalized pediatric hematology/oncology patients. In future studies replicating these findings should be conducted in a randomized control trial. Copyright 2002 John Wiley & Sons, Ltd.

Monitoring early response to taxane therapy in advanced breast cancer with circulating tumor cells and [(18)F] 3´-deoxy-3´-fluorothymidine PET: a pilot study.

PubMed

Contractor, Kaiyumars; Aboagye, Eric O; Jacob, Jimmy; Challapalli, Amarnath; Coombes, R Charles; Stebbing, Justin

2012-04-01

Early markers of response to chemotherapy, measured by blood markers and imaging, may ultimately lead to tailored therapies that avoid cumulative toxicity. We performed a small pilot study to compare early changes in levels of circulatory tumor cells (CTCs) with changes in tumor proliferation, using metabolic imaging with [(18)F] 3´-deoxy-3´-fluorothymidine PET (FLT-PET) in women with advanced breast cancer, before and during docetaxel therapy. In those individuals in whom we could detect CTCs, a decrease in CTC count correlated with a decrease in FLT-PET signal, within 2 weeks. Combined, these two technologies are likely to provide a powerful, albeit expensive, tool to assess immediate responses to therapy.

Group Therapy for Children after Homicide and Violence: A Pilot Study

ERIC Educational Resources Information Center

Salloum, Alison

2008-01-01

Objective: This pilot study evaluated a group intervention designed to reduce posttraumatic stress among children after homicide and/or violence. Method: Employing a secondary data analysis of 117 participants in 21 group interventions, pretest and posttest differences in posttraumatic stress levels and between child witnesses and nonwitnesses,…

Dolphin-Assisted Therapy for Children with Special Needs: A Pilot Study

ERIC Educational Resources Information Center

Dilts, Rachel; Trompisch, Norbert; Bergquist, Timothy M.

2011-01-01

Dolphin-assisted therapy (DAT), as a part of animal-assisted therapy and complementary and alternative medicine, yields several positive results. This study intended to add to DAT effectiveness research while using a standardized assessment. In the Ukraine, a DAT program called DolphinSwim agreed to take part in research with 37 voluntary…

Coverbal Gestures in the Recovery from Severe Fluent Aphasia: A Pilot Study

ERIC Educational Resources Information Center

Carlomagno, Sergio; Zulian, Nicola; Razzano, Carmelina; De Mercurio, Ilaria; Marini, Andrea

2013-01-01

This post hoc study investigated coverbal gesture patterns in two persons with chronic Wernicke's aphasia. They had both received therapy focusing on multimodal communication therapy, and their pre- and post-therapy verbal and gestural skills in face-to-face conversational interaction with their speech therapist were analysed by administering a…

Maintenance Model of Integrated Psychosocial Treatment in Pediatric Bipolar Disorder: A Pilot Feasibility Study

ERIC Educational Resources Information Center

West, Amy E.; Henry, David B.; Pavuluri, Mani N.

2007-01-01

Objective: The chronic and refractory course of pediatric bipolar disorder merits the study of adjunctive psychosocial interventions designed to facilitate long-term improvements. The objective of this study is to conduct a pilot study of a maintenance model of the child- and family-focused cognitive-behavioral therapy program (CFF-CBT), which…

A Pilot Evaluation of an Art Therapy Program for Refugee Youth from Burma

ERIC Educational Resources Information Center

Kowitt, Sarah Dorothy; Emmerling, Dane; Gavarkavich, Diane; Mershon, Claire-Helene; Linton, Kristin; Rubesin, Hillary; Agnew-Brune, Christine; Eng, Eugenia

2016-01-01

Art therapy is a promising form of therapy to address mental health concerns for refugee youth. This article describes the development and implementation of a pilot evaluation of an art therapy program for refugee adolescents from Burma currently living in the United States. Evaluation activities were based on the Centers for Disease Control and…

Outcomes of an acceptance and commitment therapy-based skills training group for students with high-functioning autism spectrum disorder: a quasi-experimental pilot study.

PubMed

Pahnke, Johan; Lundgren, Tobias; Hursti, Timo; Hirvikoski, Tatja

2014-11-01

Autism spectrum disorder is characterized by social impairments and behavioural inflexibility. In this pilot study, the feasibility and outcomes of a 6-week acceptance and commitment therapy-based skills training group were evaluated in a special school setting using a quasi-experimental design (acceptance and commitment therapy/school classes as usual). A total of 28 high-functioning students with autism spectrum disorder (aged 13-21 years) were assessed using self- and teacher-ratings at pre- and post-assessment and 2-month follow-up. All participants completed the skills training, and treatment satisfaction was high. Levels of stress, hyperactivity and emotional distress were reduced in the treatment group. The acceptance and commitment therapy group also reported increased prosocial behaviour. These changes were stable or further improved at the 2-month follow-up. Larger studies are needed to further evaluate the benefits of acceptance and commitment therapy for autism spectrum disorder. © The Author(s) 2013.

Feasibility and Initial Effectiveness of Home Exercise During Maintenance Therapy for Childhood Acute Lymphoblastic Leukemia

PubMed Central

Esbenshade, Adam J.; Friedman, Debra L.; Smith, Webb A.; Jeha, Sima; Pui, Ching-Hon; Robison, Leslie L.; Ness, Kirsten K.

2014-01-01

Purpose Children with acute lymphoblastic leukemia (ALL) are at increased risk of obesity and deconditioning from cancer therapy. This pilot study assessed feasibility/initial efficacy of an exercise intervention for ALL patients undergoing maintenance therapy. Methods Participants were children with ALL, age 5-10 years, receiving maintenance therapy, in first remission. A 6-month home-based intervention, with written and video instruction, was supervised with weekly calls from an exercise coach. Pre- and post-study testing evaluated strength, flexibility, fitness and motor function. Results Seventeen patients enrolled (participation 63%). Twelve (71%) finished the intervention, completing 81.7±7.2% of prescribed sessions. Improvements ≥5% occurred in 67% for knee and 75% for grip strength, 58% for hamstring/low-back and 83% for ankle flexibility, 75% for the 6-minute-walk-test, and 33% for performance on the Bruininks-Oseretsky Test of Motor Proficiency Version 2. Conclusions This pilot study demonstrated that exercise intervention during ALL therapy is feasible and has promise for efficacy. PMID:24979081

A pilot study of the effects of gonadotropin-releasing hormone agonist therapy on brain activation pattern in a man with pedophilia.

PubMed

Moulier, Virginie; Fonteille, Véronique; Pélégrini-Issac, Mélanie; Cordier, Bernard; Baron-Laforêt, Sophie; Boriasse, Emeline; Durand, Emmanuel; Stoléru, Serge

2012-02-01

Gonadotropin-releasing hormone (GnRH) agonists, such as leuprorelin, are recommended in the patients with pedophilia at highest risk of offending. However, the cerebral mechanisms of the effects of these testosterone-decreasing drugs are poorly known. This study aimed to identify changes caused by leuprorelin in a pedophilic patient's brain responses to pictures representing children. Clinical, endocrine, and fMRI investigations were done of a man with pedophilia before leuprorelin therapy and 5 months into leuprorelin therapy. Patient was compared with an age-matched healthy control also assessed 5 months apart. Before therapy, pictures of boys elicited activation in the left calcarine fissure, left insula, anterior cingulate cortex, and left cerebellar vermis. Five months into therapy, all the above-mentioned activations had disappeared. No such activations and, consequently, no such decreases occurred in the healthy control. The results of this pilot study suggest that leuprorelin decreased activity in regions known to mediate the perceptual, motivational, and affective responses to visual sexual stimuli.

Leap motion controlled videogame-based therapy for rehabilitation of elderly patients with subacute stroke: a feasibility pilot study.

PubMed

Iosa, Marco; Morone, Giovanni; Fusco, Augusto; Castagnoli, Marcello; Fusco, Francesca Romana; Pratesi, Luca; Paolucci, Stefano

2015-08-01

The leap motion controller (LMC) is a new optoelectronic system for capturing motion of both hands and controlling a virtual environment. Differently from previous devices, it optoelectronically tracks the fine movements of fingers neither using glows nor markers. This pilot study explored the feasibility of adapting the LMC, developed for videogames, to neurorehabilitation of elderly with subacute stroke. Four elderly patients (71.50 ± 4.51 years old) affected by stroke in subacute phase were enrolled and tested in a cross-over pilot trial in which six sessions of 30 minutes of LMC videogame-based therapy were added on conventional therapy. Measurements involved participation to the sessions, evaluated by means of the Pittsburgh Rehabilitation Participation Scale, hand ability and grasp force evaluated respectively by means of the Abilhand Scale and by means of the dynamometer. Neither adverse effects nor spasticity increments were observed during LMC training. Participation to the sessions was excellent in three patients and very good in one patient during the LMC trial. In this period, patients showed a significantly higher improvement in hand abilities (P = 0.028) and grasp force (P = 0.006). This feasibility pilot study was the first one using leap motion controller for conducting a videogame-based therapy. This study provided a proof of concept that LMC can be a suitable tool even for elderly patients with subacute stroke. LMC training was in fact performed with a high level of active participation, without adverse effects, and contributed to increase the recovery of hand abilities.

A Randomized Controlled Trial of Acceptance-Based Behavior Therapy and Cognitive Therapy for Test Anxiety: A Pilot Study

ERIC Educational Resources Information Center

Brown, Lily A.; Forman, Evan M.; Herbert, James D.; Hoffman, Kimberly L.; Yuen, Erica K.; Goetter, Elizabeth M.

2011-01-01

Many university students suffer from test anxiety that is severe enough to impair performance. Given mixed efficacy results of previous cognitive-behavior therapy (CBT) trials and a theoretically driven rationale, an acceptance-based behavior therapy (ABBT) approach was compared to traditional CBT (i.e., Beckian cognitive therapy; CT) for the…

Upfront triple combination therapy in pulmonary arterial hypertension: a pilot study.

PubMed

Sitbon, Olivier; Jaïs, Xavier; Savale, Laurent; Cottin, Vincent; Bergot, Emmanuel; Macari, Elise Artaud; Bouvaist, Hélène; Dauphin, Claire; Picard, François; Bulifon, Sophie; Montani, David; Humbert, Marc; Simonneau, Gérald

2014-06-01

Patients with severe pulmonary arterial hypertension (PAH) in New York Heart Association (NYHA) functional class (FC) III/IV have a poor prognosis, despite survival benefits being demonstrated with intravenous epoprostenol. In this pilot study, the efficacy and safety of a triple combination therapy regimen in patients with severe PAH was investigated. Data from newly diagnosed NYHA FC III/IV PAH patients (n=19) initiated on upfront triple combination therapy (intravenous epoprostenol, bosentan and sildenafil) were collected retrospectively from a prospective registry. Significant improvements in 6-min walk distance and haemodynamics were observed after 4 months' triple combination therapy in 18 patients (p<0.01); 17 patients had improved to NYHA FC I or II. One patient was not included in the month 4 assessment (due to an emergency lung transplant in month 3). At the final evaluation (mean ± sd 32 ± 19 months), all 18 patients had sustained clinical and haemodynamic improvement. Overall survival estimates for the triple combination cohort were 100% at 1, 2 and 3 years. Expected survival calculated from the French equation was 75% (95% CI 68-82%), 60% (95% CI 50-70%) and 49% (95% CI 38-60%) at 1, 2 and 3 years, respectively. This pilot study provides preliminary evidence of the long-term benefits of upfront triple combination therapy in patients with severe PAH. ©ERS 2014.

Combining biofeedback and Narrative Exposure Therapy for persistent pain and PTSD in refugees: a pilot study

PubMed Central

Morina, Naser; Maier, Thomas; Bryant, Richard; Knaevelsrud, Christine; Wittmann, Lutz; Rufer, Michael; Schnyder, Ulrich; Müller, Julia

2012-01-01

Objective Many traumatised refugees suffer from both persistent pain and posttraumatic stress disorder (PTSD). To date, no specific guidelines exist for treatment of this group of patients. This paper presents data on a pilot treatment study conducted with 15 traumatised refugees with persistent pain and PTSD. Methods Participants received 10 sessions of pain-focused treatment with biofeedback (BF) followed by 10 sessions of Narrative Exposure Therapy (NET). Structured interviews and standardised questionnaires were used to assess symptoms of pain intensity, pain disability, PTSD and quality of life directly before and after treatment and at 3 months follow-up. Results Following the combined intervention, participants showed a significant reduction in both pain and PTSD symptoms, as well as improved quality of life. Additionally, biofeedback increased motivation for subsequent trauma-focused therapy, which in turn was related to larger PTSD treatment gains. Conclusion This pilot study provides initial evidence that combining BF and NET is safe, acceptable, and feasible in patients with co-morbid persistent pain and PTSD. PMID:22893834

A pilot study of cognitive behaviour therapy for panic disorder augmented by panic surfing.

PubMed

Lamplugh, Claire; Berle, David; Milicevic, Denise; Starcevic, Vladan

2008-01-01

This pilot study reports the outcome of cognitive behaviour therapy for panic disorder augmented by panic surfing. This treatment approach encourages acceptance of feelings rather than control of symptoms and anxiety, at the same time also targeting catastrophic misinterpretations, bodily vigilance and safety-seeking behaviours. Eighteen participants completed a brief group treatment for panic disorder incorporating psychoeducation, panic surfing, interoceptive exposure, graded exposure and cognitive restructuring. Significant improvements occurred over the course of this treatment and were maintained at a 1-month follow-up. Results suggest that cognitive behaviour therapy augmented by panic surfing may be effective in the treatment of panic disorder, but there is a need for controlled studies and investigation of the relative contribution of its various components. 2008 John Wiley & Sons, Ltd.

Voice Therapy Techniques Adapted to Treatment of Habit Cough: A Pilot Study.

ERIC Educational Resources Information Center

Blager, Florence B.; And Others

1988-01-01

Individuals with long-standing habit cough having no organic basis can be successfully treated with a combination of psychotherapy and speech therapy. Techniques for speech therapy are adapted from those used with hyperfunctional voice disorders to fit this debilitating laryngeal disorder. (Author)

Using CALMERSS to Enhance Teacher Well-Being: A Pilot Study

ERIC Educational Resources Information Center

Taylor, Mark J.

2018-01-01

Prior research has shown that cognitive behavioural therapy, relaxation, mindfulness, exercise and positive psychology interventions, when conducted as single interventions, have a useful effect on depression and also increasing well-being. The purpose of this study was to conduct a pilot programme to determine the efficacy of a multi-modal…

Art Therapy with Sexually Abused Children and Adolescents: Extended Research Study

ERIC Educational Resources Information Center

Pifalo, Terry

2006-01-01

This article reports the outcome of a four-year follow-up of a pilot study using a combination of art therapy, cognitive behavioral therapy, and group process to address the therapeutic issues related to childhood sexual abuse. All group participants were evaluated using the Trauma Symptom Checklist for Children (Briere, 1995), commonly used in…

Restoring effective sleep tranquility (REST): A feasibility and pilot study.

PubMed

Eakman, Aaron M; Schmid, Arlene A; Henry, Kimberly L; Rolle, Natalie R; Schelly, Catherine; Pott, Christine E; Burns, Joshua E

2017-06-01

The purpose of this pilot study was to establish the feasibility of completing a future controlled trial of a multi-component cognitive behavioral therapy for insomnia program for military veterans with sleep disturbance. This was a single-arm feasibility and pilot study. Participants were United States post-9/11 veterans with service-connected injuries, university students, and had self-reported sleep disturbances. Restoring Effective Sleep Tranquility was a multi-component cognitive behavioral therapy for insomnia intervention consisting of seven sessions of group therapy and eight 1:1 sessions delivered by occupational therapists. Feasibility and pilot indicators were process, resources, management, and scientific, including pre-post-assessments of sleep difficulties, dysfunctional sleep beliefs, participation, and pain interference. Indicators were supportive of feasibility, including reduced sleep difficulties (for example Medical Outcomes Study Sleep Measure [ t  = 3.29, p  = .02]), reduced nightmares: t  = 2.79, p  = .03; fewer dysfunctional sleep beliefs: t  = 3.63, p  = .01, and greater ability to participate in social roles: t  = -2.86, p  = .03, along with trends towards improved satisfaction with participation and reduced pain interference. The Restoring Effective Sleep Tranquility program may reduce sleep difficulties and improve participation in US veterans with service-connected injuries, and evidence indicates a controlled trial would be feasible to deliver.

Restoring effective sleep tranquility (REST): A feasibility and pilot study

PubMed Central

Schmid, Arlene A; Henry, Kimberly L; Rolle, Natalie R; Schelly, Catherine; Pott, Christine E; Burns, Joshua E

2017-01-01

Introduction The purpose of this pilot study was to establish the feasibility of completing a future controlled trial of a multi-component cognitive behavioral therapy for insomnia program for military veterans with sleep disturbance. Method This was a single-arm feasibility and pilot study. Participants were United States post-9/11 veterans with service-connected injuries, university students, and had self-reported sleep disturbances. Restoring Effective Sleep Tranquility was a multi-component cognitive behavioral therapy for insomnia intervention consisting of seven sessions of group therapy and eight 1:1 sessions delivered by occupational therapists. Feasibility and pilot indicators were process, resources, management, and scientific, including pre–post-assessments of sleep difficulties, dysfunctional sleep beliefs, participation, and pain interference. Findings Indicators were supportive of feasibility, including reduced sleep difficulties (for example Medical Outcomes Study Sleep Measure [t = 3.29, p = .02]), reduced nightmares: t = 2.79, p = .03; fewer dysfunctional sleep beliefs: t = 3.63, p = .01, and greater ability to participate in social roles: t = –2.86, p = .03, along with trends towards improved satisfaction with participation and reduced pain interference. Conclusion The Restoring Effective Sleep Tranquility program may reduce sleep difficulties and improve participation in US veterans with service-connected injuries, and evidence indicates a controlled trial would be feasible to deliver. PMID:28626295

Perceived outcomes of music therapy with Body Tambura in end of life care - a qualitative pilot study.

PubMed

Teut, Michael; Dietrich, Cordula; Deutz, Bernhard; Mittring, Nadine; Witt, Claudia M

2014-04-07

In recent years, music therapy is increasingly used in palliative care. The aim of this pilot study was to record and describe the subjective experiences of patients and their relatives undergoing music therapy with a Body Tambura in a German hospice and to develop hypotheses for future studies. In a qualitative interview pilot study, data collection and analyses were performed according to the methodological framework of grounded theory. We included German-speaking patients, or relatives of patients, receiving end of life care in an inpatient hospice setting. 11 persons consisting of 8 patients (age range 51-82 years, 4 male and 4 female) and 3 relatives were treated and interviewed. All patients suffered from cancer in an advanced stage. The most often described subjective experiences were a relaxing and calming effect, sensations that the body feels lighter, and the generation of relaxing images and visualizations. Family members enjoyed listening to the music and felt more connected with the sick family member. Patient reported beneficial aspects. The small sample size could be seen as a limitation. Assessment instruments measuring relaxation, stress, quality of life and should be included in future quantitative studies.

The Effect of Aroma Hand Massage Therapy for People with Dementia.

PubMed

Yoshiyama, Kazuyo; Arita, Hideko; Suzuki, Jinichi

2015-12-01

Clinical aromatherapy is a complementary therapy that may be very helpful for elderly dementia care. Aromatherapy may reduce the behavioral and psychological symptoms of dementia (BPSD), improve quality of care, and thus improve the quality of life for people with dementia. In this pilot study, aroma hand massage therapy was used for elderly patients in a medical institution in Japan. The study assessed the effectiveness and safety of clinical aromatherapy as part of routine integrative care among people with dementia in a clinical care setting. The randomized, crossover pilot trials were performed among 14 patients with mild-to-moderate dementia older than age 65 years living in a nursing home in Nara, Japan. Participants were divided into two groups and offered, alternately, control therapy and clinical aromatherapy 3 times a week for the 4-week trials. The effects on BPSD and activities of daily living (ADLs) were evaluated quantitatively before and after the study and 4 weeks after the study ended as a follow-up. Observation records were also collected to obtain qualitative data. The quantitative data showed that neither therapy significantly improved the BPSD or ADL results. The qualitative data were classified into four main categories-mood, behavior, verbal communication, and nonverbal communication-reflecting the positive experiences of participants during both therapies. No harmful reactions or changes in medication occurred during the study. This pilot study demonstrated that clinical aromatherapy was clinically safe but did not lead to statistically significant improvements in BPSD or ADL among people with dementia. Further research on therapeutic effects is needed to develop high-quality care with clinical aromatherapy for elderly patients with dementia in Japan and to fully establish evidence for effective and safe practice in health care institutions.

HandTutor™ enhanced hand rehabilitation after stroke--a pilot study.

PubMed

Carmeli, Eli; Peleg, Sara; Bartur, Gadi; Elbo, Enbal; Vatine, Jean-Jacques

2011-12-01

This study assessed the potential therapeutic benefi t of using HandTutor™ in combination with traditional rehabilitation in a post-stroke sub-acute population. The study compares an experimental group receiving traditional therapy combined with HandTutorTM treatment, against a control group receiving only traditional therapy. An assessor-blinded, randomized controlled pilot trial, was conducted in the Reuth rehabilitation unit in Israel. Thirty-one stroke patients in the sub-acute phase, were randomly assigned to one of the two groups (experimental or control) in sets of three. The experimental group (n = 16) underwent a hand rehabilitation programme using the HandTutorTM combined with traditional therapy. The control group (n = 15) received only traditional therapy. The treatment schedules for both groups were of similar duration and frequency. Improvements were evaluated using three indicators: 1) The Brunnström-Fugl-Meyer (FM) test, 2) the Box and Blocks (B&B) test and 3) improvement parameters as determined by the HandTutorTM software. Following 15 consecutive treatment sessions, a signifi cant improvement was observed within the experimental group (95% confi dence intervals) compared with the control group: B&B p = 0.015; FM p = 0.041, HandTutor™ performance accuracy on x axis and performance accuracy on y axis p < 0.0003. The results from this pilot study support further investigation of the use of the HandTutorTM in combination with traditional occupational therapy and physiotherapy during post stroke hand function rehabilitation.

Integration of Diagnostic and Interventional MRI for the Study of Persistent Prostate Cancer after External Beam Radiotherapy

DTIC Science & Technology

2009-10-01

1500 ms). A clinical pilot study reported equivalence between central gland (CG) and peripheral zone (PZ) T1 values (CG: 1321±45 ms, n=14; PZ: 1359...across variable TI, the period of longitudinal recovery is kept independent of TI selection for any TR. Central to T1prep is RF cycling of an...pilot study A clinical pilot study involved 15 patients with low or intermediate risk localized prostate cancer and no history of prior therapy. The

Brief Acceptance and Commitment Therapy and Exposure for Panic Disorder: A Pilot Study

ERIC Educational Resources Information Center

Meuret, Alicia E.; Twohig, Michael P.; Rosenfield, David; Hayes, Steven C.; Craske, Michelle G.

2012-01-01

Cognitive and biobehavioral coping skills are central to psychosocial therapies and are taught to facilitate and improve exposure therapy. While traditional coping skills are aimed at controlling maladaptive thoughts or dysregulations in physiology, newer approaches that explore acceptance, defusion, and values-based direction have been gaining…

A Pilot Study of Marital Therapy as a Treatment for Depression.

ERIC Educational Resources Information Center

Waring, Edward M.; And Others

1995-01-01

Seventeen depressed, married women were assigned to marital therapy or a waiting list control group. Couples received 10 sessions of Enhancing Marital Intimacy Therapy (EMIT), a structured technique involving the self-disclosure of personal constructs. Comparisons revealed a significant reduction in the experimental group's depressive…

Evaluation of the effectiveness of music therapy in improving the quality of life of palliative care patients: a randomised controlled pilot and feasibility study.

PubMed

McConnell, Tracey; Graham-Wisener, Lisa; Regan, Joan; McKeown, Miriam; Kirkwood, Jenny; Hughes, Naomi; Clarke, Mike; Leitch, Janet; McGrillen, Kerry; Porter, Sam

2016-01-01

Music therapy is frequently used as a palliative therapy. In consonance with the goals of palliative care, the primary aim of music therapy is to improve people's quality of life by addressing their psychological needs and facilitating communication. To date, primarily because of a paucity of robust research, the evidence for music therapy's effectiveness on patient reported outcomes is positive but weak. This pilot and feasibility study will test procedures, outcomes and validated tools; estimate recruitment and attrition rates; and calculate the sample size required for a phase III randomised trial to evaluate the effectiveness of music therapy in improving the quality of life of palliative care patients. A pilot randomised controlled trial supplemented with qualitative methods. The quantitative data collection will involve recruitment of >52 patients from an inpatient Marie Curie hospice setting over a 12-month period. Eligibility criteria include all patients with an Eastern Cooperative Oncology Group (ECOG) performance status of 03- indicating they are medically fit to engage with music therapy and an Abbreviated Mental Test (AMT) score of ≥7 indicating they are capable of providing meaningful informed consent and accurate responses to outcome measures. Baseline data collection will include the McGill Quality of Life Questionnaire (MQOL); medical and socio-demographic data will be undertaken before randomisation to an intervention or control group. Participants in the intervention arm will be offered two 30-45 min sessions of music therapy per week for three consecutive weeks, in addition to care as usual. Participants in the control arm will receive care as usual. Follow-up measures will be administered in 1, 3 and 5 weeks. Qualitative data collection will involve focus group and individual interviews with HCPs and carers. This study will ensure a firm methodological grounding for the development of a robust phase III randomised trial of music therapy for improving quality of life in palliative care patients. By undertaking the pilot and feasibility trial under normal clinical conditions in a hospice setting, the trial will result in reliable procedures to overcome some of the difficulties in designing music therapy RCTs for palliative care settings. Clinicaltrials.gov Identifier: NCT02791048.

Effects of sculpture based art therapy in dementia patients-A pilot study.

PubMed

Seifert, Kathrin; Spottke, Annika; Fliessbach, Klaus

2017-11-01

Art and art therapy open up interesting possibilities for dementia patients. However, it has not been evaluated scientifically so far, whether the art of sculpting has any benefits. In this non-randomized pilot study with twelve participants, we investigated the feasibility and acceptance of sculptural activity in patients with dementia and the effects on their well-being. A questionnaire was custom-designed to investigate five key aspects of well-being: mental state and concentration, corporeal memory, self-reliance, self-esteem and physicality. Remarkable improvements were seen in several subscales in the sculptural activity group, but not the control group: Mental state and concentration (nine of thirteen key aspects), self-reliance (four of five), self-esteem (one of one) and physicality (two of two). The results of this pilot study indicate the multidimensional effects of sculptural activity on patients living with dementia. The field would benefit greatly from further research.

The Treatment of Maladaptive Shame in Borderline Personality Disorder: A Pilot Study of "Opposite Action"

ERIC Educational Resources Information Center

Rizvi, Shireen L.; Linehan, Marsha M.

2005-01-01

This study sought to pilot test a short-term intervention for maladaptive shame in borderline personality disorder (BPD) based on the skill of "opposite action" from dialectical behavior therapy. Five women with BPD were treated with the intervention using a single-subject, multiple-baseline design. Results indicate that, although state ratings of…

Integrating Art into Group Treatment for Adults with Post-Traumatic Stress Disorder from Childhood Sexual Abuse: A Pilot Study

ERIC Educational Resources Information Center

Becker, Carol-Lynne J.

2015-01-01

Current research supports the use of exposure-based treatments for posttraumatic stress disorder (PTSD) and integrated treatments show potential for enhanced symptom reduction. This pilot study developed a manualized group treatment integrating art interventions with exposure, grounding, and narrative therapy for five adults with PTSD who were…

[Vibration-assisted music therapy reduces pain and promotes relaxation of para- and tetraplegic patients. A pilot study of psychiatric and physical effects of simultaneous acoustic and somatosensory music stimulation as pain management].

PubMed

Mariauzouls, C; Michel, D; Schiftan, Y

1999-11-01

Pain is a well known phenomenon in posttraumatic spinal cord injuries. Nearly 10% of the patients develop most severe, invalidizing, as a rule neurogenic pain conditions that are hardly accessible to conventional therapies. A pilot study was therefore conducted with 10 paraplegics and tetraplegics suffering chronic pain, investigating how vibration supported music therapy with the Musica Medica method affected pain experience, tension/relaxation and well-being. In addition to subjective experience, we measured physiological parameters (finger tip skin temperature, electrodermal activity, heart rate, respiration frequency) during the therapy sessions. All patients had a high acceptance of the method which throughout the group had brought about an increase in relaxation and well-being as well as a decrease of pain experience. The autonomic nervous system variables correlated with relaxation and in addition pointed to an activating impact of the therapy chosen.

Self-awareness rehabilitation after Traumatic Brain Injury: A pilot study to compare two group therapies

PubMed Central

Rigon, Jessica; Burro, Roberto; Guariglia, Cecilia; Maini, Manuela; Marin, Dario; Ciurli, Paola; Bivona, Umberto; Formisano, Rita

2017-01-01

Background and Purpose: Deficits of self-awareness (SA) are very common after severe acquired brain injury (sABI), especially in traumatic brain injury (TBI), playing an important role in the efficacy of the rehabilitation process. This pilot study provides information regarding two structured group therapies for disorders of SA. Methods: Nine patients with severe TBI were consecutively recruited and randomly assigned to one SA group therapy programme, according either to the model proposed by Ben-Yishay & Lakin (1989) (B&L Group), or by Sohlberg & Mateer (1989) (S&M Group). Neuropsychological tests and self-awareness questionnaires were administered before and after a 10 weeks group therapy. Results: Results showed that both SA and neuropsychological functioning significantly improved in both groups. Conclusion: It is important to investigate and treat self-awareness, also to improve the outcome of neuropsychological disorders. The two group therapies proposed seem to be specific for impulsivity and emotional dyscontrol and for cognitive disorders. PMID:28059799

Venous leg ulcer healing with electric stimulation therapy: a pilot randomised controlled trial.

PubMed

Miller, C; McGuiness, W; Wilson, S; Cooper, K; Swanson, T; Rooney, D; Piller, N; Woodward, M

2017-03-02

Compression therapy is a gold standard treatment to promote venous leg ulcer (VLU) healing. Concordance with compression therapy is, however, often sub-optimal. The aim of this study was to evaluate the effectiveness of electric stimulation therapy (EST) to facilitate healing of VLUs among people who do not use moderate-to-high levels of compression (>25 mmHg). A pilot multicentre, single-blinded randomised controlled trial was conducted. Participants were randomised (2:1) to the intervention group or a control group where EST or a sham device was used 4 times daily for 20 minutes per session. Participants were monitored fortnightly for eight weeks. The primary outcome measure was percentage of area (wound size) change. In the 23 patients recruited, an average redution in wound size of 23.15% (standard deviation [SD]: 61.23) was observed for the control group compared with 32.67 % (SD: 42.54) for the intervention. A moderate effect size favouring the intervention group was detected from univariate [F(1,18)=1.588, p=0.224, partial eta squared=0.081] and multivariate repeated measures [F(1,18)=2.053, p=0.169, partial eta squared=0.102] analyses. The pilot study was not powered to detect statistical significance, however, the difference in healing outcomes are encouraging. EST may be an effective adjunct treatment among patients who have experienced difficulty adhering to moderate-to-high levels of compression therapy.

Reduction of fibromyalgia symptoms through intravenous nutrient therapy: results of a pilot clinical trial.

PubMed

Massey, Patrick B

2007-01-01

To evaluate the effectiveness of a modified Myers' formula of intravenous nutrient therapy (IVNT) on the symptoms of fibromyalgia (FM) in therapy-resistant FM patients. In this pilot clinical trial, 7 participants with therapy resistant FM were given IVNT once per week for 8 weeks. Patient's pain levels, fatigue, and activities of daily living were evaluated weekly. All participants reported decreased pain levels, decreased fatigue, and increased activities of daily living. Participants noted increased energy levels within 24-48 hours of the initial infusion. At the end of the study, all participants reported increased energy and activities of daily living as well as a 60% reduction in pain (P=.005) and an 80% decrease in fatigue (P=-.005). No participants, however, reported complete or lasting resolution of pain or fatigue. No side effects were reported. Anecdotal reports have indicated benefit for IVNT for patients with chronic pain, including FM. However, except for 2 reports, the medical literature is devoid of any studies of IVNT for the treatment of FM. In this pilot study, 7 participants received IVNT once a week for 8 weeks. All participants had long-standing FM (at least 8 years) and had tried conventional therapies, such as antidepressants, nonsteroidal anti-inflammatory drugs, and exercise, without significant or lasting relief. All had improvement in symptoms and increases in their activities of daily living, although no participant reported complete resolution of symptoms. IVNT appears to be safe to reduce FM symptoms.

Mirror therapy for distal radial fractures: A pilot randomized controlled study.

PubMed

Bayon-Calatayud, Manuel; Benavente-Valdepeñas, Ana Maria; Del Prado Vazquez-Muñoz, Maria

2016-10-12

To investigate the efficacy of mirror therapy in reducing pain and disability in patients with distal radial fractures. Pilot randomized controlled study. Twenty-two patients with closed distal radial fracture. Patients were randomly assigned to experimental (= 11) or control (= 11) groups. Researchers were blinded to group allocation. Both groups received conventional physiotherapy. In addition, the experimental group had 15 sessions of mirror therapy (a daily session, 30 min). The control group received the same amount of conventional occupational therapy. Assessment was made from baseline to post-treatment. Pain was measured on a visual analogue scale (VAS). Active wrist extension and Quick-DASH (Disabilities of Arm, Shoulder and Hand) were used to assess functional recovery. Pain, disability, and range of motion improved for both groups after intervention. No significant post-treatment differences were found between groups in Quick-DASH (= 0.409), active wrist extension (= 0.191) and VAS scores (= 0.807). There was no significant difference in active wrist extension between groups. Mirror therapy was not superior to conventional occupational therapy in reducing pain and disability.

Internationalization in an Occupational Therapy Curriculum: A Philippine-American Pilot Collaboration.

PubMed

Cabatan, Maria Concepcion C; Grajo, Lenin C

This study is a pilot implementation of an Internationalization at Home (IaH) teaching and learning collaboration to enhance intercultural learning and understanding of concepts of occupation in two cohorts of occupational science and occupational therapy students from the Philippines and the United States. In this collective case study, 149 students (Cohort 1, n = 65; Cohort 2, n = 84) participated. The collaboration included virtual conversations among students, faculty presentations, reflective assignments, and completion of an anonymous online survey. Analysis yielded three essential themes: (1) perception of increased knowledge about human occupation and the influence of culture, (2) identification of teaching-learning aspects that facilitated intercultural learning outcomes, and (3) identification of factors that were enablers of and barriers to learning. This study provides insights on how intercultural learning experiences can be integrated into occupational science and occupational therapy curricula and can increase understanding of concepts related to human occupation. Copyright © 2017 by the American Occupational Therapy Association, Inc.

Aquatic Physical Therapy for Children with Developmental Coordination Disorder: A Pilot Randomized Controlled Trial

ERIC Educational Resources Information Center

Hillier, Susan; McIntyre, Auburn; Plummer, Leanne

2010-01-01

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…

Cognitive therapy for antisocial and borderline personality disorders: single case study series.

PubMed

Davidson, K M; Tyrer, P

1996-09-01

Cognitive therapy for affective disorders has been recently adapted and developed for the treatment of personality disorders. In the present study, a specific and detailed cognitive therapy treatment manual for borderline and antisocial personality disorders was evaluated in a pilot study. The results of a single case series demonstrate that important clinical changes in dysfunctional behaviour and attitudes can be achieved with short-term cognitive therapy in patients with antisocial and borderline personality disorders, although these were not, on the whole, statistically significant.

The effect of music therapy on mood states in neurological patients: a pilot study.

PubMed

Magee, Wendy L; Davidson, Jane W

2002-01-01

Music therapy as a clinical intervention has been demonstrated to improve mood states with a variety of populations, however, this has not yet been shown empirically with participants with neurological impairments. This report presents the results of a pilot study examining the effect of music therapy on moods states in patients with acquired and complex neuro-disabilities. Using a single subject design, pre and post session mood states were measured using the Profile of Mood States (Bipolar form). Analyses examined the main effects of pre/post measures as well as interactions between the specific musical therapeutic intervention, mood state, and diagnosis. Results showed that, in terms of composed-anxious, energetic-tired, and agreeable-hostile mood states, there was a significant difference between pre and post music therapy intervention in a positive direction. Although the study displayed that the benefits of music therapy in treating mood states in this patient group are limited, some of the results were affected by the difficulty of the POMS-BI questionnaire for the subject group. The results are discussed considering methodological improvements and arguing for the inclusion of music therapy as an effective intervention to address negative mood states in neuro-rehabilitation populations.

A Pilot Study of Acceptance and Commitment Therapy as a Workshop Intervention for Body Dissatisfaction and Disordered Eating Attitudes

ERIC Educational Resources Information Center

Pearson, Adria N.; Follette, Victoria M.; Hayes, Steven C.

2012-01-01

Body image dissatisfaction is a source of significant distress among non-eating-disordered women, but because it is subclinical it is generally not treated. It remains stable throughout adulthood, and has proven resistant to many prevention interventions. This study presents a pilot test of a practical alternative: a 1-day Acceptance and…

Cognitive Behavioral Therapy for Depressed Adults with Mild Intellectual Disability: A Pilot Study

ERIC Educational Resources Information Center

Hartley, Sigan L.; Esbensen, Anna J.; Shalev, Rebecca; Vincent, Lori B.; Mihaila, Iulia; Bussanich, Paige

2015-01-01

There is a paucity of research on psychosocial treatments for depression in adults with intellectual disability (ID). In this pilot study, we explored the efficacy of a group CBT treatment that involved a caregiver component in adults with mild ID with a depressive disorder. Sixteen adults with mild ID and a depressive disorder participated in a…

A Pilot Study of the Use of Emerging Computer Technologies to Improve the Effectiveness of Reading and Writing Therapies in Children with Down Syndrome

ERIC Educational Resources Information Center

Felix, Vanessa G.; Mena, Luis J.; Ostos, Rodolfo; Maestre, Gladys E.

2017-01-01

Despite the potential benefits that computer approaches could provide for children with cognitive disabilities, research and implementation of emerging approaches to learning supported by computing technology has not received adequate attention. We conducted a pilot study to assess the effectiveness of a computer-assisted learning tool, named…

Ethnomedicine in healthcare systems of the world: a Semester at Sea pilot survey in 11 countries.

PubMed

Muleady-Mecham, Nancy E; Schley, Stephanie

2009-06-17

An understanding and appreciation for the varied healthcare systems in use throughout the world are increasingly vital for medical personnel as patient populations are now composed of ethnically diverse people with wide-ranging belief systems. While not a statistically valid survey, this pilot study gives a global overview of healthcare differences around the world. A pilot study of 459 individuals from 11 different countries around the world was administered by 33 students in the upper division course, People, Pathology, and World Medicine from Semester at Sea, Fall 2007, to ascertain trends in healthcare therapies. Open-ended surveys were conducted in English, through an interpreter, or in the native language. Western hospital use ranked highly for all countries, while ethnomedical therapies were utilized to a lesser degree. Among the findings, mainland China exhibited the greatest overall percentage of ethnomedical therapies, while the island of Hong Kong, the largest use of Western hospitals. The figures and trends from the surveys suggest the importance of understanding diverse cultural healthcare beliefs when treating individuals of different ethnic backgrounds. The study also revealed the increasingly complex and multisystem-based medical treatments being used internationally.

Complementary therapies in long-stay neurology in-patient settings.

PubMed

Walsh, E; Wilson, C

Complementary therapies have been embraced by many nurses, but the effectiveness of such regimes on the wellbeing of patients has never been researched successfully. This article describes a pilot study which evaluated their effects on long-stay neurology patients.

Changes in Psychological Parameters in Patients with Tension-type Headache Following Massage Therapy: A Pilot Study

PubMed Central

Moraska, Albert; Chandler, Clint

2009-01-01

Investigations into complementary and alternative medicine (CAM) approaches to address stress, depression, and anxiety of those experiencing chronic pain are rare. The objective of this pilot study was to assess the value of a structured massage therapy program, with a focus on myofascial trigger points, on psychological measures associated with tension-type headache. Participants were enrolled in an open-label trial using a baseline control with four 3-week phases: baseline, massage (two 3-week periods) and a follow-up phase. Eighteen subjects with episodic or chronic tension-type headache were enrolled and evaluated at 3-week intervals using the State-Trait Anxiety Inventory, Beck Depression Inventory, and the Perceived Stress Scale. The Daily Stress Inventory was administered over 7-day periods during baseline and the final week of massage. Twice weekly, 45-minute massage therapy sessions commenced following the baseline phase and continued for 6 weeks. A significant improvement in all psychological measures was detected over the timeframe of the study. Post hoc evaluation indicated improvement over baseline for depression and trait anxiety following 6 weeks of massage, but not 3 weeks. A reduction in the number of events deemed stressful as well as their respective impact was detected. This pilot study provides evidence for reduction of affective distress in a chronic pain population, suggesting the need for more rigorously controlled studies using massage therapy to address psychological measures associated with TTH. PMID:20046550

Randomized Controlled Trial of Problem-Solving Therapy for Minor Depression in Home Care

ERIC Educational Resources Information Center

Gellis, Zvi D.; McGinty, Jean; Tierney, Lynda; Jordan, Cindy; Burton, Jean; Misener, Elizabeth

2008-01-01

Objective: Data are presented from a pilot research program initiated to develop, refine, and test the outcomes of problem-solving therapy that targets the needs of older adults with minor depression in home care settings. Method: A pilot randomized clinical trial compares the impact of problem-solving therapy for home care to treatment as usual…

Perceptions among Occupational and Physical Therapy Students of a Nontraditional Methodology for Teaching Laboratory Gross Anatomy

ERIC Educational Resources Information Center

Thomas, K. Jackson; Denham, Bryan E.; Dinolfo, John D.

2011-01-01

This pilot study was designed to assess the perceptions of physical therapy (PT) and occupational therapy (OT) students regarding the use of computer-assisted pedagogy and prosection-oriented communications in the laboratory component of a human anatomy course at a comprehensive health sciences university in the southeastern United States. The…

Play Therapy in Elementary Schools: A Best Practice for Improving Academic Achievement

ERIC Educational Resources Information Center

Blanco, Pedro J.; Ray, Dee C.

2011-01-01

This pilot study of 1st graders who are academically at risk examined the effectiveness of child-centered play therapy (CCPT). The experimental group received biweekly, 30-minute play therapy sessions for 8 weeks. Findings indicated that these 1st graders participating in CCPT (n = 21) demonstrated a statistically significant increase on the Early…

Introduction of Vertical Integration and Case-Based Learning in Anatomy for Undergraduate Physical Therapy and Occupational Therapy Students

ERIC Educational Resources Information Center

Parmar, Suresh K.; Rathinam, Bertha A. D.

2011-01-01

The purpose of the present pilot study was to evaluate the benefits of innovative teaching methodologies introduced to final year occupational and physical therapy students in Christian Medical College in India. Students' satisfactions along the long-term retention of knowledge and clinical application of the respiratory anatomy have been…

A Pilot Randomized Clinical Trial of Intermittent Occlusion Therapy Liquid Crystal Glasses versus Traditional Patching for Treatment of Moderate Unilateral Amblyopia

PubMed Central

Wang, Jingyun; Neely, Daniel E.; Galli, Jay; Schliesser, Joshua; Graves, April; Damarjian, Tina G.; Kovarik, Jessica; Bowsher, James; Smith, Heather A.; Donaldson, Dana; Haider, Kathryn M.; Roberts, Gavin J.; Sprunger, Derek T.; Plager, David A.

2017-01-01

INTRODUCTION This pilot study was designed to compare the effectiveness of intermittent occlusion therapy (IO-Therapy) using liquid crystal glasses versus continuous occlusion therapy using traditional adhesive patches for treating amblyopia. DESIGN A randomized controlled trial. Children 3–8 years of age with previously untreated, moderate, unilateral amblyopia (visual acuity of 20/40 to 20/100 in the amblyopic eye) were enrolled. Amblyopia was associated with strabismus, anisometropia, or both. All subjects had worn optimal refractive correction (if needed) for at least 12 weeks without improvement. Subjects were randomized into two treatment groups: a 4-hour IO-Therapy Group with liquid crystal glasses (Amblyz™), set at 30-second opaque/transparent intervals (occluded 50% of wear time) or a 2-hour continuous Patching Group (occluded 100% of wear time). For each patient, visual acuity was measured with the ATS-HOTV method before and after 12 weeks of treatment. RESULTS At the conclusion of the first 12 week-treatment interval, data from 34 patients were available for analysis. Amblyopic eye visual acuity improvement from baseline was 0.15±0.12 (95% CI=0.09 to 0.15) logMAR in the IO-Therapy Group (N=19) and 0.15±0.11 (95% CI=0.1 to 0.15) logMAR in the Patching Group (N=15). Improvements in both groups were significant. The difference between groups was not statistically significant (P=0.73). No adverse effects were reported. CONCLUSION In this pilot study, IO-Therapy with Amblyz liquid crystal glasses is not inferior to adhesive patching and is a promising alternative treatment for children 3–8 years of age with moderate amblyopia. A larger randomized clinical trial is needed to confirm results in future. PMID:27418249

Oncolytic Sendai Virus Therapy of Canine Mast Cell Tumors (A Pilot Study).

PubMed

Ilyinskaya, Galina V; Mukhina, Elena V; Soboleva, Alesya V; Matveeva, Olga V; Chumakov, Peter M

2018-01-01

Background: Canine mastocytomas (mast cell tumors) represent a common malignancy among many dog breeds. A typical treatment strategy for canine mastocytomas includes surgery, chemo- and radio-therapy, although in many cases the therapy fails and the disease progression resumes. New treatment approaches are needed. Aims: The goal of this pilot study was to examine safety and efficacy of oncolytic Sendai virus therapy administered to canine patients with cutaneous or subcutaneous mastocytomas. Materials and Methods: Six canine patients, with variable grades and stages of the disease, received virus therapy, either as a monotherapy, or in combination with surgery. The therapy included two or more virus applications administered weekly or biweekly. Each application of Sendai virus (10 7 -10 8.6 EID50) consisted of multiple individual 0.01-0.1 ml injections delivered intratumorally, intradermally around a tumor, and under a tumor bed. Results: The treatment was well tolerated, with minor transitory side effects. Of the six dogs, two did not receive surgery or any other treatment besides the virus injections. The other four animals underwent radical or debulking surgeries, and in three of them the subsequent administration of Sendai virus completely cleared locally recurrent or/and remaining tumor masses. Five dogs demonstrated a complete response to the treatment, the animals remained disease free during the time of observation (2-3 years). One dog responded only partially to the virotherapy; its after-surgical recurrent tumor and some, but not all, metastases were cleared. This dog had the most advanced stage of the disease with multiple enlarged lymph nodes and cutaneous metastases. Conclusion: The results of the pilot study suggest that Sendai virus injections could be safe and efficient for the treatment of dogs affected by mastocytomas.They also suggest the need of further studies for finding optimal schemes and schedules for this kind of therapy.

Efficacy of etidronate and sequential monofluorophosphate in severe postmenopausal osteoporosis: a pilot study.

PubMed

Ringe, J D; Dorst, A; Faber, H; Kipshoven, C; Rovati, L C; Setnikar, I

2005-05-01

In a three-year pilot study on 52 women with severe postmenopausal osteoporosis, treatment with etidronate followed by calcium and vitamin D (ECaD) was compared to etidronate followed by monofluorophosphate, calcium and vitamin D (EFCaD). BMD in lumbar spine, total hip and femoral neck increased significantly more with EFCaD than with ECaD. Pain-mobility score decreased significantly more with EFCaD than with ECaD (p=0.006). New vertebral fractures occurred in three patients under EFCaD (12%) and in nine under ECaD (35%), (p=0.048). Three patients under EFCaD (12%) and 15 under ECaD (58%) did not respond to therapy (p of difference=0.001). Mild or moderate adverse reactions were reported by 25 patients, with no significant difference between the two groups. The pilot study suggests that etidronate, sequentially followed by monofluorophosphate, could be a safe, effective and relatively inexpensive therapy in severe postmenopausal osteoporosis.

Efficacy of aquatic therapy for multiple sclerosis: a systematic review.

PubMed

Corvillo, Iluminada; Varela, Enrique; Armijo, Francisco; Alvarez-Badillo, Antonio; Armijo, Onica; Maraver, Francisco

2017-12-01

Multiple sclerosis (MS) is a chronic, inflammatory, progressive, disabling autoimmune disease affecting the central nervous system. Symptoms and signs of MS vary widely and patients may lose their ability to walk. To date the benefits of aquatic therapy often used for rehabilitation in MS patients have not been reviewed. The aim of this study was to systematically review the current state of aquatic treatment for persons with MS (hydrotherapy, aquatic therapy, aquatic exercises, spa therapy) and to evaluate the scientific evidence supporting the benefits of this therapeutic option. The databases PubMed, Scopus, WoS and PEDro were searched to identify relevant reports published from January 1, 2011 to April 30, 2016. Of 306 articles identified, only 10 fulfilled the inclusion criteria: 5 randomized controlled, 2 simple randomized quasi-experimental, 1 semi-experimental, 1 blind controlled pilot and 1 pilot. Evidence that aquatic treatment improves quality of life in affected patients was very good in two studies, good in four, fair in two and weak in two.

Neurophysiological mechanisms in acceptance and commitment therapy in opioid-addicted patients with chronic pain.

PubMed

Smallwood, Rachel F; Potter, Jennifer S; Robin, Donald A

2016-04-30

Acceptance and Commitment Therapy (ACT) has been effectively utilized to treat both chronic pain and substance use disorder independently. Given these results and the vital need to treat the comorbidity of the two disorders, a pilot ACT treatment was implemented in individuals with comorbid chronic pain and opioid addiction. This pilot study supported using neurophysiology to characterize treatment effects and revealed that, following ACT, participants with this comorbidity exhibited reductions in brain activation due to painful stimulus and in connectivity at rest. Copyright © 2016 Elsevier Ireland Ltd. All rights reserved.

Comparative effectiveness and cost-effectiveness of Chuna manual therapy versus conventional usual care for nonacute low back pain: study protocol for a pilot multicenter, pragmatic randomized controlled trial (pCRN study).

PubMed

Shin, Byung-Cheul; Kim, Me-Riong; Cho, Jae-Heung; Jung, Jae-Young; Kim, Koh-Woon; Lee, Jun-Hwan; Nam, Kibong; Lee, Min Ho; Hwang, Eui-Hyoung; Heo, Kwang-Ho; Kim, Namkwen; Ha, In-Hyuk

2017-01-17

While Chuna manual therapy is a Korean manual therapy widely used primarily for low back pain (LBP)-related disorders in Korea, well-designed studies on the comparative effectiveness of Chuna manual therapy are scarce. This study is the protocol for a three-armed, multicenter, pragmatic randomized controlled pilot trial. Sixty severe nonacute LBP patients (pain duration of at least 3 weeks, Numeric Rating Scale (NRS) ≥5) will be recruited at four Korean medicine hospitals. Participants will be randomly allocated to the Chuna group (n = 20), usual care group (n = 20), or Chuna plus usual care group (n = 20) for 6 weeks of treatment. Usual care will consist of orally administered conventional medicine, physical therapy, and back pain care education. The trial will be conducted with outcome assessor and statistician blinding. The primary endpoint will be NRS of LBP at week 7 post randomization. Secondary outcomes include NRS of leg pain, the Oswestry Disability Index (ODI), the Patient Global Impression of Change (PGIC), the Credibility and Expectancy Questionnaire, lumbar range of motion (ROM), the EuroQol-5 Dimension (EQ-5D) health survey, the Health Utility Index III (HUI-III), and economic evaluation and safety data. Post-treatment follow-ups will be conducted at 1, 4, and 10 weeks after conclusion of treatment. This study will assess the comparative effectiveness of Chuna manual therapy compared to conventional usual care. Costs and effectiveness (utility) data will be analyzed for exploratory cost-effectiveness analysis. If this pilot study does not reach a definite conclusion due to its small sample size, these results will be used as preliminary results to calculate sample size for future large-scale clinical trials and contribute in the assessment of feasibility of a full-scale multicenter trial. Clinical Research Information Service (CRIS), KCT0001850 . Registered on 17 March 2016.

Teaching Evidence-Based Practice across Curricula-An Overview of a Professional Development Course for Occupational Therapy Educators.

PubMed

Daly, Marta M; DeAngelis, Tina M

2017-01-01

A professional development course for occupational therapy educators about teaching evidence-based practice (EBP) was developed and piloted. The course was developed to promote increased awareness of resources and methods for teaching EBP that are applicable across entry-level curricula. Participants included full-time faculty (n = 7) from one entry-level occupational therapy program in the New York City area. The results of the pilot informed refinement of the course in preparation for delivery to a wider audience of educators. This paper provides a description of the course, results of the pilot, and implications for future delivery of the course.

Pilot clinical study of boron neutron capture therapy for recurrent hepatic cancer involving the intra-arterial injection of a (10)BSH-containing WOW emulsion.

PubMed

Yanagie, Hironobu; Higashi, Syushi; Seguchi, Koji; Ikushima, Ichiro; Fujihara, Mituteru; Nonaka, Yasumasa; Oyama, Kazuyuki; Maruyama, Syoji; Hatae, Ryo; Suzuki, Minoru; Masunaga, Shin-ichiro; Kinashi, Tomoko; Sakurai, Yoshinori; Tanaka, Hiroki; Kondo, Natsuko; Narabayashi, Masaru; Kajiyama, Tetsuya; Maruhashi, Akira; Ono, Koji; Nakajima, Jun; Ono, Minoru; Takahashi, Hiroyuki; Eriguchi, Masazumi

2014-06-01

A 63-year-old man with multiple HCC in his left liver lobe was enrolled as the first patient in a pilot study of boron neutron capture therapy (BNCT) involving the selective intra-arterial infusion of a (10)BSH-containing water-in-oil-in-water emulsion ((10)BSH-WOW). The size of the tumorous region remained stable during the 3 months after the BNCT. No adverse effects of the BNCT were observed. The present results show that (10)BSH-WOW can be used as novel intra-arterial boron carriers during BNCT for HCC. Copyright © 2014 Elsevier Ltd. All rights reserved.

Changes in Trunk and Head Stability in Children with Cerebral Palsy after Hippotherapy: A Pilot Study

ERIC Educational Resources Information Center

Shurtleff, Tim L.; Engsberg, Jack R.

2010-01-01

Hippotherapy (HPOT) is a therapy that uses horse movement. This pilot investigation objectively evaluated the efficacy of HPOT in improving head/trunk stability in children with cerebral palsy (CP). The participants were six children with spastic diplegia and six children without disability. Head and trunk stability was challenged by using a…

Healing pathways: art therapy for American Indian cancer survivors.

PubMed

Warson, Elizabeth

2012-04-01

There is a paucity of research addressing quality of life factors for American Indian and Alaska Native cancer survivors. Complementary forms of therapy, such as art therapy, are beginning to address quality of life factors through the "healing" arts for cancer survivors. The purpose of this mixed methods pilot was to explore the effects of culturally relevant art interventions on stress reduction for American Indian cancer survivors and their family members. Forty-six adult participants attended one of three workshops held within two settlements of the Coharie tribe and one southeastern urban tribal center. The data collected consisted of a pretest and posttest State-Trait Personality Inventory (STPI) and artwork resulting from three directed interventions. The artwork was analyzed using qualitative coding methods; however, the scores from the STPI were inconclusive because the inventory was determined to be culturally biased. While statistical significance was not achieved, the findings from qualitative coding reinforced a native concept of wellness focusing on the complex interaction between mind, body, spirit, and context. This pilot study also demonstrated how a community-driven approach was instrumental in the development of the overall workshop format. An expansion of the pilot study is also presented with preliminary results available in 2012.

Singing in groups for Parkinson's disease (SING-PD): a pilot study of group singing therapy for PD-related voice/speech disorders.

PubMed

Shih, Ludy C; Piel, Jordan; Warren, Amanda; Kraics, Lauren; Silver, Althea; Vanderhorst, Veronique; Simon, David K; Tarsy, Daniel

2012-06-01

Parkinson's disease related speech and voice impairment have significant impact on quality of life measures. LSVT(®)LOUD voice and speech therapy (Lee Silverman Voice Therapy) has demonstrated scientific efficacy and clinical effectiveness, but musically based voice and speech therapy has been underexplored as a potentially useful method of rehabilitation. We undertook a pilot, open-label study of a group-based singing intervention, consisting of twelve 90-min weekly sessions led by a voice and speech therapist/singing instructor. The primary outcome measure of vocal loudness as measured by sound pressure level (SPL) at 50 cm during connected speech was not significantly different one week after the intervention or at 13 weeks after the intervention. A number of secondary measures reflecting pitch range, phonation time and maximum loudness also were unchanged. Voice related quality of life (VRQOL) and voice handicap index (VHI) also were unchanged. This study suggests that a group singing therapy intervention at this intensity and frequency does not result in significant improvement in objective and subject-rated measures of voice and speech impairment. Copyright © 2012 Elsevier Ltd. All rights reserved.

Greater than 95% success with 14-day bismuth quadruple anti- Helicobacter pylori therapy: a pilot study in US Hispanics.

PubMed

Salazar, Cesar O; Cardenas, Victor M; Reddy, Rita K; Dominguez, Delfina C; Snyder, Lindsey K; Graham, David Y

2012-10-01

A combination capsule of bismuth, metronidazole, and tetracycline plus omeprazole given as 10-day therapy has an overall effectiveness of 92-93% in per-protocol analysis (Grade B) with eradication of 86-91% of metronidazole-resistant Helicobacter pylori. This study aimed to explore whether extending the duration to 14 days would improve overall effectiveness per protocol to ≥95% (Grade A) in a population in which metronidazole resistance was anticipated to exist. A one-arm, open-label pilot study of H. pylori-infected, asymptomatic/mildly dyspeptic adults, Hispanic residents of El Paso, Texas, received a 14-day course of omeprazole, plus the combination capsule. We cultured and Gram-stained specimens obtained using a minimally invasive orogastric brush. Helicobacter pylori status was determined by (13)C-urea breath test at 4 or more weeks post-therapy. Forty-seven subjects (7 men and 40 women, average age 42 years) were entered. The per-protocol effectiveness was 97.1% (33/34) (95% mid-P CI: 86.3, 99.9); 100% of metronidazole-resistant strains were eradicated. Side effects were mild and self-limited but contributed to nonadherence. Therapy taken for <10 days was more likely to result in eradication failure (p < .001). Office-based orogastric brushing was well tolerated; positive cultures were obtained in 95%. Gram staining showed H. pylori-like forms in all specimens. This pilot study supports the concept that 14-day OBMT therapy is likely to be more efficacious for H. pylori eradication (Grade A, PP basis) than a 10-day course where metronidazole resistance is suspected. If confirmed, 14 days should be recommended in populations where metronidazole resistance is common. © 2012 Blackwell Publishing Ltd.

Cognitive Behavioral Therapy Using a Mobile Application Synchronizable With Wearable Devices for Insomnia Treatment: A Pilot Study

PubMed Central

Kang, Seung-Gul; Kang, Jae Myeong; Cho, Seong-Jin; Ko, Kwang-Pil; Lee, Yu Jin; Lee, Heon-Jeong; Kim, Leen; Winkelman, John W.

2017-01-01

Study Objectives: The use of telemedicine with a mobile application (MA) and a wearable device (WD) for the management of sleep disorders has recently received considerable attention. We designed an MA synchronizable with a WD for insomnia treatment. Our pilot study determined the efficacy of simplified group cognitive behavioral therapy for insomnia (CBT-I) delivered using our MA and assessed participant adherence to and satisfaction with the device. Methods: The efficacy of the CBT-I using MA (CBT-I-MA) was assessed by comparing sleep variables (sleep efficiency [SE], Insomnia Severity Index [ISI], and Pittsburgh Sleep Quality Inventory [PSQI] scores) before and after a 4-week treatment protocol in 19 patients with insomnia disorder patients. SE was assessed using a sleep diary, actigraphy, and the PSQI. Results: The intervention significantly improved all three measures of SE (P < .05), and the response rate to treatment was high (94.7%). Total ISI and PSQI scores and sleep latency, as measured by the sleep diary, improved significantly. Participants showed relatively good adherence to our MA, and sleep diary entries were made on 24.3 ± 3.8 of 28 days. Moreover, 94.7% of the participants reported that our MA was effective for treating insomnia. Conclusions: Our pilot study suggested the clinical usefulness of a CBT-I-MA. We expect that our findings will lead to further development and replication studies of CBT-I-MA. Citation: Kang SG, Kang JM, Cho SJ, Ko KP, Lee YJ, Lee HJ, Kim L, Winkelman JW. Cognitive behavioral therapy using a mobile application synchronizable with wearable devices for insomnia treatment: a pilot study. J Clin Sleep Med. 2017;13(4):633–640. PMID:28162145

The effect of traditional wet cupping on shoulder pain and neck pain: A pilot study.

PubMed

Arslan, Müzeyyen; Gökgöz, Nurcan; Dane, Şenol

2016-05-01

Wet cupping therapy (WCT) is a traditional complementary method recommended to decrease the symptoms of a lot of diseases and used in the treatment of pain syndromes. In this pilot study, the possible effects of wet cupping therapy on nonspecific neck and upper shoulder pain were investigated. Sixty one eligible volunteer participants with nonspecific neck and upper shoulder pain for at least 3 months were allocated. The Numeric Rating Scale (NRS) was used to assess pain scores. Pain scores were recorded before and after wet cupping therapy. The mean scores of neck pain in study group were 7.02 (SD = 1.8) before and 3.70 (SD = 2.2) after cupping therapy. The decrease of pain scores between pre- and post-test was statistically significant (p < 0.05). It can be stated that WCT has potential therapeutic effect in nonspecific neck and upper shoulder pain. Future full-scale randomized controlled trials will be needed to provide firm evidence of the effectiveness of this intervention. Copyright © 2016 Elsevier Ltd. All rights reserved.

The Efficacy of Dog Assisted Therapy in Detained Drug Users: A Pilot Study in an Italian Attenuated Custody Institute

PubMed Central

Toson, Marica; Montanaro, Maria; Farina, Luca; Costa, Aldo; Nava, Felice Alfonso

2017-01-01

Drug addiction is a major care and safety challenge in prison context. Nowadays, rehabilitation and specific therapeutic programs are suggested to improve health and well-being of inmates during their detention time and to reduce substance abuse relapse after release from prison. Among these programs, several studies reported the benefits for inmates coming from animal assisted interventions. In this pilot controlled study, we investigated the efficacy of a dog assisted therapy program addressed to 22 drug addicted male inmates housed in an attenuated custody institute in Italy. The study lasted six months, the treated group (12 inmates) was involved once a week for one hour in 20 dog assisted therapy sessions, whereas the control group (10 inmates) followed the standard rehabilitation program. One week before the beginning and one week after the end of the sessions, all inmates involved were submitted to symptom checklist-90-revised and Kennedy axis V. Inmates involved in the dog assisted therapy sessions significantly improved their social skills, reducing craving, anxiety and depression symptoms compared to the control group. Despite the limitation due to the small number of inmates enrolled and to the absence of follow up, we found these results encouraging to the use of dog assisted therapy as co-therapy in drug addicted inmates rehabilitation programs, and we claim the need of more extensive study on this subject. PMID:28672787

The Efficacy of Dog Assisted Therapy in Detained Drug Users: A Pilot Study in an Italian Attenuated Custody Institute.

PubMed

Contalbrigo, Laura; De Santis, Marta; Toson, Marica; Montanaro, Maria; Farina, Luca; Costa, Aldo; Nava, Felice Alfonso

2017-06-24

Drug addiction is a major care and safety challenge in prison context. Nowadays, rehabilitation and specific therapeutic programs are suggested to improve health and well-being of inmates during their detention time and to reduce substance abuse relapse after release from prison. Among these programs, several studies reported the benefits for inmates coming from animal assisted interventions. In this pilot controlled study, we investigated the efficacy of a dog assisted therapy program addressed to 22 drug addicted male inmates housed in an attenuated custody institute in Italy. The study lasted six months, the treated group (12 inmates) was involved once a week for one hour in 20 dog assisted therapy sessions, whereas the control group (10 inmates) followed the standard rehabilitation program. One week before the beginning and one week after the end of the sessions, all inmates involved were submitted to symptom checklist-90-revised and Kennedy axis V. Inmates involved in the dog assisted therapy sessions significantly improved their social skills, reducing craving, anxiety and depression symptoms compared to the control group. Despite the limitation due to the small number of inmates enrolled and to the absence of follow up, we found these results encouraging to the use of dog assisted therapy as co-therapy in drug addicted inmates rehabilitation programs, and we claim the need of more extensive study on this subject.

"Thank You, Sorry, Love" (TSL) Therapy with North Korean Refugee Women: A Pilot Study

ERIC Educational Resources Information Center

Kim, Hee Jin; Kim, Jae Yop; Kim, Dong Goo

2016-01-01

Objectives: This study was designed to evaluate the effectiveness of The "Thank You, Sorry, Love" (TSL) family therapy program in potentially improving the marital relationships and health of North Korean refugee women. Methods: The participants included 12 married North Korean female refugees in their 20s to 40s. Using a blinded…

Educational Applications of Vision Therapy: A Pilot Study on Children with Autism.

ERIC Educational Resources Information Center

Lovelace, Kelly; Rhodes, Heidi; Chambliss, Catherine

This report discusses the outcomes of a study that explored the feasibility of using vision therapy (VT) as part of an interdisciplinary approach to the education of children with autism. Traditional research on VT has explored its usefulness in helping patients to use both eyes together, improve depth perception, and enhance visual acuity.…

Two-Day, Intensive Cognitive-Behavioral Therapy for Panic Disorder: A Case Study

ERIC Educational Resources Information Center

Deacon, Brett

2007-01-01

Cognitive-behavioral therapy (CBT) is a highly effective treatment for panic disorder. However, few patients have access to this treatment, particularly those living in rural areas. In a pilot study, the author previously described the efficacy of a 2-day, intensive, exposure-based CBT intervention that was developed for the purpose of delivering…

The Effect of Cognitive Behavior Therapy on Decision Making in Adolescents Who Self-Harm: A Pilot Study

ERIC Educational Resources Information Center

Oldershaw, Anna; Simic, Mima; Grima, Emanuela; Jollant, Fabrice; Richards, Clair; Taylor, Lucy; Schmidt, Ulrike

2012-01-01

Research shows poor decision making in adolescents who self-harm and a positive correlation between decision-making abilities and duration since last self-harm episode. This exploratory study investigated whether decision making in self-harming adolescents could be improved through treatment with a novel cognitive behavior therapy (CBT). It also…

A Brief Cognitive Behavioural Therapy Psychoeducational Group for Chinese People with Chronic Illnesses: An Evaluation Study

ERIC Educational Resources Information Center

Wong, Daniel F. K.; Ip, Priscilla S. Y.; Lee, Kim Man

2017-01-01

This pilot study attempted to examine the effectiveness of a brief cognitive behavioural therapy (CBT) psychoeducational group for Chinese people with chronic illness in Hong Kong. It adopted a single group design, and 52 participants joined the group. A questionnaire with three outcome measures, measuring general mental health, quality of life…

A pilot study to improve adherence among MS patients who discontinue treatment against medical advice.

PubMed

Bruce, Jared; Bruce, Amanda; Lynch, Sharon; Strober, Lauren; O'Bryan, Sean; Sobotka, Deborah; Thelen, Joan; Ness, Abigail; Glusman, Morgan; Goggin, Kathy; Bradley-Ewing, Andrea; Catley, Delwyn

2016-04-01

Between 30 and 50% of MS patients may prematurely discontinue disease modifying therapies. Little research has examined how to best talk with patients who have discontinued treatment against medical advice. The aim of this pilot study was to determine whether telephone counseling increases disease modifying therapy (DMT) re-initiation among nonadherent patients with multiple sclerosis (MS). Participants were eligible if they had relapsing-remitting disease, had stopped taking a DMT, and had no plan to re-initiate treatment despite a provider recommendation. Following a baseline assessment, 81 patients were randomly assigned to either five 20 min, weekly sessions of Motivational Interviewing/Cognitive Behavioral Therapy (MI-CBT) or Treatment as Usual (TAU) with brief education. At 10 weeks, patients initially assigned to TAU switched over to MI-CBT. Compared to patients in the TAU group, patients undergoing MI-CBT were significantly more likely to indicate they were re-initiating DMT (41.7 vs. 14.3%). These significant results were replicated among patients crossing over from TAU to MI-CBT. Treatment satisfaction was high, with 97% of participants reporting that they would recommend MI-CBT to other patients with MS. Results of this pilot study provide initial support for the use of MI-CBT among MS patients who have discontinued treatment against medical advice.Clinicaltrials.gov: NCT01925690.

Recruitment and accrual of women in a placebo-controlled clinical pilot study on manual therapy.

PubMed

Cambron, Jerrilyn A; Hawk, Cheryl; Evans, Roni; Long, Cynthia R

2004-06-01

To investigate the accrual rates and recruitment processes among 3 Midwestern sites during a pilot study on manual therapy for chronic pelvic pain. Multisite pilot study for a randomized, placebo-controlled clinical trial. Three chiropractic institutions in or near major metropolitan cities in the Midwestern United States. Thirty-nine women aged 18 to 45 with chronic pelvic pain of at least 6 months duration, diagnosed by a board certified gynecologist. The method of recruitment was collected for each individual who responded to an advertisement and completed an interviewer-administered telephone screen. Participants who were willing and eligible after 3 baseline visits were entered into a randomized clinical trial. The number of responses and accrual rates were determined for the overall study, each of the 3 treatment sites, and each of the 5 recruitment efforts. In this study, 355 women were screened over the telephone and 39 were randomized, making the rate of randomization approximately 10%. The most effective recruitment methods leading to randomization were direct mail (38%) and radio advertisements (34%). However, success of the recruitment process differed by site. Based on the accrual of this multisite pilot study, a full-scale trial would not be feasible using this study's parameters. However, useful information was gained on recruitment effectiveness, eligibility criteria, and screening protocols among the 3 metropolitan sites.

The Development of a Mindfulness-Based Music Therapy (MBMT) Program for Women Receiving Adjuvant Chemotherapy for Breast Cancer

PubMed Central

Lesiuk, Teresa

2016-01-01

Problems with attention and symptom distress are common clinical features reported by women who receive adjuvant chemotherapy for breast cancer. Mindfulness practice significantly improves attention and mindfulness programs significantly reduce symptom distress in patients with cancer, and, more specifically, in women with breast cancer. Recently, a pilot investigation of a music therapy program, built on core attitudes of mindfulness practice, reported significant benefits of enhanced attention and decreased negative mood and fatigue in women with breast cancer. This paper delineates the design and development of the mindfulness-based music therapy (MBMT) program implemented in that pilot study and includes clients’ narrative journal responses. Conclusions and recommendations, including recommendation for further exploration of the function of music in mindfulness practice are provided. PMID:27517966

Anatomy in Occupational Therapy Program Curriculum: Practitioners' Perspectives

ERIC Educational Resources Information Center

Schofield, Katherine Anne

2014-01-01

Anatomy education is undergoing significant transformation. It is unknown whether changes are in accordance with occupational therapy (OT) practice needs. The purpose of this pilot study was to survey OT clinicians to determine their perspectives on the value of anatomy in OT curricula, and anatomical knowledge required for practice. In addition…

Modular Cognitive-Behavioral Therapy for Body Dysmorphic Disorder

ERIC Educational Resources Information Center

Wilhelm, Sabine; Phillips, Katharine A.; Fama, Jeanne M.; Greenberg, Jennifer L.; Steketee, Gail

2011-01-01

This study pilot tested a newly developed modular cognitive-behavioral therapy (CBT) treatment manual for body dysmorphic disorder (BDD). We tested feasibility, acceptability, and treatment outcome in a sample of 12 adults with primary BDD. Treatment was delivered in weekly individual sessions over 18 or 22 weeks. Standardized clinician ratings…

Guide Book for an Approved School of Inhalation Therapy.

ERIC Educational Resources Information Center

American Society of Anesthesiologists, Park Ridge, IL.

The "essentials" for programs in inhalation therapy were studied by the American Society of Anesthesiologists and the American College of Chest Physicians and adopted by several pilot schools between 1957 and 1962. Recommended with minor modifications, they were approved by the American Medical Association Council on Medical Education and the…

Rehabilitation robotics: pilot trial of a spatial extension for MIT-Manus

PubMed Central

Krebs, Hermano I; Ferraro, Mark; Buerger, Stephen P; Newbery, Miranda J; Makiyama, Antonio; Sandmann, Michael; Lynch, Daniel; Volpe, Bruce T; Hogan, Neville

2004-01-01

Background Previous results with the planar robot MIT-MANUS demonstrated positive benefits in trials with over 250 stroke patients. Consistent with motor learning, the positive effects did not generalize to other muscle groups or limb segments. Therefore we are designing a new class of robots to exercise other muscle groups or limb segments. This paper presents basic engineering aspects of a novel robotic module that extends our approach to anti-gravity movements out of the horizontal plane and a pilot study with 10 outpatients. Patients were trained during the initial six-weeks with the planar module (i.e., performance-based training limited to horizontal movements with gravity compensation). This training was followed by six-weeks of robotic therapy that focused on performing vertical arm movements against gravity. The 12-week protocol includes three one-hour robot therapy sessions per week (total 36 robot treatment sessions). Results Pilot study demonstrated that the protocol was safe and well tolerated with no patient presenting any adverse effect. Consistent with our past experience with persons with chronic strokes, there was a statistically significant reduction in tone measurement from admission to discharge of performance-based planar robot therapy and we have not observed increases in muscle tone or spasticity during the anti-gravity training protocol. Pilot results showed also a reduction in shoulder-elbow impairment following planar horizontal training. Furthermore, it suggested an additional reduction in shoulder-elbow impairment following the anti-gravity training. Conclusion Our clinical experiments have focused on a fundamental question of whether task specific robotic training influences brain recovery. To date several studies demonstrate that in mature and damaged nervous systems, nurture indeed has an effect on nature. The improved recovery is most pronounced in the trained limb segments. We have now embarked on experiments that test whether we can continue to influence recovery, long after the acute insult, with a novel class of spatial robotic devices. This pilot results support the pursuit of further clinical trials to test efficacy and the pursuit of optimal therapy following brain injury. PMID:15679916

Rehabilitation robotics: pilot trial of a spatial extension for MIT-Manus.

PubMed

Krebs, Hermano I; Ferraro, Mark; Buerger, Stephen P; Newbery, Miranda J; Makiyama, Antonio; Sandmann, Michael; Lynch, Daniel; Volpe, Bruce T; Hogan, Neville

2004-10-26

BACKGROUND: Previous results with the planar robot MIT-MANUS demonstrated positive benefits in trials with over 250 stroke patients. Consistent with motor learning, the positive effects did not generalize to other muscle groups or limb segments. Therefore we are designing a new class of robots to exercise other muscle groups or limb segments. This paper presents basic engineering aspects of a novel robotic module that extends our approach to anti-gravity movements out of the horizontal plane and a pilot study with 10 outpatients. Patients were trained during the initial six-weeks with the planar module (i.e., performance-based training limited to horizontal movements with gravity compensation). This training was followed by six-weeks of robotic therapy that focused on performing vertical arm movements against gravity. The 12-week protocol includes three one-hour robot therapy sessions per week (total 36 robot treatment sessions). RESULTS: Pilot study demonstrated that the protocol was safe and well tolerated with no patient presenting any adverse effect. Consistent with our past experience with persons with chronic strokes, there was a statistically significant reduction in tone measurement from admission to discharge of performance-based planar robot therapy and we have not observed increases in muscle tone or spasticity during the anti-gravity training protocol. Pilot results showed also a reduction in shoulder-elbow impairment following planar horizontal training. Furthermore, it suggested an additional reduction in shoulder-elbow impairment following the anti-gravity training. CONCLUSION: Our clinical experiments have focused on a fundamental question of whether task specific robotic training influences brain recovery. To date several studies demonstrate that in mature and damaged nervous systems, nurture indeed has an effect on nature. The improved recovery is most pronounced in the trained limb segments. We have now embarked on experiments that test whether we can continue to influence recovery, long after the acute insult, with a novel class of spatial robotic devices. This pilot results support the pursuit of further clinical trials to test efficacy and the pursuit of optimal therapy following brain injury.

Suggested early onset of true action of antidepressant drugs may be artefactual: a heuristic study.

PubMed

Parker, Gordon; Paterson, Amelia; Blanch, Bianca

2013-01-01

In recent decades, there have been many studies reporting that antidepressants have a rapid onset of action, with improvement occurring in the first week. The current pilot study questions whether such findings reflect an artefact emerging from high rates of 'nonspecific' improvement and evaluates the phenomenon in a small sample of melancholic patients seemingly lacking nonspecific improvement propensities. Twenty-nine patients with a well-defined melancholic depression completed a 12-week treatment study comparing drug therapy versus cognitive behaviour therapy. The primary outcome measure was the Hamilton Rating Scale for Depression, and a self-report measure of depressed mood severity (the Daily Rating Scale) was completed daily. Analyses seeking time till onset of action were limited to those receiving drug therapies. The lack of improvement in the first 4 weeks for those receiving cognitive behaviour therapy argued for the melancholic patients lacking the capacity for a nonspecific response to therapy. Formal 12-week responder status in those receiving the antidepressant could not be predicted from improvement status until day 12 of the study, and not in the first week as reported in most previous studies of those with major depression. This pilot study argues for any study seeking to quantify the specific interval for onset of action of antidepressant drugs focusing on only those with well-defined melancholia.

Preschool Based JASPER Intervention in Minimally Verbal Children with Autism: Pilot RCT

ERIC Educational Resources Information Center

Goods, Kelly Stickles; Ishijima, Eric; Chang, Ya-Chih; Kasari, Connie

2013-01-01

In this pilot study, we tested the effects of a novel intervention (JASPER, Joint Attention Symbolic Play Engagement and Regulation) on 3 to 5 year old, minimally verbal children with autism who were attending a non-public preschool. Participants were randomized to a control group (treatment as usual, 30 h of ABA-based therapy per week) or a…

Intravenous Lipid Emulsion Therapy Does Not Improve Hypotension Compared to Sodium Bicarbonate for Tricyclic Antidepressant Toxicity: A Randomized, Controlled Pilot Study in a Swine Model

DTIC Science & Technology

2014-11-01

ORIGINAL CONTRIBUTION Intravenous Lipid Emulsion Therapy Does Not Improve Hypotension Compared to Sodium Bicarbonate for Tricyclic Antidepressant...and chronic pain. Intravenous lipid emulsion (ILE) is a recent antidote for lipophilic drug overdose with unclear effectiveness. ILE has been studied in...Intravenous Lipid Emulsion Therapy Does Not Improve Hypotension Compared to Sodium Bicarbonate for Tricyclic Antidepressant Toxicity: A Randomized, Controlled

Aquatic therapy versus conventional land-based therapy for Parkinson's disease: an open-label pilot study.

PubMed

Vivas, Jamile; Arias, Pablo; Cudeiro, Javier

2011-08-01

To assess and compare 2 different protocols of physiotherapy (land or water therapy) for people with Parkinson's disease (PD) focused on postural stability and self-movement, and to provide methodological information regarding progression within the program for a future larger trial. Randomized, controlled, open-label pilot trial. Outpatients, Parkinson's disease Center of Ferrol-Galicia (Spain). Individuals (N=11) with idiopathic PD in stages 2 or 3 according to the Hoehn and Yahr Scale completed the investigation (intervention period plus follow-up). After baseline evaluations, participants were randomly assigned to a land-based therapy (active control group) or a water-based therapy (experimental group). Participants underwent individual sessions for 4 weeks, twice a week, for 45 minutes per session. Both interventions were matched in terms of exercise features, which were structured in stages with clear objectives and progression criteria to pass to the next phase. Participants underwent a first baseline assessment, a posttest immediately after 4 weeks of intervention, and a follow-up assessment after 17 days. Evaluations were performed OFF-dose after withholding medication for 12 hours. Functional assessments included the Functional Reach Test (FRT), the Berg Balance Scale (BBS), the UPDRS, the 5-m walk test, and the Timed Up and Go test. A main effect of both therapies was seen for the FRT. Only the aquatic therapy group improved in the BBS and the UPDRS. In this pilot study, physiotherapy protocols produced improvement in postural stability in PD that was significantly larger after aquatic therapy. The intervention protocols are shown to be feasible and seem to be of value in amelioration of postural stability-related impairments in PD. Some of the methodological aspects detailed here can be used to design larger controlled trials. Copyright © 2011 American Congress of Rehabilitation Medicine. Published by Elsevier Inc. All rights reserved.

A pilot trial of a telecommunications system in sleep apnea management.

PubMed

DeMolles, Deborah A; Sparrow, David; Gottlieb, Daniel J; Friedman, Robert

2004-08-01

Continuous positive airway pressure (CPAP) is an effective therapy for obstructive sleep apnea syndrome (OSAS), although many patients have difficulty adhering to this therapy. The purpose of this study was to investigate the effectiveness of totally automated telephone technology in improving adherence to prescribed CPAP therapy. This pilot study was a randomized clinical trial in 30 patients being started on CPAP therapy for OSAS. Patients were randomly assigned to use of a computer telephone system designed to improve CPAP adherence (telephone-linked communications for CPAP [TLC-CPAP]) in addition to usual care (n = 15) or to usual care alone (n = 15) for a period of 2 months. TLC-CPAP is a computer-based system that monitors patients' self-reported behavior and provides education and reinforcement through a structured dialogue. A sleep symptoms checklist and the Functional Outcomes of Sleep Questionnaire were administered at study entry and at 2-month follow up. Hours of CPAP use at effective mask pressure were measured by the CPAP device, stored in its memory, and retrieved at the 2-month visit. At 2 months, patients randomized to TLC-CPAP had fewer reported sleep-related symptoms (9.4 vs. 13.4, P = 0.047) than those receiving usual care. The average nightly CPAP use in the TLC-CPAP group was 4.4 hours compared with 2.9 hours (P = 0.076) in the usual-care group. This pilot study suggests that patients with OSAS started on CPAP and a concurrently administered automated education and counseling system had better CPAP adherence and better control of OSAS symptoms.

Extracorporeal shockwave therapy in calcifying tendinitis of the shoulder.

PubMed

Farr, Sebastian; Sevelda, Florian; Mader, Patrick; Graf, Alexandra; Petje, Gert; Sabeti-Aschraf, Manuel

2011-12-01

Strategies for extracorporeal shockwave therapy in calcifying tendinitis of the rotator cuff vary concerning quantity of sessions and doses. The purpose of this prospective pilot study was to determine the difference between the outcome of a single high-dosage extracorporeal shockwave therapy and two sessions of low-dosage extracorporeal shockwave therapy. This study compared a single high-level middle-energetic extracorporeal shockwave therapy (0.3 mJ/mm(2)) with a low-level middle-energetic extracorporeal shockwave therapy applied twice in a weekly interval (0.2 mJ/mm(2)). Thirty patients that suffered from calcifying tendinitis for at least 6 months received navigated, fluoroscopy-guided extracorporeal shockwave therapy. The gain of Constant Murley Score, Visual Analogue Scale during state of rest and weight-bearing situations ("stress") and radiographic progress was documented 6 and 12 weeks after therapy. In both groups, a significant reduction in pain during stress and improvement of function was observed. In contrast, no significant reduction in pain during rest was observed. No significant difference between both groups concerning reduction in the calcific deposit after 6 weeks was detected. Group B showed minor advantages in radiographical improvement after 12 weeks. In 36% of the patients, the calcific deposit completely dissoluted after 12 weeks. This pilot study indicates that a single high-level extracorporeal shockwave therapy may be as effective as two applications of a lower-dosed extracorporeal shockwave therapy for calcifying tendinitis. An effective single-session strategy could reduce treatment time, material costs and healthcare expenses and ionizing radiation in case of fluoroscopy guidance.

A pilot study of factors associated with glycaemic control in adults with Type 1 diabetes mellitus on insulin pump therapy.

PubMed

Wen, W; Frampton, R; Wright, K; Fattore, S; Shadbolt, B; Perampalam, S

2016-02-01

To identify the knowledge and management factors associated with glycaemic control among adults with Type 1 diabetes mellitus treated with insulin pump therapy. A cross-sectional study of adults with Type 1 diabetes mellitus on insulin pump therapy for at least 12 months (n = 50, 18-70 years old) was undertaken between December 2013 and May 2014. A new questionnaire was developed to evaluate participants' knowledge and management related to insulin pump therapy, and were correlated with insulin pump data, HbA1c and frequency of hypoglycaemia. Participants who changed their insulin pump settings when indicated had significantly better glycaemic control than those who did not (P = 0.04). Multivariate logistic regression analysis found that better overall insulin pump therapy management was a significant predictor of better glycaemic control (odds ratio 4.45, 95% confidence interval 1.61-12.3; P = 0.004) after adjusting for potential confounders including age, gender, duration of diabetes and insulin pump therapy. However, overall insulin pump therapy knowledge was not a significant predictor of glycaemic control (P = 0.058). There was no significant association between frequency of hypoglycaemia and insulin pump therapy knowledge or management. We identified some key knowledge and management factors associated with glycaemic control in adults with Type 1 diabetes mellitus on insulin pump therapy using a newly designed questionnaire. The pilot study assessed the clinical utility of this evaluation tool, which may facilitate provision of targeted education to insulin pump therapy users to achieve optimal glycaemic control. © 2015 The Authors. Diabetic Medicine © 2015 Diabetes UK.

Lessons Learned From a Pilot RCT of Simultaneous Versus Delayed Initiation of Continuous Glucose Monitoring in Children and Adolescents With Type 1 Diabetes Starting Insulin Pump Therapy

PubMed Central

Olivier, Patricia; Huot, Celine; Richardson, Christine; Nakhla, Meranda; Romain, Judette

2014-01-01

Uncertainty remains about effectiveness of continuous glucose monitoring (CGM) in pediatric type 1 diabetes (T1D). Success with CGM is related to CGM adherence, which may relate to readiness to make the behavior changes required for effective use. We hypothesize that readiness for change will be greater at initiation of insulin pump therapy than in established pump users, and that this will predict CGM adherence. Our objective was to evaluate the feasibility of a randomized controlled trial (RCT) in children with established T1D comparing simultaneous pump and CGM initiation to standard pump therapy with delayed CGM initiation. We randomized participants to simultaneous pump and CGM initiation or to standard pump therapy with the option of adding CGM 4 months later. CGM adherence was tracked via web-based download and readiness for change assessed with the SOCRATES questionnaire. Of 41 eligible children, 20 agreed to participate; 15 subjects completed the study (7 males; baseline age 11.8 ± 4.0 years; T1D duration 2.7 ± 2.7 years; mean A1C 8.2 ± 0.8%). Six of 8 simultaneous group subjects used CGM > 60% of the time for 4 months compared to 1 of 7 delayed group subjects (P = .02). Using SOCRATES, we could assign 87-100% of subjects to a single motivation stage at baseline and 4 months. This pilot study demonstrates the feasibility of randomizing pump naïve children and adolescents with established T1D to simultaneous pump and CGM initiation versus standard pump therapy with delayed CGM initiation. Lessons from this pilot study were used to inform development of a full-scale multicenter RCT. PMID:24876616

A pilot study of magnetic therapy for hot flashes after breast cancer.

PubMed

Carpenter, Janet S; Wells, Nancy; Lambert, Beth; Watson, Peggy; Slayton, Tami; Chak, Bapsi; Hepworth, Joseph T; Worthington, W Bradley

2002-04-01

The purpose of this randomized placebo-controlled crossover pilot study was to evaluate the effectiveness and acceptability of magnetic therapy for hot flashes among breast cancer survivors. Participants completed a 24-hour baseline hot-flash monitoring session, wore the magnetic devices or placebo for 3 days, completed an after-treatment hot-flash monitoring session, experienced a 10-day washout period, and then crossed over to the opposite study arm. Magnetic devices and placebos were placed on 6 acupressure sites corresponding to hot-flash relief. Complete data were available from 11 survivors of breast cancer. Results indicated magnetic therapy was no more effective than placebo in decreasing hot-flash severity, and contrary to expectations, placebo was significantly more effective than magnets in decreasing hot-flash frequency, bother, interference with daily activities, and overall quality of life. Implications for clinical practice and future research include the need to explore alternative interventions aimed at alleviating hot flashes in this population.

Augmenting Antidepressant Medication Treatment of Depressed Women with Emotionally Focused Therapy for Couples: A Randomized Pilot Study

ERIC Educational Resources Information Center

Denton, Wayne H.; Wittenborn, Andrea K.; Golden, Robert N.

2012-01-01

This is the first study to evaluate adding emotionally focused therapy for couples (EFT) to antidepressant medication in the treatment of women with major depressive disorder and comorbid relationship discord. Twenty-four women and their male partners were randomized to 6 months of medication management alone (MM) or MM augmented with EFT (MM +…

Effects of music therapy in the treatment of children with delayed speech development - results of a pilot study.

PubMed

Gross, Wibke; Linden, Ulrike; Ostermann, Thomas

2010-07-21

Language development is one of the most significant processes of early childhood development. Children with delayed speech development are more at risk of acquiring other cognitive, social-emotional, and school-related problems. Music therapy appears to facilitate speech development in children, even within a short period of time. The aim of this pilot study is to explore the effects of music therapy in children with delayed speech development. A total of 18 children aged 3.5 to 6 years with delayed speech development took part in this observational study in which music therapy and no treatment were compared to demonstrate effectiveness. Individual music therapy was provided on an outpatient basis. An ABAB reversal design with alternations between music therapy and no treatment with an interval of approximately eight weeks between the blocks was chosen. Before and after each study period, a speech development test, a non-verbal intelligence test for children, and music therapy assessment scales were used to evaluate the speech development of the children. Compared to the baseline, we found a positive development in the study group after receiving music therapy. Both phonological capacity and the children's understanding of speech increased under treatment, as well as their cognitive structures, action patterns, and level of intelligence. Throughout the study period, developmental age converged with their biological age. Ratings according to the Nordoff-Robbins scales showed clinically significant changes in the children, namely in the areas of client-therapist relationship and communication. This study suggests that music therapy may have a measurable effect on the speech development of children through the treatment's interactions with fundamental aspects of speech development, including the ability to form and maintain relationships and prosodic abilities. Thus, music therapy may provide a basic and supportive therapy for children with delayed speech development. Further studies should be conducted to investigate the mechanisms of these interactions in greater depth. The trial is registered in the German clinical trials register; Trial-No.: DRKS00000343.

A pilot study to assess the pharmacy impact of implementing a chemotherapy-induced nausea or vomiting collaborative disease therapy management in the outpatient oncology clinics.

PubMed

Jackson, Kasey; Letton, Cathy; Maldonado, Andy; Bodiford, Andrew; Sion, Amy; Hartwell, Rebekah; Graham, Anastasia; Bondarenka, Carolyn; Uber, Lynn

2018-01-01

Background Collaborative drug therapy management is a formal partnership between a pharmacist and physician to allow the pharmacist to manage a patient's drug therapy. Literature supports collaborative disease therapy management can improve patient outcomes, improve medication adherence, enhance medication safety, and positively influence healthcare expenditures. Chemotherapy induced nausea or vomiting is considered one of the most distressing and feared adverse events among patients receiving chemotherapy. Chemotherapy induced nausea or vomiting can impact a patient's quality of life and may affect compliance with the treatment plan. Purpose The objective of this pilot study was to determine the pharmacy impact of implementing a chemotherapy induced nausea or vomiting collaborative disease therapy management protocol in the outpatient oncology clinics at a National Cancer Institute (NCI)-designated cancer center associated with an academic medical center. The primary endpoint was to determine the number and type of chemotherapy induced nausea or vomiting clinical interventions made by the oncology pharmacists. Secondary endpoints included comparing patient's Multinational Association for Supportive Care in Cancer scores and revenue of pharmacists' services. Methods The credentialed oncology pharmacists were consulted by an oncologist to manage chemotherapy induced nausea or vomiting. Patients were included in the chemotherapy induced nausea or vomiting collaborative disease therapy management if they were seen in an outpatient oncology clinic from October 2016 to January 2017 and had a referral from a qualified provider to help manage chemotherapy induced nausea or vomiting. Patients admitted to the hospital at the time of consult were excluded from the study. The pharmacists interviewed patients and provided recommendations. The pharmacists followed up with the patient via a telephone call or during the next scheduled clinic visit to assess their symptoms. Results The chemotherapy induced nausea or vomiting collaborative disease therapy management pilot study was implemented in October 2016. From October 2016 to January 2017, there were 45 consults for the management of chemotherapy induced nausea or vomiting. The pharmacists made 188 clinical interventions, which included addition of new medications (37%), patient education (34%), deletion of medications (10%), changing a dose/duration/frequency (8%), and other interventions (11%). Multinational Association for Supportive Care in Cancer symptom scores were available for 5 patients, in which all showed improvements from baseline with the pharmacists' clinical interventions. Conclusions The implementation of our chemotherapy induced nausea or vomiting collaborative disease therapy management pilot study has shown favorable results after a 4-month evaluation period. The pharmacists have made a substantial number of clinical interventions and provided patient education to patients undergoing chemotherapy.

Efficacy of extremely low-frequency magnetic field in fibromyalgia pain: A pilot study.

PubMed

Paolucci, Teresa; Piccinini, Giulia; Iosa, Marco; Piermattei, Cristina; de Angelis, Simona; Grasso, Maria Rosaria; Zangrando, Federico; Saraceni, Vincenzo Maria

2016-01-01

The purpose of this pilot study was to determine the efficacy of an extremely low-frequency magnetic field (ELF-MF) in decreasing chronic pain in fibromyalgia (FM) patients. Thirty-seven females were recruited and randomized into two groups: one group was first exposed to systemic ELF-MF therapy (100 microtesla, 1 to 80 Hz) and then to sham therapy, and the other group received the opposite sequence of intervention. Pain, FM-related symptoms, and the ability to perform daily tasks were measured using the Visual Analog Scale, Fibromyalgia Impact Questionnaire (FIQ), Fibromyalgia Assessment Scale (FAS), and Health Assessment Questionnaire (HAQ) at baseline, end of first treatment cycle, beginning of second treatment cycle (after 1 mo washout), end of second treatment cycle, and end of 1 mo follow-up. ELF-MF treatment significantly reduced pain, which increased on cessation of therapy but remained significantly lower than baseline levels. Short-term benefits were also observed in FIQ, FAS, and HAQ scores, with less significant effects seen in the medium term. ELF-MF therapy can be recommended as part of a multimodal approach for mitigating pain in FM subjects and improving the efficacy of drug therapy or physiotherapy.

Emotion-Focused Therapy for Couples in the Treatment of Depression: A Pilot Study.

ERIC Educational Resources Information Center

Dessaulles, Andre; Johnson, Susan M.; Denton, Wayne H.

2003-01-01

Emotion-focused therapy (EFT) for couples was compared to pharmacotherapy in the treatment of major depressive disorder. Both interventions were equally effective in symptom reduction. Results suggest EFT might be useful in the treatment of comorbid major depressive disorder and relational distress. (Contains 34 references and 1 figure.) (GCP)

Applying the Formal Elements Art Therapy Scale (FEATS) to Adults in an Asian Population

ERIC Educational Resources Information Center

Nan, Joshua Kin-man; Hinz, Lisa D.

2012-01-01

Assessment is the foundation for conceptualizing effective interventions. Due to their nonverbal nature, art therapy assessments have an advantage over traditional verbal assessments in some populations and potentially across cultures. This pilot study provides preliminary reliability data to support the cross-cultural use of the Formal Elements…

Treatment Outcome for Low Socioeconomic Status African American Families in Parent-Child Interaction Therapy: A Pilot Study

ERIC Educational Resources Information Center

Fernandez, Melanie A.; Butler, Ashley M.; Eyberg, Sheila M.

2011-01-01

The course and efficacy of parent-child interaction therapy (PCIT) were examined in 18 socioeconomically disadvantaged African American families of preschoolers with disruptive behavior disorders. Mothers reported significant improvements in child disruptive behavior but not in maternal depressive symptoms or parenting stress. Attrition was 56%,…

Music therapy to promote prosocial behaviors in aggressive adolescent boys--a pilot study.

PubMed

Rickson, Daphne J; Watkins, William G

2003-01-01

This pilot study was undertaken to investigate whether music therapy is effective in promoting prosocial behaviors in aggressive adolescent boys who have social, emotional, and learning difficulties. Fifteen subjects (aged 11-15 years), enrolled at a special residential school in New Zealand, were randomly assigned to music therapy treatment groups (n = 6, n = 5), and a waitlist control group (n = 4). Examination of demographic data identified differences between groups for diagnosis (p =.044), with Group 1 all having Attention Deficit Hyperactivity Disorder (ADHD), and for age (p =.027), with Group 2 having a mean age 1.38 years older. Measures included parent and teacher versions of the Developmental Behaviour Checklist (DBC-P & DBC-T) (Einfeld & Tonge, 1994; Einfeld, Tonge, & Parmenter, 1998). While no definite treatment effects could be detected, results suggest that a music therapy program promoting autonomy and creativity may help adolescents to interact more appropriately with others in a residential villa setting, but might also lead to a temporary mild increase in disruptive behavior in the classroom. A more highly structured program and smaller group numbers may be advantageous for boys who have ADHD.

Oral rehydration therapy for preoperative fluid and electrolyte management.

PubMed

Taniguchi, Hideki; Sasaki, Toshio; Fujita, Hisae

2011-01-01

Preoperative fluid and electrolyte management is usually performed by intravenous therapy. We investigated the safety and effectiveness of oral rehydration therapy (ORT) for preoperative fluid and electrolyte management of surgical patients. The study consisted of two studies, designed as a prospective observational study. In a pilot study, 20 surgical patients consumed 1000 mL of an oral rehydration solution (ORS) until 2 h before induction of general anesthesia. Parameters such as serum electrolyte concentrations, fractional excretion of sodium (FENa) as an index of renal blood flow, volume of esophageal-pharyngeal fluid and gastric fluid (EPGF), and patient satisfaction with ORT were assessed. In a follow-up study to assess the safety of ORT, 1078 surgical patients, who consumed ORS until 2 h before induction of general anesthesia, were assessed. In the pilot study, water, electrolytes, and carbohydrate were effectively and safely supplied by ORT. The FENa value was increased at 2 h following ORT. The volume of EPGF collected following the induction of anesthesia was 5.3±5.6 mL. In the follow-up study, a small amount of vomiting occurred in one patient, and no aspiration occurred in the patients. These results suggest that ORT is a safe and effective therapy for the preoperative fluid and electrolyte management of selected surgical patients.

Oral Rehydration Therapy for Preoperative Fluid and Electrolyte Management

PubMed Central

Taniguchi, Hideki; Sasaki, Toshio; Fujita, Hisae

2011-01-01

Aim: Preoperative fluid and electrolyte management is usually performed by intravenous therapy. We investigated the safety and effectiveness of oral rehydration therapy (ORT) for preoperative fluid and electrolyte management of surgical patients. Methods: The study consisted of two studies, designed as a prospective observational study. In a pilot study, 20 surgical patients consumed 1000 mL of an oral rehydration solution (ORS) until 2 h before induction of general anesthesia. Parameters such as serum electrolyte concentrations, fractional excretion of sodium (FENa) as an index of renal blood flow, volume of esophageal-pharyngeal fluid and gastric fluid (EPGF), and patient satisfaction with ORT were assessed. In a follow-up study to assess the safety of ORT, 1078 surgical patients, who consumed ORS until 2 h before induction of general anesthesia, were assessed. Results: In the pilot study, water, electrolytes, and carbohydrate were effectively and safely supplied by ORT. The FENa value was increased at 2 h following ORT. The volume of EPGF collected following the induction of anesthesia was 5.3±5.6 mL. In the follow-up study, a small amount of vomiting occurred in one patient, and no aspiration occurred in the patients. Conclusion: These results suggest that ORT is a safe and effective therapy for the preoperative fluid and electrolyte management of selected surgical patients. PMID:21897763

Results of NVG-Induced Neck Strain Questionnaire Study in CH-146 Griffon Aircrew

DTIC Science & Technology

2004-11-01

therapeutic treatments (physiotherapeutic, chiropractic and massage therapy ) were also prominently utilized. Next the respondents were asked to indicate...chiropractic treatment and massage therapy ) would seem to indicate that there were musculoskeletal issues involved in their neck pain. When questioned about...extent massage therapy ) than the pilots. Regarding treatment, almost one third of Griffon FEs and 20% of Sea King other aircrew indicated that they had

Cognitive Behaviour Therapy versus a Counselling Intervention for Anxiety in Young People with High-Functioning Autism Spectrum Disorders: A Pilot Randomised Controlled Trial

ERIC Educational Resources Information Center

Murphy, Suzanne M.; Chowdhury, Uttom; White, Susan W.; Reynolds, Laura; Donald, Louisa; Gahan, Hilary; Iqbal, Zeinab; Kulkarni, Mahesh; Scrivener, Louise; Shaker-Naeeni, Hadi; Press, Dee A.

2017-01-01

The use of cognitive-behavioural therapy (CBT) as a treatment for children and adolescents with autism spectrum disorder (ASD) has been explored in a number of trials. Whilst CBT appears superior to no treatment or treatment as usual, few studies have assessed CBT against a control group receiving an alternative therapy. Our randomised controlled…

A 52-week pilot study of the effects of exenatide on body weight in patients with hypothalamic obesity.

PubMed

Lomenick, Jefferson P; Buchowski, Maciej S; Shoemaker, Ashley H

2016-06-01

Hypothalamic obesity (HO) is a common complication of hypothalamic tumors, and effective therapies are lacking. The objective of this pilot study was to investigate changes in body weight before and during treatment with exenatide. This was a prospective, open-label, 52-week pilot study of exenatide (10 mcg b.i.d.) in adults with HO. Ten patients enrolled, and eight completed the study. Study measures included indirect calorimetry, body composition, buffet meals, diet recall, actigraphy, and hormone assays. Participants had obesity with a baseline weight of 137.2 ± 37.6 kg. Exenatide therapy was well tolerated. Change in weight with exenatide therapy was not significant (-1.4 ± 4.3 kg [95% CI -4.9 to 2.2], P = 0.40), but six out of eight completers lost weight (-6.2 to -0.2 kg). Participants reported significantly lower intake on food recall during treatment compared with baseline (7837.8 ± 2796.6 vs. 6258.4 ± 1970.7 kJ [95% CI -2915.8 to -242.6], P = 0.027), but there was no change in intake during buffet meals. Significant weight loss was not observed in patients with HO treated with exenatide, but 75% of completers had stable or decreasing weight. Further studies are needed to evaluate weight loss efficacy in patients with HO. © 2016 The Obesity Society.

Pilot study: whole body manual subcutaneous adipose tissue (SAT) therapy improved pain and SAT structure in women with lipedema.

PubMed

Herbst, Karen L; Ussery, Christopher; Eekema, Alyna

2017-09-20

Background Lipedema is a common painful subcutaneous adipose tissue (SAT) disorder in women affecting the limbs. SAT therapy is a manual therapy to improve soft tissue quality. Objective Determine if SAT therapy improves pain and structure of lipedema SAT. Design Single arm prospective pilot study. Setting Academic medical center. Patients Seven women, 46 ± 5 years, weight 90 ± 19 kg, with lipedema. Intervention Twelve 90-min SAT therapy sessions over 4 weeks. Outcomes Dual X-ray absorptiometry (DXA) scans, SAT ultrasound (Vevo 2100), leg volumetrics, skin caliper assessment, tissue exam, weight, resting metabolic rate, pain assessment, lower extremity functional scale (LEFS) and body shape questionnaire (BSQ) at baseline and end of study. Results Weight, resting metabolic rate and BSQ did not change significantly. Limb fat over total body fat mass (p = 0.08) and trunk fat over total body mass trended down from baseline (p = 0.08) by DXA. Leg volume and caliper assessments in eight of nine areas (p < 0.007), LEFS (p = 0.002) and average pain (p = 0.007) significantly decreased from baseline. Fibrosis significantly decreased in the nodules, hips and groin. Ultrasound showed improved SAT structure in some subjects. Side effects included pain, bruising, itching, swelling and gastroesophageal reflux disease. All women said they would recommend SAT therapy to other women with lipedema. Limitations Small number of subjects. Conclusion SAT therapy in 4 weeks improved tissue structure, perceived leg function, and volume although shape was not affected. While side effects of SAT therapy were common, all women felt the therapy was beneficial.

Effect of mirror therapy and electrical stimulation on upper extremity function in stroke with hemiplegic patient: a pilot study.

PubMed

Paik, Young-Rim; Lee, Jeong-Hoon; Lee, Doo-Ho; Park, Hee-Su; Oh, Dong-Hwan

2017-12-01

[Purpose] This study investigated the effects of mirror therapy and neuromuscular electrical stimulation on upper extremity function in stroke patients. [Subjects and Methods] This study recruited 8 stroke patients. All patients were treated with mirror therapy and neuromuscular electrical stimulation five times per week for 4 weeks. Upper limb function evaluation was performed using upper extremity part of fugl meyer assessment. [Results] Before and after intervention, fugl meyer assessment showed significant improvement. [Conclusion] In this study, mirror therapy and neuromuscular electrical stimulation are effective methods for upper extremity function recovery in stroke patients.

A Comparative Study of the National Board for Respiratory Car Entry-Level Credentialling Examination Scores of the J. Sargent Reynolds Community College.

ERIC Educational Resources Information Center

Olsen, Gay

2000-01-01

States that the employment pool for respiratory workers in Virginia has declined, due to a reduction in the numbers of training programs available in local community colleges. Describes a pilot distance learning program in respiratory therapy at Virgina's J. Sargent Reynolds Community College (JSRCC). Reports that students in the pilot distance…

A case of decompression sickness in a commercial pilot.

PubMed

Wolf, C W; Petzl, D H; Seidl, G; Burghuber, O C

1989-10-01

We report a case of decompression sickness (DCS) followed by pulmonary edema in a 47-year-old commercial pilot who operated a non-pressurized turboprop twin at flight level 290. He became unconscious and recovered after an emergency descent. The pilot collapsed and a pulmonary edema occurred 8 h after landing. The patient improved rapidly with fluid replacement and without hyperbaric therapy, which was not available at that time. This course of DCS is unusual because it is reported that fluid replacement without hyperbaric therapy normally cannot recover severe cases of DCS. The considerable increase in body weight of this pilot within the last 6 months may have been a predisposing factor for development of decompression sickness.

Computer animated relaxation therapy in children between 7 and 13 years with tension-type headache: a pilot study.

PubMed

Tornoe, Birte; Skov, Liselotte

2012-03-01

This pilot study evaluated the effect of computer animated relaxation therapy in children between 7 and 13 years with tension-type headache and the children's experiences with the therapy. The therapy consisted of an uncontrolled nine-session course in modified progressive relaxation therapy assisted by computer animated surface EMG provided from the trapezius muscles and with the physiotherapist as a participant observer. Outcome measures were (a) headache frequency and intensity, (b) pericranial tenderness, (c) tension patterns, and (d) evaluations assessed at baseline and at 3 months follow up. Nine children, mean age 10.9 (SD 1.7) years, diagnosed with frequent episodic or chronic tension-type headache completed the course. The results showed a mean improvement of 45% for headache frequency at 3 months follow up versus baseline and a significant reduction in headache frequency for all participants and in Total Tenderness Score for children with frequent episodic tension-type headache. The children expressed a growing understanding of body reactions and an acquired ability to deactivate and regulate these reactions. Computer animated SEMG seems an applicable learning strategy for young headache sufferers. This study suggests that children below the age of 13 need both the dialog and guidance from a participant observer in order to achieve body awareness.

Emotion Regulation Enhancement of Cognitive Behavior Therapy for College Student Problem Drinkers: A Pilot Randomized Controlled Trial

ERIC Educational Resources Information Center

Ford, Julian D.; Grasso, Damion J.; Levine, Joan; Tennen, Howard

2018-01-01

This pilot randomized clinical trial tested an emotion regulation enhancement to cognitive behavior therapy (CBT) with 29 college student problem drinkers with histories of complex trauma and current clinically significant traumatic stress symptoms. Participants received eight face-to-face sessions of manualized Internet-supported CBT for problem…

Contextual Emotion-Regulation Therapy for Childhood Depression: Description and Pilot Testing of a New Intervention

ERIC Educational Resources Information Center

Kovacs, Maria; Sherrill, Joel; George, Charles J.; Pollock, Myrna; Tumuluru, Rameshwari V.; Ho, Vincent

2006-01-01

Objective: To pilot test the acceptability and efficacy of contextual emotion-regulation therapy (CERT), a new, developmentally appropriate intervention for childhood depression, which focuses on the self-regulation of dysphoria. Method: Two samples of convenience (n = 29, n = 2) served to verify some CERT constructs; it was then operationalized…

A virtual patient software program to improve pharmacy student learning in a comprehensive disease management course.

PubMed

Douglass, Mark A; Casale, Jillian P; Skirvin, J Andrew; DiVall, Margarita V

2013-10-14

To implement and assess the impact of a virtual patient pilot program on pharmacy students' clinical competence skills. Pharmacy students completed interactive software-based patient case scenarios embedded with drug-therapy problems as part of a course requirement at the end of their third year. Assessments included drug-therapy problem competency achievement, performance on a pretest and posttest, and pilot evaluation survey instrument. Significant improvements in students' posttest scores demonstrated advancement of clinical skills involving drug-therapy problem solving. Students agreed that completing the pilot program improved their chronic disease management skills and the program summarized the course series well. Using virtual patient technology allowed for assessment of student competencies and improved learning outcomes.

Effect of non-surgical periodontal therapy on plasma homocysteine levels in Indian population with chronic periodontitis: a pilot study.

PubMed

Bhardwaj, Smiti; Prabhuji, M L Venkatesh; Karthikeyan, Bangalore Vardhan

2015-03-01

Homocysteine (Hcy) is implicated in the development of cardiovascular diseases (CVD). The effect of periodontal disease and periodontal therapy on plasma Hcy remains controversial. Hence, in this pilot study we assessed the effect of periodontal disease and non-surgical periodontal therapy (NSPT) on plasma Hcy in systemically healthy Indian subjects. Forty participants (30 to 39 years) were enrolled in the study and were divided into two groups based on gingival index, probing depth, and clinical attachment level (CAL): Healthy (control group; n = 20) and Chronic Periodontitis (test group; n = 20). Plasma samples were collected and quantified at baseline and 12 weeks after scaling and root planing (SRP) for Hcy using High Performance Liquid Chromatography with fluorescent detection (HPLC-fld). Plasma Hcy levels of chronic periodontitis (17.87 ± 1.21 μmol/l) subjects was significantly higher than healthy subjects (9.09 ± 2.11 μmol/l). Post-therapy, the plasma Hcy concentration reduced significantly (11.34 ± 1.87 μmol/l) (p < 0.05). The rise and descent of plasma Hcy levels with periodontal inflammation and therapy, respectively, indicate a direct relationship of Hcy with chronic periodontitis. NSPT may be employed as an adjunctive Hcy Lowering Therapy, contributing towards primary prevention against CVD's. © 2015 John Wiley & Sons A/S. Published by John Wiley & Sons Ltd.

A Stage I Pilot Study of Acceptance and Commitment Therapy for Methadone Detoxification

PubMed Central

Stotts, Angela L.; Green, Charles; Masuda, Akihiko; Grabowski, John; Wilson, Kelly; Northrup, Thomas; Moeller, F. Gerard; Schmitz, Joy

2012-01-01

BACKGROUND While agonist replacement therapies are effective for managing opioid dependence, community treatment programs are increasingly choosing detoxification. Unfortunately, success rates for opioid detoxification are very low, in part, due to physical and psychological symptoms associated with opioid withdrawal. Few behavior therapies specifically address the distressing experiences specific to opioid withdrawal. A novel behavioral treatment, Acceptance and Commitment Therapy (ACT), works from the premise that the avoidance of unpleasant private experiences (thoughts, feelings, bodily sensations) is ubiquitous yet may be pathogenic, resulting in treatment drop-out and further drug use. METHODS This Stage I pilot study developed and tested an ACT-based opioid detoxification behavioral therapy. Opioid dependent patients (N = 56) who were attending a licensed methadone clinic were randomized to receive either 24 individual therapy sessions of ACT or Drug Counseling (DC) in the context of a 6-month methadone dose reduction program. RESULTS While no difference was found on opioid use during treatment, 37% of participants in the ACT condition were successfully detoxified at the end of treatment compared to 19% of those who received DC. Fear of detoxification was also reduced across time in the ACT condition relative to DC. CONCLUSION This first study of ACT to assist opioid detoxification indicates promise. Research is needed to refine specific treatment strategies for this population to further strengthen effects. PMID:22425411

Endoscopic procedure with a modified Reiki intervention: a pilot study.

PubMed

Hulse, Rosalinda S; Stuart-Shor, Eileen M; Russo, Jonathan

2010-01-01

This pilot study examined the use of Reiki prior to colonoscopy to reduce anxiety and minimize intraprocedure medications compared with usual care. A prospective, nonblinded, partially randomized patient preference design was employed using 21 subjects undergoing colonoscopy for the first time. Symptoms of anxiety and pain were assessed using a Likert-type scale. Between-group differences were assessed using chi-square analyses and analysis of variance. There were no differences between the control (n = 10) and experimental (n = 11) groups on age (mean = 58 years, SD = 8.5) and gender (53% women). The experimental group had higher anxiety (4.5 vs. 2.6, p = .03) and pain (0.8 vs. 0.2, p = .42) scores prior to colonoscopy. The Reiki intervention reduced mean heart rate (-9 beats/minute), systolic blood pressure (-10 mmHg), diastolic blood pressure (-4 mmHg), and respirations (-3 breaths/minute). There were no between-group differences on intraprocedure medication use or postprocedure physiologic measures. Although the experimental group patients had more symptoms, they did not require additional pain medication during the procedure, suggesting that (1) anxious people may benefit from an adjunctive therapy; (2) anxiety and pain are decreased by Reiki therapy for patients undergoing colonoscopy, and (3) additional intraprocedure pain medication may not be needed for colonoscopy patients receiving Reiki therapy. This pilot study provided important insights in preparation for a rigorous, randomized, controlled clinical trial.

Music therapy as specific and complementary training for adults after cochlear implantation: A pilot study.

PubMed

Hutter, E; Argstatter, H; Grapp, M; Plinkert, P K

2015-09-01

Although cochlear implant (CI) users achieve good speech comprehension, they experience difficulty perceiving music and prosody in speech. As the provision of music training in rehabilitation is limited, a novel concept of music therapy for rehabilitation of adult CI users was developed and evaluated in this pilot study. Twelve unilaterally implanted, postlingually deafened CI users attended ten sessions of individualized and standardized training. The training started about 6 weeks after the initial activation of the speech processor. Before and after therapy, psychological and musical tests were applied in order to evaluate the effects of music therapy. CI users completed the musical tests in two conditions: bilateral (CI + contralateral, unimplanted ear) and unilateral (CI only). After therapy, improvements were observed in the subjective sound quality (Hearing Implant Sound Quality Index) and the global score on the self-concept questionnaire (Multidimensional Self-Concept Scales) as well as in the musical subtests for melody recognition and for timbre identification in the unilateral condition. Discussion Preliminary results suggest improvements in subjective hearing and music perception, with an additional increase in global self-concept and enhanced daily listening capacities. The novel concept of individualized music therapy seems to provide an effective treatment option in the rehabilitation of adult CI users. Further investigations are necessary to evaluate effects in the area of prosody perception and to separate therapy effects from general learning effects in CI rehabilitation.

Reflexology versus Swedish Massage to Reduce Physiologic Stress and Pain and Improve Mood in Nursing Home Residents with Cancer: A Pilot Trial

PubMed Central

Hodgson, Nancy A.; Lafferty, Doreen

2012-01-01

Objective. The purpose of this pilot study was to investigate and compare the effects of reflexology and Swedish massage therapy on physiologic stress, pain, and mood in older cancer survivors residing in nursing homes. Methods. An experimental, repeated-measures, crossover design study of 18 nursing home residents aged 75 or over and diagnosed with solid tumor in the past 5 years and following completion of cancer treatments. The intervention tested was 20 minutes of Swedish Massage Therapy to the lower extremities, versus 20 minute Reflexology, using highly specified protocols. Pre- and post-intervention levels of salivary cortisol, observed affect, and pain were compared in the Swedish Massage Therapy and Reflexology conditions. Results. Both Reflexology and Swedish Massage resulted in significant declines in salivary cortisol and pain and improvements in mood. Conclusions. Preliminary data suggest that studies of Swedish Massage Therapy and Reflexology are feasible in this population of cancer survivors typically excluded from trials. Both interventions were well tolerated and produced measurable improvements in outcomes. Further research is needed to explore the mechanisms underlying the potential benefits of these CAM modalities in this patient population. PMID:22888364

The physical therapy profile questionnaire (PTPQ): development, validation and pilot testing.

PubMed

Dizon, Janine Margarita R; Grimmer-Somers, Karen; Kumar, Saravana

2011-09-19

Country by country similarities and differences in physical therapy practice exists. Therefore, before updates in practice can be provided, such as trainings in evidence-based practice, it is necessary to identify the profile and nature of practice in a given country or setting. Following a search of the international literature, no appropriate tool was identified to collect and establish data to create the profile of physical therapy practice in the Philippines. We therefore developed, validated and pilot tested a survey instrument which would comprehensively describe the practice of physical therapy in the Philippines We used a mixed methods design to answer our study aims. A focus group interview was conducted among a group of physical therapists to establish the content and contexts of items to be included in the survey instrument. Findings were amalgamated with the information from the literature on developing survey instruments/questionnaires. A survey instrument was drafted and named as the Physical Therapy Profile Questionnaire (PTPQ). The PTPQ was then validated and pilot tested to a different group of physical therapists.The final version consisted of five separate parts namely (A) General information and demographics, (B) Practice Profile, (C) Treatment Preferences, (D) Bases for clinical work and (E) Bases for educational/research work. At present the PTPQ is relevant to the Philippines and could be used by any country which has a similar nature of practice with the Philippines. The Physical Therapy Practice Questionnaire (PTPQ) was shown to have good face and content validity among the Filipino physical therapists and their context of practice. It has also been found to be useful, easy to administer tool and in a format appealing to respondents. The PTPQ is expected to assist comprehensive data collection to create a profile of physical therapy practice in the Philippines.

The Effectiveness of Aquatic Group Therapy for Improving Water Safety and Social Interactions in Children with Autism Spectrum Disorder: A Pilot Program

ERIC Educational Resources Information Center

Alaniz, Michele L.; Rosenberg, Sheila S.; Beard, Nicole R.; Rosario, Emily R.

2017-01-01

Drowning is the number one cause of accidental death in children with Autism Spectrum Disorder (ASD). Few studies have examined the effectiveness of swim instruction for improving water safety skills in children with moderate to severe ASD. This study examines the feasibility and effectiveness of an aquatic therapy program on water safety and…

Massage therapy and exercise therapy in patients with multiple sclerosis: a randomized controlled pilot study.

PubMed

Negahban, Hossein; Rezaie, Solmaz; Goharpey, Shahin

2013-12-01

The primary aim was to investigate the comparative effects of massage therapy and exercise therapy on patients with multiple sclerosis. The secondary aim was to investigate whether combination of both massage and exercise has an additive effect. Randomized controlled pilot trial with repeated measurements and blinded assessments. Local Multiple Sclerosis Society. A total of 48 patients with multiple sclerosis were randomly assigned to four equal subgroups labelled as massage therapy, exercise therapy, combined massage-exercise therapy and control group. The treatment group received 15 sessions of supervised intervention for five weeks. The massage therapy group received a standard Swedish massage. The exercise therapy group was given a combined set of strength, stretch, endurance and balance exercises. Patients in the massage-exercise therapy received a combined set of massage and exercise treatments. Patients in the control group were asked to continue their standard medical care. Pain, fatigue, spasticity, balance, gait and quality of life were assessed before and after intervention. Massage therapy resulted in significantly larger improvement in pain reduction (mean change 2.75 points, P = 0.001), dynamic balance (mean change, 3.69 seconds, P = 0.009) and walking speed (mean change, 7.84 seconds, P = 0.007) than exercise therapy. Patients involved in the combined massage-exercise therapy showed significantly larger improvement in pain reduction than those in the exercise therapy (mean change, 1.67 points, P = 0.001). Massage therapy could be more effective than exercise therapy. Moreover, the combination of massage and exercise therapy may be a little more effective than exercise therapy alone.

Effectiveness and cost-effectiveness of an educational intervention for practice teams to deliver problem focused therapy for insomnia: rationale and design of a pilot cluster randomised trial

PubMed Central

Siriwardena, A Niroshan; Apekey, Tanefa; Tilling, Michelle; Harrison, Andrew; Dyas, Jane V; Middleton, Hugh C; Ørner, Roderick; Sach, Tracey; Dewey, Michael; Qureshi, Zubair M

2009-01-01

Background Sleep problems are common, affecting over a third of adults in the United Kingdom and leading to reduced productivity and impaired health-related quality of life. Many of those whose lives are affected seek medical help from primary care. Drug treatment is ineffective long term. Psychological methods for managing sleep problems, including cognitive behavioural therapy for insomnia (CBTi) have been shown to be effective and cost effective but have not been widely implemented or evaluated in a general practice setting where they are most likely to be needed and most appropriately delivered. This paper outlines the protocol for a pilot study designed to evaluate the effectiveness and cost-effectiveness of an educational intervention for general practitioners, primary care nurses and other members of the primary care team to deliver problem focused therapy to adult patients presenting with sleep problems due to lifestyle causes, pain or mild to moderate depression or anxiety. Methods and design This will be a pilot cluster randomised controlled trial of a complex intervention. General practices will be randomised to an educational intervention for problem focused therapy which includes a consultation approach comprising careful assessment (using assessment of secondary causes, sleep diaries and severity) and use of modified CBTi for insomnia in the consultation compared with usual care (general advice on sleep hygiene and pharmacotherapy with hypnotic drugs). Clinicians randomised to the intervention will receive an educational intervention (2 × 2 hours) to implement a complex intervention of problem focused therapy. Clinicians randomised to the control group will receive reinforcement of usual care with sleep hygiene advice. Outcomes will be assessed via self-completion questionnaires and telephone interviews of patients and staff as well as clinical records for interventions and prescribing. Discussion Previous studies in adults have shown that psychological treatments for insomnia administered by specialist nurses to groups of patients can be effective within a primary care setting. This will be a pilot study to determine whether an educational intervention aimed at primary care teams to deliver problem focused therapy for insomnia can improve sleep management and outcomes for individual adult patients presenting to general practice. The study will also test procedures and collect information in preparation for a larger definitive cluster-randomised trial. The study is funded by The Health Foundation. Trial Registration ClinicalTrials.gov ID ISRCTN55001433 – PMID:19171070

Pilot study for the registry of complications in rheumatic diseases from the German Society of Surgery (DGORh): evaluation of methods and data from the first 1000 patients

PubMed Central

Kostuj, Tanja; Rehart, Stefan; Matta-Hurtado, Ronald; Biehl, Christoph; Willburger, Roland E; Schmidt, Klaus

2017-01-01

Objective Most patients suffering with rheumatic diseases who undergo surgical treatment are receiving immune-modulating therapy. To determine whether these medications affect their outcomes a national registry was established in Germany by the German Society of Surgery (DGORh). Data from the first 1000 patients were used in a pilot study to identify relevant corisk factors and to determine whether such a registry is suitable for developing accurate and relevant recommendations. Design and participants Data were collected from patients undergoing surgical treatments with their written consent. A second consent form was used, if complications occurred. During this pilot study, in order to obtain a quicker overview, risk factors were considered only in patients with complications. Only descriptive statistical analysis was employed in this pilot study due to limited number of observed complications and inhomogeneous data regarding the surgery and the medications the patients received. Analytical statistics will be performed to confirm the results in a future outcome study. Results Complications occurred in 26 patients and were distributed equally among the different types of surgeries. Twenty one of these patients were receiving immune-modulating therapy at the time, while five were not. Infections were observed in 2.3% of patients receiving and in 5.1% not receiving immunosuppression. Conclusions Due to the low number of cases, inhomogeneity in the diseases and the treatments received by the patients in this pilot study, it is not possible to develop standardised best-practice recommendations to optimise their care. Based on this observation we conclude that in order to be suitable to develop accurate and relevant recommendations a national registry must include the most important and relevant variables that impact the care and outcomes of these patients. PMID:29018066

A pilot study of a nurse-delivered cognitive behavioral therapy intervention (Ziphamandla) for adherence and depression in HIV in South Africa.

PubMed

Andersen, Lena S; Magidson, Jessica F; O'Cleirigh, Conall; Remmert, Jessica E; Kagee, Ashraf; Leaver, Matthew; Stein, Dan J; Safren, Steven A; Joska, John

2018-05-01

Depression is prevalent among people living with HIV in South Africa and interferes with adherence to antiretroviral therapy. This study evaluated a nurse-delivered, cognitive behavioral therapy intervention for adherence and depression among antiretroviral therapy users with depression in South Africa ( n = 14). Primary outcomes were depression, antiretroviral therapy adherence, feasibility, and acceptability. Findings support robust improvements in mood through a 3-month follow up. Antiretroviral therapy adherence was maintained during the intervention period. Participant retention supports acceptability; however, modest provider fidelity despite intensive supervision warrants additional attention to feasibility. Future effectiveness research is needed to evaluate this nurse-delivered cognitive behavioral therapy intervention for adherence and depression in this context.

Adherence to cognitive behavioral therapy for insomnia (CBTI) among women following primary breast cancer treatment: a pilot study.

PubMed

Matthews, Ellyn E; Schmiege, Sarah J; Cook, Paul F; Berger, Ann M; Aloia, Mark S

2012-01-01

Cognitive behavioral therapy for insomnia (CBTI) has proven efficacy, yet 32%-89% of patients fail to consistently follow recommendations. This pilot study examines adherence to CBTI in breast cancer survivors with insomnia. There was a significant decline in adherence to prescribed rise time, and total time in bed, but no change in adherence to prescribed bedtime during six weekly sessions. Factors associated with higher adherence included lower fatigue and higher baseline motivation. Higher adherence was associated with worse subjective sleep quality at the beginning of CBTI and fewer nocturnal awakenings at the end of treatment. Results provide preliminary evidence supporting the impact of adherence on sleep outcomes such as fewer nocturnal awakenings. Attention to adherence as part of CBTI may yield greater sleep improvements.

Brief mindfulness-based therapy for chronic tension-type headache: a randomized controlled pilot study.

PubMed

Cathcart, Stuart; Galatis, Nicola; Immink, Maarten; Proeve, Michael; Petkov, John

2014-01-01

Mindfulness-based therapy (MBT) has been demonstrated to be effective for reducing chronic pain symptoms; however, the use of MBT for Chronic Tension-Type Headache (CTH) exclusively has to date not been examined. Typically, MBT for chronic pain has involved an 8-week program based on Mindfulness Based Stress Reduction. Recent research suggests briefer mindfulness-based treatments may be effective for chronic pain. To conduct a pilot study into the efficacy of brief MBT for CTH. We conducted a randomized controlled trial of a brief (6-session, 3-week) MBT for CTH. Results indicated a significant decrease in headache frequency and an increase in the mindfulness facet of Observe in the treatment but not wait-list control group. Brief MBT may be an effective intervention for CTH.

Visualization of diffusion of the drug solution during aluminum potassium tannic acid injection therapy: a pilot study.

PubMed

Yamamoto, Yutaka; Miwa, Mitsuharu

2013-06-01

Sclerotherapy with aluminum potassium tannic acid (ALTA), which was approved in Japan for the treatment of internal hemorrhoids in July 2004 (Takano et al., Int J Colorectal Dis 21:44-51, 2006), has been widely accepted because of its effectiveness and low invasiveness. More than 200,000 patients have received ALTA injection therapy. ALTA is injected directly into 4 points of an internal hemorrhoid (4-step injection) to induce sclerosis and remission of the hemorrhoids, and consequently, resolution of symptoms such as prolapse and bleeding. The precision of the 4-step injection is considered to be a crucial determinant of the success of this therapy and the risk of complications. However, sufficient evidence has not yet been obtained concerning the diffusion and distribution of the injected drug. A pilot study visualized the real-time diffusion/distribution of the drug solution following the 4-step injection, using the ICG (indocyanine green) fluorescence technique, and an infrared camera (Photodynamic EYE; PDE, Hamamatsu Photonics K.K.).

Step One within Stepped Care Trauma-Focused Cognitive Behavioral Therapy for Young Children: A Pilot Study

PubMed Central

Robst, John; Scheeringa, Michael S.; Cohen, Judith A.; Wang, Wei; Murphy, Tanya K.; Tolin, David F.; Storch, Eric A.

2013-01-01

This pilot study explored the preliminary efficacy, parent acceptability and economic cost of delivering Step One within Stepped Care Trauma-Focused Cognitive Behavioral Therapy (SC-TF-CBT). Nine young children ages 3–6 years and their parents participated in SC-TF-CBT. Eighty-three percent (5/6) of the children who completed Step One treatment and 55.6 % (5/9) of the intent-to-treat sample responded to Step One. One case relapsed at post-assessment. Treatment gains were maintained at 3-month follow-up. Generally, parents found Step One to be acceptable and were satisfied with treatment. At 3-month follow-up, the cost per unit improvement for posttraumatic stress symptoms and severity ranged from $27.65 to $131.33 for the responders and from $36.12 to $208.11 for the intent-to-treat sample. Further research on stepped care for young children is warranted to examine if this approach is more efficient, accessible and cost-effective than traditional therapy. PMID:23584728

A randomized controlled pilot study of CBT-I Coach: Feasibility, acceptability, and potential impact of a mobile phone application for patients in cognitive behavioral therapy for insomnia.

PubMed

Koffel, Erin; Kuhn, Eric; Petsoulis, Napoleon; Erbes, Christopher R; Anders, Samantha; Hoffman, Julia E; Ruzek, Josef I; Polusny, Melissa A

2018-03-01

There has been growing interest in utilizing mobile phone applications (apps) to enhance traditional psychotherapy. Previous research has suggested that apps may facilitate patients' completion of cognitive behavioral therapy for insomnia (CBT-I) tasks and potentially increase adherence. This randomized clinical trial pilot study ( n = 18) sought to examine the feasibility, acceptability, and potential impact on adherence and sleep outcomes related to CBT-I Coach use. All participants were engaged in CBT-I, with one group receiving the app as a supplement and one non-app group. We found that patients consistently used the app as intended, particularly the sleep diary and reminder functions. They reported that it was highly acceptable to use. Importantly, the app did not compromise or undermine benefits of cognitive behavioral therapy for insomnia and patients in both groups had significantly improved sleep outcomes following treatment.

Step one within stepped care trauma-focused cognitive behavioral therapy for young children: a pilot study.

PubMed

Salloum, Alison; Robst, John; Scheeringa, Michael S; Cohen, Judith A; Wang, Wei; Murphy, Tanya K; Tolin, David F; Storch, Eric A

2014-02-01

This pilot study explored the preliminary efficacy, parent acceptability and economic cost of delivering Step One within Stepped Care Trauma-Focused Cognitive Behavioral Therapy (SC-TF-CBT). Nine young children ages 3-6 years and their parents participated in SC-TF-CBT. Eighty-three percent (5/6) of the children who completed Step One treatment and 55.6 % (5/9) of the intent-to-treat sample responded to Step One. One case relapsed at post-assessment. Treatment gains were maintained at 3-month follow-up. Generally, parents found Step One to be acceptable and were satisfied with treatment. At 3-month follow-up, the cost per unit improvement for posttraumatic stress symptoms and severity ranged from $27.65 to $131.33 for the responders and from $36.12 to $208.11 for the intent-to-treat sample. Further research on stepped care for young children is warranted to examine if this approach is more efficient, accessible and cost-effective than traditional therapy.

Investigating the experiences in a school-based occupational therapy program to inform community-based paediatric occupational therapy practice.

PubMed

Rens, Lezahn; Joosten, Annette

2014-06-01

A collaborative approach with teachers is required when providing community-based occupational therapy to educationally at risk children. Collaborators share common goals and interact and support each other but challenges arise in providing collaborative occupational therapy in settings outside the school environment. The aim of this study was to capture experiences of teachers and occupational therapists working within a school-based occupational therapy program to determine if their experiences could inform collaborative practice. In this pilot study, participant responses to questionnaires (n = 32) about their experiences formed the basis for focus groups and individual interviews. Two focus group were conducted, one with teachers (n = 11) and one with occupational therapy participants (n = 6). Individual interviews were conducted with the supervising occupational therapist, school principal and two leading teachers. Descriptive statistics were used to analyse the data from closed questions, and thematic analysis using a constant comparison approach was used to analyse open ended questions, focus groups and interviews. Three main themes emerged: (i) the need for occupational therapists to spend time in the school, to explain their role, build relationships, understand classroom routines and the teacher role; (ii) occupational therapists need to not see themselves as the expert but develop equal partnerships to set collaborative goals and (iii) occupational therapists advocating for all parties to be informed throughout the occupational therapy process. The pilot study findings identified teacher and therapist experiences within the school setting that could inform improved collaborative practice with teachers and community-based occupational therapists and these findings warrant further investigation. © 2013 Occupational Therapy Australia.

Evaluation of the Appropriate Washout Period Following Fan Therapy for Dyspnea in Patients With Advanced Cancer: A Pilot Study.

PubMed

Kako, Jun; Morita, Tatsuya; Yamaguchi, Takuhiro; Sekimoto, Asuko; Kobayashi, Masamitsu; Kinoshita, Hiroya; Ogawa, Asao; Zenda, Sadamoto; Uchitomi, Yosuke; Inoguchi, Hironobu; Matsushima, Eisuke

2018-02-01

To clarify the duration required for dyspnea to return to baseline severity after fan therapy, to evaluate whether fan-to-legs therapy or no fan therapy would be a suitable control therapy, and to investigate changes in patients' face surface temperature after fan therapy. In this pilot study, all participants received 3 interventions in the following order: no fan, fan to legs, and fan to face. Participants used a fan for 5 minutes, and they scored their dyspnea at 10-minute intervals for 60 minutes or until the score had returned to its baseline value, whichever occurred first. Nine patients with advanced cancer admitted to a palliative care unit were included; they had dyspnea at rest and rated its severity as at least 3 points on a 0- to 10-point numerical rating scale. Descriptive statistics and the Wilcoxon signed rank test were used to analyze the data. All patients completed the study. Of the 9 participants, 6 experienced a clinical benefit from using a fan to their faces. Of these patients, only 2 participants' (2 of 6) dyspnea scores returned to baseline by the end of the 60-minute assessment period after exposure to fan-to-face therapy. In fan-to-legs and no fan settings, there was no change in the dyspnea scores. There were significant differences between the baseline face surface temperature and that after fan-to-face and fan-to-legs settings. When using a crossover design to investigate the effect of fan therapy on dyspnea, 1 hour is an insufficient washout period.

Mindfulness-based exposure and response prevention for obsessive compulsive disorder: study protocol for a pilot randomised controlled trial.

PubMed

Strauss, Clara; Rosten, Claire; Hayward, Mark; Lea, Laura; Forrester, Elizabeth; Jones, Anna-Marie

2015-04-16

Obsessive Compulsive Disorder (OCD) is a distressing and debilitating condition affecting 1-2% of the population. Exposure and response prevention (ERP) is a behaviour therapy for OCD with the strongest evidence for effectiveness of any psychological therapy for the condition. Even so, only about half of people offered ERP show recovery after the therapy. An important reason for ERP failure is that about 25% of people drop out early, and even for those who continue with the therapy, many do not regularly engage in ERP tasks, an essential element of ERP. A mindfulness-based approach has the potential to reduce drop-out from ERP and to improve ERP task engagement with an emphasis on accepting difficult thoughts, feelings and bodily sessions and on becoming more aware of urges, rather than automatically acting on them. This is a pilot randomised controlled trial of mindfulness-based ERP (MB-ERP) with the aim of establishing parameters for a definitive trial. Forty participants diagnosed with OCD will be allocated at random to a 10-session ERP group or to a 10-session MB-ERP group. Primary outcomes are OCD symptom severity and therapy engagement. Secondary outcomes are depressive symptom severity, wellbeing and obsessive-compulsive beliefs. A semi-structured interview with participants will guide understanding of change processes. Findings from this pilot study will inform future research in this area, and if effect sizes on primary outcomes are in favour of MB-ERP in comparison to ERP, funding for a definitive trial will be sought. Current Controlled Trials registration number ISRCTN52684820. Registered on 30 January 2014.

Constraint-Induced Movement Therapy for Children with Obstetric Brachial Plexus Palsy: Two Single-Case Series

ERIC Educational Resources Information Center

Buesch, Francisca Eugster

2010-01-01

The objective of this pilot study was to investigate the feasibility of constraint-induced movement therapy (CIMT) in children with obstetric brachial plexus palsy and receive preliminary information about functional improvements. Two patients (age 12 years) with obstetric brachial plexus palsy were included for a 126-h home-based CIMT…

Piloting a Dialectical Behavioral Therapy (DBT) Infused Skills Group in a Disciplinary Alternative Education Program (DAEP)

ERIC Educational Resources Information Center

Ricard, Richard J.; Lerma, Eunice; Heard, Courtney C. C.

2013-01-01

This study explored the impact of a 4-week skills group intervention based on the principles of Dialectical Behavior Therapy (DBT) with a sample of adolescents attending a Disciplinary Alternative Education Program. This article provides a session-by-session overview of activities adapted from DBT-specified training modules of mindfulness,…

The Effect of Art Therapy on Cognitive Performance of Hispanic/Latino Older Adults

ERIC Educational Resources Information Center

Alders, Amanda; Levine-Madori, Linda

2010-01-01

This article presents the results of a pilot study investigating the efficacy of art therapy to enhance cognitive performance in a sample of 24 elderly Hispanic/Latino members of a community center who participated in a weekly structured thematic therapeutic arts program. A 12-week, quasi-experimental, pretest/posttest, nonrandomized, controlled…

Cognitive-Behavioral Therapy for Depression in Adolescents with Inflammatory Bowel Disease: A Pilot Study.

ERIC Educational Resources Information Center

Szigethy, Eva; Whitton, Sarah W.; Levy-Warren, Anna; DeMaso, David Ray; Weisz, John; Beardslee, William R.

2004-01-01

Objective: To evaluate the safety and feasibility of cognitive-behavioral therapy (CBT) for depression in physically ill adolescents. Method: In an open trial, 11 adolescents (12-17 years) with inflammatory bowel disease and either major or minor depression underwent 12 sessions of a manual-based CBT enhanced by social skills, physical illness…

Acceptance-Enhanced Behavior Therapy (AEBT) for Trichotillomania and Chronic Skin Picking: Exploring the Effects of Component Sequencing

ERIC Educational Resources Information Center

Flessner, Christopher A.; Busch, Andrew M.; Heideman, Paul W.; Woods, Douglas W.

2008-01-01

This pilot study examined the utility of acceptance-enhanced behavior therapy (AEBT) for trichotillomania (TTM) and chronic skin picking (CSP) and the impact of altering treatment sequence on overall treatment efficacy. Participants referred to a TTM and CSP specialty clinic were assessed by an independent evaluator within separate, nonconcurrent,…

Effectiveness of Group Activity Play Therapy on Internalizing and Externalizing Behavior Problems of Preadolescent Orphans in Uganda

ERIC Educational Resources Information Center

Ojiambo, Deborah

2011-01-01

This pilot study investigated the impact of group activity play therapy (GAPT) on displaced orphans aged 10 to 12 years living in a large children's village in Uganda. Teachers and housemothers identified 60 preadolescents exhibiting clinical levels of internalizing and externalizing behavior problems. The participants' ethnicity was African and…

Effects of Structural Family Therapy on Child and Maternal Mental Health Symptomatology

ERIC Educational Resources Information Center

Weaver, Addie; Greeno, Catherine G.; Marcus, Steven C.; Fusco, Rachel A.; Zimmerman, Tina; Anderson, Carol

2013-01-01

Objective: This pilot study examined the effect of structural family therapy (SFT) on children's impairment and depressive symptomatology and mothers' depressive symptomatology and anxiety for 31 families served by a community mental health clinic. Method: A one group predesign/postdesign, with a baseline and two follow-up time points, was used.…

Auricular Therapy for Treatment of Musculoskeletal Pain in the Setting of Military Personnel: A Randomized Trial

DTIC Science & Technology

2015-10-01

2015 with 12 subjects enrolled to date 5  Efforts for additional recruitment from Camp Pendleton Acupuncture Clinic and NMCSD Physical Therapy are...Niemtzow R, Burns SM, Fritts MJ, Crawford CC, Jonas WB. Auricular acupuncture in the treatment of acute pain syndromes: A pilot study. Mil Med. 2006 Oct

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…

Management of Chronic Lateral Epicondylitis With Manual Therapy and Local Cryostimulation: A Pilot Study.

PubMed

Richer, Nadia; Marchand, Andrée-Anne; Descarreaux, Martin

2017-12-01

The purpose of this pilot study was to evaluate the feasibility and efficacy of adding cryostimulation to manual therapy in patients with chronic lateral epicondylitis. The control group (n = 19) was treated with manual therapy consisting of soft-tissue therapy and radial head mobilizations. The experimental group (n = 18) received cryostimulation in addition to manual therapy care similar to that for the control group. Both protocols consisted of 8 treatments over a 4-week period. Outcome measures included pain intensity (visual analog scale), pain-free grip strength (handheld dynamometer), and functional index (Patient-Rated Tennis Elbow Evaluation questionnaire). Assessments were performed at baseline, postintervention, and 3-month follow-up. Adherence and dropout rates were also considered. Both groups exhibited significant improvements in pain intensity and functional index at postintervention assessments, which were maintained at follow-up. All participants attended the prescribed number of treatments, but 27% were lost at follow-up. Minor adverse events were reported after cryostimulation in 4 cases. This study indicated that it is feasible to complete a clinical trial evaluating the efficacy of adding cryostimulation to manual therapy in patients with chronic lateral epicondylitis. On the basis of these preliminary data, the combination of cryostimulation and manual therapy care did not provide any additional benefits in both the short term and the long term. Manual myofascial point treatment and mobilization techniques yielded positive outcomes in chronic lateral epicondylitis. Further studies should focus on the sole therapeutic effect of cryostimulation in both patients with acute and those with chronic conditions.

Robot-assisted therapy for improving social interactions and activity participation among institutionalized older adults: a pilot study.

PubMed

Sung, Huei-Chuan; Chang, Shu-Min; Chin, Mau-Yu; Lee, Wen-Li

2015-03-01

Animal-assisted therapy is gaining popularity as part of therapeutic activities for older adults in many long-term care facilities. However, concerns about dog bites, allergic responses to pets, disease, and insufficient available resources to care for a real pet have led to many residential care facilities to ban this therapy. There are situations where a substitute artificial companion, such as robotic pet, may serve as a better alternative. This pilot study used a one-group pre- and posttest design to evaluate the effect of a robot-assisted therapy for older adults. Sixteen eligible participants participated in the study and received a group robot-assisted therapy using a seal-like robot pet for 30 minutes twice a week for 4 weeks. All participants received assessments of their communication and interaction skills using the Assessment of Communication and Interaction Skills (ACIS-C) and activity participation using the Activity Participation Scale at baseline and at week 4. A total of 12 participants completed the study. Wilcoxon signed rank test showed that participants' communication and interaction skills (z = -2.94, P = 0.003) and activity participation (z = -2.66, P = 0.008) were significantly improved after receiving 4-week robot-assisted therapy. By interacting with a robot pet, such as Paro, the communication, interaction skills, and activity participation of the older adults can be improved. The robot-assisted therapy can be provided as a routine activity program and has the potential to improve social health of older adults in residential care facilities. Copyright © 2014 Wiley Publishing Asia Pty Ltd.

A Virtual Patient Software Program to Improve Pharmacy Student Learning in a Comprehensive Disease Management Course

PubMed Central

Casale, Jillian P.; Skirvin, J. Andrew; DiVall, Margarita V.

2013-01-01

Objective. To implement and assess the impact of a virtual patient pilot program on pharmacy students’ clinical competence skills. Design. Pharmacy students completed interactive software-based patient case scenarios embedded with drug-therapy problems as part of a course requirement at the end of their third year. Assessment. Assessments included drug-therapy problem competency achievement, performance on a pretest and posttest, and pilot evaluation survey instrument. Significant improvements in students’ posttest scores demonstrated advancement of clinical skills involving drug-therapy problem solving. Students agreed that completing the pilot program improved their chronic disease management skills and the program summarized the course series well. Conclusion. Using virtual patient technology allowed for assessment of student competencies and improved learning outcomes. PMID:24159213

Developing an instrument for assessing fidelity of motivational care planning: The Aboriginal and Islander Mental health initiative adherence scale.

PubMed

Prowse, Phuong-Tu; Nagel, Tricia

2014-01-01

The aim of this study was to design and trial an Adherence Scale to measure fidelity of Motivational Care Planning (MCP) within a clinical trial. This culturally adapted therapy MCP uses a client centered holistic approach that emphasises family and culture to motivate healthy life style changes. The Motivational Care Planning-Adherence Scale (MCP-AS) was developed through consultation with Aboriginal and Islander Mental Health Initiative (AIMhi) Indigenous and non-Indigenous trainers, and review of MCP training resources. The resultant ten-item scale incorporates a 9-Point Likert Scale with a supporting protocol manual and uses objective, behaviourally anchored criteria for each scale point. A fidelity assessor piloted the tool through analysis of four audio-recordings of MCP (conducted by Indigenous researchers within a study in remote communities in Northern Australia). File audits of the remote therapy sessions were utilised as an additional source of information. A Gold Standard Motivational Care Planning training video was also assessed using the MCP-AS. The Motivational Care Planning-Adherence Scale contains items measuring both process and content of therapy sessions. This scale was used successfully to assess therapy through observation of audio or video-recorded sessions and review of clinical notes. Treatment fidelity measured by the MCP-AS within the pilot study indicated high fidelity ratings. Ratings were high across the three domains of rapport, motivation, and self-management with especially high ratings for positive feedback and engagement, review of stressors and goal setting. The Motivational Care Planning-Adherence Scale has the potential to provide a measure of quality of delivery of Motivation Care Planning. The pilot findings suggest that despite challenges within the remote Indigenous community setting, Indigenous therapists delivered therapy that was of high fidelity. While developed as a research tool, the scale has the potential to support fidelity of delivery of Motivation Care Planning in clinical, supervision and training settings. Larger studies are needed to establish inter-rater reliability and internal and external validity.

Evaluation of the theory-based Quality Improvement in Physical Therapy (QUIP) programme: a one-group, pre-test post-test pilot study.

PubMed

Rutten, Geert M; Harting, Janneke; Bartholomew, L Kay; Schlief, Angelique; Oostendorp, Rob A B; de Vries, Nanne K

2013-05-25

Guideline adherence in physical therapy is far from optimal, which has consequences for the effectiveness and efficiency of physical therapy care. Programmes to enhance guideline adherence have, so far, been relatively ineffective. We systematically developed a theory-based Quality Improvement in Physical Therapy (QUIP) programme aimed at the individual performance level (practicing physiotherapists; PTs) and the practice organization level (practice quality manager; PQM). The aim of the study was to pilot test the multilevel QUIP programme's effectiveness and the fidelity, acceptability and feasibility of its implementation. A one-group, pre-test, post-test pilot study (N = 8 practices; N = 32 PTs, 8 of whom were also PQMs) done between September and December 2009. Guideline adherence was measured using clinical vignettes that addressed 12 quality indicators reflecting the guidelines' main recommendations. Determinants of adherence were measured using quantitative methods (questionnaires). Delivery of the programme and management changes were assessed using qualitative methods (observations, group interviews, and document analyses). Changes in adherence and determinants were tested in the paired samples T-tests and expressed in effect sizes (Cohen's d). Overall adherence did not change (3.1%; p = .138). Adherence to three quality indicators improved (8%, 24%, 43%; .000 ≤ p ≤ .023). Adherence to one quality indicator decreased (-15.7%; p = .004). Scores on various determinants of individual performance improved and favourable changes at practice organizational level were observed. Improvements were associated with the programme's multilevel approach, collective goal setting, and the application of self-regulation; unfavourable findings with programme deficits. The one-group pre-test post-test design limits the internal validity of the study, the self-selected sample its external validity. The QUIP programme has the potential to change physical therapy practice but needs considerable revision to induce the ongoing quality improvement process that is required to optimize overall guideline adherence. To assess its value, the programme needs to be tested in a randomized controlled trial.

[Multifamily therapy in children with learning disabilities].

PubMed

Retzlaff, Rüdiger; Brazil, Susanne; Goll-Kopka, Andrea

2008-01-01

Multifamily therapy is an evidence-based method used in the treatment and prevention of severe psychiatric disorders, behavioral problems and physical illnesses in children, adolescents and adults. For preventive family-oriented work with children with learning disorders there is a lack of therapeutic models. This article presents results from an innovative pilot project--multiple family groups for families with a learning disabled child of primary school age (six to eleven years old). Based on a systemic approach, this resource-oriented program integrates creative, activity-based interventions and group therapy techniques and conveys a comprehensive understanding of the challenges associated with learning disorders. Because of the pilot character of the study and the small sample size, the results have to be interpreted with care. The results do however clearly support the wider implementation and evaluation of the program in child guidance clinics, social-pediatric centers, as well as child and adolescent clinics and schools.

Developing a systematic evaluation approach for training programs within a train-the-trainer model for youth cognitive behavior therapy.

PubMed

Nakamura, Brad J; Selbo-Bruns, Alexandra; Okamura, Kelsie; Chang, Jaime; Slavin, Lesley; Shimabukuro, Scott

2014-02-01

The purpose of this small pilot study was three-fold: (a) to begin development of a coding scheme for supervisor and therapist skill acquisition, (b) to preliminarily investigate a pilot train-the-trainer paradigm for skill development, and (c) to evaluate self-reported versus observed indicators of skill mastery in that pilot program. Participants included four supervisor-therapist dyads (N = 8) working with public mental health sector youth. Master trainers taught cognitive-behavioral therapy techniques to supervisors, who in turn trained therapists on these techniques. Supervisor and therapist skill acquisition and supervisor use of teaching strategies were repeatedly assessed through coding of scripted role-plays with a multiple-baseline across participants and behaviors design. The coding system, the Practice Element Train the Trainer - Supervisor/Therapist Versions of the Therapy Process Observational Coding System for Child Psychotherapy, was developed and evaluated though the course of the investigation. The coding scheme demonstrated excellent reliability (ICCs [1,2] = 0.81-0.91) across 168 video recordings. As calculated through within-subject effect sizes, supervisor and therapist participants, respectively, evidenced skill improvements related to teaching and performing therapy techniques. Self-reported indicators of skill mastery were inflated in comparison to observed skill mastery. Findings lend initial support for further developing an evaluative approach for a train-the-trainer effort focused on disseminating evidence-based practices. Published by Elsevier Ltd.

Effects of clopidogrel therapy on whole blood platelet aggregation, the Plateletworks® assay and coagulation parameters in cats with asymptomatic hypertrophic cardiomyopathy: a pilot study.

PubMed

den Toom, M L; van Leeuwen, M W; Szatmári, V; Teske, E

2017-12-01

Although scientific evidence is limited, clopidogrel is frequently used as prophylaxis for arterial thromboembolism in cats with hypertrophic cardiomyopathy (HCM). Evaluating effects of clopidogrel therapy in asymptomatic cats with HCM on (1) conventional whole blood aggregation (WBA), (2) alternative platelet aggregation assessed with tubes of the Plateletworks® assay and (3) standard coagulation parameters. Prospective, randomized, double-blind, placebo-controlled pilot study. Fourteen asymptomatic HCM cats were randomly allocated to receive placebo (n = 5) or clopidogrel (18.75 mg/cat q24h, n = 9) as part of a larger study. Aggregation responses (to 20 µM adenosine diphosphate (ADP) and 10 µg/ml collagen) in WBA and the Plateletworks® assay and standard coagulation parameters were evaluated at baseline and after seven days of therapy. Clopidogrel therapy significantly reduced aggregation responses to ADP and collagen in the Plateletworks® agonists tubes (ADP and collagen: P < 0.001), but did not significantly reduce aggregation responses to ADP and collagen in the WBA technique (ADP: P = 0.07, collagen: P = 0.30). Clopidogrel therapy did not show a significant effect on prothrombin time, activated partial thromboplastin time, antithrombin, D-dimers and fibrinogen concentrations. Clopidogrel therapy at a dose of 18.75 mg/cat q24h for seven days causes a significant decrease in in vitro platelet aggregation evaluated with the Plateletworks® assay, without affecting standard coagulation parameters in cats with asymptomatic HCM.

HOME-BASED SELF-DELIVERED MIRROR THERAPY FOR PHANTOM PAIN: A PILOT STUDY*

PubMed Central

Darnall, Beth D.; Li, Hong

2014-01-01

Objective To test the feasibility and preliminary efficacy of self-delivered home-based mirror therapy for phantom pain. Design Uncontrolled prospective treatment outcome pilot study. Participants Forty community-dwelling adults with unilateral amputation and phantom pain >3 on a 0–10 numeric rating scale enrolled either during a one-time study visit (n = 30) or remotely (n = 10). Methods Participants received an explanation of mirror therapy and were asked to self-treat for 25 min daily. Participants completed and posted back sets of outcomes questionnaires at months 1 and 2 post-treatment. Main outcome was mean phantom pain intensity at post-treatment. Results A significant reduction in mean phantom pain intensity was found at month 1 (n = 31, p = 0.0002) and at month 2 (n = 26, p = 0.002). The overall median percentage reduction at month 2 was 15.4%. Subjects with high education (>16 years) compared with low education (<16 years) (37.5% vs 4.1%) had greater reduction in pain intensity (p = 0.01). Conclusion These findings support the feasibility and efficacy of home-based self-delivered mirror therapy; this low-cost treatment may defray medical costs, therapy visits, and the patient travel burden for people with motivation and a high level of education. More research is needed to determine methods of cost-effective support for people with lower levels of education. PMID:22378591

Ambroxol chaperone therapy for neuronopathic Gaucher disease: A pilot study.

PubMed

Narita, Aya; Shirai, Kentarou; Itamura, Shinji; Matsuda, Atsue; Ishihara, Akiko; Matsushita, Kumi; Fukuda, Chisako; Kubota, Norika; Takayama, Rumiko; Shigematsu, Hideo; Hayashi, Anri; Kumada, Tomohiro; Yuge, Kotaro; Watanabe, Yoriko; Kosugi, Saori; Nishida, Hiroshi; Kimura, Yukiko; Endo, Yusuke; Higaki, Katsumi; Nanba, Eiji; Nishimura, Yoko; Tamasaki, Akiko; Togawa, Masami; Saito, Yoshiaki; Maegaki, Yoshihiro; Ohno, Kousaku; Suzuki, Yoshiyuki

2016-03-01

Gaucher disease (GD) is a lysosomal storage disease characterized by a deficiency of glucocerebrosidase. Although enzyme-replacement and substrate-reduction therapies are available, their efficacies in treating the neurological manifestations of GD are negligible. Pharmacological chaperone therapy is hypothesized to offer a new strategy for treating the neurological manifestations of this disease. Specifically, ambroxol, a commonly used expectorant, has been proposed as a candidate pharmacological chaperone. The purpose of this study was to evaluate the safety, tolerability, and neurological efficacy of ambroxol in patients with neuronopathic GD. This open-label pilot study included five patients who received high-dose oral ambroxol in combination with enzyme replacement therapy. Safety was assessed by adverse event query, physical examination, electrocardiography, laboratory studies, and drug concentration. Biochemical efficacy was assessed through evidence of glucocerebrosidase activity in the lymphocytes and glucosylsphingosine levels in the cerebrospinal fluid. Neurological efficacy was evaluated using the Unified Myoclonus Rating Scale, Gross Motor Function Measure, Functional Independence Measure, seizure frequency, pupillary light reflex, horizontal saccadic latency, and electrophysiologic studies. High-dose oral ambroxol had good safety and tolerability, significantly increased lymphocyte glucocerebrosidase activity, permeated the blood-brain barrier, and decreased glucosylsphingosine levels in the cerebrospinal fluid. Myoclonus, seizures, and pupillary light reflex dysfunction markedly improved in all patients. Relief from myoclonus led to impressive recovery of gross motor function in two patients, allowing them to walk again. Pharmacological chaperone therapy with high-dose oral ambroxol shows promise in treating neuronopathic GD, necessitating further clinical trials.

CHHIPS (Controlling Hypertension and Hypotension Immediately Post-Stroke) Pilot Trial: rationale and design.

PubMed

Potter, J; Robinson, T; Ford, G; James, M; Jenkins, D; Mistri, A; Bulpitt, C; Drummond, A; Jagger, C; Knight, J; Markus, H; Beevers, G; Dewey, M; Lees, K; Moore, A; Paul, S

2005-03-01

High and low blood pressure (BP) levels are common following acute stroke, with up to 60% of patients being hypertensive (SBP > 160 mmHg) and nearly 20% having relative hypotension (SBP < or = 140 mmHg), within the first few hours of ictus, both conditions being associated with an adverse prognosis. At present, the optimum management of blood pressure in the immediate post-stroke period is unclear. The primary aim of the Controlling Hypertension and Hypotension Immediately Post-Stroke (CHHIPS) Pilot Trial is to assess whether hypertension and relative hypotension, manipulated therapeutically in the first 24 h following acute stroke, affects short-term outcome measures. The CHHIPS Pilot Trial is a UK based multi-centre, randomized, double-blind, placebo-controlled, titrated dose trial. Acute stroke and medical units in teaching and district general hospitals, in the UK. The CHHIPS Pilot Study aims to recruit 2050 patients, with clinically suspected stroke, confirmed by brain imaging, who have no compelling indication or contraindication for BP manipulation. The primary outcome measure will be the effects of acute pressor therapy (initiated < or = 12 h from stroke onset) or depressor therapy (started < or = 24 h post-ictus) on death and dependency at 14 days post-stroke. Secondary outcome measures will include the influence of therapy on early neurological deterioration, the effectiveness of treatment in manipulating BP levels, the influence of time to treatment and stroke type on response and a cost-effectiveness analysis.

Multi-Family Psychoeducational Support Group Therapy for Families with a Member Afflicted with Irreversible Brain Syndrome (Alzheimer's Disease): Report of a Pilot Study.

ERIC Educational Resources Information Center

Paley, Evelyn S.; And Others

Alzheimers Disease (AD), an incurable disability which afflicts older adults, can have devastating emotional consequences for the victim and the family. In an attempt to determine the effectiveness of multifamily psychoeducational support, group therapy (MFPSGT), 22 persons (13 families) from the Alzheimer's Disease and Related Disorders…

Non-Attendance and Utilization of a Speech and Language Therapy Service: A Retrospective Pilot Study of School-Aged Referrals

ERIC Educational Resources Information Center

Curran, Amy; Flynn, Catherine; Antonijevic-Elliott, Stanislava; Lyons, Rena

2015-01-01

Background: Non-attendance and inappropriate referrals affect the effective and efficient running of healthcare services. Non-engagement with speech and language therapy (SLT) services may lead to negative long-term consequences for children in need of SLT intervention. Currently there is a dearth of research on non-attendance and non-engagement…

Focusing and Expressive Arts Therapy as a Complementary Treatment for Women with Breast Cancer

ERIC Educational Resources Information Center

Klagsbrun, Joan; Rappaport, Laury; Speiser, Vivien Marcow; Post, Pamela; Byers, Julia; Stepakoff, Shanee; Karman, Shira

2005-01-01

This pilot study (N = 18) explored the effectiveness of focusing and expressive arts therapies intervention on the quality of life of women with breast cancer. The format was a 2-day (7 hours per day) retreat/support group in which complementary treatments (focusing, writing, art, and movement) were provided in an intensive format. Our hypothesis…

Urinary calculi in aviation pilots: what is the best therapeutic approach?

PubMed

Zheng, Wei; Beiko, Darren T; Segura, Joseph W; Preminger, Glenn M; Albala, David M; Denstedt, John D

2002-10-01

We reviewed treatment outcomes in a series of aviation pilots treated in the era of modern surgical techniques and provide recommendations regarding treatment in this unique group. We retrospectively analyzed the records of all aviation pilots surgically treated for urinary calculi at our 4 tertiary stone centers from January 1988 to June 2000. Preoperative data and postoperative results were evaluated. Primary outcome measures included stone-free status after initial therapy, time lost from work and overall stone-free rates. Secondary outcome measures included the need for secondary procedures and complications. Of the 36 patients 17 had renal and 19 had ureteral stones. In 4 patients the stones passed spontaneously, while 17 were initially treated with extracorporeal shock wave lithotripsy (ESWL) (Dornier Medical Systems, Marietta, Georgia), 9 were initially treated with ureteroscopy and 6 were treated with percutaneous nephrolithotripsy. There was 1 complication. The stone-free rate for ESWL, percutaneous nephrolithotripsy and ureteroscopy after initial therapy was 35%, 100% and 100%, respectively. All patients were rendered stone-free after secondary therapy. Mean time lost from work for ESWL, percutaneous nephrolithotripsy and ureteroscopy was 4.7, 2.6 and 1.6 weeks, respectively. Aviation pilots with surgical urolithiasis are best treated with an initial endoscopic procedure. Stone-free rates can be maximized, while time lost from work can be minimized when an endoscopic approach is used initially. All pilots with urolithiasis should undergo mandatory metabolic evaluations to institute medical therapy when indicated.

Effects of music therapy in the treatment of children with delayed speech development - results of a pilot study

PubMed Central

2010-01-01

Background Language development is one of the most significant processes of early childhood development. Children with delayed speech development are more at risk of acquiring other cognitive, social-emotional, and school-related problems. Music therapy appears to facilitate speech development in children, even within a short period of time. The aim of this pilot study is to explore the effects of music therapy in children with delayed speech development. Methods A total of 18 children aged 3.5 to 6 years with delayed speech development took part in this observational study in which music therapy and no treatment were compared to demonstrate effectiveness. Individual music therapy was provided on an outpatient basis. An ABAB reversal design with alternations between music therapy and no treatment with an interval of approximately eight weeks between the blocks was chosen. Before and after each study period, a speech development test, a non-verbal intelligence test for children, and music therapy assessment scales were used to evaluate the speech development of the children. Results Compared to the baseline, we found a positive development in the study group after receiving music therapy. Both phonological capacity and the children's understanding of speech increased under treatment, as well as their cognitive structures, action patterns, and level of intelligence. Throughout the study period, developmental age converged with their biological age. Ratings according to the Nordoff-Robbins scales showed clinically significant changes in the children, namely in the areas of client-therapist relationship and communication. Conclusions This study suggests that music therapy may have a measurable effect on the speech development of children through the treatment's interactions with fundamental aspects of speech development, including the ability to form and maintain relationships and prosodic abilities. Thus, music therapy may provide a basic and supportive therapy for children with delayed speech development. Further studies should be conducted to investigate the mechanisms of these interactions in greater depth. Trial registration The trial is registered in the German clinical trials register; Trial-No.: DRKS00000343 PMID:20663139

Reiki therapy for postoperative oral pain in pediatric patients: pilot data from a double-blind, randomized clinical trial.

PubMed

Kundu, Anjana; Lin, Yuting; Oron, Assaf P; Doorenbos, Ardith Z

2014-02-01

To examine the effects of Reiki as an adjuvant therapy to opioid therapy for postoperative pain control in pediatric patients. This was a double-blind, randomized controlled study of children undergoing dental procedures. Participants were randomly assigned to receive either Reiki therapy or the control therapy (sham Reiki) preoperatively. Postoperative pain scores, opioid requirements, and side effects were assessed. Family members were also asked about perioperative care satisfaction. Multiple linear regressions were used for analysis. Thirty-eight children participated. The blinding procedure was successful. No statistically significant difference was observed between groups on all outcome measures. Our study provides a successful example of a blinding procedure for Reiki therapy among children in the perioperative period. This study does not support the effectiveness of Reiki as an adjuvant therapy to opioid therapy for postoperative pain control in pediatric patients. Copyright © 2013 Elsevier Ltd. All rights reserved.

Reiki therapy for postoperative oral pain in pediatric patients: Pilot data from a double-blind, randomized clinical trial

PubMed Central

Kundu, Anjana; Lin, Yuting; Oron, Assaf P.; Doorenbos, Ardith Z.

2014-01-01

Purpose To examine the effects of Reiki as an adjuvant therapy to opioid therapy for postoperative pain control in pediatric patients. Methods This was a double-blind, randomized controlled study of children undergoing dental procedures. Participants were randomly assigned to receive either Reiki therapy or the control therapy (sham Reiki) preoperatively. Postoperative pain scores, opioid requirements, and side effects were assessed. Family members were also asked about perioperative care satisfaction. Multiple linear regressions were used for analysis. Results Thirty-eight children participated. The blinding procedure was successful. No statistically significant difference was observed between groups on all outcome measures. Implications Our study provides a successful example of a blinding procedure for Reiki therapy among children in the perioperative period. This study does not support the effectiveness of Reiki as an adjuvant therapy to opioid therapy for postoperative pain control in pediatric patients. PMID:24439640

Acceptance and Commitment Therapy for Inpatients with Psychosis (the REACH Study): Protocol for Treatment Development and Pilot Testing

PubMed Central

Gaudiano, Brandon A.; Davis, Carter H.; Epstein-Lubow, Gary; Johnson, Jennifer E.; Mueser, Kim T.; Miller, Ivan W.

2017-01-01

Patients with schizophrenia-spectrum disorders frequently require treatment at inpatient hospitals during periods of acute illness for crisis management and stabilization. Acceptance and Commitment Therapy (ACT), a “third wave” cognitive-behavioral intervention that employs innovative mindfulness-based strategies, has shown initial efficacy in randomized controlled trials for improving acute and post-discharge outcomes in patients with psychosis when studied in acute-care psychiatric hospitals in the U.S. However, the intervention has not been widely adopted in its current form because of its use of an individual-only format and delivery by doctoral-level research therapists with extensive prior experience using ACT. The aim of the Researching the Effectiveness of Acceptance-based Coping during Hospitalization (REACH) Study is to adapt a promising acute-care psychosocial treatment for inpatients with psychosis, and to pilot test its effectiveness in a routine inpatient setting. More specifically, we describe our plans to: (a) further develop and refine the treatment and training protocols, (b) conduct an open trial and make further modifications based on the experience gained, and (c) conduct a pilot randomized controlled trial in preparation for a future fully-powered clinical trial testing the effectiveness of ACT. PMID:28475123

Telephone-administered cognitive-behavioral therapy for clients with depressive symptoms in an employee assistance program: a pilot study.

PubMed

Lam, Raymond W; Lutz, Kevin; Preece, Melady; Cayley, Paula M; Bowen Walker, Anne

2011-02-01

To assess the clinical and work productivity effects of a brief intervention using telephone-administered cognitive-behavioral therapy (CBT) for clients with depressive symptoms attending an employee assistance program (EAP). Self-referred clients attending the PPC Canada EAP with clinically relevant depressive symptoms at initial assessment were offered an 8-session telephone-administered CBT program. Outcomes before and after intervention were assessed with the 9-item Personal Health Questionnaire (PHQ-9), Global Assessment of Functioning (GAF), and clinician ratings of work absence and performance impairment. Fifty clients were referred to the pilot program; 39 participated and 31 completed the telephone CBT program. Among program participants, there was significant improvement in PHQ-9 and GAF scores. There was also a significant reduction in performance impairment but not work absence. Anecdotal reports indicated high satisfaction ratings among participants. The results of this pilot study, although limited by the absence of a comparison or control group, suggest that a brief telephone-administered CBT program can improve depressive symptomatology, work productivity, and general function in depressed clients attending an EAP. Further controlled studies are needed to confirm these preliminary findings.

Pilot Study on the Effectiveness of Systematic Desensitization with Neurologically Impaired Children with Phobic Disorders

ERIC Educational Resources Information Center

Obler, Martin; Terwilliger, Robert F.

1970-01-01

A modified version of Wolpe's systematic desensitization therapy involving direct confrontation with the fear inducing stimulus was attempted with neurologically impaired children with phobic symptoms. (Author)

Morita therapy for depression and anxiety (Morita Trial): study protocol for a pilot randomised controlled trial.

PubMed

Sugg, Holly Victoria Rose; Richards, David A; Frost, Julia

2016-03-24

Morita Therapy, a psychological therapy for common mental health problems, is in sharp contrast to established western psychotherapeutic approaches in teaching that undesired symptoms are natural features of human emotion rather than something to control or eliminate. The approach is widely practiced in Japan, but untested and little known in the UK. A clinical trial of Morita Therapy is required to establish the effectiveness of Morita Therapy for a UK population. However, a number of methodological, procedural and clinical uncertainties associated with such a trial first require addressing. The Morita Trial is a mixed methods study addressing the uncertainties associated with an evaluation of Morita Therapy compared with treatment as usual for depression and anxiety. We will undertake a pilot randomised controlled trial with embedded qualitative study. Sixty participants with major depressive disorder, with or without anxiety disorders, will be recruited predominantly from General Practice record searches and randomised to receive Morita Therapy plus treatment as usual or treatment as usual alone. Morita Therapy will be delivered by accredited psychological therapists. We will collect quantitative data on depressive symptoms, general anxiety, attitudes and quality of life at baseline and four month follow-up to inform future sample size calculations; and rates of recruitment, retention and treatment adherence to assess feasibility. We will undertake qualitative interviews in parallel with the trial, to explore people's views of Morita Therapy. We will conduct separate and integrated analyses on the quantitative and qualitative data. The outcomes of this study will prepare the ground for the design and conduct of a fully-powered evaluation of Morita Therapy plus treatment as usual versus treatment as usual alone, or inform a conclusion that such a trial is not feasible and/or appropriate. We will obtain a more comprehensive understanding of these issues than would be possible from either a quantitative or qualitative approach alone. Current Controlled Trials ISRCTN17544090 registered on 23 July 2015.

Pilot study of dornase alfa (Pulmozyme) therapy for acquired ventilator-associated infection in preterm infants.

PubMed

Scala, Melissa; Hoy, Deborah; Bautista, Maria; Palafoutas, Judith Jones; Abubakar, Kabir

2017-06-01

Evaluate the feasibility, safety, and efficacy of adjunctive treatment with dornase alfa in preterm patients with ventilator-associated pulmonary infection (VAPI) compared to standard care. We hypothesize that therapy with dornase alfa will be safe and well tolerated in the preterm population with no worsening of symptoms, oxygen requirement, or need for respiratory support. Prospective, randomized, blinded, pilot study comparing adjunctive treatment with dornase alfa to sham therapy. In addition to standard care, infants were randomized to receive dornase alfa 2.5 mg nebulized via endotracheal tube (ETT) every 12 hr for 7 days or sham therapy. ETT secretion gram stain and culture and chest X-ray (CXR) findings were evaluated. Respiratory support data were downloaded from the ventilator. Fourteen infants developed VAPI between 2012 and 2014; 11 enrolled in the study. Six received dornase alfa and five received sham therapy. Average gestational age at birth was 25 weeks and age at study entry was 31 days. There were no differences in demographics, ETT white blood cell count (WBC), CXR, or mean airway pressure (MAP) between the two groups. There was a trend towards decreased oxygen requirement (FiO2) in the treatment group that did not reach statistical significance. No side effects were observed in the treatment group. Treatment with dornase alfa is safe and treated infants had some improvement in FiO 2 requirement but no improvement in MAP. A larger randomized trial is needed to evaluate the efficacy of this therapy. Pediatr Pulmonol. 2017; 52:787-791. © 2017 Wiley Periodicals, Inc. © 2017 Wiley Periodicals, Inc.

Music therapy for prisoners: pilot randomised controlled trial and implications for evaluating psychosocial interventions.

PubMed

Gold, Christian; Assmus, Jörg; Hjørnevik, Kjetil; Qvale, Liv Gunnhild; Brown, Fiona Kirkwood; Hansen, Anita Lill; Waage, Leif; Stige, Brynjulf

2014-12-01

Mental health problems are common among prison inmates. Music therapy has been shown to reduce mental health problems. It may also be beneficial in the rehabilitation of prisoners, but rigorous outcome research is lacking. We compared group music therapy with standard care for prisoners in a pilot randomised controlled trial that started with the establishment of music therapy services in a prison near Bergen in 2008. In all, 113 prisoners agreed to participate. Anxiety (STAI-State [State-Trait Anxiety Inventory], STAI-Trait), depression (HADS-D [Hospital Anxiety and Depression Scale]), and social relationships (Quality of Life Enjoyment and Satisfaction Questionnaire [Q-LES-Q]) were assessed at baseline; every 2 weeks in the experimental group; after 1, 3, and 6 months in the control group; and at release. No restrictions were placed on the frequency, duration, or contents of music therapy. Duration of stay in the institution was short (62% stayed less than 1 month). Only a minority reached clinical cutoffs for anxiety and depression at baseline. Between-group analyses of effects were not possible. Music therapy was well accepted and attractive among the prisoners. Post hoc analysis of within-group changes suggested a reduction of state anxiety after 2 weeks of music therapy (d = 0.33, p = .025). Short sentences and low baseline levels of psychological disturbance impeded the examination of effects in this study. Recommendations for planning future studies are given, concerning the careful choice of participants, interventions and settings, comparison condition and design aspects, choice of outcomes, and integration of research approaches. Thus, the present study has important implications for future studies evaluating interventions for improving prisoners' mental health. ISRCTN22518605. © The Author(s) 2013.

Pilot study evaluating the effect of massage therapy on stress, anxiety and aggression in a young adult psychiatric inpatient unit.

PubMed

Garner, Belinda; Phillips, Lisa J; Schmidt, Hans-Martin; Markulev, Connie; O'Connor, Jenny; Wood, Stephen J; Berger, Gregor E; Burnett, Peter; McGorry, Patrick D

2008-05-01

The aim of the present pilot study was to examine the effectiveness of a relaxation massage therapy programme in reducing stress, anxiety and aggression on a young adult psychiatric inpatient unit. This was a prospective, non-randomized intervention study comparing treatment as usual (TAU) with TAU plus massage therapy intervention (MT) over consecutive 7 week blocks (May-August 2006). MT consisted of a 20 min massage therapy session offered daily to patients during their period of hospitalization. The Kennedy Nurses' Observational Scale for Inpatient Evaluation (NOSIE), the Symptom Checklist-90-Revised (SCL-90-R), the State-Trait Anxiety Inventory (STAI) and stress hormone (saliva cortisol) levels were used to measure patient outcomes at admission and discharge from the unit. The Staff Observation Aggression Scale-Revised (SOAS-R) was used to monitor the frequency and severity of aggressive incidents on the unit. There was a significant reduction in self-reported anxiety (p < 0.001), resting heart rate (p < 0.05) and cortisol levels (p < 0.05) immediately following the initial and final massage therapy sessions. Significant improvements in hostility (p = 0.007) and depression scores (p < 0.001) on the SCL-90-R were observed in both treatment groups. There was no group x time interaction on any of the measures. Poor reliability of staff-reported incidents on the SOAS-R limited the validity of results in this domain. Massage therapy had immediate beneficial effects on anxiety-related measures and may be a useful de-escalating tool for reducing stress and anxiety in acutely hospitalized psychiatric patients. Study limitations preclude any definite conclusions on the effect of massage therapy on aggressive incidents in an acute psychiatric setting. Randomized controlled trials are warranted.

The Impact of Massage and Reading on Children's Pain and Anxiety After Cardiovascular Surgery: A Pilot Study.

PubMed

Staveski, Sandra L; Boulanger, Karen; Erman, Lee; Lin, Li; Almgren, Christina; Journel, Chloe; Roth, Stephen J; Golianu, Brenda

2018-06-14

The purpose of this pilot study was three-fold: 1) to evaluate the safety and feasibility of instituting massage therapy in the immediate postoperative period after congenital heart surgery, 2) to examine the preliminary results on effects of massage therapy versus standard of care plus three reading visits on postoperative pain and anxiety, and 3) to evaluate preliminary effects of opioid and benzodiazepine exposure in patients receiving massage therapy compared with reading controls. Prospective, randomized controlled trial. An academic children's hospital. Sixty pediatric heart surgery patients between ages 6 and 18 years. Massage therapy and reading. There were no adverse events related to massage or reading interventions in either group. Our investigation found no statistically significant difference in Pain or State-Trait Anxiety scores in the initial 24 hours after heart surgery (T1) and within 48 hours of transfer to the acute care unit (T2) after controlling for age, gender, and Risk Adjustment for Congenital Heart Surgery 1 score. However, children receiving massage therapy had significantly lower State-Trait Anxiety scores after receiving massage therapy at time of discharge (T3; p = 0.0075) than children receiving standard of care plus three reading visits. We found no difference in total opioid exposure during the first 3 postoperative days between groups (median [interquartile range], 0.80 mg/kg morphine equivalents [0.29-10.60] vs 1.13 mg/kg morphine equivalents [0.72-6.14]). In contrast, children receiving massage therapy had significantly lower total benzodiazepine exposure in the immediate 3 days following heart surgery (median [interquartile range], 0.002 mg/kg lorazepam equivalents [0-0.03] vs 0.03 mg/kg lorazepam equivalents [0.02-0.09], p = 0.0253, Wilcoxon rank-sum) and number of benzodiazepine PRN doses (0.5 [0-2.5] PRN vs 2 PRNs (1-4); p = 0.00346, Wilcoxon rank-sum). Our pilot study demonstrated the safety and feasibility of implementing massage therapy in the immediate postoperative period in pediatric heart surgery patients. We found decreased State-Trait Anxiety scores at discharge and lower total exposure to benzodiazepines. Preventing postoperative complications such as delirium through nonpharmacologic interventions warrants further evaluation.

Increasing the occupational therapy mental health workforce through innovative practice education: a pilot project.

PubMed

Rodger, Sylvia; Thomas, Yvonne; Holley, Sue; Springfield, Elizabeth; Edwards, Ann; Broadbridge, Jacqui; Greber, Craig; McBryde, Cathy; Banks, Rebecca; Hawkins, Rachel

2009-12-01

This paper describes the evaluation of a pilot trial of two innovative placement models in the area of mental health, namely role emerging and collaborative supervision. The Queensland Occupational Therapy Fieldwork Collaborative conducted this trial in response to workforce shortages in mental health. Six occupational therapy students and eight practice educators were surveyed pre- and post-placements regarding implementation of these innovative models. Students participating in these placements reported that they were highly likely to work in mental health upon graduation, and practice educators were positive about undertaking innovative placements in future. An overview of the placement sites, trials, outcomes and limitations of this pilot trial is provided. Though limited by its small sample size, this pilot trial has demonstrated the potential of innovative placement models to provide valuable student learning experiences in mental health. The profession needs to develop expertise in the use of innovative placement models if students are to be adequately prepared to work with the mental health issues of the Australian community now and in the future.

Effects of animal-assisted therapy on agitated behaviors and social interactions of older adults with dementia.

PubMed

Richeson, Nancy E

2003-01-01

The effects of a therapeutic recreation intervention using animal-assisted therapy (AAT) on the agitated behaviors and social interactions of older adults with dementia were examined using the Cohen-Mansfield Agitation Inventory and the Animal-Assisted Therapy Flow Sheet. In a pilot study, 15 nursing home residents with dementia participated in a daily AAT intervention for three weeks. Results showed statistically significant decreases in agitated behaviors and a statistically significant increase in social interaction pretest to post-test.

MindSurf: a pilot study to assess the usability and acceptability of a smartphone app designed to promote contentment, wellbeing, and goal achievement.

PubMed

Carey, Timothy A; Haviland, Jennifer; Tai, Sara J; Vanags, Thea; Mansell, Warren

2016-12-12

The Method of Levels (MOL) is a transdiagnostic cognitive therapy that promotes contentment, wellbeing, and goal achievement through the resolution of internal conflicts underlying psychological distress. MOL, based on Perceptual Control Theory (PCT), was developed in routine clinical practice and has been used effectively across different health services by different practitioners. Access to MOL-style questions through a smartphone app could, potentially, help both the general public maintain robust mental health, and also be a useful adjunct to therapy for clinical populations. The app is called MindSurf because of its focus on helping people explore their thinking. Prior to developing the app and using it with different populations it was necessary to determine whether such an idea would be usable for and acceptable to potential app users. Therefore, a pilot study was conducted with a non-clinical sample to assess the usability and acceptability of the app including monitoring whether the questions delivered in this way were associated with any adverse events. A pilot study using quantitative as well as qualitative methods and incorporating a repeated measures, A-B design was conducted. The 23 participants were healthy adult volunteers who were all either undergraduate students, postgraduate students, or staff of the University of Manchester. They received MOL-style questions on their mobile phones over a 1-week period. Qualitative results were encouraging and indicated that the format and style of questioning were acceptable to participants and did not lead to increased worry or concern. A one-way, repeated measures ANOVA indicated that there was a nonsignificant decrease in scores on the 21-item Depression, Anxiety, and Stress Scale (DASS21) over a 2 week period. The results of the pilot study justified development of MindSurf and further testing once it is available for use. A power analysis indicated that the pilot study was underpowered to detect significant effects but provided important information regarding the appropriate sample size for future research. The pilot study also indicated that future research should investigate the effects of receiving more than three questions per day. Results of the pilot study indicate that MindSurf will be a usable and acceptable app. Its benefits should be further explored through longer studies with larger sample of both the general population as well as clinical populations.

Therapeutic role of Vitamin B12 in patients of chronic tinnitus: A pilot study.

PubMed

Singh, Charu; Kawatra, Rahul; Gupta, Jaya; Awasthi, Vishnu; Dungana, Homnath

2016-01-01

True tinnitus is a phantom auditory perception arising from a source or trigger in the cochlea, brainstem, or at higher centers and has no detectable acoustic generator. The most accepted is the famous neurophysiologic model of Jastreboff, which stresses that tinnitus, is a subcortical perception and results from the processing of weak neural activity in the periphery. The aim of this study is to determine the role of Vitamin B12 in treatment of chronic tinnitus. In this randomized, double-blind pilot study, total 40 patients were enrolled, of which 20 in Group A (cases) received intramuscular therapy of 1 ml Vitamin B12 (2500 mcg) weekly for a period of 6 weeks and Group B (20) patients received placebo isotonic saline 01 ml intramuscular. The patients were subjected to Vitamin B12 assay and audiometry pre- and post-therapy. Of the total patients of tinnitus, 17 were Vitamin B12 deficient that is 42.5% showed deficiency when the normal levels were considered to be 250 pg/ml. A paired t-test showed that in Group A, patients with Vitamin B12 deficiency showed significant improvement in mean tinnitus severity index score and visual analog scale (VAS) after Vitamin B12 therapy. This pilot study highlights the significant prevalence of Vitamin B12 deficiency in North Indian population and improvement in tinnitus severity scores and VAS in cobalamin-deficient patients receiving intramuscular Vitamin B12 weekly for 6 weeks further provides a link between cobalamin deficiency and tinnitus thereby suggestive of a therapeutic role of B12 in cobalamin-deficient patients of tinnitus.

A pilot study of rhythm and timing training as a supplement to occupational therapy in stroke rehabilitation.

PubMed

Hill, Valerie; Dunn, Leah; Dunning, Kari; Page, Stephen J

2011-01-01

Stroke is the leading cause of disability. A need exists for an effective intervention to enhance upper extremity (UE) motor abilities and activities of daily living (ADL) performance. The objectives of this pilot study were to (1) determine the feasibility of adding Interactive Metronome (IM) to an occupational therapy (OT) program; and (2) determine changes in UE impairments, function, quality of life, and perceived physical performance ability and satisfaction using a combined IM + OT regimen compared with OT alone for adults with chronic stroke. This pilot study (n=10) used a 2-group (OT or IM+OT) pretest-posttest design. The intervention involved 60 minutes of IM + OT or OT alone, 3 days a week for 10 weeks. Outcome measures included the UE Fugl-Meyer (impairment), the Arm Motor Ability Test (function), the Box and Block Test (function), Stroke Impact Scale (quality of life), and the Canadian Occupational Performance Measure (perceived performance ability and satisfaction). It was feasible to add IM to OT. The IM+OT group demonstrated decreased impairment and increased quality of life. However, the OT-alone group demonstrated greater gains in function, perceived physical performance ability, and satisfaction. These findings suggest that rhythm and timing training using the IM is a feasible intervention to consider as part of therapy treatment. However, IM may fit best for prefunctional treatment, as it seemed to primarily decrease impairment. It may also serve as a supplement before or after treatment in order to maximize rehabilitation potential. Clinical implications and suggestions for future studies are provided.

DOE Office of Scientific and Technical Information (OSTI.GOV)

Barker, Christopher A., E-mail: barkerc@mskcc.org; Postow, Michael A.

Radiation therapy has long played a role in the management of melanoma. Recent advances have also demonstrated the efficacy of immunotherapy in the treatment of melanoma. Preclinical data suggest a biologic interaction between radiation therapy and immunotherapy. Several clinical studies corroborate these findings. This review will summarize the outcomes of studies reporting on patients with melanoma treated with a combination of radiation therapy and immunotherapy. Vaccine therapies often use irradiated melanoma cells, and may be enhanced by radiation therapy. The cytokines interferon-α and interleukin-2 have been combined with radiation therapy in several small studies, with some evidence suggesting increased toxicitymore » and/or efficacy. Ipilimumab, a monoclonal antibody which blocks cytotoxic T-lymphocyte antigen-4, has been combined with radiation therapy in several notable case studies and series. Finally, pilot studies of adoptive cell transfer have suggested that radiation therapy may improve the efficacy of treatment. The review will demonstrate that the combination of radiation therapy and immunotherapy has been reported in several notable case studies, series and clinical trials. These clinical results suggest interaction and the need for further study.« less

Brief Report: Effects of Cognitive Behavioral Therapy on Parent-Reported Autism Symptoms in School-Age Children with High-Functioning Autism

ERIC Educational Resources Information Center

Wood, Jeffrey J.; Drahota, Amy; Sze, Karen; Van Dyke, Marilyn; Decker, Kelly; Fujii, Cori; Bahng, Christie; Renno, Patricia; Hwang, Wei-Chin; Spiker, Michael

2009-01-01

This pilot study tested the effect of cognitive behavioral therapy (CBT) on parent-reported autism symptoms. Nineteen children with autism spectrum disorders and an anxiety disorder (7-11 years old) were randomly assigned to 16 sessions of CBT or a waitlist condition. The CBT program emphasized in vivo exposure supported by parent training and…

Systematic Review of Integrative Health Care Research: Randomized Control Trials, Clinical Controlled Trials, and Meta-Analysis

DTIC Science & Technology

2010-01-01

to usual care (control). Also, in the pilot study of the 4 individual Noetic therapies, off-site prayer was associated with the lowest absolute...mortality in-hospital and at 6 months [16]. The parallel randomization to 4 different Noetic therapies across 5 study arms limited the assessment of...interventional cardiac care: the Monitoring and Actualisation of Noetic Trainings (MANTRA) II randomised study ,” Lancet, vol. 366, no. 9481, pp. 211–217, 2005. [18

A Brief Survey of Patients' First Impression after CPAP Titration Predicts Future CPAP Adherence: A Pilot Study

PubMed Central

Balachandran, Jay S.; Yu, Xiaohong; Wroblewski, Kristen; Mokhlesi, Babak

2013-01-01

Background: CPAP adherence patterns are often established very early in the course of therapy. Our objective was to quantify patients' perception of CPAP therapy using a 6-item questionnaire administered in the morning following CPAP titration. We hypothesized that questionnaire responses would independently predict CPAP adherence during the first 30 days of therapy. Methods: We retrospectively reviewed the CPAP perception questionnaires of 403 CPAP-naïve adults who underwent in-laboratory titration and who had daily CPAP adherence data available for the first 30 days of therapy. Responses to the CPAP perception questionnaire were analyzed for their association with mean CPAP adherence and with changes in daily CPAP adherence over 30 days. Results: Patients were aged 52 ± 14 years, 53% were women, 54% were African American, the mean body mass index (BMI) was 36.3 ± 9.1 kg/m2, and most patients had moderate-severe OSA. Four of 6 items from the CPAP perception questionnaire— regarding difficulty tolerating CPAP, discomfort with CPAP pressure, likelihood of wearing CPAP, and perceived health benefit—were significantly correlated with mean 30-day CPAP adherence, and a composite score from these 4 questions was found to be internally consistent. Stepwise linear regression modeling demonstrated that 3 variables were significant and independent predictors of reduced mean CPAP adherence: worse score on the 4-item questionnaire, African American race, and non-sleep specialist ordering polysomnogram and CPAP therapy. Furthermore, a worse score on the 4-item CPAP perception questionnaire was consistently associated with decreased mean daily CPAP adherence over the first 30 days of therapy. Conclusions: In this pilot study, responses to a 4-item CPAP perception questionnaire administered to patients immediately following CPAP titration independently predicted mean CPAP adherence during the first 30 days. Further prospective validation of this questionnaire in different patient populations is warranted. Commentary: A commentary on this article appears in this issue on page 207. Citation: Balachandran JS; Yu X; Wroblewski K; Mokhlesi B. A brief survey of patients' first impression after CPAP titration predicts future CPAP adherence: a pilot study. J Clin Sleep Med 2013;9(3):199-205. PMID:23493772

A Pilot Study of Metabolic Effects of Omentectomy

ClinicalTrials.gov

2015-11-18

Patients Who Consented to Undergo Laparoscopic Gastric Banding Surgery for Weight Loss and Consent to Participate in This studyBMI ≥35 kg/m2; Confirmed Type 2 Diabetes Treated With Oral Agents and/or Only Diet Therapy; Age 18-64 Years

Effects of baby massage on neonatal jaundice in healthy Iranian infants: A pilot study.

PubMed

Dalili, Hosein; Sheikhi, Sanaz; Shariat, Mamak; Haghnazarian, Edith

2016-02-01

To evaluate the effects of baby massage on transcutaneous bilirubin levels and stool frequency of healthy term newborns. This Pilot study was conducted on 50 healthy newborns in Valiasr Hospital of IKHC. The infants were randomly allocated to two treatment (massage) and control group. The massage group received massage therapy (according to Touch Therapy) for four days from the first day postnatal while the control group received routine care. Main variable studied were transcutaneous bilirubin level (TCB) and stool frequency which were compared in two groups. There were 50 newborns in the study 25 in each group (50%). There was a significant difference in the TCB levels between two groups (p=0.000) with those in the massage group having lower bilirubin levels. As for the stool frequency there was a significant difference in two groups on the first day showing more defecation in the control group (p=0.042) which on the consequent days was not significant and the frequencies were almost similar. Massage group had a lower transcutaneous billirubin levels compared to the control group, thus, these pilot results indicate that massaging the newborns can be accompanied by a lower bilirubin level in the healthy term newborn. Copyright © 2015 Elsevier Inc. All rights reserved.

Pilot study: incorporation of pharmacogenetic testing in medication therapy management services.

PubMed

Haga, Susanne B; Allen LaPointe, Nancy M; Moaddeb, Jivan; Mills, Rachel; Patel, Mahesh; Kraus, William E

2014-11-01

Aim: To describe the rationale and design of a pilot study evaluating the integration of pharmacogenetic (PGx) testing into pharmacist-delivered medication therapy management (MTM). Study rationale: Clinical delivery approaches of PGx testing involving pharmacists may overcome barriers of limited physician knowledge about and experience with testing. Study design: We will assess the addition of PGx testing to MTM services for cardiology patients taking three or more medications including simvastatin or clopidogrel. We will measure the impact of MTM plus PGx testing on drug/dose adjustment and clinical outcomes. Factors associated with delivery, such as time to prepare and conduct MTM and consult with physicians will be recorded. Additionally, patient interest and satisfaction will be measured. Anticipated results: We anticipate that PGx testing can be practically integrated into standard a MTM service, providing a viable delivery model for testing. Conclusion: Given the lack of evidence of an effective PGx delivery models, this study will provide preliminary evidence regarding a pharmacist-delivered approach.

An Open, Multisite Pilot Study of Cognitive Therapy for Depressed Adolescents

PubMed Central

BELSHER, GAYLE; WILKES, T. C. R.; RUSH, A. J.

1995-01-01

In a 12-session open trial of cognitive therapy, depressed adolescent outpatients showed significant decreases in depressive symptomatology, although there was less improvement in a subgroup with comorbid attention-deficit hyperactivity or schizoid personality disorder. Decreases on measures of depressive symptoms and depressotypic cognition were maintained up to 5 months after acute-phase treatment. Outcome was not associated with age, gender, other comorbid diagnoses, concurrent use of antidepressants, duration of acute-phase therapy, or participation in subsequent booster sessions. Data suggest that cognitive therapy is a promising intervention for depressed adolescents and provide a rationale for pursuit of controlled cognitive therapy trials with this population. PMID:22700213

Ultrasound-guided stellate ganglion blocks combined with pharmacological and occupational therapy in Complex Regional Pain Syndrome (CRPS): a pilot case series ad interim.

PubMed

Wei, Karin; Feldmann, Robert E; Brascher, Anne-Kathrin; Benrath, Justus

2014-12-01

This preliminary and retrospective pilot case series examines a treatment concept consisting of ultrasound-guided stellate ganglion blocks (SGBs) combined with pharmacological and occupational therapy in patients with complex regional pain syndrome (CRPS) of the hand. Efficacy of combined treatment concepts and safety of ultrasound-guided SGB have not been sufficiently investigated yet. A total number of 156 blocks were evaluated in 16 patients with CRPS in a retrospective analysis. All patients received pharmacotherapy and a standard regimen of occupational therapy offered simultaneously to the SGBs. Changes in both spontaneous and evoked pain levels were assessed by numerical pain rating score before and after the last blockade of a series. Side effects were documented. The overall mean pain reduction was 63.2% regarding spontaneous and 45.3% regarding evoked pain. Mild complications, such as hoarseness or dysphagia, occurred in 13.5% of the blocks (21 SGBs). Serious complications, such as plexus paresis or accidental puncture of vessels or other structures, did not occur. Time between symptom onset and start of treatment did not affect the extent of pain reduction. The combination of ultrasound-guided SGB and simultaneous pharmacological and occupational therapy showed encouraging treatment results under conditions of this pilot case series. Assessment of efficacy of this combined treatment concept and safety of ultrasound-guided SGB require further prospective clinical studies with larger number of participants. Wiley Periodicals, Inc.

Influence of testosterone gel treatment on spermatogenesis in men with hypogonadism.

PubMed

George, Mskhalaya; Yulia, Tishova; Svetlana, Kalinchenko

2014-10-01

The prevalence of androgen deficiency in reproductive-aged men is increasing and needs new approach to long-term hypogonadism treatment that can preserve fertility. An open non-controlled pilot study included 18 men with eugonadotropic hypogonadism, who received transdermal testosterone gel treatment for 3 months. Sperm analysis was made before treatment and after 3 month of testosterone therapy. Testosterone level was normalized in all patients, but no negative effect was observed on spermatogenesis. Testosterone gel therapy may be a therapy of choice in hypogonadal men of reproductive age but further studies are needed.

Effects of the addition of transcranial direct current stimulation to virtual reality therapy after stroke: a pilot randomized controlled trial.

PubMed

Viana, R T; Laurentino, G E C; Souza, R J P; Fonseca, J B; Silva Filho, E M; Dias, S N; Teixeira-Salmela, L F; Monte-Silva, K K

2014-01-01

Upper limb (UL) impairment is the most common disabling deficit following a stroke. Previous studies have suggested that transcranial direct current stimulation (tDCS) enhances the effect of conventional therapies. This pilot double-blind randomized control trial aimed to determine whether or not tDCS, combined with Wii virtual reality therapy (VRT), would be superior to Wii therapy alone in improving upper limb function and quality of life in chronic stroke individuals. Twenty participants were randomly assigned either to an experimental group that received VRT and tDCS, or a control group that received VRT and sham tDCS. The therapy was delivered over 15 sessions with 13 minutes of active or sham anodal tDCS, and one hour of virtual reality therapy. The outcomes included were determined using the Fugl-Meyer scale, the Wolf motor function test, the modified Ashworth scale (MAS), grip strength, and the stroke specific quality of life scale (SSQOL). Minimal clinically important differences (MCID) were observed when assessing outcome data. Both groups demonstrated gains in all evaluated areas, except for the SSQOL-UL domain. Differences between groups were only observed in wrist spasticity levels in the experimental group, where more than 50% of the participants achieved the MCID. These findings support that tDCS, combined with VRT therapy, should be investigated and clarified further.

A decade of building massage therapy services at an academic medical center as part of a healing enhancement program.

PubMed

Rodgers, Nancy J; Cutshall, Susanne M; Dion, Liza J; Dreyer, Nikol E; Hauschulz, Jennifer L; Ristau, Crystal R; Thomley, Barb S; Bauer, Brent A

2015-02-01

The use of complementary and integrative medicine therapies is steadily becoming an integral part of health care. Massage therapy is increasingly offered to hospitalized patients for various conditions to assist with the management of common symptoms such as pain, anxiety, and tension. This article summarizes a decade of building the massage therapy service at a large tertiary care medical center, from the early pilot studies and research to the current program offerings, and the hopes and dreams for the future. Copyright © 2014 Elsevier Ltd. All rights reserved.

The CUPCIG (CAM-Use in Primary Care in Germany) Study:Part I-Pain. Study Protocol of a Pilot-trial to Assess Feasibility, Acceptability and Perceived Effectiveness of CAM in Pain Disorders in Primary Care.

PubMed

Schencking, Martin; Sönnichsen, Andreas; Bassüner, Susanne; Redaelli, Marcus

2015-01-01

There is limited valid data available on CAM procedures for chronic joint and neuropathic pain in primary care in Germany. Indiviual CAM qualifications of the general practitioners (GPs) and the potential of cost reduction through CAM treatment are almost unknown. The aim of this pilot trial preceding the main study is to examine the survey mode, to estimate the response rate by GPs with or without an additional qualification for CAM, and to identify the status quo in therapeutic approaches for chronic pain disorders in primary care. This is a cross-sectional study with an ex post facto design among German GPs consisting of 2 parts: In a first step, a pilot trial precedes the main study targeting 200 GPs with and 200 GPs without additional qualification in CAM in a selected region. The results of the CUPCIG study comprise the distribution of pain types treated in primary care practices, the GPs' attitude toward complementary pain therapy, pharmacological or CAM treatment, the estimate of cost reduction through CAM treatment of pain, the application of diverse CAM procedures, and biographical data. The CUPCIG study serves to compile pain therapy approaches in primary care in Germany with respect to the individual CAM expertise of the GPs. © 2015 S. Karger GmbH, Freiburg.

A plan analysis of pedophile sexual abusers' motivations for treatment: a qualitative pilot study.

PubMed

Drapeau, Martin; Körner, Annett; Granger, Luc; Brunet, Louis; Caspar, Franz

2005-06-01

Many authors have suggested adapting treatment programs to the specific needs of sexual abusers. However, little research has been conducted to understand what these patients seek in therapy or what elements play a key role in keeping them in treatment. In this pilot study, fifteen (N=15) pedophile sexual abusers from La Macaza clinic for sexual abusers were interviewed. Plan analysis was used to investigate the most prevalent components involved in staying in or leaving therapy. Results suggest that many components involved in the plans leading to doing and to avoiding treatment were similar. Differences were found in regards to the outcome of confrontations with the therapists, a tendency to isolate and overcomply, guilt related to the abuse, a need for a stable environment, and a need to be accepted. These results are discussed along with possible ways to improve the patients' involvement in treatment.

Pilot study for the registry of complications in rheumatic diseases from the German Society of Surgery (DGORh): evaluation of methods and data from the first 1000 patients.

PubMed

Kostuj, Tanja; Rehart, Stefan; Matta-Hurtado, Ronald; Biehl, Christoph; Willburger, Roland E; Schmidt, Klaus

2017-10-10

Most patients suffering with rheumatic diseases who undergo surgical treatment are receiving immune-modulating therapy. To determine whether these medications affect their outcomes a national registry was established in Germany by the German Society of Surgery (DGORh). Data from the first 1000 patients were used in a pilot study to identify relevant corisk factors and to determine whether such a registry is suitable for developing accurate and relevant recommendations. Data were collected from patients undergoing surgical treatments with their written consent. A second consent form was used, if complications occurred. During this pilot study, in order to obtain a quicker overview, risk factors were considered only in patients with complications. Only descriptive statistical analysis was employed in this pilot study due to limited number of observed complications and inhomogeneous data regarding the surgery and the medications the patients received. Analytical statistics will be performed to confirm the results in a future outcome study. Complications occurred in 26 patients and were distributed equally among the different types of surgeries. Twenty one of these patients were receiving immune-modulating therapy at the time, while five were not. Infections were observed in 2.3% of patients receiving and in 5.1% not receiving immunosuppression. Due to the low number of cases, inhomogeneity in the diseases and the treatments received by the patients in this pilot study, it is not possible to develop standardised best-practice recommendations to optimise their care. Based on this observation we conclude that in order to be suitable to develop accurate and relevant recommendations a national registry must include the most important and relevant variables that impact the care and outcomes of these patients. © Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2017. All rights reserved. No commercial use is permitted unless otherwise expressly granted.

A Pilot Study of CPAP Adherence Promotion by Peer Buddies with Sleep Apnea

PubMed Central

Parthasarathy, Sairam; Wendel, Christopher; Haynes, Patricia L.; Atwood, Charles; Kuna, Samuel

2013-01-01

Study Objectives: To evaluate patient ratings of the acceptability of a peer buddy system (PBS). To promote continuous positive airway pressure (CPAP) therapy adherence in patients with obstructive sleep apnea (OSA). To obtain preliminary data on the effectiveness of PBS on sleep-specific health-related quality of life and CPAP adherence. Design: Prospective, randomized, and controlled study. Setting: Academic Center. Participants: Thirty-nine patients with OSA and 13 patients with OSA who were experienced CPAP users. Interventions: Recently diagnosed patients with OSA were randomly assigned to either the PBS to promote CPAP adherence (intervention group) or usual care (control group). Measurements: Patient satisfaction, Functional Outcomes of Sleep Questionnaire (FOSQ), CPAP adherence, vigilance, self-efficacy, and patient activation were measured. Results: Ninety-one percent of the subjects rated the PBS as very satisfactory (68%) or satisfactory (23%). During the 90 days of therapy, weekly CPAP adherence was greater in the intervention than the usual care group (MANOVA; F = 2.29; p = 0.04). Patient satisfaction was positively correlated with CPAP adherence (R2 = 0.14; p = 0.02). We did not find any group differences for FOSQ, vigilance, self-efficacy, or patient activation in this pilot study. Conclusion: Our pilot study suggests that the PBS intervention is feasible and received high patient satisfaction ratings. CPAP adherence may be improved by peer-driven intervention, but a larger, adequately powered study is needed. Clinical Trial Information: ClinicalTrials.gov identifier: NCT01164683. Commentary: A commentary on this article appears in this issue on page 551. Citation: Parthasarathy S; Wendel C; Haynes PL; Atwood C; Kuna S. A pilot study of CPAP adherence promotion by peer buddies with sleep apnea. J Clin Sleep Med 2013;9(6):543-550. PMID:23772186

Prevention of recurrent urinary tract infections by intravesical administration of heparin: a pilot study.

PubMed

Ablove, Tova; Patankar, Manish; Seo, Songwon

2013-12-01

To assess the effect of bladder instillations using heparin on the rate of urinary tract infections in women resistant to standard therapy. The medical records of all women who received bladder instillations between May 2009 and January of 2010 at the University of Wisconsin urogynecology clinic were reviewed. Eighteen women (mean age 67 years) with a history of recurrent urinary tract infections received intravesical instillations (heparin 40,000 U, 2% lidocaine 8 ml, sodium bicarbonate 4 ml) once weekly for 6 weeks. Patients were considered resistant to standard therapy if their condition failed to respond to chronic suppression antibiotic therapy; they had chronic infections and for this reason could not be placed on chronic suppression; or they were not candidates for chronic suppression due to drug allergies. The number of urinary tract infections was monitored during treatment and for 6 months after therapy. The urinary tract infection rates were compared with the rates of urinary tract infection in the 6 months before treatment. Seventy-eight percent of patients responded to therapy. Subjects were thought to have responded to therapy if there was a greater than 50% reduction in the rate of urinary tract infection. Other variables reviewed included evidence of chronic infection, hormonal status, glomerular filtration rate, age, body mass index, antibiotic allergies, diabetes, hypertension, and chronic antibiotic therapy during bladder instillations. None of these variables were found to be statistically significant. Bladder instillations decreased the rate of urinary tract infection in this pilot study; this effect persisted into the post-treatment period. More research is needed to confirm these preliminary findings.

Online Therapy for Depressive Symptoms: An Evaluation of Counselor-Led and Peer-Supported Life Review Therapy.

PubMed

Westerhof, Gerben J; Lamers, Sanne M A; Postel, Marloes G; Bohlmeijer, Ernst T

2017-09-18

Life review therapy is recognized as an evidence-based treatment for depression in later life. The current article evaluates an online life review therapy in middle-aged and older persons, comparing a counselor-led to a peer-supported mode of delivery. A pilot randomized controlled trial (RCT) was carried out with 3 conditions and 4 measurement points: (a) online life review therapy with online counseling, (b) online life review therapy with online peer support, and (c) a waitlist control condition. A mixed methods study provided insight in the reach, adherence, effectiveness, user experiences, and acceptability. Fifty-eight people were included in the study. The intervention reached a vulnerable group of mainly middle-aged, college-educated women. The pilot RCT on effectiveness showed that participants in all conditions improved significantly in depressive symptoms, engaged living, mastery, and vitality, but not in ego integrity and despair, social support, loneliness, and well-being. The adherence, user experience, and acceptability were better in the counselor condition than in the peer condition. No differences were found between middle-aged and older adults. Despite the nonsignificant effects, possibly due to the small sample size, online life review therapy might be a good method for alleviating depressive symptoms in people in their second half of life. Further research is needed, addressing how online life review is best offered. © The Author 2017. Published by Oxford University Press on behalf of The Gerontological Society of America. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com.

Early intranasal insulin therapy halts progression of neurodegeneration: progress in Alzheimer's disease therapeutics.

PubMed

de la Monte, Suzanne M

Evaluation of Craft S, Baker LD, Montine TJ, Minoshima S, Watson GS, Claxton A, et al. Intranasal Insulin Therapy for Alzheimer Disease and Amnestic Mild Cognitive Impairment: A Pilot Clinical Trial. Arch Neurol . 2011 Sep 12. Alzheimer's disease is associated with brain insulin deficiency and insulin resistance, similar to the problems in diabetes. If insulin could be supplied to the brain in the early stages of Alzheimer's, subsequent neurodegeneration might be prevented. Administering systemic insulin to elderly non-diabetics poses unacceptable risks of inadvertant hypoglycemia. However, intranasal delivery directs the insulin into the brain, avoiding systemic side-effects. This pilot study demonstrates both efficacy and safety of using intranasal insulin to treat early Alzheimer's and mild cognitive impairment, i.e. the precursor to Alzheimer's. Significant improvements in learning, memory, and cognition occured within a few months, but without intranasal insulin, brain function continued to deteriorate in measurable degrees. Intranasal insulin therapy holds promise for halting progression of Alzheimer's disease.

Intermittent granulocyte and monocyte apheresis versus mercaptopurine for maintaining remission of ulcerative colitis: a pilot study.

PubMed

Sakuraba, Atsushi; Sato, Toshiro; Morohoshi, Yuichi; Matsuoka, Katsuyoshi; Okamoto, Susumu; Inoue, Nagamu; Takaishi, Hiromasa; Ogata, Haruhiko; Iwao, Yasushi; Hibi, Toshifumi

2012-06-01

The effect of granulocyte and monocyte adsorption apheresis (GMA) on prevention of relapse of ulcerative colitis (UC) is not clear. This was a pilot open-labeled, prospective, randomized, unblinded study to compare the tolerability and efficacy of intermittent GMA (once every 2 weeks) with mercaptopurine to maintain remission of UC. Twenty-one patients with UC, who had achieved remission by induction therapies were randomly assigned to receive either intermittent GMA (N = 10) or oral mercaptopurine (0.5 mg/kg per day; N = 11). The study period was 24 months. The rate of the patients maintaining remission and the incidences of adverse effects were compared between the two groups. At 24 months, seven of 10 patients (70.0%) on intermittent GMA and seven of 11 patients (63.6%, P = 1.00) on oral mercaptopurine were still in remission. Three patients relapsed in each group. One patient taking mercaptopurine, but none receiving intermittent GMA, dropped out because of adverse effects. Intermittent therapy with GMA was well tolerated and a substantial proportion of patients maintained remission. Intermittent GMA therapy in maintaining remission of UC merits further investigation. © 2012 The Authors. Therapeutic Apheresis and Dialysis © 2012 International Society for Apheresis.

Behavioral Couples Therapy for Smoking Cessation: A pilot randomized clinical trial

PubMed Central

LaChance, Heather; Cioe, Patricia A.; Tooley, Erin; Colby, Suzanne M.; O’Farrell, Timothy J.; Kahler, Christopher W.

2016-01-01

Introduction Behavioral couples therapy (BCT) has been found to improve long-term abstinence rates in alcohol- and substance-dependent populations but has not been tested for smoking cessation. This pilot study examined the feasibility and acceptability of BCT for smoking-discordant couples. Methods Forty-nine smokers (smoking >10 cigarettes/day) with non-smoking partners were randomized to receive a couples social support (BCT-S) intervention, or an individually-delivered smoking cessation (ST) treatment. The couples were married or cohabiting for at least one year, with partners who had never smoked or had not used tobacco in one year. Both treatments included seven weekly sessions and 8-weeks of nicotine replacement therapy. Participants were followed for six months post-treatment. The Partner Interaction Questionnaire (PIQ) was used to measure perceived smoking-specific partner support. Results Participants were 67% male and 88% White. Biochemically-verified cessation rates were 40.9%, 50% and 45% in BCT-S, and 59.1%, 50%, and 55% in ST, at end of treatment, 3-, and 6-months, respectively, and did not differ significantly between treatment conditions at any time point (all p’s > .05). Perceived smoking-specific partner support at post-treatment did not significantly differ between treatment groups (M=2.45, SD .81 in BCT-S; M=2.27, SD .92 in ST; t(38) = .67, p = .51). Conclusions Results of this pilot study do not provide support for the efficacy of BCT in smoking discordant couples. PMID:25642582

An open pilot study of ambulatory photodynamic therapy using a wearable low-irradiance organic light-emitting diode light source in the treatment of nonmelanoma skin cancer.

PubMed

Attili, S K; Lesar, A; McNeill, A; Camacho-Lopez, M; Moseley, H; Ibbotson, S; Samuel, I D W; Ferguson, J

2009-07-01

Photodynamic therapy (PDT) is a popular treatment for nonmelanoma skin cancer with clearance rates of between 70% and 100%. Although reported to have a superior cosmetic outcome, the inconvenience of hospital visits and discomfort during therapy are considered drawbacks. To present an open pilot study of a low-irradiance, potentially disposable, lightweight, organic light-emitting diode (OLED), which is an area-emitting light source (2 cm diameter), suitable for ambulatory PDT. Twelve patients with Bowen's disease (eight) and superficial basal cell carcinoma (four) < 2 cm in diameter were recruited into the study following histological confirmation of the diagnosis. Two treatments (45-60 J cm(-2) red light, 550-750 nm, peak 620 nm, irradiance 5 mW cm(-2)) were administered 1 month apart following application of aminolaevulinic acid for 4 h. At the 12-month follow-up, seven of the 12 patients remained clear, with four of the nonresponders demonstrating peripheral margin failure. Patients were scored for pain during and immediately after treatment using the numerical rating scale (NRS; 1-10). All 12 subjects scored pain as < 2 using the NRS (median score 1). In contrast, a similar cohort of 50 consecutive patients from our routine PDT clinic (Aktilite inorganic LED source; 75 J cm(-2), irradiance 80 mW cm(-2)) scored a median of 6 on the NRS. Pain and inconvenience are practical barriers to the use of conventional PDT. This pilot study suggests that OLED-PDT is less painful than conventional PDT with the added advantage of being lightweight, and therefore has the potential for more convenient 'home PDT'. These results need to be validated in larger studies.

Effects of movement imitation training in Parkinson's disease: A virtual reality pilot study.

PubMed

Robles-García, Verónica; Corral-Bergantiños, Yoanna; Espinosa, Nelson; García-Sancho, Carlos; Sanmartín, Gabriel; Flores, Julián; Cudeiro, Javier; Arias, Pablo

2016-05-01

Hypometria is a clinical motor sign in Parkinson's disease. Its origin likely emerges from basal ganglia dysfunction, leading to an impaired control of inhibitory intracortical motor circuits. Some neurorehabilitation approaches include movement imitation training; besides the effects of motor practice, there might be a benefit due to observation and imitation of un-altered movement patterns. In this sense, virtual reality facilitates the process by customizing motor-patterns to be observed and imitated. To evaluate the effect of a motor-imitation therapy focused on hypometria in Parkinson's disease using virtual reality. We carried out a randomized controlled pilot-study. Sixteen patients were randomly assigned in experimental and control groups. Groups underwent 4-weeks of training based on finger-tapping with the dominant hand, in which imitation was the differential factor (only the experimental group imitated). We evaluated self-paced movement features and cortico-spinal excitability (recruitment curves and silent periods in both hemispheres) before, immediately after, and two weeks after the training period. Movement amplitude increased significantly after the therapy in the experimental group for the trained and un-trained hands. Motor thresholds and silent periods evaluated with transcranial magnetic stimulation were differently modified by training in the two groups; although the changes in the input-output recruitment were similar. This pilot study suggests that movement imitation therapy enhances the effect of motor practice in patients with Parkinson's disease; imitation-training might be helpful for reducing hypometria in these patients. These results must be clarified in future larger trials. Copyright © 2016 Elsevier Ltd. All rights reserved.

Evaluation of the theory-based Quality Improvement in Physical Therapy (QUIP) programme: a one-group, pre-test post-test pilot study

PubMed Central

2013-01-01

Background Guideline adherence in physical therapy is far from optimal, which has consequences for the effectiveness and efficiency of physical therapy care. Programmes to enhance guideline adherence have, so far, been relatively ineffective. We systematically developed a theory-based Quality Improvement in Physical Therapy (QUIP) programme aimed at the individual performance level (practicing physiotherapists; PTs) and the practice organization level (practice quality manager; PQM). The aim of the study was to pilot test the multilevel QUIP programme’s effectiveness and the fidelity, acceptability and feasibility of its implementation. Methods A one-group, pre-test, post-test pilot study (N = 8 practices; N = 32 PTs, 8 of whom were also PQMs) done between September and December 2009. Guideline adherence was measured using clinical vignettes that addressed 12 quality indicators reflecting the guidelines’ main recommendations. Determinants of adherence were measured using quantitative methods (questionnaires). Delivery of the programme and management changes were assessed using qualitative methods (observations, group interviews, and document analyses). Changes in adherence and determinants were tested in the paired samples T-tests and expressed in effect sizes (Cohen’s d). Results Overall adherence did not change (3.1%; p = .138). Adherence to three quality indicators improved (8%, 24%, 43%; .000 ≤ p ≤ .023). Adherence to one quality indicator decreased (−15.7%; p = .004). Scores on various determinants of individual performance improved and favourable changes at practice organizational level were observed. Improvements were associated with the programme’s multilevel approach, collective goal setting, and the application of self-regulation; unfavourable findings with programme deficits. The one-group pre-test post-test design limits the internal validity of the study, the self-selected sample its external validity. Conclusions The QUIP programme has the potential to change physical therapy practice but needs considerable revision to induce the ongoing quality improvement process that is required to optimize overall guideline adherence. To assess its value, the programme needs to be tested in a randomized controlled trial. PMID:23705912

Developing stepped care treatment for depression (STEPS): study protocol for a pilot randomised controlled trial.

PubMed

Hill, Jacqueline J; Kuyken, Willem; Richards, David A

2014-11-20

Stepped care is recommended and implemented as a means to organise depression treatment. Compared with alternative systems, it is assumed to achieve equivalent clinical effects and greater efficiency. However, no trials have examined these assumptions. A fully powered trial of stepped care compared with intensive psychological therapy is required but a number of methodological and procedural uncertainties associated with the conduct of a large trial need to be addressed first. STEPS (Developing stepped care treatment for depression) is a mixed methods study to address uncertainties associated with a large-scale evaluation of stepped care compared with high-intensity psychological therapy alone for the treatment of depression. We will conduct a pilot randomised controlled trial with an embedded process study. Quantitative trial data on recruitment, retention and the pathway of patients through treatment will be used to assess feasibility. Outcome data on the effects of stepped care compared with high-intensity therapy alone will inform a sample size calculation for a definitive trial. Qualitative interviews will be undertaken to explore what people think of our trial methods and procedures and the stepped care intervention. A minimum of 60 patients with Major Depressive Disorder will be recruited from an Improving Access to Psychological Therapies service and randomly allocated to receive stepped care or intensive psychological therapy alone. All treatments will be delivered at clinic facilities within the University of Exeter. Quantitative patient-related data on depressive symptoms, worry and anxiety and quality of life will be collected at baseline and 6 months. The pilot trial and interviews will be undertaken concurrently. Quantitative and qualitative data will be analysed separately and then integrated. The outcomes of this study will inform the design of a fully powered randomised controlled trial to evaluate the effectiveness and efficiency of stepped care. Qualitative data on stepped care will be of immediate interest to patients, clinicians, service managers, policy makers and guideline developers. A more informed understanding of the feasibility of a large trial will be obtained than would be possible from a purely quantitative (or qualitative) design. Current Controlled Trials ISRCTN66346646 registered on 2 July 2014.

Dialectical Behaviour Therapy for Borderline Personality Disorder among Adolescents and Young Adults: Pilot Study, Extending the Research Findings in New Settings and Cultures

ERIC Educational Resources Information Center

Hjalmarsson, Erik; Kaver, Anna; Perseius, Kent-Inge; Cederberg, Kerstin; Ghaderi, Ata

2008-01-01

The aim of this paper was to investigate the feasibility and impact of dialectical behaviour therapy (DBT) for patients with borderline personality disorder (BPD) in a clinical outpatient setting. Eighteen clinicians were trained and supervised in using DBT. Twenty-seven female patients were assessed on a number of variables before the treatment,…

Effect of massage therapy on pain, anxiety, and tension in cardiac surgical patients: a pilot study.

PubMed

Cutshall, Susanne M; Wentworth, Laura J; Engen, Deborah; Sundt, Thoralf M; Kelly, Ryan F; Bauer, Brent A

2010-05-01

To assess the role of massage therapy in the cardiac surgery postoperative period. Specific aims included determining the difference in pain, anxiety, tension, and satisfaction scores of patients before and after massage compared with patients who received standard care. A randomized controlled trial comparing outcomes before and after intervention in and across groups. Saint Marys Hospital, Mayo Clinic, Rochester, Minnesota. Patients undergoing cardiovascular surgical procedures (coronary artery bypass grafting and/or valvular repair or replacement) (N=58). Patients in the intervention group received a 20-minute session of massage therapy intervention between postoperative days 2 and 5. Patients in the control group received standard care and a 20-minute quiet time between postoperative days 2 and 5. Linear Analogue Self-assessment scores for pain, anxiety, tension, and satisfaction. Statistically and clinically significant decreases in pain, anxiety, and tension scores were observed for patients who received a 20-minute massage compared with those who received standard care. Patient feedback was markedly positive. This pilot study showed that massage can be successfully incorporated into a busy cardiac surgical practice. These results suggest that massage may be an important therapy to consider for inclusion in the management of postoperative recovery of cardiovascular surgical patients. Copyright 2009 Elsevier Ltd. All rights reserved.

Using tablet-based technology in patient education about systemic therapy options for early-stage breast cancer: a pilot study.

PubMed

Morgan, E R; Laing, K; McCarthy, J; McCrate, F; Seal, M D

2015-10-01

Patient education in early-stage breast cancer has been shown to improve patient well-being and quality of life, but it poses a challenge given the increasingly complex regimens and time constraints in clinical practice. Technology-aided teaching in the clinic could help to improve the understanding of adjuvant systemic therapy for patients. In this prospective pilot study, we used a clinician-administered, tablet-based teaching aid to teach patients with early-stage breast cancer about adjuvant systemic therapy. Participation was offered to newly diagnosed patients with early-stage breast cancer presenting for their first medical oncology visit at a provincial cancer centre. Participants were shown a tablet-based presentation describing procedures, rationales, risks, and benefits of adjuvant systemic therapy as an adjunct to a discussion with the medical oncologist. After the clinic visit, participants completed a questionnaire measuring satisfaction with the visit and knowledge of the treatment plan discussed. The 25 patients recruited for the study had a mean age of 57 years. An offer of upfront chemotherapy alone was made to 12 participants (48%), chemotherapy with trastuzumab to 4 (16%), and hormonal therapy to 9 (36%). Correct answers to all questions related to treatment knowledge were given by 22 patients (88%). Satisfaction with the clinic visit was high (mean satisfaction score: 4.53 ± 0.1 of a possible 5). We found that a tablet-based presentation about adjuvant systemic therapy was satisfactory to patients with early-stage breast cancer and that knowledge retention after the clinic visit was high. Tablet-based teaching could be a feasible and effective way of educating patients in the breast oncology clinic and warrants further investigation in randomized studies.

Comparing counseling and dignity therapies in home care patients: A pilot study.

PubMed

Rudilla, David; Galiana, Laura; Oliver, Amparo; Barreto, Pilar

2016-08-01

Several studies have successfully tested psychosocial interventions in palliative care patients. Counseling is the technique most often employed. Dignity therapy (DT) has recently emerged as a tool that can be utilized to address patients' needs at the end of life. The aims of our study were to examine the effects of DT and counseling and to offer useful information that could be put into practice to better meet patients' needs. We developed a pilot randomized controlled trial at the Home Care Unit of the General University Hospital of Valencia (Spain). Some 70 patients were assigned to two therapy groups. The measurement instruments employed included the Patient Dignity Inventory (PDI), the Hospital Anxiety and Depression Scale (HADS), the Brief Resilient Coping Scale (BRCS), the GES Questionnaire, the Duke-UNC-11 Functional Social Support Questionnaire, and two items from the EORTC Quality of Life C30 Questionnaire (EORTC-QLQ-C30). The results of repeated-measures t tests showed statistically significant differences with respect to the dimensions of dignity, anxiety, spirituality, and quality of life for both groups. However, depression increased in the DT group after the intervention, and there were no differences with respect to resilience. Therapy in the counseling group did not negatively affect depression, and resilience did improve. When post-intervention differences between groups were calculated, statistically significant differences in anxiety were found, with lower scores in the counseling group (t(68) = -2.341, p = 0.022, d = 0.560). Our study provided evidence for the efficacy of dignity therapy and counseling in improving the well-being of palliative home care patients, and it found better results in the counseling therapy group with respect to depression, resilience, and anxiety.

Manual Therapy With Cryotherapy Versus Manual Therapy With Kinesio Taping for Males With Lumbar Discopathy: A Pilot Randomized Trial.

PubMed

Lizis, Pawel; Kobza, Wojciech

2017-06-23

Context • Numerous modalities of therapeutic interventions exist for lumbar discopathy. Manual therapy is one option, although its effectiveness remains controversial. The addition of cryotherapy to manual therapy may enhance the health benefits in patients with lumbar discopathy.  Objective • The study intended to evaluate the efficacy of manual therapy combined with cryotherapy vs manual therapy combined with Kinesio taping for males with lumbar discopathy. Design • The research team designed a pilot randomized trial with concealed allocation, assessor blinding, and intention-to-treat analysis. Setting • The study occurred in the Physiotherapy Outpatient Department of the Regional Hospital (Zywiec, Poland). Participants • The participants were 40 males with lumbar discopathy, aged 30-75 y, who were patients in the department at the hospital. Intervention • The participants were randomly assigned to an intervention group that received Kaltenborn-Evjenth orthopedic manual therapy (KEOMT) combined with cryotherapy, the KEOMT-C group (n = 20), or to a control group that received KEOMT combined with Kinesio taping, the KEOMT-K group (n = 20). The participants in both groups received 10 treatments, 2 per wk for 5 wk. Outcome Measures • The primary outcome was measured using a visual analog scale and the Laitinen scale pain ratings. The secondary outcome measured the quality of life using the short form-36 questionnaire. The participants completed the tests at baseline and postintervention. Results • After the treatments, the intervention group had significantly lower scores than the control group for pain as well as significantly higher scores for quality of life. Conclusions • Patients achieved better health benefits from manual therapy when it was combined with cryotherapy.

A Community Art Therapy Group for Adults with Chronic Pain

ERIC Educational Resources Information Center

O'Neill, Aimee; Moss, Hilary

2015-01-01

This paper describes a community art therapy group for people living with chronic pain. Nine adults were offered 12 weekly group art therapy sessions that included art therapy activities such as guided imagery focusing on body scans followed by art responses and artistic expressions of the pain experience. This pilot group art therapy program is…

Clinical Practice Improvement Approach in Multiple Sclerosis Rehabilitation: A Pilot Study

ERIC Educational Resources Information Center

Khan, Fary

2010-01-01

The objective of this study was to explore methods examining patient complexity and therapy interventions in relation to functional outcomes from an inpatient multiple sclerosis (MS) rehabilitation program. Retrospective and prospective data for 24 consecutive inpatients at a tertiary rehabilitation facility assessed (i)…

Medication therapy management services in community pharmacy: a pilot programme in HIV specialty pharmacies.

PubMed

Rosenquist, Ashley; Best, Brookie M; Miller, Teresa A; Gilmer, Todd P; Hirsch, Jan D

2010-12-01

Pharmacist-provided medication therapy management services (MTMS) have been shown to increase patient's adherence to medications, improve health outcomes and reduce overall medical costs. The purpose of this study was to describe a pilot programme that provided pharmacy-based MTMS for patients with HIV/AIDS in the state of California, USA. Pharmacists from the 10 pilot pharmacies were surveyed using an online data collection tool. Information was collected to describe the types of MTMS offered, proportion of patients actively using specific MTMS, pharmacist beliefs regarding effect on patient outcomes and barriers to providing MTMS, ability to offer MTMS without pilot programme funding and specialized pharmacist or staff training. Each responding pharmacy (7 of 10) varied in the number of HIV/AIDS patients served and prescription volume. All pharmacists had completed HIV/AIDS-related continuing education programmes, and some had other advanced training. The type of MTMS being offered varied at each pharmacy with 'individualized counselling by a pharmacist when overuse or underuse was detected' and 'refill reminders by telephone' being actively used by the largest proportion of patients. Most, but not all, pharmacists cited reimbursement as a barrier to MTMS provision. Pharmacists believed the MTMS they provide resulted in improved satisfaction (patient and provider), medication usage, therapeutics response and patient quality of life. The type of MTMS offered, and proportion of patients actively using, varied among participating pilot pharmacies. © 2010 Blackwell Publishing Ltd.

The Physiotherapy for Femoroacetabular Impingement Rehabilitation STudy (physioFIRST): A Pilot Randomized Controlled Trial.

PubMed

Kemp, Joanne L; Coburn, Sally L; Jones, Denise M; Crossley, Kay M

2018-04-01

Study Design A pilot double-blind randomized controlled trial (RCT). Background The effectiveness of physical therapy for femoroacetabular impingement syndrome (FAIS) is unknown. Objectives To determine the feasibility of an RCT investigating the effectiveness of a physical therapy intervention for FAIS. Methods Participants were 17 women and 7 men (mean ± SD age, 37 ± 8 years; body mass index, 25.4 ± 3.4 kg/m 2 ) with FAIS who received physical therapy interventions provided over 12 weeks. The FAIS-specific physical therapy group received personalized progressive strengthening and functional retraining. The control group received standardized stretching exercises. In addition, both groups received manual therapy, progressive physical activity, and education. The primary outcome was feasibility, including integrity of the protocol, recruitment and retention, outcome measures, randomization procedure, and sample-size estimate. Secondary outcomes included hip pain and function (international Hip Outcome Tool-33 [iHOT-33]) and hip muscle strength. Poststudy interviews were conducted to determine potential improvements for future studies. Results Twenty-four (100%) patients with known eligibility agreed to participate. Four patients (17%) were lost to follow-up. All participants and the tester remained blinded, and the control intervention was acceptable to participants. The between-group mean differences in change scores were 16 (95% confidence interval [CI]: -9, 38) for the iHOT-33 and 0.24 (95% CI: 0.02, 0.47) Nm/kg for hip adduction strength, favoring the FAIS-specific physical therapy group. Using an effect size of 0.61, between-group improvements for the iHOT-33 suggest that 144 participants are required for a full-scale RCT. Conclusion A full-scale RCT of physical therapy for FAIS is feasible. A FAIS-specific physical therapy program has the potential for a moderate to large positive effect on hip pain, function, and hip adductor strength. Level of Evidence Therapy, level 2b. J Orthop Sports Phys Ther 2018;48(4):307-315. doi:10.2519/jospt.2018.7941.

The effect of music video exposure on students' perceived clinical applications of popular music in the field of music therapy: a pilot study.

PubMed

Gooding, Lori F; Mori-Inoue, Satoko

2011-01-01

The purpose of this study was to examine the effect of video exposure on music therapy students' perceptions of clinical applications of popular music in the field of music therapy. Fifty-one participants were randomly divided into two groups and exposed to a popular song in either audio-only or music video format. Participants were asked to indicate clinical applications; specifically, participants chose: (a) possible population(s), (b) most appropriate population(s), (c) possible age range(s), (d) most appropriate age ranges, (e) possible goal area(s) and (f) most appropriate goal area. Data for each of these categories were compiled and analyzed, with no significant differences found in the choices made by the audio-only and video groups. Three items, (a) selection of the bereavement population, (b) selection of bereavement as the most appropriate population and (c) selection of the age ranges of pre teen/mature adult, were additionally selected for further analysis due to their relationship to the video content. Analysis results revealed a significant difference between the video and audio-only groups for the selection of these specific items, with the video group's selections more closely aligned to the video content. Results of this pilot study suggest that music video exposure to popular music can impact how students choose to implement popular songs in the field of music therapy.

Interoceptive Processes in Anorexia Nervosa in the Time Course of Cognitive-Behavioral Therapy: A Pilot Study.

PubMed

Fischer, Dana; Berberich, Götz; Zaudig, Michael; Krauseneck, Till; Weiss, Sarah; Pollatos, Olga

2016-01-01

Previous studies report reduced interoceptive abilities in anorexia nervosa (AN) using various methods. Recent research suggests that different levels of interoceptive processes aiming at different subdomains of interoceptive abilities must be further distinguished as these levels can be differentially affected. Two important levels refer to interoceptive accuracy (IA) derived from objective performance tasks such as the heartbeat detection task and interoceptive sensibility (IS) as assessed by self-report. There is a lack of studies investigating both IA and IS in AN and examining them in the time course of therapy. The aim of this pilot study was to evaluate the different interoceptive processes - especially IA and IS - in the time course of therapy. Fifteen patients with AN (restricting type) from the Psychosomatic Clinic in Windach were investigated three times (T1, T2, T3) during a standardized cognitive-behavioral therapy and compared with 15 matched healthy controls assessed at Ulm University in a comparable design. All participants performed the heartbeat detection task examining IA and completed standard psychological assessments including an assessment of IS. Patients with AN showed a significantly decreased weight, higher levels of depression, and both reduced IA and IS compared to healthy controls at T1. Following therapy, patients recovered in terms of weight and depression symptomatology. A descriptive trend for recovering from IA and IS was observed. Our findings suggest that interoceptive deficits are present in recovered patients. Therefore, further investigations are needed with more patients, differentiating between relapsed and recovered patients, and more specific training methods to improve interoceptive processes.

Cell therapy attempted as a novel approach for chronic traumatic brain injury - a pilot study.

PubMed

Sharma, Alok; Sane, Hemangi; Kulkarni, Pooja; Yadav, Jayanti; Gokulchandran, Nandini; Biju, Hema; Badhe, Prerna

2015-01-01

Traumatic brain injury is an injury to the brain parenchyma resulting from external factors such as vehicular accidents, falls, or sports injuries. Its outcome involves primary insult followed by a cascade of secondary insult, resulting in diffuse axonal injury further causing white matter damage. Surgical intervention targets the primary damage, whereas only few treatment alternatives are available to treat the secondary damage. Cellular therapy could be one of the prospective therapeutic options, as it has the potential to arrest the degeneration and promote regeneration of new cells in the brain. We conducted a pilot study on 14 cases who were administered with autologous bone marrow mononuclear cells, intrathecally. The follow up was done at 1 week, 3 months and 6 months after the intervention. The Functional Independence Measure scale, the SF-8 Health Survey Scoring and the disability rating scale were used as outcome measures. These scales showed a positive shift in scores at the end of 6 months. Improvements were observed in various symptoms, along with activities of daily living. Improvement in PET CT scan performed before and 6 months after the intervention in 3 patients corresponded to the clinical and functional improvements observed in these patients. The results of this study suggest that cell therapy may promote functional recovery leading to an improved quality of life in chronic TBI. Although the results are positive, the improvements after cell therapy are not optimal. Hence, additional multicenter, controlled studies are required to establish cell therapy as a standard therapeutic approach.

Supporting Stroke Motor Recovery Through a Mobile Application: A Pilot Study.

PubMed

Lawson, Sonia; Tang, Ziying; Feng, Jinjuan

Neuroplasticity and motor learning are promoted with repetitive movement, appropriate challenge, and performance feedback. ARMStrokes, a smartphone application, incorporates these qualities to support motor recovery. Engaging exercises are easily accessible for improved compliance. In a multiple-case, mixed-methods pilot study, the potential of this technology for stroke motor recovery was examined. Exercises calibrated to the participant's skill level targeted forearm, elbow, and shoulder motions for a 6-wk protocol. Visual, auditory, and vibration feedback promoted self-assessment. Pre- and posttest data from 6 chronic stroke survivors who used the app in different ways (i.e., to measure active or passive motion, to track endurance) demonstrated improvements in accuracy of movements, fatigue, range of motion, and performance of daily activities. Statistically significant changes were not obtained with this pilot study. Further study on the efficacy of this technology is supported. Copyright © 2017 by the American Occupational Therapy Association, Inc.

Self-regulation workshop and Occupational Performance Coaching with teachers: A pilot study.

PubMed

Hui, Caroline; Snider, Laurie; Couture, Mélanie

2016-04-01

Teachers' occupational role and performance can be undermined when working with students with disruptive classroom behaviours. This pilot study aimed to explore the impact of school-based occupational therapy intervention on teachers' classroom management self-efficacy and perceived performance/satisfaction in their management of students with disruptive behaviours. This pilot study used a multiple-case replication study design. A cohort of regular classroom elementary school teachers (n = 11) participated in a 1-day workshop on sensorimotor strategies for supporting student self-regulation followed by eight individual sessions of Occupational Performance Coaching (OPC). Measurement tools were the Canadian Occupational Performance Measure, Goal Attainment Scaling (GAS), and Teachers' Self-Efficacy Scale-Classroom Management. Improvement in teachers' perception of performance, satisfaction, and classroom management was seen. GAS showed clinically significant improvement. Improvements were sustained at 7 weeks follow-up. Preliminary results support the use of sensorimotor education combined with OPC to enable teachers' occupational performance. © CAOT 2016.

Mindfulness-based cognitive therapy for hypochondriasis, or severe health anxiety: a pilot study.

PubMed

Lovas, David A; Barsky, Arthur J

2010-12-01

In spite of the existence of evidence-based treatments for hypochondriasis, or severe health anxiety, recovery rates are low and morbidity is high. Therefore, more treatment options are needed for this prevalent condition. Mindfulness-based cognitive therapy (MBCT) interventions have been gaining research and clinical attention for the treatment of mood, and more recently anxiety disorders. A small, uncontrolled pilot study of an 8-week group MBCT intervention for hypochondriasis was conducted. Ten subjects (five females and five males) with a mean age of 35.6 (range=25-59) recruited from an academic community health network met criteria and completed the study. There were significant improvements in measures of health anxiety, disease-related thoughts, somatic symptoms, and mindfulness at the end of treatment, and these benefits were sustained at 3-month follow-up. Participants evidenced high treatment satisfaction, with no drop-outs or adverse events. These findings provide the basis for a larger, more rigorous, controlled trial of this promising treatment approach. Copyright © 2010 Elsevier Ltd. All rights reserved.

Feasibility of cognitive remediation therapy for adults with autism spectrum disorders: a single-group pilot study.

PubMed

Okuda, Tomoko; Asano, Kenichi; Numata, Noriko; Hirano, Yoshiyuki; Yamamoto, Tetsuya; Tanaka, Mari; Matsuzawa, Daisuke; Shimizu, Eiji; Iyo, Masaomi; Nakazato, Michiko

2017-01-01

Set-shifting (SS) difficulties and weak central coherence (CC) are commonly associated with autism spectrum disorders (ASD). Cognitive remediation therapy (CRT) aims to improve such cognitive processing; however, there are no reports on CRT for patients with ASD. This pilot study aimed to provide preliminary evidence to support the use of CRT for individuals with ASD and provide data to inform future studies. Nineteen individuals with ASD were recruited and administered a series of neuropsychological and questionnaire measures to examine cognitive function and clinical outcomes such as anxiety and depression. Participants received CRT, and cognitive function and clinical variables were re-evaluated at postintervention and after 3 months. The participants demonstrated significant improvement in CC and anxiety at postintervention, which was maintained at 3-month follow-up. Although SS scores had improved with a large effect size, this was not statistically significant. CRT improved CC and anxiety scores for individuals with ASD, suggesting that CRT is an effective treatment for individuals with ASD.

Music therapy protocol development to enhance swallowing training for stroke patients with dysphagia.

PubMed

Kim, Soo Ji

2010-01-01

Considering the devastating condition of dysphagia, it is necessary to provide intensive therapeutic regimen based on interdisciplinary approach. In this aspect, music-enhanced swallowing protocol was developed through a pilot study. Then, the modified protocol from a pilot study was examined with 8 stroke patients in a local hospital. The protocol was designed to improve oral motor control, laryngeal elevation, breathing, and swallowing functions. The dependent variables measured included reflex, respiration, and laryngeal functions using the Frenchay Dysarthria assessment. Results from the initial to the midevaluation showed that pitch in the laryngeal category were statistically significant after 6th sessions. After the 12th session, when the final evaluation was compared with the initial assessment, additional categories revealed statistically significant changes. It is recommended that this study should be replicated with a control group and a larger sample using either FEES or video fluoroscopy for scientific data to further substantiate music therapy outcomes in stroke rehabilitation.

Text message reminders to improve outpatient therapy attendance among adolescents: a pilot study.

PubMed

Branson, Christopher E; Clemmey, Philip; Mukherjee, Preetika

2013-08-01

High rates of missed appointments and attrition are common barriers to treatment for adolescents attending outpatient mental health treatment. Such figures indicate a need for innovative strategies to engage youth in treatment. The current quasi-experimental pilot study examined the feasibility, acceptability, and preliminary efficacy of text message (TM) appointment reminders to improve attendance in a sample of 48 adolescents attending outpatient therapy. The sample was approximately 46% Latino and 40% African American with an equal number of males and females. Adolescents receiving TM reminders demonstrated significantly higher rates of attendance (65%) than a historical control group (49%) (p < .05). Participants in the TM group received reminders for the majority (88%) of their scheduled sessions with only 4% of reminders not received due to phone-related problems. Additionally, TM reminders received high patient satisfaction ratings. Findings from the present study suggest that TM reminders may be a cost-effective and developmentally appropriate strategy for engaging adolescents in treatment. PsycINFO Database Record (c) 2013 APA, all rights reserved.

Results from the Periodontitis and Vascular Events (PAVE) Study: a pilot multicentered, randomized, controlled trial to study effects of periodontal therapy in a secondary prevention model of cardiovascular disease.

PubMed

Offenbacher, Steven; Beck, James D; Moss, Kevin; Mendoza, Luisito; Paquette, David W; Barrow, David A; Couper, David J; Stewart, Dawn D; Falkner, Karen L; Graham, Susan P; Grossi, Sara; Gunsolley, John C; Madden, Theresa; Maupome, Gerardo; Trevisan, Maurizio; Van Dyke, Thomas E; Genco, Robert J

2009-02-01

In the Periodontitis and Vascular Events (PAVE) pilot study, periodontal therapy was provided as an intervention in a secondary cardiac event prevention model through five coordinated cardiac-dental centers. Subjects were randomized to either community care or protocol provided scaling and root planing to evaluate effects on periodontal status and systemic levels of high-sensitivity C-reactive protein (hs-CRP). After 6 months, there was a significant reduction in mean probing depth and extent of 4- or 5-mm pockets. However, there were no significant differences in attachment levels, bleeding upon probing, or extent of subgingival calculus comparing subjects assigned to protocol therapy (n = 151) to those assigned to community care (n = 152). Using intent-to-treat analyses, there was no significant effect on serum hs-CRP levels at 6 months. However, 48% of the subjects randomized to community care received preventive or periodontal treatments. Secondary analyses demonstrated that consideration of any preventive or periodontal care (i.e., any treatment) compared to no treatment showed a significant reduction in the percentage of people with elevated hs-CRP (values >3 mg/l) at 6 months. However, obesity nullified the periodontal treatment effects on hs-CRP reduction. The adjusted odds ratio for hs-CRP levels >3 mg/l at 6 months for any treatment versus no treatment among non-obese individuals was 0.26 (95% confidence interval: 0.09 to 0.72), adjusting for smoking, marital status, and gender. This pilot study demonstrated the critical role of considering obesity as well as rigorous preventive and periodontal care in trials designed to reduce cardiovascular risk.

Results From the Periodontitis and Vascular Events (PAVE) Study: A Pilot Multicentered, Randomized, Controlled Trial to Study Effects of Periodontal Therapy in a Secondary Prevention Model of Cardiovascular Disease

PubMed Central

Offenbacher, Steven; Beck, James D.; Moss, Kevin; Mendoza, Luisito; Paquette, David W.; Barrow, David A.; Couper, David J.; Stewart, Dawn D.; Falkner, Karen L.; Graham, Susan P.; Grossi, Sara; Gunsolley, John C.; Madden, Theresa; Maupome, Gerardo; Trevisan, Maurizio; Van Dyke, Thomas E.; Genco, Robert J.

2009-01-01

Background In the Periodontitis and Vascular Events (PAVE) pilot study, periodontal therapy was provided as an intervention in a secondary cardiac event prevention model through five coordinated cardiac– dental centers. Methods Subjects were randomized to either community care or protocol provided scaling and root planing to evaluate effects on periodontal status and systemic levels of high-sensitivity C-reactive protein (hs-CRP). Results After 6 months, there was a significant reduction in mean probing depth and extent of 4- or 5-mm pockets. However, there were no significant differences in attachment levels, bleeding upon probing, or extent of subgingival calculus comparing subjects assigned to protocol therapy (n = 151) to those assigned to community care (n = 152). Using intent-to-treat analyses, there was no significant effect on serum hs-CRP levels at 6 months. However, 48% of the subjects randomized to community care received preventive or periodontal treatments. Secondary analyses demonstrated that consideration of any preventive or periodontal care (i.e., any treatment) compared to no treatment showed a significant reduction in the percentage of people with elevated hs-CRP (values >3 mg/l) at 6 months. However, obesity nullified the periodontal treatment effects on hs-CRP reduction. The adjusted odds ratio for hs-CRP levels >3 mg/l at 6 months for any treatment versus no treatment among non-obese individuals was 0.26 (95%confidence interval: 0.09 to 0.72), adjusting for smoking, marital status, and gender. Conclusion This pilot study demonstrated the critical role of considering obesity as well as rigorous preventive and periodontal care in trials designed to reduce cardiovascular risk. PMID:19186958

Therapeutic role of Vitamin B12 in patients of chronic tinnitus: A pilot study

PubMed Central

Singh, Charu; Kawatra, Rahul; Gupta, Jaya; Awasthi, Vishnu; Dungana, Homnath

2016-01-01

True tinnitus is a phantom auditory perception arising from a source or trigger in the cochlea, brainstem, or at higher centers and has no detectable acoustic generator. The most accepted is the famous neurophysiologic model of Jastreboff, which stresses that tinnitus, is a subcortical perception and results from the processing of weak neural activity in the periphery. The aim of this study is to determine the role of Vitamin B12 in treatment of chronic tinnitus. In this randomized, double-blind pilot study, total 40 patients were enrolled, of which 20 in Group A (cases) received intramuscular therapy of 1 ml Vitamin B12 (2500 mcg) weekly for a period of 6 weeks and Group B (20) patients received placebo isotonic saline 01 ml intramuscular. The patients were subjected to Vitamin B12 assay and audiometry pre- and post-therapy. Of the total patients of tinnitus, 17 were Vitamin B12 deficient that is 42.5% showed deficiency when the normal levels were considered to be 250 pg/ml. A paired t-test showed that in Group A, patients with Vitamin B12 deficiency showed significant improvement in mean tinnitus severity index score and visual analog scale (VAS) after Vitamin B12 therapy. This pilot study highlights the significant prevalence of Vitamin B12 deficiency in North Indian population and improvement in tinnitus severity scores and VAS in cobalamin-deficient patients receiving intramuscular Vitamin B12 weekly for 6 weeks further provides a link between cobalamin deficiency and tinnitus thereby suggestive of a therapeutic role of B12 in cobalamin-deficient patients of tinnitus. PMID:26960786

The effect of aquatic therapy on postural balance and muscle strength in stroke survivors--a randomized controlled pilot trial.

PubMed

Noh, Dong Koog; Lim, Jae-Young; Shin, Hyung-Ik; Paik, Nam-Jong

2008-01-01

To evaluate the effect of an aquatic therapy programme designed to increase balance in stroke survivors. A randomized, controlled pilot trial. Rehabilitation department of a university hospital. Ambulatory chronic stroke patients (n = 25):13 in an aquatic therapy group and 12 in a conventional therapy group. The aquatic therapy group participated in a programme consisting of Ai Chi and Halliwick methods, which focused on balance and weight-bearing exercises. The conventional therapy group performed gym exercises. In both groups, the interventions occurred for 1 hour, three times per week, for eight weeks. The primary outcome measures were Berg Balance Scale score and weight-bearing ability, as measured by vertical ground reaction force during four standing tasks (rising from a chair and weight-shifting forward, backward and laterally). Secondary measures were muscle strength and gait. Compared with the conventional therapy group, the aquatic therapy group attained significant improvements in Berg Balance Scale scores, forward and backward weight-bearing abilities of the affected limbs, and knee flexor strength (P < 0.05), with effect sizes of 1.03, 1.14, 0.72 and 1.13 standard deviation units and powers of 75, 81, 70 and 26%, respectively. There were no significant changes in the other measures between the two groups. Postural balance and knee flexor strength were improved after aquatic therapy based on the Halliwick and Ai Chi methods in stroke survivors. Because of limited power and a small population base, further studies with larger sample sizes are required.

Restoring voluntary grasping function in individuals with incomplete chronic spinal cord injury: pilot study.

PubMed

Kapadia, Naaz; Zivanovic, Vera; Popovic, Milos R

2013-01-01

Functional electrical stimulation (FES) therapy has been shown to be one of the most promising approaches for improving voluntary grasping function in individuals with subacute cervical spinal cord injury (SCI). To determine the effectiveness of FES therapy, as compared to conventional occupational therapy (COT), in improving voluntary hand function in individuals with chronic (≥24 months post injury), incomplete (American Spinal Injury Association Impairment Scale [AIS] B-D), C4 to C7 SCI. Eight participants were randomized to the intervention group (FES therapy; n = 5) or the control group (COT; n = 3). Both groups received 39 hours of therapy over 13 to 16 weeks. The primary outcome measure was the Toronto Rehabilitation Institute-Hand Function Test (TRI-HFT), and the secondary outcome measures were Graded Redefined Assessment of Strength Sensibility and Prehension (GRASSP), Functional Independence Measure (FIM) self-care subscore, and Spinal Cord Independence Measure (SCIM) self-care subscore. Outcome assessments were performed at baseline, after 39 sessions of therapy, and at 6 months following the baseline assessment. After 39 sessions of therapy, the intervention group improved by 5.8 points on the TRI-HFT's Object Manipulation Task, whereas the control group changed by only 1.17 points. Similarly, after 39 sessions of therapy, the intervention group improved by 4.6 points on the FIM self-care subscore, whereas the control group did not change at all. The results of the pilot data justify a clinical trial to compare FES therapy and COT alone to improve voluntary hand function in individuals with chronic incomplete tetraplegia.

Electronic problem-solving treatment: description and pilot study of an interactive media treatment for depression.

PubMed

Cartreine, James Albert; Locke, Steven E; Buckey, Jay C; Sandoval, Luis; Hegel, Mark T

2012-09-25

Computer-automated depression interventions rely heavily on users reading text to receive the intervention. However, text-delivered interventions place a burden on persons with depression and convey only verbal content. The primary aim of this project was to develop a computer-automated treatment for depression that is delivered via interactive media technology. By using branching video and audio, the program simulates the experience of being in therapy with a master clinician who provides six sessions of problem-solving therapy. A secondary objective was to conduct a pilot study of the program's usability, acceptability, and credibility, and to obtain an initial estimate of its efficacy. The program was produced in a professional multimedia production facility and incorporates video, audio, graphics, animation, and text. Failure analyses of patient data are conducted across sessions and across problems to identify ways to help the user improve his or her problem solving. A pilot study was conducted with persons who had minor depression. An experimental group (n = 7) used the program while a waitlist control group (n = 7) was provided with no treatment for 6 weeks. All of the experimental group participants completed the trial, whereas 1 from the control was lost to follow-up. Experimental group participants rated the program high on usability, acceptability, and credibility. The study was not powered to detect clinical improvement, although these pilot data are encouraging. Although the study was not powered to detect treatment effects, participants did find the program highly usable, acceptable, and credible. This suggests that the highly interactive and immersive nature of the program is beneficial. Further clinical trials are warranted. ClinicalTrials.gov NCT00906581; http://clinicaltrials.gov/ct2/show/NCT00906581 (Archived by WebCite at http://www.webcitation.org/6A5Ni5HUp).

Rifaximin and Propranolol Combination Therapy Is More Effective than Propranolol Monotherapy for the Reduction of Portal Pressure: An Open Randomized Controlled Pilot Study.

PubMed

Lim, Yoo Li; Kim, Moon Young; Jang, Yoon Ok; Baik, Soon Koo; Kwon, Sang Ok

2017-09-15

Non-selective beta blockers (NSBBs) are currently the only accepted regimen for preventing portal hypertension (PHT)-related complications. However, the effect of NSBBs is insufficient in many cases. Bacterial translocation (BT) is one of the aggravating factors of PHT in cirrhosis; therefore, selective intestinal decontamination by rifaximin is a possible therapeutic option for improving PHT. We investigated whether the addition of rifaximin to propranolol therapy can improve hepatic venous pressure gradient (HVPG) response. Sixty-four cirrhosis patients were randomly assigned to propranolol monotherapy (n=48) versus rifaximin and propranolol combination therapy (n=16). Baseline and post-treatment HVPG values, BT-related markers (lipopolysaccharide [LPS], LPS-binding protein [LBP], interleukin-6 [IL-6], and tumor necrosis factor α [TNF-α]), serological data, and adverse event data were collected. HVPG response rate was the primary endpoint. Combination therapy was associated with better HVPG response rates than monotherapy (56.2% vs 87.5%, p=0.034). In combination therapy, posttreatment BT-related markers were significantly decreased (LPS, p=0.005; LBP, p=0.005; IL-6, p=0.005; TNF-α, p=0.047). Rifaximin combination therapy showed an additive effect in improving PHT compared to propranolol monotherapy. These pilot data suggest that the addition of rifaximin to NSBBs could be a good therapeutic option for overcoming the limited effectiveness of NSBBs.

Hear here: children with hearing loss learn words by listening.

PubMed

Lew, Joyce; Purcell, Alison A; Doble, Maree; Lim, Lynne H

2014-10-01

Early use of hearing devices and family participation in auditory-verbal therapy has been associated with age-appropriate verbal communication outcomes for children with hearing loss. However, there continues to be great variability in outcomes across different oral intervention programmes and little consensus on how therapists should prioritise goals at each therapy session for positive clinical outcomes. This pilot intervention study aimed to determine whether therapy goals that concentrate on teaching preschool children with hearing loss how to distinguish between words in a structured listening programme is effective, and whether gains in speech perception skills impact on vocabulary and speech development without them having to be worked on directly in therapy. A multiple baseline across subjects design was used in this within-subject controlled study. 3 children aged between 2:6 and 3:1 with moderate-severe to severe-profound hearing loss were recruited for a 6-week intervention programme. Each participant commenced at different stages of the 10-staged listening programme depending on their individual listening skills at recruitment. Speech development and vocabulary assessments were conducted before and after the training programme in addition to speech perception assessments and probes conducted throughout the intervention programme. All participants made gains in speech perception skills as well as vocabulary and speech development. Speech perception skills acquired were noted to be maintained a week after intervention. In addition, all participants were able to generalise speech perception skills learnt to words that had not been used in the intervention programme. This pilot study found that therapy directed at listening alone is promising and that it may have positive impact on speech and vocabulary development without these goals having to be incorporated into a therapy programme. Although a larger study is necessary for more conclusive findings, the results from this preliminary study are promising in support of emphasise on listening skills within auditory-verbal therapy programmes. Crown Copyright © 2014. Published by Elsevier Ireland Ltd. All rights reserved.

The efficacy of peloid therapy in management of hand osteoarthritis: a pilot study

NASA Astrophysics Data System (ADS)

Kasapoğlu Aksoy, Meliha; Altan, Lale; Eröksüz, Rıza; Metin Ökmen, Burcu

2017-12-01

Hand osteoarthritis (OA) is associated with pain, reduced grip strength, loss of range of motion (ROM), and joint stiffness, leading to impaired hand function and difficulty in performance of daily living activities. Mud bath therapy has been reported to play a primary role in the prevention and management of OA. Thus, we planned to conduct a study aimed at investigating the effects of peloid therapy on pain, functional state, grip strength, and the quality of life and performing a comparative analysis of the outcomes of peloid therapy. In this randomized, controlled, single-blind, pilot study, patients ( n = 33) underwent peloid therapy over 2 weeks, 5 sessions a week, for a total of 10 sessions and home exercise program in group 1. Patients in group 2 (control, n = 30) received only the same home exercise program as in group 1. Patients were evaluated just before, and 2 and 6 weeks after the start of the study with Visual Analogue Scale (VAS), Australian/Canadian Hand Osteoarthritis Index (AUSCAN), Health Assessment Questionnaire (HAQ), hand grip strength (HGS), and pinch strength (PS). Statistically significant improvements were observed in all parameters assessed at week 2 and week 6 in the group 1 ( p < 0.05). Statistically significant differences were observed in HGS scores in the group 2 at week 2 and in AUSCAN scores at week 6 ( p < 0.05). Intergroup comparisons of the scores revealed significant differences between the peloid therapy group and control group in VAS, HAQ, AUSCAN, HGS, and PS scores at week 2 and week 6 ( p < 0.05). This study demonstrates that peloid therapy might be an effective and confident treatment modality in the management of symptomatic osteoarthritis of the hand and may provide effective pain control and improvements in the hand functions, quality of life, and grip strength.

ATG-Fresenius or daclizumab induction therapy in immunologically high risk kidney recipients: a prospective randomized pilot trial.

PubMed

Kim, Min Jeong; Tsinalis, Dimitrios; Franz, Stefan; Binet, Isabelle; Gürke, Lorenz; Mihatsch, Michael J; Steiger, Jürg; Thiel, Gilbert; Dickenmann, Michael

2008-01-01

Despite all the advantages in the immunosuppressive therapy, kidney transplantation in immunologically high risk patients remains a challenge. Ideally, an induction therapy should provide maximal graft protection, while adverse events rate and costs remain as low as possible. Immunologically high risk kidney recipients with CDC-PRA ł 25% within the last 3 years, a positive B-cell CDC-crossmatch or graft loss due to rejection within 3 years following a prior transplantation, were randomized 1:1 to receive ATG-Fresenius (ATG-F) (9 mg/kg day 0; 3 mg/kg day 1-4) or Daclizumab therapy (1 mg/kg day 0, 14, 28, 42, 56) in a pilot study. Additional immunosuppression consisted of cyclosporine, mycophenolate mofetil, and steroids. 11 patients were included in each group. The patient (90% in ATG-F; 100% in Daclizumab) and graft survival (censored for death) (100% in ATG-F; 90% in Daclizumab) and the mean creatinine concentration at 24 months (139+/-68 mol/l in ATG-F; 176+/-103 mol/l in Daclizumab) were similar in both groups. More severe graft rejections (3 vascular rejections in Daclizumab) and adverse events (5.3/patient in ATG-F; 6.7/patient in Daclizumab) were observed in the Daclizumab group. The costs for hospitalization/ day within 24 months were lower in ATG-F (2.32+/-3.51 USD vs. 12.25+/-9.75 USD; p=0.02) resulting in an average cost-difference of more than 10'435 USD /patient. In this pilot trial, both treatments were comparably successful regarding graft and patient outcome.

A pilot study to evaluate the effects of floatation spa treatment on patients with osteoarthritis.

PubMed

Hill, S; Eckett, M J; Paterson, C; Harkness, E F

1999-12-01

To conduct a preliminary investigation of the effects on floatation spa therapy on quality of life in patients with osteoarthritis to see if controlled trials are warranted. Uncontrolled clinical trial. Private floatation spa therapy centre. Fourteen patients with chronic osteoarthritis of the weight-bearing joints, of whom four dropped out. Six weekly sessions of floatation spa therapy. SF36, AIMS2 and MYMOP quality-of-life questionnaires. All patients improved. Differences between baseline and discharge scores showed statistically significant improvement for MYMOP, but not AIMS2 or SF-36. Controlled trials of floatation spa therapy for patients with osteoarthritis are warranted.

Perceptions among occupational and physical therapy students of a nontraditional methodology for teaching laboratory gross anatomy.

PubMed

Thomas, K Jackson; Denham, Bryan E; Dinolfo, John D

2011-01-01

This pilot study was designed to assess the perceptions of physical therapy (PT) and occupational therapy (OT) students regarding the use of computer-assisted pedagogy and prosection-oriented communications in the laboratory component of a human anatomy course at a comprehensive health sciences university in the southeastern United States. The goal was to determine whether student perceptions changed over the course of a summer session regarding verbal, visual, tactile, and web-based teaching methodologies. Pretest and post-test surveys were distributed online to students who volunteered to participate in the pilot study. Despite the relatively small sample size, statistically significant results indicated that PT and OT students who participated in this study perceived an improved ability to name major anatomical structures from memory, to draw major anatomical structures from memory, and to explain major anatomical relationships from memory. Students differed in their preferred learning styles. This study demonstrates that the combination of small group learning and digital web-based learning seems to increase PT and OT students' confidence in their anatomical knowledge. Further research is needed to determine which forms of integrated instruction lead to improved student performance in the human gross anatomy laboratory. Copyright © 2011 American Association of Anatomists.

Pilot study of a brief dialectical behavior therapy skills group for jail inmates.

PubMed

Moore, Kelly E; Folk, Johanna B; Boren, Emily A; Tangney, June P; Fischer, Sarah; Schrader, Shannon W

2018-02-01

Regulating emotions, refraining from impulsive, maladaptive behavior, and communicating effectively are considered primary treatment needs among jail inmates. Dialectical behavior therapy (DBT; Linehan, 1993a) skills address these deficits and have been implemented in long-term correctional settings, but have yet to be adapted for general population inmates in short-term jail settings. This study assessed the feasibility and acceptability of a DBT skills group in a jail setting, as well as its utility in improving coping skills and emotional/behavioral dysregulation. Male jail inmates participated in an 8-week DBT skills group and completed pre- and posttest assessments of coping skills, emotional/behavioral dysregulation, and measures of treatment acceptability. Out of 27 who started therapy, 16 completed it, primarily due to involuntary attrition such as transfer to another correctional facility. Although several logistical issues arose during this pilot study, preliminary results suggest that a brief DBT skills group is feasible and acceptable in a jail setting, and may improve coping skills and reduce externalization of blame among general population jail inmates. This study lays the groundwork for larger, controlled trials of abbreviated DBT skills groups for general population inmates in short-term jail settings. (PsycINFO Database Record (c) 2018 APA, all rights reserved).

Cognitive Behavioral Therapy for Management of Dyspnea: A Pilot Study.

PubMed

Williams, Marie T; Cafarella, Paul; Paquet, Catherine; Frith, Peter

2015-09-01

In patients with COPD, psychological interventions usually target generalized anxiety and depression rather than the sensation of breathlessness. The objectives of this pilot study were to develop and implement a cognitive behavioral therapy (CBT) program specific to the perceptual experience of breathlessness, identify practical issues in the study protocol, and estimate beneficial effects of combining the CBT program with comprehensive pulmonary rehabilitation. The CBT program for the sensation of breathlessness (Breathing: Recognize sensations, Explore thoughts and beliefs, Validate thoughts as useful or harmful, Evolve and change behavior [BREVE]) was developed as a sequential series of 8 modules enabling it to be embedded within an 8-week comprehensive pulmonary rehabilitation program. When appropriate, outcomes from the pilot group (comprehensive pulmonary rehabilitation program + BREVE) were compared with those from a retrospective control group (comprehensive pulmonary rehabilitation program only). Outcomes included feedback provided by pilot study subjects, sensation of breathlessness (volunteered and endorsed descriptors of breathlessness), 6-min walk distance (6MWD), and St George Respiratory Questionnaire (SGRQ) total score. Within-group analyses were undertaken for descriptors of breathlessness (the McNemar test), whereas between-group analyses (repeated-measures analysis of variance, effect-size comparison) were conducted for the 6MWD and SGRQ total score. Pilot (n = 11) and control (n = 58) groups were not significantly different at baseline. Feedback indicated that the program structure and content were positively received. No significant changes were evident for the sensation of breathlessness or the SGRQ score (< 4 points). The 6MWD improved significantly in both groups, with the pilot group demonstrating greater gains compared with the control group (mean change of 57 m and effect size of 0.73 vs mean change of 27 m and effect size of 0.23; between groups, P = .03, effect size of 0.69). The CBT program for the perceptual experience of breathlessness was feasible and well accepted by subjects, although the protocol raised a number of methodological limitations warranting modification. A larger randomized controlled trial is needed to determine the effectiveness and longer-term outcomes. Copyright © 2015 by Daedalus Enterprises.

Efficacy, Safety, and Tolerability of Armodafinil Therapy for Hypersomnia Associated With Dementia With Lewy Bodies: A Pilot Study

PubMed Central

Lapid, Maria I.; Kuntz, Karen M.; Mason, Sara S.; Aakre, Jeremiah A.; Lundt, Emily S.; Kremers, Walter; Allen, Laura A.; Drubach, Daniel A.; Boeve, Bradley F.

2017-01-01

Background/Aims Hypersomnia is common in dementia with Lewy bodies (DLB). We assessed the efficacy, safety, and tolerability of armodafinil for hypersomnia associated with DLB. Methods We performed a 12-week pilot trial of armodafinil therapy (125–250 mg orally daily) in DLB outpatients with hypersomnia. Patients underwent neurologic examinations, neuropsychological battery, laboratory testing, electrocardiography, and polysomnography. Efficacy was assessed at 2, 4, 8, and 12 weeks. Safety assessment included laboratory examinations, QTc interval, and heart rate. Tolerability was assessed by analysis of adverse events. Data were analyzed using the last-observation-carried-forward method. Results Of 20 participants, 17 completed the protocol. Median age was 72 years, most were men (80%), and most had spouses as caregivers. Epworth Sleepiness Scale (P<.001), Maintenance of Wakefulness Test (P=.003), and Clinical Global Impression of Change (P<.001) scores improved at week 12. Neuropsychiatric Inventory total score (P=.003), visual hallucinations (P=.003), and agitation (P=.02) improved at week 4. Caregiver overall quality of life improved at week 12 (P=.004). No adverse events occurred. Conclusion These pilot data suggest improvements in hypersomnia and wakefulness and reasonable safety and tolerability of armodafinil therapy in hypersomnolent patients with DLB. Our findings inform the use of pharmacologic strategies to manage hypersomnolence in these patients. PMID:28448998

The Effectiveness of the Progression of Widex Zen Tinnitus Therapy: A Pilot Study.

PubMed

Tyler, Richard S; Deshpande, Aniruddha K; Lau, Chi C; Kuk, Francis

2017-09-18

The aim of this study was to measure the progression of benefits to individuals with tinnitus from providing informational counseling, hearing aids, a brief tinnitus activities treatment and Zen therapy. Several magnitude estimation scales and tinnitus handicap scales were administered for the duration of the study to 20 participants. Results indicated that all participants benefited from this sequential approach of providing different components of this tinnitus treatment. Large benefits were observed following the tinnitus activities treatment and the Zen treatments. We conclude that the progressive approach of treatment demonstrated here should be of benefit to most individuals with tinnitus and that the Widex Zen sound therapy is a worthwhile treatment for many tinnitus sufferers.

Military Suicide Research Consortium

DTIC Science & Technology

2015-10-01

support face-to- face therapy away from the clinic, the CT or DBT clinician often will implement a physical “hope kit” or “hope box” with the patient (Berk...Assessments within Suicide-Specific Group Therapy Treatment for Veterans: A Pilot Study, Drs. Lori Johnson and David Jobes, Robley Rex VAMC, $429,801...40,160 o Longitudinal Assessment of Physical Activity and Suicide Risk, Dr. Collin Davidson, Denver VAMC, $46,665  The MSRC offers annual Dissertation

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.

Breast cancer and menopause: partners' perceptions and personal experiences--a pilot study.

PubMed

Sayakhot, Padaphet; Vincent, Amanda; Teede, Helena

2012-08-01

The aim of this study was to describe the partners' perceptions, understanding, and personal experiences of early menopause and menopausal therapy in women with breast cancer. A questionnaire study was completed by 50 partners of women with diagnoses of breast cancer, recruited via outpatient clinics and the community. Descriptive statistics and χ tests were applied. Most (68%) of the partners perceived hot flushes as the meaning of menopause. Most (60%) partners perceived that loss of sexuality was the key problem/fears about being menopausal. Partners perceived that exercise (72%) and reducing stress (64%) were most effective in alleviating symptoms of menopause. Most partners reported that they did not understand the risks/benefits of hormone therapy (50%), bioidentical hormones (90%), and herbal therapies (84%). The general practitioner was considered the best source of information on menopause (68%). Partners expected menopause to affect a women's everyday life and relationships with family and partner and, particularly, to cause intermittent stress on the relationship (66%) and to decrease libido or sexual interest (64%). Forty-four percent of partners reported that there was some difficulty in communication/discussion about menopause with family and partners. This pilot study highlights (1) the lack of understanding of menopause and menopausal therapies that partners of women with breast cancer have, (2) the personal experience of having a female partner with breast cancer, and (3) the partners' attitudes and responses toward menopause in women with breast cancer.

Phenytoin mouthwash to treat cancer therapy-induced oral mucositis: A pilot studyPrimary neuroendocrine carcinoma of breast: A rare tumor.

PubMed

Baharvand, M; Hamian, M; Moosavizadeh, M A; Mortazavi, A; Ameri, A

2015-01-01

Oral mucositis is one of the most common side effects of cancer therapy with no definite treatment. Phenytoin has positive effects on healing of mucosal and dermal wounds. In this study efficacy of 1% phenytoin mouthwash on severity of mucositis (on the basis of WHO scale), pain relief (based on Visual Analogue Scale), and improvement of patients' quality of life (on the basis of EORTC-QLQ-H and N35 questionnaire) was evaluated. In a pilot -double-blind randomized clinical trial, eight patients in study group were given 1% phenytoin mouthwash while eight patients in control group used normal saline. Data analysis was performed by Mann-Whitney and Repeated Measured ANOVA tests. Reduction of mucositis severity was observed, but the difference was not significant. On the other hand, patients on phenytoin therapy had better pain relief (VAS# 6.75 ± 1.58 at the beginning of the study reached to # 3.75 ± 1.16 after 3 weeks in phenytoin group) and improvement in quality of life (score of QOL was 70.63 ± 5.5 that reached to 63.61 ± 6.39 in phenytoin group) than normal saline group significantly (P < 0.05). One percent phenytoin mouthwash caused pain relief and improvement of life quality significantly in patients with mucositis due to cancer therapy, but it did not reduce the severity of mucositis in a statistically significant scale.

Recruiting and retaining family caregivers to a randomized controlled trial on mindfulness-based stress reduction.

PubMed

Whitebird, Robin R; Kreitzer, Mary Jo; Lewis, Beth A; Hanson, Leah R; Crain, A Lauren; Enstad, Chris J; Mehta, Adele

2011-09-01

Caregivers for a family member with dementia experience chronic long-term stress that may benefit from new complementary therapies such as mindfulness-based stress reduction. Little is known however, about the challenges of recruiting and retaining family caregivers to research on mind-body based complementary therapies. Our pilot study is the first of its kind to successfully recruit caregivers for a family member with dementia to a randomized controlled pilot study of mindfulness-based stress reduction. The study used an array of recruitment strategies and techniques that were tailored to fit the unique features of our recruitment sources and employed retention strategies that placed high value on establishing early and ongoing communication with potential participants. Innovative recruitment methods including conducting outreach to health plan members and generating press coverage were combined with standard methods of community outreach and paid advertising. We were successful in exceeding our recruitment goal and retained 92% of the study participants at post-intervention (2 months) and 90% at 6 months. Recruitment and retention for family caregiver interventions employing mind-body based complementary therapies can be successful despite many challenges. Barriers include cultural perceptions about the use and benefit of complementary therapies, cultural differences with how the role of family caregiver is perceived, the use of group-based designs requiring significant time commitment by participants, and travel and respite care needs for busy family caregivers. Copyright © 2011 Elsevier Inc. All rights reserved.

A psychosocial intervention for the management of functional dysphonia: complex intervention development and pilot randomised trial.

PubMed

Deary, Vincent; McColl, Elaine; Carding, Paul; Miller, Tracy; Wilson, Janet

2018-01-01

Medically unexplained loss or alteration of voice-functional dysphonia-is the commonest presentation to speech and language therapists (SLTs). Besides the impact on personal and work life, functional dysphonia is also associated with increased levels of anxiety and depression and poor general health. Voice therapy delivered by SLTs improves voice but not these associated symptoms. The aims of this research were the systematic development of a complex intervention to improve the treatment of functional dysphonia, and the trialling of this intervention for feasibility and acceptability to SLTs and patients in a randomised pilot study. A theoretical model of medically unexplained symptoms (MUS) was elaborated through literature review and synthesis. This was initially applied as an assessment format in a series of patient interviews. Data from this stage and a small consecutive cohort study were used to design and refine a brief cognitive behavioural therapy (CBT) training intervention for a SLT. This was then implemented in an external pilot patient randomised trial where one SLT delivered standard voice therapy or voice therapy plus CBT to 74 patients. The primary outcomes were of the acceptability of the intervention to patients and the SLT, and the feasibility of changing the SLT's clinical practice through a brief training. This was measured through monitoring treatment flow and through structured analysis of the content of intervention for treatment fidelity and inter-treatment contamination. As measured by treatment flow, the intervention was as acceptable as standard voice therapy to patients. Analysis of treatment content showed that the SLT was able to conduct a complex CBT formulation and deliver novel treatment strategies for fatigue, sleep, anxiety and depression in the majority of patients. On pre-post measures of voice and quality of life, patients in both treatment arms improved. These interventions were acceptable to patients. Emotional and psychosocial issues presented routinely in the study patient group and CBT techniques were used, deliberately and inadvertently, in both treatment arms. This CBT "contamination" of the voice therapy only arm reflects the chief limitation of the study: one therapist delivered both treatments. Registered with the ISRCTN under the title: Training a Speech and Language Therapist in Cognitive Behavioural Therapy to treat Functional Dysphonia - A Randomised Controlled Trial .Trial Identifier: ISRCTN20582523 Registered 19/05/2010; retrospectively registered. http://www.isrctn.com/ISRCTN20582523.

Topical oxygen therapy promotes the healing of chronic diabetic foot ulcers: a pilot study.

PubMed

Hayes, P D; Alzuhir, N; Curran, G; Loftus, I M

2017-11-02

Interventions that can heal or reduce diabetic foot ulcer (DFU) size may reduce the incidence of infection and amputation, and reduce associated social and economic costs. Many chronic wounds exhibit a degree of hypoxia and this leads to a reduction in healing processes including cell division and differentiation, angiogenesis, infection prevention, and collagen production. The aim of this pilot study was to assess the effects of a device supplying continuous oxygen ambulatory therapy on healing in chronic DFUs. Patients with chronic DFUs from two tertiary referral hospitals in the UK received treatment with the device. Data were prospectively obtained on wound size using standardised digital images measured by a clinician blinded to the study. Data on device satisfaction and pain were also obtained. We recruited 10 patients, with a mean ulcer duration of 43 weeks (median: 43 weeks) before treatment. By week eight, mean ulcer size had decreased by 51% (median: 53%). Seven of the 10 ulcers were in a healing trajectory, one ulcer present for 56 weeks healed completely, a two-year old ulcer was reduced by more than 50%, and a third, present for 88 weeks, was down to 10% of its original size by the end of the eight-week study. There was also a non-significant trend towards reduction in pain and the device was extremely well tolerated. The ambulatory topical oxygen delivery device showed a significant beneficial effect on wound size. This poses practical advantages over currently existing oxygen-based wound therapies such as hyperbaric oxygen therapy due to its continuous oxygen delivery, ease of use, safety and lower cost. The results of this study warrant further review of the device in comparison to standard wound therapies.

Nutrition therapy in cachectic cancer patients. The Tight Caloric Control (TiCaCo) pilot trial.

PubMed

De Waele, Elisabeth; Mattens, Sabrina; Honoré, Patrick Maurice; Spapen, Herbert; De Grève, Jacques; Pen, Joeri J

2015-08-01

Cancer is a common disease and many patients are diagnosed with advanced stages. Due to cancer generalization, patients may become ill-nourished and even cachectic. Malignancy-related cachexia is associated with worsening physical function, reduced tolerance to anticancer therapy and increased mortality. We assessed the effect of a patient-tailored nutritional approach in newly discovered, treatment-naive cancer patients with cachexia. In a randomized, single-blinded, controlled pilot study, patients were treated with either intensive, biometric parameter-oriented dietary counseling (nutrition therapy) compared to regular dietary counseling (control), before and during conventional cancer treatment. Twenty patients were enrolled over a one-year period, 10 receiving nutrition therapy and 10 controls. The primary endpoint was recovery of body composition after nutrition therapy. Secondary endpoints declined in morbidity and mortality with nutrition therapy. Average weight evolution in the control group after 3, 6 and 12 months was 0.19 ± 7.87 kg, -9.78 ± 7.00 kg and -5.8 kg, and in the nutrition therapy group 0.69 ± 2.4 kg, 0.77 ± 2.58 kg and 1.29 ± 3.76 kg. Control patients had a significantly longer average hospital stay than subjects from the nutrition therapy group (37.6 vs. 3.4 days). Eight nutrition therapy patients and 1 control patient were still alive after 2 years. Nutrition therapy based on patient-specific biophysical parameters helps to maintain body weight and induces a more optimal nutritional balance in cachectic cancer patients. Moreover, survival in cancer patients improved when their nutritional status, even partially, ameliorated. Copyright © 2015 Elsevier Ltd. All rights reserved.

Perceptions about Authentic Leadership Development: South African Occupational Therapy Students' Camp Experience

PubMed Central

2018-01-01

Background Twenty-three years into democracy, concern is deepening regarding the slow progress of Occupational Therapy (OT) in South Africa, especially with regard to diversity and inclusion within OT. Methods This study explores authentic leadership development primarily among Black OT students attending a pilot Occupational Therapy Association of South Africa (OTASA) National Student Leadership Camp. It seeks to ascertain their perceptions on leadership and leadership development. This descriptive pilot study employs in-depth interviews and subsequent content analysis, with 12 OT students from six university OT programs in South Africa. Findings Four categories of participant perceptions on authentic leadership development emerged from the analysis: (1) perceptions about oneself as a leader based on personal narrative, self-awareness, self-control, and psychological capital; (2) perceptions about others, specifically current leaders, with regard to their moral crisis, including continuing inequality, insincerity, greed, and selfishness; (3) goals and aspirations for leadership development via student camps; and (4) effects of leadership on the system. Conclusions Recommendations for future practice include promotion of storytelling as a means of personal reflection for authentic leadership development and focused investment in camps for developing student leadership skills and building authentic leadership knowledge. PMID:29770106

Perceptions about Authentic Leadership Development: South African Occupational Therapy Students' Camp Experience.

PubMed

Hendricks, Fatima; Toth-Cohen, Susan

2018-01-01

Twenty-three years into democracy, concern is deepening regarding the slow progress of Occupational Therapy (OT) in South Africa, especially with regard to diversity and inclusion within OT. This study explores authentic leadership development primarily among Black OT students attending a pilot Occupational Therapy Association of South Africa (OTASA) National Student Leadership Camp. It seeks to ascertain their perceptions on leadership and leadership development. This descriptive pilot study employs in-depth interviews and subsequent content analysis, with 12 OT students from six university OT programs in South Africa. Four categories of participant perceptions on authentic leadership development emerged from the analysis: (1) perceptions about oneself as a leader based on personal narrative, self-awareness, self-control, and psychological capital; (2) perceptions about others, specifically current leaders, with regard to their moral crisis, including continuing inequality, insincerity, greed, and selfishness; (3) goals and aspirations for leadership development via student camps; and (4) effects of leadership on the system. Recommendations for future practice include promotion of storytelling as a means of personal reflection for authentic leadership development and focused investment in camps for developing student leadership skills and building authentic leadership knowledge.

Group Singing as a Therapy during Diabetes Training--A Randomized Controlled Pilot Study.

PubMed

Groener, J B; Neus, I; Kopf, S; Hartmann, M; Schanz, J; Kliemank, E; Wetekam, B; Kihm, L; Fleming, T; Herzog, W; Nawroth, P P

2015-11-01

Comprehensive diabetes treatment has been shown to reduce quality of life in diabetic patients. However, there is evidence to suggest that group singing can have positive effects on quality of life in various clinical settings. In this randomized controlled pilot study, the effect of singing as a therapy to reduce stress and improve quality of life was investigated in insulin-dependent diabetic patients, undergoing a lifestyle intervention program. Patients from the singing group felt less discontented following treatment. This effect, however, was lost after 3 months. No effect on serum cortisol and plasma adrenocorticotropic hormone (ACTH) levels could be seen when comparing the singing group with the control group, although reduced levels of ACTH and cortisol 3 days after treatment could be found and were still present after 3 months within the group of patients who undertook singing as a therapy. Singing led to an increase in bodyweight, which interestingly had no effect on glucose control or methylglyoxal levels. Therefore, singing during a lifestyle intervention program for insulin-dependent diabetic patients had a short lasting and weak effect on patients' mood without affecting glucose control, but no significant effect on stress related hormones. © Georg Thieme Verlag KG Stuttgart · New York.

Management of post traumatic stress disorder after childbirth: a review.

PubMed

Lapp, Leann K; Agbokou, Catherine; Peretti, Charles-Siegfried; Ferreri, Florian

2010-09-01

Prevalence and risk factors for the development of post traumatic stress disorder (PTSD) after childbirth is well described in the literature. However, its management and treatment has only begun to be investigated. The aim of this article is to describe the studies that examine the effects of interventions on PTSD after childbirth. MedLine, PILOTS, CINAHL and ISI Web of Science databases were systematically searched for randomised controlled trials, pilot studies and case studies using key words related to PTSD, childbirth, treatment and intervention. The reference lists of the retrieved articles were also used to supplement the search. A total of nine studies were retrieved. Seven studies that examined debriefing or counselling were identified; six randomised controlled trials and one pilot study. Also found were one case report describing the effects of cognitive behavioural therapy (CBT) on two women, and one pilot study of eye movement desensitisation and reprocessing (EMDR). Overall, there is limited evidence concerning the management of women with PTSD after childbirth. The results agree with the findings from the non-childbirth related literature: debriefing and counselling are inconclusively effective while CBT and EMDR may improve PTSD status but require investigation in controlled trials before conclusions could be drawn.

A pilot study of an mHealth application for healthcare workers: poor uptake despite high reported acceptability at a rural South African community-based MDR-TB treatment program.

PubMed

Chaiyachati, Krisda H; Loveday, Marian; Lorenz, Stephen; Lesh, Neal; Larkan, Lee-Megan; Cinti, Sandro; Friedland, Gerald H; Haberer, Jessica E

2013-01-01

As the South African province of KwaZulu-Natal addresses a growing multidrug-resistant tuberculosis (MDR-TB) epidemic by shifting care and treatment from trained specialty centers to community hospitals, delivering and monitoring MDR-TB therapy has presented new challenges. In particular, tracking and reporting adverse clinical events have been difficult for mobile healthcare workers (HCWs), trained health professionals who travel daily to patient homes to administer and monitor therapy. We designed and piloted a mobile phone application (Mobilize) for mobile HCWs that electronically standardized the recording and tracking of MDR-TB patients on low-cost, functional phones. We assess the acceptability and feasibility of using Mobilize to record and submit adverse events forms weekly during the intensive phase of MDR-TB therapy and evaluate mobile HCW perceptions throughout the pilot period. All five mobile HCWs at one site were trained and provided with phones. Utilizing a mixed-methods evaluation, mobile HCWs' usage patterns were tracked electronically for seven months and analyzed. Qualitative focus groups and questionnaires were designed to understand the impact of mobile phone technology on the work environment. Mobile HCWs submitted nine of 33 (27%) expected adverse events forms, conflicting with qualitative results in which mobile HCWs stated that Mobilize improved adverse events communication, helped their daily workflow, and could be successfully expanded to other health interventions. When presented with the conflict between their expressed views and actual practice, mobile HCWs cited forgetfulness and believed patients should take more responsibility for their own care. This pilot experience demonstrated poor uptake by HCWs despite positive responses to using mHealth. Though our results should be interpreted cautiously because of the small number of mobile HCWs and MDR-TB patients in this study, we recommend carefully exploring the motivations of HCWs and technologic enhancements prior to scaling new mHealth initiatives in resource poor settings.

Yoga-Enhanced Cognitive Behavioral Therapy (Y-CBT) for Anxiety Management: A Pilot Study

PubMed Central

Khalsa, Manjit K.; Greiner-Ferris, Julie M.; Hofmann, Stefan G.; Khalsa, Sat Bir S.

2014-01-01

Cognitive behavioral therapy is an effective treatment for generalized anxiety disorder (GAD), but there is still room for improvement. The aim of the present study was to examine the potential benefit of enriching cognitive behavioral therapy (CBT) with Kundalini Yoga (Y-CBT). Participants consisted of treatment resistant clients at a community mental health clinic. A total of 32 participants enrolled in the study and 22 completed the program. After the Y-CBT intervention, pre-post comparisons showed statistically significant improvements in state and trait anxiety, depression, panic, sleep, and quality of life. Results from this preliminary study suggest that Y-CBT may have potential as a promising treatment for those suffering from GAD. PMID:24804619

The adoption and implementation of an evidence based practice in child and family mental health services organizations: a pilot study of functional family therapy in New York State.

PubMed

Zazzali, James L; Sherbourne, Cathy; Hoagwood, Kimberly Eaton; Greene, Deborah; Bigley, Michael F; Sexton, Thomas L

2008-03-01

Numerous challenges persist in providing evidence-based treatments to children and families in community-based settings. Functional Family Therapy (FFT), one such evidence-based treatment, is a family prevention and intervention program for adolescents with conduct disorder or oppositional defiant disorder. This paper presents pilot data in support of a conceptual framework explaining the adoption and implementation of FFT in a small sample of family and child mental health services organizations in New York State. The conceptual framework is grounded in the diffusion of innovations and the organizational behavior literatures, as well as previously published accounts of the adoption and implementation of evidence-based treatments in mental health. Pilot study data demonstrated that factors associated with the adoption of FFT included: The program fitting with the mission of the organization, as well as the organization having a strong interest in evidence-based treatments. Once a decision to adopt FFT was made, the degree to which it fit with organizational characteristics (e.g., available resource sets, organizational structure, and culture) influenced the ease with which it was implemented. Implications for the adoption and implementation of other evidence-based treatments are discussed.

Wii-based Balance Therapy to Improve Balance Function of Children with Cerebral Palsy: A Pilot Study

PubMed Central

Tarakci, Devrim; Ozdincler, Arzu Razak; Tarakci, Ela; Tutuncuoglu, Fatih; Ozmen, Meral

2013-01-01

[Purpose] Cerebral palsy is a sensorimotor disorder that affects the control of posture and movement. The Nintendo® Wii Fit offers an inexpensive, enjoyable, suitable alternative to more complex systems for children with cerebral palsy. The aim of this study was to investigate the efficacacy of Wii-based balance therapy for children with ambulatory cerebral palsy. [Subjects] This pilot study design included fourteen ambulatory patients with cerebral palsy (11 males, 3 females; mean age 12.07 ± 3.36 years). [Methods] Balance functions before and after treatment were evaluated using one leg standing, the functional reach test, the timed up and go test, and the 6-minute walking test. The physiotherapist prescribed the Wii Fit activities,and supervised and supported the patients during the therapy sessions. Exercises were performed in a standardized program 2 times a week for 12 weeks. [Results] Balance ability of every patient improved. Statistically significant improvements were found in all outcome measures after 12 weeks. [Conclusion] The results suggest that the Nintendo® Wii Fit provides a safe, enjoyable, suitable and effective method that can be added to conventional treatments to improve the static balance of patients with cerebral palsy; however, further work is required. PMID:24259928

Clinical Validation of Therapeutic Drug Monitoring of Imipenem in Spent Effluent in Critically Ill Patients Receiving Continuous Renal Replacement Therapy: A Pilot Study.

PubMed

Wen, Aiping; Li, Zhe; Yu, Junxian; Li, Ren; Cheng, Sheng; Duan, Meili; Bai, Jing

2016-01-01

The primary objective of this pilot study was to investigate whether the therapeutic drug monitoring of imipenem could be performed with spent effluent instead of blood sampling collected from critically ill patients under continuous renal replacement therapy. A prospective open-label study was conducted in a real clinical setting. Both blood and effluent samples were collected pairwise before imipenem administration and 0.5, 1, 1.5, 2, 3, 4, 6, and 8 h after imipenem administration. Plasma and effluent imipenem concentrations were determined by reversed-phase high-performance liquid chromatography with ultraviolet detection. Pharmacokinetic and pharmacodynamic parameters of blood and effluent samples were calculated. Eighty-three paired plasma and effluent samples were obtained from 10 patients. The Pearson correlation coefficient of the imipenem concentrations in plasma and effluent was 0.950 (P<0.0001). The average plasma-to-effluent imipenem concentration ratio was 1.044 (95% confidence interval, 0.975 to 1.114) with Bland-Altman analysis. No statistically significant difference was found in the pharmacokinetic and pharmacodynamic parameters tested in paired plasma and effluent samples with Wilcoxon test. Spent effluent of continuous renal replacement therapy could be used for therapeutic drug monitoring of imipenem instead of blood sampling in critically ill patients.

Effectiveness of a serious game for medical education on insulin therapy: a pilot study.

PubMed

Diehl, Leandro A; Gordan, Pedro A; Esteves, Roberto Z; Coelho, Izabel C M M

2015-10-01

We report the preliminary assessment of InsuOnline©, a serious game designed for medical education on insulin therapy. We conducted a pilot study with 41 undergraduate medical students and Internal Medicine residents to assess the educational effectiveness of InsuOnline©, as compared to a traditional educational activity (lecture, cases discussion). Knowledge, skills and beliefs on insulin therapy were evaluated by a questionnaire applied before, immediately after, and 3 months after both interventions. Mean knowledge/skills score was improved from 68% to 89% in traditional education group (n = 23; p < 0.001), and from 61% to 90% in game group (n = 18; p < 0.001). After 3 months, mean score decreased (to 80% in traditional education group, and to 78% in game group; p < 0.001 for both) but remained significantly higher than at baseline in both groups (p < 0.001 for both). Although mean score was lower in game group than in traditional education group at baseline (p = 0.04), no difference remained between groups either immediately or 3 months post-intervention. Score increment was better with the game (29%) than with traditional education (21%; p = 0.04). Beliefs improved in the game group only. InsuOnline© is at least as effective as a traditional educational activity for medical education on insulin therapy, and it can a good option for large-scale continuing medical education on diabetes.

Adjuvant antifungal therapy using tissue tolerable plasma on oral mucosa and removable dentures in oral candidiasis patients: a randomised double-blinded split-mouth pilot study.

PubMed

Preissner, Saskia; Kastner, Isabell; Schütte, Eyke; Hartwig, Stefan; Schmidt-Westhausen, Andrea Maria; Paris, Sebastian; Preissner, Robert; Hertel, Moritz

2016-07-01

Extended use of antimycotics in oral candidiasis therapy gives rise to problems related to fungal drug resistance. The aim of this pilot study was to investigate the efficacy of tissue tolerable plasma (TTP) in denture stomatitis patients. It was hypothesised that (I): erythema and (IIa): complaint remission would be accelerated and (IIb): colony forming unit (CFU) reduction would be improved. The halves of the upper jaws of eight patients were randomly assigned to control (nystatin, chlorhexidine and placebo treatment) and test sides (nystatin, chlorhexidine and TTP administered six times each 7 days). The patients and the investigators, who were different from the therapists, were both blinded. Compared to the control sides, the erythema surface was reduced significantly more extensively on the test sides between 2 and 6 weeks of antifungal therapy (P ≤ 0.05). Visual analogue scale values and the frequency of moderate or heavy growth of Candida post-treatment did not differ significantly between both sides (P > 0.05). The primary hypothesis was confirmed, which may be interpreted as an accelerated remission. As drug therapy is usually limited to the time in which signs of infection are present, TTP might help reducing antifungal use. Even though the secondary hypotheses were not confirmed, persistence of Candida might be only colonisation. © 2016 Blackwell Verlag GmbH.

Effect of low-impact aerobic exercise combined with music therapy on patients with fibromyalgia. A pilot study.

PubMed

Espí-López, Gemma V; Inglés, Marta; Ruescas-Nicolau, María-Arántzazu; Moreno-Segura, Noemí

2016-10-01

Fibromyalgia is a pathological entity characterized by chronic widespread musculoskeletal pain and the presence of "tender points". It constitutes a significant health problem because of its prevalence and economic impact. The aim of the present study was to determine the therapeutic benefits of low impact aerobic exercise alone or in combination with music therapy in patients with fibromyalgia. A single-blind randomized controlled pilot trial was performed. Thirty-five individuals with fibromyalgia were divided into three groups: (G1) therapeutic aerobic exercise with music therapy (n=13); (G2) therapeutic aerobic exercise at any rhythm (n=13) and (CG) control (n=9). The intervention period lasted eight weeks. Depression, quality of life, general discomfort and balance were assessed before and after intervention. At post-intervention, group G1 improved in all variables (depression (p=0.002), quality of life (p=0.017), general discomfort (p=0.001), and balance (p=0.000)), while group G2 improved in general discomfort (p=0.002). The change observed in balance was statistically different between groups (p=0.01). Therapeutic aerobic exercise is effective in improving depression and general discomfort in individuals with fibromyalgia. However, effectiveness is higher when combined with music therapy, which brings about further improvements in quality of life and balance. Copyright © 2016 Elsevier Ltd. All rights reserved.

Effects of manual therapy on treatment duration and motor development in infants with severe nonsynostotic plagiocephaly: a randomised controlled pilot study.

PubMed

Cabrera-Martos, I; Valenza, M C; Valenza-Demet, G; Benítez-Feliponi, A; Robles-Vizcaíno, C; Ruiz-Extremera, A

2016-11-01

Despite growing evidence regarding nonsynostotic plagiocephaly and their repercussions on motor development, there is little evidence to support the use of manual therapy as an adjuvant option. The aim of this study was to evaluate the effects of a therapeutic approach based on manual therapy as an adjuvant option on treatment duration and motor development in infants with severe nonsynostotic plagiocephaly. This is a randomised controlled pilot study. The study was conducted at a university hospital. Forty-six infants with severe nonsynostotic plagiocephaly (types 4-5 of the Argenta scale) referred to the Early Care and Monitoring Unit were randomly allocated to a control group receiving standard treatment (repositioning and an orthotic helmet) or to an experimental group treated with manual therapy added to standard treatment. Infants were discharged when the correction of the asymmetry was optimal taken into account the previous clinical characteristics. The outcome measures were treatment duration and motor development assessed with the Alberta Infant Motor Scale (AIMS) at baseline and at discharge. Asymmetry after the treatment was minimal (type 0 or 1 according to the Argenta scale) in both groups. A comparative analysis showed that treatment duration was significantly shorter (p < 0.001) in the experimental group (109.84 ± 14.45 days) compared to the control group (148.65 ± 11.53 days). The motor behaviour was normal (scores above the 16th percentile of the AIMS) in all the infants after the treatment. Manual therapy added to standard treatment reduces the treatment duration in infants with severe nonsynostotic plagiocephaly.

Effects of Clinician-Assisted Emotional Disclosure for Sexual Assault Survivors: A Pilot Study

ERIC Educational Resources Information Center

Anderson, Timothy; Fende Guajardo, Jennifer; Luthra, Rohini; Edwards, Katie M.

2010-01-01

This study assessed the effects of clinician-assisted emotional disclosure (CAED), an integration of emotion focused therapy (Greenberg, Rice, & Elliott, 1993) and emotional disclosure, in ameliorating distress experienced by survivors of sexual assault. A total of 670 female university students were screened for both histories of sexual…

A Pilot Study of Culturally Adapted Cognitive Behavior Therapy for Hispanics with Major Depression

ERIC Educational Resources Information Center

Interian, Alejandro; Allen, Lesley A.; Gara, Michael A.; Escobar, Javier I.

2008-01-01

The purpose of this study was to evaluate a culturally adapted cognitive-behavioral treatment (CBT) for major depression among Hispanics in primary care. Cultural adaptations were applied based on a range of cultural considerations described in the literature. Fifteen Hispanic primary care patients with major depression were enrolled. All…

Vida Alegre: Preliminary Findings of a Depression Intervention for Immigrant Latino Mothers

ERIC Educational Resources Information Center

Piedra, Lissette M.; Byoun, Soo-Jung

2012-01-01

Objectives: This article reports the outcome of a pilot study of a cognitive behavioral group therapy (CBGT) intervention--"Vida Alegre" (the contented life)--designed for use with depressed immigrant mothers living in communities with small but rapidly growing Hispanic populations. Method: The study used a pretest/posttest/follow-up…

Cognitive remediation therapy (CRT) in a specialist inpatient eating disorder service for children and adolescents: CAN-CRT study protocol for a pilot randomised controlled trial.

PubMed

Giombini, Lucia; Nesbitt, Sophie; Cox, Hannah; Foxall, Anna; Sharia, Teo; Easter, Abigail; Tchanturia, Kate

2018-03-26

Research on treatments for young people (YP) with anorexia nervosa (AN) is scarce. Evidence supports the use of cognitive remediation therapy (CRT) to improve central coherence and set-shifting, inefficiencies that can negatively impact on prognosis. The study aims to evaluate the feasibility of individual CRT in an inpatient setting for YP aged 10-18 years with AN and to qualitatively examine YP's and their parents experiences. In a single-centre, pilot, randomised controlled trial, 80 patients aged 10-18 years with AN will be randomly allocated to the immediate or delayed CRT group, in addition to standard treatment. A repeated measures design will be conducted across 3 time points. The data will provide evidence regarding the feasibility of individual CRT in YP with AN, informing directions of further development of CRT. The study is in preparation for a definitive randomised controlled trial. The aim of this manuscript is to describe the study protocol. Copyright © 2018 John Wiley & Sons, Ltd and Eating Disorders Association.

Implementation of the Enhanced Moderated Online Social Therapy (MOST+) Model Within a National Youth E-Mental Health Service (eheadspace): Protocol for a Single Group Pilot Study for Help-Seeking Young People

PubMed Central

Gleeson, John; Leicester, Steven; Bendall, Sarah; D'Alfonso, Simon; Gilbertson, Tamsyn; Killackey, Eoin; Parker, Alexandra; Lederman, Reeva; Wadley, Greg; Santesteban-Echarri, Olga; Pryor, Ingrid; Mawren, Daveena; Ratheesh, Aswin; Alvarez-Jimenez, Mario

2018-01-01

Background There is a substantial need for youth electronic mental health (e-mental health) services. In addressing this need, our team has developed a novel moderated online social therapy intervention called enhanced moderated online social therapy (MOST+). MOST+ integrates real-time, clinician-delivered Web chat counseling, interactive user-directed online therapy, expert and peer moderation, and private and secure peer-to-peer social networking. MOST+ has been designed to give young people immediate, 24-hour access to anonymous, evidence-based, and short-term mental health care. Objective The primary aims of this pilot study were to determine the feasibility, acceptability, and safety of the intervention. Secondary aims were to assess prepost changes in key psychosocial outcomes and collect qualitative data for future intervention refinement. Methods MOST+ will be embedded within eheadspace, an Australian youth e-mental health service, and will be evaluated via an uncontrolled single-group study. Approximately 250 help-seeking young people (16-25 years) will be progressively recruited to the intervention from the eheadspace home page over the first 4 weeks of an 8-week intervention period. All participants will have access to evidence-based therapeutic content and integrated Web chat counseling. Additional access to moderated peer-to-peer social networking will be granted to individuals for whom it is deemed safe and appropriate, through a three-tiered screening process. Participants will be enrolled in the MOST+ intervention for 1 week, with the option to renew their enrollment across the duration of the pilot. Participants will complete a survey at enrollment to assess psychological well-being and other mental health outcomes. Additional assessment will occur following account deactivation (ie, after participant has opted not to renew their enrollment, or at trial conclusion) and will include an online survey and telephone interview assessing psychological well-being and experience of using MOST+. Results Recruitment for the study commenced in October 2017. We expect to have initial results in March 2018, with more detailed qualitative and quantitative analyses to follow. Conclusions This is the first Australia-wide research trial to pilot an online social media platform merging real-time clinical support, expert and peer moderation, interactive online therapy, and peer-to-peer social networking. The importance of the project stems from the need to develop innovative new models for the efficient delivery of responsive evidence-based online support to help-seeking young people. If successful, this research stands to complement and enhance e-mental health services in Australia. PMID:29472177

ENGAGE: Guided Activity-Based Gaming in Neurorehabilitation after Stroke: A Pilot Study

PubMed Central

Reinthal, Ann; Szirony, Kathy; Clark, Cindy; Swiers, Jeffrey; Kellicker, Michelle; Linder, Susan

2012-01-01

Introduction. Stroke is a leading cause of disability in healthy adults. The purpose of this pilot study was to assess the feasibility and outcomes of a novel video gaming repetitive practice paradigm, (ENGAGE) enhanced neurorehabilitation: guided activity-based gaming exercise. Methods. Sixteen individuals at least three months after stroke served as participants. All participants received concurrent outpatient therapy or took part in a stroke exercise class and completed at least 500 minutes of gaming. Primary baseline and posttest outcome measures included the Wolf motor function test (WMFT) and the Fugl-Meyer assessment (FMA). ENGAGE uses a game selection algorithm providing focused, graded activity-based repetitive practice that is highly individualized and directed. The Wilcoxon signed ranks test was used to determine statistical significance. Results. There were improvements in the WMFT (P = 0.003) and the FMA (P = 0.002) that exceeded established values of minimal clinically important difference. Conclusions. ENGAGE was feasible and an effective adjunct to concurrent therapy after stroke. PMID:22593835

A randomized controlled pilot study of the effectiveness of occupational therapy for children with sensory modulation disorder.

PubMed

Miller, Lucy Jane; Coll, Joseph R; Schoen, Sarah A

2007-01-01

A pilot randomized controlled trial (RCT) of the effectiveness of occupational therapy using a sensory integration approach (OT-SI) was conducted with children who had sensory modulation disorders (SMDs). This study evaluated the effectiveness of three treatment groups. In addition, sample size estimates for a large scale, multisite RCT were calculated. Twenty-four children with SMD were randomly assigned to one of three treatment conditions; OT-SI, Activity Protocol, and No Treatment. Pretest and posttest measures of behavior, sensory and adaptive functioning, and physiology were administered. The OT-SI group, compared to the other two groups, made significant gains on goal attainment scaling and on the Attention subtest and the Cognitive/Social composite of the Leiter International Performance Scale-Revised. Compared to the control groups, OT-SI improvement trends on the Short Sensory Profile, Child Behavior Checklist, and electrodermal reactivity were in the hypothesized direction. Findings suggest that OT-SI may be effective in ameliorating difficulties of children with SMD.

Brief or new: the benefits of on-line learning in occupational therapy.

PubMed

Gallew, Heather A

2004-01-01

SUMMARY This paper discusses the benefits of incorporating an on-line program, such as Blackboard, into occupational therapy education to enhance the learning experience. An occupational therapy department at a midwestern university piloted the use of Blackboard in two classes in the spring semester of the junior year. Students (n = 16) ranging in age from 20-28 years participated in the pilot study, which lasted a period of 12 weeks. The students were given various assignments on Blackboard involving discussions, answering questions related to the lecture topic, and sharing evidence-based practice. Overall, the student perceptions of incorporating Blackboard into a traditional classroom were positive. Eighty-one percent of the students felt that Blackboard was easy to access, 75% felt that they could share thoughts and stories that they would not necessarily have shared in a classroom setting, and 81% felt that Blackboard expanded on lecture topics and relevant practice information. Data suggest that on-line learning can enhance the educational experience by building upon student fieldwork experiences, evidence-based practice, discussion of key concepts in the profession, and clinical reasoning.

The Psychotherapy and Reading Clinic.

ERIC Educational Resources Information Center

Cooper, Arline

The theoretical basis for a Figurative Therapy Reading Clinic in the elementary schools and the tentative structure for implementing that clinic as a pilot project are described in this paper. The contents include: "Figurative Therapy Defined," which refers to the psychoanalytic approach to art therapy; "The Objectives of the Figurative Therapy…

Pilot study assessing the feasibility of applying bilateral subthalamic nucleus deep brain stimulation in very early stage Parkinson's disease: study design and rationale.

PubMed

Charles, David; Tolleson, Christopher; Davis, Thomas L; Gill, Chandler E; Molinari, Anna L; Bliton, Mark J; Tramontana, Michael G; Salomon, Ronald M; Kao, Chris; Wang, Lily; Hedera, Peter; Phibbs, Fenna T; Neimat, Joseph S; Konrad, Peter E

2012-01-01

Deep brain stimulation provides significant symptomatic benefit for people with advanced Parkinson's disease whose symptoms are no longer adequately controlled with medication. Preliminary evidence suggests that subthalamic nucleus stimulation may also be efficacious in early Parkinson's disease, and results of animal studies suggest that it may spare dopaminergic neurons in the substantia nigra. We report the methodology and design of a novel Phase I clinical trial testing the safety and tolerability of deep brain stimulation in early Parkinson's disease and discuss previous failed attempts at neuroprotection. We recently conducted a prospective, randomized, parallel-group, single-blind pilot clinical trial of deep brain stimulation in early Parkinson's disease. Subjects were randomized to receive either optimal drug therapy or deep brain stimulation plus optimal drug therapy. Follow-up visits occurred every six months for a period of two years and included week-long therapy washouts. Thirty subjects with Hoehn & Yahr Stage II idiopathic Parkinson's disease were enrolled over a period of 32 months. Twenty-nine subjects completed all follow-up visits; one patient in the optimal drug therapy group withdrew from the study after baseline. Baseline characteristics for all thirty patients were not significantly different. This study demonstrates that it is possible to recruit and retain subjects in a clinical trial testing deep brain stimulation in early Parkinson's disease. The results of this trial will be used to support the design of a Phase III, multicenter trial investigating the efficacy of deep brain stimulation in early Parkinson's disease.

Pilot Study Assessing the Feasibility of Applying Bilateral Subthalamic Nucleus Deep Brain Stimulation in Very Early Stage Parkinson's Disease: Study design and rationale

PubMed Central

Charles, David; Tolleson, Christopher; Davis, Thomas L.; Gill, Chandler E.; Molinari, Anna L.; Bliton, Mark J.; Tramontana, Michael G.; Salomon, Ronald M.; Kao, Chris; Wang, Lily; Hedera, Peter; Phibbs, Fenna T.; Neimat, Joseph S.; Konrad, Peter E.

2014-01-01

Background Deep brain stimulation provides significant symptomatic benefit for people with advanced Parkinson's disease whose symptoms are no longer adequately controlled with medication. Preliminary evidence suggests that subthalamic nucleus stimulation may also be efficacious in early Parkinson's disease, and results of animal studies suggest that it may spare dopaminergic neurons in the substantia nigra. Objective We report the methodology and design of a novel Phase I clinical trial testing the safety and tolerability of deep brain stimulation in early Parkinson's disease and discuss previous failed attempts at neuroprotection. Methods We recently conducted a prospective, randomized, parallel-group, single-blind pilot clinical trial of deep brain stimulation in early Parkinson's disease. Subjects were randomized to receive either optimal drug therapy or deep brain stimulation plus optimal drug therapy. Follow-up visits occurred every six months for a period of two years and included week-long therapy washouts. Results Thirty subjects with Hoehn & Yahr Stage II idiopathic Parkinson's disease were enrolled over a period of 32 months. Twenty-nine subjects completed all follow-up visits; one patient in the optimal drug therapy group withdrew from the study after baseline. Baseline characteristics for all thirty patients were not significantly different. Conclusions This study demonstrates that it is possible to recruit and retain subjects in a clinical trial testing deep brain stimulation in early Parkinson's disease. The results of this trial will be used to support the design of a Phase III, multicenter trial investigating the efficacy of deep brain stimulation in early Parkinson's disease. PMID:23938229

Systemic Chemokine Levels with "Gut-Specific" Vedolizumab in Patients with Inflammatory Bowel Disease-A Pilot Study.

PubMed

Zwicker, Stephanie; Lira-Junior, Ronaldo; Höög, Charlotte; Almer, Sven; Boström, Elisabeth A

2017-08-22

Vedolizumab, a gut-specific biological treatment for inflammatory bowel disease (IBD), is an antibody that binds to the α₄β₇ integrin and blocks T-cell migration into intestinal mucosa. We aimed to investigate chemokine levels in serum of IBD-patients treated with vedolizumab. In this pilot study, we included 11 IBD patients (8 Crohn's disease, 3 ulcerative colitis) previously non-respondent to anti-tumor necrosis factor (TNF)-agents. Patients received vedolizumab at week 0, 2 and 6 and were evaluated for clinical efficacy at week 10. Clinical characteristics and routine laboratory parameters were obtained and patients were classified as responders or non-responders. Expression of 21 chemokines in serum was measured using Proximity Extension Assay and related to clinical outcome. At week 10, 6 out of 11 patients had clinically responded. Overall expression of CCL13 increased after treatment. In non-responders, expression of CCL13 and CXCL8 increased after treatment, and CCL20 and CXCL1 expressions were higher compared to responders. In responders, CCL28 decreased after treatment. C-reactive protein (CRP) correlated negatively with 6 chemokines before therapy, but not after therapy. Systemic CCL13 expression increases in IBD-patients after vedolizumab therapy and several chemokine levels differ between responders and non-responders. An increased CCL13-level when starting vedolizumab treatment, might indicate potential prognostic value of measuring chemokine levels when starting therapy with vedolizumab. This study provides new information on modulation of systemic chemokine levels after vedolizumab treatment.

Mirror therapy in children with hemiplegia: a pilot study.

PubMed

Gygax, Marine Jequier; Schneider, Patrick; Newman, Christopher John

2011-05-01

Mirror therapy, which provides the visual illusion of a functional paretic limb by using the mirror reflection of the non-paretic arm, is used in the rehabilitation of hemiparesis after stroke in adults. We tested the effectiveness and feasibility of mirror therapy in children with hemiplegia by performing a pilot crossover study in ten participants (aged 6-14 y; five males, five females; Manual Ability Classification System levels: one at level I, two at level II, four at level III, three at level IV) randomly assigned to 15 minutes of daily bimanual training with and without a mirror for 3 weeks. Assessments of maximal grasp and pinch strengths, and upper limb function measured by the Shriner's Hospital Upper Extremity Evaluation were performed at weeks 0 (baseline), 3, 6 (intervention), and 9 (wash-out). Testing of grasp strength behind the mirror improved performance by 15% (p=0.004). Training with the mirror significantly improved grasp strength (with mirror +20.4%, p=0.033; without +5.9%, p>0.1) and upper limb dynamic position (with mirror +4.6%, p=0.044; without +1.2%, p>0.1), while training without a mirror significantly improved pinch strength (with mirror +6.9%, p>0.1; without +21.9%, p=0.026). This preliminary study demonstrates the feasibility of mirror therapy in children with hemiplegia and that it may improve strength and dynamic function of the paretic arm. © The Authors. Developmental Medicine & Child Neurology © 2011 Mac Keith Press.

Trans people's experience of sexuality in the Netherlands: a pilot study.

PubMed

Doorduin, Tamar; van Berlo, Willy

2014-01-01

This pilot study explores the specificity of 12 Dutch trans people's experience of sexuality in order to provide new hypotheses and perspectives for future research. Emerging themes include the interconnection of sexual development with coming out and transition processes, the way incongruence between gender identity, gendered embodiment, and social perception of gender affected participants' experience of sexuality, and changes in physical sexual functioning after hormone therapy and/or various types of surgery. Our research design allowed for subjective accounts of trans people's experience of sexuality and detailed descriptions of changes in sexuality that occurred over time and throughout the coming out and transitioning processes.

Using Virtual Reality and Videogames for Traumatic Brain Injury Rehabilitation: A Structured Literature Review.

PubMed

Pietrzak, Eva; Pullman, Stephen; McGuire, Annabel

2014-08-01

This article reviews the available literature about the use of novel methods of rehabilitation using virtual reality interventions for people living with posttraumatic brain injuries. The MEDLINE, EMBASE, SCOPUS, and Cochrane Library databases were searched using the terms "virtual reality" OR "video games" AND "traumatic brain injury." Included studies investigated therapeutic use of virtual reality in adults with a brain trauma resulting from acquired closed head injury, reported outcomes that included measures of motor or cognitive functionality, and were published in a peer-reviewed journal written in English. Eighteen articles fulfilled inclusion criteria. Eight were case studies, five studies had a quasi-experimental design with a pre-post comparison, and five were pilot randomized control trials or comparative studies. The virtual reality systems used were commercial or custom designed for the study and ranged from expensive, fully immersive systems to cheap online games or videogames. In before-after comparisons, improvements in balance were seen in four case studies and two small randomized control trials. Between-group comparisons in these randomized control trials showed no difference between virtual reality and traditional therapy. Post-training improvements were also seen for upper extremity functions (five small studies) and for various cognitive function measures (four case studies and one pilot randomized control trial). Attitudes of participants toward virtual reality interventions was more positive than for traditional therapy (three studies). The evidence that the use of virtual reality in rehabilitation of traumatic brain injury improves motor and cognitive functionality is currently very limited. However, this approach has the potential to provide alternative, possibly more affordable and available rehabilitation therapy for traumatic brain injury in settings where access to therapy is limited by geographical or financial constraints.

Benefits of immediate EMDR vs. eclectic therapy intervention for victims of physical violence and accidents at the workplace: a pilot study.

PubMed

Brennstuhl, Marie-Jo; Tarquinio, Cyril; Strub, Lionel; Montel, Sebastien; Rydberg, Jenny Ann; Kapoula, Zoi

2013-06-01

This study focuses on 34 victims of aggression at the workplace, less than 48 hours following the incident of aggression. We compared victims who received an EMDR emergency protocol (URG-EMDR; n = 19) that we developed with those who received a method of intervention called eclectic therapy (n = 15). The results show that URG-EMDR therapy, provided within 48 hours, resulted in a greater decrease in perceived stress and a lower PCL-S score than eclectic therapy did. The scores were lower in both groups after 24 hours, and after 3 months, the drop was significantly greater among the victims treated with the URG-EMDR protocol; none of the EMDR-treated patients exhibited symptoms of posttraumatic stress.

Double-Blind, Placebo-Controlled Pilot Study of Processed Ultra Emu Oil Versus Placebo in the Prevention of Radiation Dermatitis

DOE Office of Scientific and Technical Information (OSTI.GOV)

Rollmann, Denise C.; Novotny, Paul J.; Petersen, Ivy A.

Purpose: The purpose of this single-institution pilot study was to evaluate the feasibility and safety of an oil-based skin agent, Ultra Emu Oil, on skin-related toxicity in patients undergoing radiation therapy to the breast or chest wall. Methods and Materials: Patients were randomized 2:1 in a double-blind fashion and were instructed to apply processed Ultra Emu Oil or placebo (cottonseed oil) twice daily during the course of radiation therapy. The oils were applied before the third fraction and continued for 6 weeks after completion of treatment. The primary endpoint was the area under the curve (AUC) of Skindex-16 scale scores overmore » time. Secondary outcomes included maximum grade of radiation dermatitis using the Common Terminology Criteria (CTC) for Adverse Events (CTCAE 3.0), the Skin Toxicity Assessment Tool, quality of life (QOL) measured by Linear Analogue Self-Assessment, and a symptom experience diary (SED). Results: In all, 42 of 45 patients completed the study and were evaluable. The median times to peak rash, skin redness, peeling, and skin swelling were weeks 6, 6, 7, and 7, respectively as measured by the SED. The Skindex AUC scores tended to be lower in emu oil patients than in placebo patients (mean total AUC 7.2 vs 10.4, respectively). This trend was also seen in all the Skindex subdomains. The overall QOL was slightly better in the emu oil group but remained stable throughout the study for both arms. Peak CTC toxicity occurred at week 6. Patients using emu oil appeared slightly worse on maximum CTC grade, but the difference was not significant. Conclusions: This pilot study confirmed the safety of oil-based skin treatments during radiation therapy and suggests a trend for reduced skin toxicity for patients receiving emu oil. A larger study is needed to evaluate the efficacy of emu oil in reducing radiation dermatitis in patients receiving breast radiation.« less

Double-Blind, Placebo-Controlled Pilot Study of Processed Ultra Emu Oil Versus Placebo in the Prevention of Radiation Dermatitis.

PubMed

Rollmann, Denise C; Novotny, Paul J; Petersen, Ivy A; Garces, Yolanda I; Bauer, Heather J; Yan, Elizabeth S; Wahner-Roedler, Dietlind; Vincent, Ann; Sloan, Jeff A; Issa Laack, Nadia N

2015-07-01

The purpose of this single-institution pilot study was to evaluate the feasibility and safety of an oil-based skin agent, Ultra Emu Oil, on skin-related toxicity in patients undergoing radiation therapy to the breast or chest wall. Patients were randomized 2:1 in a double-blind fashion and were instructed to apply processed Ultra Emu Oil or placebo (cottonseed oil) twice daily during the course of radiation therapy. The oils were applied before the third fraction and continued for 6 weeks after completion of treatment. The primary endpoint was the area under the curve (AUC) of Skindex-16 scale scores over time. Secondary outcomes included maximum grade of radiation dermatitis using the Common Terminology Criteria (CTC) for Adverse Events (CTCAE 3.0), the Skin Toxicity Assessment Tool, quality of life (QOL) measured by Linear Analogue Self-Assessment, and a symptom experience diary (SED). In all, 42 of 45 patients completed the study and were evaluable. The median times to peak rash, skin redness, peeling, and skin swelling were weeks 6, 6, 7, and 7, respectively as measured by the SED. The Skindex AUC scores tended to be lower in emu oil patients than in placebo patients (mean total AUC 7.2 vs 10.4, respectively). This trend was also seen in all the Skindex subdomains. The overall QOL was slightly better in the emu oil group but remained stable throughout the study for both arms. Peak CTC toxicity occurred at week 6. Patients using emu oil appeared slightly worse on maximum CTC grade, but the difference was not significant. This pilot study confirmed the safety of oil-based skin treatments during radiation therapy and suggests a trend for reduced skin toxicity for patients receiving emu oil. A larger study is needed to evaluate the efficacy of emu oil in reducing radiation dermatitis in patients receiving breast radiation. Copyright © 2015 Elsevier Inc. All rights reserved.

Ballroom dancing as physical activity for patients with cancer: a systematic review and report of a pilot project.

PubMed

Rudolph, Ivonne; Schmidt, Thorsten; Wozniak, Tobias; Kubin, Thomas; Ruetters, Dana; Huebner, Jutta

2018-04-01

Physical activity has positive effects on cancer patients. Dancing addresses diverse bio-psycho-social aspects. Our aim was to assess the evidence on ballroom dancing and to develop the setting for a pilot project. We performed a systematic review, extracted the data and designed a pilot training based on standard curricula. We included cancer patients during or after therapy. Training duration was 90 min with one regular pause and individual pauses as needed. We retrieved two systematic reviews and six controlled studies. Types of dancing varied. Only one study used ballroom dancing. Dance training might improve well-being, physical fitness, fatigue and coping during and after therapy. Yet, evidence is scarce and data to derive the effect size are lacking; 27 patients and their partners took part in the pilot training. Patients and partners needed more time to learn the steps than is planned in regular ballroom classes. Participants were very satisfied with the adaptation of the training to their physical strength and estimated the training in a sheltered group. No side effects occurred. In spite of a high rate of participants reporting fatigue, 90 min of physical activity with only a few minutes of rest were manageable for all participants. Ballroom dancing may offer benefits for patients with respect to quality of life. Cancer patients prefer sheltered training setting and curricula of regular ballroom classes must be adapted for cancer patients. Strict curricula might reduce motivation and adherence and exclude patients with lower or variable fitness.

Cognitive behavioural therapy for psychopathology in relatives of missing persons: study protocol for a pilot randomised controlled trial.

PubMed

Lenferink, Lonneke I M; Wessel, Ineke; de Keijser, Jos; Boelen, Paul A

2016-01-01

It is hypothesized that the grieving process of relatives of missing persons is complicated by having to deal with uncertainty about the fate of their loved one. We developed a cognitive behavioural therapy (CBT) with mindfulness that focuses on dealing with this uncertainty. In this article, we elucidate the rationale of a pilot randomised controlled trial (RCT) for testing the feasibility and potential effectiveness of this CBT for reducing symptoms of psychopathology in relatives of missing persons. A pilot RCT comparing participants of the CBT condition ( n  = 15) with waiting list controls ( n  = 15) will be executed. Individuals suffering from psychopathology related to the long-term disappearance of a loved one are eligible to participate. The treatment consists of eight individual sessions. Questionnaires tapping psychological constructs will be administered before, during, and after the treatment. The feasibility of the treatment will be evaluated using descriptive statistics (e.g., attrition rate). The primary analysis consists of a within-group analysis of changes in mean scores of persistent complex bereavement disorder from baseline to immediately post-treatment and follow-up (12 and 24 weeks post-treatment). A significant number of people experience the disappearance of a loved one. Surprisingly, an RCT to evaluate a treatment for psychopathology among relatives of missing persons has never been conducted. Knowledge about treatment effects is needed to improve treatment options for those in need of help. The strengths of this study are the development of a tailored treatment for relatives of missing persons and the use of a pilot design before exposing a large sample to a treatment that has yet to be evaluated. Future research could benefit from the results of this study. NTR4732 (The Netherlands National Trial Register (NTR)).

Effective therapy to reduce edema after total knee arthroplasty Multi-layer compression therapy or standard therapy with cool pack - a randomized controlled pilot trial

PubMed

Stocker, Brigitta; Babendererde, Christine; Rohner-Spengler, Manuela; Müller, Urs W; Meichtry, André; Luomajoki, Hannu

2018-02-01

Background: After total knee arthroplasty (TKA) efficient control and reduction of postoperative edema is of great importance. Aim: The aim of this pilot study (EKNZ 2014 – 225 DRKS00006271) was to investigate the effectiveness of multi-layer compression therapy (MLCT) to reduce edema in the early period after surgery compared to the standard treatment with Cool Pack. Methods: In this randomized controlled pilot trial, sixteen patients after TKA were randomized into an intervention group (IG) or a control group (CG). Circumferential measurements were used to assess edema. Secondary outcomes were range of motion (ROM), pain (numeric rating scale, NRS) and function as measured with the fast Self Paced Walking Test (fSPWT). Results: Clinically relevant differences in edema reduction between the two groups were found in the early postoperative period and at the six weeks follow up. Six days postoperatively the group time interaction (IE) in favor of the IG were −3.8 cm (95 % CI: −5.1; −2.4) when measured 10 cm proximal to the joint space and −2.7 cm (CI: −4.1; −1.3) when measured 5 cm proximally. We further observed differences in secondary outcomes in favor of the CG. Six days postoperatively the IE for knee flexion was –8.3 ° (CI: −22.0; 5.4) and for the fSPWT it was 12.8 seconds (CI: −16.4; 41.3). Six weeks postoperatively these differences diminished. Conclusions: The findings suggest that MLCT could be an alternative treatment to reduce postoperative edema in patients after total knee arthroplasty. Eventually possible negative effects on early knee flexion and function must be considered.

Changes in Clinical Parameters in Patients with Tension-type Headache Following Massage Therapy: A Pilot Study

PubMed Central

Moraska, Albert; Chandler, Clint

2008-01-01

Complementary and alternative medicine approaches to treatment for tension-type headache are increasingly popular among patients, but evidence supporting its efficacy is limited. The objective of this study was to assess short term changes on primary and secondary headache pain measures in patients with tension-type headache (TTH) receiving a structured massage therapy program with a focus on myofascial trigger point therapy. Participants were enrolled in an open label trial using a baseline control with four 3-week phases: baseline, massage (two 3-week phases) and follow-up. Twice weekly, 45-minute massage sessions commenced following the baseline phase. A daily headache diary was maintained throughout the study in which participants recorded headache incidence, intensity, and duration. The Headache Disability Index was administered upon study entry and at 3-week intervals thereafter. 18 subjects were enrolled with 16 completing all headache diary, evaluation, and massage assignments. Study participants reported a median of 7.5 years with TTH. Headache frequency decreased from 4.7±0.7 episodes per week during baseline to 3.7±0.9 during treatment period 2 (P<0.001); reduction was also noted during the follow-up phase (3.2±1.0). Secondary measures of headache also decreased across the study phases with headache intensity decreasing by 30% (P<0.01) and headache duration from 4.0±1.3 to 2.8±0.5 hours (P<0.05). A corresponding improvement in Headache Disability Index was found with massage (P<0.001). This pilot study provides preliminary evidence for reduction in headache pain and disability with massage therapy that targets myofascial trigger points, suggesting the need for more rigorously controlled studies. PMID:19119396

Antiviral therapy in hepatitis B virus-infected children with immune-tolerant characteristics: A pilot open-label randomized study.

PubMed

Zhu, Shishu; Zhang, Hongfei; Dong, Yi; Wang, Limin; Xu, Zhiqiang; Liu, Weiwei; Gan, Yu; Tang, Hongmei; Chen, Dawei; Wang, Fuchuan; Zhao, Pan

2018-06-01

Chronic infection with hepatitis B virus (HBV) in children is a serious health problem worldwide. How to treat children with immune-tolerant chronic hepatitis B infection, commonly characterized by hepatitis B e antigen (HBeAg) positivity, high viral load, normal or mildly elevated alanine aminotransferase and no or minimal inflammation in liver histology, remains unresolved. This trial aims to study the benefits of antiviral therapy in children with these characteristics. This is a pilot open-label randomized controlled study. From May 2014 to April 2015, 69 treatment-naive chronically HBV-infected children, aged 1 to 16 years, who had immune-tolerant characteristics were recruited to this trial and randomly assigned, in a 2:1 ratio, to treatment group and control group. Patients in the treatment group received either interferon-α (IFN) monotherapy or consecutively received IFN monotherapy, combination therapy of IFN and lamivudine (LAM), and LAM therapy alone. All patients were observed until week 96. At baseline, epidemiological, biochemical, serological, virological and histological indices were consistent across the treatment and control groups. Of the 46 patients in the treatment group, 73.91% had undetectable serum HBV DNA, 32.61% achieved HBeAg seroconversion and 21.74% lost hepatitis B surface antigen (HBsAg) at the endpoint. No LAM resistance emerged at week 96. In the control group, only one (4.35%) patient underwent spontaneous HBeAg seroconversion and had undetectable serum HBV DNA during observation, and moreover, none developed HBsAg clearance. For all patients, no serious adverse events were observed. Antiviral treatment with a sequential combination of IFN and LAM resulted in a significant improvement in the rates of undetectable serum HBV DNA, HBeAg seroconversion and HBsAg loss in children with chronic HBV infection and immune-tolerant characteristics. There is a lack of data regarding treatment of immune-tolerant chronic hepatitis B (CHB). It remains unresolved how children with immune-tolerant CHB should be treated. This paper reports the outcomes from a pilot open-label randomized controlled trial on antiviral therapy in children with immune-tolerant characteristics. It shows that a sequential combination of interferon-α and lamivudine was beneficial. Copyright © 2018 European Association for the Study of the Liver. Published by Elsevier B.V. All rights reserved.

Routine implementation of isoniazid preventive therapy in HIV-infected patients in seven pilot sites in Zimbabwe

PubMed Central

Choto, R. C.; Harries, A. D.; Mutasa-Apollo, T.; Chakanyuka-Musanhu, C.

2017-01-01

Setting: Seven pilot sites in Zimbabwe implementing 6 months of isoniazid preventive therapy (IPT) for people living with the human immunodeficiency virus (PLHIV). Objectives: To determine, among PLHIV started on IPT, the completion rates for a 6-month course of IPT and factors associated with non-adherence. Design: A retrospective cohort study. Results: Of 578 patients, 466 (81%) completed IPT. Of the 112 patients who failed to complete IPT, 69 (60%) were lost to follow-up, 30 (27%) stopped treatment with no documented reasons, 8 (7%) developed toxicity/adverse reactions, 5 (5%) were documented as having drug stock-outs and the remainder transferred out or refused to continue treatment. Currently being on antiretroviral therapy (ART) (aOR 0.09, 95%CI 0.03–0.28) and receiving a ⩾2 month supply of isoniazid at the start of treatment were associated with a lower risk of not completing IPT, while missing clinic visits prior to starting IPT (aOR 5.25, 95%CI 2.10–13.14) was associated with a higher risk of non-completion. Conclusion: IPT completion rates in seven pilot sites of Zimbabwe were comparatively high, showing that IPT roll-out in public health facilities is feasible. Enhanced adherence counselling or active tracing among pre-ART patients and those with a history of loss to follow-up may improve IPT completion rates, along with synchronising IPT and ART resupplies. PMID:28775944

A prospective randomized controlled trial comparing occupational therapy with home-based exercises in conservative treatment of rotator cuff tears.

PubMed

Krischak, Gert; Gebhard, Florian; Reichel, Heiko; Friemert, Benedikt; Schneider, Florian; Fisser, Christoph; Kaluscha, Rainer; Kraus, Michael

2013-09-01

This pilot study evaluates the outcome after occupational therapy, compared to home-based exercises in the conservative treatment of patients with full thickness rotator cuff tears. Forty-three adult subjects (range, 18-75 years), who had a full thickness rupture of the rotator cuff which was verified by magnetic imaging tomography, with clinical signs of a chronic rotator cuff impingement, and who were available for follow-up, were randomized to occupational therapy or to independent home-based exercises using a booklet. After drop-out, 38 patients were available for full examination at follow-up. Before therapy and after 2 months of conservative treatment, pain intensity, the Constant-Murley score, isokinetic strength testing in abduction and external rotation, functional limitation, clinical shoulder tests and health-related quality of life (EQ-5D) were evaluated. Two-thirds of the patients improved in clinical shoulder tests, regardless of the therapy group. There were no significant differences between the groups with reference to pain, range of motion, maximum peak force (abduction, external rotation), the Constant-Murley score, and the EQ-5D index. The only significant difference observed was the improvement in the self-assessed health- related quality of life (EQ-5D VAS) favoring home-based exercises. Home-based exercise, on the basis of an illustrated booklet with exercises twice a day, supplies comparable results to formal occupational therapy in the conservative treatment of rotator cuff tears. The results of this pilot study suggest some potential advantages related to psychological benefits using home-based treatment. Copyright © 2013 Journal of Shoulder and Elbow Surgery Board of Trustees. Published by Mosby, Inc. All rights reserved.

Keratoconus in Civil Aviation Pilots in a Report of Six Cases.

PubMed

Rebello, Albert; Rodrigues, Bênesson; Pereira, Marcos

2017-06-01

Keratoconus is a progressive noninflammatory ectatic corneal dystrophy, characterized by corneal thinning and increased curvature with central or paracentral tapered protrusion. Such changes in corneal morphology induce irregular astigmatism and myopia, resulting in visual acuity impairment. This report assesses cases in which keratoconus is not an absolute disabling condition for civil aviation pilots. Six cases of keratoconus in active pilots are presented. This report includes cases which were treated with crosslinking therapy and even corneal transplantation. In such cases, the civil aviation medical authority considered four aspects in the medical assessment: best corrected visual acuity, condition stability, risk of sudden incapacitation, and pilot category. Six civil pilots with ages between 19 and 45 yr of age presented with keratoconus in different stages. Using the Snellen scale, best corrected visual acuity (BCVA) was measured in 12 eyes, all of them having equal or better than 20/30 (20/20, N = 9; 20/25, N = 2; 20/30, N = 1). All of them are currently fit for aviation activity and have been given an aviation medical certificate with limitation of use of corrective lenses by the Brazilian Civil Aviation Authority (ANAC in Portuguese). Among these cases, there is a pilot who had undergone treatment with crosslinking therapy and another that had undergone corneal transplantation. These cases demonstrate that keratoconus is not always a disabling condition for civil aviation pilots. Nevertheless, it has to be analyzed on a case-by-case basis.Rebello A, Rodrigues B, Pereira M. Keratoconus in civil aviation pilots in a report of six cases. Aerosp Med Hum Perform. 2017; 88(6):574-578.

Cognitive Behavioral Therapy Using a Mobile Application Synchronizable With Wearable Devices for Insomnia Treatment: A Pilot Study.

PubMed

Kang, Seung-Gul; Kang, Jae Myeong; Cho, Seong-Jin; Ko, Kwang-Pil; Lee, Yu Jin; Lee, Heon-Jeong; Kim, Leen; Winkelman, John W

2017-04-15

The use of telemedicine with a mobile application (MA) and a wearable device (WD) for the management of sleep disorders has recently received considerable attention. We designed an MA synchronizable with a WD for insomnia treatment. Our pilot study determined the efficacy of simplified group cognitive behavioral therapy for insomnia (CBT-I) delivered using our MA and assessed participant adherence to and satisfaction with the device. The efficacy of the CBT-I using MA (CBT-I-MA) was assessed by comparing sleep variables (sleep efficiency [SE], Insomnia Severity Index [ISI], and Pittsburgh Sleep Quality Inventory [PSQI] scores) before and after a 4-week treatment protocol in 19 patients with insomnia disorder patients. SE was assessed using a sleep diary, actigraphy, and the PSQI. The intervention significantly improved all three measures of SE ( P < .05), and the response rate to treatment was high (94.7%). Total ISI and PSQI scores and sleep latency, as measured by the sleep diary, improved significantly. Participants showed relatively good adherence to our MA, and sleep diary entries were made on 24.3 ± 3.8 of 28 days. Moreover, 94.7% of the participants reported that our MA was effective for treating insomnia. Our pilot study suggested the clinical usefulness of a CBT-I-MA. We expect that our findings will lead to further development and replication studies of CBT-I-MA. © 2017 American Academy of Sleep Medicine

Head and neck lymphedema management: Evaluation of a therapy program.

PubMed

Pigott, Amanda; Nixon, Jodie; Fleming, Jennifer; Porceddu, Sandro

2018-06-01

The purpose of this pilot study was to examine a therapeutic intervention for head and neck lymphedema. The 22-week intervention involved therapist-led care and participant self-management. Effectiveness was evaluated using a previously described lymphedema assessment tool, the Assessment of Lymphedema of the Head and Neck (ALOHA) to detect change over the course of the 22 weeks of treatment, and before and after a single treatment session. A prospective observational pilot study was conducted with a cohort of 10 participants assessed. Measurements of size (tape measurements) and water content (tissue dielectric constant [TDC]) were used, per the ALOHA protocol. Participants received 13 lymphedema therapy treatments at reducing frequencies over 22 weeks and daily self-management. There was an overall significant reduction in lower neck circumference (F [2.15,19.35] = 7.11; P = .004), upper neck circumference (F [5,45] = 7.27; P < .001) and TDC (F (5,45) = 8.92; P < .001) over time. There were no significant differences over the course of treatment for mean ear-to-ear measurements or before and after a single session of treatment. This pilot study found a reduction in head and neck lymphedema over the 22-week lymphedema treatment course. This intervention may be successful in reducing head and neck lymphedema; however, further studies are needed to investigate these findings in a larger sample with the use of a control group to negate improvements from healing over time. © 2018 Wiley Periodicals, Inc.

Influence of sex hormone levels on gingival enlargement in adolescent patients undergoing fixed orthodontic therapy: A pilot study

PubMed Central

Hosadurga, Rajesh; Nabeel Althaf, M. S.; Hegde, Shashikanth; Rajesh, Kashyap S.; Arun Kumar, M. S.

2016-01-01

Background: Sex hormones may be a modifying factor in the periodontal disease pathogenesis. Aim: The association between gingival enlargement and sex hormone levels in adolescent patients undergoing fixed orthodontic therapy needs to be determined. Settings and Design: This study was conducted in the Department of Periodontology in association with the Department of Orthodontics, Yenepoya Dental College, Yenepoya University, Mangaluru. Materials and Methods: A pilot study was conducted on 21 adolescent patients between the age group of 13–19 years, who had undergone fixed orthodontic therapy for at least 3 months. Apicocoronally, the gingival enlargement was assessed by the index described by Miller and Damm. Miranda and Brunet index was used to assess gingival overgrowth in the buccal–lingual direction in the interdental papilla. Furthermore, the patients were assigned to two groups - Group 1-GE and Group 2-non-GE. Sex hormones assessed were estradiol and progesterone in females and testosterone in males in both groups. Results: 57.1% of the study population had enlargement of the gingiva. The mean plaque score was 0.59 and 0.56, respectively, in both groups. A statistically significant relationship was found between estradiol and testosterone levels with gingival enlargement. However, a significant relationship was not obtained for progesterone levels with the gingival enlargement. Conclusion: Direct correlation between estradiol, testosterone, and gingival enlargement was seen. PMID:27994419

Pulse pressure variation-guided fluid therapy after cardiac surgery: a pilot before-and-after trial.

PubMed

Suzuki, Satoshi; Woinarski, Nicholas C Z; Lipcsey, Miklos; Candal, Cristina Lluch; Schneider, Antoine G; Glassford, Neil J; Eastwood, Glenn M; Bellomo, Rinaldo

2014-12-01

The aim of this study is to study the feasibility, safety, and physiological effects of pulse pressure variation (PPV)-guided fluid therapy in patients after cardiac surgery. We conducted a pilot prospective before-and-after study during mandatory ventilation after cardiac surgery in a tertiary intensive care unit. We introduced a protocol to deliver a fluid bolus for a PPV≥13% for at least >10 minutes during the intervention period. We studied 45 control patients and 53 intervention patients. During the intervention period, clinicians administered a fluid bolus on 79% of the defined PPV trigger episodes. Median total fluid intake was similar between 2 groups during mandatory ventilation (1297 mL [interquartile range 549-1968] vs 1481 mL [807-2563]; P=.17) and the first 24 hours (3046 mL [interquartile range 2317-3982] vs 3017 mL [2192-4028]; P=.73). After adjusting for several baseline factors, PPV-guided fluid management significantly increased fluid intake during mandatory ventilation (P=.004) but not during the first 24 hours (P=.47). Pulse pressure variation-guided fluid therapy, however, did not significantly affect hemodynamic, renal, and metabolic variables. No serious adverse events were noted. Pulse pressure variation-guided fluid management was feasible and safe during mandatory ventilation after cardiac surgery. However, its advantages may be clinically small. Copyright © 2014 Elsevier Inc. All rights reserved.

Modified CBT using visualization for Autism Spectrum Disorder (ASD), anxiety and avoidance behavior--a quasi-experimental open pilot study.

PubMed

Ekman, Elizabeth; Hiltunen, Arto J

2015-12-01

In recent studies it has been suggested that Cognitive Behavior Therapy (CBT) is beneficial to people with Autism Spectrum Disorder (ASD) but that the method needs to be modified in relation to their cognitive profile. The aim of this study is to measure the effect of modified CBT, that is, using visualized language throughout the entire session for clients with ASD and anxiety and avoidance behavior. The modification of CBT in this study consists of focusing on CBT protocols for anxiety disorders and depression, while visualizing and systematizing "the invisible" in the conversation, in order for the clients to understand the social, cognitive and emotional context of self and others and how they should interact to avoid misunderstandings. ASD clients may need help to detect the invisible code of social interaction and communication. The level of anxiety and the frequency of target behavior were measured. Four assessments were made, two at the pre-assessment, and one in mid-therapy and end of therapy respectively. Generally, results suggest no improvement during pre-treatment period but a significant improvement during treatment. The values of the clients' psychological, social and occupational ability to function improved on the Global Function Rating scale. The preliminary conclusion of this pilot study indicates that the use of visualized language throughout the CBT therapy sessions is a promising modification of current CBT protocols for individuals with ASD. After manualization, larger studies with randomized controlled study designs can replicate or challenge these results. © 2015 The Authors. Scandinavian Journal of Psychology published by Scandinavian Psychological Associations and John Wiley & Sons Ltd.

A Pilot Study: Evaluation of the Effects of Treatment with 0.75% Topical Capsaicin in Patients with Reflex Sympathetic Dystrophy Using Three Phase Bone Scintigraphy

DTIC Science & Technology

1991-01-28

were maintained at pre-treatment levels in all patients. Non- pharmaceutical pain therapies such as transcutaneous nerve stimulation , contrast baths and...utilizing passive range of motion, physical and occupational therapy, and counter- irritation, by such means as contrast baths and transcutaneous nerve ...her pain lessened. At ten weeks of treatment she rated pain relief (VAS) to be 82%. H.W. (thalamic pain) rated pain relief at approximately 18%; his

A Pilot Study to Identify Barriers to Treatment in OIF/OEF Veterans with PTSD and Low Back Pain in Establishing Transdisciplinary Complementary Interventions

DTIC Science & Technology

2009-11-01

CLBP) with a duration of 3 months or greater, documentation by physiatrist that spine is cleared for active therapies in Back School, and documented...vulnerability to posttraumatic stress in dysfunctional pain patients. Behaviour Research & Therapy , 38, 801-812. Asmundson, J.G.G., Coons. M.J., Taylor, S...S.J. & Dijkstra, P.U. (2003). Relationship between kinesiophobia and performance in a functional capacity evaluation. Journal of Occupational

The Music Therapy Session Assessment Scale (MT-SAS): Validation of a new tool for music therapy process evaluation.

PubMed

Raglio, Alfredo; Gnesi, Marco; Monti, Maria Cristina; Oasi, Osmano; Gianotti, Marta; Attardo, Lapo; Gontero, Giulia; Morotti, Lara; Boffelli, Sara; Imbriani, Chiara; Montomoli, Cristina; Imbriani, Marcello

2017-11-01

Music therapy (MT) interventions are aimed at creating and developing a relationship between patient and therapist. However, there is a lack of validated observational instruments to consistently evaluate the MT process. The purpose of this study was the validation of Music Therapy Session Assessment Scale (MT-SAS), designed to assess the relationship between therapist and patient during active MT sessions. Videotapes of a single 30-min session per patient were considered. A pilot study on the videotapes of 10 patients was carried out to help refine the items, define the scoring system and improve inter-rater reliability among the five raters. Then, a validation study on 100 patients with different clinical conditions was carried out. The Italian MT-SAS was used throughout the process, although we also provide an English translation. The final scale consisted of 7 binary items accounting for eye contact, countenance, and nonverbal and sound-music communication. In the pilot study, raters were found to share an acceptable level of agreement in their assessments. Explorative factorial analysis disclosed a single homogeneous factor including 6 items (thus supporting an ordinal total score), with only the item about eye contact being unrelated to the others. Moreover, the existence of 2 different archetypal profiles of attuned and disattuned behaviours was highlighted through multiple correspondence analysis. As suggested by the consistent results of 2 different analyses, MT-SAS is a reliable tool that globally evaluates sonorous-musical and nonverbal behaviours related to emotional attunement and empathetic relationship between patient and therapist during active MT sessions. Copyright © 2017 John Wiley & Sons, Ltd.

Adjunctive therapy (whole body hyperthermia versus lonidamine) to total body irradiation for the treatment of favorable B-cell neoplasms: a report of two pilot clinical trials and laboratory investigations.

PubMed

Robins, H I; Longo, W L; Steeves, R A; Cohen, J D; Schmitt, C L; Neville, A J; O'Keefe, S; Lagoni, R; Riggs, C

1990-04-01

Based on earlier clinical and preclinical investigations, we designed two different pilot trials for patients with nodular lymphoma or chronic lymphocytic leukemia. These studies evaluated the use of either 41.8 degrees C whole body hyperthermia (WBH), or the nonmyelosuppressive chemotherapeutic drug, lonidamine (LON), as an adjunct to total body irradiation (TBI) (12.5 cGy twice a week, every other week for a planned total dose of 150 cGy). Whole body hyperthermia was initiated approximately 10 min after total body irradiation; lonidamine was administered orally (420 mg/m2) on a daily basis. Although entry to the studies was nonrandomized, the two patient populations were accrued during the same time frame and were comparable in terms of histology, stage of disease, performance status, and prior therapy. Of 8 patients entered on the TBI/WBH study, we observed 3 complete responses (CR), 4 partial responses (PR), and 1 improvement (i.e., a 48% decrease in tumor burden). Of 10 patients entered in the TBI/LON study, there was 1 CR and 4 PR. For the TBI/WBH study, myelosuppression was not treatment-limiting; there were no instances of infection or bleeding and platelet support was never required. The median survival time for the TBI/WBH study is 52.5 months based on Kaplan Meir estimates. Two patients remain in a CR. The median time to treatment failure (MTTF) is 9.4 months (90% confidence interval = 7-15.4 months). In the TBI/LON study, 50% of patients receiving TBI required treatment modification due to platelet-count depression during therapy, but there were no instances of infection or bleeding. Frequently observed LON-related toxicities included myalgias, testicular pain, photophobia and ototoxicity. For the TBI/LON study, median survival is 7.6 months; MTTF was 2.4 months. In analyzing the results of these pilot studies, our subjective clinical impressions lead to the hypothesis that WBH protected against TBI-induced thrombocytopenia during therapy, whereas LON had no effect on TBI-induced myelosuppression. This speculation was tested and confirmed in a series of in vitro and in vivo experiments.

Alzheimer’s Disease and Its Treatment With a Novel Transdermal Patch Therapy: Survey of Caregiver Experiences

PubMed Central

Pepp, Mike

2012-01-01

Objective: To investigate experiences and perceptions of caregivers of patients with Alzheimer’s disease using transdermal patch therapy. Method: Assessment methods for the pilot study comprised an interview between the caregiver and a moderator, an interview between 1 moderator and 2 caregivers, or a video diary. The subsequent quantitative study involved a 45-minute telephone questionnaire. For both studies, participants were required to be the principal caregiver of a patient with Alzheimer’s disease who had been receiving transdermal patch therapy for at least 3 months. Their responses were grouped into the following 6 themes: interpersonal relationships, impact on caregivers, from symptoms to treatment, help and support for caregivers, daily routine, and caregiver experience with the patch. Results: Overall, 206 caregivers were enrolled from France, Germany, Greece, Spain, and the United States between July 2009 and January 2011 (pilot study: N = 56; quantitative study: N = 150). The studies revealed that caregivers of patients with Alzheimer’s disease experienced emotional and practical impacts, and many felt that they had not received sufficient information from health care providers about Alzheimer’s disease, treatment options, or available support. In the quantitative study, 47% of caregivers who had been caring for the patient prior to diagnosis (61% of total respondents) felt that there had been a delay in seeking medical advice, frequently due to slow onset of symptoms of Alzheimer’s disease. In both studies, patch therapy was considered more convenient and easier to administer than oral treatments. The practical and efficacy advantages of the patch often translated into emotional benefits. Conclusions: With recent data highlighting the importance of early initiation of symptomatic Alzheimer’s disease therapy and the importance of reaching an optimal therapeutic dose, reasons for delay in treatment initiation need to be explored. Information that patients and caregivers receive at the time of diagnosis may aid therapeutic decisions. PMID:23251856

Museum Education and Art Therapy: Exploring an Innovative Partnership

ERIC Educational Resources Information Center

Peacock, Karen

2012-01-01

This report describes collaborations between the disciplines of museum education and art therapy, which inspired the implementation of a pilot art therapy program at the Memphis Brooks Museum of Art in Tennessee (USA). Because relatively limited research has been conducted on this trend, the author reviewed museum exhibits and programming, as well…

Prolonged Exposure versus Dynamic Therapy for Adolescent PTSD: A Pilot Randomized Controlled Trial

ERIC Educational Resources Information Center

Gilboa-Schechtman, Eva; Foa, Edna B.; Shafran, Naama; Aderka, Idan M.; Powers, Mark B.; Rachamim, Lilach; Rosenbach, Lea; Yadin, Elna; Apter, Alan

2010-01-01

Objective: To examine the efficacy and maintenance of developmentally adapted prolonged exposure therapy for adolescents (PE-A) compared with active control time-limited dynamic therapy (TLDP-A) for decreasing posttraumatic and depressive symptoms in adolescent victims of single-event traumas. Method: Thirty-eight adolescents (12 to 18 years old)…

Group Therapy for Anxiety in Children with Autism Spectrum Disorder

ERIC Educational Resources Information Center

McConachie, Helen; McLaughlin, Eleanor; Grahame, Victoria; Taylor, Helen; Honey, Emma; Tavernor, Laura; Rodgers, Jacqui; Freeston, Mark; Hemm, Cahley; Steen, Nick; Le Couteur, Ann

2014-01-01

Aim: To investigate the acceptability and feasibility of adapted group therapy for anxiety in children with autism spectrum disorder in a pilot randomised controlled trial. Method: A total of 32 children aged 9-13 years were randomised to immediate or delayed therapy using the "Exploring Feelings" manual (Attwood, 2004). Child and parent…

The clinical benefits of long-term supplementation with omega-3 fatty acids in cystic fibrosis patients - A pilot study.

PubMed

Hanssens, L; Thiébaut, I; Lefèvre, N; Malfroot, A; Knoop, C; Duchateau, J; Casimir, G

2016-05-01

Effectiveness of omega-3 supplementation in cystic fibrosis (CF) remains controversial. This study sought to evaluate clinical status, exercise tolerance, inflammatory parameters, and erythrocyte fatty acid profile after 1 year of oral omega-3 supplementation in CF patients. Fifteen ΔF508-homozygous patients undergoing chronic azithromycin were randomized to receive omega-3 fish oil supplementation at a dose of 60mg/Kg/day or placebo. In comparison with the previous year, in the supplemented group, the number of pulmonary exacerbations decreased at 12 months (1.7 vs. 3.0, p<0.01), as did the duration of antibiotic therapy (26.5 days vs. 60.0 days, p<0.025). Supplementation significantly increased the levels of eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA) as early as <3 months of administration, with concomitant decreases in arachidonic acid (AA) levels. This pilot study suggests that long-term omega-3 supplementation offers several clinical benefits as to the number of exacerbations and duration of antibiotic therapy in CF patients. Copyright © 2016 Elsevier Ltd. All rights reserved.

Combination Therapy of All-Trans Retinoic Acid With Ursodeoxycholic Acid in Patients With Primary Sclerosing Cholangitis: A Human Pilot Study.

PubMed

Assis, David N; Abdelghany, Osama; Cai, Shi-Ying; Gossard, Andrea A; Eaton, John E; Keach, Jill C; Deng, Yanhong; Setchell, Kenneth D R; Ciarleglio, Maria; Lindor, Keith D; Boyer, James L

2017-02-01

To perform an exploratory pilot study of all-trans retinoic acid (ATRA) combined with ursodeoxycholic acid (UDCA) in patients with primary sclerosing cholangitis (PSC). PSC is a progressive disorder for which there is no accepted therapy. Studies in human hepatocyte cultures and in animal models of cholestasis indicate that ATRA might have beneficial effects in cholestatic disorders. ATRA (45 mg/m/d, divided and given twice daily) was combined with moderate-dose UDCA in patients with PSC who had incomplete response to UDCA monotherapy. The combination was administered for 12 weeks, followed by a 12-week washout in which patients returned to UDCA monotherapy. We measured alkaline phosphatase (ALP), alanine aminotransferase (ALT), bilirubin, cholesterol, bile acids, and the bile acid intermediate 7α-hydroxy-4-cholesten-3-one (C4) at baseline, week 12, and after washout. Fifteen patients completed 12 weeks of therapy. The addition of ATRA to UDCA reduced the median serum ALP levels (277±211 to 243±225 U/L, P=0.09) although this, the primary endpoint, did not reach significance. In contrast, median serum ALT (76±55 to 46±32 U/L, P=0.001) and C4 (9.8±19 to 7.9±11 ng/mL, P=0.03) levels significantly decreased. After washout, ALP and C4 levels nonsignificantly increased, whereas ALT levels significantly increased (46±32 to 74±74, P=0.0006), returning to baseline. In this human pilot study, the combination of ATRA and UDCA did not achieve the primary endpoint (ALP); however, it significantly reduced ALT and the bile acid intermediate C4. ATRA appears to inhibit bile acid synthesis and reduce markers of inflammation, making it a potential candidate for further study in PSC (NCT 01456468).

[Benefits of music therapy as therapy no pharmacology and rehabilitation moderate dementia].

PubMed

Jiménez-Palomares, María; Rodríguez-Mansilla, Juan; González-López-Arza, María Victoria; Rodríguez-Domínguez, María Trinidad; Prieto-Tato, Marta

2013-01-01

An in-depth review is presented the possible benefits of music therapy in relation to the cognitive and/or behavioural level of elderly patients with dementia. We have carried out a systematic review of randomized controlled trials, case-control and pilot studies published from January 2000 to January 2012 using the Cochrane Database of Systematic Reviews, MEDLINE, Dialnet and CSIC. We focused on comparison of music therapy as non-pharmacological therapy, in patients over 65 years of age with moderate dementia, with regular therapeutic and occupational treatment. Ten articles were selected based on the inclusion criteria. The analysis of the results suggest that music Therapy influences the elderly people with dementia in a positive way by improving levels of behavioural and cognitive functioning and social participation. Copyright © 2012 SEGG. Published by Elsevier Espana. All rights reserved.

Pilot study of acupuncture for the treatment of joint symptoms related to adjuvant aromatase inhibitor therapy in postmenopausal breast cancer patients.

PubMed

Crew, Katherine D; Capodice, Jillian L; Greenlee, Heather; Apollo, Arlyn; Jacobson, Judith S; Raptis, George; Blozie, Kimberly; Sierra, Alex; Hershman, Dawn L

2007-12-01

Aromatase inhibitors (AIs) have become the standard of care for the adjuvant treatment of postmenopausal, hormone-sensitive breast cancer. However, patients receiving AIs may experience joint symptoms, which may lead to early discontinuation of this effective therapy. We hypothesize that acupuncture is a safe and effective treatment for AI-induced arthralgias. Postmenopausal women with early-stage breast cancer who had self-reported musculoskeletal pain related to adjuvant AI therapy were randomized in a crossover study to receive acupuncture twice weekly for 6 weeks followed by observation or vice-versa. The intervention included full body and auricular acupuncture, and a joint-specific point prescription. Outcome measures included the Brief Pain Inventory-Short Form (BPI-SF), Western Ontario and McMaster Universities Osteoarthritis (WOMAC) index, the Functional Assessment of Cancer Therapy-General (FACT-G) quality of life measure, and serum levels of inflammatory markers, IL-1 beta and TNF-alpha. Twenty-one women were enrolled and two discontinued early. From baseline to the end of treatment, patients reported improvement in the mean BPI-SF worst pain scores (5.3 to 3.3, p = 0.01), pain severity (3.7 to 2.5, p = 0.02), and pain-related functional interference (3.1 to 1.7, p = 0.02), as well as the WOMAC function subscale and FACT-G physical well-being (p = 0.02 and 0.04, respectively). No adverse events were reported. In this pilot study, acupuncture reduced AI-related joint symptoms and improved functional ability and was well-tolerated. Musculoskeletal side effects are common among breast cancer survivors on adjuvant AI therapy, therefore, effective treatments are needed for symptom relief and to improve adherence to these life-saving medications.

Virtual Reality Exposure and Imaginal Exposure in the Treatment of Fear of Flying: A Pilot Study

ERIC Educational Resources Information Center

Rus-Calafell, Mar; Gutierrez-Maldonado, Jose; Botella, Cristina; Banos, Rosa M.

2013-01-01

Fear of flying (FF) is an impairing psychological disorder that is extremely common in developed countries. The most effective treatment for this particular type of phobia is exposure therapy. However, there are few studies comparing imaginal exposure (IE) and virtual reality (VR) exposure for the treatment of FF. The present study compared the…

Rescripting Early Memories Linked to Negative Images in Social Phobia: A Pilot Study

ERIC Educational Resources Information Center

Wild, Jennifer; Hackmann, Ann; Clark, David M.

2008-01-01

Negative self-images are a maintaining factor in social phobia. A retrospective study (Hackmann, A., Clark, D.M., McManus, F. (2000). Recurrent images and early memories in social phobia. Behaviour Research and Therapy, 38, 601-610) suggested that the images may be linked to early memories of unpleasant social experiences. This preliminary study…

Anxiety in High-Functioning Autism: A Pilot Study of Experience Sampling Using a Mobile Platform

ERIC Educational Resources Information Center

Hare, Dougal Julian; Gracey, Carolyn; Wood, Christopher

2016-01-01

Anxiety and stress are everyday issues for many people with high-functioning autism, and while cognitive-behavioural therapy is the treatment of choice for the management of anxiety, there are challenges in using it with people with high-functioning autism. This study used modified experience sampling techniques to examine everyday anxiety and…

The Effectiveness of Irlen Filters for Improving Reading Performance: A Pilot Study.

ERIC Educational Resources Information Center

Blaskey, Penni; And Others

1990-01-01

The study compared the effectiveness of Irlen filters and traditional optometric intervention with 30 volunteers (ages 9-51). Pre- and posttesting revealed that subjects in both treatment groups were more comfortable after treatment, that only the vision therapy group showed improved visual functioning, and that the Irlen filter group did not show…

Cognitive Behaviour Therapy Versus a Counselling Intervention for Anxiety in Young People with High-Functioning Autism Spectrum Disorders: A Pilot Randomised Controlled Trial.

PubMed

Murphy, Suzanne M; Chowdhury, Uttom; White, Susan W; Reynolds, Laura; Donald, Louisa; Gahan, Hilary; Iqbal, Zeinab; Kulkarni, Mahesh; Scrivener, Louise; Shaker-Naeeni, Hadi; Press, Dee A

2017-11-01

The use of cognitive-behavioural therapy (CBT) as a treatment for children and adolescents with autism spectrum disorder (ASD) has been explored in a number of trials. Whilst CBT appears superior to no treatment or treatment as usual, few studies have assessed CBT against a control group receiving an alternative therapy. Our randomised controlled trial compared use of CBT against person-centred counselling for anxiety in 36 young people with ASD, ages 12-18. Outcome measures included parent- teacher- and self-reports of anxiety and social disability. Whilst each therapy produced improvements in participants, neither therapy was superior to the other to a significant degree on any measure. This is consistent with findings for adults.

The Intern Studio: A Pilot Study.

ERIC Educational Resources Information Center

Wix, Linney

1995-01-01

Describes and discusses the Intern Studio Project, which consists of the provision of regular open studio time for art therapy interns in a state university graduate program. Psychological and artistic bases for the open studio approach are discussed, and include the relational approach, Hillman's essentialist paradigm, and series and context…

Smoking Cessation Delivered by Medical Students Is Helpful to Homeless Population

ERIC Educational Resources Information Center

Spector, Andrew; Alpert, Hilary; Karam-Hage, Maher

2007-01-01

Objective: The authors pilot a smoking-cessation outreach for the homeless that extends medical students' tobacco cessation education. Method: In this prospective study, second-year medical students administered cognitive behavior therapy or unstructured support to homeless subjects to help them quit smoking. Self-report and biological measures…

A Child Welfare Agency Project: Therapy for Families of Status Offenders.

ERIC Educational Resources Information Center

Michaels, Kenneth W.; Green, Robert H.

1979-01-01

Describes a pilot project in York, Pennsylvania which provides therapy for the families of status offender youths (i.e. incorrigibles, runaways, truants). Results indicate that the program is effective in reducing placements and costs. (BD)

Conservative Approach in Patients with Pemphigus Gingival Vulgaris: A Pilot Study of Five Cases

PubMed Central

Gambino, Alessio; Carbone, Mario; Arduino, Paolo G.; Carbone, Lucio; Broccoletti, Roberto

2014-01-01

Objectives. The aim of this pilot study was to describe the clinical efficacy of a conservative oral hygiene protocol in patients affected by gingival pemphigus vulgaris (PV) applied in a case series. Methods. Subjects suffering from PV with gingival localisation and slightly responsive to conventional treatment with systemic corticosteroids and immunosuppressive drugs were selected among individuals treated in the Unit of Oral Medicine Section of the University of Turin. Five subjects received nonsurgical periodontal therapy, over a 7-day period, including oral hygiene instructions; patients were instructed about domiciliary oral hygiene maintenance and instructions were reinforced at each visit and personalised if necessary. Clinical outcome variables were recorded at baseline (before starting) and 16 weeks after intervention, including full mouth plaque score (FMPS), bleeding scores (FMBS), probing pocket depth (PPD), oral pemphigus clinical score (OPCS), and patient related outcomes (visual analogue score of pain). Results. Five patients were treated and, after finishing the proposed therapy protocol, a statistical significant reduction was observed for FMBS (P = 0.043) and OPCS (P = 0.038). Conclusions. Professional oral hygiene procedures with nonsurgical therapy are related to an improvement of gingival status and a decrease of gingival bleeding in patients affected by PV with specific gingival localization. PMID:25505912

Belief disconfirmation versus habituation approaches to situational exposure in panic disorder with agoraphobia: a pilot study.

PubMed

Salkovskis, Paul M; Hackmann, Ann; Wells, Adrian; Gelder, Michael G; Clark, David M

2007-05-01

Exposure therapy and cognitive behaviour therapy (CBT) are both effective in the treatment of panic disorder with agoraphobia. Cognitive theories suggest that the way in which exposure to avoided situations is implemented in either treatment may be crucial. In particular, it is suggested that clinical improvement will be greatest if opportunities for disconfirmation of feared catastrophes are maximized. In a small pilot study, 16 patients with panic disorder and (moderate or severe) agoraphobia were randomly allocated to either habituation based exposure therapy (HBET) or exposure planned as a belief disconfirmation strategy and accompanied by dropping of safety-seeking behaviours. Both treatments were brief (total of 3.25 h of exposure) and were similar in terms of expectancy of change. Patients in the CBT condition showed significantly greater improvements in self-report measures of anxiety, panic and situational avoidance. They also completed significantly more steps in a standardized behavioural walk, during which they experienced significantly less anxiety. The controlled effect sizes for CBT were substantial (range 1.7-2.7), which suggests it may be a particularly efficient way of managing therapeutic exposure to feared situations in panic disorder with agoraphobia. Further research is needed to clarify the mechanism of change involved.

Using the Habit App for Weight Loss Problem Solving: Development and Feasibility Study.

PubMed

Pagoto, Sherry; Tulu, Bengisu; Agu, Emmanuel; Waring, Molly E; Oleski, Jessica L; Jake-Schoffman, Danielle E

2018-06-20

Reviews of weight loss mobile apps have revealed they include very few evidence-based features, relying mostly on self-monitoring. Unfortunately, adherence to self-monitoring is often low, especially among patients with motivational challenges. One behavioral strategy that is leveraged in virtually every visit of behavioral weight loss interventions and is specifically used to deal with adherence and motivational issues is problem solving. Problem solving has been successfully implemented in depression mobile apps, but not yet in weight loss apps. This study describes the development and feasibility testing of the Habit app, which was designed to automate problem-solving therapy for weight loss. Two iterative single-arm pilot studies were conducted to evaluate the feasibility and acceptability of the Habit app. In each pilot study, adults who were overweight or obese were enrolled in an 8-week intervention that included the Habit app plus support via a private Facebook group. Feasibility outcomes included retention, app usage, usability, and acceptability. Changes in problem-solving skills and weight over 8 weeks are described, as well as app usage and weight change at 16 weeks. Results from both pilots show acceptable use of the Habit app over 8 weeks with on average two to three uses per week, the recommended rate of use. Acceptability ratings were mixed such that 54% (13/24) and 73% (11/15) of participants found the diet solutions helpful and 71% (17/24) and 80% (12/15) found setting reminders for habits helpful in pilots 1 and 2, respectively. In both pilots, participants lost significant weight (P=.005 and P=.03, respectively). In neither pilot was an effect on problem-solving skills observed (P=.62 and P=.27, respectively). Problem-solving therapy for weight loss is feasible to implement in a mobile app environment; however, automated delivery may not impact problem-solving skills as has been observed previously via human delivery. ClinicalTrials.gov NCT02192905; https://clinicaltrials.gov/ct2/show/NCT02192905 (Archived by WebCite at http://www.webcitation.org/6zPQmvOF2). ©Sherry Pagoto, Bengisu Tulu, Emmanuel Agu, Molly E Waring, Jessica L Oleski, Danielle E Jake-Schoffman. Originally published in JMIR Mhealth and Uhealth (http://mhealth.jmir.org), 20.06.2018.

Emotion-focused group therapy for women with symptoms of bulimia nervosa.

PubMed

Wnuk, Susan M; Greenberg, Les; Dolhanty, Joanne

2015-01-01

This study provides outcome pilot data for an outpatient emotion-focused therapy group for 12 women with DSM-IV diagnoses of binge-eating disorder, bulimia nervosa, or eating disorder not otherwise specified. The emotion-focused therapy group involved 16 weekly sessions that targeted problematic emotions connected to eating disorder symptoms. Semi-structured clinical interviews were conducted pre- and post-treatment and self-report questionnaires were administered. From pre- to post-treatment, changes in binge eating and scores on self-report measures were statistically significant. Participants reported a decrease in the frequency of binge episodes, improvements in mood, and improvements in emotion regulation and self-efficacy.

Development and pilot of an international survey: 'Radiation Therapists and Psychosocial Support'.

PubMed

Elsner, Kelly L; Naehrig, Diana; Halkett, Georgia K B; Dhillon, Haryana M

2018-06-07

Up to one third of radiation therapy patients are reported to have unmet psychosocial needs. Radiation therapists (RTs) have daily contact with patients and can provide daily psychosocial support to reduce patient anxiety, fear and loneliness. However, RTs vary in their values, skills, training, knowledge and involvement in providing psychosocial support. The aims of this study were to: (1) develop an online survey instrument to explore RT values, skills, training and knowledge regarding patient anxiety and psychosocial support, and (2) pilot the instrument with RT professionals to assess content validity, functionality and length. An online cross-sectional survey, titled 'Radiation therapists and psychosocial support' was developed. Items included patient vignettes, embedded items from RT research, and the Professional Quality of Life Scale (ProQOL5). Four radiation oncology departments volunteered to pilot the survey; each nominated four RT staff to participate. Survey data were analysed descriptively and qualitative feedback grouped and coded to determine whether the survey needed to be refined. Thirteen of sixteen RTs completed the pilot survey and feedback form. Median time to completion was 35 mins, with 54% of respondents stating this was too long. Respondents reported content, questions and response options were relevant and appropriate. Feedback was used to: refine the survey instrument, minimise responder burden and drop out and improve functionality and quality of data collection. This pilot of the 'Radiation therapists and psychosocial support' survey instrument demonstrated content validity and usability. The main survey will be circulated to a representative sample of RTs for completion. © 2018 The Authors. Journal of Medical Radiation Sciences published by John Wiley & Sons Australia, Ltd on behalf of Australian Society of Medical Imaging and Radiation Therapy and New Zealand Institute of Medical Radiation Technology.

Biomagnetic Pair Therapy and Typhoid Fever: A Pilot Study.

PubMed

Frank, Bryan L

2017-10-01

Objective: This pilot study examined the laboratory responses of patients with laboratory-documented typhoid fever who were treated with Biomagnetic Pair Therapy (BPT; medical biomagnetism), a specific application of pairs of magnets for various ailments that are infectious and otherwise. Materials and Methods: This study was an assessment of patients' response to treatment with only BPT for Salmonella typhi infections (typhoid fever) using standard conventional laboratory techniques. The research was conducted in an outpatient village clinic in Kenya. There were 52 participants who were evaluated for possible systemic illness, including typhoid fever, from an open-label study. Participants who felt sick and requested testing for possible typhoid fever were tested with a standard Widal test by a certified laboratory technician. Participants who tested positive (13 patients) were then treated with BPT (a "First Aid" approach) only. These participants then returned for follow-up laboratory and clinical evaluations after 2 days. Results: Most of the participants (10 of 13) retested as negative, and all patients reported symptomatic clinical improvement. Conclusions: As a significant majority of participants demonstrated clearing of their S. typhi after BPT, this technique should be studied further in larger trials for its efficacy in treating typhoid fever.

Review of recent non-hyperbaric oxygen interventions for mild traumatic brain injury.

PubMed

Wilson, Steffanie H; Roth, Michael; Lindblad, Anne S; Weaver, Lindell K

2016-01-01

Traumatic brain injury (TBI) affects 3.2 to 5.3 million persons in the United States (U.S.), and the impact in the U.S. military is proportionally higher. Consensus is lacking regarding an accepted outcome to measure the effectiveness of interventions to improve the symptoms associated with TBI, and no standard-of-care treatment exists for mild TBI (mTBI). A recent literature review evaluated hyperbaric oxygen therapy (HBO₂) interventions, and findings were mixed. We conducted a systematic review of non-HBO₂ mTBI interventional trials published in 2005-2015 in military and civilian populations. A total of 154 abstracts, seven randomized controlled trials (RCTs) and five pilot studies were reviewed. RCTs were evaluated using Consolidated Standards of Reporting Trials criteria. Results indicated that studies published within the period of review were small pilot studies for rehabilitation therapy and motion capture or virtual reality gaming interventions. Neuropsychological assessments were commonly specified outcomes, and most studies included a combination of symptom and neuropsychological assessments. Findings indicated a lack of large-scale, well-controlled trials to address the symptoms and sequelae of this condition, but results of small exploratory studies show evidence of potentially promising interventions. Copyright© Undersea and Hyperbaric Medical Society.

Pilot study of enhanced tobacco-cessation services coverage for low-income smokers.

PubMed

Doescher, Mark P; Whinston, Melicent A; Goo, Alvin; Cummings, Diane; Huntington, Jane; Saver, Barry G

2002-01-01

This study explored the feasibility of covering nicotine replacement therapy (NRT) and paying for pharmacist-delivered smoking cessation counseling at the time of NRT pick-up for low-income, managed Medicaid and Basic Health Plan (a state insurance program) enrollees. A prospective pilot intervention was used at two community health centers (CHCs) and two community pharmacies. Participants were adult managed-Medicaid or Basic Health Plan enrollees who attended the pilot CHCs and smoked. An innovative insurance benefit that included coverage for NRT and $15 payment to the pharmacist to deliver cessation counseling with each prescription fill. Proportion of eligible patients who used the cessation benefit and patient and pharmacist satisfaction with the intervention. During the 9-month intervention, 32 patients at the pilot clinics were referred for NRT and pharmacist-delivered counseling. This number represented roughly 5% of eligible smokers. Of these, 26 received NRT with concomitant pharmacist-delivered cessation counseling at least once. Recipients reported a high level of satisfaction with this intervention. Pharmacists indicated they would continue providing counseling if reimbursement remained adequate and if counseling lasted no longer than 5-10 min. However, 12 (38%) who were referred were no longer insured by the sponsoring plan by the end of the 9-month pilot period. Pharmacist-delivered cessation counseling may be feasible and merits further study. More importantly, this pilot reveals two key obstacles in our low-income, culturally diverse setting: low participation and rapid turnover of insureds. Future interventions will need to address these barriers.

Review of pharmacological therapies in fibromyalgia syndrome

PubMed Central

2014-01-01

This review addresses the current status of drug therapy for the management of fibromyalgia syndrome (FMS) and is based on interdisciplinary FMS management guidelines, meta-analyses of drug trial data, and observational studies. In the absence of a single gold-standard medication, patients are treated with a variety of drugs from different categories, often with limited evidence. Drug therapy is not mandatory for the management of FMS. Pregabalin, duloxetine, milnacipran, and amitriptyline are the current first-line prescribed agents but have had a mostly modest effect. With only a minority of patients expected to experience substantial benefit, most will discontinue therapy because of either a lack of efficacy or tolerability problems. Many drug treatments have undergone limited study and have had negative results. It is unlikely that these failed pilot trials will undergo future study. However, medications, though imperfect, will continue to be a component of treatment strategy for these patients. Both the potential for medication therapy to relieve symptoms and the potential to cause harm should be carefully considered in their administration. PMID:24433463

Pilot trial of osteopathic manipulative therapy for patients with frequent episodic tension-type headache.

PubMed

Rolle, Guido; Tremolizzo, Lucio; Somalvico, Francesco; Ferrarese, Carlo; Bressan, Livio C

2014-09-01

Osteopathic manipulative therapy (OMTh; manipulative care provided by foreign-trained osteopaths) may be used for managing headache pain and related disability, but there is a need for high-quality randomized controlled trials to assess the effectiveness of this intervention. To explore the efficacy of OMTh for pain management in frequent episodic tension-type headache (TTH). Single-blind randomized placebo-controlled pilot study. Patients were recruited from 5 primary care settings. Forty-four patients who were affected by frequent episodic TTH and not taking any drugs for prophylactic management of episodic TTH were recruited. Patients were randomly allocated to an experimental or control group. The experimental group received corrective OMTh techniques, tailored for each patient; the control group received assessment of the cranial rhythmic impulse (sham therapy). The study included a 1-month baseline period, a 1-month treatment period, and a 3-month follow-up period. The primary outcome was the change in patient-reported headache frequency, and secondary outcomes included changes in headache pain intensity (discrete score, 1 [lowest perceived pain] to 5 [worst perceived pain]), over-the-counter medication use, and Headache Disability Inventory score. Forty patients completed the study (OMTh, n=21; control, n=19). The OMTh group had a significant reduction in headache frequency over time that persisted 1 month (approximate reduction, 40%; P<.001) and 3 months (approximate reduction, 50%; P<.001) after the end of treatment. Moreover, there was an absolute difference between the 2 treatment groups at the end of the study, with a 33% lower frequency of headache in the OMTh group (P<.001). This feasibility study demonstrated the efficacy of OMTh in the management of frequent episodic TTH, compared with sham therapy in a control group. Osteopathic manipulative therapy may be preferred over other treatment modalities and may benefit patients who have adverse effects to medications or who have difficulty complying with pharmacologic regimens. This protocol may serve as a model for future studies. © 2014 The American Osteopathic Association.

Cognitive Behavioral Therapy for Depressed Adults with Mild Intellectual Disability: A Pilot Study

PubMed Central

Hartley, Sigan L; Esbensen, Anna J; Shalev, Rebecca; Vincent, Lori B; Mihaila, Iulia; Bussanich, Paige

2015-01-01

Background There is a paucity of research on psychosocial treatments for depression in adults with intellectual disability (ID). In this pilot study, we explored the efficacy of a group CBT treatment that involved a caregiver component in adults with mild ID with a depressive disorder. Method Sixteen adults with mild ID and a depressive disorder participated in a 10-week group CBT treatment and 8 adults with mild ID with a depressive disorder served as a treatment as usual (TAU) control group. Adults with mild ID and caregivers completed measures of depressive symptoms, behavior problems, and social skills at pre-treatment, post-treatment, and a 3-month follow-up. Adults with mild ID also completed a series of tasks to measure their understanding of the principles of cognitive therapy pre- and post-treatment. Results The CBT group demonstrated significant decreases in depressive symptoms and behavior problems from pre-treatment to post-treatment and these effects were maintained at a 3-month follow-up. The CBT group demonstrated significant improvements in their ability to infer emotions and thoughts based on various situation-thought-emotion pairings from pre-treatment to post-treatment. Conclusions Findings indicate that adults with mild ID with a depressive disorder benefitted from a group CBT treatment with a caregiver component. Moreover, adults with mild ID appeared to benefit, at least in part, from the cognitive therapy components of the treatment, in addition to the behavior therapy components. PMID:26925187

D-Cycloserine Augmentation of Cognitive-Behavioral Therapy: Directions for Pilot Research in Pediatric Obsessive-Compulsive Disorder

ERIC Educational Resources Information Center

Storch, Eric A.; McKay, Dean; Reid, Jeannette M.; Geller, Daniel A.; Goodman, Wayne K.; Lewin, Adam B.; Murphy, Tanya K.

2010-01-01

This paper discusses a recent translational success in combining behavioral psychotherapy with a novel medication, d-cycloserine (DCS), to augment cognitive-behavioral therapy (CBT) for anxiety disorders. The literature on behavioral theory of exposure-based therapies is provided, followed by a discussion of the role of DCS in enhancing extinction…

Efficacy of hormone therapy with and without methyltestosterone augmentation of venlafaxine in the treatment of postmenopausal depression: a double-blind controlled pilot study.

PubMed

Dias, Rodrigo S; Kerr-Corrêa, Florence; Moreno, Ricardo A; Trinca, Luzia A; Pontes, Anagloria; Halbe, Hans W; Gianfaldoni, Arlete; Dalben, Ivete S

2006-01-01

This study evaluated the augmentation of venlafaxine with hormone therapy in the treatment of postmenopausal depression. The hormones evaluated were estrogen (0.625 mg) in combination with medroxyprogesterone acetate (2.5 mg) and methyltestosterone (2.5 mg). Seventy-two menopausal women (mean age: 53.6 +/- 4.27 years) diagnosed with depression (Montgomery-Asberg Depression Rating Scale [MADRS] scores > or = 20) were treated with venlafaxine and one of the following hormone therapy combinations, in a double-blind regimen: estrogen + medroxyprogesterone + methyltestosterone (group 1, n = 20); estrogen + medroxyprogesterone acetate (group 2, n = 20); methyltestosterone only (group 3, n = 16); and no hormone therapy (group 4, n = 16). Study duration was 24 weeks. Primary efficacy outcome was remission according to the MADRS, whereas secondary efficacy measures included the Clinical Global Impression (CGI), Blatt-Kupperman Index, and Women's Health Questionnaire (WHQ). Forty-eight patients completed the study. All groups showed significant improvement from baseline. Group 3 demonstrated significant improvement on the MADRS compared with placebo (group 4) at weeks 20 (P = 0.048) and 24 (P = 0.030); effect size 8.04 (0.83; 15.26) (P = 0.029), but also had the highest dropout rate. Groups 1 and 3 had significant CGI improvement rates compared with placebo: 42.23% (P = 0.012) and 44.45% (P = 0.08), respectively. There were no differences in the WHQ or BKI scores among the groups. Methyltestosterone 2.5 mg had the highest effect size compared with placebo, but the high dropout rate prevented its efficacy from being determined. Estrogen plus medroxyprogesterone, combined with methyltestosterone or otherwise, demonstrated a trend toward increased efficacy of venlafaxine. Further larger-scale clinical trials are needed to elucidate the findings of this pilot study.

Eye movement desensitization and reprocessing therapy in subsyndromal bipolar patients with a history of traumatic events: a randomized, controlled pilot-study.

PubMed

Novo, Patricia; Landin-Romero, Ramon; Radua, Joaquim; Vicens, Victor; Fernandez, Isabel; Garcia, Francisca; Pomarol-Clotet, Edith; McKenna, Peter J; Shapiro, Francine; Amann, Benedikt L

2014-09-30

Traumatic events are frequent in bipolar patients and can worsen the course of the disease. Psychotherapeutic interventions for these events have not been studied so far. Twenty DSM-IV bipolar I and II patients with subsyndromal mood symptoms and a history of traumatic events were randomly assigned to Eye Movement Desensitization and Reprocessing therapy (n=10) or treatment as usual (n=10). The treatment group received between 14 and 18 Eye Movement Desensitization and Reprocessing sessions during 12 weeks. Evaluations of affective symptoms, symptoms of trauma and trauma impact were carried out by a blind rater at baseline, 2 weeks, 5 weeks, 8 weeks, 12 weeks and at 24 weeks follow-up. Patients in the treatment group showed a statistically significant improvement in depressive and hypomanic symptoms, symptoms of trauma and trauma impact compared to the treatment as usual group after intervention. This effect was only partly maintained in trauma impact at the 24 weeks follow-up visit. One patient dropped from Eye Movement Desensitization and Reprocessing group whereas four from the treatment as usual group. This pilot study suggests that Eye Movement Desensitization and Reprocessing therapy may be an effective and safe intervention to treat subsyndromal mood and trauma symptoms in traumatized bipolar patients. Copyright © 2014 Elsevier Ireland Ltd. All rights reserved.

Microwave therapy for cutaneous human papilloma virus infection.

PubMed

Bristow, Ivan; Lim, Wen Chean; Lee, Alvin; Holbrook, Daniel; Savelyeva, Natalia; Thomson, Peter; Webb, Christopher; Polak, Marta; Ardern-Jones, Michael R

2017-10-01

Human papilloma virus (HPV) infects keratinocytes of the skin and mucous membranes, and is associated with the induction of cutaneous warts and malignancy. Warts can induce significant morbidity and disability but most therapies, including cryotherapy, laser, and radiofrequency devices show low efficacy and induce discomfort through tissue destruction. Microwaves are readily capable of passing through highly keratinised skin to deliver energy and induce heating of the tissue in a highly controllable, uniform manner. To determine the effects of microwave on cutaneous HPV infection. We undertook a pilot study of microwave therapy to the skin in 32 consecutive individuals with 52 recalcitrant long-lived viral cutaneous warts. Additionally, we undertook a molecular characterisation of the effects of microwaves on the skin. Tissue inflammation was minimal, but 75.9% of lesions cleared which compares favourably with previous studies showing a clearance rate of 23-33% for cryotherapy or salicylic acid. We show that microwaves specifically induce dendritic cell cross-presentation of HPV antigen to CD8+ T cells and suggest that IL-6 may be important for DC IRF1 and IRF4 modulation to enhance this process. Keratinocyte-skin dendritic cell cross-talk is integral to host defence against HPV infections, and this pilot study supports the concept of microwave induction of anti-HPV immunity which offers a promising approach for treatment of HPV-induced viral warts and potentially HPV-related cancers.

Clinical Validation of Therapeutic Drug Monitoring of Imipenem in Spent Effluent in Critically Ill Patients Receiving Continuous Renal Replacement Therapy: A Pilot Study

PubMed Central

Wen, Aiping; Li, Zhe; Yu, Junxian; Li, Ren; Cheng, Sheng; Duan, Meili; Bai, Jing

2016-01-01

Objectives The primary objective of this pilot study was to investigate whether the therapeutic drug monitoring of imipenem could be performed with spent effluent instead of blood sampling collected from critically ill patients under continuous renal replacement therapy. Methods A prospective open-label study was conducted in a real clinical setting. Both blood and effluent samples were collected pairwise before imipenem administration and 0.5, 1, 1.5, 2, 3, 4, 6, and 8 h after imipenem administration. Plasma and effluent imipenem concentrations were determined by reversed-phase high-performance liquid chromatography with ultraviolet detection. Pharmacokinetic and pharmacodynamic parameters of blood and effluent samples were calculated. Results Eighty-three paired plasma and effluent samples were obtained from 10 patients. The Pearson correlation coefficient of the imipenem concentrations in plasma and effluent was 0.950 (P<0.0001). The average plasma-to-effluent imipenem concentration ratio was 1.044 (95% confidence interval, 0.975 to 1.114) with Bland-Altman analysis. No statistically significant difference was found in the pharmacokinetic and pharmacodynamic parameters tested in paired plasma and effluent samples with Wilcoxon test. Conclusion Spent effluent of continuous renal replacement therapy could be used for therapeutic drug monitoring of imipenem instead of blood sampling in critically ill patients. PMID:27093294

ADHD Symptom Severity following Participation in a Pilot, 10-Week, Manualized, Family-Based Behavioral Intervention

ERIC Educational Resources Information Center

Curtis, David F.

2010-01-01

This investigation examined the effectiveness of a pilot, manualized 10-week intervention of family skills training for ADHD-related symptoms. The intervention combined behavioral parent training and child focused behavioral activation therapy. Participants were families with children ages 7-10 diagnosed with ADHD-Combined Type. This pilot…

A pilot randomised controlled trial of negative pressure wound therapy to treat grade III/IV pressure ulcers [ISRCTN69032034

PubMed Central

2012-01-01

Background Negative pressure wound therapy (NPWT) is widely promoted as a treatment for full thickness wounds; however, there is a lack of high-quality research evidence regarding its clinical and cost effectiveness. A trial of NPWT for the treatment of grade III/IV pressure ulcers would be worthwhile but premature without assessing whether such a trial is feasible. The aim of this pilot randomised controlled trial was to assess the feasibility of conducting a future full trial of NPWT for the treatment of grade III and IV pressure ulcers and to pilot all aspects of the trial. Methods This was a two-centre (acute and community), pilot randomised controlled trial. Eligible participants were randomised to receive either NPWT or standard care (SC) (spun hydrocolloid, alginate or foam dressings). Outcome measures were time to healing of the reference pressure ulcer, recruitment rates, frequency of treatment visits, resources used and duration of follow-up. Results Three hundred and twelve patients were screened for eligibility into this trial over a 12-month recruitment period and 12/312 participants (3.8%) were randomised: 6 to NPWT and 6 to SC. Only one reference pressure ulcer healed (NPWT group) during follow-up (time to healing 79 days). The mean number of treatment visits per week was 3.1 (NPWT) and 5.7 (SC); 6/6 NPWT and 1/6 SC participants withdrew from their allocated trial treatment. The mean duration of follow-up was 3.8 (NPWT) and 5.0 (SC) months. Conclusions This pilot trial yielded vital information for the planning of a future full study including projected recruitment rate, required duration of follow-up and extent of research nurse support required. Data were also used to inform the cost-effectiveness and value of information analyses, which were conducted alongside the pilot trial. Trial registration Current Controlled Trials ISRCTN69032034. PMID:22839453

Bidirectional and Multi-User Telerehabilitation System: Clinical Effect on Balance, Functional Activity, and Satisfaction in Patients with Chronic Stroke Living in Long-Term Care Facilities

PubMed Central

Lin, Kwan-Hwa; Chen, Chin-Hsing; Chen, You-Yin; Huang, Wen-Tzeng; Lai, Jin-Shin; Yu, Shang-Ming; Chang, Yuan-Jen

2014-01-01

Background The application of internet technology for telerehabilitation in patients with stroke has developed rapidly. Objective The current study aimed to evaluate the effect of a bidirectional and multi-user telerehabilitation system on balance and satisfaction in patients with chronic stroke living in long-term care facilities (LTCFs). Method This pilot study used a multi-site, blocked randomization design. Twenty-four participants from three LTCFs were recruited, and the participants were randomly assigned into the telerehabilitation (Tele) and conventional therapy (Conv) groups within each LTCF. Tele group received telerehabilitation but the Conv group received conventional therapy with two persons in each group for three sessions per week and for four weeks. The outcome measures included Berg Balance Scale (BBS), Barthel Index (BI), and the telerehabilitation satisfaction of the participants. Setting A telerehabilitation system included “therapist end” in a laboratory, and the “client end” in LTCFs. The conventional therapy was conducted in LTCFs. Results Training programs conducted for both the Tele and Conv groups showed significant effects within groups on the participant BBS as well as the total and self-care scores of BI. No significant difference between groups could be demonstrated. The satisfaction of participants between the Tele and the Conv groups also did not show significant difference. Conclusions This pilot study indicated that the multi-user telerehabilitation program is feasible for improving the balance and functional activity similar to conventional therapy in patients with chronic stroke living in LTCFs. PMID:25019632

Systemic Chemokine Levels with “Gut-Specific” Vedolizumab in Patients with Inflammatory Bowel Disease—A Pilot Study

PubMed Central

Zwicker, Stephanie; Lira-Junior, Ronaldo; Höög, Charlotte

2017-01-01

Vedolizumab, a gut-specific biological treatment for inflammatory bowel disease (IBD), is an antibody that binds to the α4β7 integrin and blocks T-cell migration into intestinal mucosa. We aimed to investigate chemokine levels in serum of IBD-patients treated with vedolizumab. In this pilot study, we included 11 IBD patients (8 Crohn’s disease, 3 ulcerative colitis) previously non-respondent to anti-tumor necrosis factor (TNF)-agents. Patients received vedolizumab at week 0, 2 and 6 and were evaluated for clinical efficacy at week 10. Clinical characteristics and routine laboratory parameters were obtained and patients were classified as responders or non-responders. Expression of 21 chemokines in serum was measured using Proximity Extension Assay and related to clinical outcome. At week 10, 6 out of 11 patients had clinically responded. Overall expression of CCL13 increased after treatment. In non-responders, expression of CCL13 and CXCL8 increased after treatment, and CCL20 and CXCL1 expressions were higher compared to responders. In responders, CCL28 decreased after treatment. C-reactive protein (CRP) correlated negatively with 6 chemokines before therapy, but not after therapy. Systemic CCL13 expression increases in IBD-patients after vedolizumab therapy and several chemokine levels differ between responders and non-responders. An increased CCL13-level when starting vedolizumab treatment, might indicate potential prognostic value of measuring chemokine levels when starting therapy with vedolizumab. This study provides new information on modulation of systemic chemokine levels after vedolizumab treatment. PMID:28829369

Effect of Nd:YAG laser-assisted non-surgical periodontal therapy on clinical periodontal and serum biomarkers in patients with and without coronary artery disease: A short-term pilot study.

PubMed

Javed, Fawad; Kellesarian, Sergio V; Al-Kheraif, Abdulaziz A; Ranna, Vinisha; Qadri, Talat; Yunker, Michael; Malmstrom, Hans; Romanos, Georgios E

2016-12-01

We hypothesized that nonsurgical-periodontal-therapy (NSPT) with adjunct Nd:YAG laser therapy is more effective in reducing periodontal inflammatory parameters (plaque index [PI], bleeding-on-probing [BOP], and probing-pocket-depth [PPD]) and serum interleukin-1beta (IL-1β) and matrix metalloproteinase-9 (MMP-9) levels in patients with and without coronary artery disease (CAD) than NSPT alone. The aim of this short-term pilot study was to assess the effect of NSPT + Nd:YAG laser therapy on periodontal parameters and serum IL-1β and MMP-9 levels in patients with and without CAD. A prospective randomized clinical study was conducted on 87 patients who were divided into two groups: Group-1: 44 patients with CAD and periodontal disease (PD) and Group-2: 43 patients with PD alone. Treatment-wise, these individuals were randomly divided into two subgroups: (i) NSPT alone and (ii) NSPT + Nd:YAG laser therapy. Demographic information was collected using a self-completed questionnaire. Periodontal parameters (PI, BOP, and PPD) and serum IL-1β and MMP-9 levels were measured at baseline and after 3 months of treatment. P-values <0.05 were considered statistically significant. At 3 months follow-up, PI (P < 0.01), BOP (P < 0.01), PPD ≥ 4 mm (P < 0.01), and serum IL-1β (P < 0.01) and MMP-9 (P < 0.01) levels were significantly higher in patients treated with NSPT alone than those treated with NSPT + Nd:YAG laser therapy. Among patients that underwent NSPT + laser therapy in both groups, periodontal parameters and serum IL-1β, and MMP-9 levels were comparable at 3-months follow-up. NSPT + Nd:YAG laser therapy may be more effective in reducing periodontal inflammation and serum IL-1β and MMP-9 levels in patients with and without CAD than NSPT alone. Lasers Surg. Med. 48:929-935, 2016. © 2016 Wiley Periodicals, Inc. © 2016 Wiley Periodicals, Inc.

A Phase II randomised controlled trial assessing the feasibility, acceptability and potential effectiveness of dignity therapy for older people in care homes: study protocol.

PubMed

Hall, Sue; Chochinov, Harvey; Harding, Richard; Murray, Scott; Richardson, Alison; Higginson, Irene J

2009-03-24

Although most older people living in nursing homes die there, there is a dearth of robust evaluations of interventions to improve their end-of-life care. Residents usually have multiple health problems making them heavily reliant on staff for their care, which can erode their sense of dignity. Dignity Therapy has been developed to help promote dignity and reduce distress. It comprises a recorded interview, which is transcribed, edited then returned to the patient, who can bequeath it to people of their choosing. Piloting has suggested that Dignity Therapy is beneficial to people dying of cancer and their families. The aims of this study are to assess the feasibility, acceptability and potential effectiveness of Dignity Therapy to reduce psychological and spiritual distress in older people reaching the end of life in care homes, and to pilot the methods for a Phase III RCT. A randomised controlled open-label trial. Sixty-four residents of care homes for older people are randomly allocated to one of two groups: (i) Intervention (Dignity Therapy offered in addition to any standard care), and (ii) Control group (standard care). Recipients of the "generativity" documents are asked their views on taking part in the study and the therapy. Both quantitative and qualitative outcomes are assessed in face-to-face interviews at baseline and at approximately one and eight weeks after the intervention (equivalent in the control group). The primary outcome is residents' sense of dignity (potential effectiveness) assessed by the Patient Dignity Inventory. Secondary outcomes for residents include depression, hopefulness and quality of life. In view of the relatively small sample size, quantitative analysis is mainly descriptive. The qualitative analysis uses the Framework method. Dignity Therapy is brief, can be done at the bedside and could help both patients and their families. This detailed exploratory research shows if it is feasible to offer Dignity Therapy to residents of care homes, whether it is acceptable to them, their families and care home staff, if it is likely to be effective, and determine whether a Phase III RCT is desirable. Current Controlled Clinical Trials: ISRCTN37589515.

Goal-directed fluid optimization based on stroke volume variation and cardiac index during one-lung ventilation in patients undergoing thoracoscopy lobectomy operations: a pilot study.

PubMed

Zhang, Jian; Chen, Chao Qin; Lei, Xiu Zhen; Feng, Zhi Ying; Zhu, Sheng Mei

2013-07-01

This pilot study was designed to utilize stroke volume variation and cardiac index to ensure fluid optimization during one-lung ventilation in patients undergoing thoracoscopic lobectomies. Eighty patients undergoing thoracoscopic lobectomy were randomized into either a goal-directed therapy group or a control group. In the goal-directed therapy group, the stroke volume variation was controlled at 10%±1%, and the cardiac index was controlled at a minimum of 2.5 L.min-1.m-2. In the control group, the MAP was maintained at between 65 mm Hg and 90 mm Hg, heart rate was maintained at between 60 BPM and 100 BPM, and urinary output was greater than 0.5 mL/kg-1/h-1. The hemodynamic variables, arterial blood gas analyses, total administered fluid volume and side effects were recorded. The PaO2/FiO2-ratio before the end of one-lung ventilation in the goal-directed therapy group was significantly higher than that of the control group, but there were no differences between the goal-directed therapy group and the control group for the PaO2/FiO2-ratio or other arterial blood gas analysis indices prior to anesthesia. The extubation time was significantly earlier in the goal-directed therapy group, but there was no difference in the length of hospital stay. Patients in the control group had greater urine volumes, and they were given greater colloid and overall fluid volumes. Nausea and vomiting were significantly reduced in the goal-directed therapy group. The results of this study demonstrated that an optimization protocol, based on stroke volume variation and cardiac index obtained with a FloTrac/Vigileo device, increased the PaO2/FiO2-ratio and reduced the overall fluid volume, intubation time and postoperative complications (nausea and vomiting) in thoracic surgery patients requiring one-lung ventilation.

A pilot randomized clinical trial of intermittent occlusion therapy liquid crystal glasses versus traditional patching for treatment of moderate unilateral amblyopia.

PubMed

Wang, Jingyun; Neely, Daniel E; Galli, Jay; Schliesser, Joshua; Graves, April; Damarjian, Tina G; Kovarik, Jessica; Bowsher, James; Smith, Heather A; Donaldson, Dana; Haider, Kathryn M; Roberts, Gavin J; Sprunger, Derek T; Plager, David A

2016-08-01

To compare the effectiveness of intermittent occlusion therapy (IO therapy) using liquid crystal glasses and continuous occlusion therapy using traditional adhesive patches for treating amblyopia. Children 3-8 years of age with previously untreated, moderate, unilateral amblyopia (visual acuity of 20/40 to 20/100 in the amblyopic eye) were enrolled in this randomized controlled trial. Amblyopia was associated with strabismus, anisometropia, or both. All subjects had worn any optimal refractive correction for at least 12 weeks without improvement. Subjects were randomized into two treatment groups: a 4-hour IO therapy group with liquid crystal glasses (Amblyz), set at 30-second opaque/transparent intervals (occluded 50% of wear time), and a 2-hour continuous patching group (occluded 100% of wear time). For each patient, visual acuity was measured using ATS-HOTV before and after 12 weeks of treatment. Data from 34 patients were available for analysis. Amblyopic eye visual acuity improvement from baseline was 0.15 ± 0.12 logMAR (95% CI, 0.09-0.15) in the IO therapy group (n = 19) and 0.15 ± 0.11 logMAR (95% CI, 0.1-0.15) in the patching group (n = 15). In both groups improvement was significant, but the difference between groups was not (P = 0.73). No adverse effects were reported. In this pilot study, IO therapy with liquid crystal glasses is not inferior to adhesive patching and is a promising alternative treatment for children 3-8 years of age with moderate amblyopia. Copyright © 2016 American Association for Pediatric Ophthalmology and Strabismus. Published by Elsevier Inc. All rights reserved.

Implementation of the Enhanced Moderated Online Social Therapy (MOST+) Model Within a National Youth E-Mental Health Service (eheadspace): Protocol for a Single Group Pilot Study for Help-Seeking Young People.

PubMed

Rice, Simon; Gleeson, John; Leicester, Steven; Bendall, Sarah; D'Alfonso, Simon; Gilbertson, Tamsyn; Killackey, Eoin; Parker, Alexandra; Lederman, Reeva; Wadley, Greg; Santesteban-Echarri, Olga; Pryor, Ingrid; Mawren, Daveena; Ratheesh, Aswin; Alvarez-Jimenez, Mario

2018-02-22

There is a substantial need for youth electronic mental health (e-mental health) services. In addressing this need, our team has developed a novel moderated online social therapy intervention called enhanced moderated online social therapy (MOST+). MOST+ integrates real-time, clinician-delivered Web chat counseling, interactive user-directed online therapy, expert and peer moderation, and private and secure peer-to-peer social networking. MOST+ has been designed to give young people immediate, 24-hour access to anonymous, evidence-based, and short-term mental health care. The primary aims of this pilot study were to determine the feasibility, acceptability, and safety of the intervention. Secondary aims were to assess prepost changes in key psychosocial outcomes and collect qualitative data for future intervention refinement. MOST+ will be embedded within eheadspace, an Australian youth e-mental health service, and will be evaluated via an uncontrolled single-group study. Approximately 250 help-seeking young people (16-25 years) will be progressively recruited to the intervention from the eheadspace home page over the first 4 weeks of an 8-week intervention period. All participants will have access to evidence-based therapeutic content and integrated Web chat counseling. Additional access to moderated peer-to-peer social networking will be granted to individuals for whom it is deemed safe and appropriate, through a three-tiered screening process. Participants will be enrolled in the MOST+ intervention for 1 week, with the option to renew their enrollment across the duration of the pilot. Participants will complete a survey at enrollment to assess psychological well-being and other mental health outcomes. Additional assessment will occur following account deactivation (ie, after participant has opted not to renew their enrollment, or at trial conclusion) and will include an online survey and telephone interview assessing psychological well-being and experience of using MOST+. Recruitment for the study commenced in October 2017. We expect to have initial results in March 2018, with more detailed qualitative and quantitative analyses to follow. This is the first Australia-wide research trial to pilot an online social media platform merging real-time clinical support, expert and peer moderation, interactive online therapy, and peer-to-peer social networking. The importance of the project stems from the need to develop innovative new models for the efficient delivery of responsive evidence-based online support to help-seeking young people. If successful, this research stands to complement and enhance e-mental health services in Australia. ©Simon Rice, John Gleeson, Steven Leicester, Sarah Bendall, Simon D'Alfonso, Tamsyn Gilbertson, Eoin Killackey, Alexandra Parker, Reeva Lederman, Greg Wadley, Olga Santesteban-Echarri, Ingrid Pryor, Daveena Mawren, Aswin Ratheesh, Mario Alvarez-Jimenez. Originally published in JMIR Research Protocols (http://www.researchprotocols.org), 22.02.2018.

Telephone-administered cognitive behavioral therapy: a case study of anxiety and depression in Parkinson's disease.

PubMed

Veazey, Connie; Cook, Karon F; Stanley, Melinda; Lai, Eugene C; Kunik, Mark E

2009-09-01

Parkinson's disease (PD) is a chronic medical illness with a high incidence of psychiatric comorbidity, specifically depression and anxiety. Research on treatment of such psychiatric complications is scarce. Non-pharmaceutical treatment options are especially attractive. Cognitive behavioral therapy (CBT) is a psychotherapeutic treatment option that has been successful in other chronically medically ill populations with comorbid depression and anxiety. The current research had two aims. The first was to pilot the feasibility of screening and identifying PD patients with symptoms of anxiety and depression in a specialized outpatient clinic. The second aim was to pilot the feasibility of telephone-administered CBT for the treatment of depression and anxiety in persons with PD, which was done through a case series comparing telephone-administered CBT to a Support strategy. A fairly large portion (67.5%) of patients screened in the outpatient clinic were identified as having symptoms of anxiety and/or depression. Results also indicated that CBT delivered via the telephone is a useful approach for targeting psychiatric symptoms in this population. A case example is given to illustrate the clinical considerations associated with delivering therapy via telephone to persons with PD.

Framing and personalizing informed consent to prevent negative expectations: An experimental pilot study.

PubMed

Heisig, Sarah R; Shedden-Mora, Meike C; Hidalgo, Pablo; Nestoriuc, Yvonne

2015-10-01

Informing patients about medical treatments and their possible side effects is ethically and legally obligatory but may trigger negative expectations and nocebo-related side effects. This pilot study aims to investigate the effect of different informed consent procedures on treatment expectations for adjuvant breast cancer treatments (Study 1: endocrine therapy; Study 2: chemotherapy). Using an experimental 2-factorial design, healthy women were informed about endocrine therapy (n = 60) or chemotherapy (n = 64) within a hypothetical scenario. Information was framed with or without treatment benefit information and delivered in a personalized or standardized interaction. Primary outcomes were necessity-concern beliefs about the treatment and side-effect expectations, secondary outcomes were decisional conflicts. In Study 1, side-effect expectations (η²p= .08) and decisional conflicts (η²p = .07) were lower when framed treatment information was given. Providing personalized information resulted in more functional necessity-concern beliefs (η²p = .06) and lower decisional conflicts (η²p = .07). Personalizing and framing of information resulted in more functional necessity-concern beliefs (η²p = .10) and lower decisional conflicts. In Study 2, necessity-concern beliefs were more functional with framing (η²p = .06). Participants in the personalized groups reported lower decisional conflicts (η²p = .06). No differences in side-effect expectations were revealed. This is the first study to provide evidence for optimized treatment expectations through altered informed consent strategies. The results emphasize that framing and personalizing informed consent can positively influence treatment expectations and reduce decisional conflicts. However, generalizations are impaired by the study's pilot character. The potential to prevent nocebo responses in clinical practice should be analyzed. (PsycINFO Database Record (c) 2015 APA, all rights reserved).

Proposed primary endpoints for use in clinical trials that compare treatment options for bloodstream infection in adults: a consensus definition.

PubMed

Harris, P N A; McNamara, J F; Lye, D C; Davis, J S; Bernard, L; Cheng, A C; Doi, Y; Fowler, V G; Kaye, K S; Leibovici, L; Lipman, J; Llewelyn, M J; Munoz-Price, S; Paul, M; Peleg, A Y; Rodríguez-Baño, J; Rogers, B A; Seifert, H; Thamlikitkul, V; Thwaites, G; Tong, S Y C; Turnidge, J; Utili, R; Webb, S A R; Paterson, D L

2017-08-01

To define standardized endpoints to aid the design of trials that compare antibiotic therapies for bloodstream infections (BSI). Prospective studies, randomized trials or registered protocols comparing antibiotic therapies for BSI, published from 2005 to 2016, were reviewed. Consensus endpoints for BSI studies were defined using a modified Delphi process. Different primary and secondary endpoints were defined for pilot (small-scale studies designed to evaluate protocol design, feasibility and implementation) and definitive trials (larger-scale studies designed to test hypotheses and influence clinical practice), as well as for Staphylococcus aureus and Gram-negative BSI. For pilot studies of S. aureus BSI, a primary outcome of success at day 7 was defined by: survival, resolution of fever, stable/improved Sequential Organ Failure Assessment (SOFA) score and clearance of blood cultures, with no microbiologically confirmed failure up to 90 days. For definitive S. aureus BSI studies, a primary outcome of success at 90 days was defined by survival and no microbiologically confirmed failure. For pilot studies of Gram-negative BSI, a primary outcome of success at day 7 was defined by: survival, resolution of fever and symptoms related to BSI source, stable or improved SOFA score and negative blood cultures. For definitive Gram-negative BSI studies, a primary outcome of survival at 90 days supported by a secondary outcome of success at day 7 (as previously defined) was agreed. These endpoints provide a framework to aid future trial design. Further work will be required to validate these endpoints with respect to patient-centred clinical outcomes. Copyright © 2016 European Society of Clinical Microbiology and Infectious Diseases. All rights reserved.

Evaluation of Two Treatments for Reactive and Proactive Aggression in Preschool

ERIC Educational Resources Information Center

Whitaker, Regina Navonne

2010-01-01

Previous research has indicated that preschoolers identified for aggressive behavior would benefit from family, group, or individual therapy. However, there remains an important gap in the current literature regarding treatments for aggressive behavior based on the subtype of aggression. The purpose of this pilot study was to examine if 2…

The Psychotherapy Process with Adolescents: A First Pilot Study and Preliminary Comparisons between Different Therapeutic Modalities Using the "Adolescent Psychotherapy Q-Set"

ERIC Educational Resources Information Center

Bychkova, Tetyana; Hillman, Saul; Midgley, Nick; Schneider, Celeste

2011-01-01

An innovative methodology is presented for describing the therapeutic processes involved in five types of adolescent treatments: psychoanalysis, psychodynamic psychotherapy, cognitive-behavioural therapy, mentalisation-based treatment and interpersonal psychotherapy. Using the "Adolescent Psychotherapy Q-Set" (APQ), 18 experienced clinicians…

Perspectives of Occupational Therapists on the Challenges of Early Intervention Practice: A Pilot Study

ERIC Educational Resources Information Center

Bowyer, Patricia; Moore, Cary C.; Tiongco, Cynthia G.; Tkach, Melanie M.; Thom, Carly

2017-01-01

Occupational therapists in the field of early intervention (EI) are challenged with limited opportunities for communication and collaboration with colleagues and other EI team members. One hundred and two occupational therapists and occupational therapy assistants with early intervention experience completed a descriptive survey. Questions on the…

Efficacy of vision restoration therapy after optic neuritis (VISION study): study protocol for a randomized controlled trial.

PubMed

Schinzel, Johann; Schwarzlose, Lina; Dietze, Holger; Bartusch, Karolina; Weiss, Susanne; Ohlraun, Stephanie; Paul, Friedemann; Dörr, Jan

2012-06-28

Optic neuritis is a frequent manifestation of multiple sclerosis. Visual deficits range from a minor impairment of visual functions through to complete loss of vision. Although many patients recover almost completely, roughly 35% of patients remain visually impaired for years, and therapeutic options for those patients hardly exist. Vision restoration therapy is a software-based visual training program that has been shown to improve visual deficits after pre- and postchiasmatic injury. The aim of this pilot study is to evaluate whether residual visual deficits after past or recent optic neuritis can be reduced by means of vision restoration therapy. A randomized, controlled, patient- and observer-blinded clinical pilot study (VISION study) was designed to evaluate the efficacy of vision restoration therapy in optic neuritis patients. Eighty patients with a residual visual deficit after optic neuritis (visual acuity ≤0.7 and/or scotoma) will be stratified according to the time of optic neuritis onset (manifestation more than 12 months ago (40 patients, fixed deficit) versus manifestation 2 to 6 months ago (40 patients, recent optic neuritis)), and randomized into vision restoration therapy arm or saccadic training arm (control intervention). Patients will be instructed to complete a computer-based visual training for approximately 30 minutes each day for a period of 6 months. Patients and evaluators remain blinded to the treatment allocation throughout the study. All endpoints will be analyzed and P-values < 0.05 will be considered statistically significant. The primary outcome parameter will be the expansion of the visual field after 3 and 6 months of treatment as determined by static visual field perimetry and high resolution perimetry. Secondary outcome variables will include visual acuity at both low and high contrast, glare contrast sensitivity, visually evoked potentials, optical coherence tomography and other functional tests of the visual system, alertness, health-related quality of life, fatigue, and depression. If vision restoration therapy is shown to improve visual function after optic neuritis, this method might be a first therapeutic option for patients with incomplete recovery from optic neuritis. NCT01274702.

The Development of an Internet-Based Treatment for Problem Gamblers and Concerned Significant Others: A Pilot Randomized Controlled Trial.

PubMed

Nilsson, Anders; Magnusson, Kristoffer; Carlbring, Per; Andersson, Gerhard; Gumpert, Clara Hellner

2018-06-01

Problem gambling creates significant harm for the gambler and for concerned significant others (CSOs). While several studies have investigated the effects of individual cognitive behavioral therapy (CBT) for problem gambling, less is known about the effects of involving CSOs in treatment. Behavioral couples therapy (BCT) has shown promising results when working with substance use disorders by involving both the user and a CSO. This pilot study investigated BCT for problem gambling, as well as the feasibility of performing a larger scale randomized controlled trial. 36 participants, 18 gamblers and 18 CSOs, were randomized to either BCT or individual CBT for the gambler. Both interventions were Internet-delivered self-help interventions with therapist support. Both groups of gamblers improved on all outcome measures, but there were no differences between the groups. The CSOs in the BCT group lowered their scores on anxiety and depression more than the CSOs of those randomized to the individual CBT group did. The implications of the results and the feasibility of the trial are discussed.

Trauma Informed Guilt Reduction Therapy With Combat Veterans

PubMed Central

Norman, Sonya B.; Wilkins, Kendall C.; Myers, Ursula S.; Allard, Carolyn B.

2014-01-01

Guilt related to combat trauma is highly prevalent among veterans returning from Iraq and Afghanistan. Trauma-related guilt has been associated with increased risk for posttraumatic psychopathology and poorer response to treatment. Trauma Informed Guilt Reduction (TrIGR) therapy is a 4-module cognitive-behavioral psychotherapy designed to reduce guilt related to combat trauma. The goals of this study were to describe the key elements of TrIGR and report results of a pilot study with 10 recently deployed combat veterans. Ten combat veterans referred from a VA Posttraumatic Stress Disorder (PTSD) or mental health clinic completed TrIGR over 4 to 7 sessions. Nine veterans completed the posttreatment assessment. This initial pilot suggests that TrIGR may help to reduce trauma-related guilt severity and associated distress. Changes in trauma-related guilt were highly correlated with reductions in PTSD and depression symptoms over the course of treatment, suggesting a possible mechanistic link with severity of posttraumatic psychopathology. TrIGR warrants further evaluation as an intervention for reducing guilt related to traumatic experiences in combat. PMID:25404850

[Photodynamic therapy of dysplasias and early carcinomas in Barrett esophagus with a diode laser system--a pilot study].

PubMed

Zöpf, T; Rosenbaum, A; Apel, D; Jakobs, R; Arnold, J C; Riemann, J F

2001-04-15

Photodynamic therapy (PDT) of dysplasia and early cancer of the esophagus could show good results in the potential of ablation. Unfortunately, the existing expensive and temperamental dye laser systems foiled a broad clinical use. In this pilot study, we investigated the feasibility of an inexpensive and maintenance-free diode laser system for PDT of dysplasia and early cancer in Barrett's esophagus. Eight patients with Barrett's esophagus and/or early cancer were treated. As light source we used a diode laser system with a maximum power output of 2 W and a wavelength of 633 +/- 3 nm. One patient was treated initially with Photosan-3, seven patients received 5-aminolevulinic acid. In all patients we could achieve reduction in length and/or histologically proven downgrading. In three quarters of the patients, complete eradication of adenocarcinoma could be attained. Columnar-lined metaplastic epithelium could also be completely eradicated. PDT using a diode laser system is comparably effective in Barrett's esophagus/early cancer as PDT with dye laser systems. PDT is a gentle and effective technique with little side effects.

Higher versus lower blood pressure targets for vasopressor therapy in shock: a multicentre pilot randomized controlled trial.

PubMed

Lamontagne, François; Meade, Maureen O; Hébert, Paul C; Asfar, Pierre; Lauzier, François; Seely, Andrew J E; Day, Andrew G; Mehta, Sangeeta; Muscedere, John; Bagshaw, Sean M; Ferguson, Niall D; Cook, Deborah J; Kanji, Salmaan; Turgeon, Alexis F; Herridge, Margaret S; Subramanian, Sanjay; Lacroix, Jacques; Adhikari, Neill K J; Scales, Damon C; Fox-Robichaud, Alison; Skrobik, Yoanna; Whitlock, Richard P; Green, Robert S; Koo, Karen K Y; Tanguay, Teddie; Magder, Sheldon; Heyland, Daren K

2016-04-01

In shock, hypotension may contribute to inadequate oxygen delivery, organ failure and death. We conducted the Optimal Vasopressor Titration (OVATION) pilot trial to inform the design of a larger trial examining the effect of lower versus higher mean arterial pressure (MAP) targets for vasopressor therapy in shock. We randomly assigned critically ill patients who were presumed to suffer from vasodilatory shock regardless of admission diagnosis to a lower (60-65 mmHg) versus a higher (75-80 mmHg) MAP target. The primary objective was to measure the separation in MAP between groups. We also recorded days with protocol deviations, enrolment rate, cardiac arrhythmias and mortality for prespecified subgroups. A total of 118 patients were enrolled from 11 centres (2.3 patients/site/month of screening). The between-group separation in MAP was 9 mmHg (95% CI 7-11). In the lower and higher MAP groups, we observed deviations on 12 versus 8% of all days on vasopressors (p = 0.059). Risks of cardiac arrhythmias (20 versus 36%, p = 0.07) and hospital mortality (30 versus 33%, p = 0.84) were not different between lower and higher MAP arms. Among patients aged 75 years or older, a lower MAP target was associated with reduced hospital mortality (13 versus 60%, p = 0.03) but not in younger patients. This pilot study supports the feasibility of a large trial comparing lower versus higher MAP targets for shock. Further research may help delineate the reasons for vasopressor dosing in excess of prescribed targets and how individual patient characteristics modify the response to vasopressor therapy.

Comparison between self-formulation and compounded-formulation dexamethasone mouth rinse for oral lichen planus: a pilot, randomized, cross-over trial.

PubMed

Hambly, Jessica L; Haywood, Alison; Hattingh, Laetitia; Nair, Raj G

2017-08-01

There is a lack of appropriate, commercially-available topical corticosteroid formulations for use in oral lichen planus (OLP) and oral lichenoid reaction. Current therapy includes crushing a dexamethasone tablet and mixing it with water for use as a mouth rinse. This formulation is unpleasant esthetically and to use in the mouth, as it is a bitter and gritty suspension, resulting in poor compliance. Thus, the present study was designed to formulate and pilot an effective, esthetically-pleasing formulation. A single-blinded, cross-over trial was designed with two treatment arms. Patients were monitored for 7 weeks. Quantitative and qualitative data was assessed using VAS, numeric pain scales, the Treatment Satisfaction Questionnaire for Medication-9, and thematic analysis to determine primary patient-reported outcomes, including satisfaction, compliance, quality of life, and symptom relief. Nine patients completed the pilot trial. Data analysis revealed the new compounded formulation to be superior to existing therapy due to its convenience, positive contribution to compliance, patient-perceived faster onset of action, and improved symptom relief. Topical dexamethasone is useful in the treatment of OLP. When carefully formulated into a compounded mouth rinse, it improves patient outcomes. © 2016 John Wiley & Sons Australia, Ltd.

A Pilot Study of Eight-Session Mindfulness-Based Cognitive Therapy Adapted for Women's Sexual Interest/Arousal Disorder.

PubMed

Paterson, Laurel Q P; Handy, Ariel B; Brotto, Lori A

2017-09-01

While few treatment options exist for low sexual desire and arousal, the most common sexual dysfunction in women, a growing body of research supports the efficacy of mindfulness-based approaches. The mechanisms underlying improvements, and whether they are due to mindfulness practice or other treatment components, are unclear. As a result, we designed and pilot-tested an eight-session group mindfulness-based cognitive therapy for sexuality (MBCT-S) program that includes more extensive practice of mindfulness skills and closely aligns with the evidence-based MBCT program for depression and anxiety. A total of 26 women (mean age 43.9, range 25 to 63) with a diagnosis of sexual interest/arousal disorder participated in eight weekly group sessions, before and after which they completed validated questionnaires. The majority of women attended all sessions and completed the recommended at-home mindfulness exercises. Compared to baseline, women reported significant improvements in sexual desire, overall sexual function, and sex-related distress, regardless of treatment expectations, relationship duration, or low desire duration. Depressed mood and mindfulness also significantly improved and mediated increases in sexual function. These pilot data suggest that eight-session MBCT-S is feasible and significantly improves sexual function, and provide the basis for a larger randomized-controlled trial (RCT) with a longer follow-up period.

Pilot Study: Improving Patient Outcomes with Healing Touch.

PubMed

Hendricks, Kimberly; Wallace, Kelley F

2017-01-01

Healing Touch therapies use a practitioner's intentional placement of hands to influence the patient's energy fields to promote self-healing. In the changing climate of health care, in which the patient experience increasingly drives reimbursements, it is vital to find unique and meaningful ways beyond traditional medical therapies to ensure positive patient experiences. To that end, our peritoneal dialysis clinic staff adopted Jean Watson's theoretical framework, by which patients are treated as whole unique individuals with a "multidimensional system of energy, with a consciousness that can be affected by another to promote well-being." In a rapidly growing urban clinic of more than 100 patients, our nurses identified the need to provide more ways to improve patient care.Staff were educated on ways to set positive intentions for patient contacts and to incorporate patient narratives into contact. Optional daily prayer was initiated, and patients were invited to attend a new support group for peritoneal dialysis patients and their families. In addition, a preliminary pilot provided Healing Touch treatments to interested patients. That pilot was associated with improvement in 4 of 5 measured categories. Fatigue and pain decreased by 46% and 68% respectively. Stress and anxiety fell by 49%, and a large drop of 84% in depression was observed. Nausea was unchanged.

Effects of periodontal treatment on lung function and exacerbation frequency in patients with chronic obstructive pulmonary disease and chronic periodontitis: a 2-year pilot randomized controlled trial.

PubMed

Zhou, Xuan; Han, Jing; Liu, Zhiqiang; Song, Yiqing; Wang, Zuomin; Sun, Zheng

2014-06-01

To evaluate the direct effects of periodontal therapy in Chronic Obstructive Pulmonary Disease (COPD) patients with chronic periodontitis (CP). In a pilot randomized controlled trial, 60 COPD patients with CP were randomly assigned to receive scaling and root planing (SRP) treatment, supragingival scaling treatment, or oral hygiene instructions only with no periodontal treatment. We evaluated their periodontal indexes, respiratory function, and COPD exacerbations at baseline, 6 months, 1, and 2 years. Compared with the control group, measurements of periodontal indexes were significantly improved in patients in two treatment groups at 6-month, 1-year, and 2-year follow-up (all p < 0.05). Overall, the means of forced expiratory volume in the first second/forced vital capacity (FEV1/FVC) and FEV1 were significantly higher in the two therapy groups compared with the control group during the follow-up (p < 0.05). In addition, the frequencies of COPD exacerbation were significantly lower in the two therapy groups than in the control group at 2-year follow-up (p < 0.05). Our preliminary results from this pilot trial suggest that periodontal therapy in COPD patients with CP may improve lung function and decrease the frequency of COPD exacerbation. © 2014 John Wiley & Sons A/S. Published by John Wiley & Sons Ltd.

Proton Beam Therapy as a Nonsurgical Approach to Mucosal Melanoma of the Head and Neck: A Pilot Study

DOE Office of Scientific and Technical Information (OSTI.GOV)

Zenda, Sadamoto, E-mail: szenda@east.ncc.go.jp; Kawashima, Mitsuhiko; Nishio, Teiji

2011-09-01

Purpose: The aim of this pilot study was to assess the clinical benefit of proton beam therapy for mucosal melanoma of the head and neck. Methods and Materials: Patients with mucosal melanoma of the head and neck with histologically confirmed malignant melanoma and N0 and M0 disease were enrolled. Proton therapy was delivered three times per week with a planned total dose of 60 Gy equivalents (GyE) in 15 fractions. Results: Fourteen consecutive patients were enrolled from January 2004 through February 2008. Patient characteristics were as follows: median age 73 years old (range, 56 to 79 years); male/female ratio, 7/7;more » and T stage 1/2/3/4, 3/2/0/9. All patients were able to receive the full dose of proton therapy. The most common acute toxicities were mucositis (grade 3, 21%) and mild dermatitis (grade 3, 0%). As for late toxicity, 2 patients had a unilateral decrease in visual acuity, although blindness did not occur. No treatment-related deaths occurred throughout the study. Initial local control rate was 85.7%, and, with a median follow-up period of 36.7 months, median progression-free survival was 25.1 months, and 3-year overall survival rates were 58.0%. The most frequent site of first failure was cervical lymph nodes (6 patients), followed by local failure in 1 patient and lung metastases in 1 patient. On follow-up, 5 patients died of disease, 4 died due to cachexia caused by distant metastases, and 1 patient by carotid artery perforation cause by lymph nodes metastases. Conclusions: Proton beam radiotherapy showed promising local control benefits and would benefit from ongoing clinical study.« less

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.

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.

The effects of clinical aromatherapy for anxiety and depression in the high risk postpartum woman - a pilot study.

PubMed

Conrad, Pam; Adams, Cindy

2012-08-01

The aim of this study was to determine if aromatherapy improves anxiety and/or depression in the high risk postpartum woman and to provide a complementary therapy tool for healthcare practitioners. The pilot study was observational with repeated measures. Private consultation room in a Women's center of a large Indianapolis hospital. 28 women, 0-18 months postpartum. The treatment groups were randomized to either the inhalation group or the aromatherapy hand m'technique. Treatment consisted of 15 min sessions, twice a week for four consecutive weeks. An essential oil blend of rose otto and lavandula angustifolia @ 2% dilution was used in all treatments. The non-randomized control group, comprised of volunteers, was instructed to avoid aromatherapy use during the 4 week study period. Allopathic medical treatment continued for all participants. All subjects completed the Edinburgh Postnatal Depression Scale (EPDS) and Generalized Anxiety Disorder Scale (GAD-7) at the beginning of the study. The scales were then repeated at the midway point (two weeks), and at the end of all treatments (four weeks). Analysis of Variance (ANOVA) was utilized to determine differences in EPDS and/or GAD-7 scores between the aromatherapy and control groups at baseline, midpoint and end of study. No significant differences were found between aromatherapy and control groups at baseline. The midpoint and final scores indicated that aromatherapy had significant improvements greater than the control group on both EPDS and GAD-7 scores. There were no adverse effects reported. The pilot study indicates positive findings with minimal risk for the use of aromatherapy as a complementary therapy in both anxiety and depression scales with the postpartum woman. Future large scale research in aromatherapy with this population is recommended. Copyright © 2012 Elsevier Ltd. All rights reserved.

Hyperbaric Oxygen Therapy in the Treatment of Chronic Mild-Moderate Blast-Induced Traumatic Brain Injury Post-Concussion Syndrome (PCS) and Post Traumatic Stress Disorder (PTSD)

DTIC Science & Technology

2017-10-01

a randomized sham- controlled double-blind design with the sham- control group receiving slightly pressurized air at the beginning and end of each... controlled ( non -treatment, non -sham) single-arm crossover single-blind study. The scope of the project is to recruit, enroll, test, treat, re-test and...the P.I. conducted a non - controlled pilot trial of hyperbaric oxygen therapy (HBOT 1.5 atmospheres absolute/60 minutes, twice/day, 40 treatments

Constraint-Induced Therapy Combined with Conventional Neurorehabilitation Techniques in Chronic Stroke Patients with Plegic Hands: A Case Series

PubMed Central

Taub, Edward; Uswatte, Gitendra; Bowman, Mary H.; Mark, Victor W.; Delgado, Adriana; Bryson, Camille; Morris, David; Bishop-McKay, Staci

2012-01-01

Objective To determine in this pilot study whether the combination of CI therapy and conventional rehabilitation techniques can produce meaningful motor improvement in chronic stroke patients with initially fisted hands. In the past, limited success has been achieved using CI therapy alone for stroke patients with plegic hands. Design Case series Setting University hospital outpatient laboratory Participants Consecutive sample of 6 patients > 1 yr post-stroke with plegic hands Interventions Treatment consisted of an initial period of 3 weeks (Phase A) when adaptive equipment in the home, orthotics and splints were employed to improve ability to engage in activities of daily living. This was continued in Phase B, when CI therapy along with selected neurodevelopmental treatment techniques were added. Main Outcome Measures Motor Activity Log (MAL), accelerometry, Fugl-Meyer Motor Assessment (F-M) Results Patients exhibited a large improvement in spontaneous real-world use of the more-affected arm (mean lower-functioning MAL change = 1.3±0.4 points, P <0.001, d′ = 3.0), and a similar pattern of increase in an objective measure of real-world more-affected arm movement (mean change in ratio of more- to less-affected arm accelerometer recordings = 0.12±0.1 points, P = 0.016 d′ = 1.2). A large improvement in motor status was also recorded (mean F-M change = 5.3±3.3 points, P = 0.005, d′ = 1.6). Conclusions The findings of this pilot study suggest that stroke patients with plegic hands can benefit from CI therapy combined with some conventional rehabilitation techniques, even long after brain injury. More research is warranted. PMID:22922823

Combining levodopa and virtual reality-based therapy for rehabilitation of the upper limb after acute stroke: pilot study Part II

PubMed Central

Samuel, Geoffrey Sithamparapillai; Oey, Nicodemus Edrick; Choo, Min; Ju, Han; Chan, Wai Yin; Kok, Stanley; Ge, Yu; Dongen, Antonius M Van; Ng, Yee Sien

2017-01-01

INTRODUCTION This study aimed to evaluate the safety and efficacy of a combination of levodopa and virtual reality (VR)-based therapy for the enhancement of upper limb recovery following acute stroke. METHODS This was a pilot single-blinded case series of acute stroke patients with upper extremity hemiparesis. Patients were randomised to standard care with concomitant administration of either levodopa alone (control group) or combination therapy consisting of VR-based motivational visuomotor feedback training with levodopa neuromodulation (VR group). Main clinical outcome measures were the Fugl-Meyer Upper Extremity (FM-UE) assessment and Action Research Arm Test (ARAT). Kinematic measurements of affected upper limb movement were evaluated as a secondary measure of improvement. RESULTS Of 42 patients screened, four patients were enrolled in each of the two groups. Two patients dropped out from the control group during the trial. Patients receiving combination therapy had clinically significant improvements in FM-UE assessment scores of 16.5 points compared to a 3.0-point improvement among control patients. Similarly, ARAT scores of VR group patients improved by 15.3 points compared to a 10.0-point improvement in the control group. Corresponding improvements were noted in kinematic measures, including hand-path ratio, demonstrating that the quality of upper limb movement improved in the VR group. CONCLUSION Our results suggest that VR-based therapy and pharmacotherapy may be combined for acute stroke rehabilitation. Bedside acquisition of kinematic measurements allows accurate assessment of the quality of limb movement, offering a sensitive clinical tool for quantifying motor recovery during the rehabilitation process after acute stroke. PMID:27311739

A PILOT STUDY OF TOPICAL IMIQUIMOD THERAPY FOR THE TREATMENT OF RECURRENT EXTRAMAMMARY PAGET'S DISEASE

PubMed Central

Cowan, Renee A.; Black, Destin R.; Hoang, Lien N.; Park, Kay J.; Soslow, Robert A.; Backes, Floor J.; Gardner, Ginger J.; Abu-Rustum, Nadeen R.; Leitao, Mario M.; Eisenhauer, Eric L.; Chi, Dennis S.

2016-01-01

Objective The objective of this prospective pilot study was to assess the clinical and histologic effects of topical imiquimod therapy on recurrent extramammary Paget's disease of the vulva. Methods Patients with biopsy-proven recurrent extramammary Paget's disease presenting to the gynecology outpatient services at two participating institutions were recruited for conservative treatment with 5% imiquimod cream from 2007 to 2011. The topical cream was to be applied 3 times per week for 12 weeks. Punch biopsy and photography were performed at baseline and at the 12-week time point. Results Eight patients from two institutions were enrolled. Complete clinical and histologic response was achieved in 6 (75%) patients by the 12-week follow-up appointment. Of the two remaining patients, one had a complete clinical response but no significant histologic response; the other patient was removed from the study protocol secondary to intolerable local irritation. Two patients continue to have no evidence of disease after a median follow-up of 35 months. Five are alive with disease. No patients progressed to invasive cancer while receiving therapy. Conclusion Topical 5% imiquimod cream is a safe and feasible option for women suffering from recurrent extramammary Paget's disease of the vulva, and should be considered as a viable alternative to surgical management. Given the rare nature of this disease, additional multi-institutional prospective studies should be conducted to explore the efficacy of this treatment regime. PMID:27112632

Using a digital game for training desirable behavior in cognitive-behavioral therapy of burnout syndrome: a controlled study.

PubMed

Zielhorst, Thomas; van den Brule, Daphne; Visch, Valentijn; Melles, Marijke; van Tienhoven, Sam; Sinkbaek, Helle; Schrieken, Bart; Tan, Eduard S-H; Lange, Alfred

2015-02-01

Burnout is a globally increasing illness, and as a result, many forms of burnout therapy have arisen. The use of digital games can be psychotherapeutically effective because they can transform exercises that are by themselves unattractive into intrinsically motivated action. This pilot study aims to test whether a specially designed game contributes to patients learning desired behavior and achieving other specific therapeutic goals in an online cognitive-behavioral therapy (CBT)-based burnout treatment context. In total, 101 participants took part in the experiment, under four conditions: (a) Game+Therapy, (b) Therapy Only, (c) Game Only, and (d) No Game+No Therapy. Pre- and postmeasures were taken online. Results showed that the two therapy conditions (Game+Therapy and Therapy Only) showed a greater decrease in complaints and disengagement, and a stronger increase in coping skills than the nontherapy conditions (Game Only and No Game+No Therapy). As expected, the Game+Therapy condition outperformed the Therapy Only condition on combined improvement measures of burnout symptoms. However, analyses of individual measures showed no effects. It can be cautiously concluded that the therapeutic digital game may be a useful tool when embedded in a therapeutic burnout treatment program and is probably more efficient than CBT, as it is used in current practice.

Catheter and Laryngeal Mask Endotracheal Surfactant Therapy: the CALMEST approach as a novel MIST technique.

PubMed

Vannozzi, Ilaria; Ciantelli, Massimiliano; Moscuzza, Francesca; Scaramuzzo, Rosa T; Panizza, Davide; Sigali, Emilio; Boldrini, Antonio; Cuttano, Armando

2017-10-01

Neonatal respiratory distress syndrome (RDS) is a major cause of mortality and morbidity among preterm infants. Although the INSURE (INtubation, SURfactant administration, Estubation) technique for surfactant replacement therapy is so far the gold standard method, over the last years new approaches have been studied, i.e. less invasive surfactant administration (LISA) or minimally invasive surfactant therapy (MIST). Here we propose an originally modified MIST, called CALMEST (Catheter And Laryngeal Mask Endotracheal Surfactant Therapy), using a particular laryngeal mask as a guide for a thin catheter to deliver surfactant directly in the trachea. We performed a preliminary study on a mannequin and a subsequent in vivo pilot trial. This novel procedure is quick, effective and well tolerated and might represent an improvement in reducing neonatal stress. Ultimately, CALMEST offers an alternative approach that could be extremely useful for medical staff with low expertise in laryngoscopy and intubation.

Robotic therapy provides a stimulus for upper limb motor recovery after stroke that is complementary to and distinct from conventional therapy.

PubMed

Brokaw, Elizabeth B; Nichols, Diane; Holley, Rahsaan J; Lum, Peter S

2014-05-01

Individuals with chronic stroke often have long-lasting upper extremity impairments that impede function during activities of daily living. Rehabilitation robotics have shown promise in improving arm function, but current systems do not allow realistic training of activities of daily living. We have incorporated the ARMin III and HandSOME device into a novel robotic therapy modality that provides functional training of reach and grasp tasks. To compare the effects of equal doses of robotic and conventional therapy in individuals with chronic stroke. Subjects were randomized to 12 hours of robotic or conventional therapy and then crossed over to the other therapy type after a 1-month washout period. Twelve moderate to severely impaired individuals with chronic stroke were enrolled, and 10 completed the study. Across the 3-month study period, subjects showed significant improvements in the Fugl-Meyer (P = .013) and Box and Blocks tests (P = .028). The robotic intervention produced significantly greater improvements in the Action Research Arm Test than conventional therapy (P = .033). Gains in the Box and Blocks test from conventional therapy were larger than from robotic therapy in subjects who received conventional therapy after robotic therapy (P = .044). Data suggest that robotic therapy can elicit improvements in arm function that are distinct from conventional therapy and supplements conventional methods to improve outcomes. Results from this pilot study should be confirmed in a larger study.

Effectiveness of school-based humanistic counselling for psychological distress in young people: Pilot randomized controlled trial with follow-up in an ethnically diverse sample.

PubMed

Pearce, Peter; Sewell, Ros; Cooper, Mick; Osman, Sarah; Fugard, Andrew J B; Pybis, Joanne

2017-06-01

The aim of this study was to pilot a test of the effectiveness of school-based humanistic counselling (SBHC) in an ethnically diverse group of young people (aged 11-18 years old), with follow-up assessments at 6 and 9 months. Pilot randomized controlled trial, using linear-mixed effect modelling and intention-to-treat analysis to compare changes in levels of psychological distress for participants in SBHC against usual care (UC). ISRCTN44253140. In total, 64 young people were randomized to either SBHC or UC. Participants were aged between 11 and 18 (M = 14.2, SD = 1.8), with 78.1% of a non-white ethnicity. The primary outcome was psychological distress at 6 weeks (mid-therapy), 12 weeks (end of therapy), 6-month follow-up and 9-month follow-up. Secondary measures included emotional symptoms, self-esteem and attainment of personal goals. Recruitment and retention rates for the study were acceptable. Participants in the SBHC condition, as compared with participants in the UC condition, showed greater reductions in psychological distress and emotional symptoms, and greater improvements in self-esteem, over time. However, at follow-up, only emotional symptoms showed significant differences across groups. The study adds to the pool of evidence suggesting that SBHC can be tested and that it brings about short-term reductions in psychological and emotional distress in young people, across ethnicities. However, there is no evidence of longer-term effects. School-based humanistic counselling can be an effective means of reducing the psychological distress experienced by young people with emotional symptoms in the short term. The short-term effectiveness of school-based humanistic counselling is not limited to young people of a White ethnicity. There is no evidence that school-based humanistic counselling has effects beyond the end of therapy. © 2016 The British Psychological Society.

The functional manual therapy intervention in infants with nonsynostotic plagiocephaly: a pilot study.

PubMed

Billi, Mariangela; Greco, Angelo; Colonneli, Paola; Volpi, Giordana; Valente, Donatella; Galeoto, Giovanni

2017-10-25

To document the evolution of cranial asymmetries in infants with signs of nonsynostotic occipital plagiocephaly (NSOP) who were undergo to many functional manual therapy treatments (in addition to the standard positioning recommendations) as well as to determine the feasibility of this methodology to conduct an outcome research investigating the impact of this intervention for infants with NSOP. Pilot clinical standardization project using pre-post design in which 10 infants participated. Nine infants presented an initial Oblique Diameter Difference Index (ODDI) over 104%, three an initial Ear Deviation Index (EDI) over 4%, and three a Cranial Proportional Index (CPI) over 90%. Infants received three functional manual therapy treatments for week during the first month of intervention and two ones for week during the second month. Plagiocephalometric measurememts were administered at the first assessment pre-intervention (T0), after 30 days (+/-5) (T1) and at a third time after 60 days (+/5) of treatment (T2). 9/10 participants showed a significant decrease in ODDI under 104% between T0 and T2 assessments. 5/10 infants showed an EDI under 4%, and 3/10 showed a value about 0%. 3/10 maintained their CPI over 90% with a considerable decrease. These clinical findings support the hypothesis that functional manual therapy treatments contribute to the improvement of cranial asymmetries in infants younger than 6.5 months old presenting with NSOP.

The Effect of Ezetimibe/Statin Combination and High-Dose Statin Therapy on Thyroid Autoimmunity in Women with Hashimoto's Thyroiditis and Cardiovascular Disease: A Pilot Study.

PubMed

Krysiak, R; Szkróbka, W; Okopień, B

2016-10-01

Background: Intensive statin therapy was found to reduce thyroid autoimmunity in women with Hashimoto's thyroiditis. No similar data are available for other hypolipidemic agents. Methods: The participants of the study were 16 women with Hashimoto's thyroiditis and coronary artery disease. On the basis of statin tolerance, they were divided into 2 groups. 8 patients who did not tolerate high-dose statin therapy were treated with a statin, the dose of which was reduced by half, together with ezetimibe. The remaining 8 patients tolerating the treatment continued high-dose statin therapy. Plasma lipids, serum levels of thyrotropin, free thyroxine and free triiodothyronine, as well as titers of thyroid peroxidase and thyroglobulin antibodies were measured at the beginning of the study and 6 months later. Results: Replacing high-dose statin therapy with ezetimibe/statin combination therapy increased serum titers of thyroid peroxidase as well as led to an insignificant increase in serum titers of thyroglobulin antibodies. At the end of the study, thyroid peroxidase and thyroglobulin antibody titers were higher in patients receiving the combination therapy than in those treated only with high-dose statin. Conclusions: Our study shows that high-dose statin therapy produces a stronger effect on thyroid autoimmunity than ezetimibe/statin combination therapy. © Georg Thieme Verlag KG Stuttgart · New York.

Pilot randomized controlled trial of dialectical behavior therapy group skills training for ADHD among college students.

PubMed

Fleming, Andrew P; McMahon, Robert J; Moran, Lyndsey R; Peterson, A Paige; Dreessen, Anthony

2015-03-01

ADHD affects between 2% and 8% of college students and is associated with broad functional impairment. No prior randomized controlled trials with this population have been published. The present study is a pilot randomized controlled trial evaluating dialectical behavior therapy (DBT) group skills training adapted for college students with ADHD. Thirty-three undergraduates with ADHD between ages 18 and 24 were randomized to receive either DBT group skills training or skills handouts during an 8-week intervention phase. ADHD symptoms, executive functioning (EF), and related outcomes were assessed at baseline, post-treatment, and 3-month follow-up. Participants receiving DBT group skills training showed greater treatment response rates (59-65% vs. 19-25%) and clinical recovery rates (53-59% vs. 6-13%) on ADHD symptoms and EF, and greater improvements in quality of life. DBT group skills training may be efficacious, acceptable, and feasible for treating ADHD among college students. A larger randomized trial is needed for further evaluation. © 2014 SAGE Publications.

Exercise Training and Cardiovascular Health in Cancer Patients.

PubMed

Squires, Ray W; Shultz, Adam M; Herrmann, Joerg

2018-03-10

Cancer patients nearly universally experience a decline in quality of life, with fatigue and reduced exercise tolerance as cardinal reflections. A routine exercise program can improve these signs and symptoms as well as overall outcomes. The review provides an updated overview of the field and its translation to clinical practice. A wealth of clinical studies have documented the safety and benefits of exercise after and during cancer therapy, and pilot and larger-scale studies are currently ongoing to integrate exercise into the treatment program for cancer patients undergoing active therapy (EXACT pilot, OptiTrain, and TITAN study). More recently, efforts have emerged to commence exercise programs before the start of cancer therapy, so-called pre-habilitation. The concept of increasing the cardiovascular reserve beforehand is intuitively attractive. In agreement, preclinical studies support exercise as an effective preventive means before and during cardiotoxic drug exposure. Assuming that a pronounced drop in exercise tolerance will occur during cancer therapy, pre-habilitation can potentially curtail or raise the nadir level of exercise tolerance. Furthermore, such efforts might serve as pre-conditioning efforts in reducing not only the nadir, but even the magnitude of drop in cardiovascular reserve. Initiated beforehand, cancer patients are also more likely to continue these efforts during cancer therapy. Finally, an active exercise routine (≥ 150 min/week moderate intensity or ≥ 75 min/week vigorous intensity or combination) in conjunction with the other six American Heart Association's cardiovascular health metrics (BMI < 25 kg/m 2 , blood pressure < 120/80 mmHg, fasting plasma glucose < 100 mg/dL, total cholesterol < 200 mg/dL, 4-5 component healthy diet, no smoking) reduces not only the cardiovascular but also the cancer disease risk. Exercise can reduce the risks of developing cancer, the detrimental effects of its treatment on the cardiovascular system, and overall morbidity and mortality. Exercise should become an integral part of the care for every cancer patient.

Clitoral therapy device for treatment of sexual dysfunction in irradiated cervical cancer patients.

PubMed

Schroder, Maryann; Mell, Loren K; Hurteau, Jean A; Collins, Yvonne C; Rotmensch, Jacob; Waggoner, Steven E; Yamada, S Diane; Small, William; Mundt, Arno J

2005-03-15

The purpose of this pilot study was to evaluate the efficacy of the clitoral therapy device (Eros Therapy) in alleviating sexual dysfunction in irradiated cervical cancer patients. Eligible patients had a history of cervical cancer treated with radiotherapy and self-reported sexual dysfunction of sexual arousal and/or orgasmic disorders. Patients used the noninvasive, nonpharmacologic clitoral therapy device using a hand-held, battery-powered vacuum to cause clitoral engorgement four times weekly for 3 months during foreplay and self-stimulation. Study instruments included the Female Sexual Function Index, Derogatis Interview for Sexual Functioning, and Dyadic Adjustment Scale. The outcome evaluation was performed at 3 months. Between 2001 and 2002, 15 women were enrolled and 13 completed the study. The median patient age and radiotherapy-enrollment interval was 43.5 years and 2 years, respectively. At baseline, all patients reported symptoms of sexual arousal and/or orgasmic disorders, and some also had sexual desire and pain disorders. At 3 months, statistically significant improvements were seen in all domains tested, including sexual desire, arousal, lubrication, orgasm, sexual satisfaction, and reduced pain. The median Female Sexual Function Index total score increased from 17 to 29.4 (maximal score, 36; p <0.001). The median Derogatis Interview for Sexual Functioning total raw score increased from 46 to 95 (maximal score, 118; p <0.001). At baseline, the Derogatis Interview for Sexual Functioning total T-score corresponded to the bottom 10th percentile of normal sexual functioning. At 3 months, the total T-score placed the patients at the normalcy cutoff. Gynecologic examinations revealed improved mucosal color and moisture and vaginal elasticity and decreased bleeding and ulceration. Our results from this pilot study suggest that the clitoral therapy device may alleviate sexual dysfunction in irradiated cervical cancer patients. A randomized, controlled trial is warranted to assess the full benefits of this approach.

Implementation of a pharmacogenetic management service for postmyocardial infarction care in a community pharmacy.

PubMed

Bright, D R; Kisor, D F; Smith, A; Conaway, M; Yu, M

2015-08-01

The purpose of this study was to pilot a multisite, proof-of-concept model where community pharmacists could engage patients and physicians to provide pharmacogenetic (PGt) testing and clinical decision support. Patients with history of acute myocardial infarction and percutaneous coronary intervention with no prior history of CYP2C19 testing. Four community pharmacies provided pharmacogenetic testing and medication therapy management services to 30 patients, resulting in eight recommendations for antiplatelet therapy adjustment. Pharmacists involved in the study were able to facilitate antiplatelet therapy adjustments based on PGt data regardless of baseline antiplatelet drug selection. Whereas prior literature largely revolved around PGt management in the inpatient setting, this project supports the involvement of the community pharmacist in making PGt-based recommendations.

Stabilizing Group Treatment for Complex Posttraumatic Stress Disorder Related to Childhood Abuse Based on Psycho-Education and Cognitive Behavioral Therapy: A Pilot Study

ERIC Educational Resources Information Center

Dorrepaal, Ethy; Thomaes, Kathleen; Smit, Johannes H.; van Balkom, Anton J. L. M.; van Dyck, Richard; Veltman, Dick J.; Draijer, Nel

2010-01-01

Objective: This study tests a Stabilizing Group Treatment protocol, designed for the management of the long-term sequelae of child abuse, that is, Complex Posttraumatic Stress Disorder (Complex PTSD). Evidence-based treatment for this subgroup of PTSD patients is largely lacking. This stabilizing treatment aims at improving Complex PTSD using…

Relaxation Therapy and Anxiety, Self-Esteem, and Emotional Regulation among Adults with Intellectual Disabilities: A Randomized Controlled Trial

ERIC Educational Resources Information Center

Bouvet, Cyrille; Coulet, Aurélie

2016-01-01

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…

High Dose Vitamin D Therapy for Chronic Pain in Children and Adolescents with Sickle Cell Disease: Results of a Randomized Double Blind Pilot Study

PubMed Central

I, Osunkwo; TR, Ziegler; J, Alvarez; C, McCracken; K, Cherry; CE, Osunkwo; SF, Ofori-Acquah; S, Ghosh; A, Ogunbobode; J, Rhodes; JR, Eckman; CD, Dampier; V, Tangpricha

2012-01-01

Summary We report results of a pilot study of high-dose vitamin D in sickle cell disease (SCD). Subjects were followed for 6 months after receiving a six-week course of oral high-dose cholecalciferol or placebo. Vitamin D insufficiency and deficiency was present at baseline in 82.5% and 52.5% of subjects, respectively. Subjects who received high-dose vitamin D achieved higher serum 25-hydroxyvitamin D, experienced fewer pain days per week, and had higher physical activity quality-of-life scores. These findings suggest a potential benefit of vitamin D in reducing the number of pain days in SCD. Larger prospective studies with longer duration are needed to confirm these effects. PMID:22924607

The Cognitive Remediation in Bipolar (CRiB) pilot study: study protocol for a randomised controlled trial.

PubMed

Strawbridge, Rebecca; Fish, Jessica; Halari, Rozmin; Hodsoll, John; Reeder, Clare; Macritchie, Karine; McCrone, Paul; Wykes, Til; Young, Allan H

2016-07-29

People with bipolar disorder often show difficulties with cognitive functioning, and though these difficulties are identified as important targets for intervention, few treatment options are available. Preliminary evidence suggests that cognitive remediation therapy (a psychological treatment proven beneficial for people diagnosed as having schizophrenia) is helpful for people with bipolar disorders. We are conducting a pilot trial to determine whether individual, computerised, cognitive remediation therapy (CRT) for people with bipolar disorder 1) increases cognitive function; 2) improves global functioning, goal attainment and mood symptoms; 3) is acceptable and feasible for participants; and 4) can be addressed in a comprehensive, larger, randomised, controlled trial. The study is designed as a two-arm, randomised, controlled trial comparing cognitive remediation therapy with treatment-as-usual (TAU) for euthymic bipolar patients. Participants are eligible to take part if aged between 18 and 65 with a diagnosis of bipolar disorder (type I) and currently in euthymic state, and no neurological, substance or personality disorder diagnoses. Sixty participants will be recruited (mainly through secondary and tertiary care) and will be block-randomised to receive either treatment-as-usual alone or in addition to a 12-week course of cognitive remediation therapy totalling 20-40 therapy hours. The intervention will comprise regular sessions with a therapist and computer-based training. Research assessments will take place before and after the intervention period and at a 12-week follow-up, and will include evaluation of neuropsychological, symptom-related, demographic and social factors, as well as collecting qualitative data regarding CRT expectations and satisfaction. Intention-to-treat analyses will examine the efficacy of cognitive remediation therapy primarily on cognition and additionally on functioning, quality of life and mood symptoms. Furthermore, we will examine the acceptability of CRT and undertake a preliminary health economics analysis to ascertain the cost of delivering the intervention. The results of this trial will provide valuable information about whether cognitive remediation therapy may be beneficial for people diagnosed with bipolar disorder in a euthymic state. ISRCTN registry, ISRCTN32290525 . Registered on 2 March 2016.

e100 NeuroRobotic system.

PubMed

Stein, Joel

2009-01-01

Therapy incorporating the repeated practice of motor tasks has been found to enhance motor function after stroke. This type of therapy may be facilitated by robotic devices and several such devices are being developed for use in rehabilitation. The Myomo e100 NeuroRobotic system is a novel device developed to provide assistance during elbow movements in stroke survivors. The device uses surface electromyographic signals to control a powered elbow orthosis. Data from a pilot study reveals that the device can be used successfully by stroke survivors and suggests that it may be effective in helping to restore motor control after stroke. Further studies are needed to confirm these preliminary results.

A pilot study of the nutritional status of opiate-using pregnant women on methadone maintenance therapy.

PubMed

Tomedi, Laura Elizabeth; Bogen, Debra L; Hanusa, Barbara H; Wisner, Katherine L; Bodnar, Lisa M

2012-02-01

Pregnant women in methadone maintenance therapy may have poor nutrition during pregnancy. In 2006-2008, methadone-treated pregnant women (n = 22) were recruited at an urban academic medical center and compared with nondrug-using pregnant women (n = 119) at 20-35 weeks' gestation. We measured adiposity using prepregnancy body mass index (BMI), dietary intake using a food frequency questionnaire, and micronutrient and essential fatty acid status using biomarkers. Methadone-treated women had lower BMI, consumed more calories, had lower serum carotenoid concentrations, and higher plasma homocysteine concentrations than controls. The study's limitations and implications for future research are discussed.

Acceptance and Commitment Therapy for the Treatment of Music Performance Anxiety: A Pilot Study with Student Vocalists

PubMed Central

Juncos, David G.; Heinrichs, Glenn A.; Towle, Philip; Duffy, Kiera; Grand, Sebastian M.; Morgan, Matthew C.; Smith, Jonathan D.; Kalkus, Evan

2017-01-01

This study investigated the use of Acceptance and Commitment Therapy (ACT) as a treatment for music performance anxiety (MPA) in an uncontrolled pilot design. ACT is a newer, “third-wave” therapy that differs from previous MPA treatments, because its goal is not to reduce symptoms of MPA. Rather, ACT aims to enhance psychological flexibility in the presence of unwanted symptoms through the promotion of six core processes collectively known as the ACT “Hexaflex.” A small group of student vocalists (N = 7) from an elite choral college were recruited using objective criteria for evaluating MPA. Participants received 12 ACT sessions, and their baseline functioning served as a pre-treatment control. Treatment consisted of an orientation to ACT, identifying experientially avoidant behaviors, facilitation of Hexaflex processes, group performances in which valued behaviors were practiced in front of one another, meditations, homework, and completion of self-report measures before, during, and after treatment (at a 1- and 3-month follow-up). Improvements were observed in participants' cognitive defusion, acceptance of MPA symptoms, and psychological flexibility at post-treatment and follow-ups. Students also appeared to improve their performance quality and reduce their shame over having MPA. These results add to existing research suggesting ACT is a promising intervention for MPA, while also highlighting how vocal students may be less impaired by physical MPA symptoms. PMID:28674509

Acceptance and Commitment Therapy for the Treatment of Music Performance Anxiety: A Pilot Study with Student Vocalists.

PubMed

Juncos, David G; Heinrichs, Glenn A; Towle, Philip; Duffy, Kiera; Grand, Sebastian M; Morgan, Matthew C; Smith, Jonathan D; Kalkus, Evan

2017-01-01

This study investigated the use of Acceptance and Commitment Therapy (ACT) as a treatment for music performance anxiety (MPA) in an uncontrolled pilot design. ACT is a newer, "third-wave" therapy that differs from previous MPA treatments, because its goal is not to reduce symptoms of MPA. Rather, ACT aims to enhance psychological flexibility in the presence of unwanted symptoms through the promotion of six core processes collectively known as the ACT "Hexaflex." A small group of student vocalists ( N = 7) from an elite choral college were recruited using objective criteria for evaluating MPA. Participants received 12 ACT sessions, and their baseline functioning served as a pre-treatment control. Treatment consisted of an orientation to ACT, identifying experientially avoidant behaviors, facilitation of Hexaflex processes, group performances in which valued behaviors were practiced in front of one another, meditations, homework, and completion of self-report measures before, during, and after treatment (at a 1- and 3-month follow-up). Improvements were observed in participants' cognitive defusion, acceptance of MPA symptoms, and psychological flexibility at post-treatment and follow-ups. Students also appeared to improve their performance quality and reduce their shame over having MPA. These results add to existing research suggesting ACT is a promising intervention for MPA, while also highlighting how vocal students may be less impaired by physical MPA symptoms.

Skin adhesive low-level light therapy for dysmenorrhoea: a randomized, double-blind, placebo-controlled, pilot trial.

PubMed

Shin, Yong-Il; Kim, Nam-Gyun; Park, Kyoung-Jun; Kim, Dong-Wook; Hong, Gi-Youn; Shin, Byung-Cheul

2012-10-01

The cause of dysmenorrhoea is an abnormal function of smooth muscles in the uterus due to long-term deficient blood supply into smooth muscle tissue. The purpose of this study was to evaluate the effectiveness of skin adhesive low-level light therapy (LLLT) in participants with dysmenorrhoea. Thirty-one women were included in this randomized, double-blind, placebo-controlled, pilot trial. Twenty-one women were treated with active LLLT and ten women were treated with placebo one. The therapy was performed in a laboratory room for 20 min a day over a period of 5 days prior to the expected onset of menstruation. The outcome was measured using a visual analog scale (VAS) for each participant's dysmenorrhoeal pain severity. VAS of each subject was measured every month for 6 months. In the active LLLT group, 16 women reported successful results during their first menstrual cycle just after active LLLT and 5 women had successful results from the second menstrual cycle after active LLLT. The pain reduction rate was 83 % in the active LLLT group, whereas there was only a slight and temporary reduction in pain in the placebo LLLT group. Changes of VAS within 6 months of LLLT showed statistical significance (p = 0.001) over placebo control. Our study suggests that skin adhesive LLLT on acupuncture points might be an effective, simple and safe non-pharmacological treatment for dysmenorrhoea.

Cognitive Analytic Therapy for Bipolar Disorder: A Pilot Randomized Controlled Trial.

PubMed

Evans, Mark; Kellett, Stephen; Heyland, Simon; Hall, Jo; Majid, Shazmin

2017-01-01

The evidence base for treatment of bipolar affective disorder (BD) demands the evaluation of new psychotherapies in order to broaden patient choice. This study reports on the feasibility, safety, helpfulness and effectiveness of cognitive analytic therapy (CAT). In a pilot randomized controlled trial, BD patients in remission were randomized to either receiving 24 sessions of CAT (n = 9) or treatment as usual (n = 9) and were assessed in terms of symptoms, functioning and service usage over time. In the CAT arm no adverse events occurred, 8/9 completed treatment, 5/8 attended all 24 sessions and 2/8 were categorized as recovered. The most common helpful event during CAT was recognition of patterns in mood variability, with helpfulness themes changing according to phase of therapy. No major differences were found when comparing the arms over time in terms of service usage or psychometric outcomes. The study suggests that conducting further research into the effectiveness of CAT in treating BD is warranted and guidance regarding future trials is provided. Copyright © 2016 John Wiley & Sons, Ltd. Treating BD with CAT appears feasible and safe. Retaining fidelity to the reformulation, recognition and revision structure of CAT appears useful. Participants stated that across the phases of CAT, focussing on patterns of mood variability was consistently helpful. Copyright © 2016 John Wiley & Sons, Ltd.

The effectiveness of solution-focused brief therapy for psychological distress among Chinese parents of children with a cancer diagnosis: a pilot randomized controlled trial.

PubMed

Zhang, Anao; Ji, QingYing; Currin-McCulloch, Jennifer; Solomon, Phyllis; Chen, YuTing; Li, Yaxi; Jones, Barbara; Franklin, Cynthia; Nowicki, Jack

2018-08-01

Given the critical role of parental care for pediatric cancer patients, this pilot study evaluated the feasibility and effectiveness of a hospital-based solution-focused brief therapy (SFBT) intervention for reducing psychological distress among parents of pediatric cancer patients in China. Differences between treatment and active control (AC) groups were assessed on dimensions of psychological distress. Parents' level of hope was also assessed. Participants (N = 44) were randomly assigned to SFBT or AC. Parents received four sessions of SFBT twice a week delivered by graduate-level hospital social workers. Pre- and post-intervention assessments measured change in distress (depression, anxiety, and somatization symptoms) of parents as well as their level of hope. Analysis of covariance (ANCOVA) indicated the SFBT group had better outcomes than the AC group on overall distress of somatic, anxiety, depression symptoms and level of hope. Within- and between-group treatment effects reported significantly greater effect of the SFBT group than of the AC group. Considering the inherent limits of a pilot feasibility study, results suggest that SFBT is a feasible, culturally compatible, and promising intervention for alleviating distress among Chinese parents of children with cancer. Additional comprehensive trials are needed to draw more definitive conclusions. SFBT may be beneficial for improving the critical support systems of parents of pediatric cancer patients. Thus, SFBT may have the potential to enhance children's well-being during cancer treatment and recovery.

Cooking "shrimp à la créole": a pilot study of an ecological rehabilitation in semantic dementia.

PubMed

Bier, Nathalie; Macoir, Joël; Joubert, Sven; Bottari, Carolina; Chayer, Céline; Pigot, Hélène; Giroux, Sylvain

2011-08-01

New learning in semantic dementia (SD) seems to be tied to a specific temporal and spatial context. Thus, cognitive rehabilitation could capitalise upon preserved episodic memory and focus on everyday activities which, once learned, will have an impact in everyday life. This pilot study thus explores the effectiveness of an ecological approach in one patient suffering from SD. EC, a 68-year-old woman with SD, stopped cooking complex meals due to a substantial loss of knowledge related to all food types. The therapy consisted of preparing a target recipe. She was asked to generate semantic attributes of ingredients found in one target, one control and two no-therapy recipes. The number of recipes cooked by EC between therapy sessions was computed. She was also asked to prepare a generalisation recipe combining ingredients from the target and control recipes. EC's generated semantic attributes (GSA) of ingredients pertaining to the target and control recipes increased significantly (p < .001), compared to the no-therapy recipes (ps > .79). The proportion of meals cooked also increased significantly (p = .021). For the generalisation recipe, she could not succeed without assistance. Frequent food preparation may have provided EC with new memories about the context, usage and appearance of some concepts. These memories seem very context-bound, but EC nonetheless re-introduced some recipes into her day-to-day life. The impact of these results on the relationship between semantic, episodic and procedural memory is discussed, as well as the relevance of an ecological approach in SD.

Reiki Therapy for Symptom Management in Children Receiving Palliative Care: A Pilot Study.

PubMed

Thrane, Susan E; Maurer, Scott H; Ren, Dianxu; Danford, Cynthia A; Cohen, Susan M

2017-05-01

Pain may be reported in one-half to three-fourths of children with cancer and other terminal conditions and anxiety in about one-third of them. Pharmacologic methods do not always give satisfactory symptom relief. Complementary therapies such as Reiki may help children manage symptoms. This pre-post mixed-methods single group pilot study examined feasibility, acceptability, and the outcomes of pain, anxiety, and relaxation using Reiki therapy with children receiving palliative care. A convenience sample of children ages 7 to 16 and their parents were recruited from a palliative care service. Two 24-minute Reiki sessions were completed at the children's home. Paired t tests or Wilcoxon signed-rank tests were calculated to compare change from pre to post for outcome variables. Significance was set at P < .10. Cohen d effect sizes were calculated. The final sample included 8 verbal and 8 nonverbal children, 16 mothers, and 1 nurse. All mean scores for outcome variables decreased from pre- to posttreatment for both sessions. Significant decreases for pain for treatment 1 in nonverbal children ( P = .063) and for respiratory rate for treatment 2 in verbal children ( P = .009). Cohen d effect sizes were medium to large for most outcome measures. Decreased mean scores for outcome measures indicate that Reiki therapy did decrease pain, anxiety, heart, and respiratory rates, but small sample size deterred statistical significance. This preliminary work suggests that complementary methods of treatment such as Reiki may be beneficial to support traditional methods to manage pain and anxiety in children receiving palliative care.

Prevalence of periodontopathogens and Candida spp. in smokers after nonsurgical periodontal therapy - a pilot study.

PubMed

Camargo, Gabriela Alessandra da Cruz Galhardo; Abreu, Mariana Gouvêa Latini; Cordeiro, Renata Dos Santos; Wenderoscky, Letícia de Farias; Duque, Cristiane

2016-08-22

This pilot study aimed to evaluate the influence of smoking on clinical and microbiological parameters after nonsurgical periodontal therapy. Forty-eight subjects were grouped into smokers (SM, n = 24) and nonsmokers (NS, n = 24) and paired according to gender, age, ethnicity, and periodontal status. Both groups received oral hygiene education and scaling and root planing. Clinical evaluation was performed using plaque index (PI), bleeding on probing (BOP), pocket probing depth (PPD), gingival recession (GR), and clinical attachment level (CAL) before instrumentation (baseline) and at 3 and 6 months. The prevalence of Aggregatibacter actinomycetemcomitans, Porphyromonas gingivalis, Tannerella forsythia, Candida albicans, Candida glabrata, Candida tropicalis, and Candida dubliniensis in subgingival biofilm was determined by polymerase chain reaction. The data were statistically analyzed considering p < 0.05. Clinical conditions improved between baseline and 3 months after periodontal treatment. However, NS had a better clinical response, presenting greater PPD reduction and CAL increase in comparison to SM. Periodontal treatment reduced the levels of P. gingivalis, A. actinomycetemcomitans, and T. forsythia individually after 3 months for the NS group and after 6 months for both groups. The prevalence of Candida species was markedly higher in SM than in NS at all time points evaluated. Periodontopathogens associated or not with C. albicans or C. dubliniensis were more prevalent in SM than in NS at baseline and after 3 months. It was concluded that smoking impairs clinical and microbiological responses to periodontal therapy. Periodontopathogens combined or not with some Candida species are resistant to short-term periodontal therapy in SM.

A Pilot Randomized Controlled Trial of Cognitive-Behavioral Therapy for Adolescents With Body Dysmorphic Disorder.

PubMed

Mataix-Cols, David; Fernández de la Cruz, Lorena; Isomura, Kayoko; Anson, Martin; Turner, Cynthia; Monzani, Benedetta; Cadman, Jacinda; Bowyer, Laura; Heyman, Isobel; Veale, David; Krebs, Georgina

2015-11-01

Body dysmorphic disorder (BDD) typically starts in adolescence, but evidence-based treatments are yet to be developed and formally evaluated in this age group. We designed an age-appropriate cognitive-behavioral therapy (CBT) protocol for adolescents with BDD and evaluated its acceptability and efficacy in a pilot randomized controlled trial. Thirty adolescents aged 12 to 18 years (mean = 16.0, SD = 1.7) with a primary diagnosis of BDD, together with their families, were randomly assigned to 14 sessions of CBT delivered over 4 months or a control condition of equivalent duration, consisting of written psycho-education materials and weekly telephone monitoring. Blinded evaluators assessed participants at baseline, midtreatment, posttreatment, and at 2-month follow-up. The primary outcome measure was the Yale-Brown Obsessive-Compulsive Scale Modified for BDD, Adolescent Version (mean baseline score = 37.13, SD = 4.98, range = 24-43). The CBT group showed a significantly greater improvement than the control group, both at posttreatment (time × group interaction coefficient [95% CI] = -11.26 [-17.22 to -5.31]; p = .000) and at 2-month follow-up (time × group interaction coefficient [95% CI] = -9.62 [-15.74 to -3.51]; p = .002). Six participants (40%) in the CBT group and 1 participant (6.7%) in the control condition were classified as responders at both time points (χ(2) = 4.658, p = .031). Improvements were also seen on secondary measures, including insight, depression, and quality of life at posttreatment. Both patients and their families deemed the treatment as highly acceptable. Developmentally tailored CBT is a promising intervention for young people with BDD, although there is significant room for improvement. Further clinical trials incorporating lessons learned in this pilot study and comparing CBT and pharmacological therapies, as well as their combination, are warranted. Cognitive-Behaviour Therapy for Adolescents With Body Dysmorphic Disorder; http://www.isrctn.com/; ISRCTN67699666. Copyright © 2015 American Academy of Child and Adolescent Psychiatry. Published by Elsevier Inc. All rights reserved.

Goal-orientated cognitive rehabilitation for dementias associated with Parkinson's disease-A pilot randomised controlled trial.

PubMed

Hindle, John V; Watermeyer, Tamlyn J; Roberts, Julie; Brand, Andrew; Hoare, Zoe; Martyr, Anthony; Clare, Linda

2018-05-01

To examine the appropriateness and feasibility of cognitive rehabilitation for people with dementias associated with Parkinson's in a pilot randomised controlled study. This was a single-blind pilot randomised controlled trial of goal-oriented cognitive rehabilitation for dementias associated with Parkinson's. After goal setting, participants were randomised to cognitive rehabilitation (n = 10), relaxation therapy (n = 10), or treatment-as-usual (n = 9). Primary outcomes were ratings of goal attainment and satisfaction with goal attainment. Secondary outcomes included quality of life, mood, cognition, health status, everyday functioning, and carers' ratings of goal attainment and their own quality of life and stress levels. Assessments were at 2 and 6 months following randomisation. At 2 months, cognitive rehabilitation was superior to treatment-as-usual and relaxation therapy for the primary outcomes of self-rated goal attainment (d = 1.63 and d = 1.82, respectively) and self-rated satisfaction with goal attainment (d = 2.04 and d = 1.84). At 6 months, cognitive rehabilitation remained superior to treatment-as-usual (d = 1.36) and relaxation therapy (d = 1.77) for self-rated goal attainment. Cognitive rehabilitation was superior to treatment as usual and/or relaxation therapy in a number of secondary outcomes at 2 months (mood, self-efficacy, social domain of quality of life, carers' ratings of participants' goal attainment) and at 6 months (delayed recall, health status, quality of life, carer ratings of participants' goal attainment). Carers receiving cognitive rehabilitation reported better quality of life, health status, and lower stress than those allocated to treatment-as-usual. Cognitive rehabilitation is feasible and potentially effective for dementias associated with Parkinson's disease. Copyright © 2018 John Wiley & Sons, Ltd.

Brief Report: Problem Solving Therapy in College Students with Autism Spectrum Disorders: Feasibility and Preliminary Efficacy

ERIC Educational Resources Information Center

Pugliese, Cara E.; White, Susan W.

2014-01-01

Students with autism spectrum disorder (ASD), though academically capable, can have difficulty succeeding in college. Evidence-based intervention to promote effective problem solving may improve quality of life, as well as success and satisfaction in college. This study adapted and piloted a group-based cognitive-behavioral intervention program,…

Pilot Study: Implementing a Brief DBT Skills Program in Schools to Reduce Health Risk Behaviors among Early Adolescents

ERIC Educational Resources Information Center

Zapolski, Tamika C. B.; Smith, Gregory T.

2017-01-01

A significant proportion of youth engage in health risk behaviors, which are of concern, as they are associated with adverse health consequences across development. Two factors associated with engagement in such behaviors are emotion dysregulation and impulsivity. Dialectical behavioral therapy (DBT) is an effective intervention that enhances…

Viral Oncolytic Therapeutics for Neoplastic Meningitis

DTIC Science & Technology

2014-09-01

our animal vendor, Charles River Laboratories (CRL), to adopt their intrathecal catheterization service for this purpose. Cannulated animals from CRL...pilot “idea” study. Thus, both experimental approaches, catheterization did not allow us to obtain statistically significant therapeutic efficacy...fluid, which will help developing new approaches for delivery of therapies, in particular biopharmaceuticals, to the central nervous system and

Healthy Choices: Motivational Enhancement Therapy for Health Risk Behaviors in HIV-Positive Youth

ERIC Educational Resources Information Center

Naar-King, Sylvie; Wright, Kathryn; Parsons, Jeffrey T.; Frey, Maureen; Templin, Thomas; Lam, Phebe; Murphy, Debra

2006-01-01

This study piloted a brief individual motivational intervention targeting multiple health risk behaviors in HIV-positive youth aged 16-25. Interviews about sexual behavior and substance use and viral load testing were obtained from 51 HIV-positive youth at baseline and post intervention. Youth were randomized to receive a four-session motivational…

A Parent-Only Group Intervention for Children with Anxiety Disorders: Pilot Study

ERIC Educational Resources Information Center

Thienemann, Margo; Moore, Phoebe; Tompkins, Kim

2006-01-01

Objective: Working to optimize treatment outcome and use resources efficiently, investigators conducted the first test of an existing parent-only group cognitive-behavioral therapy protocol to treat 24 children 7 to 16 years old with primary anxiety disorder diagnoses. Method: Over the course of 7 months, the authors evaluated a manual-based…

Pilot Trial of Inpatient Cognitive Therapy for the Prevention of Suicide in Military Personnel with Acute Stress Disorder or Post-Traumatic Stress Disorder

DTIC Science & Technology

2013-08-01

meeting was held on April 14, 2013. The members of the DSMB included Dr. Sunil Bhar (Swinburne University), Dr. Walter Matweychuk (University of...Depression (NARSAD) Study Representatives: Dr. Marjan Holloway (PI); Dr. Laura Neely (Clinical Coordinator) DSMB Members: Dr. Sunil Bhar

Behavioral and Psychosocial Outcomes of a 16-Week Rebound Therapy-Based Exercise Program for People with Profound Intellectual Disabilities

ERIC Educational Resources Information Center

Jones, Martyn C.; Walley, Robert M.; Leech, Amanda; Paterson, Marion; Common, Stephanie; Metcalf, Charlotte

2007-01-01

People with profound intellectual disabilities rarely experience a physically active lifestyle, and their long-term physical inactivity likely contributes to poor health. The authors developed and implemented a pilot exercise program for persons with a profound intellectual disability and conducted a study to evaluate the effort. The development…

One-Session Exposure Treatment for Social Anxiety with Specific Fear of Public Speaking

ERIC Educational Resources Information Center

Hindo, Cindy S.; Gonzalez-Prendes, A. Antonio

2011-01-01

Objectives: This pilot study evaluated the effectiveness of one-session, exposure-based therapy, to treat social anxiety disorder (SAD) with specific fear of public speaking. Methods: A quasi-experimental pre-posttest design with repeated measures-within-subject Analysis of Variance and paired sample t-tests was used to compare pretest, posttest…

Effects of Combining a Brief Cognitive Intervention with Transcranial Direct Current Stimulation on Pain Tolerance: A Randomized Controlled Pilot Study.

PubMed

Powers, Abigail; Madan, Alok; Hilbert, Megan; Reeves, Scott T; George, Mark; Nash, Michael R; Borckardt, Jeffrey J

2018-04-01

Cognitive behavioral therapy has been shown to be effective for treating chronic pain, and a growing literature shows the potential analgesic effects of minimally invasive brain stimulation. However, few studies have systematically investigated the potential benefits associated with combining approaches. The goal of this pilot laboratory study was to investigate the combination of a brief cognitive restructuring intervention and transcranial direct current stimulation (tDCS) over the left dorsolateral prefrontal cortex in affecting pain tolerance. Randomized, double-blind, placebo-controlled laboratory pilot. Medical University of South Carolina. A total of 79 healthy adult volunteers. Subjects were randomized into one of six groups: 1) anodal tDCS plus a brief cognitive intervention (BCI); 2) anodal tDCS plus pain education; 3) cathodal tDCS plus BCI; 4) cathodal tDCS plus pain education; 5) sham tDCS plus BCI; and 6) sham tDCS plus pain education. Participants underwent thermal pain tolerance testing pre- and postintervention using the Method of Limits. A significant main effect for time (pre-post intervention) was found, as well as for baseline thermal pain tolerance (covariate) in the model. A significant time × group interaction effect was found on thermal pain tolerance. Each of the five groups that received at least one active intervention outperformed the group receiving sham tDCS and pain education only (i.e., control group), with the exception of the anodal tDCS + education-only group. Cathodal tDCS combined with the BCI produced the largest analgesic effect. Combining cathodal tDCS with BCI yielded the largest analgesic effect of all the conditions tested. Future research might find stronger interactive effects of combined tDCS and a cognitive intervention with larger doses of each intervention. Because this controlled laboratory pilot employed an acute pain analogue and the cognitive intervention did not authentically represent cognitive behavioral therapy per se, the implications of the findings on chronic pain management remain unclear.

TC-325 versus the conventional combined technique for endoscopic treatment of peptic ulcers with high-risk bleeding stigmata: A randomized pilot study.

PubMed

Kwek, Boon Eu Andrew; Ang, Tiing Leong; Ong, Peng Lan Jeannie; Tan, Yi Lyn Jessica; Ang, Shih Wen Daphne; Law, Ngai Moh; Thurairajah, Prem Harichander; Fock, Kwong Ming

2017-06-01

Preliminary studies on a new topical hemostatic agent, TC-325, have shown its safety and effectiveness in treating active upper gastrointestinal (GI) bleeding. However, to date there have been no randomized trials comparing TC-325 with the conventional combined technique (CCT). Our pilot study aimed to compare the efficacy and safety of TC-325 with those of CCT in treating peptic ulcers with active bleeding or high-risk stigmata. This was a comparative randomized study of patients with upper GI bleeding who had Forrest class I, IIA or IIB ulcers. Altogether 20 patients with a mean age of 70 years (range 23-87 years) were recruited, including 16 men, with a mean hemoglobin of 97 g/L. Initial hemostasis was successful in 19 (95.0%) patients, including 90.0% (9/10) in the TC-325 group and 100% (10/10) in the CCT group. TC-325 monotherapy failed to stop bleeding in a patient with Forrest IB posterior duodenal wall ulcer. Rebleeding was seen in 33.3% (3/9) of the patients in the TC-325 group and 10.0% (1/10) in the CCT group. One patient required angio-embolization therapy while three had successful conventional endotherapy. Two patients from the TC-325 group had serious adverse events that were not procedure- or therapy-related. In patients with Forrest IIA or IIB ulcers, five received TC-325 monotherapy; none had rebleeding. Our pilot study showed that TC-325 has a tendency towards a higher rebleeding rate than CCT, when treating actively bleeding ulcers. Larger trials are necessary for definitive results. © 2017 Chinese Medical Association Shanghai Branch, Chinese Society of Gastroenterology, Renji Hospital Affiliated to Shanghai Jiaotong University School of Medicine and John Wiley & Sons Australia, Ltd.

A pilot study of operational tolerance with a regulatory T-cell-based cell therapy in living donor liver transplantation.

PubMed

Todo, Satoru; Yamashita, Kenichiro; Goto, Ryoichi; Zaitsu, Masaaki; Nagatsu, Akihisa; Oura, Tetsu; Watanabe, Masaaki; Aoyagi, Takeshi; Suzuki, Tomomi; Shimamura, Tsuyoshi; Kamiyama, Toshiya; Sato, Norihiro; Sugita, Junichi; Hatanaka, Kanako; Bashuda, Hisashi; Habu, Sonoko; Demetris, Anthony J; Okumura, Ko

2016-08-01

Potent immunosuppressive drugs have significantly improved early patient survival after liver transplantation (LT). However, long-term results remain unsatisfactory because of adverse events that are largely associated with lifelong immunosuppression. To solve this problem, different strategies have been undertaken to induce operational tolerance, for example, maintenance of normal graft function and histology without immunosuppressive therapy, but have achieved limited success. In this pilot study, we aimed to induce tolerance using a novel regulatory T-cell-based cell therapy in living donor LT. Adoptive transfer of an ex vivo-generated regulatory T-cell-enriched cell product was conducted in 10 consecutive adult patients early post-LT. Cells were generated using a 2-week coculture of recipient lymphocytes with irradiated donor cells in the presence of anti-CD80/86 monoclonal antibodies. Immunosuppressive agents were tapered from 6 months, reduced every 3 months, and completely discontinued by 18 months. After the culture, the generated cells displayed cell-number-dependent donor-specific inhibition in the mixed lymphocyte reaction. Infusion of these cells caused no significant adverse events. Currently, all patients are well with normal graft function and histology. Seven patients have completed successful weaning and cessation of immunosuppressive agents. At present, they have been drug free for 16-33 months; 4 patients have been drug free for more than 24 months. The other 3 recipients with autoimmune liver diseases developed mild rejection during weaning and then resumed conventional low-dose immunotherapy. A cell therapy using an ex vivo-generated regulatory T-cell-enriched cell product is safe and effective for drug minimization and operational tolerance induction in living donor liver recipients with nonimmunological liver diseases. (Hepatology 2016;64:632-643). © 2016 by the American Association for the Study of Liver Diseases.

Dabigatran Levels in Elderly Patients with Atrial Fibrillation: First Post-Marketing Experiences.

PubMed

Bolek, Tomáš; Samoš, Matej; Škorňová, Ingrid; Stančiaková, Lucia; Staško, Ján; Galajda, Peter; Kubisz, Peter; Mokáň, Marián

2018-05-08

The number of elderly individuals with non-valvular atrial fibrillation (NV-AF) requiring long-term anticoagulation is rising. The pharmacokinetics of oral anticoagulants in elderly individuals may differ from that for younger patients. The aim of this study was to assess the dabigatran levels in elderly patients with NV-AF. A pilot prospective post-marketing study in patients with NV-AF on dabigatran therapy was performed; we enrolled 21 consecutive elderly patients (aged ≥ 75 years) on a reduced dabigatran regimen (110 mg twice daily) and compared them with 13 younger (≤ 70 years) individuals on reduced dabigatran therapy due to renal impairment and with 16 younger patients on standard dabigatran therapy (150 mg twice daily). Blood samples were taken for the assessment of dabigatran trough and peak levels. Dabigatran levels were measured with the Hemoclot ® Thrombin Inhibitor Assay. There were significant differences in dabigatran trough levels when comparing elderly patients on reduced dabigatran with non-elderly patients on reduced dabigatran (99.3 ± 73.6 vs 51.6 ± 25.6 ng/mL; p < 0.01). Similarly, the detected dabigatran peak levels were significantly higher in elderly patients on reduced dabigatran compared with non-elderly patients on reduced dabigatran (173.4 ± 116.2 vs 116.1 ± 19.1 ng/mL; p < 0.01). No significant differences in dabigatran trough and peak levels were found when comparing elderly patients on reduced dabigatran with non-elderly patients on standard dabigatran therapy. This pilot study demonstrated that elderly patients on reduced dabigatran exhibit significantly higher dabigatran levels than younger individuals on a reduced regimen, and similar levels compared with younger individuals on standard dabigatran.

Comparing Sildenafil alone vs. Sildenafil plus brief couple sex therapy on erectile dysfunction and couples' sexual and marital quality of life: a pilot study.

PubMed

Aubin, Sylvie; Heiman, Julia R; Berger, Richard E; Murallo, A V; Yung-Wen, Liu

2009-01-01

Treatment options for managing erectile dysfunction (ED) include medical and psychological interventions. The present study examined the effectiveness of a drug-only vs. combined treatment approach on erectile function as well as other domains of sexual function and cognition, couple intimacy and adaptation, and treatment satisfaction. Couples with ED were randomly assigned to either Viagra-only (VO) or Viagra plus sex therapy (VST). Sexual and relationship variables were measured at specific time points. Despite limitations, study findings extend previous conclusions and provide empirical support for the effectiveness and satisfaction with the combined treatment approach for treating men with ED of mixed etiology.

Wii-based interactive video games as a supplement to conventional therapy for rehabilitation of children with cerebral palsy: A pilot, randomized controlled trial.

PubMed

Sajan, Jane Elizabeth; John, Judy Ann; Grace, Pearlin; Sabu, Sneha Sara; Tharion, George

2017-08-01

To assess the effect of interactive video gaming (IVG) with Nintendo Wii (Wii) supplemented to conventional therapy in rehabilitation of children with cerebral palsy (CP). Randomized, controlled, assessor-blinded study. Children with CP; 10 children each in the control and intervention groups. IVG using Wii, given as a supplement to conventional therapy, for 45 min per day, 6 days a week for 3 weeks. The children in the control group received conventional therapy alone. Posture control and balance, upper limb function, visual-perceptual skills, and functional mobility. Significant improvement in upper limb functions was seen in the intervention group but not in the control group. Improvements in balance, visual perception, and functional mobility were not significantly different between control and intervention groups. Wii-based IVG may be offered as an effective supplement to conventional therapy in the rehabilitation of children with CP.

Cognitive-behavioural suicide prevention for male prisoners: a pilot randomized controlled trial.

PubMed

Pratt, D; Tarrier, N; Dunn, G; Awenat, Y; Shaw, J; Ulph, F; Gooding, P

2015-12-01

Prisoners have an exceptional risk of suicide. Cognitive-behavioural therapy for suicidal behaviour has been shown to offer considerable potential, but has yet to be formally evaluated within prisons. This study investigated the feasibility of delivering and evaluating a novel, manualized cognitive-behavioural suicide prevention (CBSP) therapy for suicidal male prisoners. A pilot randomized controlled trial of CBSP in addition to treatment as usual (CBSP; n = 31) compared with treatment as usual (TAU; n = 31) alone was conducted in a male prison in England. The primary outcome was self-injurious behaviour occurring within the past 6 months. Secondary outcomes were dimensions of suicidal ideation, psychiatric symptomatology, personality dysfunction and psychological determinants of suicide, including depression and hopelessness. The trial was prospectively registered (number ISRCTN59909209). Relative to TAU, participants receiving CBSP therapy achieved a significantly greater reduction in suicidal behaviours with a moderate treatment effect [Cohen's d = -0.72, 95% confidence interval -1.71 to 0.09; baseline mean TAU: 1.39 (S.D. = 3.28) v. CBSP: 1.06 (S.D. = 2.10), 6 months mean TAU: 1.48 (S.D. = 3.23) v. CBSP: 0.58 (S.D. = 1.52)]. Significant improvements were achieved on measures of psychiatric symptomatology and personality dysfunction. Improvements on psychological determinants of suicide were non-significant. More than half of the participants in the CBSP group achieved a clinically significant recovery by the end of therapy, compared with a quarter of the TAU group. The delivery and evaluation of CBSP therapy within a prison is feasible. CBSP therapy offers significant promise in the prevention of prison suicide and an adequately powered randomized controlled trial is warranted.

Cognitive Existential Couple Therapy for newly diagnosed prostate cancer patients and their partners: a descriptive pilot study.

PubMed

Collins, Anna L; Love, Anthony W; Bloch, Sidney; Street, Annette F; Duchesne, Gillian M; Dunai, Judy; Couper, Jeremy W

2013-02-01

This paper aims to describe 'Cognitive Existential Couple Therapy' (CECT), a novel couples-based intervention for men with early stage prostate cancer (PCa) and their partners, and to report preliminary findings from a pilot study that investigated the acceptability and feasibility of the intervention and the measures to be used in a subsequent randomised controlled trial. A manualised CECT programme was delivered to 12 couples facing a diagnosis of PCa within the previous 12 months by psychiatrists and clinical psychologists. Participants completed measures of psychological distress, marital function and coping pattern before and after CECT. Semi-structured interviews were conducted with nine couples shortly after the completion of CECT. The application of CECT was both feasible and acceptable as indicated by favourable participant compliance (10 of the 12 couples attended all six designated sessions), completion of measures before and after CECT and participation in semi-structured interviews by nine couples. Preliminary results included reduced levels of avoidance and hyperarousal after the programme, with this effect stronger in partners than in patients. Interviews demonstrated that couples valued the therapist's contribution to their overall care. Previous research suggests that a couple-focused psychological intervention is desirable in the context of early stage PCa. This pilot study has established that CECT is acceptable, feasible and valued by couples facing a recent PCa diagnosis and demonstrates a potential for reduced psychological distress following CECT. A randomised controlled trial is currently being undertaken to validate the efficacy of this novel approach. Copyright © 2011 John Wiley & Sons, Ltd.

Effectiveness of Electroconvulsive Therapy in Persistent Methamphetamine Psychosis: A Pilot Study

PubMed Central

Ziaaddini, Hassan; Roohbakhsh, Toktam; Nakhaee, Nouzar; Ghaffari-Nejad, Alireza

2015-01-01

Background Persistent methamphetamine (METH) psychosis is a psychotic state beyond 1-month after abstinence, for which there is no effective treatment. This study aimed to evaluate the effectiveness of electroconvulsive therapy (ECT) in persistent METH psychosis patients hospitalized at Shahid Beheshti Hospital, Kerman, Iran, from 6 September 2012 until 6 September 2013, who were not remitted after treatment with olanzapine. Methods This research was a pilot study on hospitalized patients. After 4 weeks of treatment with olanzapine, 10 out of 71 studied patients did not show complete remission of psychotic symptoms despite their response to the treatment. The mentioned 10 patients were divided into 2 groups by random digit numbers. 5 patients had continued olanzapine and other 5 received 6 sessions of bilateral ECT every other day in addition to olanzapine. Findings Remission rate of patients in the initial 4 weeks was 78.7%. Reduction in total brief psychiatric rating scale (BPRS) scale at the end of 1-week compared with the next week demonstrated improvement in the symptoms until the end of the study. There was no significant difference in BPRS scores between weeks 4 and 6 in the two groups. Conclusion This research demonstrated that few sessions of ECT in persistent METH psychosis will not lead to remission in all patients. PMID:26322206

Development of Occupational Therapy Proficiency Examinations. Therapist Level, Assistant Level. Final Report.

ERIC Educational Resources Information Center

Professional Examination Service, New York, NY.

Criterion-referenced proficiency examinations have been prepared for entry level occupational therapists and entry level occupational therapy assistants. Item development was based on a task inventory solicited from occupational therapists throughout the country, with six occupational therapists reviewing test development. A small scale pilot test…

A brief survey of patients' first impression after CPAP titration predicts future CPAP adherence: a pilot study.

PubMed

Balachandran, Jay S; Yu, Xiaohong; Wroblewski, Kristen; Mokhlesi, Babak

2013-03-15

CPAP adherence patterns are often established very early in the course of therapy. Our objective was to quantify patients' perception of CPAP therapy using a 6-item questionnaire administered in the morning following CPAP titration. We hypothesized that questionnaire responses would independently predict CPAP adherence during the first 30 days of therapy. We retrospectively reviewed the CPAP perception questionnaires of 403 CPAP-naïve adults who underwent in-laboratory titration and who had daily CPAP adherence data available for the first 30 days of therapy. Responses to the CPAP perception questionnaire were analyzed for their association with mean CPAP adherence and with changes in daily CPAP adherence over 30 days. Patients were aged 52 ± 14 years, 53% were women, 54% were African American, the mean body mass index (BMI) was 36.3 ± 9.1 kg/m(2), and most patients had moderate-severe OSA. Four of 6 items from the CPAP perception questionnaire- regarding difficulty tolerating CPAP, discomfort with CPAP pressure, likelihood of wearing CPAP, and perceived health benefit-were significantly correlated with mean 30-day CPAP adherence, and a composite score from these 4 questions was found to be internally consistent. Stepwise linear regression modeling demonstrated that 3 variables were significant and independent predictors of reduced mean CPAP adherence: worse score on the 4-item questionnaire, African American race, and non-sleep specialist ordering polysomnogram and CPAP therapy. Furthermore, a worse score on the 4-item CPAP perception questionnaire was consistently associated with decreased mean daily CPAP adherence over the first 30 days of therapy. In this pilot study, responses to a 4-item CPAP perception questionnaire administered to patients immediately following CPAP titration independently predicted mean CPAP adherence during the first 30 days. Further prospective validation of this questionnaire in different patient populations is warranted.

A Pilot RCT of Psychodynamic Group Art Therapy for Patients in Acute Psychotic Episodes: Feasibility, Impact on Symptoms and Mentalising Capacity

PubMed Central

Montag, Christiane; Haase, Laura; Seidel, Dorothea; Bayerl, Martin; Gallinat, Jürgen; Herrmann, Uwe; Dannecker, Karin

2014-01-01

This pilot study aimed to evaluate the feasibility of an assessor-blind, randomised controlled trial of psychodynamic art therapy for the treatment of patients with schizophrenia, and to generate preliminary data on the efficacy of this intervention during acute psychotic episodes. Fifty-eight inpatients with DSM-diagnoses of schizophrenia were randomised to either 12 twice-weekly sessions of psychodynamic group art therapy plus treatment as usual or to standard treatment alone. Primary outcome criteria were positive and negative psychotic and depressive symptoms as well as global assessment of functioning. Secondary outcomes were mentalising function, estimated with the Reading the mind in the eyes test and the Levels of emotional awareness scale, self-efficacy, locus of control, quality of life and satisfaction with care. Assessments were made at baseline, at post-treatment and at 12 weeks' follow-up. At 12 weeks, 55% of patients randomised to art therapy, and 66% of patients receiving treatment as usual were examined. In the per-protocol sample, art therapy was associated with a significantly greater mean reduction of positive symptoms and improved psychosocial functioning at post-treatment and follow-up, and with a greater mean reduction of negative symptoms at follow-up compared to standard treatment. The significant reduction of positive symptoms at post-treatment was maintained in an attempted intention-to-treat analysis. There were no group differences regarding depressive symptoms. Of secondary outcome parameters, patients in the art therapy group showed a significant improvement in levels of emotional awareness, and particularly in their ability to reflect about others' emotional mental states. This is one of the first randomised controlled trials on psychodynamic group art therapy for patients with acute psychotic episodes receiving hospital treatment. Results prove the feasibility of trials on art therapy during acute psychotic episodes and justify further research to substantiate preliminary positive results regarding symptom reduction and the recovery of mentalising function. Trial Registration ClinicalTrials.gov NCT01622166 PMID:25393414

A pilot RCT of psychodynamic group art therapy for patients in acute psychotic episodes: feasibility, impact on symptoms and mentalising capacity.

PubMed

Montag, Christiane; Haase, Laura; Seidel, Dorothea; Bayerl, Martin; Gallinat, Jürgen; Herrmann, Uwe; Dannecker, Karin

2014-01-01

This pilot study aimed to evaluate the feasibility of an assessor-blind, randomised controlled trial of psychodynamic art therapy for the treatment of patients with schizophrenia, and to generate preliminary data on the efficacy of this intervention during acute psychotic episodes. Fifty-eight inpatients with DSM-diagnoses of schizophrenia were randomised to either 12 twice-weekly sessions of psychodynamic group art therapy plus treatment as usual or to standard treatment alone. Primary outcome criteria were positive and negative psychotic and depressive symptoms as well as global assessment of functioning. Secondary outcomes were mentalising function, estimated with the Reading the mind in the eyes test and the Levels of emotional awareness scale, self-efficacy, locus of control, quality of life and satisfaction with care. Assessments were made at baseline, at post-treatment and at 12 weeks' follow-up. At 12 weeks, 55% of patients randomised to art therapy, and 66% of patients receiving treatment as usual were examined. In the per-protocol sample, art therapy was associated with a significantly greater mean reduction of positive symptoms and improved psychosocial functioning at post-treatment and follow-up, and with a greater mean reduction of negative symptoms at follow-up compared to standard treatment. The significant reduction of positive symptoms at post-treatment was maintained in an attempted intention-to-treat analysis. There were no group differences regarding depressive symptoms. Of secondary outcome parameters, patients in the art therapy group showed a significant improvement in levels of emotional awareness, and particularly in their ability to reflect about others' emotional mental states. This is one of the first randomised controlled trials on psychodynamic group art therapy for patients with acute psychotic episodes receiving hospital treatment. Results prove the feasibility of trials on art therapy during acute psychotic episodes and justify further research to substantiate preliminary positive results regarding symptom reduction and the recovery of mentalising function. ClinicalTrials.gov NCT01622166.

Virtual reality for upper extremity rehabilitation in early stroke: a pilot randomized controlled trial.

PubMed

Yin, Chan Wai; Sien, Ng Yee; Ying, Low Ai; Chung, Stephanie Fook-Chong Man; Tan May Leng, Dawn

2014-11-01

To investigate the effect of virtual reality (VR) rehabilitation on upper extremity motor performance of patients with early stroke. Pilot randomized controlled trial. Rehabilitation wards. Twenty three adults with stroke (mean age (SD) = 58.35 (13.45) years and mean time since stroke (SD) = 16.30 (7.44) days). Participants were randomly assigned to VR group (n=11) or control group (n=12). VR group received nine 30 minutes upper extremity VR therapy in standing (five weekdays in two weeks) plus conventional therapy, which included physical and occupational therapy. Control group received only conventional therapy, which was comparable to total training time received by VR group (mean training hours (SD):VR = 17.07 (2.86); control = 15.50 (2.79)). The main outcome measure was the Fugl-Meyer Assessment (FMA). Secondary outcomes included Action Research Arm Test, Motor Activity Log and Functional Independence Measure. Results were taken at baseline, post intervention and 1-month post intervention. Participants' feedback and adverse effects were recorded. All participants improved in FMA scores (mean change (SD) = 11.65 (8.56), P<.001). These effects were sustained at one month after intervention (mean (SD) change from baseline = 18.67 (13.26), P<.001). All other outcome measures showed similar patterns. There were no significant differences in improvement between both groups. Majority of the participants found VR training useful and enjoyable, with no serious adverse effects reported. Although additional VR training was not superior to conventional therapy alone, this study demonstrates the feasibility of VR training in early stroke. © The Author(s) 2014.

Feasibility and acceptability of two incentive-based implementation strategies for mental health therapists implementing cognitive-behavioral therapy: a pilot study to inform a randomized controlled trial.

PubMed

Beidas, Rinad S; Becker-Haimes, Emily M; Adams, Danielle R; Skriner, Laura; Stewart, Rebecca E; Wolk, Courtney Benjamin; Buttenheim, Alison M; Williams, Nathaniel J; Inacker, Patricia; Richey, Elizabeth; Marcus, Steven C

2017-12-15

Informed by our prior work indicating that therapists do not feel recognized or rewarded for implementation of evidence-based practices, we tested the feasibility and acceptability of two incentive-based implementation strategies that seek to improve therapist adherence to cognitive-behavioral therapy for youth, an evidence-based practice. This study was conducted over 6 weeks in two community mental health agencies with therapists (n = 11) and leaders (n = 4). Therapists were randomized to receive either a financial or social incentive if they achieved a predetermined criterion on adherence to cognitive-behavioral therapy. In the first intervention period (block 1; 2 weeks), therapists received the reward they were initially randomized to if they achieved criterion. In the second intervention period (block 2; 2 weeks), therapists received both rewards if they achieved criterion. Therapists recorded 41 sessions across 15 unique clients over the project period. Primary outcomes included feasibility and acceptability. Feasibility was assessed quantitatively. Fifteen semi-structured interviews were conducted with therapists and leaders to assess acceptability. Difference in therapist adherence by condition was examined as an exploratory outcome. Adherence ratings were ascertained using an established and validated observational coding system of cognitive-behavioral therapy. Both implementation strategies were feasible and acceptable-however, modifications to study design for the larger trial will be necessary based on participant feedback. With respect to our exploratory analysis, we found a trend suggesting the financial reward may have had a more robust effect on therapist adherence than the social reward. Incentive-based implementation strategies can be feasibly administered in community mental health agencies with good acceptability, although iterative pilot work is essential. Larger, fully powered trials are needed to compare the effectiveness of implementation strategies to incentivize and enhance therapists' adherence to evidence-based practices such as cognitive-behavioral therapy.

Dual Therapy with Aspirin and Cilostazol May Improve Platelet Aggregation in Noncardioembolic Stroke Patients: A Pilot Study.

PubMed

Ohnuki, Yoichi; Ohnuki, Yuko; Kohara, Saori; Shimizu, Mie; Takizawa, Shunya

2017-01-01

Objective Some previous studies have found clinical benefit of dual antiplatelet therapy with aspirin and cilostazol for prevention of secondary stroke, but the physiological mechanism involved remains unknown. We aimed to clarify the effects of aspirin/cilostazol therapy on the platelet and endothelial functions of patients with acute noncardioembolic ischemic stroke, in comparison to patients who were treated with aspirin alone. Methods The present randomized prospective pilot study enrolled 24 patients within a week after the onset of noncardioembolic ischemic stroke. The patients were randomly allocated to receive aspirin (100 mg/day) (A group; 11 patients) or cilostazol (200 mg/day) plus aspirin (100 mg/day) (CA group; 13 patients). We measured platelet aggregation, platelet activation, and the thrombomodulin (TM), highly sensitive C-reactive protein (hs-CRP), intercellular adhesion molecule-1 (ICAM-1), vascular cell adhesion molecule-1 (VCAM-1) and von Willebrand (vWF) antigen levels and vWF activity over a 4-week period after enrollment. Results There was no significant difference in the platelet functions of the A and CA groups. However, the platelet aggregation induced by adenosine diphosphate (ADP) was decreased at 2 and 4 weeks (p<0.05) after treatment in comparison to the pre-treatment values in the CA group, but not in the A group. Platelet activation, and the hs-CRP, TM, ICAM-1, VCAM-1 and vWF values did not significantly decrease after treatment in either group. Conclusion Although there were no significant differences in platelet aggregation, platelet activation or the endothelial biomarker levels of the A and CA groups, dual therapy with aspirin and cilostazol inhibited platelet aggregation in comparison to the pre-treatment values, similarly to patients who received aspirin alone. This may suggest the clinical usefulness of dual therapy with aspirin and cilostazol in the treatment of patients with noncardioembolic ischemic stroke.

Pilot Trial of Inpatient Cognitive Therapy for the Prevention of Suicide in Military Personnel with Acute Stress Disorder or Post-Traumatic Stress Disorder

DTIC Science & Technology

2010-08-01

Therapy (PACT) as a targeted inpatient treatment for individuals admitted for a recent suicide attempt to a military hospital . (2) To assess the... therapy (PACT). Invited presentation at the Department of Defense Suicide Prevention Research Program Working Group, Frederick, MD. Martin, J. S ...depressed and anxious outpatients. Cognitive Behaviour Therapy , 36, 170-178. Bhar, S ., Ghahramanlou-Holloway, M., Brown, G., & Beck, A. T. (2008). Self

NHLBI's program for VAD therapy for moderately advanced heart failure: the REVIVE-IT pilot trial.

PubMed

Baldwin, J Timothy; Mann, Douglas L

2010-11-01

Ventricular assist devices (VADs) are used to bridge heart failure patients to transplantation, to allow their own hearts to recover, or as permanent ("destination") therapy. To date, the use of VADs has been limited to late-stage heart failure patients because of the associated device risks. In 2008, a National Heart, Lung, and Blood Institute (NHLBI) working group met to evaluate the treatment of heart failure using VADs and to advise the institute on how therapy for heart failure may be best advanced by clinical trials involving the devices. Recognizing the improvements in VAD technology and in patient care and selection over the past decade, the working group recommended that a trial be performed to assess the use of chronic VAD therapy in patients who are less ill than those currently eligible for destination therapy. The hypothesis proposed for the trial is that VAD therapy may improve both survival and quality of life in moderately advanced heart failure patients who are neither inotrope-dependent nor exercise-intolerant and have not yet developed serious consequences such as malnourishment, end-organ damage, and immobility. Based on the group's recommendations, NHLBI issued an RFP in 2009 for the REVIVE-IT Pilot Trail, which will serve to test the hypothesis and inform the pivotal trial. Published by Elsevier Inc.

NHLBI’s Program for VAD Therapy for Moderately Advanced Heart Failure: The REVIVE-IT Pilot Trial

PubMed Central

Baldwin, J. Timothy; Mann, Douglas L.

2010-01-01

Background VADs are used to bridge heart failure patients to transplantation, to allow their own hearts to recover, or as permanent (“destination”) therapy. To date, the use of VADs has been limited to late-stage heart failure patients because of the associated device risks. In 2008, an NHLBI working group met to evaluate the treatment of heart failure using VADs and to advise the institute on how therapy for heart failure may be best advanced by clinical trials involving the devices. Discussion and Recommendations Recognizing the improvements in VAD technology and in patient care and selection over the past decade, the working group recommended that a trial be performed to assess the use of chronic VAD therapy in patients who are less ill than those currently eligible for destination therapy. The hypothesis proposed for the trial is that VAD therapy may improve both survival and quality of life in moderately advanced heart failure patients who are neither inotrope-dependent nor exercise-intolerant and have not yet developed serious consequences such as malnourishment, end-organ damage, and immobility. Based on the group’s recommendations, NHLBI issued an RFP in 2009 for the REVIVE-IT Pilot Trail which will serve to test the hypothesis and inform the pivotal trial. PMID:21055648

A Controlled Pilot Trial of PainTracker Self-Manager, a Web-Based Platform Combined With Patient Coaching, to Support Patients' Self-Management of Chronic Pain.

PubMed

Sullivan, Mark; Langford, Dale J; Davies, Pamela Stitzlein; Tran, Christine; Vilardaga, Roger; Cheung, Gifford; Yoo, Daisy; McReynolds, Justin; Lober, William B; Tauben, David; Vowles, Kevin E

2018-03-29

The objective of this study was to develop and pilot test a chronic pain empowerment and self-management platform, derived from acceptance and commitment therapy, in a pain specialty setting. A controlled, sequential, nonrandomized study design was used to accommodate intervention development and to test the efficacy of the PainTracker Self-Manager (PTSM) intervention (Web-based educational modules and outcome tracking combined with tailored patient coaching sessions and provider guidance). Generalized estimating equations evaluated changes over time (baseline, 3 months, 6 months) in pain self-efficacy (primary outcome), chronic pain acceptance (activity engagement and pain willingness), perceived efficacy in patient-provider interactions, pain intensity and interference, and overall satisfaction with pain treatment (secondary outcomes) between intervention (n = 48) and usual care control groups (n = 51). The full study sample (N = 99) showed greater improvements over time (significant Group × Time interactions) in pain self-efficacy and satisfaction with pain treatment. Among study completers (n = 82), greater improvement in activity engagement as well as pain intensity and interference were also observed. These preliminary findings support the efficacy of the PTSM intervention in a pain specialty setting. Further research is needed to refine and expand the PTSM intervention and to test it in a randomized trial in primary care settings. We developed a Web-based patient empowerment platform that combined acceptance and commitment therapy-based educational modules and tailored coaching sessions with longitudinal tracking of treatments and patient-reported outcomes, named PTSM. Pilot controlled trial results provide preliminary support for its efficacy in improving pain self-efficacy, activity engagement, pain intensity and interference, and satisfaction with pain treatment. Copyright © 2018 The American Pain Society. Published by Elsevier Inc. All rights reserved.

A Randomized, Placebo-Controlled Pilot Study of Quetiapine-XR Monotherapy or Adjunctive Therapy to Antidepressant in Acute Major Depressive Disorder with Current Generalized Anxiety Disorder.

PubMed

Li, Ranran; Wu, Renrong; Chen, Jun; Kemp, David E; Ren, Ming; Conroy, Carla; Chan, Philip; Serrano, Mary Beth; Ganocy, Stephen J; Calabrese, Joseph R; Gao, Keming

2016-03-01

To pilot efficacy and safety data of quetiapine-XR monotherapy or adjunctive therapy to antidepressant(s) in the acute treatment of MDD with current generalized anxiety disorder (GAD). The Mini International Neuropsychiatric Interview was used to ascertain the diagnosis of DSM-IV Axis I disorders. Eligible patients were randomly assigned to quetiapine-XR or placebo for up to 8 weeks. Changes from baseline to endpoint in Hamilton Depression Rating Scale-17 items (HAMD-17), Hamilton Anxiety Rating Scale (HAM-A), Clinical Global Impression-Severity (CGI-S), Quick Inventory of Depression Symptomatology-16 items Self-Report (QIDS-16-SR) total scores, and other outcome measures were analyzed with the last observation carried forward strategy and/or mixed-effects modeling for repeated measures. Of the 34 patients screened, 23 patients were randomized to receive quetiapine-XR (n = 11) or placebo (n = 12), with 5 and 4 completing the study, respectively. The mean dose of quetiapine-XR was 154 ± 91 mg/d. The change from baseline to endpoint in the total scores of HAMD-17, HAM-A, QIDS-16-SR, and CGI-S were significant in the quetiapine-XR group, but only the change in HAM-A total score was significant in the placebo group. The differences in these changes between the two groups were only significant in CGI-S scores, with the rest of numerical larger in the quetiapine-XR group. The most common side effects from quetiapine-XR were dry mouth, somnolence/sedation, and fatigue. In this pilot study, quetiapine-XR was numerically superior to placebo in reducing depressive and anxiety symptoms in patients with MDD and current GAD. Large sample studies are warranted to support or refute these preliminary findings.

The development and feasibility of an online aphasia group intervention and networking program - TeleGAIN.

PubMed

Pitt, Rachelle; Theodoros, Deborah; Hill, Anne J; Russell, Trevor

2017-09-04

Aphasia group therapy offers many benefits, however people with aphasia report difficulty accessing groups and speech-language pathologists are faced with many challenges in providing aphasia group therapy. Telerehabilitation may offer an alternative service delivery option. An online aphasia group therapy program - Telerehabilitation Group Aphasia Intervention and Networking (TeleGAIN) - has been developed according to the guidelines of the Medical Research Council (MRC) framework for complex interventions. The purpose of this paper is to describe the development of TeleGAIN and the results of a pilot trial to determine feasibility and acceptability. The development of TeleGAIN was informed through literature reviews in relevant topic areas, consideration of expert opinion and application of the social cognitive theory. TeleGAIN was then modelled through a feasibility pilot trial with four people with aphasia. TeleGAIN appeared to be feasible and acceptable to participants and able to be implemented as planned. Participant satisfaction with treatment was high and results suggested some potential for improvements in language functioning and communication-related quality of life. TeleGAIN appeared to be feasible and acceptable, however the study highlighted issues related to technology, clinical implementation and participant-specific factors that should be addressed prior to a larger trial.

Effects of animal-assisted therapy on behavioral and/or psychological symptoms in dementia: a case report.

PubMed

Nordgren, Lena; Engström, Gabriella

2012-12-01

Recently, interest in nonpharmaceutical interventions in dementia care has increased. Animal-assisted therapy has been shown to be one promising intervention but more knowledge is needed. The present article reports on a pilot study involving an 84-year-old woman with vascular dementia who was systematically trained with a therapy dog team for 8 weeks. A quasi-experimental longitudinal interventional design with pre-post measures was used. Data were collected on 3 occasions. Descriptive statistics were used for data analysis. Some effects on the woman's ability to walk and move were identified. In addition, some effects in the woman's cognitive state were observed. Physical, psychological, and/or social training with certified therapy dog teams can have effects on behavioral and psychological symptoms in people living with dementia. Further research is needed.

Assessment of Haptic Interaction for Home-Based Physical Tele-Therapy using Wearable Devices and Depth Sensors.

PubMed

Barmpoutis, Angelos; Alzate, Jose; Beekhuizen, Samantha; Delgado, Horacio; Donaldson, Preston; Hall, Andrew; Lago, Charlie; Vidal, Kevin; Fox, Emily J

2016-01-01

In this paper a prototype system is presented for home-based physical tele-therapy using a wearable device for haptic feedback. The haptic feedback is generated as a sequence of vibratory cues from 8 vibrator motors equally spaced along an elastic wearable band. The motors guide the patients' movement as they perform a prescribed exercise routine in a way that replaces the physical therapists' haptic guidance in an unsupervised or remotely supervised home-based therapy session. A pilot study of 25 human subjects was performed that focused on: a) testing the capability of the system to guide the users in arbitrary motion paths in the space and b) comparing the motion of the users during typical physical therapy exercises with and without haptic-based guidance. The results demonstrate the efficacy of the proposed system.

Pharmaceutic factors affecting pediatric compliance.

PubMed

Mattar, M E; Markello, J; Yaffe, S J

1975-01-01

Evaluation of treatment given at home was studied in children with otitis media who were seen in an outpatient clinic. Full compliance was present in only 5% of the initial 100 patients (Study A). Practical factors limiting their compliance included inadequate dispensing of medication at drug stores, 15%; incorrect therapy schedule, 36%; early termination, 37%; spilled medicine, 7%; therapy shared, 5%. Because of these findings, a plan was implemented (Study B) in which hospital pharmacy personnel gave patient families verbal and written instructions for administering medications that were dispensed, together with a calibrated measuring device and a calendar to record doses taken. Full compliance was raised to 51% in this pilot group (of 33 patients) as compared with 8.5% in 20 concurrent controls who went to neighborhood drug stores. The importance of detailed therapy instructions is stressed. The potential role of the pharmacist in improving compliance is demonstrated.

Patients' quality of life after stopping plasma exchange: a pilot study.

PubMed

Dahlan, Randah; McCormick, Brendan B; Alkhattabi, Maan; Gallo, Kerri; Clark, William F; Rock, Gail

2014-10-01

Plasma exchange is being widely used to treat various serious medical conditions. There has been very little follow-up data to describe the quality of life (QOL) of plasma exchange-recipients after active plasma exchange has stopped. To assess the QOL of plasma exchange recipients after stopping plasma exchange. A pilot study, based on responses to a postal questionnaire and clinical data obtained from the patients' charts, was carried out. The scores were computed from questionnaire responses and analyzed. The response rate was 59% with 58 patients completing a questionnaire three months after their final plasma exchange therapy. We identified significant heterogeneity in the quality of life of plasma exchange recipients after stopping plasma exchange therapy. This could be driven by different patient co-morbidities. We recommend that during follow up visits, a multi-disciplinary approach including consultation with a social worker might be considered for patients who may continue to have some limitations in their psychosocial activities post-discontinuation of plasma exchange. The high response rate to the questionnaire indicates that PLEX patients are interested in being involved in QOL studies, which suggests potential support for a prospective study of QOL with pre and post questionnaires and more detailed tracking of baseline co-morbidities. Copyright © 2014 Elsevier Ltd. All rights reserved.

Effectiveness of cognitive behavioral therapy based on the pain sustainment/exacerbation model in patients with tension-type headache: a pilot study.

PubMed

Motoya, Ryo; Oda, Keiko; Ito, Eiji; Ichikawa, Masahiro; Sato, Taku; Watanabe, Tadashi; Sakuma, Jun; Saito, Kiyoshi; Niwa, Shin-Ichi; Yabe, Hirooki

2014-01-01

The purpose of this study was to carry out a program of Cognitive Behavioral Therapy (CBT) based on the pain sustainment/exacerbation model for tension-type headache (TTH) patients and to examine the effectiveness as a pilot study. The participants were 4 TTH patients who consulted the outpatient clinic of a university hospital. It consisted of 4 individualized sessions as CBT program (including psychological education, self-monitoring, relaxation technique, cognitive restricting and exposure), and a follow-up examination was carried out 1 month after its completion. The sessions, each of which was 60 minutes long, were executed at weekly intervals. As a result, the score of the Pain Catastrophizing Scale (PCS) decreased after program compared with before program in all patients. The score of escape/avoidance was also reduced at the post-program and follow-up (1 month later) compared with the score of pre-program in patients except Case 2, in whom the score was 0 throughout the study. The degree of the Headache Impact Test (HIT-6) improved by program and changed to "mild" or "none" in all participants. These findings show that in patients with TTH this short CBT program has effect on pain catastrophizing, escape/avoidance and daily disability.

Effectiveness of two modalities of physiotherapy in the treatment of haemophilic arthropathy of the ankle: a randomized pilot study.

PubMed

Cuesta-Barriuso, R; Gómez-Conesa, A; López-Pina, J-A

2014-01-01

Although different techniques of physiotherapy have been described for the treatment of haemophilic arthropathy (HA) of ankle, hardly any studies have been applied manual therapy or educational physiotherapy and home exercises. The aim of this study was to assess the effectiveness of manual therapy and educational physiotherapy in the treatment of HA of the ankle. Thirty-one patients with HA of the ankle with a mean age of 35.29 (SD: 12.877) years randomized to manual therapy group (n = 11), educational group (n = 10) and a control group (n = 10). The two physiotherapy programmes were one with manual therapy articular traction, passive stretching of the gastrocnemius muscles, and exercises for muscle strength and proprioception (MT group) and the other with educational sessions and home exercises (E group). The study lasted for 12 weeks. The treatment with manual therapy improved the gastrocnemius muscle circumference, and the pain of ankle (P < 0.05). Six months later, MT group still enjoyed improvement. In the educational group there were improvements, but not significant, in the measured variables. No patient had ankle haemarthrosis during the study. The treatment with manual therapy improved the circumference of gastrocnemius and lessened pain in the patients with haemophilic arthropathy of the ankle. © 2013 John Wiley & Sons Ltd.

Family adjustment across cultural groups in autistic spectrum disorders.

PubMed

Lobar, Sandra L

2014-01-01

This pilot ethnomethodological study examined perceptions of parents/caregivers of children diagnosed with autistic spectrum disorders concerning actions, norms, understandings, and assumptions related to adjustment to this chronic illness. The sample included 14 caregivers (75% Hispanic of various ethnic groups). Maximum variation sampling was used to compare participants on variables that were inductively derived via constant comparative methods of analysis. The following action categories emerged: "Seeking Diagnosis," "Engaging in Routines to Control behavior," "Finding Therapies (Types of Therapies)," "Finding School Accommodations," "Educating Others," "Rising to Challenges," and "Finding the Role of Spiritual and Religious Belief."

Impact of Bromocriptine-QR Therapy on Glycemic Control and Daily Insulin Requirement in Type 2 Diabetes Mellitus Subjects Whose Dysglycemia Is Poorly Controlled on High-Dose Insulin: A Pilot Study.

PubMed

Roe, Erin D; Chamarthi, Bindu; Raskin, Philip

2015-01-01

The concurrent use of a postprandial insulin sensitizing agent, such as bromocriptine-QR, a quick release formulation of bromocriptine, a dopamine D2 receptor agonist, may offer a strategy to improve glycemic control and limit/reduce insulin requirement in type 2 diabetes (T2DM) patients on high-dose insulin. This open label pilot study evaluated this potential utility of bromocriptine-QR. Ten T2DM subjects on metformin (1-2 gm/day) and high-dose (TDID ≥ 65 U/day) basal-bolus insulin were enrolled to receive once daily (morning) bromocriptine-QR (1.6-4.8 mg/day) for 24 weeks. Subjects with at least one postbaseline HbA1c measurement (N = 8) were analyzed for change from baseline HbA(1c), TDID, and postprandial glucose area under the curve of a four-hour mixed meal tolerance test (MMTT). Compared to the baseline, average HbA1c decreased 1.76% (9.74 ± 0.56 to 7.98 ± 0.36, P = 0.01), average TDID decreased 27% (199 ± 33 to 147 ± 31, P = 0.009), and MMTT AUC(60-240) decreased 32% (P = 0.04) over the treatment period. The decline in HbA(1c) and TDID was observed at 8 weeks and sustained over the remaining 16-week study duration. In this study, bromocriptine-QR therapy improved glycemic control and meal tolerance while reducing insulin requirement in T2DM subjects poorly controlled on high-dose insulin therapy.

Expanding stroke telerehabilitation services to rural veterans: a qualitative study on patient experiences using the robotic stroke therapy delivery and monitoring system program.

PubMed

Cherry, Colleen O'Brien; Chumbler, Neale R; Richards, Kimberly; Huff, Amber; Wu, David; Tilghman, Laura M; Butler, Andrew

2017-01-01

The present study reports on a robotic stroke therapy delivery and monitoring system intervention. The aims of this pilot implementation project were to determine participants' general impressions about the benefits and barriers of using robotic therapy devices for in-home rehabilitation. We used a qualitative study design employing ethnographic-based anthropological methods including direct observation of the in-home environment and in-depth semi-structured interviews with 10 users of the hand or foot robotic devices. Thematic analysis was conducted using an inductive approach. Participants reported positive experiences with the robotic stroke therapy delivery and monitoring system. Benefits included convenience, self-reported increased mobility, improved mood and an outlet for physical and mental tension and anxiety. Barriers to use were few and included difficulties with placing the device on the body, bulkiness of the monitor and modem connection problems. Telerehabilitation robotic devices can be used as a tool to extend effective, evidence-based and specialized rehabilitation services for upper and lower limb rehabilitation to rural Veterans with poor access to care. Implications for Rehabilitation Participants whose formal therapy services had ended either because they had exhausted their benefits or because traveling to outpatient therapy was too cumbersome due to distance were able to perform therapeutic activities in the home daily (or at least multiple times per week). Participants who were still receiving formal therapy services either in-home or in the clinic were able to perform therapeutic activities in the home on the days they were not attending/receiving formal therapy. Based on the feedback from these veterans and their caregivers, the manufacturing company is working on modifying the devices to be less cumbersome and more user-friendly (lighter-weight, more mobile, changing software, etc.), as well as more adaptable to participants' homes. Removing these specific barriers will potentially allow participants to utilize the device more easily and more frequently. Since participants expressed that they wished they could have the device in their homes longer than the 3-month usage period required for this pilot project, the project team is working on a proposal to extend this project to a wider area and the new paradigm would extend the usage period until the patient reaches a plateau in progress or no longer wants to use the device.

A Phase II randomised controlled trial assessing the feasibility, acceptability and potential effectiveness of Dignity Therapy for older people in care homes: Study protocol

PubMed Central

Hall, Sue; Chochinov, Harvey; Harding, Richard; Murray, Scott; Richardson, Alison; Higginson, Irene J

2009-01-01

Background Although most older people living in nursing homes die there, there is a dearth of robust evaluations of interventions to improve their end-of-life care. Residents usually have multiple health problems making them heavily reliant on staff for their care, which can erode their sense of dignity. Dignity Therapy has been developed to help promote dignity and reduce distress. It comprises a recorded interview, which is transcribed, edited then returned to the patient, who can bequeath it to people of their choosing. Piloting has suggested that Dignity Therapy is beneficial to people dying of cancer and their families. The aims of this study are to assess the feasibility, acceptability and potential effectiveness of Dignity Therapy to reduce psychological and spiritual distress in older people reaching the end of life in care homes, and to pilot the methods for a Phase III RCT. Methods/design A randomised controlled open-label trial. Sixty-four residents of care homes for older people are randomly allocated to one of two groups: (i) Intervention (Dignity Therapy offered in addition to any standard care), and (ii) Control group (standard care). Recipients of the "generativity" documents are asked their views on taking part in the study and the therapy. Both quantitative and qualitative outcomes are assessed in face-to-face interviews at baseline and at approximately one and eight weeks after the intervention (equivalent in the control group). The primary outcome is residents' sense of dignity (potential effectiveness) assessed by the Patient Dignity Inventory. Secondary outcomes for residents include depression, hopefulness and quality of life. In view of the relatively small sample size, quantitative analysis is mainly descriptive. The qualitative analysis uses the Framework method. Discussion Dignity Therapy is brief, can be done at the bedside and could help both patients and their families. This detailed exploratory research shows if it is feasible to offer Dignity Therapy to residents of care homes, whether it is acceptable to them, their families and care home staff, if it is likely to be effective, and determine whether a Phase III RCT is desirable. Trial registration Current Controlled Clinical Trials: ISRCTN37589515 PMID:19317898

Assessing the feasibility, acceptability and potential effectiveness of Dignity Therapy for people with advanced cancer referred to a hospital-based palliative care team: Study protocol

PubMed Central

Hall, Sue; Edmonds, Polly; Harding, Richard; Chochinov, Harvey; Higginson, Irene J

2009-01-01

Background Loss of dignity for people with advanced cancer is associated with high levels of psychological and spiritual distress and the loss of the will to live. Dignity Therapy is a brief psychotherapy, which has been developed to help promote dignity and reduce distress. It comprises a recorded interview, which is transcribed, edited then returned to the patient, who can bequeath it to people of their choosing. Piloting in Canada, Australia and the USA, has suggested that Dignity Therapy is beneficial to people with advanced cancer and their families. The aims of this study are to assess the feasibility, acceptability and potential effectiveness of Dignity Therapy to reduce psychological and spiritual distress in people with advanced cancer who have been referred to hospital-based palliative care teams in the UK, and to pilot the methods for a Phase III RCT. Design A randomised controlled open-label trial. Forty patients with advanced cancer are randomly allocated to one of two groups: (i) Intervention (Dignity Therapy offered in addition to any standard care), and (ii) Control group (standard care). Recipients of the 'generativity' documents are asked their views on taking part in the study and the therapy. Both quantitative and qualitative outcomes are assessed in face-to-face interviews at baseline and at approximately one and four weeks after the intervention (equivalent in the control group). The primary outcome is patients' sense of dignity (potential effectiveness) assessed by the Patient Dignity Inventory. Secondary outcomes for patients include distress, hopefulness and quality of life. In view of the relatively small sample size, quantitative analyses are mainly descriptive. The qualitative analysis uses the Framework method. Discussion Dignity Therapy is brief, can be delivered at the bedside and may help both patients and their families. This detailed exploratory research shows if it is feasible to offer Dignity Therapy to patients with advanced cancer, many of whom are likely to be in the terminal stage of their illness, whether it is acceptable to them and their families, if it is likely to be effective, and determine whether a Phase III RCT is desirable. Trial registration Current Controlled Clinical Trials: ISRCTN29868352 PMID:19445711

"Walkabout: Looking In, Looking Out": A Mindfulness-Based Art Therapy Program

ERIC Educational Resources Information Center

Peterson, Caroline

2015-01-01

This brief report describes a mindfulness-based art therapy (MBAT) intervention, "Walkabout: Looking In, Looking Out," which was piloted in 2010 and has since been offered at the Abramson Cancer Center at Pennsylvania Hospital in Philadelphia. The author adapted the original MBAT intervention using a walkabout conceptual model, which was…

Avatar-Based Therapy within Prison Settings: Pilot Evaluation

ERIC Educational Resources Information Center

van Rijn, Biljana; Cooper, Mick; Jackson, Andrew; Wild, Ciara

2017-01-01

The paper presents an introduction of a newly developed, avatar-based virtual reality therapy, as an addition to the therapeutic programme, within a therapeutic community prison in the UK. The participants had six group sessions facilitated by a counsellor. The aim of the project was to investigate whether this approach would improve mental health…

A Pilot Study of Seeking Safety Therapy with OEF/OIF Veterans

PubMed Central

Norman, Sonya B.; Wilkins, Kendall C.; Tapert, Susan F.; Lang, Ariel J.; Najavits, Lisa M.

2010-01-01

PTSD and substance use disorder (SUD) are highly prevalent among Veterans returning from Iraq and Afghanistan (Operation Enduring Freedom/Operation Iraqi Freedom; OEF/OIF). Seeking Safety (SS) is a cognitive-behavioral psychotherapy for co-occurring PTSD/SUD. This pilot study with fourteen male OEF/OIF Veterans suggests that SS may help to reduce alcohol use, PTSD, and depression in some participants at clinically significant levels, even when providing less than half of the full model. We emphasize several SS features as especially helpful: the case management component to help engage clients in further mental health and SUD care; offering PTSD as an entry point, and emphasis on community resources. Issues particular to Veterans include reintegration to civilian life and supporting Veterans’ connection with other Veterans. PMID:20464809

Low-dose aspirin in polycythaemia vera: a pilot study. Gruppo Italiano Studio Policitemia (GISP).

PubMed

1997-05-01

In this pilot study, aimed at exploring the feasibility of a large-scale trial of low-dose aspirin in polycythaemia vera (PV), 112 PV patients (42 females, 70 males. aged 17-80 years) were selected for not having a clear indication for, or contraindication to, aspirin treatment and randomized to receive oral aspirin (40 mg/d) or placebo. Follow-up duration was 16 +/- 6 months. Measurements of thromboxane A2 production during whole blood clotting demonstrated complete inhibition of platelet cyclooxygenase activity in patients receiving aspirin. Aspirin administration was not associated with any bleeding complication. Within the limitations of the small sample size, this study indicates that a biochemically effective regimen of antiplatelet therapy is well tolerated in patients with polycythaemia vera and that a large-scale placebo-controlled trial is feasible.

A Pilot Study of the DBT Coach: An Interactive Mobile Phone Application for Individuals with Borderline Personality Disorder and Substance Use Disorder

ERIC Educational Resources Information Center

Rizvi, Shireen L.; Dimeff, Linda A.; Skutch, Julie; Carroll, David; Linehan, Marsha M.

2011-01-01

Dialectical behavior therapy (DBT) has received strong empirical support and is practiced widely as a treatment for borderline personality disorder (BPD) and BPD with comorbid substance use disorders (BPD-SUD). Therapeutic success in DBT requires that individuals generalize newly acquired skills to their natural environment. However, there have…

Developmental Outcome in Five Children with Hurler Syndrome after Stem Cell Transplantation: A Pilot Study

ERIC Educational Resources Information Center

Lucke, Thomas; Das, Anibh M.; Hartmann, Hans; Sykora, Karl-Walter; Donnerstag, Frank; Schmid-Ott, Gerhard; Grigull, Lorenz

2007-01-01

Hurler syndrome (mucopolysaccharidosis type 1H; MPS1H) is a lysosomal storage disease caused by a deficiency of [alpha]-L-iduronidase activity. The natural course of this neurodegenerative disease inevitably leads to premature death within the first 10 years of life. Enzyme replacement therapy is effective in correcting the enzymatic deficiency of…

Extending supplementary feeding for children younger than 5 years with moderate acute malnutrition leads to lower relapse rates

USDA-ARS?s Scientific Manuscript database

Children with moderate acute malnutrition (MAM) have a high rate of relapse and death in the year following recovery. In this pilot study, we evaluate the long-term benefits of an extended course of nutritional therapy for children with MAM. Rural Malawian children 6 to 59 months old with MAM, defin...

Stepped and Standard Care for Childhood Trauma: A Pilot Randomized Clinical Trial

ERIC Educational Resources Information Center

Salloum, Alison; Small, Brent J.; Robst, John; Scheeringa, Michael S.; Cohen, Judith A.; Storch, Eric A.

2017-01-01

Objective: This study explored the feasibility of stepped care trauma-focused cognitive behavioral therapy (SC-TF-CBT) relative to TF-CBT with children (aged 8--12). Method: Children (N = 33) with post-traumatic stress symptoms (PTSS) were randomly assigned (2:1) to SC-TF-CBT or TF-CBT. SC-TF-CBT consisted of Step 1, parent-led therapist-assisted…

A Pilot Study of Telepractice for Teaching Listening and Spoken Language to Mandarin-Speaking Children with Congenital Hearing Loss

ERIC Educational Resources Information Center

Chen, Pei-Hua; Liu, Ting-Wei

2017-01-01

Telepractice provides an alternative form of auditory-verbal therapy (eAVT) intervention through videoconferencing; this can be of immense benefit for children with hearing loss, especially those living in rural or remote areas. The effectiveness of eAVT for the language development of Mandarin-speaking preschoolers with hearing loss was…

Development of a Therapists' Self-Report Measure of Pluralistic Thought and Practice: The Therapy Pluralism Inventory

ERIC Educational Resources Information Center

Thompson, Allison; Cooper, Mick; Pauli, Regina

2017-01-01

This study aimed to develop a self-report measure of pluralistic thought and practice. Following pilot development, a 23-item inventory was placed on an online survey site, and 474 participants satisfactorily completed the measure. Respondents were trainee or qualified therapists, predominantly female, based in the UK, and of a humanistic or…

Outcome Measurement Using Naturalistic Language Samples: A Feasibility Pilot Study Using Language Transcription Software and Speech and Language Therapy Assistants

ERIC Educational Resources Information Center

Overton, Sarah; Wren, Yvonne

2014-01-01

The ultimate aim of intervention for children with language impairment is an improvement in their functional language skills. Baseline and outcome measurement of this is often problematic however and practitioners commonly resort to using formal assessments that may not adequately reflect the child's competence. Language sampling,…

Can a Targeted, Group-Based CBT Intervention Reduce Depression and Anxiety and Improve Self-Concept in Primary-Age Children?

ERIC Educational Resources Information Center

O'Callaghan, Paul; Cunningham, Enda

2015-01-01

This pilot study examined the impact of a 10 session, group-based, early-intervention cognitive behavioural therapy (CBT) programme (Cool Connections) on anxiety, depression and self-concept in nine 8-11 year old pupils in Northern Ireland. The intervention was facilitated by a teacher, education welfare officer and two classroom assistants, with…

Effects of Dog-Assisted Therapy on Communication and Basic Social Skills of Adults with Intellectual Disabilities: A Pilot Study

ERIC Educational Resources Information Center

Scorzato, Ivano; Zaninotto, Leonardo; Romano, Michela; Menardi, Chiara; Cavedon, Lino; Pegoraro, Alessandra; Socche, Laura; Zanetti, Piera; Coppiello, Deborah

2017-01-01

Thirty-nine adults with severe to profound intellectual disability (ID) were randomly assigned to either an experimental group (n = 21) or a control group (n = 18). Assessment was blinded and included selected items from the International Classification of Functioning, Disability and Health (ICF), the Behavioral Assessment Battery (BAB), and the…

Propofol interruption of ECT seizure to reduce side-effects: a pilot study.

PubMed

Warnell, Ronald L; Swartz, Conrad M; Thomson, Alice

2010-01-30

Fifteen depressed subjects received six bitemporal electroconvulsive therapy (ECT) treatments under etomidate anesthesia. They were randomized to blindly either receive propofol 0.5mg/kg 15s post-stimulus or not. Propofol infusion significantly prevented long seizures, and prevented cognitive decrements in most neuropsychological tests, several significantly. Propofol interruption may clinically help reduce ECT side-effects.

A Pilot Study of Cognitive-Behavioral Therapy of Insomnia in People with Mild Depression

ERIC Educational Resources Information Center

Taylor, Daniel J.; Lichstein, Kenneth L.; Weinstock, Jeremiah; Sanford, Stacy; Temple, Jeff R.

2007-01-01

In some cases, insomnia and depression may have a reciprocal relationship, in which each aggravates and maintains the other. To test the hypothesis that reduction of insomnia would result in reduction of depression in patients (N=10) with both disorders, a repeated-measures design was used comparing depression and insomnia levels before and after…

A randomized, open-label pilot of the combination of low-level laser therapy and lorcaserin for weight loss.

PubMed

Croghan, Ivana T; Ebbert, Jon O; Schroeder, Darrell R; Hurt, Ryan T; Hagstrom, Victoria; Clark, Matthew M

2016-01-01

Obesity is a significant public health problem and innovative treatments are needed. The purpose of this pilot study was to assess the preliminary efficacy and safety of a combined treatment of low-level laser therapy (LLLT) and lorcaserin on weight loss, health quality of life (QOL) measures, and cardiovascular risk factors. Forty-five overweight and obese adult participants with a body mass index (BMI) >26.9 and <40 were randomized to receive LLLT, lorcaserin, or a combination of the two therapies. All study participants received treatment for 3 months and were followed for 3 months post-treatment. Participants were recruited from June 2014 through September 2014. The majority of the 44 participants accrued to this study were female (84 %) with an average age of 43.9 years (range 22 to 64 years). Most participants (93 % LLLT alone, 87 % LLLT + lorcaserin) completed at least 80 % of the LLLT treatments. From baseline to end of treatment, significant reductions in waist circumference were noted for each treatment group (-2.3 ± 4.1 cm, -6.0 ± 7.3 cm, and -4.0 ± 5.5 cm for LLLT, lorcaserin and combination respectively); however, the reduction in body weight was only significant in those receiving lorcaserin and combination treatment (-0.4 ± 1.5 kg, -1.3 ± 1.2 kg and -1.3 ± 1.3 kg). No significant differences were noted between the groups. Self-reported satisfaction was higher in the lorcaserin versus the LLLT group. This small pilot demonstrates that when combined with behavioral intervention, Lorcaserin and LLLT may be effective components of a comprehensive approach to the treatment of overweight and obesity in the clinical setting. Further studies with larger sample size and longer duration of treatment and follow-up are needed to further address efficacy. Trial registration: NCT02129608. Registered June 15, 2014.

A pilot study on the effectiveness of anticipatory grief therapy for elderly facing the end of life.

PubMed

Cheng, Joanna Oi-Yue; Lo, Raymond; Chan, Faye; Woo, Jean

2010-01-01

This pilot study evaluates the benefits of anticipatory grief therapy (AGT) for day hospice patients and long-term care (LTC) residents with cancer and non-malignant chronic diseases. Twenty-six elderly people (69.2 percent female; average age 81.8 years) participated in experiential, expressive activities and discussions during AGT. The McGill Quality of Life Questionnaire-Hong Kong version and the 15-item Geriatrics Depression Scale (Chinese version) were administered immediately before and after AGT, and at a four-week follow-up. Focus groups were held to collect qualitative feedback. Significant post-AGT improvements were found in physical (Z = -2.12, p < 0.05), psychological (Z = -2.22, p < 0.05), and total quality of life measures (Z = -2.66, p < 0.01), and in depression levels (Z = -2.49, p < 0.05). Emergent qualitative themes included grief and existential concerns, pros and cons of reminiscence, reflection and affirmation of meaning through expressive art, perceived benefits of AGT, and comments and suggestions for improving AGT in the future. We conclude that AGT delivered in both day hospice and LTC settings could be acceptable, feasible, and useful for elderly people facing the end of life.

"We're All in the Same Boat": A Review of the Benefits of Dragon Boat Racing for Women Living with Breast Cancer.

PubMed

Harris, Susan R

2012-01-01

This narrative review summarizes findings from quantitative and qualitative research literature that has been published over the past 15 years since an initial, community-based pilot study first challenged the long-held medical belief that vigorous, upper-body exercise would lead to lymphedema in women who were at risk due to treatments for breast cancer. Dragon boat racing originated in China more than 2000 years ago and has become a popular recreational and competitive support around the world. From the advent of the world's first breast cancer survivor dragon boat team, Abreast in a Boat launched in Vancouver, British Columbia, in 1996, there are now more than 140 breast cancer survivor dragon boat teams paddling and competing in 12 different countries. The wealth of quantitative and qualitative research that has ensued since that pilot study further supports the initial hypothesis that resistance exercise, for example, dragon boat paddling, is not only safe for women recovering from conventional breast cancer therapies but also shows that dragon boating has been embraced as a complementary exercise therapy by the cancer survivors participating in this magical sport.

Metabolic impact of switching antipsychotic therapy to aripiprazole after weight gain: a pilot study.

PubMed

Kim, Sun H; Ivanova, Oxana; Abbasi, Fahim A; Lamendola, Cindy A; Reaven, Gerald M; Glick, Ira D

2007-08-01

Switching antipsychotic regimen to agents with low weight gain potential has been suggested in patients who gain excessive weight on their antipsychotic therapy. In an open-label pilot study, we evaluated the metabolic and psychiatric efficacy of switching to aripiprazole in 15 (9 men, 6 women) outpatients with schizophrenia who had gained at least 10 kg on their previous antipsychotic regimen. Individuals had evaluation of glucose tolerance, insulin resistance (insulin suppression test), lipid concentrations, and psychiatric status before and after switching to aripiprazole for 4 months. A third of the individuals could not psychiatrically tolerate switching to aripiprazole. In the remaining individuals, psychiatric symptoms significantly improved with decline in Clinical Global Impression Scale (by 26%, P = 0.015) and Positive and Negative Syndrome Scale (by 22%, P = 0.023). Switching to aripiprazole did not alter weight or metabolic outcomes (fasting glucose, insulin resistance, and lipid concentrations) in the patients of whom 73% were insulin resistant and 47% had impaired or diabetic glucose tolerance at baseline. In conclusion, switching to aripiprazole alone does not ameliorate the highly prevalent metabolic abnormalities in the schizophrenia population who have gained weight on other second generation antipsychotic medications.

A pilot study of telephone cognitive-behavioural therapy for obsessive-compulsive disorder in young people.

PubMed

Turner, Cynthia; Heyman, Isobel; Futh, Annabel; Lovell, Karina

2009-07-01

Cognitive-behaviour therapy (CBT) is the recommended psychological treatment for obsessive compulsive disorder (OCD) in young people. Access to CBT may be limited by a number of factors, including lack of trained therapists, and geographic or financial factors preventing access to a specialized service. Telephone delivery of CBT represents one way of overcoming some of these accessibility issues. This pilot study describes outcomes for a telephone-based cognitive-behavioural treatment for obsessive-compulsive disorder (OCD) in young people. Ten participants, aged 13 to 17 years, and their parents received up to 16 sessions of telephone CBT (TCBT). Measures of OCD symptoms were obtained using multiple informants and a repeated measures design. Assessments were conducted at pre-treatment, post-treatment, and at 6- and 12-month follow-up. Improvements were found for OCD symptoms across all informants. Family satisfaction with treatment over the telephone was high. The findings suggest that TCBT is a clinically effective, feasible and acceptable means of service delivery that offers the potential to make CBT a more accessible treatment for young people. TCBT requires further evaluation in randomized, controlled trials to compare effectiveness with face-to-face CBT, which currently represents the usual care model.

Competence feedback improves CBT competence in trainee therapists: A randomized controlled pilot study.

PubMed

Weck, Florian; Kaufmann, Yvonne M; Höfling, Volkmar

2017-07-01

The development and improvement of therapeutic competencies are central aims in psychotherapy training; however, little is known about which training interventions are suitable for the improvement of competencies. In the current pilot study, the efficacy of feedback regarding therapeutic competencies was investigated in cognitive behavioural therapy (CBT). Totally 19 trainee therapists and 19 patients were allocated randomly to a competence feedback group (CFG) or control group (CG). Two experienced clinicians and feedback providers who were blind to the treatment conditions independently evaluated therapeutic competencies on the Cognitive Therapy Scale at five treatment times (i.e., at Sessions 1, 5, 9, 13, and 17). Whereas CFG and CG included regular supervision, only therapists in the CFG additionally received written qualitative and quantitative feedback regarding their demonstrated competencies in conducting CBT during treatment. We found a significant Time × Group interaction effect (η² = .09), which indicates a larger competence increase in the CFG in comparison to the CG. Competence feedback was demonstrated to be suitable for the improvement of therapeutic competencies in CBT. These findings may have important implications for psychotherapy training, clinical practice, and psychotherapy research. However, further research is necessary to ensure the replicability and generalizability of the findings.

Potential determinants of efficacy of mirror therapy in stroke patients--A pilot study.

PubMed

Brunetti, Maddalena; Morkisch, Nadine; Fritzsch, Claire; Mehnert, Jan; Steinbrink, Jens; Niedeggen, Michael; Dohle, Christian

2015-01-01

Mirror therapy (MT) was found to improve motor function after stroke. However, there is high variability between patients regarding motor recovery. The following pilot study was designed to identify potential factors determining this variability between patients with severe upper limb paresis, receiving MT. Eleven sub-acute stroke patients with severe upper limb paresis participated, receiving in-patient rehabilitation. After a set of pre-assessments (including measurement of brain activity at the primary motor cortex and precuneus during the mirror illusion, using near-infrared spectroscopy as described previously), four weeks of MT were applied, followed by a set of post-assessments. Discriminant group analysis for MT responders and non-responders was performed. Six out of eleven patients were defined as responders and five as non-responders on the basis of their functional motor improvement. The initial motor function and the activity shift in both precunei (mirror index) were found to discriminate significantly between responders and non-responders. In line with earlier results, initial motor function was confirmed as crucial determinant of motor recovery. Additionally, activity response to the mirror illusion in both precunei was found to be a candidate for determination of the efficacy of MT.

The effects of very early mirror therapy on functional improvement of the upper extremity in acute stroke patients.

PubMed

Yeldan, Ipek; Huseyınsınoglu, Burcu Ersoz; Akıncı, Buket; Tarakcı, Ela; Baybas, Sevim; Ozdıncler, Arzu Razak

2015-11-01

[Purpose] The aim of the study was to evaluate the effects of a very early mirror therapy program on functional improvement of the upper extremity in acute stroke patients. [Subjects] Eight stroke patients who were treated in an acute neurology unit were included in the study. [Methods] The patients were assigned alternatively to either the mirror therapy group receiving mirror therapy and neurodevelopmental treatment or the neurodevelopmental treatment only group. The primary outcome measures were the upper extremity motor subscale of the Fugl-Meyer Assessment, Motricity Index upper extremity score, and the Stroke Upper Limb Capacity Scale. Somatosensory assessment with the Ayres Southern California Sensory Integration Test, and the Barthel Index were used as secondary outcome measures. [Results] No statistically significant improvements were found for any measures in either group after the treatment. In terms of minimally clinically important differences, there were improvements in Fugl-Meyer Assessment and Barthel Index in both mirror therapy and neurodevelopmental treatment groups. [Conclusion] The results of this pilot study revealed that very early mirror therapy has no additional effect on functional improvement of upper extremity function in acute stroke patients. Multicenter trials are needed to determine the results of early application of mirror therapy in stroke rehabilitation.

Music therapy, emotions and the heart: a pilot study.

PubMed

Raglio, Alfredo; Oasi, Osmano; Gianotti, Marta; Bellandi, Daniele; Manzoni, Veronica; Goulene, Karine; Imbriani, Chiara; Badiale, Marco Stramba

2012-01-01

The autonomic nervous system plays an important role in the control of cardiac function. It has been suggested that sound and music may have effects on the autonomic control of the heart inducing emotions, concomitantly with the activation of specific brain areas, i.e. the limbic area, and they may exert potential beneficial effects. This study is a prerequisite and defines a methodology to assess the relation between changes in cardiac physiological parameters such as heart rate, QT interval and their variability and the psychological responses to music therapy sessions. We assessed the cardiac physiological parameters and psychological responses to a music therapy session. ECG Holter recordings were performed before, during and after a music therapy session in 8 healthy individuals. The different behaviors of the music therapist and of the subjects have been analyzed with a specific music therapy assessment (Music Therapy Checklist). After the session mean heart rate decreased (p = 0.05), high frequency of heart rate variability tended to be higher and QTc variability tended to be lower. During music therapy session "affect attunements" have been found in all subjects but one. A significant emotional activation was associated to a higher dynamicity and variations of sound-music interactions. Our results may represent the rational basis for larger studies in diferent clinical conditions.

Progressive Staging of Pilot Studies to Improve Phase III Trials for Motor Interventions

PubMed Central

Dobkin, Bruce H.

2014-01-01

Based on the suboptimal research pathways that finally led to multicenter randomized clinical trials (MRCTs) of treadmill training with partial body weight support and of robotic assistive devices, strategically planned successive stages are proposed for pilot studies of novel rehabilitation interventions Stage 1, consideration-of-concept studies, drawn from animal experiments, theories, and observations, delineate the experimental intervention in a small convenience sample of participants, so the results must be interpreted with caution. Stage 2, development-of-concept pilots, should optimize the components of the intervention, settle on most appropriate outcome measures, and examine dose-response effects. A well-designed study that reveals no efficacy should be published to counterweight the confirmation bias of positive trials. Stage 3, demonstration-of-concept pilots, can build out from what has been learned to test at least 15 participants in each arm, using random assignment and blinded outcome measures. A control group should receive an active practice intervention aimed at the same primary outcome. A third arm could receive a substantially larger dose of the experimental therapy or a combinational intervention. If only 1 site performed this trial, a different investigative group should aim to reproduce positive outcomes based on the optimal dose of motor training. Stage 3 studies ought to suggest an effect size of 0.4 or higher, so that approximately 50 participants in each arm will be the number required to test for efficacy in a stage 4, proof-of-concept MRCT. By developing a consensus around acceptable and necessary practices for each stage, similar to CONSORT recommendations for the publication of phase III clinical trials, better quality pilot studies may move quickly into better designed and more successful MRCTs of experimental interventions. PMID:19240197

Developing and testing accelerated partner therapy for partner notification for people with genital Chlamydia trachomatis diagnosed in primary care: a pilot randomised controlled trial

PubMed Central

Estcourt, Claudia S; Sutcliffe, Lorna J; Copas, Andrew; Mercer, Catherine H; Roberts, Tracy E; Jackson, Louise J; Symonds, Merle; Tickle, Laura; Muniina, Pamela; Rait, Greta; Johnson, Anne M; Aderogba, Kazeem; Creighton, Sarah; Cassell, Jackie A

2015-01-01

Background Accelerated partner therapy (APT) is a promising partner notification (PN) intervention in specialist sexual health clinic attenders. To address its applicability in primary care, we undertook a pilot randomised controlled trial (RCT) of two APT models in community settings. Methods Three-arm pilot RCT of two adjunct APT interventions: APTHotline (telephone assessment of partner(s) plus standard PN) and APTPharmacy (community pharmacist assessment of partner(s) plus routine PN), versus standard PN alone (patient referral). Index patients were women diagnosed with genital chlamydia in 12 general practices and three community contraception and sexual health (CASH) services in London and south coast of England, randomised between 1 September 2011 and 31 July 2013. Results 199 women described 339 male partners, of whom 313 were reported by the index as contactable. The proportions of contactable partners considered treated within 6 weeks of index diagnosis were APTHotline 39/111 (35%), APTPharmacy 46/100 (46%), standard patient referral 46/102 (45%). Among treated partners, 8/39 (21%) in APTHotline arm were treated via hotline and 14/46 (30%) in APTPharmacy arm were treated via pharmacy. Conclusions The two novel primary care APT models were acceptable, feasible, compliant with regulations and capable of achieving acceptable outcomes within a pilot RCT but intervention uptake was low. Although addition of these interventions to standard PN did not result in a difference between arms, overall PN uptake was higher than previously reported in similar settings, probably as a result of introducing a formal evaluation. Recruitment to an individually randomised trial proved challenging and full evaluation will likely require service-level randomisation. Trial registration number Registered UK Clinical Research Network Study Portfolio id number 10123. PMID:26019232

Comparison of the effects of mirror therapy and electromyography-triggered neuromuscular stimulation on hand functions in stroke patients: a pilot study.

PubMed

Amasyali, Saliha Y; Yaliman, Ayşe

2016-12-01

To determine the effectiveness of mirror therapy and electromyography (EMG)-triggered neuromuscular stimulation on improvement of functions of the upper extremity in patients with subacute stroke in comparison with conventional therapy as well as to evaluate the advantage of each treatment over another, we conducted a prospective, randomized, and controlled trial involving 24 patients with ischemic stroke. The mean age and mean time since stroke of the patients were 58.79±11.49 years and 5.25±2.25 months. Patients were assigned randomly to a mirror therapy group (MT group, n=9), which consisted of therapy with a mirror box 5 days/week, 30 min/day, for 3 weeks, an electrostimulation group (ES group, n=7), which consisted of therapy with EMG-triggered stimulation (EMG-stim) of similar duration and frequency of treatment as the MT group, and a control group (n=8). All the groups received conventional physiotherapy for the same period as the MT group. Patients in the MT group practiced their therapy at home after supervised sessions. The Fugl-Meyer scores of the upper extremity, grip force, wrist extension, and Box and Block Test were evaluated at baseline, after treatment, and at 3 months after the treatment. All of these measures were evaluated by a blinded researcher. We found that there was no significant improvement in wrist extension range and grip force in control group. The MT and EMG-stim were effective in increasing the Fugl-Meyer motor scale for upper extremity (MT group: P<0.01), increasing wrist extension range, grip force, and hand dexterity determined by the Box and Block Test (MT group and ES group P<0.05). Furthermore, hand skills were increased significantly in the MT group compared with the ES group at the follow-up assessment (P<0.05). This pilot study suggested that MT was more efficient in improving motor performance than physiotherapy alone. Also, MT may be more useful in improving the hand skills compared with EMG-stim. We assume that this difference might be related to the feasibility of maintenance of MT at home.

Feasibility and safety of early combined cognitive and physical therapy for critically ill medical and surgical patients: the Activity and Cognitive Therapy in ICU (ACT-ICU) trial.

PubMed

Brummel, N E; Girard, T D; Ely, E W; Pandharipande, P P; Morandi, A; Hughes, C G; Graves, A J; Shintani, A; Murphy, E; Work, B; Pun, B T; Boehm, L; Gill, T M; Dittus, R S; Jackson, J C

2014-03-01

Cognitive impairment after critical illness is common and debilitating. We developed a cognitive therapy program for critically ill patients and assessed the feasibility and safety of administering combined cognitive and physical therapy early during a critical illness. We randomized 87 medical and surgical ICU patients with respiratory failure and/or shock in a 1:1:2 manner to three groups: usual care, early once-daily physical therapy, or early once-daily physical therapy plus a novel, progressive, twice-daily cognitive therapy protocol. Cognitive therapy included orientation, memory, attention, and problem-solving exercises, and other activities. We assessed feasibility outcomes of the early cognitive plus physical therapy intervention. At 3 months, we also assessed cognitive, functional, and health-related quality of life outcomes. Data are presented as median (interquartile range) or frequency (%). Early cognitive therapy was a delivered to 41/43 (95%) of cognitive plus physical therapy patients on 100% (92-100%) of study days beginning 1.0 (1.0-1.0) day following enrollment. Physical therapy was received by 17/22 (77%) of usual care patients, by 21/22 (95%) of physical therapy only patients, and 42/43 (98%) of cognitive plus physical therapy patients on 17% (10-26%), 67% (46-87%), and 75% (59-88%) of study days, respectively. Cognitive, functional, and health-related quality of life outcomes did not differ between groups at 3-month follow-up. This pilot study demonstrates that early rehabilitation can be extended beyond physical therapy to include cognitive therapy. Future work to determine optimal patient selection, intensity of treatment, and benefits of cognitive therapy in the critically ill is needed.

Feasibility and safety of early combined cognitive and physical therapy for critically ill medical and surgical patients: the Activity and Cognitive Therapy in ICU (ACT-ICU) trial

PubMed Central

Brummel, N.E.; Girard, T.D.; Ely, E.W.; Pandharipande, P.P.; Morandi, A.; Hughes, C.G.; Graves, A.J.; Shintani, A.K.; Murphy, E.; Work, B.; Pun, B.T.; Boehm, L.; Gill, T.M.; Dittus, R.S.; Jackson, J.C.

2013-01-01

PURPOSE Cognitive impairment after critical illness is common and debilitating. We developed a cognitive therapy program for critically ill patients and assessed the feasibility and safety of administering combined cognitive and physical therapy early during a critical illness. METHODS We randomized 87 medical and surgical ICU patients with respiratory failure and/or shock in a 1:1:2 manner to three groups: usual care, early once-daily physical therapy, or early once-daily physical therapy plus a novel, progressive, twice-daily cognitive therapy protocol. Cognitive therapy included orientation, memory, attention, and problem solving exercises, and other activities. We assessed feasibility outcomes of the early cognitive plus physical therapy intervention. At 3-months, we also assessed cognitive, functional and health-related quality of life outcomes. Data are presented as median [interquartile range] or frequency (%). RESULTS Early cognitive therapy was a delivered to 41/43 (95%) of cognitive plus physical therapy patients on 100% [92–100%] of study days beginning 1.0 [1.0–1.0] day following enrollment. Physical therapy was received by 17/22 (77%) of usual care patients, by 21/22 (95%) of physical therapy only patients and 42/43 (98%) of cognitive plus physical therapy patients on 17% [10–26%], 67% [46–87%] and 75% [59–88%] of study days, respectively. Cognitive, functional and health-related quality of life outcomes did not differ between groups at 3-month follow-up. CONCLUSIONS This pilot study demonstrates that early rehabilitation can be extended beyond physical therapy to include cognitive therapy. Future work to determine optimal patient selection, intensity of treatment and benefits of cognitive therapy in the critically ill is needed. PMID:24257969

Occupational Therapy Treatment to Improve Upper Extremity Function in Individuals with Early Systemic Sclerosis: A Pilot Study.

PubMed

Murphy, Susan L; Barber, Mary; Homer, Kristen; Dodge, Carole; Cutter, Gary; Khanna, Dinesh

2018-01-30

To determine feasibility and preliminary effects of an occupational therapy treatment to improve upper extremity (UE) function in patients with early systemic sclerosis (SSc) who have UE contractures. A one-arm pilot clinical rehabilitation trial was conducted at a university health system. Participants with SSc and ≥ 1 UE contracture (n = 21) participated in a total of 8 weekly in-person occupational therapy sessions. The therapy consisted of thermal modalities, tissue mobilization, and UE mobility. Between sessions, participants were instructed to complete UE home exercises. Feasibility was measured by percent enrollment and session attendance and duration. The primary outcome measure was the QuickDASH, secondary and exploratory outcomes included PROMIS physical function, objective UE measures, and skin thickening. Linear mixed models were performed to determine treatment effects on primary and secondary outcomes. Fifty percent (24/48) of potentially eligible participants were interested. Of those, 88% (21/24) enrolled; and nineteen out of 21 (91%) completed all sessions. The mean (SD) age was 47.9 years (± 16.1); 100% had diffuse SSc, and mean disease duration was 3.1 years. At 8 weeks, participants reported statistically significant improvement on QuickDASH and PROMIS physical function measures (p =.0012 and p = .004). Forty-seven and 53% percent of the sample achieved improvements that exceeded minimally important differences. In-person treatment sessions were feasible for individuals with SSc and demonstrated statistically significant and clinically meaningful improvements on UE and physical function. Future studies need to examine effects against a control condition and examine durability of treatment effects. This article is protected by copyright. All rights reserved. This article is protected by copyright. All rights reserved.

A Mixed-Methods Pilot Study to Assess Perceptions of Antimicrobial Stewardship in Nursing Homes

PubMed Central

Carter, Rebecca R.; Montpetite, Michelle M.; Jump, Robin L. P.

2016-01-01

Objectives Practicing antimicrobial stewardship in nursing homes faces many challenges, particularly in non-academic settings. We sought to identify features of community nursing home environments that are associated with lower rates of overall antibiotic use. Design In this pilot study, we used an explanatory sequential design that incorporated comparative feedback about antibiotic use to inform a discussion about antimicrobial stewardship practices among community nursing homes. Measurements For the quantitative phase, we measured the number of antibiotic prescriptions, length of therapy and days of therapy/1000 days of care at 6 nursing homes. For the qualitative phase, we conducted semi-structured interviews with healthcare workers in leadership positions at 5 community nursing homes. Transcripts from the recorded interviews were assessed using emergent thematic analysis. For the triangulation phase, we evaluated themes from the semi-structured interviews in the context of each NHs antibiotic use. Results The number of antibiotic prescriptions ranged from 172 to 1244, with 50% to 83% written for ≤ 7 days. All nursing homes reported a similar proportion of fluoroquinolone use (27–32% days of therapy). Triangulation yielded 6 themes for which the environment at each facility ranged from less to more supportive antimicrobial stewardship: practice patterns, external influences, infection control, leadership, communication and facility culture. All nursing homes reported pressure from well-intentioned family members to prescribe antibiotics. Nursing homes with shorter lengths of therapy and lower overall antibiotic use were consonant with an environment more supportive of antimicrobial stewardship. Conclusion Our findings suggest several features of nursing homes that are supportive of antimicrobial stewardship: practice patterns grounded in established diagnostic criteria, proactive infection control and prevention, open communication and interconnectedness among staff. PMID:28152171

Participation in an occupational therapy referral program for children with retinoblastoma.

PubMed

Sparrow, Jessica; Brennan, Rachel; Mao, Shenghua; Ness, Kirsten K; Rodriguez-Galindo, Carlos; Wilson, Matthew; Qaddoumi, Ibrahim

2016-05-31

Because retinoblastoma typically arises at a very young age, children are particularly vulnerable to vision impairment, associated developmental delays, and functional limitations. Limited information is available describing developmental delay and functional limitations in this population, necessitating supportive services including rehabilitation. The aims of this study were to describe the participation of children with newly diagnosed retinoblastoma in an occupational therapy program that identifies children in need of rehabilitation services. We also identify indications for referral to rehabilitation services among children with newly diagnosed retinoblastoma and enumerate the likelihood of these children receiving the recommended services. Twenty-two children participated in longitudinal occupational therapy assessments during the first year after diagnosis. We recommended 1 or more types of rehabilitation services for 16 of 22 (72.7%) participants. Twelve of 16 (75%) received services. The results of this pilot study indicate that implementing a prospective occupational therapy-screening program is feasible and results in identification and initiation of therapy services in some children with retinoblastoma. Developmental screenings and follow-up of children with retinoblastoma is strongly recommended.

Virtual reality exposure versus cognitive restructuring for treatment of public speaking anxiety: a pilot study.

PubMed

Wallach, Helene S; Safir, Marilyn P; Bar-Zvi, Margalit

2011-01-01

To determine the utility of Virtual Reality Exposure Therapy (VRE) in comparison with Cognitive Therapy (CT ) and with Cognitive-Behavior Therapy (CBT). Subjects suffering from public speaking anxiety (PSA) were randomly allocated to VRE and CT , and received 12 therapy sessions, employing standardized treatment manuals. Outcome (questionnaires, observer and self ratings of a behavioral task) was compared to results of subjects in a previous study CBT and Wait List Controls who were not significantly different on demographic data. CT was not superior to VRE on cognitive measures, but was superior to VRE on one behavioral measure (LSAS fear). VRE was superior to CT on one behavioral measure (fear reduction on a behavioral task). No differences were found between either CT , or VRE, and CBT and all were superior to WL. Subject group was small and homogeneous. It appeared advisable to increase number of therapy sessions. VRE and CT proved to be equally effective to CBT in reducing PSA relative to a control group, with minimal differential effects between them. Therefore, employing either one may be satisfactory and sufficient.

A pilot randomized controlled trial of on-line interventions to improve sleep quality in adults after mild or moderate traumatic brain injury.

PubMed

Theadom, Alice; Barker-Collo, Suzanne; Jones, Kelly; Dudley, Margaret; Vincent, Norah; Feigin, Valery

2018-05-01

To explore feasibility and potential efficacy of on-line interventions for sleep quality following a traumatic brain injury (TBI). A two parallel-group, randomized controlled pilot study. Community-based. In all, 24 participants (mean age: 35.9 ± 11.8 years) who reported experiencing sleep difficulties between 3 and 36 months after a mild or moderate TBI. Participants were randomized to receive either a cognitive behaviour therapy or an education intervention on-line. Both interventions were self-completed for 20-30 minutes per week over a six-week period. The Pittsburgh Sleep Quality Index assessed self-reported sleep quality with actigraphy used as an objective measure of sleep quality. The CNS Vital Signs on-line neuropsychological test assessed cognitive functioning and the Rivermead Post-concussion Symptoms and Quality of Life after Brain Injury questionnaires were completed pre and post intervention. Both programmes demonstrated feasibility for use post TBI, with 83.3% of participants completing the interventions. The cognitive behaviour therapy group experienced significant reductions ( F = 5.47, p = 0.04) in sleep disturbance (mean individual change = -4.00) in comparison to controls post intervention (mean individual change = -1.50) with a moderate effect size of 1.17. There were no significant group differences on objective sleep quality, cognitive functioning, post-concussion symptoms or quality of life. On-line programmes designed to improve sleep are feasible for use for adults following mild-to-moderate TBI. Based on the effect size identified in this pilot study, 128 people (64 per group) would be needed to determine clinical effectiveness.

Remediation of social communication impairments following traumatic brain injury using metacognitive strategy intervention: a pilot study.

PubMed

Finch, Emma; Cornwell, Petrea; Copley, Anna; Doig, Emmah; Fleming, Jennifer

2017-01-01

To perform a pilot study to evaluate whether a novel metacognitive, goal-based intervention improved and maintained the social communication skills of adults with traumatic brain injury (TBI). Eight community-dwelling participants with TBI completed three study phases: (1) baseline, (2) eight-week intervention targeting social communication impairments and (3) follow-up. Participants completed the Profile of Pragmatic Impairment in Communication (PPIC), LaTrobe Communication Questionnaire (LCQ) and Goal Attainment Scaling (GAS) at the commencement of baseline phase, pre- and post-intervention and completion of the follow-up phase. During the intervention programme phase, participants attended two 1-hour therapy sessions (one individual; one group) per week focusing on remediating impaired social communication skills using metacognitive strategy intervention and goal-based therapy. Variable changes in PPIC feature-summary scores were observed post-intervention. A non-significant improvement in LCQ scores was also observed. There was a significant increase in GAS goal T-scores following the intervention, with six of the eight participants achieving or exceeding their expected level of performance on all goals. A goal-driven, metacognitive approach to intervention may assist individuals with TBI to achieve their personal social communication goals, with benefits reported by participants and observable during conversations. Further research is required.

Relationship between the formation of volatile sulfur compounds (VSC) and the severity of the periodontal disease: a pilot study.

PubMed

Nogueira-Filho, G R; Peruzzo, D; Sallum, A W

2008-03-01

This aim of this study was to evaluate the relationship between the formation of volatile sulfur compounds (VSC) and the severity of different kinds of periodontal disease. Twenty patients suffering from biofilm-related periodontal diseases and a control group of ten healthy individuals were selected. The patients were divided according to their periodontal diagnoses: marginal gingivitis (MG/n = 10) and chronic periodontitis (CP/n = 10). The patients received non-surgical therapy that consisted of motivation, scaling and root planing. Two experimental periods were used: T1 = baseline and T2 = final evaluation after three months. The data analysis showed that CP group had a significant reduction (p < 0.05) in probing depth (PD) and clinical attachment level (CAL), and group MG presented a reduction in GI (p < 0.05). There was a significant reduction (p < 0.05) in the aspartate aminotransferase (AST), N-a-benzoyl-DL-arginine-p-nitroanilide (BAPNA) and VSC levels in both MG and CP groups, although the deeper residual pockets led to higher AST and VSC levels in the CP group. Within the limits of the present pilot study, it can be concluded that the non-surgical therapy may influence VSC formation in a manner dependent on periodontal disease severity.

Dance program for physical rehabilitation and participation in children with cerebral palsy.

PubMed

López-Ortiz, Citlali; Gladden, Kim; Deon, Laura; Schmidt, Jennifer; Girolami, Gay; Gaebler-Spira, Deborah

2012-02-01

Objective : This pilot study aimed to examine a classical ballet program created for children with cerebral palsy (CP) as an emerging physical rehabilitation modality. The main program goals were to promote participation and to provide an artistic, physically therapeutic activity. Methods : The study was conducted in collaboration with a tertiary rehabilitation hospital, one outpatient physical therapy clinic, and one community center. As a pilot exploratory study, the research design included questionnaires to assess the participants' (children ( n  = 16), parents ( n  = 16), and therapists ( n  = 13)) perceptions on the therapeutic benefit of the dance program. A binomial statistical model was adopted for the analysis of the results. Results : Main results were that the children reported high enjoyment level ( p  < .0001) and desire for more classes (.0001); the parents reported perceived therapeutic benefit ( p  < .0001); and the therapists viewed the class as a positive adjunct to therapy ( p  < .0001). Conclusions : The main limitation of this work was the utilization of subjective outcome measures. However, this is the first step toward the development of objective measures of an intervention that, to our knowledge, has not been analyzed in the past. We conclude that the program has the potential of developing into an evidence based rehabilitation resource for children with CP.

A pilot feasibility study of the effects of touch therapy on nurses.

PubMed

McElligott, Deborah; Holz, Mary Beth; Carollo, Laurie; Somerville, Susan; Baggett, Margarita; Kuzniewski, Sally; Shi, Qiuhu

2003-01-01

The White House Commission on Complementary Alternative Medicine (CAM) has recommended that safe and effective CAM practices be evaluated to determine their role in maintaining wellness and promoting health. There is little research on individual bodywork/energy therapies and their effects on wellness. The purpose of this pilot study was to assess the effect of AMMA treatments on relaxation and anxiety in staff nurses, and to examine themes describing the nurses' experiences. It was hypothesized that nurses receiving AMMA treatments would demonstrate reduced anxiety, as measured by a Visual Analog Scale (VAS) and increased relaxation, measured by physiologic parameters. The study was designed as a prospective, randomized, blinded clinical trial, with convenience sampling of 24 nurses working 12-hour shifts. While both groups demonstrated decreased anxiety after intervention, the experimental group consistently showed greater differences between pre- and post-treatment anxiety scores. The mean change in physiologic parameters between groups was not significant. Themes derived from a final interview included: importance of touch in nursing care, stress reduction, increased self-awareness, the need for self-care and a new understanding of the mind-body connection. Outcomes suggest the need for further research with a larger population to assess this intervention's impact on anxiety, stress, self-care and caring relationships.

The use of an Energy Monitor in the management of diabetes: a pilot study.

PubMed

Voon, Rudi; Celler, Branko G; Lovell, Nigel H

2009-02-01

This study evaluated the use of an accelerometer-based device in helping to manage blood glucose levels (BGLs) in people with diabetes mellitus. Five people with diabetes were given a triaxial accelerometer-based device (Energy Monitor) that measured energy levels associated with activities of daily living. For 3 months, they were required to wear the device and to continue with their usual diabetes therapy. The body mass index (BMI) and glycosylated hemoglobin (HbA(1c)) were recorded to assess any potential improvement in blood glucose control. The relationship between BGL and measured energy level was also investigated. Overall, there was a significant reduction of HbA(1c) from 7.48 +/- 1.21% to 6.98 +/- 1.44% (P < 0.05). There was no significant change in BMI. It was also found that higher energy levels resulted in much lower fluctuations in BGL change between meals compared to low energy levels. Moreover, the weekly mean activity score showed an increase in activity levels from the second week to the final week. This pilot study demonstrated that the Energy Monitor could improve the management of diabetes by allowing people with diabetes to view and manage daily physical activity in addition to their usual diabetes therapy.

Negative pressure and nanocrystalline silver dressings for nonhealing ulcer: A randomized pilot study.

PubMed

Sáez-Martín, Luis C; García-Martínez, Lourdes; Román-Curto, Concepción; Sánchez-Hernández, Miguel V; Suárez-Fernández, Ricardo M

2015-01-01

Chronic wounds have a high prevalence and wound care, treatment, and prevention consume large quantities of resources. Chronic wounds are a growing challenge for clinicians. A prospective randomized pilot study was conducted to assess the effectiveness in terms of reduction in area and safety of the combined use of negative-pressure wound therapy and nanocrystalline silver dressings as compared to negative pressure wound therapy (NPWT) alone in the management of outpatients with chronic wounds. A total of 17 patients were included in the study, 10 were treated with the combined method and 7 with NPWT. Patients were followed for 6 weeks, with a final assessment at 3 months. Clinical improvement, microbiologic data, and toxicity of silver were evaluated. The antibacterial effects of ionic silver together with the development of granulation tissue promoted by NPWT reduced significantly the median extension of the wound between weeks 3 and 6 of treatment. The combination with silver also reduced bacterial colonization with Pseudomonas aeruginosa and the bacterial load on the surface of the wound. The silver levels correlated positively with the extension of the wound, although in none of the patients' toxic levels were reached. The combination of NPWT with nanocrystalline silver dressings was safe and as effective as NPWT alone. © 2015 by the Wound Healing Society.

Mortality prediction in patients with severe septic shock: a pilot study using a target metabolomics approach.

PubMed

Ferrario, Manuela; Cambiaghi, Alice; Brunelli, Laura; Giordano, Silvia; Caironi, Pietro; Guatteri, Luca; Raimondi, Ferdinando; Gattinoni, Luciano; Latini, Roberto; Masson, Serge; Ristagno, Giuseppe; Pastorelli, Roberta

2016-02-05

Septic shock remains a major problem in Intensive Care Unit, with high lethality and high-risk second lines treatments. In this preliminary retrospective investigation we examined plasma metabolome and clinical features in a subset of 20 patients with severe septic shock (SOFA score >8), enrolled in the multicenter Albumin Italian Outcome Sepsis study (ALBIOS, NCT00707122). Our purpose was to evaluate the changes of circulating metabolites in relation to mortality as a pilot study to be extended in a larger cohort. Patients were analyzed according to their 28-days and 90-days mortality. Metabolites were measured using a targeted mass spectrometry-based quantitative metabolomic approach that included acylcarnitines, aminoacids, biogenic amines, glycerophospholipids, sphingolipids, and sugars. Data-mining techniques were applied to evaluate the association of metabolites with mortality. Low unsaturated long-chain phosphatidylcholines and lysophosphatidylcholines species were associated with long-term survival (90-days) together with circulating kynurenine. Moreover, a decrease of these glycerophospholipids was associated to the event at 28-days and 90-days in combination with clinical variables such as cardiovascular SOFA score (28-day mortality model) or renal replacement therapy (90-day mortality model). Early changes in the plasma levels of both lipid species and kynurenine associated with mortality have potential implications for early intervention and discovering new target therapy.

Mortality prediction in patients with severe septic shock: a pilot study using a target metabolomics approach

PubMed Central

Ferrario, Manuela; Cambiaghi, Alice; Brunelli, Laura; Giordano, Silvia; Caironi, Pietro; Guatteri, Luca; Raimondi, Ferdinando; Gattinoni, Luciano; Latini, Roberto; Masson, Serge; Ristagno, Giuseppe; Pastorelli, Roberta

2016-01-01

Septic shock remains a major problem in Intensive Care Unit, with high lethality and high-risk second lines treatments. In this preliminary retrospective investigation we examined plasma metabolome and clinical features in a subset of 20 patients with severe septic shock (SOFA score >8), enrolled in the multicenter Albumin Italian Outcome Sepsis study (ALBIOS, NCT00707122). Our purpose was to evaluate the changes of circulating metabolites in relation to mortality as a pilot study to be extended in a larger cohort. Patients were analyzed according to their 28-days and 90-days mortality. Metabolites were measured using a targeted mass spectrometry-based quantitative metabolomic approach that included acylcarnitines, aminoacids, biogenic amines, glycerophospholipids, sphingolipids, and sugars. Data-mining techniques were applied to evaluate the association of metabolites with mortality. Low unsaturated long-chain phosphatidylcholines and lysophosphatidylcholines species were associated with long-term survival (90-days) together with circulating kynurenine. Moreover, a decrease of these glycerophospholipids was associated to the event at 28-days and 90-days in combination with clinical variables such as cardiovascular SOFA score (28-day mortality model) or renal replacement therapy (90-day mortality model). Early changes in the plasma levels of both lipid species and kynurenine associated with mortality have potential implications for early intervention and discovering new target therapy. PMID:26847922

Augmenting Prolonged Exposure therapy for PTSD with intranasal oxytocin: A randomized, placebo-controlled pilot trial.

PubMed

Flanagan, Julianne C; Sippel, Lauren M; Wahlquist, Amy; Moran-Santa Maria, Megan M; Back, Sudie E

2018-03-01

Posttraumatic stress disorder (PTSD) is a chronic, debilitating condition for which Prolonged Exposure (PE) therapy is highly efficacious. However, for some individuals, premature dropout and residual PTSD symptoms remain obstacles. The neuropeptide oxytocin is a promising candidate to enhance PE due to its ability to enhance 1) prosocial cognition and behavior, which are theorized to promote positive working alliance, and 2) extinction learning, which is the central mechanism of action underlying successful PE treatment. Despite a robust theoretical rationale, no studies to date have combined evidence-based psychotherapy for PTSD with oxytocin. This randomized, placebo-controlled, double-blind pilot trial examined the feasibility, safety, and preliminary efficacy of augmenting PE with oxytocin. Participants were 17 individuals with diverse index traumas. Participants self-administered intranasal oxytocin (40 IU) or matching placebo 45 min prior to each weekly PE therapy session. One adverse event occurred in the placebo group and three individuals dropped out (17.6%; 2 oxytocin group and 1 placebo group). The oxytocin group demonstrated lower PTSD and depression symptoms during PE, and had higher working alliance scores, although these differences did not reach statistical significance. Although preliminary, the findings support the feasibility of oxytocin combined with PE. Adequately powered studies are necessary to determine whether oxytocin enhances PE treatment outcomes and to examine potential mechanisms, such as accelerating extinction learning, enhancing early response, and preventing premature dropout. NCT03238924. Copyright © 2017. Published by Elsevier Ltd.

Serum lipid profile changes after successful treatment with electroconvulsive therapy in major depression: A prospective pilot trial.

PubMed

Aksay, Suna Su; Bumb, Jan Malte; Janke, Christoph; Biemann, Ronald; Borucki, Katrin; Lederbogen, Florian; Deuschle, Michael; Sartorius, Alexander; Kranaster, Laura

2016-01-01

Cholesterol is reduced in depressed patients, however, these patients have a higher risk for cardiovascular diseases. Electroconvulsive therapy (ECT) is a highly effective treatment option for specific forms of depression. Like for other non-pharmacological therapies targeting depression such as psychotherapy or sleep deprivation, there is a lack of evidence about the effects on peripheral lipid parameters. Our objective was to study the impact of ECT as a non-pharmacological treatment on the peripheral lipid pattern in depressive patients. Peripheral lipid profile composition before and after a course of ECT was analysed in 27 non-fasting inpatients at a university psychiatric hospital with DSM-IV major depressive episode. For the impact of ECT treatment on each lipid parameter a multivariate repeated measurement regression analysis was performed and computed separately for every dependent variable. Total Cholesterol and the cholesterol subtypes HDL and LDL were increased after the treatment compared to baseline. Apolipoprotein A1 was also increased after ECT, whereas apolipoprotein B was not. Indices for the prediction of cardiovascular diseases were unchanged after successful treatment by ECT. The reduction of depressive psychopathology negatively correlated with increases of HDL cholesterol and apolipoprotein A1. Subjects received several antidepressants and other psychotropic medication before and during the ECT. In our preliminary pilot study ECT as a non-pharmacological, effective treatment of depression led to distinct effects on the peripheral lipid pattern. Copyright © 2015 Elsevier B.V. All rights reserved.

Autonomic Evaluation of Patients With Gastroparesis and Neurostimulation: Comparisons of Direct/Systemic and Indirect/Cardiac Measures

PubMed Central

Stocker, Abigail; Abell, Thomas L.; Rashed, Hani; Kedar, Archana; Boatright, Ben; Chen, Jiande

2016-01-01

Background Disorders of nausea, vomiting, abdominal pain, and related problems often are manifestations of gastrointestinal, neuromuscular, and/or autonomic dysfunction. Many of these patients respond to neurostimulation, either gastric electrical stimulation or electroacupuncture. Both of these therapeutic techniques appear to influence the autonomic nervous system which can be evaluated directly by traditional testing and indirectly by heart rate variability. Methods We studied patients undergoing gastric neuromodulation by both systemic autonomic testing (39 patients, six males and 33 females, mean age 38 years) and systemic autonomic testing and heart rate variability (35 patients, seven males and 28 females, mean age 37 years) testing before and after gastric neuromodulation. We also performed a pilot study using both systemic autonomic testing and heart rate variability in a small number of patients (five patients, all females, mean age 48.6 years) with diabetic gastroparesis at baseline to compare the two techniques at baseline. Systemic autonomic testing and heart rate variability were performed with standardized techniques and gastric electrical stimulation was performed as previously described with electrodes implanted serosally in the myenteric plexus. Results Both systemic autonomic testing and heart rate variability measures were often abnormal at baseline and showed changes after gastric neuromodulation therapy in two groups of symptomatic patients. Pilot data on a small group of similar patients with systemic automatic nervous measures and heart rate variability showed good concordance between the two techniques. Conclusions Both traditional direct autonomic measures and indirect measures such as heart rate variability were evaluated, including a pilot study of both methods in the same patient group. Both appear to be useful in evaluation of patients at baseline and after stimulation therapies; however, a future full head-to-head comparison is warranted. PMID:27785318

Improving discharge care: the potential of a new organisational intervention to improve discharge after hospitalisation for acute stroke, a controlled before-after pilot study.

PubMed

Cadilhac, Dominique A; Andrew, Nadine E; Stroil Salama, Enna; Hill, Kelvin; Middleton, Sandy; Horton, Eleanor; Meade, Ian; Kuhle, Sarah; Nelson, Mark R; Grimley, Rohan

2017-08-04

Provision of a discharge care plan and prevention therapies is often suboptimal. Our objective was to design and pilot test an interdisciplinary, organisational intervention to improve discharge care using stroke as the case study using a mixed-methods, controlled before-after observational study design. Acute care public hospitals in Queensland, Australia (n=15). The 15 hospitals were ranked against a benchmark based on a composite outcome of three discharge care processes. Clinicians from a 'top-ranked' hospital participated in a focus group to elicit their success factors. Two pilot hospitals then participated in the organisational intervention that was designed with experts and consumers. Hospital clinicians involved in discharge care for stroke and patients admitted with acute stroke or transient ischaemic attack. A four-stage, multifaceted organisational intervention that included data reviews, education and facilitated action planning. Three discharge processes collected in Queensland hospitals within the Australian Stroke Clinical Registry were used to select study hospitals: (1) discharge care plan; (2) antihypertensive medication prescription and (3) antiplatelet medication prescription (ischaemic events only). Primary measure: composite outcome. Secondary measures: individual adherence changes for each discharge process; sensitivity analyses. The performance outcomes were compared 3 months before the intervention (preintervention), 3 months postintervention and at 12 months (sustainability). Data from 1289 episodes of care from the two pilot hospitals were analysed. Improvements from preintervention adherence were: antiplatelet therapy (88%vs96%, p=0.02); antihypertensive prescription (61%vs79%, p<0.001); discharge planning (72%vs94%, p<0.001); composite outcome (73%vs89%, p<0.001). There was an insignificant decay effect over the 12-month sustainability period (composite outcome: 89% postintervention vs 85% sustainability period, p=0.08). Discharge care in hospitals may be effectively improved and sustained through a staged and peer-informed, organisational intervention. The intervention warrants further application and trialling on a larger scale. © Article author(s) (or their employer(s) unless otherwise stated in the text of the article) 2017. All rights reserved. No commercial use is permitted unless otherwise expressly granted.

Effects of Music Therapy on Drug Therapy of Adult Psychiatric Outpatients: A Pilot Randomized Controlled Study

PubMed Central

Degli Stefani, Mario; Biasutti, Michele

2016-01-01

Objective: Framed in the patients’ engagement perspective, the current study aims to determine the effects of group music therapy in addition to drug care in comparison with drug care in addition to other non-expressive group activities in the treatment of psychiatric outpatients. Method: Participants (n = 27) with ICD-10 diagnoses of F20 (schizophrenia), F25 (schizoaffective disorders), F31 (bipolar affective disorder), F32 (depressive episode), and F60 (specific personality disorders) were randomized to receive group music therapy plus standard care (48 weekly sessions of 2 h) or standard care only. The clinical measures included dosages of neuroleptics, benzodiazepines, mood stabilizers, and antidepressants. Results: The participants who received group music therapy demonstrated greater improvement in drug dosage with respect to neuroleptics than those who did not receive group music therapy. Antidepressants had an increment for both groups that was significant only for the control group. Benzodiazepines and mood stabilizers did not show any significant change in either group. Conclusion: Group music therapy combined with standard drug care was effective for controlling neuroleptic drug dosages in adult psychiatric outpatients who received group music therapy. We discussed the likely applications of group music therapy in psychiatry and the possible contribution of music therapy in improving the psychopathological condition of adult outpatients. In addition, the implications for the patient-centered perspective were also discussed. PMID:27774073

The effects of infrared laser therapy and weightbath traction hydrotherapy as components of complex physical treatment in disorders of the lumbar spine: a controlled pilot study with follow-up

NASA Astrophysics Data System (ADS)

Oláh, Csaba; Oláh, Mihály; Demeter, Béla; Jancsó, Zoltán; Páll, Valéria; Bender, Tamás

2010-02-01

Introduction: The therapeutic modalities available for the conservative management of chronic lumbar pain included infrared laser therapy and underwater traction, which usefulness is not universally acknowledged. This study was intended to ascertain any beneficial impact of infrared laser therapy and weightbath treatment on the clinical parameters and quality of life of patients with lumbar discopathy. Material and methods: The study population comprised 54 randomised subjects. I. group of 18 patents received only infrared laser therapy to lumbar region and painful Valley points. II. group of 18 subjects each received underwater traction therapy of lumbar spine with add-on McKenzie exercise and iontophoresis. The remaining III. group treated with exercise and iontophoresis, served as control. VAS, Oswestry index, SF36 scores, range of motion, neurological findings and thermography were monitored to appraise therapeutic afficacy in lumbar discopathy. A CT or MRI scan was done at baseline and after 3 months follow-up. Result:Infrared laser therapy and underwater traction for discopathy achieved significant improvement of all study parameters, which was evident 3 months later. Among the controls, significant improvement of only a single parameter was seen in patients with lumbar discopathy. Conclusions: Infrared laser therapy and underwater traction treatment effectively mitigate pain, muscle spasms, enhance joint flexibility, and improve the quality of life of patients with lumbar discopathy.

LumenRECON Guidewire: Pilot Study of a Novel, Nonimaging Technology for Accurate Vessel Sizing and Delivery of Therapy in Femoropopliteal Disease.

PubMed

Nair, Pradeep K; Carr, Jeffrey G; Bigelow, Brian; Bhatt, Deepak L; Berwick, Zachary C; Adams, George

2018-01-01

Proper vessel sizing during endovascular interventions is crucial to avoid adverse procedural and clinical outcomes. LumenRECON (LR) is a novel, nonimaging, 0.035-inch wire-based technology that uses the physics-based principle of Ohm's law to provide a simple, real-time luminal size while also providing a platform for therapy delivery. This study evaluated the accuracy, reliability, and safety of the LR system in patients presenting for a femoropopliteal artery intervention. This multicenter, prospective pilot study of 24 patients presenting for peripheral intervention compared LR measurements of femoropopliteal artery size to angiographic visual estimation, duplex ultrasound, quantitative angiography, and intravascular ultrasound. The primary effectiveness and safety end point was comparison against core laboratory adjudicated intravascular ultrasound values and major adverse events, respectively. Additional preclinical studies were also performed in vitro and in vivo in swine to determine the accuracy of the LR guidewire system. No intra- or postprocedure device-related adverse events occurred. A balloon or stent was successfully delivered in 12 patients (50%) over the LR wire. Differences in repeatability between successive LR measurements was 2.5±0.40% ( R 2 =0.96) with no significant bias. Differences in measurements of LR to other modalities were 0.5±1.7%, 5.0±1.8%, -1.5±2.0%, and 6.8±3.4% for intravascular ultrasound core laboratory, quantitative angiography, angiographic, and duplex ultrasound, respectively. This study demonstrates that through a physics-based principle, LR provides a real-time, safe, reproducible, and accurate vessel size of the femoropopliteal artery during intervention and can additionally serve as a conduit for therapy delivery over its wire-based platform. © 2018 American Heart Association, Inc.

Efficacy and safety of oral alitretinoin in severe oral lichen planus--results of a prospective pilot study.

PubMed

Kunz, M; Urosevic-Maiwald, M; Goldinger, S M; Frauchiger, A L; Dreier, J; Belloni, B; Mangana, J; Jenni, D; Dippel, M; Cozzio, A; Guenova, E; Kamarachev, J; French, L E; Dummer, R

2016-02-01

Patients with severe oral lichen planus refractory to standard topical treatment currently have limited options of therapy suitable for long-term use. Oral alitretinoin (9-cis retinoic acid) was never systematically investigated in clinical trials, although case reports suggest its possible efficacy. To assess the efficacy and safety of oral alitretinoin taken at 30 mg once daily for up to 24 weeks in the treatment of severe oral lichen planus refractory to standard topical therapy. We conducted a prospective open-label single arm pilot study to test the efficacy and safety of 30 mg oral alitretinoin once daily for up to 24 weeks in severe oral lichen planus. Ten patients were included in the study. Primary end point was reduction in signs and symptoms measured by the Escudier severity score. Secondary parameters included pain and quality of life scores. Safety parameters were assessed during a follow-up period of 5 weeks. A substantial response at the end of treatment, i.e. >50% reduction in disease severity measured by the Escudier severity score, was apparent in 40% of patients. Therapy was well tolerated. Adverse events were mild and included headache, mucocutaneous dryness, musculoskeletal pain, increased thyroid-stimulating hormone and dyslipidaemia. Alitretinoin given at 30 mg daily reduced disease severity of severe oral lichen planus in a substantial proportion of patients refractory to standard treatment, was well tolerated and may thus represent one therapeutic option for this special group of patients. © 2015 European Academy of Dermatology and Venereology.

cDNA microarray analysis of human keratinocytes cells of patients submitted to chemoradiotherapy and oral photobiomodulation therapy: pilot study.

PubMed

Antunes, Heliton S; Wajnberg, Gabriel; Pinho, Marcos B; Jorge, Natasha Andressa Nogueira; de Moraes, Joyce Luana Melo; Stefanoff, Claudio Gustavo; Herchenhorn, Daniel; Araújo, Carlos M M; Viégas, Celia Maria Pais; Rampini, Mariana P; Dias, Fernando L; de Araujo-Souza, Patricia Savio; Passetti, Fabio; Ferreira, Carlos G

2018-01-01

Oral mucositis is an acute toxicity that occurs in patients submitted to chemoradiotherapy to treat head and neck squamous cell carcinoma. In this study, we evaluated differences in gene expression in the keratinocytes of the oral mucosa of patients treated with photobiomodulation therapy and tried to associate the molecular mechanisms with clinical findings. From June 2009 to December 2010, 27 patients were included in a randomized double-blind pilot study. Buccal smears from 13 patients were obtained at days 1 and 10 of chemoradiotherapy, and overall gene expression of samples from both dates were analyzed by complementary DNA (cDNA) microarray. In addition, samples from other 14 patients were also collected at D1 and D10 of chemoradiotherapy for subsequent validation of cDNA microarray findings by qPCR. The expression array analysis identified 105 upregulated and 60 downregulated genes in our post-treatment samples when compared with controls. Among the upregulated genes with the highest fold change, it was interesting to observe the presence of genes related to keratinocyte differentiation. Among downregulated genes were observed genes related to cytotoxicity and immune response. The results indicate that genes known to be induced during differentiation of human epidermal keratinocytes were upregulated while genes associated with cytotoxicity and immune response were downregulated in the laser group. These results support previous clinical findings indicating that the lower incidence of oral mucositis associated with photobiomodulation therapy might be correlated to the activation of genes involved in keratinocyte differentiation.

Effect of task-based mirror therapy on motor recovery of the upper extremity in chronic stroke patients: a pilot study.

PubMed

Arya, Kamal Narayan; Pandian, Shanta

2013-01-01

Mirror therapy (MT) is an alternative therapeutic intervention that uses the interaction of visuomotor-proprioception inputs to enhance movement performance of the impaired limb. Despite strong evidence for task-specific training in stroke, MT has been investigated using nontask movements. The aim of this pilot study was to assess the effectiveness of task-based MT on motor recovery of the upper extremity in chronic stroke patients. In a pretest-posttest single-group design, a convenience sample of 13 chronic stroke patients at an occupational therapy department of a rehabilitation institute was assessed on a task-based MT intervention. Participants received a task-based MT program, performing various tasks by the less affected upper extremity and observing in the mirror box along with conventional management, 4 days per week for 4 weeks. Fugl-Meyer Assessment (FMA), which includes subsection upper extremity (FMA-UE) and subpart upper arm (FMA-UA) and hand (FMA-WH), was used as an outcome measure. Participants showed no significant improvement for FMA-UE and FMA-UA at postassessment. FMA-UE changed from 43% to 51%. Post FMA-UA score showed only 2% improvement. However, there was statistically significant improvement on mean scores of FMA-WH at postassessment (16.21 ± 3.06) as compared with the prescores (12.29 ± 3.1; P < .05). FMA-WH improved from 41% to 54%. The preliminary findings suggest that task-based MT is effective in improving wrist and hand motor recovery in chronic stroke patients. Further studies in the form of randomized trials are needed to validate its effectiveness.

Relationship Between Lymph Node Volume and Pain Following Certolizumab Therapy for Rheumatoid Arthritis Flare: A Pilot Study.

PubMed

Rahimi, Homaira; Dieudonne, Gregory; Kheyfits, Valeriy; Bouta, Echoe M; Wood, Ronald W; Barrett, Rick; Moorehead, Sharon; Schwarz, Edward M; Ritchlin, Christopher T

2016-01-01

The mechanisms that trigger flare in rheumatoid arthritis (RA) are unknown. In murine arthritis models, dysfunctional lymph node (LN) drainage is associated with joint flare. To examine if LN alterations are associated with RA flare, we analyzed the change in LN volume via contrast-enhanced magnetic resonance imaging (CE-MRI) in patients with active joint flare at baseline and 16 weeks after certolizumab pegol (CZP) therapy. We also assessed the changes in popliteal or epitrochlear LN volumes versus the Rheumatoid and Arthritis Outcome Score (RAOS) (knee), or the Michigan Hand Questionnaire (MHQ; wrist/hand), and Disease Activity Score 28 (DAS28), at baseline and 16 weeks. Total LN volume in 7 of 10 patients with measurable LN on CE-MRI significantly decreased 16 weeks after CZP therapy (mean decrease 37%; P = 0.0019). Improvement in knee pain measured by the RAOS ( P = 0.03) inversely correlated with a decrease in total popliteal LN volume ( R 2 = 0.94). All patients demonstrated significant improvement in DAS28 (mean decrease 1.48; P = 0.0002). For flare in the hand, significant improvement in activities of daily living (ADL) as measured by the MHQ was observed (left hand mean improvement 20%; P = 0.02; right hand mean improvement 37%; P = 0.03). RA patients with the smallest change in LN volume during anti-tumor necrosis factor (anti-TNF) therapy experienced the greatest pain relief in symptomatic knee joints. Moreover, the remarkably linear inverse correlation between LN volume and joint pain observed in this small clinical pilot provides initial evidence to support the concept that dynamic changes in draining LN volume are a biomarker of clinical response to therapy in RA.

[Music therapy in different dental specialties].

PubMed

Mehr, Katarzyna; Wyganowska-Swiatkowska, Marzena; Kowalkowska, Iwona; Kurhańska-Flisykowska, Anna; Piotrowski, Paweł

2012-01-01

Music is generally recognized as the best and, in parallel, the simplest medium of communication. The music therapy, applied in various spheres linked to a therapeutic process, is particularly valued in rehabilitation, medicine, humanities and social sciences. Present study aimed at determination of usefulness of selected techniques of music therapy in different dental specialties. The studies were conducted on 81 generally healthy patients aging 18 to 62 years. Various planned dental procedures were performed first time or were appraised by the patients as unpleasant ones. On the basis of pilot studies, a stable scheme of the visits was established. At the beginning of the studies, music therapy according to Kierył was conducted. Subsequently, basing on description of Schwabe, a form of regulatory individual music therapy was conducted. Depending on psychoemotional condition of the patient, music programming was based on ISO and LEVEL principles, taking into account musical preferences of the patient and his/her age. After every visit the patients filled questionnaires and appropriate results, together with results of studies performed by the dentist, were subjected to statistical analysis. 1. Results of the studies encourage application of musicotherapeutic techniques in different dental specialties. 2. Dental visit can be made attractive and patient's visits in dental office can be facilitated with no significant financial input or organizational.

Hope Therapy in a Community Sample: A Pilot Investigation

ERIC Educational Resources Information Center

Cheavens, Jennifer S.; Feldman, David B.; Gum, Amber; Michael, Scott T.; Snyder, C. R.

2006-01-01

We report findings from an initial empirical test of a hope-based, group therapy protocol. In this context, hope is defined as a cognitive process through which individuals pursue their goals [Snyder, C. R.: 1994, Free Press, New York]. As such, the eight-session group treatment emphasized building goal-pursuit skills. Findings from a randomized,…

Changes in co-contraction during stair descent after manual therapy protocol in knee osteoarthritis: A pilot, single-blind, randomized study.

PubMed

Cruz-Montecinos, Carlos; Flores-Cartes, Rodrigo; Montt-Rodriguez, Agustín; Pozo, Esteban; Besoaín-Saldaña, Alvaro; Horment-Lara, Giselle

2016-10-01

Manual therapy has shown clinical results in patients with knee osteoarthritis. However, the biomechanical aspects during functional tasks have not been explored in depth. Through surface electromyography, the medial and lateral co-contractions of the knee were measured while descending stairs, prior and posterior to applying a manual therapy protocol in the knee, with emphasis on techniques of joint mobilization and soft-tissue management. Sixteen females with slight or moderate knee osteoarthritis were recruited (eight experimental, eight control). It was observed that the lateral co-contraction index of the experimental group, posterior to intervention, increased by 11.7% (p = 0.014). The application of a manual therapy protocol with emphasis on techniques of joint mobilization and soft-tissue management modified lateral co-contraction, which would have a protective effect on the joint. Copyright © 2016 Elsevier Ltd. All rights reserved.

Evaluation of a multi-component approach to cognitive-behavioral therapy (CBT) using guided visualizations, cranial electrotherapy stimulation, and vibroacoustic sound.

PubMed

Rogers, Donna R B; Ei, Sue; Rogers, Kim R; Cross, Chad L

2007-05-01

This pilot study examines the use of guided visualizations that incorporate both cognitive and behavioral techniques with vibroacoustic therapy and cranial electrotherapy stimulation to form a multi-component therapeutic approach. This multi-component approach to cognitive-behavioral therapy (CBT) was used to treat patients presenting with a range of symptoms including anxiety, depression, and relationship difficulties. Clients completed a pre- and post-session symptom severity scale and CBT skills practice survey. The program consisted of 16 guided visualizations incorporating CBT techniques that were accompanied by vibroacoustic therapy and cranial electrotherapy stimulation. Significant reduction in symptom severity was observed in pre- and post-session scores for anxiety symptoms, relationship difficulties, and depressive symptoms. The majority of the clients (88%) reported use of CBT techniques learned in the guided visualizations at least once per week outside of the sessions.

Comparing Mindfulness-Based Group Therapy With Treatment as Usual for Opioid Dependents: A Pilot Randomized Clinical Trial Study Protocol.

PubMed

Imani, Saeed; Atef Vahid, Mohammad Kazem; Gharraee, Banafsheh; Habibi, Mojtaba; Bowen, Sarah; Noroozi, Alireza

2015-03-01

In response to high burden of opioid abuse in Iran, Ministry of Health has launched a large-scale opioid maintenance treatment program, delivered through a network of certified drug treatment centers. To promote opioid pharmacotherapies, there is an urgent need to develop and introduce evidence-based psychosocial interventions into the network. This is a randomized clinical trial (RCT) to investigate feasibility and effectiveness of adding mindfulness-based group therapy to opioid pharmacotherapies as compared to opioid pharmacotherapies alone. The primary outcomes were treatment retention and percentage of weekly morphine, methamphetamine, and benzodiazepine negative tests. This is the first RCT that explores the effectiveness of mindfulness-based relapse prevention group therapy among opioid dependent clients in Iran. The feasibility of group therapy and comparison of outcomes in intervention and control groups should be discussed in the outcome article.

Two-year results after convective radiofrequency water vapor thermal therapy of symptomatic benign prostatic hyperplasia.

PubMed

Dixon, Christopher M; Cedano, Edwin Rijo; Pacik, Dalibor; Vit, Vítězslav; Varga, Gabriel; Wagrell, Lennart; Larson, Thayne R; Mynderse, Lance A

2016-01-01

The objective of this study was to assess the effectiveness and safety of convective radiofrequency (RF) water vapor thermal therapy in men with lower urinary tract symptoms (LUTS) associated with benign prostatic hyperplasia (BPH); a pilot study design with 2-year follow-up evaluations. Men aged ≥45 years with an International Prostate Symptom Score ≥13, a maximum urinary flow rate (Q max ) ≤15 mL/s, and prostate volume 20-120 cc were enrolled in a prospective, open-label pilot study using convective RF water vapor energy with the Rezūm System. Patients were followed up for 2 years after transurethral thermal treatment at 3 international centers in the Dominican Republic, Czech Republic, and Sweden. The transurethral thermal therapy utilizes radiofrequency to generate wet thermal energy in the form of water vapor injected through a rigid endoscope into the lateral lobes and median lobe as needed. Urinary symptom relief, urinary flow, quality of life (QOL) impact, sexual function, and adverse events (AEs) were assessed at 1 week, 1, 3, 6, 12, and 24 months. LUTS, flow rate, and QOL showed significant improvements from baseline; prostate volumes were appreciably reduced. Sexual function was maintained and no de novo erectile dysfunction occurred. The responses evident as early as 1 month after treatment remained consistent and durable over the 24 months of study. Early AEs were typically transient and mild to moderate; most were related to endoscopic instrumentation. No procedure related to late AEs were seen. The Rezūm System convective RF thermal therapy is a minimally invasive treatment for BPH/LUTS which can be performed in the office or as an outpatient procedure with minimal associated perioperative AEs. It has no discernable effect on sexual function and provides significant improvement of LUTS that remain durable at 2 years.

Two-year results after convective radiofrequency water vapor thermal therapy of symptomatic benign prostatic hyperplasia

PubMed Central

Dixon, Christopher M; Cedano, Edwin Rijo; Pacik, Dalibor; Vit, Vítězslav; Varga, Gabriel; Wagrell, Lennart; Larson, Thayne R; Mynderse, Lance A

2016-01-01

Objective The objective of this study was to assess the effectiveness and safety of convective radiofrequency (RF) water vapor thermal therapy in men with lower urinary tract symptoms (LUTS) associated with benign prostatic hyperplasia (BPH); a pilot study design with 2-year follow-up evaluations. Patients and methods Men aged ≥45 years with an International Prostate Symptom Score ≥13, a maximum urinary flow rate (Qmax) ≤15 mL/s, and prostate volume 20–120 cc were enrolled in a prospective, open-label pilot study using convective RF water vapor energy with the Rezūm System. Patients were followed up for 2 years after transurethral thermal treatment at 3 international centers in the Dominican Republic, Czech Republic, and Sweden. The transurethral thermal therapy utilizes radiofrequency to generate wet thermal energy in the form of water vapor injected through a rigid endoscope into the lateral lobes and median lobe as needed. Urinary symptom relief, urinary flow, quality of life (QOL) impact, sexual function, and adverse events (AEs) were assessed at 1 week, 1, 3, 6, 12, and 24 months. Results LUTS, flow rate, and QOL showed significant improvements from baseline; prostate volumes were appreciably reduced. Sexual function was maintained and no de novo erectile dysfunction occurred. The responses evident as early as 1 month after treatment remained consistent and durable over the 24 months of study. Early AEs were typically transient and mild to moderate; most were related to endoscopic instrumentation. No procedure related to late AEs were seen. Conclusion The Rezūm System convective RF thermal therapy is a minimally invasive treatment for BPH/LUTS which can be performed in the office or as an outpatient procedure with minimal associated perioperative AEs. It has no discernable effect on sexual function and provides significant improvement of LUTS that remain durable at 2 years. PMID:27921028

A Pilot Prospective Randomized Control Trial Comparing Exercises Using Videogame Therapy to Standard Physical Therapy: 6 Months Follow-Up.

PubMed

Parry, Ingrid; Painting, Lynda; Bagley, Anita; Kawada, Jason; Molitor, Fred; Sen, Soman; Greenhalgh, David G; Palmieri, Tina L

2015-01-01

Commercially available, interactive videogames that use body movements for interaction are used clinically in burn rehabilitation and have been shown to facilitate functional range of motion (ROM) but their efficacy with burn patients has not yet been proven. The purpose of this pilot randomized control study was to prospectively compare planar and functional ROM, compliance, pain, enjoyment, and exertion in pediatric burn patients receiving two types of rehabilitation therapy. Seventeen school-aged children with 31 affected limbs who demonstrated limited shoulder ROM from burn injury were randomized to receive exercises using either standard therapy ROM activities (ST) or interactive videogame therapy (VGT). Patients received 3 weeks of the designated therapy intervention twice daily. They were then given a corresponding home program of the same type of therapy to perform regularly for 6 months. Standard goniometry and three-dimensional motion analysis during functional tasks were used to assess ROM. Measures were taken at baseline, 3 weeks, 3 months, and 6 months. Pain was measured before and after each treatment session during the 3-week intervention. There was no difference in compliance, enjoyment, or exertion between the groups. Patients in both the ST and VGT groups showed significant improvement in shoulder flexion (P < .001), shoulder abduction (P <.001), shoulder external rotation (P = .01), and elbow flexion (P = .004) ROM from baseline to 6 months as measured with goniometry. Subjects also showed significant gains in elbow flexion (P = .04) during hand to head and shoulder flexion (P = .04) during high reach. There was no difference in ROM gains between the groups. Within group comparison showed that the VGT group had significantly more recovery of ROM during the first 3 weeks than any other timeframe in the study, whereas ST had most gains at 3 months. There was a significant difference between the groups in the subjects' pain response. ST subjects showed an increase in pain during the intervention, whereas VGT subjects did not (VGT: r = .047, ST: r = .18; P = .015). In this study, interactive videogames were equally effective as traditional therapy for overall ROM gains and resulted in quicker recovery of motion with less pain experienced. Such videogames are a useful adjunct to therapy and should be considered as part of a holistic approach to rehabilitation within the hospital and at home after discharge in pediatric patients recovering from burn injury.

[Effects of an intensive thalassotherapy and aquatic therapy program in stroke patients. A pilot study].

PubMed

Morer, C; Boestad, C; Zuluaga, P; Alvarez-Badillo, A; Maraver, F

2017-09-16

Stroke remains the leading cause of acquired disability. Health and social planning and management may vary and although prevention is crucial, having better treatments and strategies to reduce disability is needed. To determine the effect of an intensive program of thalassotherapy and aquatic therapy in stroke patients, valuing clinical parameters and functional validated scales. A quasi-experimental prospective study consisting of a specific program assessed pre- and post- 3 weeks treatment to 26 stroke patients with a mild-moderate disability. The outcomes measured were: Berg Balance scale, Timed Up and Go test, 10-meter walking test, 6-minute walking test and pain Visual Analogue Scale. After intervention, participants had a significant improvement in all outcomes measured. Our results suggest that an intensive program of thalassotherapy and aquatic therapy could be useful during stroke rehabilitation to improve balance, gait and pain.

Investigating relationships between left atrial volume, symmetry, and sphericity

NASA Astrophysics Data System (ADS)

Menon, Prahlad G.; Nedios, Sotiris; Hindricks, Gerhard; Bollmann, Andreas

2016-03-01

Catheter ablation is a safe and effective therapy for drug-refractory patients symptomatic of atrial fibrillation (AF), with up to 80% of patients experiencing long-term arrhythmia-free survival. However, up to 20-40% of patients require more than one procedure in order to become arrhythmia-free. Therefore, appropriate patient selection is paramount to the effective implementation and long-term success of ablation therapy for patients with atrial fibrillation (AF). In this study, as a precursor to evaluating clinical significance of specific LA shape metrics as pre-procedural predictors of AF recurrence following ablative pulmonary vein isolation therapy, we report on a computational geometric analysis in a pilot cohort evaluating relationships between various patient-specific metrics of LA shape which might have such predictive value. This study specifically is focused on establishing the relationship between LA volume and sphericity, using a novel methodology for computing atrial sphericity based on regional shape.

Effect of integrated Yoga and Physical therapy on audiovisual reaction time, anxiety and depression in patients with chronic multiple sclerosis: a pilot study.

PubMed

Chobe, Shivaji; Bhargav, Hemant; Raghuram, Nagarathna; Garner, Christoph

2016-09-01

Multiple sclerosis (MS) is characterized by a significant deterioration in auditory and visual reaction times along with associated depression and anxiety. Yoga and Physical therapy (PT) interventions have been found to enhance recovery from these problems in various neuropsychiatric illnesses, but sufficient evidence is lacking in chronic MS population. The aim of this study was to assess the effect of integrated Yoga and Physical therapy (IYP) on audiovisual reaction times, depression and anxiety in patients suffering from chronic MS. From a neuro-rehabilitation center in Germany, 11 patients (six females) suffering from MS for 19±7.4 years were recruited. Subjects were in the age range of 55.45±10.02 years and had Extended Disability Status Scores (EDSS) below 7. All the subjects received mind-body intervention of integrated Yoga and Physical therapy (IYP) for 3 weeks. The intervention was given in a residential setup. Patients followed a routine involving Yogic physical postures, pranayama, and meditations along with various Physical therapy (PT) techniques for 21 days, 5 days a week, 5 h/day. They were assessed before and after intervention for changes in audiovisual reaction times (using Brain Fit Model No. OT 400), anxiety, and depression [using Hospital Anxiety and Depression Scale (HADS)]. Data was analyzed using paired samples test. There was significant improvement in visual reaction time (p=0.01), depression (p=0.04), and anxiety (p=0.02) scores at the end of 3 weeks as compared to the baseline. Auditory reaction time showed reduction with borderline statistical significance (p=0.058). This pilot project suggests utility of IYP intervention for improving audiovisual reaction times and psychological health in chronic MS patients. In future, randomized controlled trials with larger sample size should be performed to confirm these findings.

Interdisciplinary concepts for design and implementation of mixed reality interactive neurorehabilitation systems for stroke.

PubMed

Baran, Michael; Lehrer, Nicole; Duff, Margaret; Venkataraman, Vinay; Turaga, Pavan; Ingalls, Todd; Rymer, W Zev; Wolf, Steven L; Rikakis, Thanassis

2015-03-01

Interactive neurorehabilitation (INR) systems provide therapy that can evaluate and deliver feedback on a patient's movement computationally. There are currently many approaches to INR design and implementation, without a clear indication of which methods to utilize best. This article presents key interactive computing, motor learning, and media arts concepts utilized by an interdisciplinary group to develop adaptive, mixed reality INR systems for upper extremity therapy of patients with stroke. Two INR systems are used as examples to show how the concepts can be applied within: (1) a small-scale INR clinical study that achieved integrated improvement of movement quality and functionality through continuously supervised therapy and (2) a pilot study that achieved improvement of clinical scores with minimal supervision. The notion is proposed that some of the successful approaches developed and tested within these systems can form the basis of a scalable design methodology for other INR systems. A coherent approach to INR design is needed to facilitate the use of the systems by physical therapists, increase the number of successful INR studies, and generate rich clinical data that can inform the development of best practices for use of INR in physical therapy. © 2015 American Physical Therapy Association.