Improving Classroom Learning Environments by Cultivating Awareness and Resilience in Education (CARE): Results of Two Pilot Studies

ERIC Educational Resources Information Center

Jennings, Patricia A.; Snowberg, Karin E.; Coccia, Michael A.; Greenberg, Mark T.

2011-01-01

Cultivating Awareness and Resilience in Education (CARE) is a professional development program designed to reduce stress and improve teachers' performance. Two pilot studies examined program feasibility and attractiveness and preliminary evidence of efficacy. Study 1 involved educators from a high-poverty urban setting (n = 31). Study 2 involved…

Further Evidence for the Efficacy of an Evidence-Based, Small Group, Literacy Intervention Program for Young Struggling Readers

ERIC Educational Resources Information Center

Wheldall, Kevin; Wheldall, Robyn; Madelaine, Alison; Reynolds, Meree; Arakelian, Sarah

2017-01-01

An earlier series of pilot studies and small-scale experimental studies had previously provided some evidence for the efficacy of a small group early literacy intervention program for young struggling readers. The present paper provides further evidence for efficacy based on a much larger sample of young, socially disadvantaged, at-risk readers.…

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.

Pilot Study of Community-Based Cognitive Behavioral Group Therapy for Adolescents with Social Phobia.

ERIC Educational Resources Information Center

Baer, Susan; Garland, E. Jane

2005-01-01

Objective: A pilot study to evaluate the efficacy of a cognitive-behavioral group therapy program for adolescents with social phobia, simplified both in terms of time and labor intensity from a previously studied program (Social Effectiveness Therapy for Children and Adolescents) to be more appropriate for a community outpatient psychiatric…

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…

The Feasibility of Virtual Home Visits to Provide Early Intervention: A Pilot Study

ERIC Educational Resources Information Center

Kelso, Ginger L.; Fiechtl, Barbara J.; Olsen, Susan T.; Rule, Sarah

2009-01-01

Although videoconferencing has been used to deliver distance education, tutoring for children, and telemedicine observations, there is limited information on the efficacy of its use in delivering part C early intervention services. Four families receiving early intervention services in a rural program participated in a pilot study to test the…

Prediction and measurement of human pilot dynamic characteristics

NASA Technical Reports Server (NTRS)

Hess, Ronald A.; Reedy, James T.

1988-01-01

An analytical and experimental study of human pilot control strategies in a manned rotorcraft simulation is described. The task simulated involves a low-speed, constant-altitude maneuvering task in which a head-down display is utilized to allow the pilot to track a moving hover point. The efficacy of the display law driving an 'acceleration symbol' is determined and the manner in which the prediction and measurement of pilot/vehicle dynamics can be made part of man/machine system evaluations is demonstrated.

A Pilot Controlled Trial of Topiramate for Mania in Children and Adolescents with Bipolar Disorder.

ERIC Educational Resources Information Center

DelBello, Melissa P.; Findling, Robert L.; Kushner, Stuart; Wang, Daniel; Olson, William H.; Capece, Julie A.; Fazzio, Lydia; Rosenthal, Norman R.

2005-01-01

Objective: To assess the efficacy of topiramate monotherapy for acute mania in children and adolescents with bipolar disorder type 1. Method: This double-blind, placebo-controlled study was discontinued early when adult mania trials with topiramate failed to show efficacy. Efficacy end points included the Young Mania Rating Scale (YMRS), Brief…

78 FR 19649 - Fisheries of the Caribbean, Gulf of Mexico, and South Atlantic; Reef Fish Fishery of the Gulf of...

Federal Register 2010, 2011, 2012, 2013, 2014

2013-04-02

...- year pilot study. This study, to be conducted in the exclusive economic zone (EEZ) of the Gulf of... effectiveness of a more timely electronic data reporting system; and evaluate the potential social and economic... conduct a pilot study to evaluate the efficacy of an allocation-based management strategy, which if proven...

A six week contextualised physical activity intervention for women living with HIV and AIDS of low socioeconomic status: a pilot study.

PubMed

Mabweazara, S Z; Leach, L L; Ley, C; Smith, M

2018-05-30

Research has consistently shown the benefits of regular physical activity (PA) for women living with HIV and AIDS (WLWHA). This study is a pilot, randomised controlled crossover trial, reporting the effects of a contextualised PA intervention amongst a sample of 21 HIV positive Xhosa-speaking women of low socioeconomic status (SES). The study determined total moderate-to-vigorous PA (TMVPA) as measured subjectively by the Global Physical Activity Questionnaire (GPAQ), total weekly steps (TWS) as measured by a pedometer, and self-efficacy for PA as measured by the Physical Exercise Self-efficacy scale (PESES). Multivariate analysis of covariance (MANCOVA) was used to compute the impact of the intervention on TMVPA, TWS, and self-efficacy for PA from baseline to six weeks, and baseline to 12 weeks post-intervention controlling for pre-test differences in TMVPA. Results showed that participants exposed to the intervention had significant increases in PA as measured by TMVPA (p = .027), TWS (p = .032), as well as exercise self-efficacy (p = .000) from pre-test to 6 weeks. Insignificant findings were reported for all three variables when measured from baseline to 12 weeks. In conclusion, the findings of the pilot study suggest that the intervention was effective in producing significant increases in PA in a sample of PLWHA of low SES over six weeks. Careful consideration of behavioural constructs, such as self-efficacy, can help WLWHA of low SES to adopt regular PA as a complementary therapy for managing their health.

Enhancing Learners' Problem Solving Performance in Mathematics: A Cognitive Load Perspective

ERIC Educational Resources Information Center

Dhlamini, Joseph J.

2016-01-01

This paper reports on a pilot study that investigated the effect of implementing a context-based problem solving instruction (CBPSI) to enhance the problem solving performance of high school mathematics learners. Primarily, the pilot study aimed: (1) to evaluate the efficiency of data collection instruments; and, (2) to test the efficacy of CBPSI…

Mindfulness for Teachers: A Pilot Study to Assess Effects on Stress, Burnout, and Teaching Efficacy

ERIC Educational Resources Information Center

Flook, Lisa; Goldberg, Simon B.; Pinger, Laura; Bonus, Katherine; Davidson, Richard J.

2013-01-01

Despite the crucial role of teachers in fostering children's academic learning and social-emotional well-being, addressing teacher stress in the classroom remains a significant challenge in education. This study reports results from a randomized controlled pilot trial of a modified Mindfulness-Based Stress Reduction course (mMBSR) adapted…

A Social-Cognitive Intervention Program for Adolescents with Autism: A Pilot Study

ERIC Educational Resources Information Center

Cheung, Pui Pui Phoebe; Siu, Andrew M. H.; Brown, Ted; Yu, Mong-lin

2018-01-01

This pilot study explored the efficacy of a social-cognitive intervention program for adolescents with Autism Spectrum Disorder (ASD). Seven adolescents with ASD (mean age = 12.57 years) attended a school-based 10-week program. Social Skills Improvement System Rating Scales, Goal Attainment Scaling (GAS), and Theory of Mind Inventory were…

A new computer-based counselling system for the promotion of physical activity in patients with chronic diseases--results from a pilot study.

PubMed

Becker, Annette; Herzberg, Dominikus; Marsden, Nicola; Thomanek, Sabine; Jung, Hartmut; Leonhardt, Corinna

2011-05-01

To develop a computer-based counselling system (CBCS) for the improvement of attitudes towards physical activity in chronically ill patients and to pilot its efficacy and acceptance in primary care. The system is tailored to patients' disease and motivational stage. During a pilot study in five German general practices, patients answered questions before, directly and 6 weeks after using the CBCS. Outcome criteria were attitudes and self-efficacy. Qualitative interviews were performed to identify acceptance indicators. Seventy-nine patients participated (mean age: 64.5 years, 53% males; 38% without previous computer experience). Patients' affective and cognitive attitudes changed significantly, self-efficacy showed only minor changes. Patients mentioned no difficulties in interacting with the CBCS. However, perception of the system's usefulness was inconsistent. Computer-based counselling for physical activity related attitudes in patients with chronic diseases is feasible, but the circumstances of use with respect to the target group and its integration into the management process have to be clarified in future studies. This study adds to the understanding of computer-based counselling in primary health care. Acceptance indicators identified in this study will be validated as part of a questionnaire on technology acceptability in a subsequent study. Copyright © 2010 Elsevier Ireland Ltd. All rights reserved.

A pilot study of the efficacy of a computerized executive functioning remediation training with game elements for children with ADHD in an outpatient setting: outcome on parent- and teacher-rated executive functioning and ADHD behavior.

PubMed

van der Oord, S; Ponsioen, A J G B; Geurts, H M; Ten Brink, E L; Prins, P J M

2014-11-01

This pilot study tested the short- and long-term efficacy (9 weeks follow-up) of an executive functioning (EF) remediation training with game elements for children with ADHD in an outpatient clinical setting, using a randomized controlled wait-list design. Furthermore, in a subsample, that is, those treated with methylphenidate, additive effects of the EF training were assessed. A total of 40 children (aged 8-12 years) were randomized to the EF training or wait-list. The training consisted of a 25-session training of inhibition, cognitive flexibility, and working memory. Treatment outcome was assessed by parent- and teacher-rated EF, ADHD, oppositional deviant disorder, and conduct disorder symptoms. Children in the EF training showed significantly more improvement than those in the wait-list condition on parent-rated EF and ADHD behavior in the total sample and in the subsample treated with methylphenidate. Effects were maintained at follow-up. This pilot study shows promising evidence for the efficacy of an EF training with game elements. © 2012 SAGE Publications.

Improvement in Stress, General Self-Efficacy, and Health Related Quality of Life following Patient Education for Patients with Neuroendocrine Tumors: A Pilot Study.

PubMed

Haugland, Trude; Veenstra, Marijke; Vatn, Morten H; Wahl, Astrid K

2013-01-01

The purpose of the study was to evaluate changes in general self-efficacy, health related quality of life (HRQoL), and stress among patients with neuroendocrine tumors (NET) following a multidisciplinary educational intervention. Forty-one patients were enrolled in this exploratory pilot study. A total of 37 patients completed the full 26-week intervention based on the principles of self-efficacy. General self-efficacy was measured by the General Self-Efficacy Scale, HRQoL was measured with the SF-36, and stress was measured with the Impact of Event Scale. Mixed effect models were used to evaluate changes in general self-efficacy, mental and physical components of HRQoL, and stress adjusting for demographic and clinical variables. Results showed significant improvements in patients' general self-efficacy (β = 0.71; P < 0.05), physical component scores of HRQoL (β = 3.09; P < 0.01), and stress (β = -2.10, P = 0.008). Findings suggest that patients with NET have the capacity to improve their ability to cope with their disease, problem-solve, improve their physical status, and reduce their stress following an educational intervention based on the principles of self-efficacy. These preliminary data provide a basis for future randomized controlled trials to test interventions to improve HRQoL for patients with NET.

Investigating the Efficacy of Practical Skill Teaching: A Pilot-Study Comparing Three Educational Methods

ERIC Educational Resources Information Center

Maloney, Stephen; Storr, Michael; Paynter, Sophie; Morgan, Prue; Ilic, Dragan

2013-01-01

Effective education of practical skills can alter clinician behaviour, positively influence patient outcomes, and reduce the risk of patient harm. This study compares the efficacy of two innovative practical skill teaching methods, against a traditional teaching method. Year three pre-clinical physiotherapy students consented to participate in a…

An open-label pilot study to assess the efficacy and safety of virgin coconut oil in reducing visceral adiposity.

PubMed

Liau, Kai Ming; Lee, Yeong Yeh; Chen, Chee Keong; Rasool, Aida Hanum G

2011-01-01

Introduction. This is an open-label pilot study on four weeks of virgin coconut oil (VCO) to investigate its efficacy in weight reduction and its safety of use in 20 obese but healthy Malay volunteers. Methodology. Efficacy was assessed by measuring weight and associated anthropometric parameters and lipid profile one week before and one week after VCO intake. Safety was assessed by comparing organ function tests one week before and one week after intake of VCO. Paired t-test was used to analyse any differences in all the measurable variables. Results. Only waist circumference (WC) was significantly reduced with a mean reduction of 2.86 cm or 0.97% from initial measurement (P = .02). WC reduction was only seen in males (P < .05). There was no change in the lipid profile. There was a small reduction in creatinine and alanine transferase levels. Conclusion. VCO is efficacious for WC reduction especially in males and it is safe for use in humans.

An Open-Label Pilot Study to Assess the Efficacy and Safety of Virgin Coconut Oil in Reducing Visceral Adiposity

PubMed Central

Liau, Kai Ming; Lee, Yeong Yeh; Chen, Chee Keong; Rasool, Aida Hanum G.

2011-01-01

Introduction. This is an open-label pilot study on four weeks of virgin coconut oil (VCO) to investigate its efficacy in weight reduction and its safety of use in 20 obese but healthy Malay volunteers. Methodology. Efficacy was assessed by measuring weight and associated anthropometric parameters and lipid profile one week before and one week after VCO intake. Safety was assessed by comparing organ function tests one week before and one week after intake of VCO. Paired t-test was used to analyse any differences in all the measurable variables. Results. Only waist circumference (WC) was significantly reduced with a mean reduction of 2.86 cm or 0.97% from initial measurement (P = .02). WC reduction was only seen in males (P < .05). There was no change in the lipid profile. There was a small reduction in creatinine and alanine transferase levels. Conclusion. VCO is efficacious for WC reduction especially in males and it is safe for use in humans. PMID:22164340

A Double-Blind, Placebo-Controlled Study of Risperidone for the Treatment of Adolescents and Young Adults with Anorexia Nervosa: A Pilot Study

ERIC Educational Resources Information Center

Hagman, Jennifer; Gralla, Jane; Sigel, Eric; Ellert, Swan; Dodge, Mindy; Gardner, Rick; O'Lonergan, Teri; Frank, Guido; Wamboldt, Marianne Z.

2011-01-01

Objective: The purpose of this double-blind, placebo-controlled exploratory pilot study was to evaluate the safety and efficacy of risperidone for the treatment of anorexia nervosa. Method: Forty female subjects 12 to 21 years of age (mean, 16 years) with primary anorexia nervosa in an eating disorders program were randomized to receive…

Qigong Sensory Training Pilot Study: A Tactile Home Program for Children with or At-Risk for Autism

ERIC Educational Resources Information Center

Tal-Atzili, Orit; Salls, Joyce

2017-01-01

This pilot study investigated the efficacy of Qigong Sensory Training, a parent-implemented tactile intervention, in improving sensory processing and self-regulation in children with or at-risk for autism who were enrolled in early intervention. A pretest-posttest, single-subject design was implemented with three families. After 5 months, atypical…

Sharing the Data along with the Responsibility: Examining an Analytic Scale-Based Model for Assessing School Climate.

ERIC Educational Resources Information Center

Shindler, John; Taylor, Clint; Cadenas, Herminia; Jones, Albert

This study was a pilot effort to examine the efficacy of an analytic trait scale school climate assessment instrument and democratic change system in two urban high schools. Pilot study results indicate that the instrument shows promising soundness in that it exhibited high levels of validity and reliability. In addition, the analytic trait format…

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…

Open-Trial Pilot Study of a Comprehensive School-Based Intervention for High-Functioning Autism Spectrum Disorders

ERIC Educational Resources Information Center

Lopata, Christopher; Thomeer, Marcus L.; Volker, Martin A.; Lee, Gloria K.; Smith, Tristram H.; Rodgers, Jonathan D.; Smith, Rachael A.; Gullo, Gaetano; McDonald, Christin A.; Mirwis, Joshua; Toomey, Jennifer A.

2013-01-01

There is a notable lack of manualized comprehensive school-based interventions (CSBIs) for children with high-functioning autism spectrum disorders (HFASDs). This pilot study examined the feasibility and initial efficacy of a CSBI for 12 children with HFASDs, aged 6 to 9 years. Treatment included a 3-week summer preparation program followed by a…

Prediction and measurement of human pilot dynamic characteristics in a manned rotorcraft simulation

NASA Technical Reports Server (NTRS)

Hess, Ronald A.; Reedy, James T.

1988-01-01

An analytical and experimental study of the human pilot control strategies in a manned rotorcraft simulation is described. The task simulated involves a low-speed, constant-altitude maneuvering task in which a head-down display is utilized to allow the pilot to track a moving hover point. The efficacy of the display law driving an acceleration symbol is determined and the manner in which the prediction and measurement of pilot/vehicle dynamics can be made part of man/machine system evaluations is demonstrated.

LAM Pilot Study with Imatinib Mesylate (LAMP-1)

DTIC Science & Technology

2017-10-01

AWARD NUMBER: W81XWH-14-1-0132 TITLE: LAM Pilot Study with Imatinib Mesylate (LAMP-1) PRINCIPAL INVESTIGATOR: Charlie Strange, MD...completion dates or the percentage of completion. The LAMP-1 study is designed to generate short-term safety and efficacy data...block the growth of LAM cells through initiation of targeted cell death. This study employs a small clinical trial design using 20 participants at two

[Efficacy of Arnica in varicose vein surgery: results of a randomized, double-blind, placebo-controlled pilot study].

PubMed

Wolf, M; Tamaschke, C; Mayer, W; Heger, M

2003-10-01

In homeopathy ARNICA is widely used as a woundhealing medication and for the treatment of hematomas. In this pilot study the efficacy and safety of ARNICA D12 in patients following varicose vein surgery were investigated. Prospective, randomized, double-blind, placebo-controlled pilot trial according to ICH GCP guidelines. The study was conducted by a surgeon at the Angiosurgical Clinic, Berlin- Buch. After randomized allocation, 60 patients received either ARNICA D12 or placebo. Start of medication occurred the evening before operation with 5 globules. On the operation day one preoperative and hourly postoperative dosages after awakening were given. On days 2-14 of the study 5 globules 3 times a day were given. OUTCOME CRITERIA: Surface (in cm(2) and using a three-point verbal rating scale) and intensity of hematomas induced by operation, complications of wound healing, and intensity of pain (five-point verbal rating scale) as well as efficacy and safety of the study medication were assessed. Hematoma surface was reduced (from day 7 to day 14) under ARNICA by 75.5% and under placebo by 71.5% (p = 0.4726). The comparison of hematoma surface (small, medium, large) using the verbal rating scale yielded a value of p = 0.1260. Pain score decreased by 1.0 +/- 2.2 points under ARNICA and 0.3 +/- 0.8 points under placebo (p = 0.1977). Remission or improvement of pain was observed in 43.3% of patients in the ARNICA group and in 27.6% of patients in the placebo group. Tolerability was rated as very good in all cases. The results of this pilot study showed a trend towards a beneficial effect of ARNICA D12 with regard to reduction of hematoma and pain during the postoperative course. For a statistically significant proof of efficacy of ARNICA D12 in patients following varicose vein surgery a larger sample size is necessary. Copyright 2003 S. Karger GmbH, Freiburg

Measuring Literary Reading Motivation: Questionnaires Design and Pilot Testing

ERIC Educational Resources Information Center

Chrysos, Michail

2017-01-01

This study aims to present the design and pilot testing procedures of the two specific self-report questionnaires were used to measure the two key aspects of reading motivation, self-efficacy and intrinsic motivation in the field of literary (narrative) reading, and the partial factors that jointly shape them. These instruments were outlined in…

Teaching Health Literacy Using Popular Television Programming: A Qualitative Pilot Study

ERIC Educational Resources Information Center

Primack, Brian A.; Wickett, Dustin J.; Kraemer, Kevin L.; Zickmund, Susan

2010-01-01

Background: Teaching of health and medical concepts in the K-12 curriculum may help improve health literacy. Purpose: The purpose of this project was to determine acceptability and preliminary efficacy of pilot implementation of a health literacy curriculum using brief clips from a popular television program. Methods: Participants included 55…

Pilot Test of Standup, an Online School-Based Bullying Prevention Program

ERIC Educational Resources Information Center

Timmons-Mitchell, Jane; Levesque, Deborah A.; Harris, Leon A., III.; Flannery, Daniel J.; Falcone, Tatiana

2016-01-01

Bullying is a significant public health problem for students in schools. Prevention programs have addressed targets with some success; however, meta-analyses find small effects among older youths. A pilot study was conducted with high school students to evaluate the potential efficacy of StandUp, a three-session online program that delivers…

A Study of the Efficacy of Computerized Skill Building for Adolescents: Reducing Aggression and Increasing Pro-Social Behavior.

ERIC Educational Resources Information Center

Stern, Robin; Repa, J. Theodore

This article describes a pilot study that evaluated the efficacy of a computer-based, behavioral skill-building program in reducing aggression and improving academic performance among middle school students. The program is Ripple Effects'"Relate for Teens," a media rich, interactive application based on combining a proprietary learning…

The Psychometric Properties of the Difficult Behavior Self-Efficacy Scale

ERIC Educational Resources Information Center

Oh, Hyun-Kyoung; Kozub, Francis M.

2010-01-01

The study was designed to estimate the psychometric properties of Hastings and Brown's (2002a) Difficult Behavior Self-efficacy Scale. Participants were two samples of physical educators teaching in Korea (n = 229) and the United States (U.S.; n = 139). An initial translation of the questionnaire to Korean and pilot study were conducted along with…

A Pilot Study of a Distress Tolerance Treatment for Opiate Dependent Patients Initiating Buprenorphine: Rationale, Methodology, and Outcomes

PubMed Central

Brown, Richard A.; Bloom, Erika Litvin; Hecht, Jacki; Moitra, Ethan; Herman, Debra S.; Stein, Michael D.

2016-01-01

Buprenorphine, an opioid that is a long-acting partial opiate agonist, is an efficacious treatment for opiate dependence that is growing in popularity. Nevertheless, evidence suggests that many patients will lapse within the first week of treatment, and that lapses are often associated with withdrawal-related or emotional distress. Recent research suggests that individuals’ reactions to this distress may represent an important treatment target. In the current study, we describe the development and outcomes from a preliminary pilot evaluation (N = 5) of a novel distress tolerance treatment for individuals initiating buprenorphine. This treatment incorporates exposure-based and acceptance-based treatment approaches that we have previously applied to the treatment of tobacco dependence. Results from this pilot study establish the feasibility and acceptability of this approach. We are now conducting a randomized controlled trial of this treatment that we hope will yield clinically significant findings and offer clinicians an efficacious behavioral treatment to complement the effects of buprenorphine. PMID:24973401

A tutorial on pilot studies: the what, why and how

PubMed Central

2010-01-01

Pilot studies for phase III trials - which are comparative randomized trials designed to provide preliminary evidence on the clinical efficacy of a drug or intervention - are routinely performed in many clinical areas. Also commonly know as "feasibility" or "vanguard" studies, they are designed to assess the safety of treatment or interventions; to assess recruitment potential; to assess the feasibility of international collaboration or coordination for multicentre trials; to increase clinical experience with the study medication or intervention for the phase III trials. They are the best way to assess feasibility of a large, expensive full-scale study, and in fact are an almost essential pre-requisite. Conducting a pilot prior to the main study can enhance the likelihood of success of the main study and potentially help to avoid doomed main studies. The objective of this paper is to provide a detailed examination of the key aspects of pilot studies for phase III trials including: 1) the general reasons for conducting a pilot study; 2) the relationships between pilot studies, proof-of-concept studies, and adaptive designs; 3) the challenges of and misconceptions about pilot studies; 4) the criteria for evaluating the success of a pilot study; 5) frequently asked questions about pilot studies; 7) some ethical aspects related to pilot studies; and 8) some suggestions on how to report the results of pilot investigations using the CONSORT format. PMID:20053272

A self-efficacy education programme on foot self-care behaviour among older patients with diabetes in a public long-term care institution, Malaysia: a Quasi-experimental Pilot Study

PubMed Central

Sharoni, Siti Khuzaimah Ahmad; Abdul Rahman, Hejar; Minhat, Halimatus Sakdiah; Shariff Ghazali, Sazlina; Azman Ong, Mohd Hanafi

2017-01-01

Objective A pilot self-efficacy education programme was conducted to assess the feasibility, acceptability and potential impact of the self-efficacy education programme on improving foot self-care behaviour among older patients with diabetes in a public long-term care institution. Method A prequasi-experimental and postquasi-experimental study was conducted in a public long-term care institution in Selangor, Malaysia. Patients with diabetes aged 60 years and above who fulfilled the selection criteria were invited to participate in this programme. Four self-efficacy information sources; performance accomplishments, vicarious experience, verbal persuasion and physiological information were translated into programme interventions. The programme consisted of four visits over a 12-week period. The first visit included screening and baseline assessment and the second visit involved 30 min of group seminar presentation. The third and fourth visits entailed a 20-min one-to-one follow-up discussion and evaluation. A series of visits to the respondents was conducted throughout the programme. The primary outcome was foot self-care behaviour. Foot self-efficacy (efficacy-expectation), foot care outcome expectation, knowledge of foot care, quality of life, fasting blood glucose and foot condition were secondary outcomes. Data were analysed with descriptive and inferential statistics (McNemar's test and Wilcoxon signed-rank test) using the Statistical Package for the Social Sciences V.20.0. Results Fifty-two residents were recruited but only 31 met the inclusion criteria and were included in the analysis at baseline and at 12 weeks postintervention. The acceptability rate was moderately high. At postintervention, foot self-care behaviour (p<0.001), foot self-efficacy (efficacy-expectation), (p<0.001), foot care outcome expectation (p<0.001), knowledge of foot care (p<0.001), quality of life (physical symptoms) (p=0.003), fasting blood glucose (p=0.010), foot hygiene (p=0.030) and anhydrosis (p=0.020) showed significant improvements. Conclusion Findings from this pilot study would facilitate the planning of a larger study among the older population with diabetes living in long-term care institutions. Trial registration number ACTRN12616000210471; Pre-results. PMID:28600363

Differences Training for the Glass Cockpit

NASA Technical Reports Server (NTRS)

Wiener, Earl L.; Shafto, Michael G. (Technical Monitor)

1998-01-01

This study followed two groups of pilots from a major US air carrier as they went through a transition to advanced technology aircraft. Specifically, these were pilots were no previous automation experience undergoing Differences training from the 737-100/200 aircraft to the 737-300/500 aircraft. Each were given a different curriculum and data were collected on the efficacy of each training model and the pilots' attitudes toward automation. Results of the analyses performed and guidelines for training are included.

Student Satisfaction with EFL Speaking Classes: Relating Speaking Self-Efficacy and Skills Achievement

ERIC Educational Resources Information Center

Asakereh, Ahmad; Dehghannezhad, Maliheh

2015-01-01

This study investigated the relationship between student satisfaction with speaking classes, speaking skills self-efficacy beliefs, and speaking skills achievement. To this end, one hundred Iranian EFL undergraduate students filled out two questionnaires; a research-made and pilot-tested questionnaire for student satisfaction with speaking…

Video Modeling for Teaching Daily Living Skills to Children with Autism Spectrum Disorder: A Pilot Study

ERIC Educational Resources Information Center

Meister, Christine; Salls, Joyce

2015-01-01

This pilot study investigated the efficacy of point-of-view video modeling as an intervention strategy to improve self-help skills in children with autism spectrum disorder (ASD). A single-subject A-B design was implemented with eight school-aged children ages 7.5 years to 13.5 years. Six of the students participated in general education classes…

The FAV-S Pilot Study: Increasing Self-Efficacy and Fruit and Vegetable Intake Among Somali Women and Children

ERIC Educational Resources Information Center

Kehm, Rebecca; Hearst, Mary O.; Sherman, Shelley; Elwell, Kate L.

2017-01-01

The 2012 FAV-S pilot study was developed as a dietary intervention program for low-income Somali mothers grounded in the health belief model. The intervention was geared toward increasing fruit and vegetable intake among participants' children. The purpose of this analysis was to determine the impact of the FAV-S program on participants' (1)…

Connecting Students to Mental Health Care: Pilot Findings from an Engagement Program for School Nurses

ERIC Educational Resources Information Center

Kim, Rachel E.; Becker, Kimberly D.; Stephan, Sharon H.; Hakimian, Serop; Apocada, Dee; Escudero, Pia V.; Chorpita, Bruce F.

2015-01-01

Schools function as the major provider of mental health services (MHS) for youth, but can struggle with engaging them in services. School nurses are well-positioned to facilitate referrals for MHS. This pilot study examined the feasibility, acceptability, and preliminary efficacy of an engagement protocol (EP) designed to enhance school nurses'…

Improving Coping Self-Efficacy among Distressed Students after Exposure to University Mass Violence: A Pilot Online Intervention

ERIC Educational Resources Information Center

Liu, Sabrina R.; Kia-Keating, Maryam

2018-01-01

Given the rise of incidents of mass violence affecting college campuses, interventions for students are gravely needed, especially ones with broader accessibility and reach. This pilot study examined two online narrative writing interventions for undergraduates experiencing distress a year after exposure to a mass murder at their university.…

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…

White matter volume mediates the relationship between self-efficacy and mobility in older women

PubMed Central

Nagamatsu, Lindsay S.; Hsu, Chun Liang; Davis, Jennifer C.; Best, John R.; Liu-Ambrose, Teresa

2017-01-01

Background With our aging population, understanding determinants of healthy aging is a priority. One essential component of healthy aging is mobility. While self-efficacy can directly impact mobility in older adults, it is unknown what role brain health may play in this relationship. Methods We conducted a cross-sectional pilot analysis of community-dwelling women (n = 80, mean age = 69 years) to examine whether brain volume mediates the relationship between falls-related self-efficacy, as measured by the Activities-specific Balance Confidence (ABC) scale, and mobility, as measured by the Timed Up and Go (TUG) test. Age, depression, education, functional comorbidities, and Montreal Cognitive Assessment (MoCA) were included in the model as covariates. Results We report that total white matter volume, specifically, significantly mediates the relationship between self-efficacy and mobility, where higher self-efficacy was associated with greater white matter volume (r=0.28), which in turn, was associated with better mobility (r=−0.30). Conclusions Our pilot study extends our understanding of the psychosocial and neurological factors that contribute to mobility, and provides insight into effective strategies that may be used to improve functional independence among older adults. Future prospective and intervention studies are required to further elucidate the nature of the relationship between self-efficacy, mobility, and brain health. PMID:27749206

Effectiveness of an Intensive Handwriting Program for First Grade Students Using the Application Letterschool: A Pilot Study

ERIC Educational Resources Information Center

Jordan, Géraldine; Michaud, Fanny; Kaiser, Marie-Laure

2016-01-01

The purpose of this pilot study is to analyze the efficacy of a program that combines fine motor activities, animated models, exercises on a digital tablet and paper-pencil exercises. The 10-week program with a 45-minute session and daily exercises was implemented in a class of 16 students of first grade (mean age = 6.9 years old), with another…

Using Tic-Tac Software to Reduce Anxiety-Related Behaviour in Adults with Autism and Learning Difficulties during Waiting Periods: A Pilot Study

ERIC Educational Resources Information Center

Campillo, Cristina; Herrera, Gerardo; Remírez de Ganuza, Conchi; Cuesta, José L.; Abellán, Raquel; Campos, Arturo; Navarro, Ignacio; Sevilla, Javier; Pardo, Carlos; Amati, Fabián

2014-01-01

Deficits in the perception of time and processing of changes across time are commonly observed in individuals with autism. This pilot study evaluated the efficacy of the use of the software tool Tic-Tac, designed to make time visual, in three adults with autism and learning difficulties. This research focused on applying the tool in waiting…

White Matter Volume Mediates the Relationship Between Self-Efficacy and Mobility in Older Women.

PubMed

Nagamatsu, Lindsay S; Hsu, Chun Liang; Davis, Jennifer C; Best, John R; Liu-Ambrose, Teresa

2016-01-01

Background/Study Context: With our aging population, understanding determinants of healthy aging is a priority. One essential component of healthy aging is mobility. Although self-efficacy can directly impact mobility in older adults, it is unknown what role brain health may play in this relationship. The authors conducted a cross-sectional pilot analysis of community-dwelling women (N = 80, mean age = 69 years) to examine whether brain volume mediates the relationship between falls-related self-efficacy, as measured by the Activities-specific Balance Confidence (ABC) scale, and mobility, as measured by the Timed Up and Go (TUG) test. Age, depression, education, functional comorbidities, and Montreal Cognitive Assessment (MoCA) were included in the model as covariates. The authors report that total white matter volume, specifically, significantly mediates the relationship between self-efficacy and mobility, where higher self-efficacy was associated with greater white matter volume (r = .28), which, in turn, was associated with better mobility (r = -.30). This pilot study extends our understanding of the psychosocial and neurological factors that contribute to mobility and provides insight into effective strategies that may be used to improve functional independence among older adults. Future prospective and intervention studies are required to further elucidate the nature of the relationship between self-efficacy, mobility, and brain health.

Building Self-Efficacy, Strategy Use, and Motivation to Support Extensive Reading in Multilingual University Students

ERIC Educational Resources Information Center

Lipp, Ellen

2017-01-01

This pilot study examined multilingual university students' willingness to engage in voluntary extensive reading (ER) of books after they received training. The research questions were whether training appeared to promote self-efficacy, motivation for the task, use of metacognitive strategies, and independent reading. University freshmen in an ESL…

Testing the Efficacy of Brief Multicultural Education Interventions in White College Students

ERIC Educational Resources Information Center

Garriott, Patton O.; Reiter, Stephanie; Brownfield, Jenna

2016-01-01

This pilot study tested the overall and relative efficacy of 3 common approaches to multicultural education in a sample (N = 52) of White undergraduate students using a randomized controlled trial. Brief multicultural education interventions were delivered in the form of educational, social norming, and entertainment conditions. Affective (i.e.,…

Preliminary Efficacy of a Cognitive-Behavioral Treatment Program for Anxious Youth with Autism Spectrum Disorders

ERIC Educational Resources Information Center

White, Susan W.; Ollendick, Thomas; Scahill, Lawrence; Oswald, Donald; Albano, Anne Marie

2009-01-01

Anxiety is a commonly occurring psychiatric concern in adolescents with autism spectrum disorders (ASD). This pilot study examined the preliminary efficacy of a manual-based intervention targeting anxiety and social competence in four adolescents with high-functioning ASD. Anxiety and social functioning were assessed at baseline, midpoint,…

Practice and Implications of a Correlational Approach to Motivation, Efficacy, and Behavior Research in Teacher Education.

ERIC Educational Resources Information Center

So, Hosung; Sharpe, Tom; Klockow, Jeanne; Martin, Matt

This paper summarizes historically separate literatures related to motivation, efficacy, and behavioral analysis in education, with a view toward the potential benefits of pursuing correlational study across these historically separate research domains. It also provides pilot data illustrating the potential appeal of a correlational approach…

A Pilot Randomized Controlled Trial of DIR/Floortime[TM] Parent Training Intervention for Pre-School Children with Autistic Spectrum Disorders

ERIC Educational Resources Information Center

Pajareya, Kingkaew; Nopmaneejumruslers, Kaewta

2011-01-01

This pilot study was designed to test the efficacy of adding home-based Developmental, Individual-Difference, Relationship-Based (DIR)/Floortime[TM] intervention to the routine care of preschool children with autistic spectrum disorder. Measures of functional emotional development and symptom severity were taken. It was found that after the…

Food, fun, and fitness internet program for girls: Pilot evaluation of an e-Health youth obesity prevention program examining predictors of obesity

USDA-ARS?s Scientific Manuscript database

This pilot study tested whether an Internet-based intervention could achieve change in fruit, juice, and vegetable consumption, physical activity, and self-efficacy in youth at-risk of obesity. Participants were 80 8- to 10-year-old African American girls at-risk of obesity, with a home computer, In...

Spatial Disorientation Training in the Rotor Wing Flight Simulator.

PubMed

Powell-Dunford, Nicole; Bushby, Alaistair; Leland, Richard A

This study is intended to identify efficacy, evolving applications, best practices, and challenges of spatial disorientation (SD) training in flight simulators for rotor wing pilots. Queries of a UK Ministry of Defense research database and Pub Med were undertaken using the search terms 'spatial disorientation,' 'rotor wing,' and 'flight simulator.' Efficacy, evolving applications, best practices, and challenges of SD simulation for rotor wing pilots were also ascertained through discussion with subject matter experts and industrial partners. Expert opinions were solicited at the aeromedical physiologist, aeromedical psychologist, instructor pilot, aeromedical examiner, and corporate executive levels. Peer review literature search yielded 129 articles, with 5 relevant to the use of flight simulators for the spatial disorientation training of rotor wing pilots. Efficacy of such training was measured subjectively and objectively. A preponderance of anecdotal reports endorse the benefits of rotor wing simulator SD training, with a small trial substantiating performance improvement. Advancing technologies enable novel training applications. The mobile nature of flight students and concurrent anticollision technologies can make long-range assessment of SD training efficacy challenging. Costs of advanced technologies could limit the extent to which the most advanced simulators can be employed across the rotor wing community. Evidence suggests the excellent training value of rotor wing simulators for SD training. Objective data from further research, particularly with regards to evolving technologies, may justify further usage of advanced simulator platforms for SD training and research. Powell-Dunford N, Bushby A, Leland RA. Spatial disorientation training in the rotor wing flight simulator. Aerosp Med Hum Perform. 2016; 87(10):890-893.

Connecting Students to Mental Health Care: Pilot Findings from an Engagement Program for School Nurses

PubMed Central

Kim, Rachel E.; Becker, Kimberly D.; Stephan, Sharon H.; Hakimian, Serop; Apocada, Dee; Escudero, Pia V.; Chorpita, Bruce F.

2015-01-01

Schools function as the major provider of mental health services (MHS) for youth, but can struggle with engaging them in services. School nurses are well-positioned to facilitate referrals for MHS. This pilot study examined the feasibility, acceptability, and preliminary efficacy of an engagement protocol (EP) designed to enhance school nurses’ utilization of evidence-based engagement practices when referring youth to MHS. Participants were six school nurses and twenty-five adolescents in a large, urban school district. School nurses reported positive attitudes towards the EP, suggesting that they found it feasible and acceptable. Though there were small increases in school nurses’ use of engagement practices and in adolescents’ readiness for services following training, due to limited sample size, differences were not statistically significant. Still, pilot results suggest preliminary efficacy of training school nurses to strategically implement evidence-based engagement practices to increase adolescents’ engagement in MHS. PMID:26251671

Acupuncture at Houxi (SI 3) acupoint for acute neck pain caused by stiff neck: study protocol for a pilot randomised controlled trial.

PubMed

Sun, Zhong-ren; Yue, Jin-huan; Tian, Hong-zhao; Zhang, Qin-hong

2014-12-23

The use of acupuncture has been suggested for the treatment of acute neck pain caused by stiff neck in China. However, current evidence is insufficient to draw any conclusions about its efficacy. Therefore this pilot study was designed to evaluate the feasibility and efficacy of acupuncture at the Houxi (SI3) acupoint for treatment of acute neck pain. This pilot study will be a two-parallel-group, assessor-blinded, randomised controlled trial. Thirty-six stiff neck participants with acute neck pain will be recruited and randomly divided into two groups in a 1:1 ratio. Participants in the control group will receive massage on the local neck region (5 min each session, three times a day for 3 days). In addition to massage, patients in the treatment group will receive acupuncture (one session a day for 3 days). Measures will be taken at 0, 3 and 15 days. The primary outcome is the Northwick Park Neck Pain Questionnaire (NPQ). The secondary outcome is the Short Form of the McGill Pain Questionnaire (SF-MPQ). The protocol for this pilot randomised clinical trial has undergone ethics scrutiny and been approved by the ethics review boards of the First Affiliated Hospital of Heilongjiang University of Traditional Chinese Medicine (Permission number: HZYLL201303502). The findings of this study will provide important clinical evidence on the feasibility and efficacy of acupuncture treatment for stiff neck patients with acute neck pain. In addition, it will explore the feasibility of further acupuncture research. ChiCTR-TRC-13003911. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://group.bmj.com/group/rights-licensing/permissions.

A Pilot Study of an Intervention Designed to Promote Walking, Balance, and Self-Efficacy in Older Adults with Fear of Falling

ERIC Educational Resources Information Center

Dattilo, John; Martire, Lynn; Gottschall, Jinger; Weybright, Elizabeth

2014-01-01

There is a need to provide interventions that are of interest to older adults who are not inclined to participate in conventional exercise programs and that can improve balance and fear of falling. One purpose of this pilot study was to assess feasibility and acceptability of an eight-week (3x/wk, 90-minute sessions) multifaceted, small group,…

The Effects of an Early Motor Skill Intervention on Motor Skills, Levels of Physical Activity, and Socialization in Young Children with Autism Spectrum Disorder: A Pilot Study

ERIC Educational Resources Information Center

Ketcheson, Leah; Hauck, Janet; Ulrich, Dale

2017-01-01

Despite evidence suggesting one of the earliest indicators of an eventual autism spectrum disorder diagnoses is an early motor delay, there remain very few interventions targeting motor behavior as the primary outcome for young children with autism spectrum disorder. The aim of this pilot study was to measure the efficacy of an intensive motor…

Safety and efficacy of intravenous infusion of allogeneic cryopreserved mesenchymal stem cells for treatment of chronic kidney disease in cats: results of three sequential pilot studies

PubMed Central

2013-01-01

Introduction Administration of mesenchymal stem cells (MSCs) has been shown to improve renal function in rodent models of chronic kidney disease (CKD), in part by reducing intrarenal inflammation and suppressing fibrosis. CKD in cats is characterized by tubulointerstitial inflammation and fibrosis, and thus treatment with MSCs might improve renal function and urinary markers of inflammation in this disease. Therefore, a series of pilot studies was conducted to assess the safety and efficacy of intravenous administration of allogeneic adipose-derived MSCs (aMSCs) in cats with naturally occurring CKD. Methods Cats enrolled in these studies received an intravenous infusion of allogeneic aMSCs every 2 weeks collected from healthy, young, specific pathogen-free cats. Cats in pilot study 1 (six cats) received 2 × 106 cryopreserved aMSCs per infusion, cats in pilot study 2 (five cats) received 4 × 106 cryopreserved aMSCs per infusion, and cats in pilot study 3 (five cats) received 4 × 106 aMSCs cultured from cryopreserved adipose. Serum biochemistry, complete blood count, urinalysis, urine protein, glomerular filtration rate, and urinary cytokine concentrations were monitored during the treatment period. Changes in clinical parameters were compared statistically by means of repeated measures analysis of variance (ANOVA) followed by Bonferroni’s correction. Results Cats in pilot study 1 had few adverse effects from the aMSC infusions and there was a statistically significant decrease in serum creatinine concentrations during the study period, however the degree of decrease seems unlikely to be clinically relevant. Adverse effects of the aMSC infusion in cats in pilot study 2 included vomiting (2/5 cats) during infusion and increased respiratory rate and effort (4/5 cats). Cats in pilot study 3 did not experience any adverse side effects. Serum creatinine concentrations and glomerular filtration rates did not change significantly in cats in pilot studies 2 and 3. Conclusions Administration of cryopreserved aMSCs was associated with significant adverse effects and no discernible clinically relevant improvement in renal functional parameters. Administration of aMSCs cultured from cryopreserved adipose was not associated with adverse effects, but was also not associated with improvement in renal functional parameters. PMID:23632128

Engaging Overweight Adolescents in a Health and Fitness Program Using Wearable Activity Trackers.

PubMed

Wilson, Marian; Ramsay, Samantha; Young, Kimberly J

Our objectives were to (a) examine feasibility and receptivity of overweight adolescents joining a community-based group fitness program and (b) test preliminary efficacy of a 12-week pilot intervention designed to promote health, fitness, and self-efficacy for the identified teens. The 12-week fitness program for overweight adolescents was developed and included planned physical activities, nutrition classes, and goal-setting sessions. A one-group pre-/posttest study design evaluated 20 participants from grades 10 through 12 who enrolled in the program pilot study. Participants were given a wearable activity tracker that captured data using an Internet-based platform. Outcome measures included body mass index, screen time, fitness, and cardiovascular measures. A community fitness program for overweight adolescents was successfully implemented. High school students were receptive to the intervention and reported high program satisfaction. Positive effects included measurements of strength, systolic blood pressure, weight, and screen time behaviors. This study provides evidence to support the feasibility, acceptance, and preliminary effects of the pilot program with overweight adolescents. Copyright © 2017 National Association of Pediatric Nurse Practitioners. Published by Elsevier Inc. All rights reserved.

Raising Children's Self-Efficacy through Parental Involvement in Homework

ERIC Educational Resources Information Center

Williams, Keith; Swift, Jennifer; Williams, Hefin; Van Daal, Victor

2017-01-01

Background: This paper is a qualitative evaluation of a small-scale pilot study that attempted to generate parental involvement in children's learning. It used problem-solving mathematics homework in order to raise the children's self-efficacy, or, put another way, the child's belief that success lies in their own hands. Purpose: Homework is often…

Teacher Efficacy Beliefs toward Serving Culturally and Linguistically Diverse Students in Special Education: Implications of a Pilot Study

ERIC Educational Resources Information Center

Chu, Szu-Yin

2013-01-01

Educating a nation of culturally, ethnically/racially, and linguistically diverse (CLD) students is one of the many challenges facing teachers and teacher educators, resulting in teachers' questioning their ability to improve learning for these groups. Yet teacher efficacy is significantly related to student achievement, motivation, and students'…

Perceived Self-Efficacy and Its Role in Education-Related Cognitive Performance in Latino American Elderly

ERIC Educational Resources Information Center

Alders, Amanda

2011-01-01

This article describes the methodology, data analysis, and results for a pilot study investigating perceived self-efficacy of cognitive performance among Latino American elderly. The sample included 24 Latino American elderly. A 12-week quasi-experimental design was utilized. Participants were provided with weekly 2-hr art education sessions…

Measuring Teachers' Efficacy Working with Diverse Student Needs: Testing a Measurement Model. Technical Report # 38

ERIC Educational Resources Information Center

Alonzo, Julie; Tindal, Gerald; McCoy, Jan

2005-01-01

This technical report describes the development, pilot testing, and revision of a survey instrument designed to measure secondary school teachers' perceptions of their efficacy working with students from diverse backgrounds. A brief review of relevant literature frames the current study in the context of survey development that is technically…

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…

Peer Mentoring for Male Parolees: A CBPR Pilot Study.

PubMed

Marlow, Elizabeth; Grajeda, William; Lee, Yema; Young, Earthy; Williams, Malcolm; Hill, Karen

2015-01-01

Formerly incarcerated adults are impoverished, have high rates of substance use disorders, and have long histories of imprisonment. This article describes the development of a peer mentoring program for formerly incarcerated adults and the pilot study designed to evaluate it. The research team, which included formerly incarcerated adults and academic researchers, developed the peer mentoring program to support formerly incarcerated adults' transition to the community after prison. The purposes of the pilot evaluation study were to (1) assess the feasibility of implementing a peer-based intervention for recently released men developed using a community-based participatory research (CBPR) approach; (2) establish preliminary data on the program's impact on coping, self-esteem, abstinence self-efficacy, social support, and participation in 12-step meetings; and (3) establish a CBPR team of formerly incarcerated adults and academic researchers to develop, implement, and test interventions for this population. This pilot evaluation study employed a mixed-methods approach with a single group pretest/posttest design with 20 men on parole released from prison within the last 30 days. Quantitative findings showed significant improvement on two abstinence self-efficacy subscales, negative affect and habitual craving. Qualitative findings revealed the relevance and acceptance of peer mentoring for this population. This study demonstrated the feasibility and import of involving formerly incarcerated adults in the design, implementation, and testing of interventions intended to support their reintegration efforts.

Effects of a mindfulness-based intervention on psychological distress, well-being, and maternal self-efficacy in breast-feeding mothers: results of a pilot study.

PubMed

Perez-Blasco, Josefa; Viguer, Paz; Rodrigo, Maria F

2013-06-01

Several pilot studies have provided evidence that mindfulness-based intervention is beneficial during pregnancy, yet its effects in mothers during the early parenting period are unknown. The purpose of the present pilot study was to examine the effectiveness of a mindfulness-based intervention in breast-feeding mothers. We developed and tested an 8-week mindfulness-based intervention aimed at improving maternal self-efficacy, mindfulness, self-compassion, satisfaction with life, and subjective happiness, and at reducing psychological distress. A randomized controlled, between-groups design was used with treatment and control groups (n = 26) and pretest and posttest measures. ANCOVA results indicated that, compared to the control group, mothers in the treatment group scored significantly higher on maternal self-efficacy, some dimensions of mindfulness (observing, acting with awareness, non-judging, and non-reactivity), and self-compassion (self-kindness, mindfulness, over-identification, and total self-compassion). In addition, mothers who received the treatment exhibited significantly less anxiety, stress, and psychological distress. The results supported previous research findings about the benefits of mindfulness-based intervention in women from the perinatal and postpartum periods through the early parenting period. Additional research is needed to validate our findings in non-breast-feeding mothers and to examine the intervention's indirect benefits in terms of family relationships and child development.

Placebo-controlled pilot trial testing dose titration and intravenous, intramuscular and subcutaneous routes for ketamine in depression.

PubMed

Loo, C K; Gálvez, V; O'Keefe, E; Mitchell, P B; Hadzi-Pavlovic, D; Leyden, J; Harper, S; Somogyi, A A; Lai, R; Weickert, C S; Glue, P

2016-07-01

This pilot study assessed the feasibility, efficacy and safety of an individual dose-titration approach, and of the intravenous (IV), intramuscular (IM) and subcutaneous (SC) routes for treating depression with ketamine. Fifteen treatment-refractory depressed participants received ketamine or midazolam (control treatment) in a multiple crossover, double-blind study. Ketamine was administered by IV (n = 4), IM (n = 5) or SC (n = 6) injection. Dose titration commenced at 0.1 mg/kg, increasing by 0.1 mg/kg up to 0.5 mg/kg, given in separate treatment sessions separated by ≥1 week, with one placebo control treatment randomly inserted. Mood, psychotomimetic and hemodynamic effects were assessed and plasma ketamine concentrations assayed. Twelve participants achieved response and remission criteria, achieved at doses as low as 0.1 mg/kg. All three routes of administration resulted in comparable antidepressant effects. Fewest adverse effects were noted with the SC route. Antidepressant response, adverse effects and ketamine concentrations were dose-related. Antidepressant response occurred at a range of doses and at <0.5 mg/kg. The dose-titration approach is a practical method for optimizing the efficacy - side-effects trade-off on an individual patient basis. This pilot study provides preliminary evidence for SC injection as a practical, feasible and efficacious treatment approach. © 2016 John Wiley & Sons A/S. Published by John Wiley & Sons Ltd.

A self-efficacy education programme on foot self-care behaviour among older patients with diabetes in a public long-term care institution, Malaysia: a Quasi-experimental Pilot Study.

PubMed

Sharoni, Siti Khuzaimah Ahmad; Abdul Rahman, Hejar; Minhat, Halimatus Sakdiah; Shariff Ghazali, Sazlina; Azman Ong, Mohd Hanafi

2017-06-08

A pilot self-efficacy education programme was conducted to assess the feasibility, acceptability and potential impact of the self-efficacy education programme on improving foot self-care behaviour among older patients with diabetes in a public long-term care institution. A prequasi-experimental and postquasi-experimental study was conducted in a public long-term care institution in Selangor, Malaysia. Patients with diabetes aged 60 years and above who fulfilled the selection criteria were invited to participate in this programme. Four self-efficacy information sources; performance accomplishments, vicarious experience, verbal persuasion and physiological information were translated into programme interventions. The programme consisted of four visits over a 12-week period. The first visit included screening and baseline assessment and the second visit involved 30 min of group seminar presentation. The third and fourth visits entailed a 20-min one-to-one follow-up discussion and evaluation. A series of visits to the respondents was conducted throughout the programme. The primary outcome was foot self-care behaviour. Foot self-efficacy (efficacy-expectation), foot care outcome expectation, knowledge of foot care, quality of life, fasting blood glucose and foot condition were secondary outcomes. Data were analysed with descriptive and inferential statistics (McNemar's test and Wilcoxon signed-rank test) using the Statistical Package for the Social Sciences V.20.0. Fifty-two residents were recruited but only 31 met the inclusion criteria and were included in the analysis at baseline and at 12 weeks postintervention. The acceptability rate was moderately high. At postintervention, foot self-care behaviour (p<0.001), foot self-efficacy (efficacy-expectation), (p<0.001), foot care outcome expectation (p<0.001), knowledge of foot care (p<0.001), quality of life (physical symptoms) (p=0.003), fasting blood glucose (p=0.010), foot hygiene (p=0.030) and anhydrosis (p=0.020) showed significant improvements. Findings from this pilot study would facilitate the planning of a larger study among the older population with diabetes living in long-term care institutions. ACTRN12616000210471; Pre-results. © 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.

Web-based family intervention for overweight children: a pilot study.

PubMed

Delamater, Alan M; Pulgaron, Elizabeth R; Rarback, Sheah; Hernandez, Jennifer; Carrillo, Adriana; Christiansen, Steven; Severson, Herbert H

2013-02-01

Research has shown the efficacy of family-based behavioral interventions for overweight children, but a major difficulty is access to effective treatment programs. The objective of this study was to develop and test the initial feasibility and efficacy of a web-based family program for overweight 8- to 12-year-old children. A website was created using concepts from effective family-based behavioral programs and input from focus groups with overweight children, parents, and pediatricians. The website provided information about obesity and healthy lifestyles, assessment of dietary and physical activity habits, interactive dietary and physical activity games, and instruction in goal-setting and monitoring of goals. Children selected a dietary and physical activity goal and a daily step goal with pedometers. Feasibility and pilot testing over 4 weeks was conducted with 24 overweight children referred by a physician. Outcomes were z-BMI, healthy eating and physical activity, and intrinsic motivation and self-efficacy for weight control. Mean number of logins over the study period was 11.4 for the study sample. Eighteen families (75%) returned for the follow-up assessment. Pre-post analyses for these participants showed improvements in intrinsic motivation, (p=0.05), self-efficacy (p=0.025), physical activity (p=0.005), and healthy lifestyle behaviors (p=0.001). Comparisons between high and low users of the program indicated that high users reduced their BMI while low users increased their BMI over time (p=0.02); high users also improved their dietary intake relative to low users (p=0.04). Consumer satisfaction ratings were high. These pilot findings suggest this is a feasible approach for treatment of overweight children and that children who used the web program frequently improved their BMI and dietary intake.

Matching Interventions to Children's Mental Health Needs: Feasibility and Acceptability of a Pilot School-Based Trauma Intervention Program

ERIC Educational Resources Information Center

Brown, Elissa J.; McQuaid, Jennifer; Farina, Lana; Ali, Rehana; Winnick-Gelles, Amy

2006-01-01

The primary goal was to develop and implement a school-based, trauma-specific intervention program for inner-city children exposed to the World Trade Center attacks on September 11th, 2001. The feasibility and acceptability of the program, and its research component, were examined. The efficacy of the program was evaluated in a pilot study.…

Predictors of weight loss success. Exercise vs. dietary self-efficacy and treatment attendance.

PubMed

Byrne, Shannon; Barry, Danielle; Petry, Nancy M

2012-04-01

Pre-treatment diet and exercise self-efficacies can predict weight loss success. Changes in diet self-efficacy across treatment appear to be even stronger predictors than baseline levels, but research on changes in exercise self-efficacy is lacking. Using data from a pilot study evaluating tangible reinforcement for weight loss (N=30), we examined the impact of changes in diet and exercise self-efficacy on outcomes. Multiple regression analyses indicated that treatment attendance and changes in exercise self-efficacy during treatment were the strongest predictors of weight loss. Developing weight loss programs that foster the development of exercise self-efficacy may enhance participants' success. Published by Elsevier Ltd.

Improving Hearing Aid Self-Efficacy and Utility Through Revising a Hearing Aid User Guide: A Pilot Study.

PubMed

McMullan, Alexandra; Kelly-Campbell, Rebecca J; Wise, Kim

2018-03-08

This pilot study aimed to investigate whether revising a hearing aid user guide (HAUG) is associated with improved hearing aid self-efficacy and utility performance. In Part 1, an HAUG was evaluated using the Suitability Assessment of Material (SAM) and readability formulas (Flesch Reading Ease [Flesch, 1943], Flesch-Kincaid Readability Formula [Kincaid, Fishburne, Rogers, & Chissom, 1957], and Simple Measure of Gobbledygook [McLaughlin, 1969]). The HAUG was revised using results from the SAM and best practice guidelines. The revision included generating a video. In Part 2, 30 adults with hearing impairment were randomly assigned to use either the original guide (N = 15) or the revised guide and video (N = 15) to perform a utility task. Participants' self-efficacy was measured using the Basic and Advanced Handling subscales of the Measure of Audiologic Rehabilitation Self-Efficacy for Hearing Aids questionnaire. SAM and readability were compared between the original and revised guides (Doak, Doak, & Root, 1996). SAM and readability were improved following the revision. Participants in the revised guide group performed significantly better on the utility task and on the Measure of Audiologic Rehabilitation Self-Efficacy for Hearing Aids subscales than participants in the original guide group. These results are encouraging as they indicate that there is scope to influence self-efficacy and utility performance through the use of appropriate HAUGs.

The outcomes of anxiety, confidence, and self-efficacy with Internet health information retrieval in older adults: a pilot study.

PubMed

Chu, Adeline; Mastel-Smith, Beth

2010-01-01

Technology has a great impact on nursing practice. With the increasing numbers of older Americans using computers and the Internet in recent years, nurses have the capability to deliver effective and efficient health education to their patients and the community. Based on the theoretical framework of Bandura's self-efficacy theory, the pilot project reported findings from a 5-week computer course on Internet health searches in older adults, 65 years or older, at a senior activity learning center. Twelve participants were recruited and randomized to either the intervention or the control group. Measures of computer anxiety, computer confidence, and computer self-efficacy scores were analyzed at baseline, at the end of the program, and 6 weeks after the completion of the program. Analysis was conducted with repeated-measures analysis of variance. Findings showed participants who attended a structured computer course on Internet health information retrieval reported lowered anxiety and increased confidence and self-efficacy at the end of the 5-week program and 6 weeks after the completion of the program as compared with participants who were not in the program. The study demonstrated that a computer course can help reduce anxiety and increase confidence and self-efficacy in online health searches in older adults.

Gender-Focused HIV and Pregnancy Prevention for School-Going Adolescents: The Mpondombili Pilot Intervention in KwaZulu-Natal, South Africa

PubMed Central

Harrison, Abigail; Hoffman, Susie; Mantell, Joanne E.; Smit, Jennifer A.; Leu, Cheng-Shiun; Exner, Theresa M.; Stein, Zena A.

2016-01-01

This pilot study evaluated a 15 session classroom intervention for HIV and pregnancy prevention among grade 8–10 boys and girls (ages 14–17) in rural South Africa, guided by gender-empowerment theory and implemented by teachers, nurses, and youth peer educators. Pre- and post-intervention surveys included 933 male and female students in two intervention and two comparison schools. Main outcome: condom use at last sex; secondary outcomes: partner communication; gender beliefs and values; perceived peer behaviors; self-efficacy for safer sex. At five months post-intervention, change in condom use did not differ between intervention and comparison schools. Intervention school youth had greater increases in self-efficacy for unsafe sex refusal [OR=1.61; 95% CI=1.01, 2.57] and condom use [OR=1.76; 95% CI=1.07, 2.89], partner communication [OR=2.42; 95% CI=1.27, 4.23], and knowledge of HIV testing opportunities [OR=1.76; 95% CI=1.08, 2.87]. This gender-focused pilot intervention increased adolescents’ self-efficacy and partner communication, and has potential to improve preventive behaviors. PMID:27642267

Feasibility and Preliminary Efficacy of the Fit4Fun Intervention for Improving Physical Fitness in a Sample of Primary School Children: A Pilot Study

ERIC Educational Resources Information Center

Eather, Narelle; Morgan, Philip J.; Lubans, David R.

2013-01-01

Objective: The primary objective of this study was to evaluate the feasibility and preliminary efficacy of a school-based physical fitness intervention (Fit4Fun) on the physical fitness and physical activity (PA) levels of primary school children. Methods: A group-randomized controlled trial with a 3-month wait-list control group was conducted in…

Safety and Efficacy of Modified Preoperative Lung Nodule Microcoil Localization Without Pleural Marking: A Pilot Study.

PubMed

Kha, Lan-Chau T; Hanneman, Kate; Donahoe, Laura; Chung, Taebong; Pierre, Andrew F; Yasufuku, Kazuhiro; Keshavjee, Shafique; Mayo, John R; Paul, Narinder S; Nguyen, Elsie T

2016-01-01

The purpose of this pilot study was to evaluate the safety and efficacy of preoperative computed tomography (CT)-guided percutaneous microcoil lung nodule localization without pleural marking compared with the established technique with pleural marking. Sixty-three consecutive patients (66.7% female, mean age 61.6±11.4 y) with 64 lung nodules resected between October 2008 and January 2014 were retrospectively evaluated. Of the nodules, 29.7% (n=19) had microcoil deployment with pleural marking (control group) and 70.3% (n=45) had microcoil deployment without pleural marking (pilot group). Clinical, pathologic, and imaging characteristics, radiation dose, CT procedure and operating room time, and complete resection and complication rates were compared between the pilot and control groups. There was no significant difference in nodule size (P=0.552) or distance from the pleural surface (P=0.222) between the pilot and control groups. However, mean procedure duration (53.6±18.3 vs. 72.8±25.3 min, P=0.001) and total effective radiation dose (5.1±2.6 vs. 7.1±4.9 mSv, P=0.039) were significantly lower in the pilot group compared with the control group. CT procedure-related complications (P=0.483) [including pneumothoraces (P=0.769) and pulmonary hemorrhage (P=1.000)], operating room time (P=0.926), complete resection rates (P=0.520), intraoperative complications (P=0.549), and postoperative complications (P=1.000) were similar between the pilot and control groups. Preoperative CT-guided lung nodule microcoil localization performed without visceral pleural marking appears to decrease the CT procedure time and radiation dose while maintaining equivalent complete resection rates and procedural and surgical complications, when compared with microcoil localization performed with pleural marking.

Implementation Intentions on the Effect of Salt Intake among Hypertensive Women: A Pilot Study

PubMed Central

Cornélio, Marilia Estevam; Rodrigues, Roberta Cunha Matheus; Gallani, Maria-Cecilia

2014-01-01

This experimental study was aimed at assessing the potential effect of a theory-driven intervention—implementation intentions—on reducing salt intake among hypertensive Brazilian women. Ninety-eight participants were randomly assigned to participate in an implementation intentions intervention aimed at promoting lower salt intake through decreased addition of salt and salty spices to meals (intervention group, n = 49; group, n = 49). Endpoints were assessed at baseline and at the 2-month follow-up. Primary endpoints were a self-reporting measure of salt intake given by salt addition to meals (discretionary salt + salty spices = total added salt) and the 24 h urinary-sodium excretion. Secondary endpoints included intention, self-efficacy, and habit related to adding salt to meals. Patients in the intervention group showed a significant reduction in salt intake as assessed by 24 h urinary-sodium excretion. A significant reduction in the measure of habit was observed for both groups. No differences were observed for intention and self-efficacy. The results of this pilot study suggest the efficacy of planning strategies to help hypertensive women reduce their salt intake. PMID:25243084

Combined Use of Self-Efficacy Scale for Oral Health Behaviour and Oral Health Questionnaire: A Pilot Study

ERIC Educational Resources Information Center

Soutome, Sakiko; Kajiwara, Kazumi; Oho, Takahiko

2012-01-01

Objective: To examine whether the combined use of a task-specific self-efficacy scale for oral health behaviour (SEOH) and an oral health questionnaire (OHQ) would be useful for evaluating subjects' behaviours and cognitions. Design: Questionnaires. Methods: One hundred and eighty-five students completed the SEOH and OHQ. The 30-item OHQ uses a…

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

Virtual Sprouts: A Virtual Gardening Pilot Intervention Increases Self-Efficacy to Cook and Eat Fruits and Vegetables in Minority Youth.

PubMed

Bell, Brooke M; Martinez, Lauren; Gotsis, Marientina; Lane, H Chad; Davis, Jaimie N; Antunez-Castillo, Luz; Ragusa, Gisele; Spruijt-Metz, Donna

2018-04-01

To examine the effect of the Virtual Sprouts intervention, an interactive multiplatform mobile gardening game, on dietary intake and psychosocial determinants of dietary behavior in minority youth. In this quasi-experimental pilot intervention, 180 third-, fourth-, and fifth-grade students in Los Angeles Unified School District participated in a 3-week program that included three Virtual Sprouts gaming sessions, three in-school lessons, and three in-home activities, using a nutrition- and gardening-focused curriculum. Pre- and postintervention questionnaires were used to assess psychosocial determinants of dietary behavior, including knowledge about and self-efficacy to eat fruits and vegetables (FV). Data were collected on FV, whole grains, fiber, total sugar, added sugar, and energy from sugary beverages through the Block Kids Food Screener ("last week" version) for Ages 2-17. Repeated measures analysis of covariance models was used for continuous outcomes, controlling for age, sex, ethnicity, school, and free school lunch. After the intervention, the intervention group (n = 116) compared with the control group (n = 64) had a significantly improved self-efficacy to eat FV score (+1.6% vs. -10.3%, P = 0.01), and an improved self-efficacy to cook FV score (+2.9% vs. -5.0%, P = 0.05). There were no significant differences in dietary intake or self-efficacy to garden scores between intervention and control groups. The results from this 3-week pilot study suggest that an interactive mobile game with a nutrition- and gardening-focused curriculum can improve psychosocial determinants of dietary behavior in minority youth.

A standardized curriculum to introduce novice health professional students to practice-based learning and improvement: a multi-institutional pilot study.

PubMed

Huntington, Jonathan T; Dycus, Paula; Hix, Carolyn; West, Rita; McKeon, Leslie; Coleman, Mary T; Hathaway, Donna; McCurren, Cynthia; Ogrinc, Greg

2009-01-01

Practice-based learning and improvement (PBLI) combines the science of continuous quality improvement with the pragmatics of day-to-day clinical care delivery. PBLI is a core-learning domain in nursing and medical education. We developed a workbook-based, project-focused curriculum to teach PBLI to novice health professional students. Evaluate the efficacy of a standardized curriculum to teach PBLI. Nonrandomized, controlled trial with medical and nursing students from 3 institutions. Faculty used the workbook to facilitate completion of an improvement project with 16 participants. Both participants and controls (N = 15) completed instruments to measure PBLI knowledge and self-efficacy. Participants also completed a satisfaction survey and presented project posters at a national conference. There was no significant difference in PBLI knowledge between groups. Self-efficacy of participants was higher than that of controls in identifying best practice, identifying measures, identifying successful local improvement work, implementing a structured change plan, and using Plan-Do-Study-Act methodology. Participant satisfaction with the curriculum was high. Although PBLI knowledge was similar between groups, participants had higher self-efficacy and confidently disseminated their findings via formal poster presentation. This pilot study suggests that using a workbook-based, project-focused approach may be effective in teaching PBLI to novice health professional students.

The development of an online decision aid to support persons having a genetic predisposition to cancer and their partners during reproductive decision-making: a usability and pilot study.

PubMed

Reumkens, Kelly; Tummers, Marly H E; Gietel-Habets, Joyce J G; van Kuijk, Sander M J; Aalfs, Cora M; van Asperen, Christi J; Ausems, Margreet G E M; Collée, Margriet; Dommering, Charlotte J; Kets, C Marleen; van der Kolk, Lizet E; Oosterwijk, Jan C; Tjan-Heijnen, Vivianne C G; van der Weijden, Trudy; de Die-Smulders, Christine E M; van Osch, Liesbeth A D M

2018-05-30

An online decision aid to support persons having a genetic predisposition to cancer and their partners during reproductive decision-making was developed. A two-phase usability test was conducted among 12 couples (N = 22; 2 persons participated without their partner) at risk for hereditary cancer and 15 health care providers. Couples and health care providers expressed similar suggestions for improvements, and evaluated the modified decision aid as acceptable, easy to use, and comprehensible. The final decision aid was pilot tested (N = 16) with paired sample t tests comparing main outcomes (decisional conflict, knowledge, realistic expectations regarding the reproductive options and decision self-efficacy) before (T0), immediately (T1) and 2 weeks after (T2) use of the decision aid. Pilot testing indicated decreased decisional conflict scores, increased knowledge, and improved realistic expectations regarding the reproductive options, at T1 and T2. No effect was found for couples' decision self-efficacy. The positive findings during usability testing were thus reflected in the pilot study. The decision aid will be further evaluated in a nationwide pretest-posttest study to facilitate implementation in the onco-genetic counselling setting. Ultimately, it is expected that the decision aid will enable end-users to make an informed decision.

Pilot study of a budget-tailored culinary nutrition education program for undergraduate food science students

NASA Astrophysics Data System (ADS)

Kerrison, Dorothy Adair

The primary objective of this pilot study is to provide evidence that a budget-tailored culinary nutrition program is both appropriate and applicable to undergraduate food science students both in everyday life as well as their future health careers. Two validated programs were combined into one program in order to evaluate their combined effects: Cooking With a Chef and Cooking Matters at the Store. The secondary objective of this pilot study is to evaluate the components and reliability of a questionnaire created specifically for this pilot study. A review of past literature was written, which included culinary nutrition as a source of primary prevention, the importance of incorporating cost with culinary nutrition, and the importance of incorporating cost with culinary nutrition. Based on the literature review, it was determined that a budget-tailored culinary nutrition program was appropriate and applicable to undergraduate food science students interested in pursuing health-related careers. The pilot study design was a semi-crossover study: all four groups received the program, however, two groups were first treated as the control groups. All fifty-four participants received 5 sessions of culinary nutrition information from Cooking With a Chef, collaboratively delivered by a nutrition educator and a chef, and one session of information about shopping healthy on a budget from Cooking Matters at the Store in the form of a grocery store tour led by the nutrition educator. Three questionnaires were administered to the participants that evaluated culinary nutrition and price knowledge, cooking attitudes, and opinions of the programs' relevance to participants' everyday lives and careers. Two of the questionnaires, including a questionnaire developed specifically for the pilot study, were delivered as a pre- and post-test while the third questionnaire was delivered as a post-test. Eight random participants also partook in a focus group session led by the nutrition educator. Based on statistical results, there were significant differences between the treatment group and control group in Cooking Self-Efficacy (p=0.0024), Self-Efficacy for Using Basic Cooking Techniques (p=<0.0001), Self-Efficacy for Using Fruits, Vegetables, and Seasonings (p=<0.0001), and the ability to use economical methods to purchase low-cost produce and identify different forms of produce (p=<0.0001). For the one-time post-program administered questionnaire, the participants received an average score of 89.44 percent. The reliability procedure performed on the pilot study questionnaire showed that 13 of the 15 items were statistically reliable (p<0.05). The factor analysis procedure performed showed that there were five factors within the pilot study questionnaire. Participant responses from the focus group included how the program was a positive change from other mandatory courses, reaffirmed or increased interest in their major(s) and applied both to their everyday life and future career. This pilot study demonstrates preliminary results of the effects of combining culinary nutrition information with budget and price concepts to deliver to undergraduate food science students. The significance of understanding both culinary nutrition and price is important in order to effectively deliver nutrition counseling to patients of all different demographics. Additional testing and modification could be performed on the curriculum as well as the pilot study questionnaire in order to effectively relate the instrument to the program and increase the instrument's reliability.

Examining the Impact of a Simulation Classroom Experience on Teacher Candidates' Sense of Efficacy in Communicating with English Learners

ERIC Educational Resources Information Center

Regalla, Michele; Hutchinson, Cynthia; Nutta, Joyce; Ashtari, Nooshan

2016-01-01

This pilot study examined the use of a simulation classroom in helping teacher candidates enrolled in a general methods class adjust their communication for English learners (ELs). Surveys were administered to teacher candidates asking them to report their sense of efficacy in meeting the needs of English learners. According to survey data, the…

A Pilot Study to Determine the Efficacy of a Social Story [TM] Intervention for a Child with Autistic Disorder, Intellectual Disability and Limited Language Skills

ERIC Educational Resources Information Center

Reynhout, Georgina; Carter, Mark

2008-01-01

Social Stories[TM] have gained wide acceptance as an intervention for children with autism spectrum disorders (ASD) yet extant research provides only circumscribed empirical evidence in support of their efficacy. While it is claimed that Social Stories may be appropriate to children with significant levels of intellectual disability and basic…

Advance care treatment plan (ACT-Plan) for African American family caregivers: a pilot study.

PubMed

Bonner, Gloria J; Wang, Edward; Wilkie, Diana J; Ferrans, Carol E; Dancy, Barbara; Watkins, Yashika

2014-01-01

Research is limited on end-of-life treatment decisions made by African American family caregivers. In a pilot study, we examined the feasibility of implementing an advance care treatment plan (ACT-Plan), a group-based education intervention, with African American dementia caregivers. Theoretically based, the ACT-Plan included strategies to enhance knowledge, self-efficacy, and behavioral skills to make end-of-life treatment plans in advance. Cardiopulmonary resuscitation, mechanical ventilation, and tube feeding were end-of-life treatments discussed in the ACT-Plan. In a four-week pre/posttest two-group design at urban adult day care centers, 68 caregivers were assigned to the ACT-Plan or attention-control health promotion conditions. Findings strongly suggest that the ACT-Plan intervention is feasible and appropriate for African American caregivers. Self-efficacy and knowledge about dementia, cardiopulmonary resuscitation, mechanical ventilation, and tube feeding increased for ACT-Plan participants but not for the attention-control. More ACT-Plan than attention-control participants developed advance care plans for demented relatives. Findings warrant a randomized efficacy trial.

Efficacy and tolerability of bromelain in patients with chronic rhinosinusitis--a pilot study.

PubMed

Büttner, L; Achilles, N; Böhm, M; Shah-Hosseini, K; Mösges, R

2013-01-01

To evaluate the efficacy, tolerability, and impact on quality of life (QoL) of bromelain tablets (500 FIP) in patients with chronic rhinosinusitis (CRS). In this prospective, open-label observational pilot study, 12 patients suffering from CRS with (CRS+NP) or without (CRS-NP) nasal polyps who had undergone prior sinus surgery were treated with bromelain tablets (500 FIP) for three months. Efficacy was evaluated using symptom scores (Total Symptom Scores: TSS); a Total Rhinoscopy Score (TRS) was also determined. QoL was assessed by using the German, adapted version of the Sinonasal Outcome Test 20 (SNOT-20 GAV). Treatment with bromelain tablets (500 FIP) improved TSS, TRS and SNOT-20 GAV on average. This treatment was found to be more effective, however, for CRS-NP than for CRS+NP. The average intake was six tablets, equivalent to a daily dosage of 3000 FIP. No adverse events were observed. Preliminary results indicate good tolerability, symptom control, and improvement in QoL for the treatment of CRS using bromelain tablets (500 FIP).

Improving communication in general practice when mental health issues appear: piloting a set of six evidence-based skills.

PubMed

Stensrud, Tonje Lauritzen; Gulbrandsen, Pål; Mjaaland, Trond Arne; Skretting, Sidsel; Finset, Arnstein

2014-04-01

To test a communication skills training program teaching general practitioners (GPs) a set of six evidence-based mental health related skills. A training program was developed and tested in a pilot test-retest study with 21 GPs. Consultations were videotaped and actors used as patients. A coding scheme was created to assess the effect of training on GP behavior. Relevant utterances were categorized as examples of each of the six specified skills. The GPs' self-perceived learning needs and self-efficacy were measured with questionnaires. The mean number of GP utterances related to the six skills increased from 13.3 (SD 6.2) utterances before to 23.6 (SD 7.2) utterances after training; an increase of 77.4% (P<0.001). Effect sizes varied from 0.23 to 1.37. Skills exploring emotions, cognitions and resources, and the skill Promote coping, increased significantly. Self-perceived learning needs and self-efficacy did not change significantly. The results from this pilot test are encouraging. GPs enhanced their use on four out of six mental health related communication skills significantly, and the effects were medium to large. This training approach appears to be an efficacious approach to mental health related communication skills training in general practice. Copyright © 2013 Elsevier Ireland Ltd. All rights reserved.

Methylphenidate in the management of asthenia in breast cancer patients treated with docetaxel: results of a pilot study.

PubMed

Cueva, Juan F; Calvo, Marcos; Anido, Urbano; León, Luis; Gallardo, Elena; Areses, Carmen; Bernárdez, Beatriz; Gayoso, Lucía; García, Jorge; Jesús Lamas, María; Curiel, Teresa; Vázquez, Francisca; Candamio, Sonia; Vidal, Yolanda; Javier Barón, Francisco; López, Rafael

2012-04-01

The objectives of this pilot study were to evaluate the safety and efficacy of the central nervous system stimulant methylphenidate in the management of asthenia in breast cancer patients treated with docetaxel. Patients with early breast cancer who presented asthenia >3 on the Visual Analogue Scale (VAS) after the first cycle of docetaxel-based chemotherapy were included. Patients received two additional cycles of chemotherapy, one with methylphenidate (10 mg bid) and the other without methylphenidate. Asthenia was evaluated using VAS and the Functional Assessment of Cancer Therapy-Fatigue (FACT-F) scale. Distress was assessed using the Hospital Anxiety and Depression Scale (HADS), and quality of life using FACT-F. Ten patients were included and evaluated for efficacy and safety. Overall, cycles with methylphenidate were better tolerated than those without methylphenidate in terms of asthenia (VAS, p = 0.004; FACT-F, p = 0.027) and quality of life (FACT-F, p = 0.047). No significant differences were observed in terms of distress (HADS, p = 0.297). Six (60%) patients continued with methylphenidate after study end. Main adverse events during study were palpitations and insomnia (30% of patients each). This pilot study suggests that methylphenidate may reduce asthenia and improve quality of life in breast cancer patients treated with docetaxel.

Efficacy and safety of a new coverlet device on skin microclimate management: a pilot study in critical care patients.

PubMed

Forriez, O; Masseline, J; Coadic, D; David, V; Trouiller, P; Sztrymf, B

2017-02-02

To test the effect of a new coverlet device, allowing air circulation at the body/underlying surface interface, on skin microclimate management. This prospective observational pilot study took place in a 15-bed university-affiliated intensive care unit. Overall, 34 mechanically ventilated patients were included. Skin humidity and temperature were monitored before and after the implementation of the tested device at the occiput, scapulas, buttocks and sacrum. Humidity and temperature were evaluated through surface skin impedance and an infra-red thermometer, respectively. Health professionals were asked to evaluate the device. After implementation of the coverlet device, there was a rapid, sustained and significant decrease in skin humidity at all sites ranging from 6 % to 15 %, excluding the occiput. Skin temperature also significantly decreased from 1 % at both scapulas, but not at the other studied body sites. No side effects were observed. Health professionals reported that the device was easy and quick to install. Although they did not report a subjective improvement in skin moisture or temperature, they considered the device to be efficient. Although limited by its design, this pilot study suggests a good efficacy of the studied device on skin microclimate management. Further data are warranted to test the clinical implications of our findings.

Intensive, Manual-based Intervention for Pediatric Feeding Disorders: Results From a Randomized Pilot Trial.

PubMed

Sharp, William G; Stubbs, Kathryn H; Adams, Heyward; Wells, Brian M; Lesack, Roseanne S; Criado, Kristen K; Simon, Elizabeth L; McCracken, Courtney E; West, Leanne L; Scahill, Larry D

2016-04-01

The aim of this pilot study was to investigate feasibility and preliminary efficacy of an intensive, manual-based behavioral feeding intervention for children with chronic food refusal and dependence on enteral feeding or oral nutritional formula supplementation. Twenty children ages 13 to 72 months (12 boys and 8 girls) meeting criteria for avoidant/restrictive food intake disorder were randomly assigned to receive treatment for 5 consecutive days in a day treatment program (n = 10) or waitlist (n = 10). A team of trained therapists implemented treatment under the guidance of a multidisciplinary team. Parent training was delivered to support generalization of treatment gains. We tracked parental attrition and attendance, as well as therapist fidelity. Primary outcome measures were bite acceptance, disruptions, and grams consumed during meals. Caregivers reported high satisfaction and acceptability of the intervention. Three participants (1 intervention; 2 waitlist) dropped out of the study before endpoint. Of the expected 140 treatment meals for the intervention group, 137 (97.8%) were actually attended. The intervention group showed significantly greater improvements (P < 0.05) on all primary outcome measures (d = 1.03-2.11) compared with waitlist (d = -1.13-0.24). A 1-month follow-up suggested stability in treatment gains. Results from this pilot study corroborate evidence from single-subject and nonrandomized studies on the positive effects of behavioral intervention. Findings support the feasibility and preliminary efficacy of this manual-based approach to intervention. These results warrant a large-scale randomized trial to test the safety and efficacy of this intervention.

Gender Differences in Career Self-Efficacy: Combining a Career with Home and Family.

ERIC Educational Resources Information Center

Stickel, Sue A.; Bonett, Rhonda M.

1991-01-01

Piloted Career Attitude Scale, measure of career self-efficacy, with college students (n=130) and examined gender differences in career self-efficacy. Compared to men, women reported greater efficacy in terms of combining traditional career with family and home activities. Women also revealed greater confidence that they could competently handle…

Efficacy of Chloroquine as a first line agent in the treatment of uncomplicated malaria due to Plasmodium vivax in children and treatment practices in Pakistan: A Pilot study.

PubMed

Waqar, Talal; Khushdil, Arshad; Haque, Khalid

2016-01-01

To ascertain the efficacy of chloroquine as first line agent in treatment of uncomplicated malaria -caused by Plasmodium vivax in children---and to determine its current treatment practice in Pakistan. This pilot study was conducted at the Paediatrics Department of Combined Military Hospital (CMH), Lahore, Pakistan. Forty-eight children between six months and twelve years of age having positive blood film for Plasmodium vivax were included. They were treated with chloroquine as a drug of - choice. Efficacy of chloroquine was assessed by clinical response, absence of parasitaemia on day seven and twenty-eight after initiation of therapy. A survey was also conducted to determine the first line therapeutic choice of Paediatricians in the treatment of uncomplicated Plasmodium vivax malaria in children in Pakistan. The results showed 100% efficacy of chloroquine in treating uncomplicated malaria caused by Plasmodium vivax in children. Artemisin was preferred by 74.28% Paediatricians' in combination therapy as 1st line treatment. Guidelines proposed by Malaria Control Programme Pakistan (MCPP) in collaboration with World Health Organization (WHO) are comprehensive but not being adhered to. The recently reported resistance of Plasmodium vivax to artemisin should urge measures to implement WHO guidelines.

Metacognitive therapy versus cognitive behavioural therapy for depression: a randomized pilot study.

PubMed

Jordan, Jennifer; Carter, Janet D; McIntosh, Virginia V W; Fernando, Kumari; Frampton, Christopher M A; Porter, Richard J; Mulder, Roger T; Lacey, Cameron; Joyce, Peter R

2014-10-01

Metacognitive therapy (MCT) is one of the newer developments within cognitive therapy. This randomized controlled pilot study compared independently applied MCT with cognitive behavioural therapy (CBT) in outpatients with depression to explore the relative speed and efficacy of MCT, ahead of a planned randomized controlled trial. A total of 48 participants referred for outpatient therapy were randomized to up to 12 weeks of MCT or CBT. Key outcomes were reduction in depressive symptoms at week 4 and week 12, measured using the independent-clinician-rated Quick Inventory of Depressive Symptomatology16. Intention-to-treat and completer analyses as well as additional methods of reporting outcome of depression are presented. Both therapies were effective in producing clinically significant change in depressive symptoms, with moderate-to-large effect sizes obtained. No differences were detected between therapies in overall outcome or early change on clinician-rated or self-reported measures. Post-hoc analyses suggest that MCT may have been adversely affected by greater comorbidity. In this large pilot study conducted independently of MCT's developers, MCT was an effective treatment for outpatients with depression, with similar results overall to CBT. Insufficient power and imbalanced comorbidity limit conclusions regarding comparative efficacy so further studies of MCT and CBT are required. © The Royal Australian and New Zealand College of Psychiatrists 2014.

Feasibility of using a personal digital assistant to self-monitor diet and fluid intake: a pilot study.

PubMed

Welch, Janet; Dowell, Shannon; Johnson, Cynthia S

2007-01-01

The feasibility of using an electronic device to self-monitor diet and fluid intake was assessed using the treatment implementation model. The three patients on hemodialysis who participated in this pilot study were asked to self-monitor diet and fluid intake for 12 weeks with a personal digital assistant. The intervention was delivered as intended; however, participants reported problems with usability, and compliance to self-monitoring was lower than desirable. Further adjustments to the intervention will be made before testing efficacy.

Mental health benefits of outdoor adventures: Results from two pilot studies.

PubMed

Mutz, Michael; Müller, Johannes

2016-06-01

This paper investigates potential mental health benefits of outdoor and adventure education programs. It is argued that experiences made in successful programs can increase self-efficacy, mindfulness and subjective well-being. Furthermore, programs may reduce feelings of time pressure and mental stress amongst participants. Evidence comes from two pilot studies: In the school project "Crossing the Alps" (Study 1), 14-year-old participants reported an increase in life satisfaction, mindfulness and a decrease in the PSQ Subscale 'demand' after a successful nine-day hike through the German, Austrian, and Italian Alps. In the university project "Friluftsliv" (Study 2) participants scored higher in life satisfaction, happiness, mindfulness, and self-efficacy and lower in perceived stress after having spent eight days in the wilderness of the Norwegian Hardangervidda region, miles away from the next locality. The findings suggest that outdoor education and wilderness programs can foster mental health in youths and young adults. Copyright © 2016 The Authors. Published by Elsevier Ltd.. All rights reserved.

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.

The South Asian heart lifestyle intervention (SAHELI) study to improve cardiovascular risk factors in a community setting: Design and methods

PubMed Central

Kandula, Namratha R.; Patel, Yasin; Dave, Swapna; Seguil, Paola; Kumar, Santosh; Baker, David W.; Spring, Bonnie; Siddique, Juned

2013-01-01

Disseminating and implementing evidence-based, cardiovascular disease (CVD) prevention lifestyle interventions in community settings and in ethnic minority populations is a challenge. We describe the design and methods for the South Asian heart lifestyle intervention (SAHELI) study, a pilot study designed to determine the feasibility and initial efficacy of a culturally-targeted, community-based lifestyle intervention to improve physical activity and diet behaviors among medically underserved South Asians (SAs). Participants with at least one CVD risk factor will be randomized to either a lifestyle intervention or a control group. Participants in both groups will be screened in a community setting and receive a primary care referral after randomization. Intervention participants will receive 6 weeks of group classes, followed by 12 weeks of individual telephone support where they will be encouraged to initiate and maintain a healthy lifestyle goal. Control participants will receive their screening results and monthly mailings on CVD prevention. Primary outcomes will be changes in moderate/vigorous physical activity and saturated fat intake between baseline, 3-, and 6-month follow-up. Secondary outcomes will be changes in weight, clinical risk factors, primary care visits, self-efficacy, and social support. This study will be one of the first to pilot-test a lifestyle intervention for SAs, one of the fastest growing racial/ethnic groups in the U.S. and one with disparate CVD risk. Results of this pilot study will provide preliminary data about the efficacy of a lifestyle intervention on CVD risk in SAs and inform community-engaged CVD prevention efforts in an increasingly diverse U.S. population. PMID:24060673

How Are Boston Pilot School Students Faring? "Student Demographics, Engagement, and Performance," 1998-2003

ERIC Educational Resources Information Center

Tung, Rosann; Ouimette, Monique; Feldman, Jay

2004-01-01

This report examines the efficacy of the Boston Pilot Schools, a model of urban schools created in 1994 to promote innovation and increased choice options within the Boston Public Schools (BPS). Unlike most urban public schools, the Boston Pilot Schools have control over budget, staffing, curriculum, governance, and time, all critical conditions…

Cardiovascular Disease Self-Management: Pilot Testing of an mHealth Healthy Eating Program

PubMed Central

Pfaeffli Dale, Leila; Whittaker, Robyn; Eyles, Helen; Ni Mhurchu, Cliona; Ball, Kylie; Smith, Natasha; Maddison, Ralph

2014-01-01

Cardiac rehabilitation (CR) is crucial in the management of cardiovascular disease (CVD), yet attendance is poor. Mobile technology (mHealth) offers a potential solution to increase reach of CR. This paper presents two development studies to determine mobile phone usage in adults with CVD and to evaluate the acceptability of an mHealth healthy eating CR program. Methods: CR attendees were surveyed to determine mobile phone usage rates. A second single-subject pilot study investigated perceptions of a 4-week theory-based healthy eating mHealth program and explored pre-post changes in self-efficacy. Results: 74 adults with CVD completed the survey (50/74 male; mean age 63 ± 10). Nearly all had mobile phones (70/74; 95%) and used the Internet (69/74; 93%), and most were interested in receiving CR by text message (57/74; 77%). 20 participants took part in the healthy eating pilot study. Participants read all/most of the text messages, and most (19/20) thought using mobile technology was a good way to deliver the program. The website was not widely used as visiting the website was reported to be time consuming. Exploratory t-tests revealed an increase in heart healthy eating self-efficacy post program, in particular the environmental self-efficacy subset (Mean = 0.62, SD = 0.74, p = 0.001). Conclusions: Text messaging was seen as a simple and acceptable way to deliver nutrition information and behavior change strategies; however, future research is needed to determine the effectiveness of such programs. PMID:25562145

Cockpit Technology for Prevention of General Aviation Runway Incursions

NASA Technical Reports Server (NTRS)

Prinzel, Lawrence J., III; Jones, Denise R.

2007-01-01

General aviation accounted for 74 percent of runway incursions but only 57 percent of the operations during the four-year period from fiscal year (FY) 2001 through FY2004. Elements of the NASA Runway Incursion Prevention System were adapted and tested for general aviation aircraft. Sixteen General Aviation pilots, of varying levels of certification and amount of experience, participated in a piloted simulation study to evaluate the system for prevention of general aviation runway incursions compared to existing moving map displays. Pilots flew numerous complex, high workload approaches under varying weather and visibility conditions. A rare-event runway incursion scenario was presented, unbeknownst to the pilots, which represented a typical runway incursion situation. The results validated the efficacy and safety need for a runway incursion prevention system for general aviation aircraft.

Evaluation of Brāhmī ghṛtam in children suffering from Attention Deficit Hyperactivity Disorder

PubMed Central

Bhalerao, Supriya; Munshi, Renuka; Nesari, Tanuja; Shah, Heenal

2013-01-01

Introduction: Attention Deficit Hyperactivity Disorder (ADHD) is characterized by a persistent pattern of inattention and/or hyperactivity-impulsivity. In view of the adverse effects associated with psycho-stimulants used for the treatment of this disorder, efficacy of Brāhmī ghṛtam was evaluated in this condition. Materials and Methods: After following due ethical considerations, children of either sex between the age group of 6 and 12 years diagnosed to be suffering from mixed variety of ADHD as per The Diagnostic and Statistical Manual of Mental Disorders (DSM) IV criteria irrespective of other co-morbid psychiatric illnesses were recruited in the study. Initially a pilot study (n = 10) was carried out to confirm the efficacy of the identified dose of Brāhmī ghṛtam. Using this dose, further therapeutic confirmatory study (n = 27) was carried out, wherein Brāhmī ghṛtam was compared with methylphenidate. Effect on ADHD symptoms was assessed using the Dupaul ADHD rating scale and this was the main efficacy parameter. Results: In the pilot exploratory study, Brāhmī ghṛtam showed 66% decrease in total ADHD score. In the therapeutic confirmatory study, only 16% improvement was seen with Brāhmī ghṛtam, which was similar to methylphenidate, standard treatment for ADHD that was used as a comparator in the present study. No side-effects were reported in both studies. Conclusion: Our study thus has adequately demonstrated efficacy and safety of Brāhmī ghṛtam in ADHD. PMID:25284947

Do Mothers Benefit from a Child-Focused Cognitive Behavioral Treatment (CBT) for Childhood Functional Abdominal Pain? A Randomized Controlled Pilot Trial

PubMed Central

Calvano, Claudia; Groß, Martina; Warschburger, Petra

2017-01-01

While the efficacy of cognitive-behavioral treatment (CBT) approaches for childhood functional abdominal pain (FAP) is well-established for child outcomes, only a few studies have reported on parent-specific outcomes. This randomized controlled pilot trial analyzed effects of a group CBT on maternal variables (i.e., pain-related behavior, worries and self-efficacy, as well as general psychosocial strain). Methods: The sample constituted of 15 mothers in the intervention group (IG) and 14 mothers in the waitlist control group (WLC). Outcome measures were assessed pre-treatment, post-treatment and at three months follow-up. Results: Analyses revealed significant, large changes in maladaptive maternal reactions related to the child’s abdominal pain in the IG compared to the WLC—i.e., reduced attention (d = 0.95), medical help-seeking (d = 0.92), worries (d = 1.03), as well as a significant increase in behaviors that encourage the child’s self-management (d = 1.03). In addition, maternal self-efficacy in dealing with a child’s pain significantly increased in the IG as well (d = 0.92). Treatment effects emerged post-treatment and could be maintained until three months follow-up. There were no effects on general self-efficacy and maternal quality of life. Conclusion: While these results are promising, and underline the efficacy of the CBT approach for both the child and mothers, further studies, including long-term follow-ups, are warranted. PMID:28212279

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.

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

Finasteride for Chronic Central Serous Chorioretinopathy

PubMed Central

Forooghian, Farzin; Meleth, Annal D.; Cukras, Catherine; Chew, Emily Y.; Wong, Wai T.; Meyerle, Catherine B.

2010-01-01

Purpose To evaluate the safety and efficacy of finasteride, an inhibitor of dihyroxytestosterone (DHT) synthesis, in the treatment of chronic central serous chorioretinopathy (CSC). Methods Five patients with chronic CSC were prospectively enrolled in this pilot study. Patients were administered finasteride (5mg) daily for 3 months, following which study medication was withheld and patients were observed for 3 months. Main outcome measures included best-corrected visual acuity (BCVA), center-subfield macular thickness and subretinal fluid volume as assessed by optical coherence tomography (OCT). Serum DHT, serum testosterone, and urinary cortisol were also measured. Results There was no change in mean BCVA. Mean center-subfield macular thickness and subretinal fluid volume reached a nadir at 3 months, and rose to levels that were below baseline by 6 months. The changes in both OCT parameters paralleled changes in serum DHT level. In four patients, center-subfield macular thickness and/or subretinal fluid volume increased following discontinuation of finasteride. In the remaining patient, both OCT parameters normalized with finasteride and remained stable when the study medication was discontinued. Conclusion Finasteride may represent a novel medical treatment for chronic CSC. Larger controlled clinical trials are needed to further assess the efficacy of finasteride for the treatment of CSC. Summary Pilot study to evaluate finasteride for treatment of chronic central serous chorioretinopathy suggests efficacy and tolerability. PMID:21273946

Finding the critical cue: implementation intentions to change one's diet work best when tailored to personally relevant reasons for unhealthy eating.

PubMed

Adriaanse, Marieke A; de Ridder, Denise T D; de Wit, John B F

2009-01-01

Implementation intentions promote acting on one's good intentions. But does specifying where and when to act also suffice when goals involve complex change that requires not merely initiating a behavior but rather substituting a habit with a new response? In a pilot study and two experiments, the authors investigated the efficacy of implementation intentions to replace unhealthy snacks with healthy snacks by linking different types of cues for unhealthy snacking (if-part) to healthy snacking (then-part). The pilot study identified cues for unhealthy snacking, differentiating between situational (where/when) and motivational (why) cues. Studies 1 and 2 tested the efficacy of implementation intentions that specified either situational or motivational cues in altering snacking habits. Results showed that implementation intentions specifying motivational cues decreased unhealthy snack consumption whereas the classic specification of where and when did not. Extending previous research, for complex behavior change "why" seems more important than "where and when."

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

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

Development and pilot testing of an integrated, web-based self-management program for irritable bowel syndrome (IBS).

PubMed

Dorn, S D; Palsson, O S; Woldeghebriel, M; Fowler, B; McCoy, R; Weinberger, M; Drossman, D A

2015-01-01

Although essential, many medical practices are unable to adequately support irritable bowel syndrome (IBS) patient self-management. Web-based programs can help overcome these barriers. We developed, assessed, and refined an integrated IBS self-management program (IBS Self-care). We then conducted a 12-week pilot test to assess program utilization, evaluate its association with patients' self-efficacy and quality of life, and collect qualitative feedback to improve the program. 40 subjects with generally mild IBS were recruited via the Internet to participate in a 12-week pilot study. Subjects found the website easy to use (93%) and personally relevant (95%), and 90% would recommend it to a friend. Self-rated IBS knowledge increased from an average of 47.1 on a 100-point VAS scale (SD 22.1) at baseline to 77.4 (SD: 12.4) at week 12 (p < 0.0001). There were no significant changes in patient self-efficacy (Patient Activation Measure) or quality of life (IBS -Quality of Life Scale). The IBS Self-Care program was well received by users who after 12 weeks reported improved knowledge about IBS, but no significant changes in self-efficacy or quality of life. If applied to the right population, this low cost solution can overcome some of the deficiencies of medical care and empower individuals to better manage their own IBS. © 2014 John Wiley & Sons 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

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.

Adult Beginner Instrumentalists' Practice, Self-Regulation, and Self-Efficacy: A Pilot Study

ERIC Educational Resources Information Center

Ritchie, Laura; Kearney, Phil

2018-01-01

The self-regulation of practice behaviour has repeatedly been shown to distinguish between novice and expert performers, however interventions designed to encourage self-regulation by novice musicians have shown limited effectiveness. Guided by successful research in sporting contexts, the present study investigated the behaviours of beginner…

Guidelines for the Clinical Evaluation of Psychoactive Drugs in Infants and Children.

ERIC Educational Resources Information Center

Food and Drug Administration (DHEW), Washington, DC.

These guidelines are intended to help those who design and conduct investigations of psychopharmacologic agents in children. A progression of studies in four phases is advocated. First, early short term studies should establish single and multiple dose safety baselines. Second, early pilot efficacy studies may be initiated jointly with longer…

Voucher-Based Contingent Reinforcement of Smoking Abstinence among Methadone-Maintained Patients: A Pilot Study

ERIC Educational Resources Information Center

Dunn, Kelly E.; Sigmon, Stacey C.; Thomas, Colleen S.; Heil, Sarah H.; Higgins, Stephen T.

2008-01-01

This study evaluated the efficacy of a contingency management (CM) intervention to promote smoking cessation in methadone-maintained patients. Twenty participants, randomized into contingent (n = 10) or noncontingent (n = 10) experimental conditions, completed the 14-day study. Abstinence was determined using breath carbon monoxide and urine…

Expanding Horizons: A Pilot Mentoring Program Linking College/Graduate Students and Teens With ASD.

PubMed

Curtin, Carol; Humphrey, Kristin; Vronsky, Kaela; Mattern, Kathryn; Nicastro, Susan; Perrin, Ellen C

2016-02-01

A small pilot program of 9 youth 13 to 18 years old with high-functioning autism spectrum disorder (ASD) or Asperger's syndrome assessed the feasibility, acceptability, and potential efficacy of an individualized mentoring program. Youth met weekly for 6 months with trained young adult mentors at a local boys and girls club. Participants reported improvements in self-esteem, social anxiety, and quality of life. Participants, parents, mentors, and staff reported that the program improved participants' social connectedness. Although the pilot study was small, it provides preliminary data that mentoring for youth with ASD has promise for increasing self-esteem, social skills, and quality of life. © The Author(s) 2015.

EXPANDING HORIZONS: A PILOT MENTORING PROGRAM LINKING COLLEGE/GRADUATE STUDENTS AND TEENS WITH ASD

PubMed Central

Curtin, Carol; Humphrey, Kristin; Vronsky, Kaela; Mattern, Kathryn; Nicastro, Susan; Perrin, Ellen C.

2015-01-01

A small pilot program of nine youth ages 13–18 with high functioning autism spectrum disorder (ASD) or Asperger’s syndrome assessed the feasibility, acceptability, and potential efficacy of an individualized mentoring program. Youth met weekly for 6 months with trained young adult mentors at a local Boys and Girls Clubs. Participants reported improvements in self-esteem, social anxiety, and quality of life. Participants, parents, mentors, and staff reported that the program improved participants’ social connectedness. While the pilot study was small, it provides preliminary data that mentoring for youth with ASD has promise for increasing self-esteem, social skills, and quality of life. PMID:26016838

Training General Aviation Pilots for Convective Weather Situations.

PubMed

Blickensderfer, Elizabeth L; Lanicci, John M; Vincent, Michael J; Thomas, Robert L; Smith, MaryJo; Cruit, Jessica K

2015-10-01

Over the past 10-15 yr, considerable research has occurred for the development, testing, and fielding of real-time Datalink weather products for general aviation (GA) pilots to use before and during flight. As is the case with the implementation of most new technologies, work is needed to ensure that the users (in this case, the pilots) understand both the capabilities and limitations of the new technologies as well as how to use the new systems to improve their task performance. The purpose of this study was to replicate and extend a previous study on training pilots how and when to use these new weather technologies. This field study used a quasi-experimental design (pre- vs. post-test with a control group). There were 91 GA pilots from the Midwest, Northeastern, and Southeastern United States who participated in a 2-h short course or a control activity. The lecture-based short course covered radar basics, Next Generation Weather Radar (NEXRAD), NEXRAD specifics/limitations, thunderstorm basics, radar products, and decision making. The pilots who participated in the course earned higher knowledge test scores, improved at applying the concepts in paper-based flight scenarios, had higher self-efficacy in post-training assessments as compared to pre-training assessments, and also performed better than did control subjects on post-test knowledge and skills assessments. GA pilots lack knowledge about real-time Datalink weather technology. This study indicates that a relatively short training program was effective for fostering Datalink weather-related knowledge and skills in GA pilots.

Evaluating the treatment efficacy of Bacillus thuriengiensis Var. Kurstaki: reliability of various tools

Treesearch

Ghislain Rousseau

2003-01-01

The success of an operational or pilot insecticide spraying program against the spruce budworm (Choristoneura fumiferana Clemens) depends to a great extent on a variety of factors, and, in particular on: spraying efficacy and the meteorological conditions during and immediately following spraying. Among other things, spraying efficacy depends on:...

Feasibility and Effectiveness of a Pilot Health Promotion Program for Adults With Type 2 Diabetes

PubMed Central

Kluding, Patricia M.; Singh, Rupali; Goetz, Jeanine; Rucker, Jason; Bracciano, Sarah; Curry, Natasha

2013-01-01

Purpose The purpose of this pilot study was to assess the feasibility and effectiveness of an intense health promotion program in older adults with diabetes. The program combined individually prescribed and supervised exercise with nutrition and education programs on glycemic control and aerobic fitness. Methods Various recruitment and retention strategies were analyzed for effectiveness. Out of 28 potential subjects assessed for eligibility, 6 subjects with type 2 diabetes (2 male and 4 female; all white; age, 60.2 ± 4.7 years) participated in the 10-week intervention. Aerobic and resistance exercise was performed on alternate days (3-4 days per week), with individualized nutrition counseling and diabetes health education sessions once weekly. The primary outcome measures were aerobic fitness and glycemic control (A1C), and secondary outcome measures included body mass index (BMI), self-efficacy, and symptoms of neuropathy. Changes in outcomes were assessed using descriptive statistics and paired t test analysis (α = .05). Results Following the intervention, subjects had improvements that approached significance in A1C and pain, with significant improvements in self-efficacy. Conclusions A systematic approach to analysis of feasibility revealed issues with recruitment and retention that would need to be addressed for future studies or clinical implementation of this program. However, for the subset of subjects who did complete the intervention, adherence was excellent, and satisfaction with the program was confirmed by exit interview comments. Following participation in this pilot health promotion program, subjects had meaningful improvements in glycemic control, pain, and self-efficacy. PMID:20530663

Pilot Study of the 5-HT2AR Agonist Psilocybin in the Treatment of Tobacco Addiction

PubMed Central

Johnson, Matthew W.; Garcia-Romeu, Albert; Cosimano, Mary P.; Griffiths, Roland R.

2014-01-01

Despite suggestive early findings on the therapeutic use of hallucinogens in the treatment of substance use disorders, rigorous follow up has not been conducted. To determine the safety and feasibility of psilocybin as an adjunct to tobacco smoking cessation treatment we conducted an open-label pilot study administering moderate (20mg/70kg) and high (30mg/70kg) doses of psilocybin within a structured 15-week smoking cessation treatment protocol. Participants were 15 psychiatrically healthy nicotine-dependent smokers (10 males; mean age of 51 years), with a mean of 6 previous lifetime quit attempts, and smoking a mean of 19 cigarettes per day for a mean of 31 years at intake. Biomarkers assessing smoking status, and self-report measures of smoking behavior demonstrated that 12 of 15 participants (80%) showed seven-day point prevalence abstinence at 6-month follow-up. The observed smoking cessation rate substantially exceeds rates commonly reported for other behavioral and/or pharmacological therapies (typically <35%). Although the open-label design does not allow for definitive conclusions regarding the efficacy of psilocybin, these findings suggest psilocybin may be a potentially efficacious adjunct to current smoking cessation treatment models. The present study illustrates a framework for future research on the efficacy and mechanisms of hallucinogen-facilitated treatment of addiction. PMID:25213996

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.

Pediatric Primary Care-Based Obesity Prevention for Parents of Preschool Children: A Pilot Study.

PubMed

Sherwood, Nancy E; JaKa, Meghan M; Crain, A Lauren; Martinson, Brian C; Hayes, Marcia G; Anderson, Julie D

2015-12-01

The Healthy Homes/Healthy Kids Preschool (HHHK-Preschool) pilot program is an obesity prevention intervention integrating pediatric care provider counseling and a phone-based program to prevent unhealthy weight gain among 2- to 4-year-old children at risk for obesity (BMI percentile between the 50th and 85th percentile and at least one overweight parent) or currently overweight (85th percentile ≤ BMI < 95th percentile). The aim of this randomized, controlled pilot study was to evaluate the feasibility, acceptability, and potential efficacy of the HHHK-Preschool intervention. Sixty parent-child dyads recruited from pediatric primary care clinics were randomized to: (1) the Busy Bodies/Better Bites Obesity Prevention Arm or the (2) Healthy Tots/Safe Spots safety/injury prevention Contact Control Arm. Baseline and 6-month data were collected, including measured height and weight, accelerometry, previous day dietary recalls, and parent surveys. Intervention process data (e.g., call completion) were also collected. High intervention completion and satisfaction rates were observed. Although a statistically significant time by treatment interaction was not observed for BMI percentile or BMI z-score, post-hoc examination of baseline weight status as a moderator of treatment outcome showed that the Busy Bodies/Better Bites obesity prevention intervention appeared to be effective among children who were in the overweight category at baseline relative to those who were categorized as at risk for obesity (p = 0.04). HHHK-Preschool pilot study results support the feasibility, acceptability, and potential efficacy in already overweight children of a pediatric primary care-based obesity prevention intervention integrating brief provider counseling and parent-targeted phone coaching. What's New: Implementing pediatric primary care-based obesity interventions is challenging. Previous interventions have primarily involved in-person sessions, a barrier to sustained parent involvement. HHHK-preschool pilot study results suggest that integrating brief provider counseling and parent-targeted phone coaching is a promising approach.

Safety and efficacy of overnight orthokeratology in myopic children.

PubMed

Mika, Renée; Morgan, Bruce; Cron, Michael; Lotoczky, Josh; Pole, John

2007-05-01

This prospective case series was conducted to describe the safety and efficacy of orthokeratology with the Emerald Contact Lens for Overnight Orthokeratology (Oprifocon A; Euclid Systems Corporation, Herndon, Virginia) among young myopes. Twenty subjects (ages 10 to 16) were enrolled in the 6-month pilot study. Subjects were fit empirically with overnight orthokeratology lenses and evaluated at 1 day, 1 week, 1 month, 2 months, 3 months, and 6 months. Sixteen subjects completed the study. The mean baseline spherical equivalent refraction (SER) was -2.06 diopters (D) (+/-0.75). The mean SER at 6 months was -0.16 D (+/-0.38). The mean baseline uncorrected acuity was 0.78 (+/-0.28) logarithmic minimum angle of resolution (logMAR) equivalent (20/100 Snellen). The mean logMAR equivalent at 6 months was -0.03 +/- 0.12 (<20/20 Snellen). On average, 40% of eyes showed some type of corneal staining between the 1-week and 6-month visits. No serious adverse events occurred during the study. In contrast to previously published studies that reported maximum results at 2 weeks, subjects reached maximum reduction in myopia at the 1-week visit and, on average, obtained a 92.2% reduction in spherical equivalent refractive error at 6 months. This pilot study lends to a growing body of evidence that short-term correction of mild to moderate myopia with overnight orthokeratology is safe and efficacious in children and adolescents.

Results of a Pilot Study to Ameliorate Psychological and Behavioral Outcomes of Minority Stress Among Young Gay and Bisexual Men.

PubMed

Smith, Nathan Grant; Hart, Trevor A; Kidwai, Ammaar; Vernon, Julia R G; Blais, Martin; Adam, Barry

2017-09-01

Project PRIDE (Promoting Resilience In Discriminatory Environments) is an 8-session small group intervention aimed at reducing negative mental and behavioral health outcomes resulting from minority stress. This study reports the results of a one-armed pilot test of Project PRIDE, which aimed to examine the feasibility and potential for efficacy of the intervention in a sample of 33 gay and bisexual men aged 18 to 25. The intervention appeared feasible to administer in two different sites and all participants who completed posttreatment (n = 22) or follow-up (n = 19) assessments reported high satisfaction with the intervention. Small to large effect sizes were observed for increases in self-esteem; small effect sizes were found for decreases in loneliness and decreases in minority stress variables; and small and medium effect sizes were found for reductions in alcohol use and number of sex partners, respectively. Overall, Project PRIDE appears to be a feasible intervention with promise of efficacy. Copyright © 2017. Published by Elsevier Ltd.

Resourcefulness training intervention: a promising approach to improve mental health of mothers with technology-dependent children.

PubMed

Toly, Valerie Boebel; Musil, Carol M; Zauszniewski, Jaclene A

2014-02-01

The population of children dependent on medical technology such as mechanical ventilation, feeding tubes, and supplemental oxygen continues to grow in the United States. These children are frequently cared for by their mothers at home following hospital discharge. Research indicates that these mothers are at high risk for negative mental health outcomes that affect both caregiver and care recipient. The purpose of this randomized controlled pilot trial was to determine the feasibility, acceptability, and efficacy of resourcefulness training (RT), a cognitive-behavioral intervention, among mothers of technology-dependent children. RT was found to be a feasible and acceptable intervention with this population during the 6 week study. The effect size in this pilot study demonstrates initial efficacy and indicates areas for strengthening the intervention protocol. RT is a promising intervention that can be employed by pediatric nurses to assist mothers in the home management of technology-dependent children. Copyright © 2014 Elsevier Inc. All rights reserved.

Efficacy of a brief treatment for nightmares and sleep disturbances for veterans.

PubMed

Balliett, Noelle E; Davis, Joanne L; Miller, Katherine E

2015-11-01

Nightmares and sleep disturbances are common complaints among military Veterans (Plumb & Zelman, 2009) and may be difficult to eradicate (Forbes, Phelps, & McHugh, 2001). A treatment protocol (Exposure, Relaxation, and Rescription Therapy [ERRT]) targeting nightmares and sleep disturbances, which has been used effectively in civilian populations, was adapted for the military (ERRT-M). A pilot study evaluated the efficacy of ERRT-M in improving sleep quality and quantity and reducing nightmares, symptoms of posttraumatic stress disorder, and depression in a trauma-exposed, Veteran sample (N = 19). At 1 week after treatment, analyses revealed improvements in nightmare frequency and severity, depression, sleep quality, and insomnia severity. Treatment gains were maintained at a 2-month follow-up. Fifty percent of the sample was considered treatment responders (i.e., no nightmares in the previous week). Results of this pilot study suggest that directly targeting sleep and nightmares is successful in alleviating sleep disturbances and related psychopathology in some Veterans. (c) 2015 APA, all rights reserved).

Design and Feasibility of a Text Messaging Intervention to Prevent Indoor Tanning Among Young Adult Women: A Pilot Study

PubMed Central

Mays, Darren

2016-01-01

Background Although skin cancer is largely preventable, it affects nearly 1 of 5 US adults. There is a need for research on how to optimally design persuasive public health indoor tanning prevention messages. Objective The objective of our study was to examine whether framed messages on indoor tanning behavioral intentions delivered through short message service (SMS) text messaging would produce (1) positive responses to the messages, including message receptivity and emotional response; (2) indoor tanning efficacy beliefs, including response efficacy and self-efficacy; and (3) indoor tanning risk beliefs. Methods We conducted a pilot study of indoor tanning prevention messages delivered via mobile phone text messaging in a sample of 21 young adult women who indoor tan. Participants completed baseline measures, were randomly assigned to receive gain-, loss-, or balanced-framed text messages, and completed postexposure outcome measures on indoor tanning cognitions and behaviors. Participants received daily mobile phone indoor tanning prevention text messages for 1 week and completed the same postexposure measures as at baseline. Results Over the 1-week period there were trends or significant changes after receipt of the text messages, including increased perceived susceptibility (P<.001), response efficacy beliefs (P<.001), and message receptivity (P=.03). Ordinary least squares stepwise linear regression models showed an effect of text message exposure on self-efficacy to quit indoor tanning (t6=–2.475, P<.02). Ordinary least squares linear regression including all measured scales showed a marginal effect of SMS texts on self-efficacy (t20=1.905, P=.08). Participants endorsed highly favorable views toward the text messaging protocol. Conclusions This study supports this use of mobile text messaging as an indoor tanning prevention strategy. Given the nature of skin cancer risk perceptions, the addition of multimedia messaging service is another area of potential innovation for disseminating indoor tanning prevention messages. PMID:28007691

Design and Feasibility of a Text Messaging Intervention to Prevent Indoor Tanning Among Young Adult Women: A Pilot Study.

PubMed

Evans, William D; Mays, Darren

2016-12-22

Although skin cancer is largely preventable, it affects nearly 1 of 5 US adults. There is a need for research on how to optimally design persuasive public health indoor tanning prevention messages. The objective of our study was to examine whether framed messages on indoor tanning behavioral intentions delivered through short message service (SMS) text messaging would produce (1) positive responses to the messages, including message receptivity and emotional response; (2) indoor tanning efficacy beliefs, including response efficacy and self-efficacy; and (3) indoor tanning risk beliefs. We conducted a pilot study of indoor tanning prevention messages delivered via mobile phone text messaging in a sample of 21 young adult women who indoor tan. Participants completed baseline measures, were randomly assigned to receive gain-, loss-, or balanced-framed text messages, and completed postexposure outcome measures on indoor tanning cognitions and behaviors. Participants received daily mobile phone indoor tanning prevention text messages for 1 week and completed the same postexposure measures as at baseline. Over the 1-week period there were trends or significant changes after receipt of the text messages, including increased perceived susceptibility (P<.001), response efficacy beliefs (P<.001), and message receptivity (P=.03). Ordinary least squares stepwise linear regression models showed an effect of text message exposure on self-efficacy to quit indoor tanning (t 6 =-2.475, P<.02). Ordinary least squares linear regression including all measured scales showed a marginal effect of SMS texts on self-efficacy (t 20 =1.905, P=.08). Participants endorsed highly favorable views toward the text messaging protocol. This study supports this use of mobile text messaging as an indoor tanning prevention strategy. Given the nature of skin cancer risk perceptions, the addition of multimedia messaging service is another area of potential innovation for disseminating indoor tanning prevention messages. ©William Evans, Darren Mays. Originally published in JMIR Mhealth and Uhealth (http://mhealth.jmir.org), 22.12.2016.

NURTURE: Development and Pilot Testing of a Novel Parenting Intervention for Mothers with Histories of an Eating Disorder

PubMed Central

Runfola, Cristin D.; Zucker, Nancy L.; Von Holle, Ann; Mazzeo, Suzanne; Hodges, Eric A.; Perrin, Eliana M.; Bentley, Margaret E.; Ulman, T. Frances; Hoffman, Elizabeth R.; Forsberg, Sarah; Ålgars, Monica; Zerwas, Stephanie; Pisetsky, Emily M.; Taico Colie, L.C.S.W.; Kuhns, Rebecca A.; Hamer, Robert M.; Bulik, Cynthia M.

2014-01-01

Objective To describe the treatment development and pilot testing of a group parenting intervention, NURTURE (Networking, Uniting, and Reaching out To Upgrade Relationships and Eating), for mothers with histories of eating disorders. Method Based on focus group findings, extant research, and expert opinion, NURTURE was designed to be delivered weekly over 16 (1.5 hour) sessions via an interactive web conferencing forum. It comprises four modules: 1) laying the foundation, 2) general parenting skills, 3) eating and feeding, and 4) breaking the cycle of risk. Pilot testing was conducted with three groups of 3–6 mothers (N = 13) who had children ages 0–3 years to determine feasibility (e.g., retention), acceptability (e.g., feedback questionnaire responses), and preliminary efficacy. Maternal satisfaction with NURTURE and changes in mother-child feeding relationship measures, maternal feeding style, maternal self-efficacy, and maternal psychopathology (eating disorder, depression, and anxiety symptoms) across three time points (baseline, post-treatment, 6-month follow-up) were examined. All outcomes were exploratory. Results The intervention was well tolerated with a 100% retention rate. Feedback from mothers was generally positive and indicated that the groups provided an engaging, supportive experience to participants. We observed changes suggestive of improvement in self-reported maternal self-efficacy and competence with parenting. There were no notable changes in measures of maternal feeding style or psychopathology. Discussion NURTURE is a feasible, acceptable, and potentially valuable intervention for mothers with eating disorder histories. Results of this pilot will inform a larger randomized-controlled intervention to determine efficacy and impact on child outcomes. PMID:23983082

NURTURE: development and pilot testing of a novel parenting intervention for mothers with histories of an eating disorder.

PubMed

Runfola, Cristin D; Zucker, Nancy L; Von Holle, Ann; Mazzeo, Suzanne; Hodges, Eric A; Perrin, Eliana M; Bentley, Margaret E; Ulman, T Frances; Hoffman, Elizabeth R; Forsberg, Sarah; Algars, Monica; Zerwas, Stephanie; Pisetsky, Emily M; Taico, Colie; Kuhns, Rebecca A; Hamer, Robert M; Bulik, Cynthia M

2014-01-01

To describe the treatment development and pilot testing of a group parenting intervention, NURTURE (Networking, Uniting, and Reaching out To Upgrade Relationships and Eating), for mothers with histories of eating disorders. Based on focus group findings, extant research, and expert opinion, NURTURE was designed to be delivered weekly over 16 (1.5 h) sessions via an interactive web conferencing forum. It comprises four modules: (1) laying the foundation, (2) general parenting skills, (3) eating and feeding, and (4) breaking the cycle of risk. Pilot testing was conducted with three groups of 3-6 mothers (N = 13) who had children ages 0-3 years to determine feasibility (e.g., retention), acceptability (e.g., feedback questionnaire responses), and preliminary efficacy. Maternal satisfaction with NURTURE and changes in mother-child feeding relationship measures, maternal feeding style, maternal self-efficacy, and maternal psychopathology (eating disorder, depression, and anxiety symptoms) across three time points (baseline, post-treatment, 6-month follow-up) were examined. All outcomes were exploratory. The intervention was well tolerated with a 100% retention rate. Feedback from mothers was generally positive and indicated that the groups provided an engaging, supportive experience to participants. We observed changes suggestive of improvement in self-reported maternal self-efficacy and competence with parenting. There were no notable changes in measures of maternal feeding style or psychopathology. NURTURE is a feasible, acceptable, and potentially valuable intervention for mothers with eating disorder histories. Results of this pilot will inform a larger randomized-controlled intervention to determine efficacy and impact on child outcomes. Copyright © 2013 Wiley Periodicals, Inc.

Adolescent HIV Prevention: An Application of the Elaboration Likelihood Model.

ERIC Educational Resources Information Center

Metzler, April E.; Weiskotten, David; Morgen, Keith J.

Ninth grade students (n=298) participated in a study to examine the influence source credibility, message, quality, and personal relevance on HIV prevention message efficacy. A pilot study with adolescent focus groups created the high and low quality messages, as well as the high (HIV+) and low (worried parent) credibility sources. Participants…

Implementation of an Evidence-Based Seizure Algorithm in Intellectual Disability Nursing: A Pilot Study

ERIC Educational Resources Information Center

Auberry, Kathy; Cullen, Deborah

2016-01-01

Based on the results of the Surrogate Decision-Making Self Efficacy Scale (Lopez, 2009a), this study sought to determine whether nurses working in the field of intellectual disability (ID) experience increased confidence when they implemented the American Association of Neuroscience Nurses (AANN) Seizure Algorithm during telephone triage. The…

Chemical additive to maximize antimicrobial effect of chlorine during pilot scale immersion chilling of broiler carcasses

USDA-ARS?s Scientific Manuscript database

A prior laboratory scale study demonstrated the potential for T-128, a proprietary blend including propylene glycol and phosphoric acid, to enhance the antimicrobial efficacy of chlorine during immersion chilling of broiler parts. The objective of the current study was to test the addition of T-128...

An educational intervention on drug interactions and contraceptive options for epilepsy patients: a pilot randomized controlled trial.

PubMed

Mody, Sheila K; Haunschild, Carolyn; Farala, John Paul; Honerkamp-Smith, Gordon; Hur, Vivian; Kansal, Leena

2016-01-01

This pilot study investigates whether an educational handout could increase short-term information retention about drug interactions between antiepileptic drugs (AEDs) and hormonal contraceptives among female epilepsy patients of reproductive age. This is a pilot randomized controlled trial of an educational intervention among reproductive-age women with epilepsy in an academic neurology clinic. Investigators measured knowledge before and after participants received either usual care or the educational handout. The 10-question test assessed increased knowledge of which AEDs affected efficacy of certain hormonal contraceptives and was assessed by calculating the improvement in score between the pretest and posttest. The educational handout included the names of AEDs that have drug interactions with certain contraceptives and the efficacy of the contraceptives. A total of 42 epilepsy patients participated in this study. Fourteen participants were taking AEDs that are enzyme p450 inducers and 13 participants were taking Lamotrigine. Twenty women were randomized to receive the educational handout and 22 women were randomized to usual care. We found no statistical difference in the groups with regard to age, ethnicity or level of education. We found a significantly higher improvement in quiz scores in the educational handout group (3.65 point increase) compared to the usual care group (0.68 point increase) as calculated by the Student's two-sample t test (p<.001). An educational handout on drug interactions and contraceptives resulted in increased short-term information retention on this topic among reproductive-age female epilepsy patients. This pilot study highlights the need for further larger studies to evaluate the impact of educational interventions on improving patient knowledge about the drug interaction of AEDs and hormonal contraceptives. Copyright © 2016. Published by Elsevier Inc.

Switching from subcutaneous insulin injection to oral vildagliptin administration in hemodialysis patients with type 2 diabetes: a pilot study.

PubMed

Yoshida, Naoshi; Babazono, Tetsuya; Hanai, Ko; Uchigata, Yasuko

2016-08-01

We conducted this pilot study to examine efficacy and safety of switching from subcutaneous injection of insulin to oral administration of a DPP-4 inhibitor, vildagliptin, in type 2 diabetic patients undergoing hemodialysis. Consecutive type 2 diabetic patients on hemodialysis who were switched from insulin to vildagliptin between August 2010 and April 2011 were extracted from the hospital database. In patients whose post-switch increase in glycated albumin (GA) levels was <1.5 % without resuming insulin at least 24 weeks, the switch was defined as efficacious. In patients who resumed insulin therapy due to worsening of glycemic control or in patients whose GA levels increased by 1.5 % or more, the switch was considered inefficacious. To predict patients in whom switch to vildagliptin proved efficacious, receiver-operating characteristic (ROC) analysis and logistic regression analysis were performed. A total of 20 patients were extracted; insulin dose was 12 ± 4 units/day; levels of GA and HbA1c was 21.0 ± 3.7 % and 6.5 ± 0.6 %, respectively. Among them, 11 patients were efficaciously switched to vildagliptin. ROC analysis and logistic analysis showed that patients with a shorter duration of diabetes, as well as lower levels of GA and HbA1c, appeared to have a higher likelihood of successful treatment switches. None of the patients developed hypoglycemic symptoms, ketoacidosis, or serious adverse events. In conclusion, efficacious change from insulin to vildagliptin was possible in approximately a half of type 2 diabetic dialysis patients. Long-term follow-up studies including large number of patients are needed to confirm these results.

Efficacy of botulinum toxin in treating myofascial pain in bruxers: a controlled placebo pilot study.

PubMed

Guarda-Nardini, Luca; Manfredini, Daniele; Salamone, Milena; Salmaso, Luigi; Tonello, Stefano; Ferronato, Giuseppe

2008-04-01

The present investigation is a preliminary double-blind, controlled placebo, randomized clinical trial with a six month follow-up period. The study aimed to assess the efficacy of type A botulinum toxin (Botox, Allergan, Inc. Irvine, CA) to treat myofascial pain symptoms and to reduce muscle hyperactivity in bruxers. Twenty patients (ten males, ten females; age range 25-45) with a clinical diagnosis of bruxism and myofascial pain of the masticatory muscles were enrolled in a double-blind, controlled placebo, randomized clinical trial, with a treatment group (ten subjects treated with botulinum toxin injections- BTX-A) and a control group (ten subjects treated with saline placebo injections). A number of objective and subjective clinical parameters (pain at rest and during chewing; mastication efficiency; maximum nonassisted and assisted mouth opening, protrusive and laterotrusive movements; functional limitation during usual jaw movements; subjective efficacy of the treatment; tolerance of the treatment) were assessed at baseline time and at one week, one month, and six months follow-up appointments. Descriptive analysis showed that improvements in both objective (range of mandibular movements) and subjective (pain at rest; pain during chewing) clinical outcome variables were higher in the Botox treated group than in the placebo treated subjects. Patients treated with BTX-A had a higher subjective improvement in their perception of treatment efficacy than the placebo subjects. Differences were not significant in some cases due to the small sample size. Results from the present study supported the efficacy of BTX-A to reduce myofascial pain symptoms in bruxers, and provided pilot data which need to be confirmed by further research using larger samples.

Improving Social Competence through Emotion Knowledge in 2-Year-Old Children: A Pilot Study

ERIC Educational Resources Information Center

Giménez-Dasí, Marta; Fernández-Sánchez, Marta; Quintanilla, Laura

2015-01-01

Research Findings: The goal of this study was to determine the efficacy of an educational intervention program to improve emotion knowledge, emotion regulation, and social competence in 2-year-old Spanish children. This study makes two original contributions because there are no validated education programs for such young children and because it…

Virtual Laboratories in Science Education: Students' Motivation and Experiences in Two Tertiary Biology Courses

ERIC Educational Resources Information Center

Dyrberg, Nadia Rahbek; Treusch, Alexander H.; Wiegand, Claudia

2017-01-01

Potential benefits of simulations and virtual laboratory exercises in natural sciences have been both theorised and studied recently. This study reports findings from a pilot study on student attitude, motivation and self-efficacy when using the virtual laboratory programme Labster. The programme allows interactive learning about the workflows and…

Customization of home closed-loop insulin delivery in adult patients with type 1 diabetes, assisted with structured remote monitoring: the pilot WP7 Diabeloop study.

PubMed

Benhamou, Pierre Yves; Huneker, Erik; Franc, Sylvia; Doron, Maeva; Charpentier, Guillaume

2018-06-01

Improvement in closed-loop insulin delivery systems could result from customization of settings to individual needs and remote monitoring. This pilot home study evaluated the efficacy and relevance of this approach. A bicentric clinical trial was conducted for 3 weeks, using an MPC-based algorithm (Diabeloop Artificial Pancreas system) featuring five settings designed to modulate the reactivity of regulation. Remote monitoring was ensured by expert nurses with a web platform generating automatic Secured Information Messages (SIMs) and with a structured procedure. Endpoints were glucose metrics and description of impact of monitoring on regulation parameters. Eight patients with type 1 diabetes (six men, age 41.8 ± 11.4 years, HbA1c 7.7 ± 1.0%) were included. Time spent in the 70-180 mg/dl range was 70.2% [67.5; 76.9]. Time in hypoglycemia < 70 mg/dl was 2.9% [2.1; 3.4]. Eleven SIMs led to phone intervention. Original default settings were modified in all patients by the intervention of the nurses. This pilot trial suggests that the Diabeloop closed-loop system could be efficient regarding metabolic outcomes, whereas its telemedical monitoring feature could contribute to enhanced efficacy and safety. This study is registered at ClinicalTrials.gov with trial registration number NCT02987556.

Randomized, Controlled Pilot Trial of a Smartphone App for Smoking Cessation Using Acceptance and Commitment Therapy

PubMed Central

Bricker, Jonathan B.; Mull, Kristin; Kientz, Julie A.; Vilardaga, Roger M.; Mercer, Laina D.; Akioka, Katrina; Heffner, Jaimee L.

2014-01-01

Background There is a dual need for (1) innovative theory-based smartphone applications for smoking cessation and (2) controlled trials to evaluate their efficacy. Accordingly, this study tested the feasibility, acceptability, preliminary efficacy, and mechanism of behavioral change of an innovative smartphone-delivered Acceptance and Commitment Therapy (ACT) application for smoking cessation versus an application following US Clinical Practice Guidelines. Method Adult participants were recruited nationally into the double-blind randomized controlled pilot trial (N = 196) that compared smartphone-delivered ACT for smoking cessation application (SmartQuit) with the National Cancer Institute's application for smoking cessation (QuitGuide). Results We recruited 196 participants in two months. SmartQuit participants opened their application an average of 37.2 times, as compared to 15.2 times for QuitGuide participants (p <.0001). The overall quit rates were 13% in SmartQuit vs. 8% in QuitGuide (OR=2.7; 95% CI=0.8-10.3). Consistent with ACT's theory of change, among those scoring low (below the median) on acceptance of cravings at baseline (n = 88), the quit rates were 15% in SmartQuit vs. 8% in QuitGuide (OR=2.9; 95% CI=0.6-20.7). Conclusions ACT is feasible to deliver by smartphone application and shows higher engagement and promising quit rates compared to an application that follows US Clinical Practice Guidelines. As results were limited by the pilot design (e.g., small sample), a full-scale efficacy trial is now needed. PMID:25085225

In vivo screening and evaluation of four herbs against MRSA infections.

PubMed

Arshad, Najma; Mehreen, Arifa; Liaqat, Iram; Arshad, Muhammad; Afrasiab, Humera

2017-11-23

Recently, we reported high in vitro antibacterial efficacy of Althaea officinalis, Ziziphus jujuba, Cordia latifolia and Thymus vulgaris out of a total 21 plants against wide range of bacteria including MRSA. This study was therefore, designed to confirm efficacy of these four herbs against MRSA in an animal model. A pilot study was conducted to establish the dose of S. aureus (KY698020) required to induce clinical infection. Afterword, in main trial, efficacy of aforementioned plant extracts on the course of sore throat was checked by evaluating general health, gross lesion score, bacterial load and hematology in mice. Pilot study revealed that 40 μl dose of 10 7  CFU/ml could induce infection which persist upto 08 days post infection. Mice treated with T. vulgaris and Z. jujuba showed reduction in gross lesion score of both heart and lungs. Treatment with only some plants could significantly decrease bacterial load of throat (T. vulgaris) heart, blood and joint (C. latifolia, and T. vulagris). Hematological indicators confirmed in vivo control of MRSA infection in all treatment groups except A. officinalis. This is first report confirming in vivo anti-MRSA potential of C. latifolia and T. vulgaris and highlight the need to explore bioactive constituents of these plants. Moreover, previously reported in vitro antibacterial efficiency of A. officinalis could not be validated in current study.

The safety and efficacy of irreversible electroporation for the ablation of prostate cancer: a multicentre prospective human in vivo pilot study protocol.

PubMed

van den Bos, W; de Bruin, D M; Muller, B G; Varkarakis, I M; Karagiannis, A A; Zondervan, P J; Laguna Pes, M P; Veelo, D P; Savci Heijink, C D; Engelbrecht, M R W; Wijkstra, H; de Reijke, T M; de la Rosette, J J M C H

2014-10-29

Current surgical and ablative treatment options for prostate cancer have a relatively high incidence of side effects, which may diminish the quality of life. The side effects are a consequence of procedure-related damage of the blood vessels, bowel, urethra or neurovascular bundle. Ablation with irreversible electroporation (IRE) has shown to be effective in destroying tumour cells and harbours the advantage of sparing surrounding tissue and vital structures. The aim of the study is to evaluate the safety and efficacy and to acquire data on patient experience of minimally invasive, transperineally image-guided IRE for the focal ablation of prostate cancer. In this multicentre pilot study, 16 patients with prostate cancer who are scheduled for a radical prostatectomy will undergo an IRE procedure, approximately 30 days prior to the radical prostatectomy. Data as adverse events, side effects, functional outcomes, pain and quality of life will be collected and patients will be controlled at 1 and 2 weeks post-IRE, 1 day preprostatectomy and postprostatectomy. Prior to the IRE procedure and the radical prostatectomy, all patients will undergo a multiparametric MRI and contrast-enhanced ultrasound of the prostate. The efficacy of ablation will be determined by whole mount histopathological examination, which will be correlated with the imaging of the ablation zone. The protocol is approved by the ethics committee at the coordinating centre (Academic Medical Center (AMC) Amsterdam) and by the local Institutional Review Board at the participating centres. Data will be presented at international conferences and published in peer-reviewed journals. This pilot study will determine the safety and efficacy of IRE in the prostate. It will show the radiological and histopathological effects of IRE ablations and it will provide data to construct an accurate treatment planning tool for IRE in prostate tissue. Clinicaltrials.gov database: NCT01790451. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://group.bmj.com/group/rights-licensing/permissions.

Changes in eating pathology and associated symptoms among chronically ill adults attending a brief psychoeducational group.

PubMed

von Ranson, Kristin M; Stevenson, Andrea S; Cannon, Colleen K; Shah, Wendy

2010-08-01

Two quasi-experimental pilot studies examined eating pathology, eating self-efficacy, shame, guilt, and pride in adults with chronic illness before and after participating in brief cognitive-behavioral psychoeducational groups addressing eating concerns. In Study 1, 60 adults completed assessments before and after a series of two groups; in Study 2, 21 adults also completed an assessment five weeks prior to the first group to identify time-related changes in symptoms. Study 1 participants improved across domains, whereas Study 2 analyses also examining time-related changes showed improvements in eating self-efficacy, shame, guilt, and pride, but not in eating pathology. Psychoeducational groups may help improve symptoms including eating pathology, eating self-efficacy, shame, guilt, and pride among chronically-ill adults with eating concerns. 2009 Elsevier Ltd. All rights reserved.

Prospective trial of an herbal formula BYSH and Saw palmetto in patients with hormonal refractory prostate cancer: a pilot study.

PubMed

Ng, Anthony C-F; Cheng, K-F; Leung, P-C

2014-01-01

BYSH, a herbal formula, was evaluated for efficacy and safety in a pilot study for patients with advanced hormone refractory prostate cancer (HRPC). The pilot study was designed as a single-center open-label trial. Patients with HRPC were treated with BYSH for 24 weeks. The primary end point was the changes in serum prostate-specific antigen (PSA) level. Safety parameters such as liver and renal functions were monitored during the study period. Ten patients were eligible for the study. Most of them had stable PSA levels while taking BYSH. However, at the end of the BYSH treatment, the level of PSA increased. The median survival from diagnosis of HRPC was 16.4 months. Liver and renal functions remained normal. BYSH was well tolerated and no patient reported adverse events during the study period. Although it is inappropriate to make a conclusion based on the pilot study results, the trend of improvement is obvious. Further investigations should be conducted to demonstrate its clinical benefits. We have also briefly reviewed some plant products which are patented and also available in market.

Treatment of inflammatory facial acne vulgaris in Chinese patients with the 1450-nm diode laser: a pilot study

NASA Astrophysics Data System (ADS)

Liu, Huaxu; Dang, Yongyan; Wang, Zhan; Ma, Li; Ren, Qiushi

2007-02-01

The 1450-nm diode laser has been found to be effective for the treatment of inflammatory acne in USA, Europe and Japan. However, there is no report on its efficacy in Chinese acne vulgaris patients. We conduct this pilot study to evaluate the efficacy and safety of the 1450-nm diode laser in the treatment of inflammatory facial acne vulgaris in Chinese patients. Nineteen patients with inflammatory facial acne were treated with the 1450-nm diode laser at 4- to 6-week intervals. Clinical photographs and lesion counts were obtained at baseline and after each treatment. Subjective evaluation of response to treatment and pain was assessed using a questionnaire. In our study, clinical improvement was seen in all patients and was generally dramatic. Lesion counts decreased 34% after one treatment (p<0.01), 56% after two treatments (p<0.01), and 81% after three treatments (p<0.01). However, the treatment-related pain was comparatively hard to be tolerated in Chinese patitents, and the other main adverse effect was the hyper-pigmentation after treatments (36.84%, 7/19).

Peer mentoring for eating disorders: evaluation of a pilot program.

PubMed

Beveridge, Jennifer; Phillipou, Andrea; Edwards, Kelly; Hobday, Alice; Hilton, Krissy; Wyett, Cathy; Saw, Anna; Graham, Georgia; Castle, David; Brennan, Leah; Harrison, Philippa; de Gier, Rebecca; Warren, Narelle; Hanly, Freya; Torrens-Witherow, Benjamin; Newton, J Richard

2018-01-01

Eating disorders are serious psychiatric illnesses that are often associated with poor quality of life and low long-term recovery rates. Peer mentor programs have been found to improve psychiatric symptoms and quality of life in other mental illnesses, and a small number of studies have suggested that eating disorder patients may benefit from such programs. The aim of this study is to assess the efficacy of a peer mentor program for individuals with eating disorders in terms of improving symptomatology and quality of life. Up to 30 individuals with a past history of an eating disorder will be recruited to mentor 30 individuals with a current eating disorder. Mentoring will involve 13 sessions (held approximately every 2 weeks), of up to 3 h each, over 6 months. This pilot proof-of-concept feasibility study will inform the efficacy of a peer mentoring program on improving eating disorder symptomatology and quality of life, and will inform future randomised controlled trials. Australian and New Zealand Clinical Trials Registration Number: ACTRN12617001412325. The date of registration (retrospective): 05/10/2017.

Efficacy of mometasone furoate microemulsion in the treatment of erosive-ulcerative oral lichen planus: pilot study.

PubMed

Aguirre, J M; Bagán, J V; Rodriguez, C; Jimenez, Y; Martínez-Conde, R; Díaz de Rojas, F; Ponte, A

2004-08-01

Oral lichen planus (OLP) is a frequent immunological chronic disease, having different clinical forms: asymptomatic and symptomatic. Symptomatic OLP has been palliated with topical corticosteroids with different levels of efficacy and safety. The purpose of this pilot phase II clinical trial was to determine the efficacy of mometasone furoate microemulsion upon the symptoms and signs of erosive-ulcerative OLP. Forty-nine patients with clinical and histologically confirmed erosive-ulcerative OLP were enrolled in this study (36 women and 13 men). Their average age was 56.4 years (from 28 to 78). The treatment consisted of 0.1% mometasone furoate microemulsion mouthwash three times a day over 30 days. Pain, erythema and ulceration were assessed after 15 and 30 days of treatment. The data was processed and statistically analysed by student's t-test for paired samples. Mometasone caused a statistically significant reduction in pain (3.58 vs. 0.65, P = 0.0000). Treatment significantly reduced the surface area of erythema (155.2 vs. 21.9 mm(2), P = 0.0001) and ulceration (30.7 vs. 7.3 mm(2), P = 0.0000). None of these patients suffered severe adverse effects. Mometasone furoate microemulsion is a safe and effective therapy in the treatment of symptomatic erosive-ulcerative OLP.

Training peers to provide ongoing diabetes self-management support (DSMS): Results from a pilot study

PubMed Central

Tang, Tricia S.; Funnell, Martha M.; Gillard, Marylou; Nwankwo, Robin; Heisler, Michele

2013-01-01

Objective This study determined the feasibility of training adults with diabetes to lead diabetes self-management support (DSMS) interventions, examined whether participants can achieve the criteria required for successful graduation, and assessed perceived efficacy of and satisfaction with the peer leader training (PLT) program. Methods We recruited nine African-American adults with diabetes for a 46-hour PLT pilot program conducted over 12 weeks. The program utilized multiple instructional methods, reviewed key diabetes education content areas, and provided communication, facilitation, and behavior change skills training. Participants were given three attempts to achieve the pre-established competency criteria for diabetes knowledge, empowerment-based facilitation, active listening, and self-efficacy. Results On the first attempt 75%, 75%, 63%, and 75% passed diabetes knowledge, empowerment-based facilitation, active listening, and self-efficacy, respectively. Those participants who did not pass on first attempt passed on the second attempt. Participants were highly satisfied with the program length, balance between content and skills development, and preparation for leading support activities. Conclusion Findings suggest that it is feasible to train and graduate peer leaders with the necessary knowledge and skills to facilitate DSMS interventions. Practical Implications With proper training, peer support may be a viable model for translating and sustaining DSMS interventions into community-based settings. PMID:21292425

TextTB: A Mixed Method Pilot Study Evaluating Acceptance, Feasibility, and Exploring Initial Efficacy of a Text Messaging Intervention to Support TB Treatment Adherence

PubMed Central

Pearce, Patricia F.; Chirico, Cristina; Etchevarria, Mirta; Cardinale, Daniel; Rubinstein, Fernando

2013-01-01

Objective. To assess a text messaging intervention to promote tuberculosis (TB) treatment adherence. Methods. A mixed-methods pilot study was conducted within a public pulmonary-specialized hospital in Argentina. Patients newly diagnosed with TB who were 18 or older, and had mobile phone access were recruited and randomized to usual care plus either medication calendar (n = 19) or text messaging intervention (n = 18) for the first two months of treatment. Primary outcomes were feasibility and acceptability; secondary outcomes explored initial efficacy. Results. Feasibility was evidenced by high access to mobile phones, familiarity with texting, most phones limited to basic features, a low rate of participant refusal, and many describing suboptimal TB understanding. Acceptability was evidenced by participants indicating feeling cared for, supported, responsible for their treatment, and many self-reporting adherence without a reminder. Participants in the texting group self-reported adherence on average 77% of the days whereas only 53% in calendar group returned diaries. Exploring initial efficacy, microscopy testing was low and treatment outcomes were similar in both groups. Conclusion. The texting intervention was well accepted and feasible with greater reporting of adherence using text messaging than the diary. Further evaluation of the texting intervention is warranted. PMID:24455238

Exploring Physical Activity Behaviour of Persons with Multiple Sclerosis: A Qualitative Pilot Study

PubMed Central

Resnik, Linda; Allen, Susan

2015-01-01

Purpose Identify facilitators and barriers to physical activity (PA), and explore the utility of Social Cognitive Theory (SCT) and Transactional Model of Stress and Coping (TMSC) in understanding PA behaviour among persons with multiple sclerosis (MS). Methods Thirteen participants from a clinical trial were interviewed and classified as physically active, sometimes active, or inactive based on the Health-Promoting Lifestyle Profile-II. Interviews were analysed using analytical induction, which consisted of coding data into pre-established categories and then exploring similarities and differences between groups. Pre-established coding categories were constructs from SCT (i.e. environment, expectations, self-efficacy, and self-regulation) and TMSC (i.e. stress appraisal and coping style). Results Inactive and active participants differed in their self-regulation skills, self-efficacy, and coping styles. Common barriers to PA included symptoms and the physical and social environment. Facilitators of PA included strong self-regulation skills, confidence to overcome symptoms to engage in PA (i.e. barrier self-efficacy), and positive coping styles. Conclusion Results from this pilot study suggest that PA interventions will need to implement multiple strategies that target self-efficacy, social environment, and coping styles. We found SCT and TMSC useful in understanding PA behaviour among persons with MS; however, a limitation to these theories is that they are not explicit in the relationship between health and cognitions. Future research will need to explore how to incorporate models of health and function into existing behaviour change theories. PMID:19479491

Motivational Interviewing as an Intervention for At-Risk Couples.

ERIC Educational Resources Information Center

Cordova, James V.; Warren, Lisa Zepeda; Gee, Christina B.

2001-01-01

Thirty-one couples participated in the Marriage Checkup (MC), a pilot, motivational interviewing intervention for at-risk couples. Marital satisfaction improved significantly from pre- to post-checkup and remained improved at one month follow up. Although not addressing the efficacy of MC, this study supports its validity as an indicative…

Group Versus Individual Cognitive Therapy: A Pilot Study.

ERIC Educational Resources Information Center

Rush, A. John; Watkins, John T.

Group therapy and individual cognitive therapy were investigated with non-bipolar moderate-to-severely-depressed outpatients (N=44) assigned to group cognitive therapy, individual cognitive therapy only, or to individual cognitive therapy in combination with anti-depressant medication. Treatment efficacy was measured by self-report and a clinical…

Culturally Responsive Teaching Knowledge and Practices of Online Faculty

ERIC Educational Resources Information Center

Heitner, Keri L.; Jennings, Miranda

2016-01-01

Cultural differences between faculty and their students can create important challenges that affect the quality and efficacy of online teaching and learning. The objectives of this study were to: (a) create and pilot test an assessment for online faculty to measure culturally responsive teaching knowledge (CRT) and culturally responsive…

Depression in Adolescents with ASD: A Pilot RCT of a Group Intervention

ERIC Educational Resources Information Center

Santomauro, Damian; Sheffield, Jeanie; Sofronoff, Kate

2016-01-01

Depression is a potentially life threatening affective disorder that is highly prevalent in individuals with autism spectrum disorders (ASD). This study aimed to evaluate the feasibility, acceptability and preliminary efficacy of a cognitive behavioural intervention for depression in adolescents with ASD. Participants were randomly assigned to the…

Grief-Processing-Based Psychological Intervention for Children Orphaned by AIDS in Central China: A Pilot Study

ERIC Educational Resources Information Center

Lin, Xiuyun; Fang, Xiaoyi; Chi, Peilian; Li, Xiaoming; Chen, Wenrui; Heath, Melissa Allen

2014-01-01

A group of 124 children orphaned by AIDS (COA), who resided in two orphanages funded by the Chinese government, participated in a study investigating the efficacy of a grief-processing-based psychological group intervention. This psychological intervention program was designed to specifically help COA process their grief and reduce their…

The Relative Contribution of Economic Valence to Contingency Management Efficacy: A Pilot Study

ERIC Educational Resources Information Center

Roll, John M.; Howard, Joni T.

2008-01-01

We investigated the extent to which a contingency management (CM) procedure that deducted money from a grand total available at the end of the study compared to a procedure in which money accumulated with continued abstinence from cigarette smoking. Results suggested that the procedure in which money increased contingent on abstinence resulted in…

Pivotal Response Treatment for Infants At-Risk for Autism Spectrum Disorders: A Pilot Study

ERIC Educational Resources Information Center

Steiner, Amanda Mossman; Gengoux, Grace W.; Klin, Ami; Chawarska, Katarzyna

2013-01-01

Presently there is limited research to suggest efficacious interventions for infants at-risk for autism. Pivotal response treatment (PRT) has empirical support for use with preschool children with autism, but there are no reports in the literature utilizing this approach with infants. In the current study, a developmental adaptation of PRT was…

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…

Treatment of carcinoma in situ of the urinary bladder with an alpha-emitter immunoconjugate targeting the epidermal growth factor receptor: a pilot study.

PubMed

Autenrieth, Michael E; Seidl, Christof; Bruchertseifer, Frank; Horn, Thomas; Kurtz, Florian; Feuerecker, Benedikt; D'Alessandria, Calogero; Pfob, Christian; Nekolla, Stephan; Apostolidis, Christos; Mirzadeh, Saed; Gschwend, Jürgen E; Schwaiger, Markus; Scheidhauer, Klemens; Morgenstern, Alfred

2018-07-01

Patients with carcinoma in situ (CIS) of the bladder refractory to bacillus Calmette-Guérin (BCG) treatment are usually treated with cystectomy. Therefore, new treatment options with preservation of the urinary bladder are needed. The objective of the study was to investigate the feasibility, safety and efficacy of a novel targeted alpha-emitter immunotherapy for CIS after BCG treatment failure. A pilot study was conducted in 12 patients (age range 64-86 years, ten men, two women) with biopsy-proven CIS of the bladder refractory to BCG treatment. The patients were treated intravesically with a single instillation (one patient was treated twice) of the alpha-emitter 213 Bi coupled to an anti-EGFR antibody (366-821 MBq). The primary aims of the study were to determine the feasibility of treatment with the 213 Bi-immunoconjugate and evaluation of adverse effects. Therapeutic efficacy was monitored by histological mapping of the urinary bladder 8 weeks after treatment and at different time points thereafter. The study proved that intravesical instillation of the 213 Bi-immunoconjugate targeting EGFR is feasible. No adverse effects were observed and all blood and urine parameters determined remained in their normal ranges. Therapeutic efficacy was considered satisfactory, in that three of the 12 patients showed no signs of CIS 44, 30 and 3 months after treatment. Intravesical instillation of 213 Bi-anti-EGFR monoclonal antibody was well tolerated and showed therapeutic efficacy. Repeated instillation and/or instillation of higher activities of the 213 Bi-immunoconjugate might lead to better therapeutic outcomes. A phase I clinical trial is planned.

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.

Effects of an Infant-Focused Relationship-Based Hospital and Home Visiting Intervention on Reducing Symptoms of Postpartum Maternal Depression: A Pilot Study

ERIC Educational Resources Information Center

Nugent, J. Kevin; Bartlett, Jessica Dym; Valim, Clarissa

2014-01-01

Relationship-based interventions are an effective means for reducing postpartum depression (PPD), but few cost-effective tools that can be administered efficiently in medical and home settings are available or well-studied. This study examines the efficacy of the Newborn Behavioral Observations (NBO), an infant-centered relationship-based…

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

Endobronchial ultrasound-guided lymph node biopsy with transbronchial needle forceps: a pilot study.

PubMed

Herth, F J F; Schuler, H; Gompelmann, D; Kahn, N; Gasparini, S; Ernst, A; Schuhmann, M; Eberhardt, R

2012-02-01

One limitation of endobronchial ultrasound-guided transbronchial needle aspiration (EBUS-TBNA) is the size of the available needles, frequently yielding only cells for cytological examination. The aim of this pilot study was to evaluate the efficacy and safety of newly developed needle forceps to obtain tissue for the histological diagnosis of enlarged mediastinal lymph nodes. Patients with enlarged, positron emission tomography (PET)-positive lymph nodes were included. The transbronchial needle forceps (TBNF), a sampling instrument combining the characteristics of a needle (bevelled tip for penetrating through the bronchial wall) with forceps (two serrated jaws for grasping tissue) was used through the working channel of the EBUS-TBNA scope. Efficacy and safety was assessed. 50 patients (36 males and 14 females; mean age 51 yrs) with enlarged or PET-positive lymph nodes were included in this pilot study. In 48 (96%) patients penetration of the bronchial wall was possible and in 45 patients tissue for histological diagnosis was obtained. In three patients TBNF provided inadequate material. For patients in whom the material was adequate for a histological examination, a specific diagnosis was established in 43 (86%) out of 50 patients (nonsmall cell lung cancer: n=24; small cell lung cancer: n=7; sarcoidosis: n=4; Hodgkin's lymphoma: n=4; tuberculosis: n=2; and non-Hodgkin's lymphoma: n=2).No clinically significant procedure-related complications were encountered. This study demonstrated that EBUS-TBNF is a safe procedure and provides diagnostic histological specimens of mediastinal lymph nodes.

The Development and piloting of an eHealth breastfeeding resource targeting fathers and partners as co-parents.

PubMed

Abbass-Dick, Jennifer; Xie, Fangli; Koroluk, Jaymie; Alcock Brillinger, Shelley; Huizinga, Joanne; Newport, Amber; Goodman, William M; Dennis, Cindy-Lee

2017-07-01

Traditionally breastfeeding education programs target mothers solely. The objective of this study was to design and pilot test an interactive eHealth breastfeeding co-parenting resource developed to target both mothers and fathers. eHealth resources provide an accessible and engaging format on which to educate parents and assist them in meeting their breastfeeding goals. Best practices to design such resources are not currently known. A three phase pilot study was conducted. The three phases included conducting a needs assessment, creating the resource and pilot testing the resource with mother, father and health care professionals to determine their perspectives regarding the usability and design of the prototype resource. The interactive prototype resource was designed to provide information to parents on breastfeeding and co-parenting, which included suggestions on how fathers can be involved and support breastfeeding and how the couples can work as a team to meet their breastfeeding goals. Setting: Recruitment took place in a health region in Southern Ontario, Canada between June 2014 and March 2015. Online questionnaires were completed by participants in all phases of the study. Participants (n=149) were pregnant or new mothers and their partners in the health region who read and speak English and had access to the internet and health care professionals who work with breastfeeding families in Ontario, Canada. A prototype eHealth breastfeeding co-parenting resource was developed based on maternal and paternal feedback from Phase I and utilized an interactive interface which included games and multimodal information delivery. The prototype eHealth resource was provided to the parents in Phase II and health care professionals in Phase III. The final resource was created based on feedback from these participants. The resource was pilot tested with new and expectant parents using pre- and post-test questionnaires which included measures for breastfeeding self-efficacy (Breastfeeding Self-Efficacy Short Form), infant feeding attitude (Iowa Infant Feeding Attitude Scale), breastfeeding knowledge (Breastfeeding Knowledge Questionnaire) and co-parenting relationship (Co-parenting Relationship Scale). Maternal and paternal breastfeeding self-efficacy and knowledge and infant feeding attitude scores all increased from pre-test to post-test. However, there was no difference in the co-parenting relationship scores from pretest to post-test. This study has used feedback from parents and health professionals to develop a prototype resource which appears to be effective in increasing parents' breastfeeding knowledge, attitude and self-efficacy. The prototype resource was rated positively by parents and health care providers. An eHealth breastfeeding co-parenting resource designed with input from the target population is an effective way of providing information to mothers and fathers. Further research with a randomized controlled design and more diverse populations is needed to determine effectiveness of the resource on breastfeeding duration and exclusivity. Crown Copyright © 2017. Published by Elsevier Ltd. All rights reserved.

Pilot study of the 5-HT2AR agonist psilocybin in the treatment of tobacco addiction.

PubMed

Johnson, Matthew W; Garcia-Romeu, Albert; Cosimano, Mary P; Griffiths, Roland R

2014-11-01

Despite suggestive early findings on the therapeutic use of hallucinogens in the treatment of substance use disorders, rigorous follow-up has not been conducted. To determine the safety and feasibility of psilocybin as an adjunct to tobacco smoking cessation treatment we conducted an open-label pilot study administering moderate (20 mg/70 kg) and high (30 mg/70 kg) doses of psilocybin within a structured 15-week smoking cessation treatment protocol. Participants were 15 psychiatrically healthy nicotine-dependent smokers (10 males; mean age of 51 years), with a mean of six previous lifetime quit attempts, and smoking a mean of 19 cigarettes per day for a mean of 31 years at intake. Biomarkers assessing smoking status, and self-report measures of smoking behavior demonstrated that 12 of 15 participants (80%) showed seven-day point prevalence abstinence at 6-month follow-up. The observed smoking cessation rate substantially exceeds rates commonly reported for other behavioral and/or pharmacological therapies (typically <35%). Although the open-label design does not allow for definitive conclusions regarding the efficacy of psilocybin, these findings suggest psilocybin may be a potentially efficacious adjunct to current smoking cessation treatment models. The present study illustrates a framework for future research on the efficacy and mechanisms of hallucinogen-facilitated treatment of addiction. © The Author(s) 2014.

Efficacy of Atopy Patch Testing in Directed Dietary Therapy of Eosinophilic Esophagitis: A Pilot Study.

PubMed

Eckmann, Jason D; Ravi, Karthik; Katzka, David A; Davis, Dawn R; See, Jacalyn A; Geno, Debra R; Kryzer, Lori A; Alexander, Jeffrey A

2018-03-01

Atopy patch testing (APT) has shown potential for predicting dietary food triggers in studies of children and adolescents with eosinophilic esophagitis (EoE). To assess the efficacy of APT in adults with EoE. We conducted a prospective open-label pilot study of patients ≥ 18 years old with diagnosis of EoE at Mayo Clinic in Rochester, Minnesota, from November 2014 to January 2016. All patients underwent patch testing using intact food products, followed by a six food elimination diet and stepwise food reintroduction. Response to elimination diet was assessed with serial endoscopy with biopsies as well as clinical symptoms. APT results were directly compared to elimination diet results for assessment of efficacy. Correlation between clinical symptoms, endoscopic score, and histology was also qualitatively evaluated. Fifty percent of the patients had a positive APT, while only 16% had an APT result confirmed histologically during food reintroduction. Sensitivity of APT was calculated to be 5.9%, with specificity of 92.0%. Furthermore, we found significant qualitative inter-patient heterogeneity in the correlation between clinical symptoms, EREFS score, and histology. APT does not reliably predict food triggers identified by food elimination diet in adult patients with EoE. As a result, APT does not have a clear role in the evaluation of patients with EoE.

Threatening communication: a critical re-analysis and a revised meta-analytic test of fear appeal theory.

PubMed

Peters, Gjalt-Jorn Ygram; Ruiter, Robert A C; Kok, Gerjo

2013-05-01

Despite decades of research, consensus regarding the dynamics of fear appeals remains elusive. A meta-analysis was conducted that was designed to resolve this controversy. Publications that were included in previous meta-analyses were re-analysed, and a number of additional publications were located. The inclusion criteria were full factorial orthogonal manipulations of threat and efficacy, and measurement of behaviour as an outcome. Fixed and random effects models were used to compute mean effect size estimates. Meta-analysis of the six studies that satisfied the inclusion criteria clearly showed a significant interaction between threat and efficacy, such that threat only had an effect under high efficacy (d = 0.31), and efficacy only had an effect under high threat (d = 0.71). Inconsistency in results regarding the effectiveness of threatening communication can likely be attributed to flawed methodology. Proper tests of fear appeal theory yielded the theoretically hypothesised interaction effect. Threatening communication should exclusively be used when pilot studies indicate that an intervention successfully enhances efficacy.

Supporting nurse preceptors through online continuing education.

PubMed

Zahner, Susan J; Tipple, Susan M; Rather, Marsha L; Schendzielos, Christine

2009-10-01

A pilot study was conducted to assess the feasibility of using an online continuing education course to increase knowledge and self-efficacy in nurse preceptors who work with student nurses in acute and primary care settings. A one-group pre- and posttest repeated measures design was used. Pre-course knowledge and self-efficacy were assessed with an electronic survey. Post-course knowledge and satisfaction assessments were embedded in the course. Knowledge retention and change in self-efficacy were assessed with an electronic follow-up survey. Analysis used paired sample t tests. Participants (N = 13) reported satisfaction with the course. Participant knowledge increased from pretest to post-course and from pretest to follow-up. Knowledge declined from post-course to follow-up. No change in self-efficacy ratings was observed. This study suggests that online continuing education is a feasible strategy to support preceptor learning. Further research on the effectiveness of this approach in changing and retaining knowledge and improving self-efficacy is needed. Copyright 2009, SLACK Incorporated.

Threatening communication: a critical re-analysis and a revised meta-analytic test of fear appeal theory

PubMed Central

Peters, Gjalt-Jorn Ygram; Ruiter, Robert A.C.; Kok, Gerjo

2013-01-01

Despite decades of research, consensus regarding the dynamics of fear appeals remains elusive. A meta-analysis was conducted that was designed to resolve this controversy. Publications that were included in previous meta-analyses were re-analysed, and a number of additional publications were located. The inclusion criteria were full factorial orthogonal manipulations of threat and efficacy, and measurement of behaviour as an outcome. Fixed and random effects models were used to compute mean effect size estimates. Meta-analysis of the six studies that satisfied the inclusion criteria clearly showed a significant interaction between threat and efficacy, such that threat only had an effect under high efficacy (d = 0.31), and efficacy only had an effect under high threat (d = 0.71). Inconsistency in results regarding the effectiveness of threatening communication can likely be attributed to flawed methodology. Proper tests of fear appeal theory yielded the theoretically hypothesised interaction effect. Threatening communication should exclusively be used when pilot studies indicate that an intervention successfully enhances efficacy. PMID:23772231

Introducing technology into medical education: two pilot studies.

PubMed

George, Paul; Dumenco, Luba; Dollase, Richard; Taylor, Julie Scott; Wald, Hedy S; Reis, Shmuel P

2013-12-01

Educators are integrating new technology into medical curriculum. The impact of newer technology on educational outcomes remains unclear. We aimed to determine if two pilot interventions, (1) introducing iPads into problem-based learning (PBL) sessions and (2) online tutoring would improve the educational experience of our learners. We voluntarily assigned 26 second-year medical students to iPad-based PBL sessions. Five students were assigned to Skype for exam remediation. We performed a mixed-method evaluation to determine efficacy. Pilot 1: Seventeen students completed a survey following their use of an iPad during the second-year PBL curriculum. Students noted the iPad allows for researching information in real time, annotating lecture notes, and viewing sharper images. Data indicate that iPads have value in medical education and are a positive addition to the curriculum. Pilot 2: Students agreed that online tutoring is at least or more effective than in-person tutoring. In our pilot studies, students experienced that iPads and Skype are beneficial in medical education and can be successfully employed in areas such as PBL and remediation. Educators should continue to further examine innovative opportunities for introducing technology into medical education. Copyright © 2013 Elsevier Ireland Ltd. All rights reserved.

West End Walkers 65+: a randomised controlled trial of a primary care-based walking intervention for older adults: study rationale and design.

PubMed

Macmillan, Freya; Fitzsimons, Claire; Black, Karen; Granat, Malcolm H; Grant, Margaret P; Grealy, Madeleine; Macdonald, Hazel; McConnachie, Alex; Rowe, David A; Shaw, Rebecca; Skelton, Dawn A; Mutrie, Nanette

2011-02-19

In Scotland, older adults are a key target group for physical activity intervention due to the large proportion who are inactive. The health benefits of an active lifestyle are well established but more research is required on the most effective interventions to increase activity in older adults. The 'West End Walkers 65+' randomised controlled trial aims to examine the feasibility of delivering a pedometer-based walking intervention to adults aged 65 years through a primary care setting and to determine the efficacy of this pilot. The study rationale, protocol and recruitment process are discussed in this paper. The intervention consisted of a 12-week pedometer-based graduated walking programme and physical activity consultations. Participants were randomised into an immediate intervention group (immediate group) or a 12-week waiting list control group (delayed group) who then received the intervention. For the pilot element of this study, the primary outcome measure was pedometer step counts. Secondary outcome measures of sedentary time and physical activity (time spent lying/sitting, standing or walking; activPAL™ monitor), mood (Positive and Negative Affect Schedule), functional ability (Perceived Motor-Efficacy Scale for Older Adults), quality of life (Short-Form (36) Health Survey version 2) and loneliness (UCLA Loneliness Scale) were assessed. Focus groups with participants and semi-structured interviews with the research team captured their experiences of the intervention. The feasibility component of this trial examined recruitment via primary care and retention of participants, appropriateness of the intervention for older adults and the delivery of the intervention by a practice nurse. West End Walkers 65+ will determine the feasibility and pilot the efficacy of delivering a pedometer-based walking intervention through primary care to Scottish adults aged 65 years. The study will also examine the effect of the intervention on the well-being of participants and gain an insight into both participant and research team member experiences of the intervention.

Cognitive Behavioral Treatment for Recurrent Binge Eating in Adolescent Girls: A Pilot Trial

ERIC Educational Resources Information Center

DeBar, Lynn L.; Wilson, G. Terence; Yarborough, Bobbi Jo; Burns, Beryl; Oyler, Barbara; Hildebrandt, Tom; Clarke, Gregory N.; Dickerson, John; Striegel, Ruth H.

2013-01-01

There is a need for treatment interventions to address the high prevalence of disordered eating throughout adolescence and early adulthood. We developed an adolescent-specific manualized CBT protocol to treat female adolescents with recurrent binge eating and tested its efficacy in a small, pilot randomized controlled trial. We present lessons…

A feasibility study of valerian extract for sleep disturbance in person with arthritis.

PubMed

Taibi, Diana M; Bourguignon, Cheryl; Gill Taylor, Ann

2009-04-01

To present a pilot study of valerian to explore issues of feasibility and efficacy in studies of sedative herbs for arthritis-related sleep disturbance. Fifteen persons with arthritis and mild sleep disturbance were randomized to receive 600 mg valerian (Valeriana officinalis, n = 7) or placebo (n = 8) for five nights. Protocol adherence (dosing and data collection) was high. Allocation concealment was successful using a novel approach for matching the placebo on the distinctive odor of valerian. Nonsignificant differences between the groups were found on all sleep outcomes, measured by daily diaries and wrist actigraphy. The study methods were feasible, except for recruitment issues (addressed in the discussion), and may guide the testing of other sedative herbs for persons with arthritis. Although efficacy outcomes were inconclusive due to the small sample size of this study, recent evidence from larger trials of valerian also does not support its efficacy.

A Pilot Study of Naltrexone and BASICS for Heavy Drinking Young Adults

PubMed Central

Leeman, Robert F.; Palmer, Rebekka S.; Corbin, William R.; Romano, Denise M.; Meandzija, Boris; O’Malley, Stephanie S.

2008-01-01

Heavy drinking young adults often have limited motivation to change their drinking behavior. Adding pharmacotherapy to brief counseling is a novel approach to treating this population. A small open-label pilot study was conducted to assess the feasibility of offering eight weeks of daily and targeted (i.e., taken as needed in anticipation of drinking) naltrexone with BASICS (brief motivational) counseling to heavy drinking young adults; to assess the tolerability of the medication in this population and to obtain preliminary efficacy data. The sample (N = 14) showed strong adherence to study appointments and medication taking, supporting the feasibility of this approach. Overall, the medication was well-tolerated. Significant reductions from baseline were observed in drinks per drinking day and in percent heavy drinking days and these gains were maintained one month after treatment ended. A significant decrease in alcohol-related consequences was also observed. Findings from this small pilot study suggest that naltrexone in combination with BASICS represents a promising strategy to reduce heavy drinking among young adults. PMID:18502591

Autism Treatment in the First Year of Life: A Pilot Study of Infant Start, a Parent-Implemented Intervention for Symptomatic Infants

PubMed Central

Vismara, L.; Wagner, A. L.; McCormick, C.; Young, G.; Ozonoff, S.

2016-01-01

The goal of early autism screening is earlier treatment. We pilot-tested a 12-week, low-intensity treatment with seven symptomatic infants ages 7–15 months. Parents mastered the intervention and maintained skills after treatment ended. Four comparison groups were matched from a study of infant siblings. The treated group of infants was significantly more symptomatic than most of the comparison groups at 9 months of age but was significantly less symptomatic than the two most affected groups between 18 and 36 months. At 36 months, the treated group had much lower rates of both ASD and DQs under 70 than a similarly symptomatic group who did not enroll in the treatment study. It appears feasible to identify and enroll symptomatic infants in parent-implemented intervention before 12 months, and the pilot study outcomes are promising, but testing the treatment’s efficacy awaits a randomized trial. PMID:25212413

Handling Qualities Evaluation of Pilot Tools for Spacecraft Docking in Earth Orbit

NASA Technical Reports Server (NTRS)

Bilimoria, Karl D.; Mueller, Eric; Frost, Chad

2009-01-01

A new generation of spacecraft is now under development by NASA to replace the Space Shuttle and return astronauts to the Moon. These spacecraft will have a manual control capability for several mission tasks, and the ease and precision with which pilots can execute these tasks will have an important effect on mission risk and training costs. This paper focuses on the handling qualities of a spacecraft based on dynamics similar to that of the Crew Exploration Vehicle, during the last segment of the docking task with a space station in low Earth orbit. A previous study established that handling qualities for this task degrade significantly as the level of translation-into-rotation coupling increases. The goal of this study is to evaluate the efficacy of various pilot aids designed to mitigate the handling qualities degradation caused by this coupling. Four pilot tools were ev adluaetead:d-band box/indicator, flight-path marker, translation guidance cues, and feed-forward control. Each of these pilot tools improved handling qualities, generally with greater improvements resulting from using these tools in combination. A key result of this study is that feedforward control effectively counteracts coupling effects, providing solid Level 1 handling qualities for the spacecraft configuration evaluated.

Randomized, controlled pilot trial of a smartphone app for smoking cessation using acceptance and commitment therapy.

PubMed

Bricker, Jonathan B; Mull, Kristin E; Kientz, Julie A; Vilardaga, Roger; Mercer, Laina D; Akioka, Katrina J; Heffner, Jaimee L

2014-10-01

There is a dual need for (1) innovative theory-based smartphone applications for smoking cessation and (2) controlled trials to evaluate their efficacy. Accordingly, this study tested the feasibility, acceptability, preliminary efficacy, and mechanism of behavioral change of an innovative smartphone-delivered acceptance and commitment therapy (ACT) application for smoking cessation vs. an application following US Clinical Practice Guidelines. Adult participants were recruited nationally into the double-blind randomized controlled pilot trial (n=196) that compared smartphone-delivered ACT for smoking cessation application (SmartQuit) with the National Cancer Institute's application for smoking cessation (QuitGuide). We recruited 196 participants in two months. SmartQuit participants opened their application an average of 37.2 times, as compared to 15.2 times for QuitGuide participants (p<0001). The overall quit rates were 13% in SmartQuit vs. 8% in QuitGuide (OR=2.7; 95% CI=0.8-10.3). Consistent with ACT's theory of change, among those scoring low (below the median) on acceptance of cravings at baseline (n=88), the quit rates were 15% in SmartQuit vs. 8% in QuitGuide (OR=2.9; 95% CI=0.6-20.7). ACT is feasible to deliver by smartphone application and shows higher engagement and promising quit rates compared to an application that follows US Clinical Practice Guidelines. As results were limited by the pilot design (e.g., small sample), a full-scale efficacy trial is now needed. Copyright © 2014 Elsevier Ireland Ltd. All rights reserved.

Mindfulness-based stress reduction for Tourette Syndrome and Chronic Tic Disorder: a pilot study.

PubMed

Reese, Hannah E; Vallejo, Zayda; Rasmussen, Jessica; Crowe, Katherine; Rosenfield, Elizabeth; Wilhelm, Sabine

2015-03-01

In this pilot study we sought to develop and test a modified form of mindfulness-based stress reduction (MBSR-tics) for the treatment of Tourette Syndrome (TS) and Chronic Tic Disorder (CTD). Our specific aims were: 1) To determine the feasibility and acceptability of an 8-week trial of MBSR-tics in individuals 16 and older with TS or CTD and 2) To determine the efficacy of an 8-week trial of MBSR-tics in individuals 16 and older with TS or CTD. Eighteen individuals age 16-67 completed an uncontrolled open trial of MBSR-tics. The intervention consisted of 8 weekly 2-hour classes and one 4hour retreat in the fifth or sixth week of the program. Symptomatic assessments were performed at baseline, post-treatment, and one-month follow-up. MBSR-tics proved to be a feasible and acceptable intervention. It resulted in significant improvement in tic severity and tic-related impairment. 58.8% of subjects were deemed treatment responders. Therapeutic gains were maintained at 1-month follow-up. Improvements in tic severity were correlated with increases in self-reported levels of mindfulness. This small open pilot study provides preliminary support for the feasibility, acceptability, and efficacy of MBSR-tics for individuals 16 or older with TS or CTD. A larger randomized controlled trial with blind assessment is necessary to confirm these initial, promising findings. Trial Registration Partners Clinical Trials Registry Number 2011P000606 (clinicaltrials.partners.org). Copyright © 2014 Elsevier Inc. All rights reserved.

Clobetasol propionate shampoo 0.05% in the treatment of seborrheic dermatitis of the scalp: results of a pilot study.

PubMed

Reygagne, Pascal; Poncet, Michel; Sidou, Farzaneh; Soto, Pascale

2007-05-01

Seborrheic dermatitis (SD), a common dermatosis associating hyperseborrhea, erythema, itching, and dandruff, has frequent scalp involvement. Malassezia furfur infection seems to play an important role in the condition's etiopathology. Treatment of SD usually consists of corticosteroids or antifungals, such as ketoconazole. The aim of this multicenter, randomized, investigator-blinded, parallel-group pilot study was to evaluate the efficacy and safety of clobetasol propionate shampoo 0.05% after different short-contact application times compared with its vehicle and ketoconazole foaming gel 2% in the treatment of SD of the scalp. For 4 weeks, 55 subjects received one of the following treatments twice weekly: clobetasol propionate shampoo for 2.5, 5, or 10 minutes; clobetasol propionate vehicle for 10 minutes; or ketoconazole foaming gel for 5 minutes before rinsing off. Efficacy criteria included total severity score (TSS) and individual scores of signs such as itching and global improvement. Safety included reporting of burning, overall tolerance, and adverse events. Results showed that an application of clobetasol propionate for 5 and 10 minutes provided a similar mean percentage decrease of TSS, and the mean percentage decrease of TSS for all active groups was significantly superior to that of the vehicle (P < .01). Overall and local safety were good for all treatment groups. The present pilot study demonstrated that a short-contact application of clobetasol propionate shampoo is effective and safe in the treatment of SD of the scalp.

Can Technology Decrease Sexual Risk Behaviors among Young People? Results of a Pilot Study Examining the Effectiveness of a Mobile Application Intervention

ERIC Educational Resources Information Center

Jackson, Dawnyéa D.; Ingram, Lucy Annang; Boyer, Cherrie B.; Robillard, Alyssa; Huhns, Michael N.

2016-01-01

College students represent an important population for studying and understanding factors that influence sexual risk given the populations' high risk of sexually transmitted infections and unintended pregnancies. Using a quasi-experimental design, the efficacy of a brief and theory-driven mobile application intervention designed to decrease sexual…

Using Robotics and Game Design to Enhance Children's Self-Efficacy, STEM Attitudes, and Computational Thinking Skills

ERIC Educational Resources Information Center

Leonard, Jacqueline; Buss, Alan; Gamboa, Ruben; Mitchell, Monica; Fashola, Olatokunbo S.; Hubert, Tarcia; Almughyirah, Sultan

2016-01-01

This paper describes the findings of a pilot study that used robotics and game design to develop middle school students' computational thinking strategies. One hundred and twenty-four students engaged in LEGO® EV3 robotics and created games using Scalable Game Design software. The results of the study revealed students' pre-post self-efficacy…

Evaluation of a DVD-Based Self-Help Program in Highly Socially Anxious Individuals--Pilot Study

ERIC Educational Resources Information Center

Mall, Anna K.; Mehl, Annette; Kiko, Sonja; Kleindienst, Nikolaus; Salize, Hans-Joachim; Hermann, Christiane; Hoffmann, Torsten; Bohus, Martin; Steil, Regina

2011-01-01

High social anxiety is a risk factor for the incidence of social anxiety disorder (SAD). Early diagnosis and intervention may prevent more severe psychiatric courses. Self-help programs may be a convenient, accessible, and effective intervention. This study examined the efficacy of a newly developed self-help program for SAD in individuals with…

High School-Based Treatment for Adolescents with Attention-Deficit/Hyperactivity Disorder: Results from a Pilot Study Examining Outcomes and Dosage

ERIC Educational Resources Information Center

Evans, Steven W.; Schultz, Brandon K.; DeMars, Christine E.

2014-01-01

The purpose of this study was to examine the efficacy and dose-response relationship of a school-based treatment program for high school students with attention-deficit/hyperactivity disorder (ADHD). Two paraprofessionals provided interventions to 24 students with ADHD randomly assigned to the treatment condition at two public high schools. They…

Preliminary Evaluation of a Tier 2 Mathematics Intervention for First-Grade Students: Using a Theory of Change to Guide Formative Evaluation Activities

ERIC Educational Resources Information Center

Clarke, Ben; Doabler, Christian T.; Strand Cary, Mari; Kosty, Derek; Baker, Scott; Fien, Hank; Smolkowski, Keith

2014-01-01

This pilot study examined the efficacy of a Tier 2 first-grade mathematics intervention program targeting whole-number understanding for students at risk in mathematics. The study used a randomized block design. Students (N = 89) were randomly assigned to treatment (Fusion) or control (standard district practice) conditions. Measures of…

Working Memory Training for Children with Cochlear Implants: A Pilot Study

ERIC Educational Resources Information Center

Kronenberger, William G.; Pisoni, David B.; Henning, Shirley C.; Colson, Bethany G.; Hazzard, Lindsey M.

2011-01-01

Purpose: This study investigated the feasibility and efficacy of a working memory training program for improving memory and language skills in a sample of 9 children who are deaf (age 7-15 years) with cochlear implants (CIs). Method: All children completed the Cogmed Working Memory Training program on a home computer over a 5-week period.…

A Double-Blind Randomized Pilot Study Comparing Quetiapine and Divalproex for Adolescent Mania

ERIC Educational Resources Information Center

Delbello, Melissa P.; Kowatch, Robert A.; Adler, Caleb M.; Stanford, Kevin E.; Welge, Jeffrey A.; Barzman, Drew H.; Nelson, Erik; Strakowski, Stephen M.

2006-01-01

Objective: To determine the comparative efficacy of quetiapine and divalproex for the treatment of adolescent mania. Method: Fifty adolescents (ages 12-18 years) with bipolar I disorder, manic or mixed episode, were randomized to quetiapine (400-600 mg/day) or divalproex (serum level 80-120 [micro]g/mL) for 28 days for this double-blind study,…

Measuring the Effects of an On-Line Training Module for School Psychologists Working with Traumatized Children: A Pilot Study

ERIC Educational Resources Information Center

Dezen, Kristin

2012-01-01

The present study was designed to address the current lack of trauma training provided to school psychologists. Specifically, this study employed a randomized, controlled design to test the efficacy of an on-line training targeting school psychology graduate student trainees' awareness of the signs and symptoms of child abuse as well as their…

Expectations and self-efficacy of African American parents who discuss sexuality with their adolescent sons: an intervention study.

PubMed

Weekes, Carmon V N; Haas, Barbara K; Gosselin, Kevin P

2014-01-01

Despite research that suggests parental communication may help deter high-risk sexual behavior among adolescents, parents report a lack of confidence in their ability to answer sexually related questions. The purpose of this study was to test the effect of a multimedia intervention on outcome expectations and perceived self-efficacy for the sex educator role for parents of African American adolescent males. A pilot study using mixed methods was conducted. A nonprobability sample (N = 61) was obtained from a large urban community using a combination of convenience and snowball recruitment methods. Self-efficacy and outcome expectations were measured using self-reported questionnaires. A multimedia intervention for use at home and incorporating an audio CD and associated activities was implemented over a 3-week time period. Outcome expectations and self-efficacy both significantly improved after the intervention (p < .001). Findings indicate that using a multimedia approach may be effective in improving parents' outcome expectancy and self-efficacy for talking about sex with adolescent sons. © 2013 Wiley Periodicals, Inc.

School-Based Smoking Prevention with Media Literacy: A Pilot Study

ERIC Educational Resources Information Center

Bier, Melinda C.; Schmidt, Spring J.; Shields, David; Zwarun, Lara; Sherblom, Stephen; Pulley, Cynthia; Rucker, Billy

2011-01-01

School-based tobacco prevention programs have had limited success reducing smoking rates in the long term. Media literacy programs offer an innovative vehicle for delivery of potentially more efficacious anti-tobacco education. However, these programs have been neither widely implemented nor well evaluated. We conducted a pre-post evaluation of a…

Using Storytelling Strategies to Improve Student Comprehension in Online Classes

ERIC Educational Resources Information Center

Powell, Rasby Marlene; Murray, Ottis

2012-01-01

Previous research shows that presenting class material in story formats can improve student learning in lecture classes. This pilot study of eight sociology classes investigates the efficacy of using storytelling as a means to improve student comprehension in online classes. Our findings show that when material is presented in story format rather…

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%,…

Feasibility, safety and efficacy of transcutaneous vagus nerve stimulation in chronic tinnitus: an open pilot study.

PubMed

Kreuzer, Peter M; Landgrebe, Michael; Resch, Markus; Husser, Oliver; Schecklmann, Martin; Geisreiter, Florian; Poeppl, Timm B; Prasser, Sarah J; Hajak, Goeran; Rupprecht, Rainer; Langguth, Berthold

2014-01-01

Vagus nerve stimulation represents an established treatment strategy for epilepsy and affective disorders. Recently, positive effects were also shown in animals and humans with tinnitus. Here we report the results of an open pilot study exploring feasibility, safety and efficacy of tVNS in the treatment of chronic tinnitus. Fifty patients with chronic tinnitus underwent tVNS in an open single-armed pilot study which was conducted in two phases applying two different stimulating devices (Cerbomed CM02 and NEMOS). Clinical assessment was based on Tinnitus Questionnaire (TQ), Tinnitus Handicap Inventory (THI), Beck Depression Inventory (BDI), WHO Quality of Life, and various numeric rating scales. Primary outcome was defined as change in TQ (baseline vs. final visit in week 24). The study has been registered with clinicaltrials.gov (NCT01176734). Primary analysis indicated mean TQ reductions of 3.7 points (phase 1) and 2.8 points (phase 2) significant for the first study phase. Secondary analyses indicated a significant BDI reduction for phase 1 (uncorrected for multiple testing), but no further systematic or significant effects. Adverse events included twitching and pressure at electrode placement site. The occurrence of one hospitalization because of palpations and the development of a left bundle branch block were considered as unrelated to the intervention. Cognitive testing revealed no significant changes. Our data demonstrate the feasibility of tVNS over a period of 6 months. There was no clinically relevant improvement of tinnitus complaints. Our data suggest tVNS to be considered safe in patients without a history of cardiac disease. Copyright © 2014 Elsevier Inc. All rights reserved.

Beneficial Effects of Oral Supplementation With Ovoderm on Human Skin Physiology: Two Pilot Studies.

PubMed

Aguirre, Andrés; Gil-Quintana, Erena; Fenaux, Marisa; Erdozain, Sandra; Sarria, Itziar

2017-11-02

Collagens and hyaluronic acid have long been used in pharmaceuticals and food supplements for the improvement of skin elasticity and hydration. These compounds provide the building blocks of the skin. Ovoderm is an oral supplement obtained from eggshells that contains naturally occurring collagen and glycosaminoglycans, such as hyaluronic acid. We evaluated the efficacy of Ovoderm on skin biophysical parameters related to cutaneous aging such as elasticity, hydration, and pigmentation. Two pilot studies were run to assess the effect of daily oral supplementation with 300 mg Ovoderm on skin parameters. The first consisted of a self-assessment questionnaire intended to perform an assessment on skin, hair, and nail health after 50 days of treatment. The second measured the effect of 5-week treatment on hydration by corneometry, on elasticity with the cutometer, and on pigmentation with the mexameter. In the pilot study 1, participants were predominantly satisfied with the effects obtained on general face (100% volunteers satisfied) and body (94% volunteers satisfied) skin condition and skin properties (100% volunteers satisfied with facial skin softness, 94% with facial skin hydration, and 89% with body skin hydration) and partly with effects on hair (67% volunteers satisfied) and nail (50% volunteers satisfied) condition. The study 2 revealed a statistically significant improvement in skin elasticity (12% increase, p =.0136), a tendency to reduce skin pigmentation (5% decrease), and no significant change in skin hydration. Our study reflects that oral supplementation with Ovoderm is efficacious to reduce the gradual loss of skin elasticity characteristic of aged skin, which helps to improve the appearance of the skin.

Using ecological momentary assessment to examine antecedents and correlates of physical activity bouts in adults age 50+ years: a pilot study.

PubMed

Dunton, Genevieve Fridlund; Atienza, Audie A; Castro, Cynthia M; King, Abby C

2009-12-01

National recommendations supporting the promotion of multiple short (10+ minute) physical activity bouts each day to increase overall physical activity levels in middle-aged and older adults underscore the need to identify antecedents and correlates of such daily physical activity episodes. This pilot study used Ecological Momentary Assessment to examine the time-lagged and concurrent effects of empirically supported social, cognitive, affective, and physiological factors on physical activity among adults age 50+ years. Participants (N = 23) responded to diary prompts on a handheld computer four times per day across a 2-week period. Moderate-to-vigorous physical activity (MVPA), self-efficacy, positive and negative affect, control, demand, fatigue, energy, social interactions, and stressful events were assessed during each sequence. Multivariate results showed that greater self-efficacy and control predicted greater MVPA at each subsequent assessment throughout the day (p < 0.05). Also, having a positive social interaction was concurrently related to higher levels of MVPA (p = 0.052). Time-varying multidimensional individual processes predict within daily physical activity levels.

Feasibility and Preliminary Outcomes From a Pilot Study of an Integrated Health-Mental Health Promotion Program in School Mental Health Services

PubMed Central

George, Melissa W.; Trumpeter, Nevelyn N.; Wilson, Dawn K.; McDaniel, Heather L.; Schiele, Bryn; Prinz, Ron; Weist, Mark D.

2014-01-01

The prevalence of unmet health and mental health needs among youth has spurred the growing consensus to develop strategies that integrate services to promote overall well-being. This pilot study reports on the feasibility and outcomes of a theory-driven, family-focused, integrated health-mental health promotion program for underserved adolescents receiving school mental health services. Parent and adolescent assessments conducted prior to and following the brief, 6-session promotion program showed significant improvements in family support, youth self-efficacy, health behaviors, and mental health outcomes. Clinician reports contributed to a characterization of the feasibility, acceptability, and future recommendations for the integrated program. PMID:24297005

Small Intestinal Submucosa Plug for Closure of Dilated Nephrostomy Tracts: A Pilot Study in Swine

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

Kakizawa, Hideyaki; Conlin, M. J.; Pavcnik, Dusan, E-mail: pavcnikd@ohsu.edu

2010-06-15

The aim of this study was to evaluate efficacy of a plug made of small intestinal submucosa (SIS) for closure of dilated nephrostomy tract in the kidney after nephroscopy. Ten kidneys in 5 swine had nephrostomy tracts dilated up to 8 mm. The SIS plug was placed into the dilated renal cortex under nephroscopic control. Follow-up arteriograms, retrograde pyelograms, and macroscopic and histologic studies at 24 h (n = 4), 6 weeks (n = 2), and 3 months (n = 4) were performed to evaluate the efficacy of the plug. The SIS plug effectively closed the dilated nephrostomy tract. Follow-upmore » studies showed minimal changes of the kidneys, except for 1 small infarction, regarding inflammatory and foreign-body reactions and progressive scarring of the SIS. SIS plug is effective for occlusion of dilated nephrostomy tract after nephroscopy. Its efficacy should be compared with other therapeutic options.« less

Arts-inspired students sync their assets to a nuts and bolts world: A career mentoring pilot progam

NASA Astrophysics Data System (ADS)

Hudson, Lynn

This research examined how students who are arts-inspired feel about their futures in a STEM-based work climate. Science, Technology, Engineering, and Math are the nuts and bolts, and in education today, the only avenue touted for our country and our students' success in this 21st century economy. This can be disconcerting to those interested in other fields, like the arts. This study was guided by the following questions in an effort to understand if our artists and arts-inspired students realize their options and importance in this 21st century climate. The pilot study was designed to help improve the students' perception of their abilities or self-efficacy in the STEM areas by introducing STEM professionals as mentors who designed hands-on activities that simulate work in the STEM fields. Research Questions: 1. Do arts-inspired students have an interest in a STEM career area prior to participating in the career mentoring program? 2. Does participation in a STEM career mentoring program improve student's self-efficacy in STEM fields? 3. Does participation in STEM career mentoring program increase student's interest in pursuing STEM-related careers? Lent, Brown and Hackett's Social Cognitive Career Theory and Daniel Pink's, "A Whole New Mind: Why Left-Brainers Will Rule the Future" were used as the theoretical framework for this study. Seventeen African-American girls who were enrolled in the "I AM COMPLETE" summer program participated in the pilot study. Data was collected from the College Foundation of North Carolina Career Interest Explorer and the STEM Career Interest Survey, which served as a pre and post-test. This pilot offered limited support for the hypothesis, however, career mentoring and opportunities for young people to experience careers, especially in the STEM areas must continue to grow. The role that the arts play in this process is pivotal in galvanizing females and minorities to join these professions. It is the hope of this researcher that the pilot be replicated using a much larger population of students and school communities.

A Pilot Test of the Additive Benefits of Physical Exercise to CBT for OCD.

PubMed

Rector, Neil A; Richter, Margaret A; Lerman, Bethany; Regev, Rotem

2015-01-01

The majority of "responders" to first-line cognitive-behavioural therapy (CBT) and pharmacological treatments for obsessive-compulsive disorder (OCD) are left with residual symptoms that are clinically relevant and disabling. Therefore, there is pressing need for widely accessible efficacious alternative and/or adjunctive treatments for OCD. Accumulating evidence suggests that physical exercise may be one such intervention in the mood and anxiety disorders broadly, although we are aware of only two positive small-scale pilot studies that have tested its clinical benefits in OCD. This pilot study aimed to test the feasibility and preliminary efficacy of adding a structured physical exercise programme to CBT for OCD. A standard CBT group was delivered concurrently with a 12-week customized exercise programme to 11 participants. The exercise regimen was individualized for each participant based on peak heart rate measured using an incremental maximal exercise test. Reports of exercise adherence across the 12-week regimen exceeded 80%. A paired-samples t-test indicated very large treatment effects in Yale-Brown Obsessive-Compulsive Scale scores from pre- to post-treatment in CBT group cohorts led by expert CBT OCD specialists (d = 2.55) and junior CBT clinician non-OCD specialists (d = 2.12). These treatment effects are very large and exceed effects typically observed with individual and group-based CBT for OCD based on leading meta-analytic reviews, as well as previously obtained treatment effects for CBT using the same recruitment protocol without exercise. As such, this pilot work demonstrates the feasibility and significant potential clinical utility of a 12-week aerobic exercise programme delivered in conjunction with CBT for OCD.

Systematic cultural adaptation of cognitive-behavioral therapy to reduce alcohol use among HIV-infected outpatients in western Kenya.

PubMed

Papas, Rebecca K; Sidle, John E; Martino, Steve; Baliddawa, Joyce B; Songole, Rogers; Omolo, Otieno E; Gakinya, Benson N; Mwaniki, Michael M; Adina, Japheth O; Nafula, Tobista; Owino-Ong'or, Willis D; Bryant, Kendall J; Carroll, Kathleen M; Goulet, Joseph L; Justice, Amy C; Maisto, Stephen A

2010-06-01

Two-thirds of those with HIV worldwide live in sub-Saharan Africa. Alcohol use is associated with the HIV epidemic through risky sex and suboptimal ARV adherence. In western Kenya, hazardous drinking was reported by HIV (53%) and general medicine (68%) outpatients. Cognitive behavioral treatment (CBT) has demonstrated strong efficacy to reduce alcohol use. This article reports on a systematic cultural adaptation and pilot feasibility study of group paraprofessional-delivered CBT to reduce alcohol use among HIV-infected outpatients in Eldoret, Kenya. Following adaptation and counselor training, five pilot groups were run (n = 27). Overall attendance was 77%. Percent days abstinent from alcohol (PDA) before session 1 was 52-100% (women) and 21-36% (men), and by session 6 was 96-100% (women) and 89-100% (men). PDA effect sizes (Cohen's d) between first and last CBT session were 2.32 (women) and 2.64 (men). Participants reported treatment satisfaction. Results indicate feasibility, acceptability and preliminary efficacy for CBT in Kenya.

Integrating HIV Prevention and Relationship Education for Young Same-Sex Male Couples: A Pilot Trial of the 2GETHER Intervention.

PubMed

Newcomb, Michael E; Macapagal, Kathryn R; Feinstein, Brian A; Bettin, Emily; Swann, Gregory; Whitton, Sarah W

2017-08-01

Young men who have sex with men are at high risk for HIV, and most new HIV infections occur in serious relationships. This pilot study assessed the feasibility, acceptability and preliminary efficacy of the 2GETHER couples-based HIV prevention and relationship education intervention for young same-sex male couples. We enrolled 57 young male couples (N = 114) into a four-session hybrid group and individual intervention. We assessed acceptability via post-session surveys and exit interviews, and we examined preliminary efficacy at a two week posttest. The vast majority of participants (93%) reported exclusively positive impressions of 2GETHER, and all components received high mean ratings. We observed decreases in HIV risk behavior, increases in information, motivation and behavioral skills related to HIV prevention, and improvement in relationship investment between pretest and posttest. Integrating relationship education and sexual health programming may be an effective way to reduce HIV transmissions in young male couples.

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…

Interim Report on Ed Tech PILOTS. A Report to the 78th Texas Legislature from the Texas Education Agency.

ERIC Educational Resources Information Center

Texas Education Agency, Austin.

The primary goals of the Texas Education Agency's Educational Technologies Providing Increased Learning Opportunities for Texas Students (Ed Tech PILOTS) are to employ technology to more efficiently and effectively delivery information to students and teachers to enhance the efficacy of classroom instruction. This interim report discusses the…

Study protocol of a randomised controlled trial of intranasal ketamine compared with intranasal fentanyl for analgesia in children with suspected, isolated extremity fractures in the paediatric emergency department.

PubMed

Reynolds, Stacy L; Studnek, Jonathan R; Bryant, Kathleen; VanderHave, Kelly; Grossman, Eric; Moore, Charity G; Young, James; Hogg, Melanie; Runyon, Michael S

2016-09-08

Fentanyl is the most widely studied intranasal (IN) analgesic in children. IN subdissociative (INSD) ketamine may offer a safe and efficacious alternative to IN fentanyl and may decrease overall opioid use during the emergency department (ED) stay. This study examines the feasibility of a larger, multicentre clinical trial comparing the safety and efficacy of INSD ketamine to IN fentanyl and the potential role for INSD ketamine in reducing total opioid medication usage. This double-blind, randomised controlled, pilot trial will compare INSD ketamine (1 mg/kg) to IN fentanyl (1.5 μg/kg) for analgesia in 80 children aged 4-17 years with acute pain from a suspected, single extremity fracture. The primary safety outcome for this pilot trial will be the frequency of cumulative side effects and adverse events at 60 min after drug administration. The primary efficacy outcome will be exploratory and will be the mean reduction of pain scale scores at 20 min. The study is not powered to examine efficacy. Secondary outcome measures will include the total dose of opioid pain medication in morphine equivalents/kg/hour (excluding study drug) required during the ED stay, number and reason for screen failures, time to consent, and the number and type of protocol deviations. Patients may receive up to 2 doses of study drug. This study was approved by the US Food and Drug Administration, the local institutional review board and the study data safety monitoring board. This study data will be submitted for publication regardless of results and will be used to establish feasibility for a multicentre, non-inferiority trial. NCT02521415. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/

ACTG A5353: A Pilot Study of Dolutegravir Plus Lamivudine for Initial Treatment of Human Immunodeficiency Virus-1 (HIV-1)-infected Participants With HIV-1 RNA <500000 Copies/mL.

PubMed

Taiwo, Babafemi O; Zheng, Lu; Stefanescu, Andrei; Nyaku, Amesika; Bezins, Baiba; Wallis, Carole L; Godfrey, Catherine; Sax, Paul E; Acosta, Edward; Haas, David; Smith, Kimberly Y; Sha, Beverly; Van Dam, Cornelius; Gulick, Roy M

2018-05-17

Limited data exist on initial human immunodeficiency virus type 1 (HIV-1) treatment with dolutegravir plus lamivudine. A5353 is a phase 2, single-arm, pilot study of once-daily dolutegravir (50 mg) plus lamivudine (300 mg) in treatment-naive participants with HIV-1 RNA ≥1000 and <500000 copies/mL. Exclusion criteria included active hepatitis B or major protease, reverse transcriptase, or integrase resistance. The primary efficacy measure was the proportion with HIV-1 RNA <50 copies/mL (FDA [US Food and Drug Administration] Snapshot) at week 24. Virologic failure (VF) was confirmed HIV-1 RNA >400 copies/mL at week 16/20 or >200 copies/mL at or after week 24. Dolutegravir levels and drug resistance testing were performed at VF. One hundred and twenty participants (87% male, median age 30 years, 37 (31%) HIV-1 RNA >100000 copies/mL) initiated study treatment. Median entry HIV-1 RNA and CD4 count were 4.61 log10 copies/mL and 387 cells/mm3. Virologic efficacy at week 24 was 108/120 (90%, confidence interval [83%, 95%]), with comparable results in the >100000 copies/mL and ≤100000 copies/mL strata, that is, 89% (75%, 97%) and 90% (82%, 96%), respectively. Three participants with VF, had undetected plasma dolutegravir at ≥1 time points; the M184V and R263R/K mutations developed in 1 participant. Two participants experienced grade 3 possible/probable treatment-related adverse events; none discontinued treatment due to adverse events. Dolutegravir plus lamivudine demonstrated efficacy in individuals with pretreatment HIV-1 RNA up to 500000 copies/mL in this pilot trial, but a participant developed resistance mutations. NCT02582684.

A Pilot Randomized Controlled Trial of the ACCESS Program: A Group Intervention to Improve Social, Adaptive Functioning, Stress Coping, and Self-Determination Outcomes in Young Adults with Autism Spectrum Disorder.

PubMed

Oswald, Tasha M; Winder-Patel, Breanna; Ruder, Steven; Xing, Guibo; Stahmer, Aubyn; Solomon, Marjorie

2018-05-01

The purpose of this pilot randomized controlled trial was to investigate the acceptability and efficacy of the Acquiring Career, Coping, Executive control, Social Skills (ACCESS) Program, a group intervention tailored for young adults with autism spectrum disorder (ASD) to enhance critical skills and beliefs that promote adult functioning, including social and adaptive skills, self-determination skills, and coping self-efficacy. Forty-four adults with ASD (ages 18-38; 13 females) and their caregivers were randomly assigned to treatment or waitlist control. Compared to controls, adults in treatment significantly improved in adaptive and self-determination skills, per caregiver report, and self-reported greater belief in their ability to access social support to cope with stressors. Results provide evidence for the acceptability and efficacy of the ACCESS Program.

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.

Pilot study of erlotinib in patients with acute myeloid leukemia.

PubMed

Sayar, Hamid; Czader, Magdalena; Amin, Chirag; Cangany, Mary; Konig, Heiko; Cripe, Larry D

2015-02-01

We conducted a pilot study to investigate clinical efficacy of tyrosine kinase inhibitor erlotinib in the treatment of acute myeloid leukemia (AML). A total of 11 patients with de novo AML were treated, including 2 with relapsed and/or refractory disease and 9 older patients with previously untreated AML. Patients with high baseline leukocyte count were excluded. Erlotinib was given orally at 150 mg per day continuously in 28-day cycles. The treatment was tolerated well, and no toxicities were observed. An initial reduction in circulating blasts, followed by disease progression, was observed in 2 patients. Nine other patients did not demonstrate any response in blood or bone marrow. Baseline and post-cycle 1 flow-cytometry were performed on bone marrow blasts to investigate signs of differentiation. No immunophenotypic changes suggestive of differentiation were observed. This pilot study did not demonstrate response to standard doses of erlotinib in patients with AML. Copyright © 2014 Elsevier Ltd. All rights reserved.

Testing the Feasibility and Acceptability of a Chaplaincy Intervention to Improving Treatment Attitudes and Self-Efficacy of Adolescents With Cystic Fibrosis: A Pilot Study

PubMed Central

Cheng, Joy; Purcell, Hillary N.; Dimitriou, Sophia M.; Grossoehme, Daniel H.

2015-01-01

Religious factors are known to contribute to treatment adherence in different patient populations, and religious coping has been found to be particularly important to adolescents dealing with chronic diseases. Adherence to prescribed treatments slows disease progression and contributes to desirable outcomes in most patients, and, therefore, adherence-promoting interventions provided by chaplains could be beneficial to various patient populations. The current article describes a pilot study to test the feasibility of a theoretically and empirically based chaplain intervention to promote treatment adherence for adolescents with CF. Cognitive interviews were conducted 24 with adolescents with CF, and content analysis was used to identify themes, which informed revision of the intervention protocol. The authors thought that presenting the methods and results of this pilot study would be helpful for chaplains who want to conduct intervention research. The results indicated that the proposed intervention was acceptable and feasible to deliver in hard copy or an electronic platform. PMID:25793423

The Emotional Resources Group: Provisional outcome data for a pilot six-session emotion regulation programme for secondary care.

PubMed

Bacon, Thomas; Doughty, Caitriona; Summers, Andrew; Wiffen, Benjamin; Stanley, Zoe; McAlpine, Susan

2018-06-01

To examine the effectiveness of a new, six-session emotion regulation group intervention designed for the secondary care setting: The Emotional Resources Group (ERG). In this pilot study, participants were recruited by referral from secondary care mental health services. Forty-seven individuals participated in the study. Participants who attended the ERG were compared on measures of emotion regulation, well-being, and self-efficacy, pre- and post-intervention. Intent-to-treat analyses indicated highly statistically significant improvements in measures of emotion regulation, well-being, and self-efficacy, accompanied by large effect sizes. In addition, improvements in emotion regulation produced good rates of both reliable and clinically significant change. The ERG may be an effective, brief intervention to improve emotion regulation in the secondary care setting, worthy of further evaluation. Clinical implications Emotion regulation may be an appropriate treatment target to improve well-being and self-efficacy in a transdiagnostic population. The ERG may be effective as a brief emotion regulation intervention for secondary care mental health settings. Outcomes of the ERG appear to be equivalent to other more intensive group-based emotion regulation interventions. The ERG's tailored design may be responsible for positive outcomes. Limitations There was a small sample size. There was no control group. There was no follow-up data. © 2018 The British Psychological Society.

Prospective, open-label, uncontrolled pilot study to study safety and efficacy of sildenafil in systemic sclerosis-related pulmonary artery hypertension and cutaneous vascular complications.

PubMed

Kumar, Uma; Sankalp, Gokhale; Gokhle, Sankalp S; Sreenivas, V; Kaur, Satbir; Misra, Durgaprasanna

2013-04-01

Pulmonary artery hypertension (PAH) remains the leading cause of morbidity and mortality in systemic sclerosis, while Raynaud's phenomenon and digital ulcers significantly add to the morbidity in systemic sclerosis (SSc). This study was undertaken to evaluate the role of sildenafil in PAH, Raynaud's phenomenon, and digital ulcers in systemic sclerosis patients. A prospective, open-label, uncontrolled pilot study was done at a tertiary care centre in India to study the safety and efficacy of oral sildenafil in PAH, Raynaud's phenomenon, digital infarcts, and ulcers in SSc. Seventeen patients fulfilling ACR classification criteria for scleroderma and having PAH were recruited. Six-minute walk test, WHO class of dyspnoea, severity of Raynaud's phenomenon, and 2D ECHO were performed in all the study subjects at baseline and at 3 months post-treatment. All patients were treated with oral sildenafil 25 mg three times a day for a period of 3 months. The pre- and post-treatment values of mean pulmonary artery pressure (PAP), 6-min walk test, WHO class of dyspnoea, and severity of Raynaud's phenomenon were compared to look for any significant change. Sixteen patients who completed 3-month follow-up had shown statistically significant improvement in 6-min walk test, WHO class of dyspnoea, severity of Raynaud's phenomenon, and mPAP. Also, there was no occurrence of new digital infarcts or ulcers, and existing ulcers showed signs of healing. Sildenafil is highly efficacious cheaper and safe alternative to other available therapies for SSc-associated PAH, Raynaud's phenomenon, and digital infarcts/ulcers.

Suggestion of an oral hygiene program for orthodontic patients with cleft lip and palate: findings of a pilot study.

PubMed

Brasil, Juliana Marcelina Plácido; de Almeida Pernambuco, Renata; da Silva Dalben, Gisele

2007-11-01

To evaluate the efficacy of an oral hygiene program for orthodontic patients with cleft lip and palate. Retrospective pilot study. Hospital for Rehabilitation of Craniofacial Anomalies, Bauru, Brazil. One hundred twenty-two patients with complete cleft lip and palate undergoing orthodontic treatment. Orientation on toothbrushing and flossing, plaque disclosure, and scoring according to an especially designed index. Statistical comparison of variation in plaque index between sessions; correlation of intervals between sessions and variation in plaque index. Mean scores were reduced significantly, from 2.17 to 1.75 between first and second, 2.18 to 1.62 between first and third, and 1.93 to 1.62 between second and third sessions. Plaque reduction was inversely proportional to the time interval. The program demonstrated a significant plaque reduction. The highest reduction between the first and second sessions reveals the need to reinforce the initial instructions at all sessions. The greatest reduction observed at shorter intervals highlights the need for regular follow up. More controlled studies on larger samples should be encouraged to evaluate the validity of the index and the efficacy of similar programs worldwide.

Prospective, pilot evaluation of the performance of nanofractional radiofrequency for improvement of skin texture via skin resurfacing.

PubMed

Bohnert, Krista; Dorizas, Andrew; Sadick, Neil

2018-02-01

The latest generation of radiofrequency, nanofractional radiofrequency, allows the heat energy to be delivered through the use of pins or needles as electrodes, facilitating increased efficacy and reduced pain, downtime, and side effects. The objective of this prospective pilot clinical study was to evaluate the efficacy of nanofractional radiofrequency in skin resurfacing. Seventeen subjects were enrolled in the study, and each received three nanofractional radiofrequency (160-pin tip) treatments in the facial area at 3-week intervals. Follow-up visits were scheduled at 1 and 2 months after the final treatment. Clinical photography, patient, and investigator assessments were conducted during the treatment visits and follow-up. All subjects completed the study. At the 1- and 2-month follow-up, there was a moderate to significant improvement (2.6 and 3.5, respectively, P = .01) according to the investigator global esthetic improvement scale rating. Most subjects reported that they were satisfied or very satisfied with the outcome and level of comfort. Nanofractional radiofrequency is a safe and effective strategy for improving texture, tone, and skin laxity with high patient satisfaction and tolerable safety profile. © 2017 Wiley Periodicals, Inc.

Electrolytic ablation as an adjunct to liver resection: Safety and efficacy in patients.

PubMed

Wemyss-Holden, Simon A; Berry, David P; Robertson, Gavin S M; Dennison, Ashley R; De La M Hall, Pauline; Maddern, Guy J

2002-08-01

Electrolytic ablation is a relatively new method for the local destruction of colorectal liver metastases. Experimental work in animal models has shown this method to be safe and efficacious. However, before proceeding to clinical trials it was necessary to confirm these findings in a pilot study of five patients. Five patients with colorectal liver metastases were studied prospectively. Each patient underwent a potentially curative liver resection. One of the metastases to be removed was treated using electrolysis before resection. Each patient was monitored closely during and after electrolysis to determine any morbidity associated with the treatment. Once resected, the metastases were examined histologically for completeness of ablation. All patients tolerated the electrolysis well; there were no deaths or complications related to the treatment. Histological examination of the resected metastases which had been treated electrolytically showed complete tissue destruction with no viable malignant cells remaining at the site of treatment. This pilot study of electrolytic ablation of liver metastases in five patients showed the treatment to be well tolerated and safe. Additionally, it demonstrated total destruction of the malignant tissue at the site of electrolysis. Based on these encouraging results, clinical trials can now begin.

PROTECT: A Pilot Program to Integrate Mental Health Treatment Into Elder Abuse Services for Older Women.

PubMed

Sirey, Jo Anne; Halkett, Ashley; Chambers, Stephanie; Salamone, Aurora; Bruce, Martha L; Raue, Patrick J; Berman, Jacquelin

2015-01-01

The goal of this pilot program was to test the usefulness of adapted Problem-Solving Therapy (PST) and anxiety management, called PROTECT, integrated into elder abuse services to reduce depression and improve self-efficacy. Depressed women victims were randomized to receive elder abuse resolution services combined with either PROTECT or a mental health referral. At follow-up, the PROTECT group showed greater reduction in depressive symptoms and endorsed greater improved self-efficacy in problem-solving when compared to those in the Referral condition. These preliminary findings support the potential usefulness of PROTECT to alleviate depressive symptoms and enhance personal resources among abused older women.

The Development and Evaluation of a Professional Development Model to Build Meaningful and Effective IEPs for Transition-Aged Students

ERIC Educational Resources Information Center

Doren, Bonnie; Flannery, K. Brigid; Lombardi, Allison

2012-01-01

The purpose of the study was to examine the potential efficacy of a professional development training model targeting IEP case managers of transition-age students. A training model was developed and a pilot study conducted to understand the promise of the model to improve the development of critical components within the IEP document that support…

Common Evaluation Tools across Multi-State Programs: A Study of Parenting Education and Youth Engagement Programs in Children, Youth, and Families At-Risk

ERIC Educational Resources Information Center

Payne, Pamela B.; McDonald, Daniel A.

2015-01-01

Community-based education programs must demonstrate effectiveness to various funding sources. The pilot study reported here (funded by CYFAR, NIFA, USDA award #2008-41520-04810) had the goal of determining if state level programs with varied curriculum could use a common evaluation tool to demonstrate efficacy. Results in parenting and youth…

Impact of Metacognitive Acceptance on Body Dissatisfaction and Negative Affect: Engagement and Efficacy

ERIC Educational Resources Information Center

Atkinson, Melissa J.; Wade, Tracey D.

2012-01-01

Objective: To investigate engagement in metacognitive acceptance and subsequent efficacy with respect to decreasing 2 risk factors for disordered eating, body dissatisfaction (BD), and negative affect (NA). Method: In a pilot experiment, 20 female undergraduates (M[subscript age] = 24.35, SD = 9.79) underwent a BD induction procedure, received…

Development of a Drug Use Resistance Self-Efficacy (DURSE) Scale

ERIC Educational Resources Information Center

Carpenter, Carrie M.; Howard, Donna

2009-01-01

Objectives: To develop and evaluate psychometric properties of a new instrument, the drug use resistance self-efficacy (DURSE) scale, designed for young adolescents. Methods: Scale construction occurred in 3 phases: (1) initial development, (2) pilot testing of preliminary items, and (3) final scale administration among a sample of seventh graders…

Telehealth delivery of cognitive-behavioral intervention to youth with autism spectrum disorder and anxiety: A pilot study

PubMed Central

Hepburn, Susan L; Blakeley-Smith, Audrey; Wolff, Brian; Reaven, Judy A

2015-01-01

Youth with autism spectrum disorders frequently experience significant symptoms of anxiety. Empirically supported psychosocial interventions exist, yet access is limited, especially for families in rural areas. Telehealth (i.e. videoconferencing) has potential to reduce barriers to access to care; however, little is known about the feasibility or efficacy of directly intervening with youth with autism spectrum disorders through this modality. This study details the pilot testing of a telehealth version of an empirically supported intervention targeting anxiety in youth with autism spectrum disorders. The primary focus of this study is on feasibility, with evaluation of outcomes as a starting point for future randomized trials. In all, 33 families of youth with autism spectrum disorders and significant anxiety symptoms participated in this study (Telehealth Facing Your Fears (FYF) Intervention: n = 17; Wait-list control: n = 16). Youth of all functioning levels were included. Acceptability was strong; however, the usability of the technology was problematic for some families and impeded some sessions significantly. Fidelity of the telehealth version to the critical elements of the original, in vivo version was excellent. More work is needed to improve delivery of exposure practices and parent coaching. Preliminary efficacy analyses are promising, with improvements observed in youth anxiety over time (relative to a comparison group waiting for live intervention) and parent sense of competence (within group). Clearly, stronger designs are necessary to evaluate efficacy sufficiently; however, this study does provide support for further investigation of clinic-to-home videoconferencing as a direct intervention tool for youth with autism spectrum disorders and their parents. PMID:25896267

Safety and efficacy evaluation of tretinoin cream 0.02% for the reduction of photodamage: a pilot study.

PubMed

Kircik, Leon H

2012-01-01

Clinical studies as well as histologic data maintain that tretinoin improves the appearance of photodamage; however, the long-term benefits of tretinoin 0.02% in moderate to severe photodamage have not been established. We performed independent assessments to demonstrate the long-term safety and efficacy of tretinoin emollient cream 0.02% for moderate to severe facial photodamage. A single-center, open-label, single-group observational study followed 19 patients over 52 weeks. Efficacy assessments consisted of the Glogau Photodamage Classification Scale and severity grading of photodamage signs and symptoms. Facial photography and biopsies were taken from three subjects at baseline and final visits. Tolerability was assessed by the investigator. Twelve patients completed 52 weeks of treatment. Mean change in Glogau photodamage demonstrated statistically significant differences at 3, 6, 9, and 12 months (P<.0005). All patients with moderate to severe photodamage had improved to mild photodamage status by 9 months. Statistically significant improvements (P<.05) were observed at all time points for fine wrinkling, tactile roughness, and mottled hyperpigmentation as well as for lentigines at 6, 9, and 12 months and telangiectasia at 12 months. Biopsy samples revealed microscopic improvement in photodamage. Tretinoin cream 0.02% was generally well-tolerated, with few subjects experiencing adverse events. Our pilot study is limited by lack of control and the small study sample. Tretinoin cream 0.02% was safe and effective for moderate to severe photodamage of facial skin and demonstrated sustainable benefits over an entire year based on the clinically validated Glogau classification system and expert visual grading analysis.

Telehealth delivery of cognitive-behavioral intervention to youth with autism spectrum disorder and anxiety: A pilot study.

PubMed

Hepburn, Susan L; Blakeley-Smith, Audrey; Wolff, Brian; Reaven, Judy A

2016-02-01

Youth with autism spectrum disorders frequently experience significant symptoms of anxiety. Empirically supported psychosocial interventions exist, yet access is limited, especially for families in rural areas. Telehealth (i.e. videoconferencing) has potential to reduce barriers to access to care; however, little is known about the feasibility or efficacy of directly intervening with youth with autism spectrum disorders through this modality. This study details the pilot testing of a telehealth version of an empirically supported intervention targeting anxiety in youth with autism spectrum disorders. The primary focus of this study is on feasibility, with evaluation of outcomes as a starting point for future randomized trials. In all, 33 families of youth with autism spectrum disorders and significant anxiety symptoms participated in this study (Telehealth Facing Your Fears (FYF) Intervention: n = 17; Wait-list control: n = 16). Youth of all functioning levels were included. Acceptability was strong; however, the usability of the technology was problematic for some families and impeded some sessions significantly. Fidelity of the telehealth version to the critical elements of the original, in vivo version was excellent. More work is needed to improve delivery of exposure practices and parent coaching. Preliminary efficacy analyses are promising, with improvements observed in youth anxiety over time (relative to a comparison group waiting for live intervention) and parent sense of competence (within group). Clearly, stronger designs are necessary to evaluate efficacy sufficiently; however, this study does provide support for further investigation of clinic-to-home videoconferencing as a direct intervention tool for youth with autism spectrum disorders and their parents. © The Author(s) 2015.

Efficacy and safety of acupuncture for dizziness and vertigo in emergency department: a pilot cohort study.

PubMed

Chiu, Chih-Wen; Lee, Tsung-Chieh; Hsu, Po-Chi; Chen, Chia-Yun; Chang, Shun-Chang; Chiang, John Y; Lo, Lun-Chien

2015-06-09

Dizziness and vertigo account for roughly 4% of chief symptoms in the emergency department (ED). Pharmacological therapy is often applied for these symptoms, such as vestibular suppressants, anti-emetics and benzodiazepines. However, every medication is accompanied with unavoidable side-effects. There are several research articles providing evidence of acupuncture treating dizziness and vertigo but few studies of acupuncture as an emergent intervention in ED. We performed a pilot cohort study to evaluate the efficacy and safety of acupuncture in treating patients with dizziness and vertigo in ED. A total of 60 participants, recruited in ED, were divided into acupuncture and control group. Life-threatening conditions or central nervous system disorders were excluded to ensure participants' safety. The clinical effect of treating dizziness and vertigo was evaluated by performing statistical analyses on data collected from questionnaires of Dizziness Handicap Inventory (DHI), Visual Analog Scale (VAS) of dizziness and vertigo, and heart rate variability (HRV). The variation of VAS demonstrated a significant decrease (p-value: 0.001 and p-value: 0.037) between two groups after two different durations: 30 mins and 7 days. The variation of DHI showed no significant difference after 7 days. HRV revealed a significant increase in high frequency (HF) in the acupuncture group. No adverse event was reported in this study. Acupuncture demonstrates a significant immediate effect in reducing discomforts and VAS of both dizziness and vertigo. This study provides clinical evidence on the efficacy and safety of acupuncture to treat dizziness and vertigo in the emergency department. ClinicalTrials.gov ID: NCT02358239 . Registered 5 February 2015.

Achievement Goals, Motivation to Learn, and Mathematics Anxiety among Pre-Service Teachers

ERIC Educational Resources Information Center

Vásquez-Colina, María D.; Gonzalez-DeHass, Alyssa R.; Furner, Joseph M.

2014-01-01

This paper reports findings of a pilot study examining the feasibility of a research design to investigate how achievement goals relate to the construct of math anxiety. In addition, we also consider how other important achievement-related behaviors, like self-efficacy, help-seeking, and self-regulation, might also relate to students' math…

A Placebo Double-Blind Pilot Study of Dextromethorphan for Problematic Behaviors in Children with Autism

ERIC Educational Resources Information Center

Woodard, Cooper; Groden, June; Goodwin, Matthew; Bodfish, James

2007-01-01

We used a mixed group/single-case, double-blind, placebo-controlled, ABAB design to examine the safety and efficacy of the glutamate antagonist dextromethorphan for the treatment of problematic behaviors and core symptoms in eight children diagnosed with autism. All participants had increased levels of irritability at baseline as measured by the…

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,…

Use of Text Messaging for Monitoring Sugar-Sweetened Beverages, Physical Activity, and Screen Time in Children: A Pilot Study

ERIC Educational Resources Information Center

Shapiro, Jennifer R.; Bauer, Stephanie; Hamer, Robert M.; Kordy, Hans; Ward, Dianne; Bulik, Cynthia M.

2008-01-01

Objective: To examine acceptability, attrition, adherence, and preliminary efficacy of mobile phone short message service (SMS; text messaging) for monitoring healthful behaviors in children. Design: All randomized children received a brief psychoeducational intervention. They then either monitored target behaviors via SMS with feedback or via…

A Pilot Study of Strong Start: Preliminary Evidence of Feasibiliy and Efficacy of Social and Emotional Learning in Preschool

ERIC Educational Resources Information Center

Felver, Sarah

2013-01-01

Social and emotional competencies have received increased attention as important components of school readiness for young children. Universal programs incorporating social and emotional learning (SEL) instruction for all preschool students are needed given the relation between social and emotional competencies in early childhood and later…

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…

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

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,…

Pilot Investigation of the Katie Brown Educational Program: A School-Community Partnership

ERIC Educational Resources Information Center

Joppa, Meredith C.; Rizzo, Christie J.; Nieves, Amethys V.; Brown, Larry K.

2016-01-01

Background: Schools in the United States are increasingly being urged to address the problem of adolescent dating violence (DV) with their students. Given the limited time available to implement prevention programming during the school day, brief programs are needed. The purpose of this study was to test the efficacy of a widely disseminated,…

Efficacy of a School-Based Treatment Program for Middle School Youth With ADHD: Pilot Data

ERIC Educational Resources Information Center

Evans, Steven W.; Axelrod, Jennifer; Langberg, Joshua M.

2004-01-01

The effects of a set of behavioral and educational interventions provided in a middle-school-based mental health program on the behavior and academic performance of 7 students diagnosed with attention-deficit/hyperactivity disorder (ADHD) were studied. The treatments included educational, social skills and family interventions designed to target…

The Efficacy of a Multifaceted Weight Management Program for Children and Young Adolescents

ERIC Educational Resources Information Center

Kihm, Holly Spencer

2014-01-01

The incidence of overweight and obesity among children and young adolescents remains unacceptably high and places our youth at risk for several negative outcomes. Recognizing the need for a youth-focused weight management program in our community, the researcher developed, implemented, and evaluated a small pilot study, FitKids. The aims of…

Exploratory Research to Design a School Nurse-Delivered Intervention to Treat Adolescent Overweight and Obesity

ERIC Educational Resources Information Center

Gellar, Lauren; Druker, Sue; Osganian, Stavroula K.; Gapinski, Mary Ann; LaPelle, Nancy; Pbert, Lori

2012-01-01

Objective: In preparation for a pilot study to evaluate the efficacy of a school nurse-delivered intervention, focus groups were conducted to gain insight into the perceptions of stakeholders regarding the design and implementation of the intervention. Setting and Participants: Fifteen focus groups at participating schools. One hundred subjects,…

Development of dry gram-negative bacteria biocontrol products and small pilot tests against dry rot

USDA-ARS?s Scientific Manuscript database

Pseudomonas fluorescens strains S11:P:12, P22:Y:05, and S22:T:04 suppress four important storage potato maladies; dry rot, late blight, pink rot, and sprouting. Studies were designed to identify methods for producing a dried, efficacious biological control product. The strains were evaluated individ...

Comparison of a Self-Directed and Therapist-Assisted Telehealth Parent-Mediated Intervention for Children with ASD: A Pilot RCT

ERIC Educational Resources Information Center

Ingersoll, Brooke; Wainer, Allison L.; Berger, Natalie I.; Pickard, Katherine E.; Bonter, Nicole

2016-01-01

This pilot RCT compared the effect of a self-directed and therapist-assisted telehealth-based parent-mediated intervention for young children with ASD. Families were randomly assigned to a self-directed or therapist-assisted program. Parents in both groups improved their intervention fidelity, self-efficacy, stress, and positive perceptions of…

Changing Parent's Mindfulness, Child Management Skills and Relationship Quality with Their Youth: Results from a Randomized Pilot Intervention Trial

ERIC Educational Resources Information Center

Coatsworth, J. Douglas; Duncan, Larissa G.; Greenberg, Mark T.; Nix, Robert L.

2010-01-01

We evaluated the efficacy of a mindful parenting program for changing parents' mindfulness, child management practices, and relationships with their early adolescent youth and tested whether changes in parents' mindfulness mediated changes in other domains. We conducted a pilot randomized trial with 65 families and tested an adapted version of the…

Impacts from the Youth Incentive Entitlement Pilot Projects: Participation, Work, and Schooling Over the Full Program Period.

ERIC Educational Resources Information Center

Farkas, George; And Others

The Youth Incentive Entitlement Pilot Projects (YIEPP) demonstration, which was in full operation from 1978 to 1980, was established to test the efficacy of work combined with education as a remedy for high unemployment, low labor force participation, and the excessive school dropout rate of teenagers. YIEPP offered Federal minimum-wage jobs…

Concept mapping to promote meaningful learning, help relate theory to practice and improve learning self-efficacy in Asian mental health nursing students: A mixed-methods pilot study.

PubMed

Bressington, Daniel T; Wong, Wai-Kit; Lam, Kar Kei Claire; Chien, Wai Tong

2018-01-01

Student nurses are provided with a great deal of knowledge within university, but they can find it difficult to relate theory to nursing practice. This study aimed to test the appropriateness and feasibility of assessing Novak's concept mapping as an educational strategy to strengthen the theory-practice link, encourage meaningful learning and enhance learning self-efficacy in nursing students. This pilot study utilised a mixed-methods quasi-experimental design. The study was conducted in a University school of Nursing in Hong Kong. A total of 40 third-year pre-registration Asian mental health nursing students completed the study; 12 in the concept mapping (CM) group and 28 in the usual teaching methods (UTM) group. The impact of concept mapping was evaluated thorough analysis of quantitative changes in students' learning self-efficacy, analysis of the structure and contents of the concept maps (CM group), a quantitative measure of students' opinions about their reflective learning activities and content analysis of qualitative data from reflective written accounts (CM group). There were no significant differences in self-reported learning self-efficacy between the two groups (p=0.38). The concept mapping helped students identify their current level of understanding, but the increased awareness may cause an initial drop in learning self-efficacy. The results highlight that most CM students were able to demonstrate meaningful learning and perceived that concept mapping was a useful reflective learning strategy to help them to link theory and practice. The results provide preliminary evidence that the concept mapping approach can be useful to help mental health nursing students visualise their learning progress and encourage the integration of theoretical knowledge with clinical knowledge. Combining concept mapping data with quantitative measures and qualitative reflective journal data appears to be a useful way of assessing and understanding the effectiveness of concept mapping. Future studies should utilise a larger sample size and consider using the approach as a targeted intervention immediately before and during clinical learning placements. Copyright © 2017 Elsevier Ltd. All rights reserved.

Evaluating undergraduate nursing students' self-efficacy and competence in writing: Effects of a writing intensive intervention.

PubMed

Miller, Louise C; Russell, Cynthia L; Cheng, An-Lin; Skarbek, Anita J

2015-05-01

While professional nurses are expected to communicate clearly, these skills are often not explicitly taught in undergraduate nursing education. In this research study, writing self-efficacy and writing competency were evaluated in 52 nontraditional undergraduate baccalaureate completion students in two distance-mediated 16-week capstone courses. The intervention group (n = 44) experienced various genres and modalities of written assignments set in the context of evidence-based nursing practice; the comparison group (n = 8) received usual writing undergraduate curriculum instruction. Self-efficacy, measured by the Post Secondary Writerly Self-Efficacy Scale, indicated significant improvements for all self-efficacy items (all p's = 0.00). Writing competency, assessed in the intervention group using a primary trait scoring rubric (6 + 1 Trait Writing Model(®) of Instruction and Assessment), found significant differences in competency improvement on five of seven items. This pilot study demonstrated writing skills can improve in nontraditional undergraduate students with guided instruction. Further investigation with larger, culturally diverse samples is indicated to validate these results. Copyright © 2014 Elsevier Ltd. All rights reserved.

Undergraduate training in palliative medicine: is more necessarily better?

PubMed

Mason, Stephen R; Ellershaw, John E

2010-04-01

The General Medical Council's call to modernize medical education prompted the University of Liverpool Medical School to develop a new undergraduate programme, integrating palliative medicine as 'core' curricula. Following successful piloting, the palliative medicine training programme was further developed and expanded. This paper examines whether the additional investment produces improved outcomes. In 1999, fourth year undergraduate medical students (Cohort 1, n = 217) undertook a 2-week pilot education programme in palliative medicine. Subsequently, the training programme was refined and extended, incorporating advanced communication skills training, an ethics project and individual case presentations (Cohort 2, n = 443). Congruent with the study's theoretical driver of self-efficacy, both cohorts were surveyed pre- and post-programme with validated measures of: (i) self-efficacy in palliative care scale; (ii) thanatophobia scale. No significant differences between cohorts' pre-programme scores were identified. Within each cohort, statistically and educationally significant post-education improvements were recorded in both scales. Further post-education analysis indicated that the extended programme produces significantly greater improvements in all domains of the self-efficacy in palliative care scale (communication, t =-7.28, patient management, t =-5.96, multidisciplinary team-working t =-3.77 at p < 0.000), but not thanatophobia. Although improvements were recorded in both cohorts, participation in the extended education programme resulted in further statistically significant gains. Interpreted through the theoretical model employed, improved self-efficacy and outcome expectancies will result in behavioural change that leads to improved practice and better patient care.

Alcohol expectancies and social self-efficacy as mediators of differential intervention outcomes for college hazardous drinkers with social anxiety.

PubMed

Black, Jessica J; Tran, Giao Q; Goldsmith, Abigail A; Thompson, Rachel D; Smith, Joshua P; Welge, Jeffrey A

2012-03-01

The current pilot study examined the roles of two cognitive factors - positive alcohol expectancies of social anxiety reduction and drink refusal self-efficacy relevant to social situations - in mediating greater reduction in alcohol behaviors by the Brief Intervention for Socially Anxious Drinkers (BISAD; n=21) compared to an alcohol psychoeducation (n=20) in a sample of college hazardous drinkers with social anxiety. Mediation analysis results indicated that decreased positive alcohol expectancies and increased drink refusal self-efficacy relevant to social situations accounted for an average of 67% of the variance in treatment outcomes as measured by total quantity of alcohol consumption, heavy drinking days and problems related to alcohol use in the past month. Study results may enhance the understanding of cognitive factors' role in alcohol treatment outcomes, which could in turn improve the efficacy of interventions aimed to reduce hazardous drinking and comorbid social anxiety. Copyright © 2011 Elsevier Ltd. All rights reserved.

High-Intensity Interval or Continuous-Moderate Exercise: A 24-Week Pilot Trial.

PubMed

Locke, Sean R; Bourne, Jessica E; Beauchamp, Mark R; Little, Jonathan P; Barry, Julianne; Singer, Joel; Jung, Mary E

2018-05-14

High-intensity interval training (HIIT) may lead to superior cardiometabolic improvements when compared to moderate-intensity continuous training (MICT). However, adherence to HIIT requires examination. The purpose of this pilot study was to examine moderate-to-vigorous physical activity (MVPA) adherence 24 weeks following a brief counselling intervention combined with either HIIT or MICT. Individuals at high risk of type 2 diabetes (T2D) were randomized to HIIT (n = 15) or MICT (n = 17) and completed 10 exercise sessions accompanied by a brief 10-minute counselling intervention over a 2-week period. Objectively measured purposeful MVPA (accelerometry) and cardiorespiratory fitness (VO2peak) were assessed at baseline and 24 weeks post-intervention. Self-regulatory efficacy and task self-efficacy were examined at baseline, post-intervention and 24 weeks post-intervention. Using an intention-to-treat analysis, change scores were calculated for HIIT and MICT and compared between groups. Individuals assigned to HIIT increased their MVPA by 53 minutes (Cohen's d=1.52) at 24 weeks compared to 19 minutes in MICT (tbetween=1.96, p=.06, d =.56). Both HIIT and MICT increased relative VO2peak by 2 and 1 ml/kg/min, respectively (tbetween=0.72, p=0.47). Participants in both groups increased in their self-regulatory and task self-efficacy post-intervention but both groups demonstrated similar decline at 24 weeks. This pilot intervention was successful in increasing, and maintaining, free-living MVPA over a 24-week period in individuals at high risk of T2D. Speculation that HIIT is inappropriate or unattainable for overweight individuals at high risk of T2D may be unfounded.

Exclusive breast-feeding promotion among HIV-infected women in South Africa: an Information-Motivation-Behavioural Skills model-based pilot intervention.

PubMed

Tuthill, Emily L; Butler, Lisa M; Pellowski, Jennifer A; McGrath, Jacqueline M; Cusson, Regina M; Gable, Robert K; Fisher, Jeffrey D

2017-06-01

Exclusive breast-feeding (EBF) provides optimal nutrition for infants and mothers. The practice of EBF while adhering to antiretroviral medication decreases the risk of mother-to-child transmission of HIV from approximately 25 % to less than 5 %. Thus the WHO recommends EBF for the first 6 months among HIV-infected women living in resource-limited settings; however, EBF rates remain low. In the present study our aim was to design and implement a pilot intervention promoting EBF among HIV-infected women. The Information-Motivation-Behavioural Skills (IMB) model was applied in a brief motivational interviewing counselling session that was tested in a small randomized controlled trial. Pietermaritzburg, South Africa, at two comparable rural public health service clinics. Sixty-eight HIV-infected women in their third trimester were enrolled and completed baseline interviews between June and August 2014. Those randomized to the intervention arm received the IMB-based pilot intervention directly following baseline interviews. Follow-up interviews occurred at 6 weeks postpartum. While not significantly different between trial arms, high rates of intention and practice of EBF at 6-week follow-up were reported. Findings showed high levels of self-efficacy being significantly predictive of breast-feeding initiation and duration regardless of intervention arm. Future research must account for breast-feeding self-efficacy on sustaining breast-feeding behaviour and leverage strategies to enhance self-efficacy in supportive interventions. Supporting breast-feeding behaviour through programmes that include both individual-level and multi-systems components targeting the role of health-care providers, family and community may create environments that value and support EBF behaviour.

Piloting an email-based resource package for job seekers with multiple sclerosis.

PubMed

Dorstyn, Diana; Roberts, Rachel; Murphy, Gregory; Kneebone, Ian; Migliorini, Christine; Craig, Ashley; Hutchinson, Claire; Field, Deborah

2017-05-01

Media-based rehabilitation provides a powerful opportunity to examine vocational behaviors in the disability sector. However, this research is preliminary at best. This paper reports pilot data. Eighteen adults with multiple sclerosis (MS) accessed an email-delivered, resource-based package, Work and MS. Pre- and post-access vocational self-efficacy and identity (Job-Procurement Self Efficacy Scale, My Vocational Situation Scale- primary outcomes), life orientation and depressed mood (Life Orientation Test - revised and Patient Health Questionnaire-9 - secondary outcomes) were assessed. Pre- and post-change scores were examined with Wilcoxon signed ranks tests and Hedges g effect sizes with associated 95% confidence intervals. Reliable change analyses were additionally calculated to determine the clinical significance of individual change scores. Significant and positive effects were reported for vocational self-efficacy, identity, and optimism. Reliable change scores in one or more of these key outcomes were reported by 30% of the sample. Satisfaction with the content and delivery of the email-based intervention was also noted. Preliminary evidence suggests that Work and MS can help to promote vocational goals, interests and strengths among job seekers with a disability by providing a set of tools, information and linkages relating to vocational pursuits and career development. Replication with a randomized control design is indicated. Implications for Rehabilitation Research indicates a high unemployment rate among working-age adults with MS. A combination of disease-specific, psychological, programmatic and societal variables contribute to employment instability in this group. This pilot study demonstrates that an e-mail-based resource package, Work and MS, provides an innovative and feasible option for promoting consumer engagement with vocational services and, potentially, improving vocational outcomes. Work and MS has potential applicability to other disability groups.

A pilot study investigating the effects of trauma, experiential avoidance, and disease management in HIV-positive MSM using methamphetamine.

PubMed

Chartier, Maggie; Vinatieri, Trisha; Delonga, Kathryn; McGlynn, Lawrence M; Gore-Felton, Cheryl; Koopman, Cheryl

2010-01-01

With high rates of trauma among HIV-positive men who have sex with men (MSM) who use methamphetamine, this preliminary pilot study examined the associations between experiential avoidance, trauma symptoms, and management of a chronic illness. Among a small sample of HIV-positive, methamphetamine-using MSM in a California Bay Area County, greater reported experiential avoidance was significantly related to greater reported trauma and symptoms of traumatic stress. Furthermore, greater reported experiential avoidance was significantly related to reduced self-efficacy of illness management and more frequent methamphetamine use. Although further research is needed, these data suggest that addressing issues of experiential avoidance and trauma could affect behavioral choices and treatment outcomes in this high-risk population.

Pilot Testing of the NURSE Stress Management Intervention.

PubMed

Delaney, Colleen; Barrere, Cynthia; Robertson, Sue; Zahourek, Rothlyn; Diaz, Desiree; Lachapelle, Leeanne

2016-12-01

Student nurses experience significant stress during their education, which may contribute to illness and alterations in health, poor academic performance, and program attrition. The aim of this pilot study was to evaluate the feasibility and potential efficacy of an innovative stress management program in two baccalaureate nursing programs in Connecticut, named NURSE (Nurture nurse, Use resources, foster Resilience, Stress and Environment management), that assists nursing students to develop stress management plans. An explanatory sequential mixed-methods design was used to evaluate the effects of the intervention with 40 junior nursing students. Results from this study provide evidence that the NURSE intervention is highly feasible, and support further testing to examine the effect of the intervention in improving stress management in nursing students. © The Author(s) 2015.

Cognitive Behavioral Treatment for Recurrent Binge Eating in Adolescent Girls: A Pilot Trial

PubMed Central

DeBar, Lynn L.; Wilson, G. Terence; Yarborough, Bobbi Jo; Burns, Beryl; Oyler, Barbara; Hildebrandt, Tom; Clarke, Gregory N.; Dickerson, John; Striegel, Ruth H.

2013-01-01

There is a need for treatment interventions to address the high prevalence of disordered eating throughout adolescence and early adulthood. We developed an adolescent-specific manualized CBT protocol to treat female adolescents with recurrent binge eating and tested its efficacy in a small, pilot randomized controlled trial. We present lessons learned in recruiting adolescents, a description of our treatment approach, acceptability of the treatment for teens and parents, as well as results from the pilot trial. Participants in the CBT group had significantly fewer posttreatment eating binges than those in a treatment as usual/delayed treatment (TAU-DT) control group; 100% of CBT participants were abstinent at follow-up. Our results provide preliminary support for the efficacy of this adolescent adaptation of evidence-based CBT for recurrent binge eating. The large, robust effect size estimate observed for the main outcome (NNT=2) places this among the larger effects observed for any mental health intervention. PMID:23645978

Efficacy and safety of combined treatment of miniscalpel acupuncture and non-steroidal anti-inflammatory drugs: an assessor-blinded randomized controlled pilot study.

PubMed

Jun, Seungah; Lee, Jung Hee; Gong, Han Mi; Chung, Yeon-Joong; Kim, Ju-Ran; Park, Chung A; Choi, Seong Hun; Lee, Geon-Mok; Lee, Hyun-Jong; Kim, Jae Soo

2018-01-12

Chronic neck pain is a common musculoskeletal disease during the lifespan of an individual. With an increase in dependence on computer technology, the prevalence of chronic neck pain is expected to rise and this can lead to socioeconomic problems. We have designed the current pilot study to evaluate the efficacy and safety of miniscalpel acupuncture treatment combined with non-steroidal anti-inflammatory drugs (NSAIDs) in patients with chronic neck pain. This seven-week clinical trial has been designed as an assessor-blinded, randomized controlled trial with three parallel arms. Thirty-six patients will be recruited and randomly allocated to three treatment groups: miniscalpel acupuncture treatment; NSAIDs; and miniscalpel acupuncture treatment combined with NSAIDs. Patients in the miniscalpel acupuncture and combined treatment groups will receive three sessions of miniscalpel acupuncture over a three-week period. Patients in the NSAIDs and combined treatment groups will receive zaltoprofen (one oral tablet, three times a day for three weeks). Primary and secondary outcomes will be measured at weeks 0 (baseline), 1, 2, 3 (primary end point), and 7 (four weeks after treatment completion) using the visual analogue scale and the Neck Disability Index, EuroQol 5-dimension questionnaire, and Patients' Global Impression of Change scale, respectively. Adverse events will also be recorded. This pilot study will provide a basic foundation for a future large-scale trial as well as information about the feasibility of miniscalpel acupuncture treatment combined with NSAIDs for chronic neck pain. Korean Clinical Research Information Service registry, KCT0002258 . Registered on 9 March 2017.

Development and Assessment of the Feasibility of a Nurse-Led Care Program for Cancer Patients in a Chemotherapy Day Center: Results of the Pilot Study.

PubMed

Lai, Xiaobin; Wong, Frances Kam Yuet; Leung, Carenx Wai Yee; Lee, Lai Ha; Wong, Jessica Shuk Yin; Lo, Yim Fan; Ching, Shirley Siu Yin

2015-01-01

The increasing number of cancer patients and inadequate communication in clinics are posing challenges to cancer patients receiving outpatient-based chemotherapy and healthcare providers. A nurse-led care program was proposed as one way of dealing with at least some of these challenges. The objectives of the pilot study were to assess the feasibility of the subject recruitment, care, and data collection procedures and to explore the acceptability of this program. A pilot study with a 1-group pretest-posttest design was conducted. Five cancer patients receiving chemotherapy in a chemotherapy day center participated. Each patient had a nurse consultation before chemotherapy and received 2 telephone calls after the first and second cycles of chemotherapy. Four questionnaires were adopted to evaluate the subjects' quality of life, self-efficacy, symptom experiences, and satisfaction with care. Questionnaires were completed before the chemotherapy and after the second cycle. The subjects were also interviewed to understand their comments on the service. The recruitment, care, and data collection procedures were completed smoothly. Slight changes were observed in quality of life and self-efficacy. All 5 subjects were highly satisfied with the care. The nurse-led care program is feasible and acceptable. The effect of the nurse-led care program will be evaluated in a single-center, open, randomized controlled trial. If the encouraging results can be confirmed, it may be an effective approach to improving the quality of ambulatory chemotherapy care. It would also shed light on the development of nurse-led care in other areas.

Comparative efficacy and safety of oxcarbazepine versus divalproex sodium in the treatment of acute mania: a pilot study.

PubMed

Kakkar, Ashish Kumar; Rehan, H S; Unni, K E S; Gupta, Neeraj Kumar; Chopra, Deepti; Kataria, Dinesh

2009-04-01

This study compared the efficacy and safety of oxcarbazepine and divalproex sodium in acute mania patients. In this 12 week, randomized, double-blind pilot study, 60 patients diagnosed with acute mania (DSM-IV) and a baseline Young Mania Rating Scale (YMRS) score of 20 or more received flexibly dosed oxcarbazepine (1,000-2,400 mg/day) or divalproex (750-2,000 mg/day). The mean decrease in the YMRS score from baseline was used as the main outcome measure of response to treatment. A priori protocol-defined threshold scores were or=15 for relapse. Number of patients showing adequate response and the time taken to achieve improvement was compared. Adverse events were systematically recorded throughout the study. Over 12 weeks, mean improvement in YMRS scores was comparable for both the groups including the mean total scores as well as percentage fall from baseline. There were no significant differences between treatments in the rates of symptomatic mania remission (90% in divalproex and 80% in oxcarbazepine group) and subsequent relapse. Median time taken to symptomatic remission was 56 days in divalproex group while it was 70 days in the oxcarbazepine group (p=0.123). A significantly greater number of patients in divalproex group experienced one or more adverse drug events as compared to patients in the oxcarbazepine group (66.7% versus 30%, p<0.01). Oxcarbazepine demonstrated comparable efficacy to divalproex sodium in the management of acute mania. Also the overall adverse event profile was found to be superior for oxcarbazepine.

Impact of ao-dake-humi, Japanese traditional bamboo foot stimulator, on lower urinary tract symptoms, constipation and hypersensitivity to cold: a single-arm prospective pilot study.

PubMed

Minagawa, Tomonori; Saitou, Tetsuichi; Suzuki, Toshiro; Domen, Takahisa; Yokoyama, Hitoshi; Ishikawa, Masakuni; Hirakata, Shiro; Nagai, Takashi; Nakazawa, Masaki; Ogawa, Teruyuki; Ishizuka, Osamu

2016-12-09

Ao-dake-humi is a traditional Japanese bamboo foot stimulator consisting of a half-pipe-shaped step made of bamboo used to stimulate the foot by stepping on it, and is commonly used to promote general health among the elderly in Japan. However, its efficacy has not been reported in the scientific literature. This study was performed to investigate the role of ao-dake-humi focusing on lower urinary tract symptoms (LUTS), constipation, and hypersensitivity to cold (HC). Participants with LUTS, constipation, or HC were enrolled in this study. Ao-dake-humi was used twice a day for 28 days. Before and 28 days after starting ao-dake-humi use, international prostate symptom score (IPSS), quality-of-life (QoL) score, and overactive bladder symptom score (OABSS) were measured to evaluate the efficacy of ao-dake-humi on LUTS. To evaluate the objective efficacy of ao-dake-humi on LUTS, a frequency-volume chart (FVC) was plotted in LUTS patients for 3 days. A visual analogue scale (VAS) was used to evaluate the efficacy of ao-dake-humi on constipation (VAS-constipation) and HC (VAS-HC) in the participants with constipation or HC. A total of 24 participants were enrolled in this study. Twenty-one participants had LUTS, 11 had constipation, and 17 participants had HC. IPSS, especially storage-subscore, QoL score and OABSS, decreased significantly after use of ao-dake-humi. The use of ao-dake-humi increased maximal bladder capacity, resulting in a significant decrease in urinary frequency as determined from the FVC. In accordance with the results of VAS-constipation and VAS-HC, both constipation and HC were significantly relieved after ao-dake-humi use. The results of this prospective pilot study indicated that ao-dake-humi is safe and has therapeutic efficacy in cases of LUTS, constipation and HC. The possibility of using ao-dake-humi as physical neuromodulation therapy was shown in the management of LUTS, constipation and HC. UMIN000019333 (UMIN-CTR, Registered October-15-2015) retrospectively registered.

[Changing of the patient safety culture in the pilot institutes of the Hungarian accreditation program].

PubMed

Lám, Judit; Merész, Gergő; Bakacsi, Gyula; Belicza, Éva; Surján, Cecília; Takács, Erika

2016-10-01

The accreditation system for health care providers was developed in Hungary aiming to increase safety, efficiency, and efficacy of care and optimise its organisational operation. The aim of this study was to assess changes of organisational culture in pilot institutes of the accreditation program. 7 volunteer pilot institutes using an internationally validated questionnaire were included. The impact study was performed in 2 rounds: the first before the introduction of the accreditation program, and the second a year later, when the standards were already known. Data were analysed using descriptive statistics and logistic regression models. Statistically significant (p<0.05) positive changes were detected in hospitals in three dimensions: organisational learning - continuous improvement, communication openness, teamwork within the unit while in outpatient clinics: overall perceptions of patient safety, and patient safety within the unit. Organisational culture in the observed institutes needs improvement, but positive changes already point to a safer care. Orv. Hetil., 2016, 157(42), 1667-1673.

Topical Allium ampeloprasum subsp Iranicum (Leek) extract cream in patients with symptomatic hemorrhoids: a pilot randomized and controlled clinical trial.

PubMed

Mosavat, Seyed Hamdollah; Ghahramani, Leila; Sobhani, Zahra; Haghighi, Ehsan Rahmanian; Heydari, Mojtaba

2015-04-01

Allium ampeloprasum subsp iranicum (Leek) has been traditionally used in antihemorrhoidal topical herbal formulations. This study aimed to evaluate its safety and efficacy in a pilot randomized controlled clinical trial. Twenty patients with symptomatic hemorrhoids were randomly allocated to receive the topical leek extract cream or standard antihemorrhoid cream for 3 weeks. The patients were evaluated before and after the intervention in terms of pain, defecation discomfort, bleeding severity, anal itching severity, and reported adverse events. A significant decrease was observed in the grade of bleeding severity and defecation discomfort in both the leek and antihemorrhoid cream groups after the intervention, while no significant change was observed in pain scores. There was no significant difference between the leek and antihemorrhoid cream groups with regard to mean changes in outcome measures. This pilot study showed that the topical use of leek cream can be as effective as a standard antihemorrhoid cream. © The Author(s) 2015.

Evaluation of rivaroxaban use in patients with gynecologic malignancies at an academic medical center: A pilot study.

PubMed

Signorelli, Jessie R; Gandhi, Arpita S

2017-01-01

Background Patients with gynecologic malignancies are at an increased risk for venous thromboembolism. National guidelines recommend treatment of an acute venous thromboembolism with low molecular weight heparin for 5-10 days followed by long-term secondary prophylaxis with low molecular weight heparin for at least six months. Non-vitamin K oral anticoagulants are not currently recommended to be used in cancer patients for the management of venous thromboembolism because robust data on their efficacy and safety have yet to become available in cancer patients. The objectives of this study were to determine the proportion of gynecologic oncology patients with venous thromboembolism using rivaroxaban compared to warfarin or low molecular weight heparin as well as compare the safety and efficacy of these anticoagulants. Methods This study was a retrospective pilot analysis of adult patients with gynecologic malignancies who received either rivaroxaban, warfarin or low molecular weight heparin for treatment of venous thromboembolism at Augusta University Medical Center from 1 July 2013 to 30 June 2015. Statistical comparisons between the enoxaparin and rivaroxaban group were made using T-tests and Chi-square or Fisher's exact tests, where appropriate. Results Out of the 49 patients, 37% (18) patients were on rivaroxaban, 53% (26) on enoxaparin, and 10% (5) on warfarin. Only one patient (4%) in the enoxaparin group experienced a recurrent deep vein thrombosis while there were no cases of recurrent venous thromboembolism in the rivaroxaban and warfarin group. The incidence of major bleeding was 17% ( n = 2), 20% ( n = 1), and 8% ( n = 2) in patients receiving rivaroxaban, enoxaparin, and warfarin, respectively. The rate of switching to a different anticoagulant than originally prescribed was 42% ( n = 14) in the enoxaparin arm, and 5.5% ( n = 1) in the rivaroxaban arm. Conclusion A high proportion of our gynecologic oncology patients received rivaroxaban for the management of venous thromboembolism. The sample size of this pilot analysis was too small to draw any conclusions regarding efficacy and safety of rivaroxaban compared with enoxaparin and warfarin. High rate of rivaroxaban use in gynecologic oncology patients at our institution highlights the need for larger, well-designed randomized controlled trials to confirm the safety and efficacy of its use in this population.

Pairing motivational interviewing with a nutrition and physical activity assessment and counseling tool in pediatric clinical practice: a pilot study.

PubMed

Christison, Amy L; Daley, Brendan M; Asche, Carl V; Ren, Jinma; Aldag, Jean C; Ariza, Adolfo J; Lowry, Kelly W

2014-10-01

Recommendations to screen and counsel for lifestyle behaviors can be challenging to implement during well-child visits in the primary care setting. A practice intervention was piloted using the Family Nutrition and Physical Activity (FNPA) Screening Tool paired with a motivational interviewing (MI)-based counseling tool during well-child visits. Acceptability and feasibility of this intervention were assessed. Its impact on parent-reported obesigenic behavior change and provider efficacy in lifestyle counseling were also examined. This was an observational study in a pediatric primary care office. During well-child visits of 100 patients (ages 4-16 years), the FNPA tool was implemented and providers counseled patients in an MI-consistent manner based on its results. Duration of implementation, patient satisfaction of the intervention, and success of stated lifestyle goals were measured. Provider self-efficacy and acceptability were also surveyed. The FNPA assessment was efficient to administer, requiring minutes to complete and score. Patient acceptability was high, ranging from 4.0 to 4.8 on a 5-point scale. Provider acceptability was good, with the exception of duration of counseling; self-efficacy in assessing patient "readiness for change" was improved. Parent-reported success of primary lifestyle goal was 68% at 1 month and 46% at 6 months. The FNPA assessment with an MI-based counseling tool shows promise as an approach to identify and address obesigenic behaviors during pediatric well-child visits. It has the potential to improve provider efficacy in obesity prevention and also influence patient health behaviors, which can possibly impact childhood excessive weight gain. After refinement, this practice intervention will be used in a larger trial.

A Pilot Randomized Controlled Trial of Omega-3 Fatty Acids for Autism Spectrum Disorder

ERIC Educational Resources Information Center

Bent, Stephen; Bertoglio, Kiah; Ashwood, Paul; Bostrom, Alan; Hendren, Robert L.

2011-01-01

We conducted a pilot randomized controlled trial to determine the feasibility and initial safety and efficacy of omega-3 fatty acids (1.3 g/day) for the treatment of hyperactivity in 27 children ages 3-8 with autism spectrum disorder (ASD). After 12 weeks, hyperactivity, as measured by the Aberrant Behavior Checklist, improved 2.7 (plus or minus…

Online Teaching Efficacy: A Product of Professional Development and Ongoing Support.

PubMed

Richter, Sally; Idleman, Lynda

2017-08-22

The purpose of the pilot study was to investigate the perceptions of online teaching efficacy of nursing faculty who teach courses in which 51% or more of the content is offered online. Bandura's psychological construct of self-efficacy served as the conceptual framework. The research survey was administered to nursing faculty in a state university system located in the southeastern United States of America, plus two private universities. The Michigan Nurse Educator's Sense of Efficacy for Online Teaching Scale, which contains 32 items that measure how nurse educators judge their current capabilities for teaching online nursing courses, was used to gather data. Overall, the scores reflected that faculty perceived themselves as quite a bit efficacious on a scale that ranged from 1 to 9. As nursing educators received more support in designing and implementing online courses, their efficacy increased. It is critical that faculty are supported on an ongoing basis to increase and develop online teaching skills in order to teach high-quality courses in online programs. Faculty members must also be recognized for their work, time, and commitment required to be effective online educators. The findings of this study revealed those participants who had a number of professional development supports and release time to develop online courses have a greater sense of efficacy.

Development and initial validation of the appropriate antibiotic use self-efficacy scale.

PubMed

Hill, Erin M; Watkins, Kaitlin

2018-06-04

While there are various medication self-efficacy scales that exist, none assess self-efficacy for appropriate antibiotic use. The Appropriate Antibiotic Use Self-Efficacy Scale (AAUSES) was developed, pilot tested, and its psychometric properties were examined. Following pilot testing of the scale, a 28-item questionnaire was examined using a sample (n = 289) recruited through the Amazon Mechanical Turk platform. Participants also completed other scales and items, which were used in assessing discriminant, convergent, and criterion-related validity. Test-retest reliability was also examined. After examining the scale and removing items that did not assess appropriate antibiotic use, an exploratory factor analysis was conducted on 13 items from the original scale. Three factors were retained that explained 65.51% of the variance. The scale and its subscales had adequate internal consistency. The scale had excellent test-retest reliability, as well as demonstrated convergent, discriminant, and criterion-related validity. The AAUSES is a valid and reliable scale that assesses three domains of appropriate antibiotic use self-efficacy. The AAUSES may have utility in clinical and research settings in understanding individuals' beliefs about appropriate antibiotic use and related behavioral correlates. Future research is needed to examine the scale's utility in these settings. Copyright © 2018 Elsevier B.V. All rights reserved.

A tactual pilot aid for the approach-and-landing task: Inflight studies

NASA Technical Reports Server (NTRS)

Gilson, R. D.; Fenton, R. E.

1973-01-01

A pilot aid -- a kinesthetic-tactual compensatory display -- for assisting novice pilots in various inflight situations has undergone preliminary inflight testing. The efficacy of this display, as compared with two types of visual displays, was evaluated in both a highly structured approach-and-landing task and a less structured test involving tight turns about a point. In both situations, the displayed quantity was the deviation (alpha sub 0 - alpha) in angle at attack from a desired value alpha sub 0. In the former, the performance with the tactual display was comparable with that obtained using a visual display of (alpha sub 0 - alpha), while in the later, substantial improvements (reduced tracking error (55%), decreased maximum altitude variations (67%), and decreased speed variations (43%)), were obtained using the tactual display. It appears that such a display offers considerable potential for inflight use.

Development of a tobacco cessation intervention for Alaska Native youth

PubMed Central

Patten, Christi A.; Fadahunsi, Oluwole; Hanza, Marcelo; Smith, Christina M.; Hughes, Christine A.; Brockman, Tabetha A.; Boyer, Rahnia; Decker, Paul A.; Luger, Elizabeth; Sinicrope, Pamela S.; Offord, Kenneth P.

2013-01-01

Tobacco cessation treatments have not been evaluated among Alaska Native (AN) adolescents. This pilot study evaluated the feasibility and acceptability of a targeted cessation intervention developed for AN youth. Intervention components were informed by prior focus groups assessing treatment preferences among AN youth, a social cognitive theoretical framework and feedback obtained from a teen advisory group. The intervention consisted of a weekend program where youth traveled by small airplane from their villages to stay overnight with other adolescents who quit tobacco use together. The program included recreational activities, talking circles, personal stories from elders and teen advisors, and cognitive behavioral counseling. Two intervention pilots were conducted from October 2010 to January 2011 using a non-randomized, uncontrolled study design with assessments at baseline and six-week follow-up. One village in Western Alaska was selected for each pilot with a targeted enrollment of 10 adolescents each. Participants were recruited for each pilot within five days, but recruitment challenges and ‘‘lessons learned’’ are described. The first pilot enrolled nine adolescents (all female) aged 13–16 years; all nine attended the intervention program and 78% (7/9) completed follow-up. The second pilot enrolled 12 adolescents (eight females, four males) aged 12–17 years, of which seven attended the intervention program. Six of these seven participants (86%) completed follow-up. In both pilots, participants rated the intervention as highly acceptable. A targeted cessation intervention was feasible and acceptable to AN youth. The intervention will be tested for efficacy in a subsequent randomized controlled trial. PMID:24058327

A pilot randomized trial of two cognitive rehabilitation interventions for mild cognitive impairment: caregiver outcomes.

PubMed

Cuc, Andrea V; Locke, Dona E C; Duncan, Noah; Fields, Julie A; Snyder, Charlene Hoffman; Hanna, Sherrie; Lunde, Angela; Smith, Glenn E; Chandler, Melanie

2017-12-01

This study aims to provide effect size estimates of the impact of two cognitive rehabilitation interventions provided to patients with mild cognitive impairment: computerized brain fitness exercise and memory support system on support partners' outcomes of depression, anxiety, quality of life, and partner burden. A randomized controlled pilot trial was performed. At 6 months, the partners from both treatment groups showed stable to improved depression scores, while partners in an untreated control group showed worsening depression over 6 months. There were no statistically significant differences on anxiety, quality of life, or burden outcomes in this small pilot trial; however, effect sizes were moderate, suggesting that the sample sizes in this pilot study were not adequate to detect statistical significance. Either form of cognitive rehabilitation may help partners' mood, compared with providing no treatment. However, effect size estimates related to other partner outcomes (i.e., burden, quality of life, and anxiety) suggest that follow-up efficacy trials will need sample sizes of at least 30-100 people per group to accurately determine significance. Copyright © 2017 John Wiley & Sons, Ltd. Copyright © 2017 John Wiley & Sons, Ltd.

Practicing Dentists’ Self-Efficacy and Associated Factors in Managing the Treatment of Adults with Mental and Physical Disabilities: An Exploratory Cross-Sectional Study in Riyadh, Saudi Arabia

PubMed Central

AlQahtani, Sakher; Zakaria Murshid, Ebtissam; Kassim, Saba

2017-01-01

Background: Provision of oral healthcare to adults with mental and physical disabilities (AMPD) remains a challenging area across various healthcare systems. The present study aimed to assess self-reported efficacy and investigate factors associated with self-efficacy in the management of AMPD among practicing dentists in Saudi Arabia. Methods: A pilot-tested, self-administered questionnaire was distributed to a convenience sample of 1000 dentists. Descriptive and inferential analyses were performed on the collected responses. Results: Among the respondents (54%), 43% were males. Only 14% described their self-efficacy in managing AMPD as “High”. Multivariable regression analyses revealed significant associations between “High” self-efficacy and male gender (Odd ratio (OR) = 2.39, 95% CI = 1.16–4.89), experience practicing dentistry for 11 years or more (OR = 2.19, 95% CI = 1.04–4.47), specialization in pediatric dentistry (OR = 3.98, 95% CI = 1.31–12.07), previous experience in managing AMPD (OR = 4.23, 95% CI = 1.59–11.22), and awareness of regulations for managing AMPD (OR = 2.62, 95% CI = 1.42–4.38). The interaction of gender x age was significantly associated (p = 0.028) with “High” self-efficacy. Gender-stratified analyses revealed a significant association between age and “High” self-efficacy among male dentists only. Conclusions: The findings of the present study highlight that a large percentage of dentists reported “Low/Moderate” self-efficacy in managing AMPD, particularly among female dentists. However, further studies are required to verify the factors associated with self-efficacy in the present study, and to identify other factors that may influence self-efficacy in managing AMPD. PMID:29232884

Practicing Dentists' Self-Efficacy and Associated Factors in Managing the Treatment of Adults with Mental and Physical Disabilities: An Exploratory Cross-Sectional Study in Riyadh, Saudi Arabia.

PubMed

AlQahtani, Sakher; Murshid, Ebtissam Zakaria; Fadel, Hani Talal; Kassim, Saba

2017-12-11

Background: Provision of oral healthcare to adults with mental and physical disabilities (AMPD) remains a challenging area across various healthcare systems. The present study aimed to assess self-reported efficacy and investigate factors associated with self-efficacy in the management of AMPD among practicing dentists in Saudi Arabia. Methods: A pilot-tested, self-administered questionnaire was distributed to a convenience sample of 1000 dentists. Descriptive and inferential analyses were performed on the collected responses. Results: Among the respondents (54%), 43% were males. Only 14% described their self-efficacy in managing AMPD as "High". Multivariable regression analyses revealed significant associations between "High" self-efficacy and male gender (Odd ratio (OR) = 2.39, 95% CI = 1.16-4.89), experience practicing dentistry for 11 years or more (OR = 2.19, 95% CI = 1.04-4.47), specialization in pediatric dentistry (OR = 3.98, 95% CI = 1.31-12.07), previous experience in managing AMPD (OR = 4.23, 95% CI = 1.59-11.22), and awareness of regulations for managing AMPD (OR = 2.62, 95% CI = 1.42-4.38). The interaction of gender x age was significantly associated ( p = 0.028) with "High" self-efficacy. Gender-stratified analyses revealed a significant association between age and "High" self-efficacy among male dentists only. Conclusions: The findings of the present study highlight that a large percentage of dentists reported "Low/Moderate" self-efficacy in managing AMPD, particularly among female dentists. However, further studies are required to verify the factors associated with self-efficacy in the present study, and to identify other factors that may influence self-efficacy in managing AMPD.

Pilot Evaluation of a Sexual Abuse Prevention Program for Taiwanese Children

ERIC Educational Resources Information Center

Chen, Yi-Chuen; Fortson, Beverly L.; Tseng, Kai-Wen

2012-01-01

The purpose of the current study was to develop and evaluate the efficacy of a school-based child sexual abuse prevention program for Taiwanese children. Forty-six Taiwanese children age 6 to 13 were divided into one of two groups based on their school grade and then randomly assigned to a skills-based child sexual abuse prevention program who…

[Enhancing development of children at risk and their parents by video counselling according to the Marte Meo method].

PubMed

Bünder, Peter

2011-01-01

Marte Meo is a low-intensity programme of counselling parents and other persons significantly involved with children which aims to foster parenting capacity and facilitate child development. The article describes a preliminary pilot study with the aim of identifying variables for the future evaluation of efficacy and effectiveness of the Marte Meo method.

Fun with Foodella: A Pilot Study for Determining the Efficacy of a 2nd Grade Nutrition and Physical Activity Curriculum

ERIC Educational Resources Information Center

Winter, Elizabeth M.; Stluka, Suzanne; Wells, Karlys; Wey, Howard; Kemmer, Teresa M.

2012-01-01

Fun with Foodella is a nutrition and physical activity workbook designed for elementary-aged youth. The objective was to determine if the Fun with Foodella program increased participant preference for fruit, vegetables, low-fat dairy products, and physical activity. Four intervention (53 students) and four control (68 students) schools…

A Pilot Evaluation of Small Group Challenging Horizons Program (CHP): A Randomized Trial

ERIC Educational Resources Information Center

Langberg, Joshua M.; Smith, Bradley H.; Bogle, Kristin E.; Schmidt, Jonathan D.; Cole, Wesley R.; Pender, Carolyn A. S.

2007-01-01

This study examined the efficacy of an after-school program, the Challenging Horizons Program (CHP), that met four days a week and focused on improving organization, academic skills, and classroom behavior. The CHP was compared with a community control that included involvement in a district-run after-school program that met one to three days a…

Brief Report: Pilot Randomized Controlled Trial of Reciprocal Imitation Training for Teaching Elicited and Spontaneous Imitation to Children with Autism

ERIC Educational Resources Information Center

Ingersoll, Brooke

2010-01-01

Children with autism exhibit significant deficits in imitation skills. Reciprocal Imitation Training (RIT), a naturalistic imitation intervention, was developed to teach young children with autism to imitate during play. This study used a randomized controlled trial to evaluate the efficacy of RIT on elicited and spontaneous imitation skills in 21…

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

ERIC Educational Resources Information Center

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

2011-01-01

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

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…

Effects of Age, Experience, and Instruction on Elementary Music Teacher Movement Self-Efficacy: A Pilot Study

ERIC Educational Resources Information Center

Fisher, Ryan; Rose, Paige

2011-01-01

As one of the recognized media of the Orff-Schulwerk method of music instruction, movement is fundamental to music specialists' teaching. It can embody the mantra of "sound before sign," and provide the means by which students experience the kinesthetic learning that is so natural to their musical development. Because there are multiple…

Multisyllabic Word-Reading Instruction with and without Motivational Beliefs Training for Struggling Readers in the Upper Elementary Grades: A Pilot Investigation

ERIC Educational Resources Information Center

Toste, Jessica R.; Capin, Philip; Vaughn, Sharon

2017-01-01

This randomized controlled trial focused on 59 struggling readers in the third and fourth grades (30 female, 29 male) and examined the efficacy of an intervention aimed at increasing students' multisyllabic word reading (MWR). The study also explored the relative effects of an embedded motivational beliefs (MB) training component. Struggling…

Lateral hypothalamic area deep brain stimulation for refractory obesity: a pilot study with preliminary data on safety, body weight, and energy metabolism

PubMed Central

Whiting, Donald M.; Tomycz, Nestor D.; Bailes, Julian; De Jonge, Lilian; Lecoultre, Virgile; Wilent, Bryan; Alcindor, Dunbar; Prostko, E. Richard; Cheng, Boyle C.; Angle, Cynthia; Cantella, Diane; Whiting, Benjamin B.; Mizes, J. Scott; Finnis, Kirk W.; Ravussin, Eric; Oh, Michael Y.

2017-01-01

Object Deep brain stimulation (DBS) of the lateral hypothalamic area (LHA) has been suggested as a potential treatment for intractable obesity. The authors present the 2-year safety results as well as early efficacy and metabolic effects in 3 patients undergoing bilateral LHA DBS in the first study of this approach in humans. Methods Three patients meeting strict criteria for intractable obesity, including failed bariatric surgery, under-went bilateral implantation of LHA DBS electrodes as part of an institutional review board– and FDA-approved pilot study. The primary focus of the study was safety; however, the authors also received approval to collect data on early efficacy including weight change and energy metabolism. Results No serious adverse effects, including detrimental psychological consequences, were observed with continuous LHA DBS after a mean follow-up of 35 months (range 30–39 months). Three-dimensional nonlinear transformation of postoperative imaging superimposed onto brain atlas anatomy was used to confirm and study DBS contact proximity to the LHA. No significant weight loss trends were seen when DBS was programmed using standard settings derived from movement disorder DBS surgery. However, promising weight loss trends have been observed when monopolar DBS stimulation has been applied via specific contacts found to increase the resting metabolic rate measured in a respiratory chamber. Conclusions Deep brain stimulation of the LHA may be applied safely to humans with intractable obesity. Early evidence for some weight loss under metabolically optimized settings provides the first “proof of principle” for this novel antiobesity strategy. A larger follow-up study focused on efficacy along with a more rigorous metabolic analysis is planned to further explore the benefits and therapeutic mechanism behind this investigational therapy. PMID:23560573

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.

Minocycline in leprosy patients with recent onset clinical nerve function impairment.

PubMed

Narang, Tarun; Arshdeep; Dogra, Sunil

2017-01-01

Nerve function impairment (NFI) in leprosy may occur and progress despite multidrug therapy alone or in combination with corticosteroids. We observed improvement in neuritis when minocycline was administered in patients with type 2 lepra reaction. This prompted us to investigate the role of minocycline in recent onset NFI, especially in corticosteroid unresponsive leprosy patients. Leprosy patients with recent onset clinical NFI (<6 months), as determined by Monofilament Test (MFT) and Voluntary Muscle Test (VMT), were recruited. Minocycline 100mg/day was given for 3 months to these patients. The primary outcome was the proportion of patients with 'restored,' 'improved,' 'stabilized,' or 'deteriorated' NFI. Secondary outcomes included any improvement in nerve tenderness and pain. In this pilot study, 11 patients were recruited. The progression of NFI was halted in all; with 9 out of 11 patients (81.82%) showing ?restored? or ?improved? sensory or motor nerve functions, on assessment with MFT and VMT. No serious adverse effects due to minocycline were observed. Our pilot study demonstrates the efficacy and safety of minocycline in recent onset NFI in leprosy patients. However, larger and long term comparative trials are needed to validate the efficacy of minocycline in leprosy neuropathy. © 2016 Wiley Periodicals, Inc.

Using Facebook in a Healthy Lifestyle Intervention: Feasibility and Preliminary Efficacy.

PubMed

Ling, Jiying; Robbins, Lorraine B; Zhang, Nanhua; Kerver, Jean M; Lyons, Haley; Wieber, Nicole; Zhang, Mi

2018-02-01

The purpose of this pilot quasi-experimental study was to examine the feasibility and preliminary efficacy of using Facebook in a 10-week lifestyle intervention with Head Start caregiver-preschooler dyads to improve healthy behaviors and reduce body mass index. Sixty-nine dyads participated with 39 in the intervention group. Average preschooler attendance rate for the Head Start center-based program was 77%, and caregiver participation rate was 87%. About 94% of the caregivers were satisfied with the program, and 97% would recommend the program to others and/or participate again. The intervention decreased preschoolers' body mass index z score (Cohen's d = -.30) and screen time ( d = -.21), and increased their fruit and vegetable intake ( d = .40) and moderate-to-vigorous physical activity ( d = .42). The intervention increased caregivers' fruit and vegetable intake ( d = .40). The intervention is feasible, and preliminary efficacy is encouraging, but further investigation using a rigorous study design is warranted.

Pilot of the Chronic Disease Self-Management Program (CDSMP) for Adolescents and Young Adults with Sickle Cell Disease

PubMed Central

Crosby, Lori E.; Joffe, Naomi E.; Peugh, James; Ware, Russell E.; Britto, Maria T.

2016-01-01

Purpose This study evaluated the feasibility of a group self-management intervention, the well-established Stanford Chronic Disease Self-Management Program (CDSMP), for adolescents and young adults (AYA) with sickle cell disease (SCD). Methods A total of 22 AYA participants with SCD, ages 16 to 24 years, completed self-efficacy and quality of life (HRQOL) measures before the CDSMP, after, and 3 and 6 months later. Results This AYA cohort showed significant improvements in self-efficacy (primary outcome) after the intervention. Analyses of follow-up data revealed a medium effect of the CDSMP on patient activation 3 months post although this was not sustained. Participants were highly satisfied, but only 64% completed the program. Conclusions This study demonstrates that the CDSMP is acceptable, and has the ability to improve self-efficacy. Additional research is needed to determine feasibility and evaluate health outcomes for AYA with SCD. PMID:27793727

Once-daily, oral levofloxacin monotherapy for low-risk neutropenic fever in cancer patients: a pilot study in China

PubMed Central

He, Lixian; Zhao, Su; Weng, Heng; Yang, Guowang

2015-01-01

This pilot study assesses the safety and efficacy of once-daily, oral levofloxacin monotherapy in Chinese patients with low-risk febrile neutropenia. In this prospective, single-arm, open-label, multicenter clinical trial, 46 adult Chinese patients with solid tumors and low-risk febrile neutropenia were included. Patients received oral levofloxacin monotherapy (500 mg orally/day) until day 12, followed by 7 days of follow-up (day 19). Body temperature was measured three times per day. On days 2, 3, 5–7, 9, 12, and 19, disease symptoms and vital signs were recorded, adverse drug reactions were assessed, and blood samples were collected to determine the whole-blood cell count and the absolute neutrophil count. Blood cultures and chest radiographs were performed simultaneously until negative results were found. Oral levofloxacin was effective and well tolerated in 97.6% of patients irrespective of the cancer type and cause of fever. Body temperature began to decline in 24.4, 68.3, and 90.2% of patients, respectively, at 12, 24, and 48 h after initiating levofloxacin therapy. On days 5 and 7, 95.1 and 97.6% of the patients had complete defervescence, respectively. The median time for absolute neutrophil count recovery to at least 1500/mm3 after initiation of treatment was 3 days. Only one patient reported mild diarrhea. This pilot study showed that oral levofloxacin quickly and effectively reduced fever, initiated neutrophil recovery, and was well tolerated in Chinese low-risk febrile neutropenic patients with solid tumors. Further study is needed to compare patient data of levofloxacin with the standard amoxicillin/ciprofloxacin protocol in this population for both safety and efficacy. PMID:25486597

Using brothel leadership to promote condom use among brothel-based female sex workers in Abuja, Nigeria: study protocol for a cluster randomized pilot trial.

PubMed

Okafor, Uchenna; Crutzen, Rik; Okekearu, Ifeanyi; Adebajo, Sylvia; Uzoh, Adaora; Awo, Egbe Aneotah; Chima, Chukwuemeka; Agwagwa, Ogechukwu; van den Borne, Bart

2017-01-01

The HIV prevalence among female populations involved in sex work in Nigeria has heightened interest in HIV prevention programming for this sub-population with brothel-based female sex workers (BB FSWs) having a prevalence of 27.4%, six times higher than the prevalence in the general population. The clusters in the randomized pilot trial will be brothels and female sex workers (FSWs) residing in the brothels will be the participants of the study. The participants will receive free condom distribution as well as HIV prevention messages on condom use and negotiation skills to increase self-efficacy in handling social and gender power plays within their environment. Twelve brothels will be randomized into experimental and control conditions with a minimum total sample size of 200 participants. Recruitment of participants will be carried out from within the brothels. The control condition will receive a standard intervention consisting of a minimum of six interactive sessions with peer educators (PE) engaging their peers through group discussions and one on one interaction using pre-designed HIV prevention messages. The experimental condition will receive the standard intervention as well as interactive sessions with the brothel leadership (chairladies and brothel managers) to facilitate consistent condom use and appropriate condom use policies, conditions, and messaging. Both interventions will be delivered over a maximum period of 16 weeks, and male and female condoms will be distributed during the intervention. Quantitative assessments will be carried out at baseline and at 16 weeks follow-up, and the pilot findings will inform feasibility of and sample size estimation for a phase III trial. The primary outcomes measured are recruitment rate attrition rate and adherence to the intervention. Consistent condom use outcomes by FSWs within the brothel with all partner types and enhanced self-efficacy for condom negotiation with all partner types will be the primary outcomes for the main study, and the feasibility of their measurement will be determined in this pilot trial. The manuscript describes the protocol for a pilot study to determine the feasibility of a behavioral intervention to improve consistent condom use among BB FSWs. The results of this pilot will inform a larger intervention for HIV prevention for this target group in Nigeria. The Institutional Review Board (IRB) of the Institute of Human Virology, Nigeria; Protocol Number NHREC/10/15/2014a-026.

Development of a questionnaire for assessing factors predicting blood donation among university students: a pilot study.

PubMed

Jalalian, Mehrdad; Latiff, Latiffah; Hassan, Syed Tajuddin Syed; Hanachi, Parichehr; Othman, Mohamed

2010-05-01

University students are a target group for blood donor programs. To develop a blood donation culture among university students, it is important to identify factors used to predict their intent to donate blood. This study attempted to develop a valid and reliable measurement tool to be employed in assessing variables in a blood donation behavior model based on the Theory of Planned Behavior (TPB), a commonly used theoretical foundation for social psychology studies. We employed an elicitation study, in which we determined the commonly held behavioral and normative beliefs about blood donation. We used the results of the elicitation study and a standard format for creating questionnaire items for all constructs of the TPB model to prepare the first draft of the measurement tool. After piloting the questionnaire, we prepared the final draft of the questionnaire to be used in our main study. Examination of internal consistency using Chronbach's alpha coefficient and item-total statistics indicated the constructs "Intention" and "Self efficacy" had the highest reliability. Removing one item from each of the constructs, "Attitude," "Subjective norm," "Self efficacy," or "Behavioral beliefs", can considerably increase the reliability of the measurement tool, however, such action is controversial, especially for the variables "attitude" and "subjective norm." We consider all the items of our first draft questionnaire in our main study to make it a reliable measurement tool.

Building youths' resilience within a psychiatric outpatient setting: results from a pilot clinical intervention project.

PubMed

Waaktaar, Trine; Christie, Helen J; Borge, Anne Inger Helmen; Torgersen, Svenn

2004-02-01

The relevance of resilience research for clinical practice has not yet been established. In this intervention pilot study, the aim was to explore how group work based on enhancing the participants' creativity, self-efficacy, active coping, and sense of continuity could be utilized within a clinical context for adolescents with stressful background experiences. 31 participants and 24 parents completed pre-, post-, and 1-yr. follow-up assessments of the youths' behavior difficulties, as well as depression, positive life attitude, coping, and prosocial behavior. Apart from a drop in self-rated prosocial behavior, no significant treatment effects were found. Implications for clinical practice and research are indicated.

Head-to-Head Comparison of Aripiprazole and Risperidone in the Treatment of ADHD Symptoms in Children with Autistic Spectrum Disorder and ADHD: A Pilot, Open-Label, Randomized Controlled Study.

PubMed

Lamberti, Marco; Siracusano, Rosamaria; Italiano, Domenico; Alosi, Norma; Cucinotta, Francesca; Di Rosa, Gabriella; Germanò, Eva; Spina, Edoardo; Gagliano, Antonella

2016-08-01

Autism spectrum disorder (ASD) and attention-deficit/hyperactivity disorder (ADHD) are frequently overlapping neurodevelopmental disorders. Individuals in whom the disorders are comorbid show more severe impairment because of deficits in the processing of social situations, adaptive functioning, and executive control than individuals with either disorder alone. This open-label pilot study aimed to evaluate and compare the efficacy and tolerability of risperidone and aripiprazole for treating ADHD symptoms in patients with both ASD and ADHD over the course of 24 weeks of treatment. Patients (n = 44) were randomly assigned to start treatment with risperidone (22 patients) or aripiprazole (22 patients). Children were evaluated before starting treatment (T0), and after 12 weeks (T1) and 24 weeks (T2) of treatment. At each visit, specific psychiatric clinical scales were administered to assess the efficacy of the two drugs. The mean age was 8.4 ± 2.9 years in the aripiprazole group and 7.8 ± 2.3 years in the risperidone group. A total of 37 children (29 boys and 8 girls) completed the study (18 in the aripiprazole group and 19 in the risperidone group). Aripiprazole and risperidone appeared to have similar benefits in terms of efficacy and tolerability, although there were slight differences between the two drugs. Both groups showed a significant improvement in ADHD symptoms after 24 weeks of treatment (ADHD Rating Scale, Conners Parent Rating Scale-Hyperactivity, and Clinical Global Improvement-Severity Scale). No significant difference between the two drugs on any parameters at 24 weeks were found. Prolactin levels were decreased in the aripiprazole group. Both drugs were well tolerated, with no serious adverse events detected. Our study confirms the efficacy of both aripiprazole and risperidone in ameliorating ADHD symptoms of children also presenting with ASD.

Mobile and traditional cognitive behavioral therapy programs for generalized anxiety disorder: A cost-effectiveness analysis

PubMed Central

2018-01-01

Background Generalized anxiety disorder (GAD) is a debilitating mental health illness that affects approximately 3.1% of U.S. adults and can be treated with cognitive behavioral therapy (CBT). With the emergence of digital health technologies, mobile CBT may be a cost-effective way to deliver care. We developed an analysis framework to quantify the cost-effectiveness of internet-based CBT for individuals with GAD. As a case study, we examined the potential value of a new mobile-delivered CBT program for GAD. Methods We developed a Markov model of GAD health states combined with a detailed economic analysis for a cohort of adults with GAD in the U.S. In our case study, we used pilot program efficacy data to evaluate a mobile CBT program as either prevention or treatment only and compared the strategies to traditional CBT and no CBT. Traditional CBT efficacy was estimated from clinical trial results. We calculated discounted incremental costs and quality-adjusted life-years (QALYs) over the cohort lifetime. Case study results In the base case, for a cohort of 100,000 persons with GAD, we found that mobile CBT is cost-saving. It leads to a gain of 34,108 QALYs and 81,492 QALYs and a cost reduction of $2.23 billion and $4.54 billion when compared to traditional CBT and no CBT respectively. Results were insensitive to most model inputs and mobile CBT remained cost-saving in almost all scenarios. Limitations The case study was conducted for illustrative purposes and used mobile CBT efficacy data from a small pilot program; the analysis should be re-conducted once robust efficacy data is available. The model was limited in its ability to measure the effectiveness of CBT in combination with pharmacotherapy. Conclusions Mobile CBT may lead to improved health outcomes at lower costs than traditional CBT or no intervention and may be effective as either prevention or treatment. PMID:29300754

Systematic cultural adaptation of cognitive-behavioral therapy to reduce alcohol use among HIV-infected outpatients in western Kenya

PubMed Central

Sidle, John E.; Martino, Steve; Baliddawa, Joyce B.; Songole, Rogers; Omolo, Otieno E.; Gakinya, Benson N.; Mwaniki, Michael M.; Adina, Japheth O.; Nafula, Tobista; Owino-Ong’or, Willis D.; Bryant, Kendall J.; Carroll, Kathleen M.; Goulet, Joseph L.; Justice, Amy C.; Maisto, Stephen A.

2010-01-01

Two-thirds of those with HIV worldwide live in sub-Saharan Africa. Alcohol use is associated with the HIV epidemic through risky sex and suboptimal ARV adherence. In western Kenya, hazardous drinking was reported by HIV (53%) and general medicine (68%) outpatients. Cognitive behavioral treatment (CBT) has demonstrated strong efficacy to reduce alcohol use. This article reports on a systematic cultural adaptation and pilot feasibility study of group paraprofessional-delivered CBT to reduce alcohol use among HIV-infected outpatients in Eldoret, Kenya. Following adaptation and counselor training, five pilot groups were run (n=27). Overall attendance was 77%. Percent days abstinent from alcohol (PDA) before session 1 was 52%–100% (women) and 21–36% (men), and by session 6 was 96%–100% (women) and 89%–100% (men). PDA effect sizes (Cohen’s d) between first and last CBT session were 2.32 (women) and 2.64 (men). Participants reported treatment satisfaction. Results indicate feasibility, acceptability and preliminary efficacy for CBT in Kenya. PMID:19967441

Utilization of 3-month yoga program for adults at high risk for type 2 diabetes: a pilot study.

PubMed

Yang, Kyeongra; Bernardo, Lisa M; Sereika, Susan M; Conroy, Molly B; Balk, Judy; Burke, Lora E

2011-01-01

Various modes of physical activity, combined with dieting, have been widely recommended to prevent or delay type 2 diabetes. Among these, yoga holds promise for reducing risk factors for type 2 diabetes by promoting weight loss, improving glucose levels and reducing blood pressure and lipid levels. This pilot study aimed to assess the feasibility of implementing a 12-week yoga program among adults at high risk for type 2 diabetes. Twenty-three adults (19 Whites and 4 non-Whites) were randomly assigned to the yoga intervention group or the educational group. The yoga group participated in a 3-month yoga intervention with sessions twice per week and the educational group received general health educational materials every 2 weeks. All participants completed questionnaires and had blood tests at baseline and at the end of 3 months. Effect sizes were reported to summarize the efficacy of the intervention. All participants assigned to the yoga intervention completed the yoga program without complication and expressed high satisfaction with the program (99.2%). Their yoga session attendance ranged from 58.3 to 100%. Compared with the education group, the yoga group experienced improvements in weight, blood pressure, insulin, triglycerides and exercise self-efficacy indicated by small to large effect sizes. This preliminary study indicates that a yoga program would be a possible risk reduction option for adults at high risk for type 2 diabetes. In addition, yoga holds promise as an approach to reducing cardiometabolic risk factors and increasing exercise self-efficacy for this group.

Effect of lyophilized lactobacilli and 0.03 mg estriol (Gynoflor®) on vaginitis and vaginosis with disrupted vaginal microflora: a multicenter, randomized, single-blind, active-controlled pilot study.

PubMed

Donders, G G G; Van Bulck, B; Van de Walle, P; Kaiser, R R; Pohlig, G; Gonser, S; Graf, F

2010-01-01

To evaluate the efficacy of lyophilized lactobacilli in combination with 0.03 mg estriol when compared to metronidazole in the treatment of bacterial vaginal infections. Multicenter, randomized, single-blind, active-controlled pilot study in 3 independent gynecological practices in Belgium. Forty-six, 18- to 50-year-old premenopausal women with a disrupted vaginal flora due to a bacterial vaginal infection (bacterial vaginosis, aerobic vaginitis) were included, provided that fresh phase-contrast microscopy of the vaginal fluid showed lactobacillary flora grade 2B or 3. Patients were given a blinded box with either 12 vaginal tablets of Gynoflor® (study medication) or 6 vaginal suppositories containing 500 mg metronidazole (control medication). Eight efficacy variables were studied to assess the status of the vaginal flora at entry, 3-7 days (control 1), 4-6 (control 2) weeks and 4 months after the end of therapy. At control 1, the combined variables equally improved in the lactobacilli group as in the metronidazole group. At control 2, the lactobacillus preparation showed slightly inferior results when compared to metronidazole. At 4 months, this analysis could not be performed due to low numbers, but analysis of recurrence rate and extra medication needed was not different between both groups. Lyophilized lactobacilli in combination with low-dose estriol are equivalent to metronidazole in the short-term treatment of bacterial vaginal infections, but have less effect after 1 month. Further studies are required to evaluate the long-term efficacy of lactobacilli when applied repeatedly. Copyright © 2010 S. Karger AG, Basel.

Using Robotics and Game Design to Enhance Children's Self-Efficacy, STEM Attitudes, and Computational Thinking Skills

NASA Astrophysics Data System (ADS)

Leonard, Jacqueline; Buss, Alan; Gamboa, Ruben; Mitchell, Monica; Fashola, Olatokunbo S.; Hubert, Tarcia; Almughyirah, Sultan

2016-12-01

This paper describes the findings of a pilot study that used robotics and game design to develop middle school students' computational thinking strategies. One hundred and twenty-four students engaged in LEGO® EV3 robotics and created games using Scalable Game Design software. The results of the study revealed students' pre-post self-efficacy scores on the construct of computer use declined significantly, while the constructs of videogaming and computer gaming remained unchanged. When these constructs were analyzed by type of learning environment, self-efficacy on videogaming increased significantly in the combined robotics/gaming environment compared with the gaming-only context. Student attitudes toward STEM, however, did not change significantly as a result of the study. Finally, children's computational thinking (CT) strategies varied by method of instruction as students who participated in holistic game development (i.e., Project First) had higher CT ratings. This study contributes to the STEM education literature on the use of robotics and game design to influence self-efficacy in technology and CT, while informing the research team about the adaptations needed to ensure project fidelity during the remaining years of the study.

A Pilot Randomized Controlled Trial of the ACCESS Program: A Group Intervention to Improve Social, Adaptive Functioning, Stress Coping, and Self-Determination Outcomes in Young Adults with Autism Spectrum Disorder

ERIC Educational Resources Information Center

Oswald, Tasha M.; Winder-Patel, Breanna; Ruder, Steven; Xing, Guibo; Stahmer, Aubyn; Solomon, Marjorie

2018-01-01

The purpose of this pilot randomized controlled trial was to investigate the acceptability and efficacy of the Acquiring Career, Coping, Executive control, Social Skills (ACCESS) Program, a group intervention tailored for young adults with autism spectrum disorder (ASD) to enhance critical skills and beliefs that promote adult functioning,…

Efficacy and Safety of Ashwagandha (Withania somnifera) Root Extract in Improving Sexual Function in Women: A Pilot Study.

PubMed

Dongre, Swati; Langade, Deepak; Bhattacharyya, Sauvik

2015-01-01

Many women experience sexual dysfunction where there are orgasm disorders and sexual difficulties. Ashwagandha (Withania somnifera) is a herb known to improve the body's physical and psychological condition. The purpose of the study was to determine the efficacy and safety of a high-concentration ashwagandha root extract (HCARE) supplementation for improving sexual function in healthy females. In this pilot study, 50 study subjects were randomized to either (i) HCARE-treated group or (ii) placebo- (starch-) treated group. The subjects consumed either HCARE or placebo capsules of 300mg twice daily for 8 weeks. Sexual function was assessed using two psychometric scales, the Female Sexual Function Index (FSFI) Questionnaire and the Female Sexual Distress Scale (FSDS), and by the number of total and successful sexual encounters. The analysis indicates that treatment with HCARE leads to significantly higher improvement, relative to placebo, in the FSFI Total score (p < 0.001), FSFI domain score for "arousal" (p < 0.001), "lubrication" (p < 0.001), "orgasm" (p = 0.004), and "satisfaction" (p < 0.001), and also FSDS score (p < 0.001) and the number of successful sexual encounters (p < 0.001) at the end of the treatment. This study demonstrated that oral administration of HCARE may improve sexual function in healthy women. The present study is registered in the Clinical Trial Registry, Government of India, with a number CTRI/2015/07/006045.

Comparing systemic therapy and cognitive behavioral therapy for social anxiety disorders: study protocol for a randomized controlled pilot trial.

PubMed

Hunger, Christina; Hilzinger, Rebecca; Koch, Theresa; Mander, Johannes; Sander, Anja; Bents, Hinrich; Schweitzer, Jochen

2016-03-31

Social anxiety disorders are among the most prevalent anxiety disorders in the general population. The efficacy of cognitive behavioral therapy (CBT) for social anxiety disorders is well demonstrated. However, only three studies point to the efficacy of systemic therapy (ST) in anxiety disorders, and only two of them especially focus on social anxiety disorders. These ST studies either do not use a good comparator but minimal supportive therapy, they do not use a multi-person ST but a combined therapy, or they do not especially focus on social anxiety disorders but mood and anxiety disorders in general. Though ST was approved as evidence based in Germany for a variety of disorders in 2008, evidence did not include anxiety disorders. This is the first pilot study that will investigate multi-person ST, integrating a broad range of systemic methods, specifically for social anxiety disorders and that will compare ST to the "gold standard" CBT. This article describes the rationale and protocol of a prospective, open, interventive, balanced, bi-centric, pilot randomized controlled trial (RCT). A total of 32 patients with a primary SCID diagnosis of social anxiety disorder will be randomized to either CBT or ST. Both treatments will be manualized. The primary outcome will include social anxiety symptoms at the end of therapy. Therapy will be restricted to no more than 26 hours (primary endpoint). Secondary outcomes will include psychological, social systems and interpersonal functioning, symptom adjustment, and caregiver burden, in addition to change measures, therapist variables and treatment adherence. At the secondary endpoints, 9 and 12 months after the beginning of therapy, we will again assess all outcomes. The study is expected to pilot test a RCT which will be the first to directly compare CBT and multi-person ST, integrating a broad range of systemic methods, for social anxiety disorders, and it will provide empirical evidence for the calculation of the number of patients needed for a confirmatory RCT. ClinicalTrials.gov: NCT02360033 ; date of registration: 21 January 2015.

An empowerment-based diabetes self-management education program for Hispanic/Latinos: a quasi-experimental pilot study.

PubMed

Peña-Purcell, Ninfa C; Boggess, May M; Jimenez, Natalia

2011-01-01

The purpose of this pilot study was to evaluate the effects of a culturally sensitive, empowerment-based diabetes self-management education program for Spanish-speaking Hispanic/Latinos. A prospective quasi-experimental repeated measures design tested the effectiveness of the ¡Si, Yo Puedo Controlar Mi Diabetes! diabetes self-management education program. In sum, 144 persons residing in 2 Texas counties at the Texas-Mexico border (Starr and Hidalgo) served as participants. Two groups were formed, an intervention and a control (wait list). Clinical (A1C), cognitive, attitudinal, behavioral, and cultural assessments were collected at baseline and 3 months. Demographic characteristics for the intervention and control groups were similar. Both groups were predominately female, low income, older than 40 years, and minimally acculturated. Baseline and posttest findings showed that the intervention group had a significant reduction in A1C values; median difference was 0.3 (n = 45), especially for those with higher baseline values. Participants in the intervention group also improved in their self-efficacy and self-care scores. Findings from the study suggest that additional dissemination of a diabetes self-management education program for Spanish-speaking Hispanic/Latinos is warranted to improve clinical outcomes and associated diabetes self-efficacy and self-care behaviors.

A pilot study: the efficacy of virgin coconut oil as ocular rewetting agent on rabbit eyes.

PubMed

Mutalib, Haliza Abdul; Kaur, Sharanjeet; Ghazali, Ahmad Rohi; Chinn Hooi, Ng; Safie, Nor Hasanah

2015-01-01

Purpose. An open-label pilot study of virgin coconut oil (VCO) was conducted to determine the safety of the agent as ocular rewetting eye drops on rabbits. Methods. Efficacy of the VCO was assessed by measuring NIBUT, anterior eye assessment, corneal staining, pH, and Schirmer value before instillation and at 30 min, 60 min, and two weeks after instillation. Friedman test was used to analyse any changes in all the measurable variables over the period of time. Results. Only conjunctival redness with instillation of saline agent showed significant difference over the period of time (P < 0.05). However, further statistical analysis had shown no significant difference at 30 min, 60 min, and two weeks compared to initial measurement (P > 0.05). There were no changes in the NIBUT, limbal redness, palpebral conjunctiva redness, corneal staining, pH, and Schirmer value over the period of time for each agent (P > 0.05). Conclusion. VCO acts as safe rewetting eye drops as it has shown no significant difference in the measurable parameter compared to commercial brand eye drops and saline. These study data suggest that VCO is safe to be used as ocular rewetting agent on human being.

Intracapsular tonsillectomy for keratosis pharyngeous: A pilot study of postoperative recovery and surgical efficacy.

PubMed

Gaudreau, Philip A; Gessler, Eric M

2017-09-01

Our objective was to perform a pilot study comparing intracapsular radiofrequency ablation tonsillectomy with subcapsular tonsillectomy in adult patients with keratosis pharyngeous. Patients diagnosed with keratosis pharyngeous between December 2010 and February 2013 were randomized to undergo either intracapsular or subcapsular tonsillectomy using radiofrequency ablation. Postoperative pain scores and amount of pain medication taken were recorded for 2 weeks. A 6-month follow-up questionnaire was used to assess efficacy of the procedure. Twenty-two patients completed the initial 2-week questionnaire. Eighteen completed the 6-month follow-up questionnaire. The amount of pain medication consumed on postoperative days 8 (p = 0.0293), 9 (p = 0.0146), and 10 (p = 0.035) was significantly less in the intracapsular group. Risk of recurrence of tonsilloliths was significantly greater at the 6-month follow-up in the intracapsular cohort (p = 0.0291). Based on these findings, in patients undergoing tonsillectomy for keratosis pharyngeous, intracapsular radiofrequency ablation tonsillectomy may result in decreased pain medication consumption compared with subcapsular tonsillectomy. Intracapsular tonsillectomy, however, resulted in a higher rate of recurrence of tonsilloliths. The benefit of decreased pain medication may be offset by the greater likelihood for symptoms to recur. Larger studies are needed to confirm these findings.

A Pilot Study: The Efficacy of Virgin Coconut Oil as Ocular Rewetting Agent on Rabbit Eyes

PubMed Central

Mutalib, Haliza Abdul; Kaur, Sharanjeet; Ghazali, Ahmad Rohi; Chinn Hooi, Ng; Safie, Nor Hasanah

2015-01-01

Purpose. An open-label pilot study of virgin coconut oil (VCO) was conducted to determine the safety of the agent as ocular rewetting eye drops on rabbits. Methods. Efficacy of the VCO was assessed by measuring NIBUT, anterior eye assessment, corneal staining, pH, and Schirmer value before instillation and at 30 min, 60 min, and two weeks after instillation. Friedman test was used to analyse any changes in all the measurable variables over the period of time. Results. Only conjunctival redness with instillation of saline agent showed significant difference over the period of time (P < 0.05). However, further statistical analysis had shown no significant difference at 30 min, 60 min, and two weeks compared to initial measurement (P > 0.05). There were no changes in the NIBUT, limbal redness, palpebral conjunctiva redness, corneal staining, pH, and Schirmer value over the period of time for each agent (P > 0.05). Conclusion. VCO acts as safe rewetting eye drops as it has shown no significant difference in the measurable parameter compared to commercial brand eye drops and saline. These study data suggest that VCO is safe to be used as ocular rewetting agent on human being. PMID:25802534

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.

Determining the effectiveness of an Elder Abuse Nurse Examiner Curriculum: A pilot study.

PubMed

Du Mont, Janice; Kosa, Daisy; Yang, Rebecca; Solomon, Shirley; Macdonald, Sheila

2017-08-01

To pilot and evaluate a novel Elder Abuse Nurse Examiner Curriculum and its associated training materials for their efficacy in improving Sexual Assault Nurse Examiner (SANE)s' knowledge of elder abuse and competence in delivering care to abused older adults. Pilot training was held with 18 SANEs from across Ontario, Canada. A 52-item pre- and post-training questionnaire was administered that assessed participants' self-reported knowledge and perceived skills-based competence related to elder abuse care. A curriculum training evaluation survey was also delivered following the training. Qualitative non-participant observational data were collected throughout the training. There were statistically significant improvements in self-reported knowledge and perceived skills-based competence from pre-training to post-training for all content domains of the curriculum: older adults and abuse (p<0.0001), documentation, legislative, and legal issues (p<0.0001); interview with the older adult, caregiver, and other relevant contacts (p<0.0001); assessment (p=0.0018); medical and forensic examination (p<0.0001); case summary, discharge plan, and follow-up care (p<0.0001). The post-training evaluation survey demonstrated satisfaction among participants across all components of the curriculum and its delivery, particularly with reference to the comprehensiveness of the curriculum, and the clarity and appropriateness of the training materials. The Elder Abuse Nurse Examiner Curriculum and associated training materials were efficacious in improving SANEs' self-reported knowledge of and perceived competence in delivering elder abuse care. Future steps will further evaluate these materials as a component of a pilot of a larger comprehensive Elder Abuse Intervention at multiple sites across Ontario. Copyright © 2017 Elsevier Ltd. All rights reserved.

A prospective study of adjustment to hemodialysis.

PubMed

Lev, E L; Owen, S V

1998-10-01

To examine (a) changes in subjects' self-care self-efficacy over time and (b) the relationship of subjects' self-care self-efficacy with adjustment to hemodialysis. A longitudinal design was used to study changes in self-care self-efficacy and associations between self-care self-efficacy and measures of adjustment: health status, mood distress, symptom distress, dialysis stress, and perceived adherence to fluid restriction. Subjects were recruited from 8 settings in the Northeast where outpatient hemodialysis treatment was administered. Sixty-four subjects were recruited to the study. Twenty-eight subjects completed 3 occasions of data collection. Data were collected on three occasions: (a) baseline-within 100 days of beginning treatment; (b) 4 months after beginning treatment; and (c) 8 months after beginning treatment. Eta-squared, a measure of practical significance, is reported for four factors of the self-care self-efficacy measure on each of the three occasions. Associations between self-care self-efficacy and measures of adjustment were examined by means of Pearson correlations. Eta-squared estimates showed generally positive changes occurring over time in subjects' self-care self-efficacy, health status, mood distress, symptom distress, dialysis stress, and perceived adherence to fluid restriction. Changes were more positive at 4-months than at 8-months after enrollment. Significant correlations (p < .05) occurred between self-care self-efficacy and mood states, health status, symptom distress, and perceived adherence to fluid restrictions. Correlations occurred more frequently between self-care self-efficacy and mood states than between self-care self-efficacy and other measures of adjustment. The study provided pilot data suggesting that hemodialysis patients' self-care self-efficacy and measures of adjustment change over time. Patients who had increased confidence in self-care strategies (self-efficacy) were associated with having more positive mood states, health status, and perceived adherence to fluid restrictions and less symptom distress. Interventions designed to increase patients' self-care self-efficacy may yield positive results. Nurses are in an excellent position to give efficacy enhancing feedback that may promote patients' adjustment.

Laser light visual cueing for freezing of gait in Parkinson disease: A pilot study with male participants.

PubMed

Bunting-Perry, Lisette; Spindler, Meredith; Robinson, Keith M; Noorigian, Joseph; Cianci, Heather J; Duda, John E

2013-01-01

Freezing of gait (FOG) is a debilitating feature of Parkinson disease (PD). In this pilot study, we sought to assess the efficacy of a rolling walker with a laser beam visual cue to treat FOG in PD patients. We recruited 22 subjects with idiopathic PD who experienced on- and off-medication FOG. Subjects performed three walking tasks both with and without the laser beam while on medications. Outcome measures included time to complete tasks, number of steps, and number of FOG episodes. A crossover design allowed within-group comparisons between the two conditions. No significant differences were observed between the two walking conditions across the three tasks. The laser beam, when applied as a visual cue on a rolling walker, did not diminish FOG in this study.

Faith-based intervention to increase fruit and vegetable intake among Koreans in the USA: a feasibility pilot.

PubMed

Hughes, Suzanne C; Obayashi, Saori

2017-02-01

In the USA, adults of Korean descent tend to eat fewer vegetables than adults in South Korea. The present pilot study examined the feasibility of developing and implementing a faith-based intervention to improve knowledge, attitudes and intake of fruit and vegetables (F&V) for Koreans in the USA. Feasibility pilot using a cluster-randomized intervention trial design. The multicomponent intervention included motivational interviewing sessions by telephone and church-based group activities. Eleven of the largest Korean churches in Southern California. Adults (n 71) from the eleven Korean churches. Feasibility was demonstrated for the study procedures, including recruitment of churches and individual participants. Allocating time throughout the study for church collaboration and having a study church coordinator to coordinate multiple churches were crucial. Participants' attendance at church activities (89 %) and participation by pastors and fellow churchgoers exceeded expectations. Participants' use of intervention materials was high (94 % or above) and satisfaction with coaching sessions was also high (75 % or above). Having a centralized coach trained in motivational interviewing, instead of one at each church, proved practical. Pilot results are promising for F&V knowledge, attitudes and behaviours. The intervention group improved knowledge and intake of the recommended amounts of F&V, above that of the control group. This pilot suggests that Koreans in the USA can be reached through their church and that a faith-based intervention study can be implemented to increase F&V intake. Preliminary results for the intervention appear promising but further research is needed to properly evaluate its efficacy.

Challenges of the pharmacological management of benzodiazepine withdrawal, dependence, and discontinuation

PubMed Central

Revadigar, Neelambika; Manobianco, Brittany E.

2018-01-01

Background: Benzodiazepines (BZDs) are among the most prescribed sedative hypnotics and among the most misused and abused medications by patients, in parallel with opioids. It is estimated that more than 100 million Benzodiazepine (BZD) prescriptions were written in the United States in 2009. While medically useful, BZDs are potentially dangerous. The co-occurring abuse of opioids and BZD, as well as increases in BZD abuse, tolerance, dependence, and short- and long-term side effects, have prompted a worldwide discussion about the challenging aspects of medically managing the discontinuation of BZDs. Abrupt cessation can cause death. This paper addresses the challenges of medications suggested for the management of BZD discontinuation, their efficacy, the risks of abuse and associated medical complications. The focus of this review is on the challenges of several medications suggested for the management of BZD discontinuation, their efficacy, the risks of abuse, and associated medical complications. Methods: An electronic search was performed of Medline, Worldwide Science, Directory of Open Access Journals, Embase, Cochrane Library, Google Scholar, PubMed Central, and PubMed from 1990 to 2017. The review includes double-blind, placebo-controlled studies for the most part, open-label pilot studies, and animal studies, in addition to observational research. We expand the search to review articles, naturalistic studies, and to a lesser extent, letters to the editor/case reports. We exclude abstract and poster presentations, books, and book chapters. Results: The efficacy of these medications is not robust. While some of these medicines are relatively safe to use, some of them have a narrow therapeutic index, with severe, life-threatening side effects. Randomized studies have been limited. There is a paucity of comparative research. The review has several limitations. The quality of the documents varies according to whether they are randomized studies, nonrandomized studies, naturalistic studies, pilot studies, letters to the editors, or case reports. Conclusions: The use of medications for the discontinuation of BZDs seems appropriate. It is a challenge that requires further investigation through randomized clinical trials to maximize efficacy and to minimize additional risks and side effects. PMID:29713452

Challenges of the pharmacological management of benzodiazepine withdrawal, dependence, and discontinuation.

PubMed

Fluyau, Dimy; Revadigar, Neelambika; Manobianco, Brittany E

2018-05-01

Benzodiazepines (BZDs) are among the most prescribed sedative hypnotics and among the most misused and abused medications by patients, in parallel with opioids. It is estimated that more than 100 million Benzodiazepine (BZD) prescriptions were written in the United States in 2009. While medically useful, BZDs are potentially dangerous. The co-occurring abuse of opioids and BZD, as well as increases in BZD abuse, tolerance, dependence, and short- and long-term side effects, have prompted a worldwide discussion about the challenging aspects of medically managing the discontinuation of BZDs. Abrupt cessation can cause death. This paper addresses the challenges of medications suggested for the management of BZD discontinuation, their efficacy, the risks of abuse and associated medical complications. The focus of this review is on the challenges of several medications suggested for the management of BZD discontinuation, their efficacy, the risks of abuse, and associated medical complications. An electronic search was performed of Medline, Worldwide Science, Directory of Open Access Journals, Embase, Cochrane Library, Google Scholar, PubMed Central, and PubMed from 1990 to 2017. The review includes double-blind, placebo-controlled studies for the most part, open-label pilot studies, and animal studies, in addition to observational research. We expand the search to review articles, naturalistic studies, and to a lesser extent, letters to the editor/case reports. We exclude abstract and poster presentations, books, and book chapters. The efficacy of these medications is not robust. While some of these medicines are relatively safe to use, some of them have a narrow therapeutic index, with severe, life-threatening side effects. Randomized studies have been limited. There is a paucity of comparative research. The review has several limitations. The quality of the documents varies according to whether they are randomized studies, nonrandomized studies, naturalistic studies, pilot studies, letters to the editors, or case reports. The use of medications for the discontinuation of BZDs seems appropriate. It is a challenge that requires further investigation through randomized clinical trials to maximize efficacy and to minimize additional risks and side effects.

Increasing patient involvement in the diabetic foot pathway: a pilot randomized controlled trial.

PubMed

McBride, E; Hacking, B; O'Carroll, R; Young, M; Jahr, J; Borthwick, C; Callander, A; Berrada, Z

2016-11-01

This pilot study aimed to explore whether the use of an intervention to increase shared decision-making (Decision Navigation) increased decision self-efficacy and foot-treatment adherence in patients with a diabetic foot ulcer. Fifty-six patients with a diabetic foot ulcer were randomized to receive Decision Navigation (N = 30) or usual care (N = 26). Primary outcomes included decision self-efficacy, adherence to foot treatment as reported by the participant and adherence to foot treatment as reported by the clinician. Secondary outcomes included foot ulcer healing rate, health-related quality of life, decision conflict and decision regret. Despite participants rating Decision Navigation as very helpful, mixed analyses of variance revealed no differences in decision self-efficacy or adherence between those receiving Decision Navigation and those receiving usual care. There were no differences between groups with regards to the secondary outcomes, with the exception of decision conflict which increased over time (12 weeks) for those receiving Decision Navigation. An intervention that facilitated patient involvement in treatment decisions did not have any impact on decisional confidence or adherence to foot treatment. This does not provide support for the suggestion that personalized care can improve health-related outcomes at this progressed stage of the patient's disease trajectory. We suggest that the diabetic foot population may benefit from interventions aimed at increasing motivation to engage with care pathways, centred on challenging personal controllability beliefs. © 2016 Diabetes UK.

Efficacy of the I Can Control Asthma and Nutrition Now (ICAN) Pilot Program on Health Outcomes in High School Students with Asthma

ERIC Educational Resources Information Center

Kouba, Joanne; Velsor-Friedrich, Barbarba; Militello, Lisa; Harrison, Patrick R.; Becklenberg, Amy; White, Barb; Surya, Shruti; Ahmed, Avais

2013-01-01

Asthma is the most prevalent chronic illness in childhood affecting 7 million youth. Many youth with asthma face another risk factor in obesity. Obesity, in turn, increases disorders such as asthma. Studies have recommended that asthma programs also address weight management in youth. Taking this into consideration, the I Can Control Asthma and…

Mentoring to Promote Courage and Confidence among Elementary School Students with Internalizing Problems: A Single-Case Design Pilot Study

ERIC Educational Resources Information Center

Fiat, Aria E.; Cook, Clayton R.; Zhang, Yanchen; Renshaw, Tyler L.; DeCano, Polocarpio; Merrick, Jillian S.

2017-01-01

There is a paucity of selective, Tier 2 interventions that educators can implement for students with internalizing problems as part of their schools' Multi-Tiered Systems of Supports. To fill this void, the authors' purpose was to evaluate the efficacy, acceptability, and integrity of a structured school-based mentoring program, the Courage and…

Divalproex Sodium for the Treatment of PTSD and Conduct Disordered Youth: A Pilot Randomized Controlled Clinical Trial

ERIC Educational Resources Information Center

Steiner, Hans; Saxena, Kirti S.; Carrion, Victor; Khanzode, Leena A.; Silverman, Melissa; Chang, Kiki

2007-01-01

We examined the efficacy of divalproex sodium (DVP) for the treatment of PTSD in conduct disorder, utilizing a previous study in which 71 youth were enrolled in a randomized controlled clinical trial. Twelve had PTSD. Subjects (all males, mean age 16, SD 1.0) were randomized into high and low dose conditions. Clinical Global Impression (CGI)…

Implementing a Foot-Screening Clinic for University Musical Theater Students: A Pilot Program

ERIC Educational Resources Information Center

Ford, Lyndsey; Schmieg, Rose

2014-01-01

Musical theater is a unique genre within the field of the performing arts. Research of injury epidemiology and treatment efficacy is growing in the field of dance, but little is published specific to the field of musical theater. One study has reported that injury rates in musical theater are high and that injuries occur often to the foot and…

Video Self-Modeling in Children with Autism: A Pilot Study Validating Prerequisite Skills and Extending the Utilization of VSM across Skill Sets

ERIC Educational Resources Information Center

Williamson, Robert L.; Casey, Laura B.; Robertson, Janna Siegel; Buggey, Tom

2013-01-01

Given the recent interest in the use of video self-modeling (VSM) to provide instruction within iPod apps and other pieces of handheld mobile assistive technologies, investigating appropriate prerequisite skills for effective use of this intervention is particularly timely and relevant. To provide additional information regarding the efficacy of…

A Novel, Self-Guided, Home-Based Intervention to Improve Condom Use among Young Men Who Have Sex with Men

ERIC Educational Resources Information Center

Emetu, Roberta E.; Marshall, Alexandra; Sanders, Stephanie A.; Yarber, William L.; Milhausen, Robin R.; Crosby, Richard A.; Graham, Cynthia A.

2014-01-01

Objective: This pilot study tested the efficacy of a brief, novel, theory-driven, self-guided, home-based intervention designed to promote condom use among young men who have sex with men (YMSM). Participants: Thirty YMSM were recruited from a large public US midwestern university during spring of 2012. Methods: The intervention was tested using a…

A Pilot Study of the Feasibility and Efficacy of the Strategies to Enhance Positive Parenting (STEPP) Program for Single Mothers of Children with ADHD

ERIC Educational Resources Information Center

Chacko, Anil; Wymbs, Brian T.; Flammer-Rivera, Lizette M.; Pelham, William E.; Walker, Kathryn S.; Arnold, Fran W.; Visweswaraiah, Hema; Swanger-Gagne, Michelle; Girio, Erin L.; Pirvics, Lauma L.; Herbst, Laura

2008-01-01

Objective: The Strategies to Enhance Positive Parenting (STEPP) program was developed to address putative factors related to poor engagement in and outcomes following traditional behavioral parent training (BPT) for single mothers of children diagnosed with ADHD. Method: Twelve single mothers of children with ADHD were enrolled in an initial…

Can Physical Education and Physical Activity Outcomes Be Developed Simultaneously Using a Game-Centered Approach?

ERIC Educational Resources Information Center

Miller, Andrew; Christensen, Erin; Eather, Narelle; Gray, Shirley; Sproule, John; Keay, Jeanne; Lubans, David

2016-01-01

The primary objective of this study was to evaluate the efficacy of a pilot intervention using a game-centered approach for improvement of physical activity (PA) and physical education (PE) outcomes simultaneously, and if this had an impact on enjoyment of PE. A group-randomized controlled trial with a 7-week wait-list control group was conducted…

Pilot Testing a Professional Development Model for Preservice Teachers in the Area of Health and Weight: Feasibility, Utility, and Efficacy

ERIC Educational Resources Information Center

Russell-Mayhew, Shelly; Nutter, Sarah; Ireland, Alana; Gabriele, Tina; Bardick, Angela; Crooks, Jackie; Peat, Gavin

2015-01-01

Studies indicate that both preservice and in-service teachers find it difficult to connect to their role as health promoters within a school context. There is also evidence that those teachers most often responsible for delivering health education (i.e., physical education teachers) are at an increased risk for body dissatisfaction, dieting, and…

Efficacy and Safety of a Novel Autologous Wound Matrix in the Management of Complicated, Chronic Wounds: A Pilot Study.

PubMed

Kushnir, Igal; Kushnir, Alon; Serena, Thomas E; Garfinkel, Doron

2016-09-01

The objective of this pilot study was to evaluate the efficacy and safety of a novel method using an autologous whole blood clot formed with the RedDress Wound Care System (RD1, RedDress Ltd, Israel), a provisional whole blood clot matrix used in the treatment of chronic wounds of various etiologies. Patients were treated at the bedside with the whole blood clot matrix. Blood was withdrawn from each patient using citrate, mixed with a calcium gluconate/kaolin suspension, and injected into an RD1 clotting tray. Within 10 minutes, a clot was formed, placed upon the wound, and fixed with primary and secondary dressings. Wounds were redressed weekly with a whole blood clot matrix. Treatment was terminated when complete healing was achieved, or when the clinician determined that the wound could not further improve without additional invasive procedures. Seven patients with multiple and serious comorbidities and 9 chronic wounds were treated with 35 clot matrices. Complete healing was achieved in 7 of 9 wounds (78%). In 1 venous ulcer with a nonhealing fistula, 77% healing was achieved. Treatment was terminated in 1 pressure ulcer at 82% closure, because an unexpected mechanical trauma resulted in deterioration; this was the only adverse event reported, unrelated to the product. No systemic adverse events occurred. This pilot study demonstrates the in vitro autologous whole blood clot matrix is effective and safe for treating patients with chronic wounds of different etiologies. A larger clinical trial is needed to assess the relative success rate of the matrix in different types of wounds in a diverse population with comorbidities.

A pilot study evaluating the safety and efficacy of modafinal for cancer-related fatigue.

PubMed

Blackhall, Leslie; Petroni, Gina; Shu, Jianfen; Baum, Lora; Farace, Elena

2009-05-01

Fatigue is a common symptom that lowers the quality of life of patients with cancer, affecting between 60% and 90% of patients. Relatively few options are available for the treatment of this debilitating condition. Modafinal, a psychostimulant developed for the treatment of narcolepsy, has been used to treat fatigue in other diseases such as multiple sclerosis, but little data support its use in cancer patients. The primary objective of this open-label pilot study was to evaluate the safety, and efficacy of modafinil in improving cancer-related fatigue (CRF) as measured by the Brief Fatigue Inventory (BFI). The effect of this agent on depression, quality of life, functional status, and cognitive function was also assessed. Modafinal was self-administered at a dose of 100 mg/d during weeks 1-2, and 200 mg during weeks 3-4. Assessments were performed at baseline, 2, and 4 weeks. BFI score was improved in 46% of patients at 2 weeks and 75% at 4 weeks (p = 0.025). Hospital Anxiety and Depression Scale scores declined at 2 and 4 weeks (p < 0.001). Most scales for neurocognitive function were unchanged. Score for all Functional Assessment of Cancer Therapy-Brain (FACT-BR) subscales (measuring quality of life), except social/family well-being, were improved (p < 0.05) at 2 and 4 weeks. Significant changes in Eastern Cooperative Oncology Group (ECOG) performance status were noted, with 40% of patients improving at least one level. Modafinil was well-tolerated with only one patient discontinuing treatment due to drug-related toxicity. In this pilot study modafinil was well-tolerated and effective for fatigue in patients with cancer. Improvements were also seen in mood, quality of life, and functional status.

Exploratory analysis of glyburide as a novel therapy for preventing brain swelling.

PubMed

Sheth, Kevin N; Kimberly, W Taylor; Elm, Jordan J; Kent, Thomas A; Yoo, Albert J; Thomalla, Götz; Campbell, Bruce; Donnan, Geoffrey A; Davis, Stephen M; Albers, Gregory W; Jacobson, Sven; del Zoppo, Gregory; Simard, J Marc; Stern, Barney J; Mandava, Pitchaiah

2014-08-01

Malignant infarction is characterized by the formation of cerebral edema, and medical treatment is limited. Preclinical data suggest that glyburide, an inhibitor of SUR1-TRPM4, is effective in preventing edema. We previously reported feasibility of the GAMES-Pilot study, a two-center prospective, open label, phase IIa trial of 10 subjects at high risk for malignant infarction based on diffusion weighted imaging (DWI) threshold of 82 cm(3) treated with RP-1127 (glyburide for injection). In this secondary analysis, we tested the hypothesis that RP-1127 may be efficacious in preventing poor outcome when compared to controls. Controls suffering large hemispheric infarction were obtained from the EPITHET and MMI-MRI studies. We first screened subjects for controls with the same DWI threshold used for enrollment into GAMES-Pilot, 82 cm(3). Next, to address imbalances, we applied a weighted Euclidean matching. Ninety day mRS 0-4, rate of decompressive craniectomy, and mortality were the primary clinical outcomes of interest. The mean age of the GAMES cohort was 51 years and initial DWI volume was 102 ± 23 cm(3). After Euclidean matching, GAMES subjects showed similar NIHSS, higher DWI volume, younger age and had mRS 0-4-90% versus 50% in controls p = 0.049; with a similar trend in mRS 0-3 (40 vs. 25%; p = 0.43) and trend toward lower mortality (10 vs. 35%; p = 0.21). In this pilot study, RP-1127-treated subjects showed better clinical outcomes when compared to historical controls. An adequately powered and randomized phase II trial of patients at risk for malignant infarction is needed to evaluate the potential efficacy of RP-1127.

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.

Acceptance and commitment therapy in youth with neurofibromatosis type 1 (NF1) and chronic pain and their parents: A pilot study of feasibility and preliminary efficacy.

PubMed

Martin, Staci; Wolters, Pamela L; Toledo-Tamula, Mary Anne; Schmitt, Shawn Nelson; Baldwin, Andrea; Starosta, Amy; Gillespie, Andrea; Widemann, Brigitte

2016-06-01

Neurofibromatosis type 1 (NF1) is an autosomal dominant genetic disorder affecting about 1 in 3,500 individuals. Chronic pain is commonly reported among individuals with NF1 and plexiform neurofibroma tumors (PNs). Acceptance and Commitment Therapy (ACT), an empirically supported method for addressing chronic pain, helps individuals re-focus on valued relationships and activities. This pilot study investigated the feasibility and preliminary efficacy of a brief ACT workshop in the NF1 population. Eligible participants included adolescents and young adults (AYA; 12-21 years) with NF1 and chronic pain that interfered with daily functioning and their parents. Patients and parents completed baseline measures of pain interference, pain intensity, functional disability, pain acceptance, depression, and anxiety. Then, AYA and parents participated separately in a 2-day small-group ACT workshop. A telephone booster session occurred 1 month post-intervention. Three-month post-treatment measures were completed by mail. Ten adolescents (4 males; M age = 16.9 years) and seven parents provided baseline and 3-month data. Mean satisfaction with the study was moderate to high (3.9 for patients and 4.6 for parents on a 1-5 scales). Patients and parents reported significant declines in patients' pain interference at 3 months post-treatment. Patient-reported pain intensity significantly declined from baseline to 3 months. Parents reported marginally greater acceptance of their child's pain. No changes emerged in functional ability or mood. Preliminary findings suggest that a brief ACT group intervention is feasible and may help AYA with NF1 and PNs cope with their chronic pain, although larger randomized studies are needed to confirm treatment efficacy. © 2016 Wiley Periodicals, Inc. © 2016 Wiley Periodicals, Inc.

Effectiveness of Virtual Reality Exercises in STroke Rehabilitation (EVREST): rationale, design, and protocol of a pilot randomized clinical trial assessing the Wii gaming system.

PubMed

Saposnik, G; Mamdani, M; Bayley, M; Thorpe, K E; Hall, J; Cohen, L G; Teasell, R

2010-02-01

Evidence suggests that increasing intensity of rehabilitation results in better motor recovery. Limited evidence is available on the effectiveness of an interactive virtual reality gaming system for stroke rehabilitation. EVREST was designed to evaluate feasibility, safety and efficacy of using the Nintendo Wii gaming virtual reality (VRWii) technology to improve arm recovery in stroke patients. Pilot randomized study comparing, VRWii versus recreational therapy (RT) in patients receiving standard rehabilitation within six months of stroke with a motor deficit of > or =3 on the Chedoke-McMaster Scale (arm). In this study we expect to randomize 20 patients. All participants (age 18-85) will receive customary rehabilitative treatment consistent of a standardized protocol (eight sessions, 60 min each, over a two-week period). The primary feasibility outcome is the total time receiving the intervention. The primary safety outcome is the proportion of patients experiencing intervention-related adverse events during the study period. Efficacy, a secondary outcome measure, will be measured by the Wolf Motor Function Test, Box and Block Test, and Stroke Impact Scale at the four-week follow-up visit. From November, 2008 to September, 2009 21 patients were randomized to VRWii or RT. Mean age, 61 (range 41-83) years. Mean time from stroke onset 25 (range 10-56) days. EVREST is the first randomized parallel controlled trial assessing the feasibility, safety, and efficacy of virtual reality using Wii gaming technology in stroke rehabilitation. The results of this study will serve as the basis for a larger multicentre trial. ClinicalTrials.gov registration# NTC692523.

Transcontinental anaesthesia: a pilot study.

PubMed

Hemmerling, T M; Arbeid, E; Wehbe, M; Cyr, S; Giunta, F; Zaouter, C

2013-05-01

Although telemedicine is one of the key initiatives of the World Health Organization, no study has explored the feasibility and efficacy of teleanaesthesia. This bi-centre pilot study investigates the feasibility of transcontinental anaesthesia. Twenty patients aged ≥ 18 yr undergoing elective thyroid surgery for ≥ 30 min were enrolled in this study. The remote and local set-up was composed of a master-computer (Montreal) and a slave-computer (Pisa). Standard Internet connection, remote desktop control, and video conference software were used. All patients received total i.v. anaesthesia controlled remotely (Montreal). The main outcomes were feasibility, clinical performance, and controller performance of transcontinental anaesthesia. The clinical performance of hypnosis control was the efficacy to maintain bispectral index (BIS) at 45: 'excellent', 'good', 'poor', and 'inadequate' control represented BIS values within 10, from 11 to 20, from 21 to 30, or >30% from target. The clinical performance of analgesia was the efficacy to maintain Analgoscore values at 0 (-9 to 9); -3 to +3 representing 'excellent' pain control, -3 to -6 and +3 to +6 representing 'good' pain control, and -6 to -9 and +6 to +9 representing 'insufficient' pain control. The controller performance was evaluated using Varvel parameters. Transcontinental anaesthesia was successful in all 20 consecutive patients. The clinical performance of hypnosis showed an 'excellent and good' control for 69% of maintenance time, and the controller performance showed an average global performance index of 57. The clinical performance of analgesia was 'excellent and good' for 92% of maintenance time, and the controller performance showed a global performance index of 1118. Transcontinental anaesthesia is feasible; control of anaesthesia shows good performance indexes. Clinical registration number NCT01331096.

Combinations of Radiotherapy and Immunotherapy for Melanoma: A Review of Clinical Outcomes

PubMed Central

Barker, Christopher A.; Postow, Michael A.

2015-01-01

Radiotherapy 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 radiotherapy 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 radiotherapy and immunotherapy. Vaccine therapies often use irradiated melanoma cells, and may be enhanced by radiotherapy. The cytokines interferon-alpha and interleukin-2 have been combined with radiotherapy in several small studies, with some evidence suggesting increased toxicity and/or efficacy. Ipilimumab, a monoclonal antibody which blocks cytotoxic T-lymphocyte antigen-4, has been combined with radiotherapy in several notable case studies and series. Finally, pilot studies of adoptive cell transfer have suggested radiotherapy may improve the efficacy of treatment. The review will demonstrate that the combination of radiotherapy 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. PMID:24661650

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

No-patch 23-gauge vitrectomy under topical anesthesia: a pilot study.

PubMed

Deka, Satyen; Bhattacharjee, Harsha; Barman, M J; Kalita, Kruto; Singh, Sunil Kumar

2011-01-01

A pilot study was designed to evaluate the safety and efficacy of 23-gauge vitrectomy under topical anesthesia. Five eyes of five patients underwent 23-gauge sutureless vitrectomy under topical anesthesia with a pledget soaked in 0.5% proparacaine hydrochloride anesthetic, for vitreous hemorrhage (four eyes), epiretinal membrane (one eye). Subjective pain and discomfort were graded using a visual analogue chart from 0 (no pain or discomfort) to 4 (severe pain and discomfort). At the end of surgery no patch was applied and patients were given dark glasses. Patients underwent an immediate postoperative assessment, followed by next day and one week postoperative evaluation. Four patients had Grade 0 pain during the surgery. One patient had Grade 1 pain during the placement and withdrawal of the micro cannulas. The surgical outcomes were favorable. 23-gauge vitrectomy under topical anesthesia is safe and effective in selected cases. Further study is recommended to validate the outcome of this study.

Evaluating a Culturally Tailored HIV Risk Reduction Intervention Among Latina Immigrants in the Farmworker Community.

PubMed

Sanchez, Mariana; Rojas, Patria; Li, Tan; Ravelo, Gira; Cyrus, Elena; Wang, Weize; Kanamori, Mariano; Peragallo, Nilda P; De La Rosa, Mario R

2016-09-01

Latina immigrants in the farmworker community are a vulnerable and understudied population at risk of acquiring HIV. Employing a CBPR framework, this pilot study was the first to evaluate the efficacy of SEPA, a CDC evidenced-based and culturally tailored HIV risk reduction intervention on a cohort of N = 110 predominantly undocumented Latina immigrants in a farmworker community. Findings revealed SEPA was effective in increasing HIV knowledge and decreasing HIV risk behaviors. However, no changes in self-efficacy were found in the present sample. We posit specific socio-cultural and structural barriers specific to the farmworker community not targeted in the original intervention may have hindered the program's capacity to influence changes in self-efficacy among this less acculturated population. Possible socio-cultural adaptations of the intervention to the target population and policy implications are discussed.

Shopper marketing nutrition interventions: Social norms on grocery carts increase produce spending without increasing shopper budgets.

PubMed

Payne, Collin R; Niculescu, Mihai; Just, David R; Kelly, Michael P

2015-01-01

We assessed the efficacy of an easy-to-implement shopper marketing nutrition intervention in a pilot and two additional studies to increase produce demand without decreasing store profitability or increasing shopper budgets. We created grocery cart placards that detailed the number of produce items purchased (i.e., descriptive norm) at particular stores (i.e., provincial norm). The effect of these placards on produce spending was assessed across 971,706 individual person grocery store transactions aggregated by day. The pilot study designated a baseline period (in both control and intervention store) followed by installation of grocery cart placards (in the intervention store) for two weeks. The pilot study was conducted in Texas in 2012. In two additional stores, we designated baseline periods followed by 28 days of the same grocery cart placard intervention as in the pilot. Additional interventions were conducted in New Mexico in 2013. The pilot study resulted in a significant difference between average produce spending per day per person across treatment periods (i.e., intervention versus same time period in control) (16%) and the difference between average produce spending per day per person across stores in the control periods (4%); Furthermore, the same intervention in two additional stores resulted in significant produce spending increases of 12.4% and 7.5% per day per person respectively. In all stores, total spending did not change. Descriptive and provincial social norm messages (i.e., on grocery cart placards) may be an overlooked tool to increase produce demand without decreasing store profitability and increasing shopper budgets.

Shopper marketing nutrition interventions: Social norms on grocery carts increase produce spending without increasing shopper budgets☆

PubMed Central

Payne, Collin R.; Niculescu, Mihai; Just, David R.; Kelly, Michael P.

2015-01-01

Objectives We assessed the efficacy of an easy-to-implement shopper marketing nutrition intervention in a pilot and two additional studies to increase produce demand without decreasing store profitability or increasing shopper budgets. Methods We created grocery cart placards that detailed the number of produce items purchased (i.e., descriptive norm) at particular stores (i.e., provincial norm). The effect of these placards on produce spending was assessed across 971,706 individual person grocery store transactions aggregated by day. The pilot study designated a baseline period (in both control and intervention store) followed by installation of grocery cart placards (in the intervention store) for two weeks. The pilot study was conducted in Texas in 2012. In two additional stores, we designated baseline periods followed by 28 days of the same grocery cart placard intervention as in the pilot. Additional interventions were conducted in New Mexico in 2013. Results The pilot study resulted in a significant difference between average produce spending per day per person across treatment periods (i.e., intervention versus same time period in control) (16%) and the difference between average produce spending per day per person across stores in the control periods (4%); Furthermore, the same intervention in two additional stores resulted in significant produce spending increases of 12.4% and 7.5% per day per person respectively. In all stores, total spending did not change. Conclusions Descriptive and provincial social norm messages (i.e., on grocery cart placards) may be an overlooked tool to increase produce demand without decreasing store profitability and increasing shopper budgets. PMID:26844084

Effects of Role-Playing Scenarios on the Self-efficacy of Students in Resisting Against Substance Addiction: A Pilot Study.

PubMed

Karatay, Gülnaz; Gürarslan Baş, Nazan

2017-01-01

During the first phases of adolescent development, young people have little self-efficacy and resistance against substance use. The aim of this study was to demonstrate the effectiveness of role-playing scenarios on the self-efficacy of students in resisting substance use. A pre test and post test study design was used with a single group. The study was carried out with 245 secondary school students. The scenario-based training, developed by the researchers, was presented by the school counselors once a week for 4 weeks. For this purpose, a booklet of scenarios was prepared for the teachers. The role-playing scenarios were intended to improve adolescents' abilities to say "no" to substance offers, to prevent them from becoming addicted to certain substances, and to call for help if needed. The data of the study were collected using the Personal Information Form and the Self-Efficacy for Adolescences Protecting Substance Abuse Scale . The obtained data were assessed using percentages, chi-square, t test, and F test in the SPSS software. Results showed that, after the training, the mean score in the Self-Efficacy for Adolescences Protecting Substance Abuse Scale increased significantly (103.20 ± 20.00) compared with before the training (92.11 ± 17.08) ( P < .05). Short-term outcomes of the class-based scenario training were observed to be effective in the development of students' self-efficacy to resist the temptations of substance use.

Fibromyalgia with Gabapentin and Osteopathic Manipulative Medicine: A Pilot Study.

PubMed

Marske, Cynthia; Bernard, Natasha; Palacios, Alison; Wheeler, Cary; Preiss, Ben; Brown, Mackenzie; Bhattacharya, Saveri; Klapstein, Gloria

2018-04-01

This pilot study compares the safety and efficacy of three treatments in reducing pain and improving fibromyalgia symptoms. This study was an 8-week prospective, single center feasibility study. Forty subjects were recruited from Solano, Sonoma, and Contra Costa counties of California in 2006-2009. Subjects were aged 18-65 and met the American College of Rheumatology (ACR) 1990 criteria for fibromyalgia. This study had three treatment arms: gabapentin only (900 mg/day), osteopathic manipulative medicine (OMM) only, and combined treatment of gabapentin plus OMM. OMM treatment was administered by advanced medical students for 30 min, once a week. The trial lasted for 8 weeks, which included 6 weeks of treatment plus initial and final visits. Key outcome measures included Wong-Baker FACES Pain Rating Scale (WBF), Clinical Global Impression of Health (CGI), Fibromyalgia Impact Questionnaire (FIQ), and number of tender points. Twenty-nine subjects completed the trial; 8 subjects received gabapentin only, 11 patients received OMM only, and 10 patients received gabapentin plus OMM. Subjects receiving OMM alone and subjects receiving the combined treatment of OMM and gabapentin displayed clinical improvements based on WBF (p < 0.01 and p = 0.03, respectively), while the change among the gabapentin-only group was nonsignificant. The OMM only group was the only group to experience a significant decline in CGI scale (p < 0.01). No statistically significant changes were observed with the FIQ or number of tender points. No differences across groups were statistically significant. This is to be expected in a feasibility study with a small sample size. This pilot study suggests that OMM treatment and gabapentin are safe and clinically efficacious treatment of pain and other constitutional and somatic symptoms associated with fibromyalgia. A larger trial using the new ACR 2010 Fibromyalgia criteria is needed to confirm these findings.

Using video feedback to improve early father-infant interaction: a pilot study.

PubMed

Lawrence, Peter J; Davies, Beverley; Ramchandani, Paul G

2013-01-01

Preventive interventions with parents of infants have tended to focus on mothers. Recent research focused on fathers suggests that their involvement in interventions might enhance effectiveness. One effective approach with mothers is the brief, home-based Video-feedback Intervention to promote Positive Parenting (VIPP). This paper is a report of a pilot study of VIPP with fathers to assess its feasibility. Five fathers were recruited from an existing longitudinal study of parents. The primary outcome was acceptability, assessed using a semi-structured questionnaire after completion of the intervention. All fathers completed all sessions of the intervention. Fathers rated the intervention as having had a significant impact on their understanding of their child's thoughts and feelings, and as having improved their communication and relationship with their baby. Fathers' feedback was generally positive. The flexibility to conduct sessions at home (or at fathers' places of work) and the flexible timing of sessions were identified as fundamental to successful delivery. The results of this pilot study are encouraging, as VIPP with fathers was feasible. In light of the modest sample size, and the use of a non-clinical sample, the intervention must be evaluated with larger, clinical samples to evaluate its efficacy with fathers.

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.

Efficacy of Dentaq® Oral and ENT Health Probiotic Complex on Clinical Parameters of Gingivitis in Patients Undergoing Fixed Orthodontic Treatment: A Pilot Study.

PubMed

Kolip, Duygu; Yılmaz, Nuray; Gökkaya, Berna; Kulan, Pinar; Kargul, Betul; MacDonald, Kyle W; Cadieux, Peter A; Burton, Jeremy P; James, Kris M

2016-09-01

Probiotics act as a unique approach to maintaining oral health by supplementing the endogenous oral bacteria with additional naturally occurring beneficial microbes to provide defense against pathogens harmful to teeth and gingiva. The aim of this pilot study was to clinically evaluate the effects of probiotics on plaque accumulation and gingival inflammation in subjects with fixed orthodontics. The pilot study was comprised of 15 healthy patients, aged 11 to 18 years, undergoing fixed orthodontic treatment. Patients used an all-natural, dissolving lozenge containing six proprietary probiotic strains (Dentaq® Oral and ENT Health Probiotic Complex)for 28 days. Gingival Index (GI) according to Löe-Silness and Plaque Index (PI) according to Quigley-Hein for all teeth were measured at baseline (Day Zero) and at the end of the probiotic regimen (Day 28). The mean baseline GI and PI scores within each patient decreased by 28.4% and 35.8%, respectively, by Day 28. Patients reported decreased tooth and gingival pain, decreased oral bleeding, and increased motivation to maintain proper oral hygiene over the course of the study. This pilot study provided preliminary support for the use of Dentaq Oral and ENT Health Probiotic Complex as a safe and effective natural health product for the reduction of plaque accumulation and gingival inflammation. The results demonstrate its potential therapeutic value and open the door for larger scale placebo-controlled clinical studies to verify these findings.

Neurofeedback as a treatment for major depressive disorder--a pilot study.

PubMed

Peeters, Frenk; Oehlen, Mare; Ronner, Jacco; van Os, Jim; Lousberg, Richel

2014-01-01

There is growing interest in neurofeedback as a treatment for major depressive disorder. Reduction of asymmetry of alpha-activity between left and right prefrontal areas with neurofeedback has been postulated as effective in earlier studies. Unfortunately, methodological shortcomings limit conclusions that can be drawn from these studies. In a pilot-study, we investigated the effectiveness of reduction of asymmetry of alpha-activity with neurofeedback in depressed participants with the use of a stringent methodological approach. Nine participants meeting DSM-IV criteria for major depressive disorder were treated with a maximum of 30 neurofeedback-sessions, aimed at reducing asymmetry of alpha-activity, over a 10-week period. No changes in the use of antidepressants were allowed 6 weeks before and during the intervention. Changes in depressive symptomatology were assessed with the Quick Inventory of Depressive Symptoms, self-report version. We observed response in 1 and remission in 4 out of a total of 9 participants. The effectiveness appeared largest in female participants. The mean asymmetry of alpha-activity decreased significantly over sessions in a quadratic fashion. This decrease was associated with clinical response. This pilot study suggests that neurofeedback aimed at a reduction of frontal asymmetry of alpha-activity may be effective as a treatment for depression. However, this was an open label pilot study. Non-specific effects of the procedure and/or a beneficial natural course may have confounded the results. Randomized controlled trials will have to establish the efficacy of neurofeedback for depression. Nederlands Trial Register NTR1629.

Sexuality Education Intervention for Parents of Children with Disabilities: A Pilot Training Program

PubMed Central

Clatos, Kristen; Asare, Matthew

2016-01-01

The purpose of the study is to evaluate pilot sexuality education intervention for parents of children with disabilities between ages of 6 and 25 years old. A within subjects design was utilized and 15 parents of children with disabilities were recruited to receive a two-week sexuality education without a control group. A paired-samples t-test results showed that there was a significant difference between the participants’ pre-test and post intervention scores in their: attitude and beliefs, sexual communication, knowledge, and self-efficacy of sexuality education among children with disabilities (all p<.001). The intervention change the participants sexual communication behavior and increased knowledge about sexuality education with children with disabilities PMID:28690386

Consumption of gluten with gluten-degrading enzyme by celiac patients: A pilot-study

PubMed Central

Tack, Greetje J; van de Water, Jolanda MW; Bruins, Maaike J; Kooy-Winkelaar, Engelina MC; van Bergen, Jeroen; Bonnet, Petra; Vreugdenhil, Anita CE; Korponay-Szabo, Ilma; Edens, Luppo; von Blomberg, B Mary E; Schreurs, Marco WJ; Mulder, Chris J; Koning, Frits

2013-01-01

AIM: To assesses the safety and efficacy of Aspergillus niger prolyl endoprotease (AN-PEP) to mitigate the immunogenic effects of gluten in celiac patients. METHODS: Patients with initial diagnosis of celiac disease as confirmed by positive serology with subtotal or total villous atrophy on duodenal biopsies who adhere to a strict gluten-free diet (GFD) resulting in normalised antibodies and mucosal healing classified as Marsh 0 or I were included. In a randomised double-blind placebo-controlled pilot study, patients consumed toast (approximately 7 g/d gluten) with AN-PEP for 2 wk (safety phase). After a 2-wk washout period with adherence of the usual GFD, 14 patients were randomised to gluten intake with either AN-PEP or placebo for 2 wk (efficacy phase). Measurements at baseline included complaints, quality-of-life, serum antibodies, immunophenotyping of T-cells and duodenal mucosa immunohistology. Furthermore, serum and quality of life questionnaires were collected during and after the safety, washout and efficacy phase. Duodenal biopsies were collected after the safety phase and after the efficacy phase. A change in histological evaluation according to the modified Marsh classification was the primary endpoint. RESULTS: In total, 16 adults were enrolled in the study. No serious adverse events occurred during the trial and no patients withdrew during the trial. The mean score for the gastrointestinal subcategory of the celiac disease quality (CDQ) was relatively high throughout the study, indicating that AN-PEP was well tolerated. In the efficacy phase, the CDQ scores of patients consuming gluten with placebo or gluten with AN-PEP did not significantly deteriorate and moreover no differences between the groups were observed. During the efficacy phase, neither the placebo nor the AN-PEP group developed significant antibody titers. The IgA-EM concentrations remained negative in both groups. Two patients were excluded from entering the efficacy phase as their mucosa showed an increase of two Marsh steps after the safety phase, yet with undetectable serum antibodies, while 14 patients were considered histologically stable on gluten with AN-PEP. Also after the efficacy phase, no significant deterioration was observed regarding immunohistological and flow cytometric evaluation in the group consuming placebo compared to the group receiving AN-PEP. Furthermore, IgA-tTG deposit staining increased after 2 wk of gluten compared to baseline in four out of seven patients on placebo. In the seven patients receiving AN-PEP, one patient showed increased and one showed decreased IgA-tTG deposits. CONCLUSION: AN-PEP appears to be well tolerated. However, the primary endpoint was not met due to lack of clinical deterioration upon placebo, impeding an effect of AN-PEP. PMID:24124328

A pilot randomized controlled trial of a self-management group intervention for people with early-stage dementia (The SMART study).

PubMed

Quinn, Catherine; Toms, Gill; Jones, Carys; Brand, Andrew; Edwards, Rhiannon Tudor; Sanders, Fiona; Clare, Linda

2016-05-01

Self-management equips people to manage the symptoms and lifestyle changes that occur in long-term health conditions; however, there is limited evidence about its effectiveness for people with early-stage dementia. This pilot randomized controlled trial (RCT) explored the feasibility of a self-management intervention for people with early-stage dementia. The participants were people with early-stage dementia (n = 24) and for each participant a caregiver also took part. Participants were randomly allocated to either an eight-week self-management group intervention or treatment as usual (TAU). Assessments were conducted at baseline, three months and six months post-randomization by a researcher blind to group allocation. The primary outcome measure was self-efficacy score at three months. Thirteen people with dementia were randomized to the intervention and 11 to TAU. Two groups were run, the first consisting of six people with dementia and the second of seven people with dementia. There was a small positive effect on self-efficacy with the intervention group showing gains in self-efficacy compared to the TAU group at three months (d = 0.35), and this was maintained at six months (d = 0.23). In terms of intervention acceptability, attrition was minimal, adherence was good, and satisfaction ratings were high. Feedback from participants was analyzed with content analysis. The findings suggest the positive aspects of the intervention were that it fostered independence and reciprocity, promoted social support, offered information, and provided clinician support. This study has provided preliminary evidence that self-management may be beneficial for people with early-stage dementia.

Development of an instrument to measure self-efficacy in caregivers of people with advanced cancer.

PubMed

Ugalde, Anna; Krishnasamy, Meinir; Schofield, Penelope

2013-06-01

Informal caregivers of people with advanced cancer experience many negative impacts as a result of their role. There is a lack of suitable measures specifically designed to assess their experience. This study aimed to develop a new measure to assess self-efficacy in caregivers of people with advanced cancer. The development and testing of the new measure consisted of four separate, sequential phases: generation of issues, development of issues into items, pilot testing and field testing. In the generation of issues, 17 caregivers were interviewed to generate data. These data were analysed to generate codes, which were then systematically developed into items to construct the instrument. The instrument was pilot tested with 14 health professionals and five caregivers. It was then administered to a large sample for field testing to establish the psychometric properties, with established measures including the Brief Cope and the Family Appraisals for Caregiving Questionnaire for Palliative Care. Ninety-four caregivers completed the questionnaire booklet to establish the factor structure, reliability and validity. The factor analysis resulted in a 21-item, four-factor instrument, with the subscales being termed Resilience, Self-Maintenance, Emotional Connectivity and Instrumental Caregiving. The test-retest reliability and internal consistency were both excellent, ranging from 0.73 to 0.85 and 0.81 to 0.94, respectively. Six convergent and divergent hypotheses were made, and five were supported. This study has developed a new instrument to assess self-efficacy in caregivers of people with advanced cancer. The result is a four-factor, 21-item instrument with demonstrated reliability and validity. Copyright © 2012 John Wiley & Sons, Ltd.

Preliminary examination of the efficacy and safety of a standardized chamomile extract for chronic primary insomnia: a randomized placebo-controlled pilot study.

PubMed

Zick, Suzanna M; Wright, Benjamin D; Sen, Ananda; Arnedt, J Todd

2011-09-22

Despite being the most commonly used herbal for sleep disorders, chamomile's (Matricaria recutita) efficacy and safety for treating chronic primary insomnia is unknown. We examined the preliminary efficacy and safety of chamomile for improving subjective sleep and daytime symptoms in patients with chronic insomnia. We performed a randomized, double-blind, placebo-controlled pilot trial in 34 patients aged 18-65 years with DSM-IV primary insomnia for ≥ 6-months. Patients were randomized to 270 mg of chamomile twice daily or placebo for 28-days. The primary outcomes were sleep diary measures. Secondary outcomes included daytime symptoms, safety assessments, and effect size of these measures. There were no significant differences between groups in changes in sleep diary measures, including total sleep time (TST), sleep efficiency, sleep latency, wake after sleep onset (WASO), sleep quality, and number of awakenings. Chamomile did show modest advantage on daytime functioning, although these did not reach statistical significance. Effect sizes were generally small to moderate (Cohen's d ≤ 0.20 to < 0.60) with sleep latency, night time awakenings, and Fatigue Severity Scale (FSS), having moderate effect sizes in favor of chamomile. However, TST demonstrated a moderate effect size in favor of placebo. There were no differences in adverse events reported by the chamomile group compared to placebo. Chamomile could provide modest benefits of daytime functioning and mixed benefits on sleep diary measures relative to placebo in adults with chronic primary insomnia. However, further studies in select insomnia patients would be needed to investigate these conclusions.

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

PubMed Central

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. PMID:25383173

Pilot study on agricultural pesticide poisoning in Burkina Faso

PubMed Central

Ouedraogo, Mustapha; Ouedraogo, Richard; Ilboudo, Sylvain; Guissou, Pierre I.

2013-01-01

Epidemiologic data related to agricultural pesticide poisoning cases in Burkina Faso were collected. The study was carried out using retrospective (from January 2002 to June 2010) surveys conducted among farmers and healthcare centers. One hundred and fifty-three (153) pest control products were recorded during the survey and 56 active ingredients were identified. Out of the 153 pest control products, 49 (i.e. 32%) were authorized for sale in Burkina Faso. The main risk factors are socio-demographic characteristics of farmers, their low education level, and some attitudes and practices on using agricultural pesticides. Pesticide poisonings are relatively frequent and their management was not always efficacious. Actions are needed to reduce pesticide poisoning as a global public health problem and to improve management of pesticide poisoning. To this purpose, advanced investigations should be carried out over a longer period of time to complement the present pilot study. PMID:24678256

Pilot study on agricultural pesticide poisoning in Burkina Faso.

PubMed

Toe, Adama M; Ouedraogo, Mustapha; Ouedraogo, Richard; Ilboudo, Sylvain; Guissou, Pierre I

2013-12-01

Epidemiologic data related to agricultural pesticide poisoning cases in Burkina Faso were collected. The study was carried out using retrospective (from January 2002 to June 2010) surveys conducted among farmers and healthcare centers. One hundred and fifty-three (153) pest control products were recorded during the survey and 56 active ingredients were identified. Out of the 153 pest control products, 49 (i.e. 32%) were authorized for sale in Burkina Faso. The main risk factors are socio-demographic characteristics of farmers, their low education level, and some attitudes and practices on using agricultural pesticides. Pesticide poisonings are relatively frequent and their management was not always efficacious. Actions are needed to reduce pesticide poisoning as a global public health problem and to improve management of pesticide poisoning. To this purpose, advanced investigations should be carried out over a longer period of time to complement the present pilot study.

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.

Interventional Audiology to Address Hearing Health Care Disparities: Oyendo Bien Pilot Study

PubMed Central

Marrone, Nicole; Ingram, Maia; Somoza, Maria; Jacob, Daisey Sánchez; Sanchez, Adriana; Adamovich, Stephanie; Harris, Frances P.

2017-01-01

Interventional audiology, specifically community-based outreach, can connect people with the hearing health care system. Community-based participatory research methods were applied in two phases of research to: (1) investigate the needs of families affected by hearing loss in a rural Arizona community on the U.S.–Mexico border; and (2) evaluate an outreach program on hearing health. The needs assessment included interviews with persons with hearing loss and focus groups with family members and the greater community. The needs assessment revealed that despite perceived severity of hearing loss, help-seeking for audiologic care was limited due to barriers, stigma, and low self-efficacy. Results informed development of a community-based pilot study conducted as part of an academic-community partnership between audiology, public health, and community health workers of a federally qualified health center. An outreach program, Oyendo Bien (hearing wellness), a 5-week, Spanish-language health education program for older adults (n = 21) incorporated communication strategies and behavioral change techniques. Postprogram focus groups revealed increased self-efficacy and decreased stigma. After 1 year, 7 of 9 participants with hearing loss contacted for follow-up had sought some form of hearing-related health care. Future research should further investigate interventional audiology approaches to address health disparities. PMID:28522894

A multi-stakeholder evaluation of the Baltimore City virtual supermarket program.

PubMed

Lagisetty, Pooja; Flamm, Laura; Rak, Summer; Landgraf, Jessica; Heisler, Michele; Forman, Jane

2017-10-23

Increasing access to healthy foods and beverages in disadvantaged communities is a public health priority due to alarmingly high rates of obesity. The Virtual Supermarket Program (VSP) is a Baltimore City Health Department program that uses online grocery ordering to deliver food to low-income neighborhoods. This study evaluates stakeholder preferences and barriers of program implementation. This study assessed the feasibility, sustainability and efficacy of the VSP by surveying 93 customers and interviewing 14 programmatic stakeholders who had recently used the VSP or been involved with program design and implementation. We identified the following themes: The VSP addressed transportation barriers and food availability. The VSP impacted customers and the city by including improving food purchasing behavior, creating a food justice "brand for the city", and fostering a sense of community. Customers appreciated using Supplemental Nutrition Assistance Program (SNAP) benefits to pay for groceries, but policy changes are needed allow online processing of SNAP benefits. This evaluation summarizes lessons learned and serves as a guide to other public health leaders interested in developing similar programs. Provisions in the U.S. Department of Agriculture (USDA) Farm Bill 2014 allow for select grocers to pilot online transactions with SNAP benefits. If these pilots are efficacious, the VSP model could be easily disseminated.

Developing and piloting an expert system for better routine voluntary HIV counseling and testing in China: preliminary results and lessons.

PubMed

Chai, Jing; Wang, DeBin; Zhou, Meng; Xu, WangQuan; Liang, Guojun; Shen, Yi Fang

2012-01-01

This study aims at developing and testing a pragmatic expert system for HIV voluntary counseling (VCT-ES) that leverages best practices. The VCT-ES was developed via evolutionary prototyping and piloted in 10 voluntary HIV counseling and testing (VCT) clinics from Anhui and Beijing representative of prefecture and county level VCT clinics in China. All counselors with the clinics and the clients to the clinics within selected two weeks at baseline and the end of study were invited to participate. Assessment measures included essential counseling procedures (ECPs); clients' satisfaction, knowledge, and behavior efficacy. VCT-ES was developed which tries to model and facilitate standard VCT operation procedures and best practices. One hundred and eighty-two (96 at baseline vs. 86 after intervention) cases recordings, 172 (96 vs. 76) client questionnaires, 10 counselor, and 2 expert rating instruments were collected; and 17 clients and 8 counselors participated in qualitative interviews. VCT-ES increased delivery of ECPs from 18.94% to 66.39% on average; increased clients' knowledge from 40.51% to 86.34% and self-efficacy by 22.42%. The VCT-ES applications listed were rated 9.1 on average (maximum = 10). The VCT-ES could be an easy and effective solution to better routine VCT and merits further research.

Changes in salivary oxytocin after inhalation of clary sage essential oil scent in term-pregnant women: a feasibility pilot study.

PubMed

Tadokoro, Yuriko; Horiuchi, Shigeko; Takahata, Kaori; Shuo, Takuya; Sawano, Erika; Shinohara, Kazuyuki

2017-12-08

This pilot study using a quasi-experimental design was conducted to evaluate the feasibility (i.e., limited efficacy, practicality, and acceptability) of our intervention protocol involving inhalation of the scent of clary sage essential oil by pregnant women and measurement of their preinhalation and postinhalation oxytocin levels. Participants were women of singleton pregnancies between 38 and 40 gestation weeks (N = 11). The experiment group (n = 5) inhaled the scent of clary sage essential oil diluted 50-fold with 10 mL of odorless propylene glycol for 20 min. Regarding limited efficacy, the oxytocin level 15 min postinhalation increased in 3 women and was unmeasurable in 2. The control group (n = 6) inhaled similarly without the 50-fold dilution of clary sage essential oil. Their oxytocin level increased in 2 women, decreased in 2, and was unmeasurable in 2. Uterine contraction was not observed in both groups. Regarding practicality, 3 of the 11 women could not collect sufficient saliva. The cortisol level decreased in both groups postinhalation. The protocol had no negative effects. Regarding acceptability, burden of the protocol was not observed. Trial registration The Clinical Trials Registry of University Hospital Medical Information Network in Japan-UMIN000017830. Registered:  June 8, 2015.

Potential determinants of efficacy of mirror therapy in stroke patients – A pilot study

PubMed Central

Brunetti, Maddalena; Morkisch, Nadine; Fritzsch, Claire; Mehnert, Jan; Steinbrink, Jens; Niedeggen, Michael; Dohle, Christian

2015-01-01

Abstract Background: Mirror therapy (MT) was found to improve motor function after stroke. However, there is high variability between patients regarding motor recovery. Objectives: The following pilot study was designed to identify potential factors determining this variability between patients with severe upper limb paresis, receiving MT. Methods: 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. Results: 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. Conclusions: 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. PMID:26409402

"Merging Yoga and Occupational Therapy (MY-OT): A feasibility and pilot study".

PubMed

Schmid, Arlene A; Puymbroeck, Marieke Van; Portz, Jennifer D; Atler, Karen E; Fruhauf, Christine A

2016-10-01

To examine the feasibility and benefits of the Merging Yoga and Occupational Therapy (MY-OT) intervention. This is the primary analysis of a non-controlled pretest-posttest pilot study to understand the feasibility and impact of MY-OT on balance, balance self-efficacy, and fall risk factor management in people with chronic stroke. University research laboratory. People with chronic stroke were included in the study if they: had sustained a fall or had fear of falling, were able to stand, and hand impaired balance and were at risk for falls (≤46 on the Berg Balance Scale (BBS)). Individuals completed an 8 week intervention that included 16 sessions of both yoga and group occupational therapy (OT). Yoga included physical postures, breathing exercises, and meditation. OT focused on post-stroke fall risk factor management. The BBS was used to assess balance, the Activities-specific Balance Confidence Scale (ABC) was used to measure balance self-efficacy. Five fall risk factor management scales were used. Overall, the intervention was considered feasible, as individuals were able to safely complete the intervention with little attrition and high attendance. Balance improved by 30% (p=0.002). Balance self-efficacy improved by 15% (p=0.034). Each of the five fall risk factor management scales improved, but only two significantly improved (Fall Prevention and Management Questionnaire, 29%, p=0.004 and Fall Prevention Strategy Survey, 42%, p=0.032). The results demonstrate that MY-OT is a potential intervention to improve multiple fall related outcomes for people with stroke. Therapists may consider these interventions for people with stroke, but additional research is warranted. Copyright © 2016 Elsevier Ltd. All rights reserved.

Repeated intranasal ketamine for treatment-resistant depression - the way to go? Results from a pilot randomised controlled trial.

PubMed

Gálvez, Verònica; Li, Adrienne; Huggins, Christina; Glue, Paul; Martin, Donel; Somogyi, Andrew A; Alonzo, Angelo; Rodgers, Anthony; Mitchell, Philip B; Loo, Colleen K

2018-04-01

Ketamine research in depression has mostly used intravenous, weight-based approaches, which are difficult to translate clinically. Intranasal (IN) ketamine is a promising alternative but no controlled data has been published on the feasibility, safety and potential efficacy of repeated IN ketamine treatments. This randomised, double-blind, placebo-controlled pilot study compared a 4-week course of eight treatments of 100 mg ketamine or 4.5 mg midazolam. Each treatment was given as 10 separate IN sprays, self-administered 5 min apart. The study was stopped early due to poor tolerability after five treatment-resistant depressed participants were included. Feasibility, safety (acute and cumulative), cognitive and efficacy outcomes were assessed. Plasma ketamine and norketamine concentrations were assayed after the first treatment. Significant acute cardiovascular, psychotomimetic and neurological side effects occurred at doses < 100 mg ketamine. No participants were able to self-administer all 10 ketamine sprays due to incoordination; treatment time occasionally had to be extended (>45 min) due to acute side effects. No hepatic, cognitive or urinary changes were observed after the treatment course in either group. There was an approximately two-fold variation in ketamine and norketamine plasma concentrations between ketamine participants. At course end, one participant had remitted in each of the ketamine and midazolam groups. IN ketamine, with the drug formulation and delivery device used, was not a useful treatment approach in this study. Absorption was variable between individuals and acute tolerability was poor, requiring prolonged treatment administration time in some individuals. The drug formulation, the delivery device, the insufflation technique and individual patient factors play an important role in tolerability and efficacy when using IN ketamine for TRD.

A Breathing-Based Meditation Intervention for Patients With Major Depressive Disorder Following Inadequate Response to Antidepressants: A Randomized Pilot Study.

PubMed

Sharma, Anup; Barrett, Marna S; Cucchiara, Andrew J; Gooneratne, Nalaka S; Thase, Michael E

2017-01-01

To evaluate feasibility, efficacy, and tolerability of Sudarshan Kriya yoga (SKY) as an adjunctive intervention in patients with major depressive disorder (MDD) with inadequate response to antidepressant treatment. Patients with MDD (defined by DSM-IV-TR) who were depressed despite ≥ 8 weeks of antidepressant treatment were randomized to SKY or a waitlist control (delayed yoga) arm for 8 weeks. The primary efficacy end point was change in 17-item Hamilton Depression Rating Scale (HDRS-17) total score from baseline to 2 months. The key secondary efficacy end points were change in Beck Depression Inventory (BDI) and Beck Anxiety Inventory (BAI) total scores. Analyses of the intent-to-treat (ITT) and completer sample were performed. The study was conducted at the University of Pennsylvania between October 2014 and December 2015. In the ITT sample (n = 25), the SKY arm (n = 13) showed a greater improvement in HDRS-17 total score compared to waitlist control (n = 12) (-9.77 vs 0.50, P = .0032). SKY also showed greater reduction in BDI total score versus waitlist control (-17.23 vs -1.75, P = .0101). Mean changes in BAI total score from baseline were significantly greater for SKY than waitlist (ITT mean difference: -5.19; 95% CI, -0.93 to -9.34; P = .0097; completer mean difference: -6.23; 95% CI, -1.39 to -11.07; P = .0005). No adverse events were reported. Results of this randomized, waitlist-controlled pilot study suggest the feasibility and promise of an adjunctive SKY-based intervention for patients with MDD who have not responded to antidepressants. ClinicalTrials.gov identifier: NCT02616549. © Copyright 2016 Physicians Postgraduate Press, Inc.

Launching College Students on Academic Probation into the First Phase of Self-Efficacy: A Descriptive Case Survey

ERIC Educational Resources Information Center

Holland, Rochelle

2005-01-01

The purpose of this case survey was to examine the reasons that students provide regarding why they are on academic probation and the efficacy of discussing the family life cycle among this group. Initially, a pilot population of 93 students on academic probation, who are a part of a multi-cultural community college in New York City, were surveyed…

Two Pilot Randomized Trials To Examine Feasibility and Impact of Treated Parents as Peer Interventionists in Family-Based Pediatric Weight Management.

PubMed

Saelens, Brian E; Scholz, Kelley; Walters, Kelly; Simoni, Jane M; Wright, Davene R

2017-08-01

To examine feasibility and initial efficacy of having previously treated parents serve as peer interventionists in family-based behavioral weight management treatment (FBT). Children aged 7-11 years with overweight/obesity and parents (n = 59 families) were enrolled in one of two pilot trials, the EPICH (Engaging Parents in Child Health) randomized trial comparing professional versus peer FBT delivery or the Parent Partnership trial, which provided professionally delivered FBT to families (first generation) and then randomly assigned first generation parents to either be or not be peer interventionists for subsequent families (second generation). Efficacy (child zBMI change), feasibility, and costs for delivering FBT, and impacts of being a peer interventionist were examined. In EPICH, families receiving professional versus peer intervention had similar decreases in child zBMI and parent BMI, with markedly lower costs for peer versus professional delivery. In Parent Partnership, families receiving peer intervention significantly decreased weight status, with very preliminary evidence suggesting better maintenance of child zBMI changes if parents served as peer interventionists. Previously treated parents were willing, highly confident, and able to serve as peer interventionists in FBT. Two pilot randomized clinical trials suggest parents-as-peer interventionists in FBT may be feasible, efficacious, and delivered at lower costs, with perhaps some additional benefits to serving as a peer interventionist. More robust investigation is warranted of peer treatment delivery models for pediatric weight management.

The development of a community and home-based chronic care management program for older adults.

PubMed

Cooper, Jennifer; McCarter, Kathryn A

2014-01-01

The objective of this paper was to evaluate a chronic care management program piloted by a visiting nurses association. Desired outcomes were to increase nurses' knowledge of self-management of chronic conditions and improve patient self-efficacy and clinical measures. The program provided educational development for nurses and piloted encounters with patients with chronic conditions targeting community health nurses for a chronic care professional (CCP) certification and invited 300 faith community nurses to an education program on chronic condition(s). Thirteen patients with chronic condition(s) were enrolled. Chronic care professional modules were used to increase nurses' knowledge and were measured by successful completion of a certification exam. Faith community nurses participated in an education program and completed a posttest to measure knowledge of content. Patient improvement in self-management was measured by pre- and postintervention self-efficacy scores and clinical measures. Seventeen nurses successfully completed the exam, and 38 faith community nurses participated in the program and completed the posttest. Three patients showed improvement in self-efficacy scores and eight in clinical measures. The educational development of community nurses prepared them to provide effective encounters to improve self-efficacy and clinical outcomes for older adults with chronic conditions. © 2013 Wiley Periodicals, Inc.

The Efficacy and Safety of Azelaic Acid 15% Foam in the Treatment of Truncal Acne Vulgaris.

PubMed

Hoffman, Lauren K; Del Rosso, James Q; Kircik, Leon H

2017-06-01

INTRODUCTION: Truncal acne is often associated with facial acne, but there are fewer options for an effective topical treatment on the trunk. Given the advent of foam formulations with enhanced percutaneous absorption and convenient application due to easy spreadability on skin, the previously held idea that effective treatment of truncal acne requires oral treatment is challenged. Azelaic acid cream has been previously approved for acne vulgaris, thus azelaic acid foam may be a viable treatment option for truncal acne.

STUDY DESIGN: A single-center, open label pilot study was conducted to investigate the efficacy and safety of azelaic acid 15% foam as a treatment modality for moderate truncal acne. Use for facial acne was also allowed and monitored during the study.

RESULTS: Twice-daily application of azelaic acid 15% foam to affected areas resulted in a 1-grade reduction in truncal investigator global assessment (IGA) scores in nearly all patients (16/18). Eight out of 18 patients (44%) were rated as Clear or Almost Clear in the trunk by the end of the study. There were also improvements in facial IGA scores; 9 of 18 patients (50%) exhibited a 1-grade improvement in IGA scores and 11 of 18 were Clear or Almost Clear by the end of the study. A significant reduction in lesion counts was found throughout the study and the medication was well tolerated.

CONCUSION: Azelaic acid 15% foam was effective in treating moderate truncal acne and facial acne in this pilot study. Given the efficacy and convenience of the foam vehicle, azelaic acid may be considered as a viable option for treatment of acne vulgaris, including on the trunk. Further studies are suggested in a larger population of patients, including adult females with acne.

J Drugs Dermatol. 2017;16(6):534-538.

Android Robot-Mediated Mock Job Interview Sessions for Young Adults with Autism Spectrum Disorder: A Pilot Study

PubMed Central

Kumazaki, Hirokazu; Warren, Zachary; Corbett, Blythe A.; Yoshikawa, Yuichiro; Matsumoto, Yoshio; Higashida, Haruhiro; Yuhi, Teruko; Ikeda, Takashi; Ishiguro, Hiroshi; Kikuchi, Mitsuru

2017-01-01

The feasibility and preliminary efficacy of an android robot-mediated mock job interview training in terms of both bolstering self-confidence and reducing biological levels of stress in comparison to a psycho-educational approach human interview was assessed in a randomized study. Young adults (ages 18–25 years) with autism spectrum disorder (ASD) were randomized to participate either in a mock job interview training with our android robot system (n = 7) or a self-paced review of materials about job-interviewing skills (n = 8). Baseline and outcome measurements of self-reported performance/efficacy and salivary cortisol were obtained after a mock job interview with a human interviewer. After training sessions, individuals with ASD participating in the android robot-mediated sessions reported marginally improved self-confidence and demonstrated significantly lower levels of salivary cortisol as compared to the control condition. These results provide preliminary support for the feasibility and efficacy of android robot-mediated learning. PMID:28955254

Android Robot-Mediated Mock Job Interview Sessions for Young Adults with Autism Spectrum Disorder: A Pilot Study.

PubMed

Kumazaki, Hirokazu; Warren, Zachary; Corbett, Blythe A; Yoshikawa, Yuichiro; Matsumoto, Yoshio; Higashida, Haruhiro; Yuhi, Teruko; Ikeda, Takashi; Ishiguro, Hiroshi; Kikuchi, Mitsuru

2017-01-01

The feasibility and preliminary efficacy of an android robot-mediated mock job interview training in terms of both bolstering self-confidence and reducing biological levels of stress in comparison to a psycho-educational approach human interview was assessed in a randomized study. Young adults (ages 18-25 years) with autism spectrum disorder (ASD) were randomized to participate either in a mock job interview training with our android robot system ( n  = 7) or a self-paced review of materials about job-interviewing skills ( n  = 8). Baseline and outcome measurements of self-reported performance/efficacy and salivary cortisol were obtained after a mock job interview with a human interviewer. After training sessions, individuals with ASD participating in the android robot-mediated sessions reported marginally improved self-confidence and demonstrated significantly lower levels of salivary cortisol as compared to the control condition. These results provide preliminary support for the feasibility and efficacy of android robot-mediated learning.

Evidence-based HIV pilot program for Chinese college students: Differences by gender.

PubMed

Tung, Wei-Chen; Serratt, Teresa D; Lu, Minggen

2015-06-01

This study explored gender differences in the effectiveness of the translated VOICES (Video Opportunities for Condom Education and Safer Sex) intervention on the condom use intention, perceived benefits and barriers to condom use, condom use self-efficacy, and HIV/AIDS knowledge among Chinese students in a US university. We utilized a pretest/post-test quasi-experimental design and recruited 67 Chinese students at the local university. Participants viewed a 20-min video with Chinese subtitles, attended one 25-min small group discussion and condom interactive educational activity. Female participants showed significantly greater mean scores of perceived benefits and condom use self-efficacy, in comparison with male participants. Female participants also reported significantly higher scores than male participants in five of the perceived benefits items and one self-efficacy item. These study results provide important information for developing more differentiated intervention strategies specific to gender for HIV and STI education programs. © 2014 Wiley Publishing Asia Pty Ltd.

Bridging the digital divide in HIV care: a pilot study of an iPod personal health record.

PubMed

Luque, Amneris E; Corales, Roberto; Fowler, Richard J; DiMarco, Jamie; van Keken, Adjuah; Winters, Paul; Keefer, Michael C; Fiscella, Kevin

2013-01-01

Persons living with HIV (PLWH) need practical tools to self-manage their condition. We conducted a proof-of-concept study among PLWH to assess whether patients could learn to use a personal health record (PHR) on a hand-held device (iPod Touch) to manage their condition. We began individual trainings and later adapted this to group training. We assessed usability, acceptability and also effects on self-efficacy for treatment adherence using the HIV Treatment Adherence Self-Efficacy Scale (HIV-ASES). Nine PLWH participated in the individual training and 29 participated in the group sessions. The participants were largely middle aged, low-income and of racial/ethnic minorities. The sessions were well attended and participants fully engaged in tasks and shared learning. Most participants stated they intended to use the PHR and reported improved self-efficacy in treatment adherence (P = .05) particularly on the integration of treatment adherence into one's routine (P < .02). Training PLWH in use of a handheld PHR shows promise.

Pilot of the Chronic Disease Self-Management Program for Adolescents and Young Adults With Sickle Cell Disease.

PubMed

Crosby, Lori E; Joffe, Naomi E; Peugh, James; Ware, Russell E; Britto, Maria T

2017-01-01

This study evaluated the feasibility of a group self-management intervention, the well-established Stanford Chronic Disease Self-Management Program (CDSMP), for adolescents and young adults (AYA) with sickle cell disease (SCD). A total of 22 AYA participants with SCD, ages 16-24 years, completed self-efficacy and quality of life measures before the CDSMP, after, and 3 and 6 months later. This AYA cohort showed significant improvements in self-efficacy (primary outcome) after the intervention. Analyses of follow-up data revealed a medium effect of the CDSMP on patient activation 3 months post although this was not sustained. Participants were highly satisfied, but only 64% completed the program. This study demonstrates that the CDSMP is acceptable and has the ability to improve self-efficacy. Additional research is needed to determine feasibility and evaluate health outcomes for AYA with SCD. Copyright © 2016 Society for Adolescent Health and Medicine. Published by Elsevier Inc. All rights reserved.

[A pilot study of antibiotic cycling for the treatment of febrile neutropenia patients with hematological diseases].

PubMed

Ikegaya, Satoshi; Iwasaki, Hiromichi; Kinoshita, Keiichi; Urasaki, Yoshimasa; Tsutani, Hiroshi; Ueda, Takanori

2004-03-01

Two antibiotics recommended by the guideline of Infectious Diseases Society of America (IDSA) were selected for treatment of febrile neutropenia, and these paired antibiotics were changed periodically three times. The clinical efficacy of each antibiotic was retrospectively evaluated at the end of the final period. There was no significant difference about efficacy rate between two kinds of antibiotics in the same sequential period. However, the efficacy rate has been rising and febrile duration has been shortening by degrees. Only a few drug resistant bacteria were recognized by the surveillance culture during antibiotic cycling. Recently, antibiotic cycling therapy has attracted attention especially in the ICU. However, a clinical study of treatment for febrile neutropenia has not been reported. Our trial suggests that cycling therapy may be useful for febrile neutropenia. However, Some deviation in the patients characteristics of each period may affect the result. It seems that further examination is necessary about usefullness of the cycling therapy for febrile neutropenia.

Efficacy and Safety of Ashwagandha (Withania somnifera) Root Extract in Improving Sexual Function in Women: A Pilot Study

PubMed Central

Dongre, Swati

2015-01-01

Background. Many women experience sexual dysfunction where there are orgasm disorders and sexual difficulties. Ashwagandha (Withania somnifera) is a herb known to improve the body's physical and psychological condition. Objective. The purpose of the study was to determine the efficacy and safety of a high-concentration ashwagandha root extract (HCARE) supplementation for improving sexual function in healthy females. Methods. In this pilot study, 50 study subjects were randomized to either (i) HCARE-treated group or (ii) placebo- (starch-) treated group. The subjects consumed either HCARE or placebo capsules of 300mg twice daily for 8 weeks. Sexual function was assessed using two psychometric scales, the Female Sexual Function Index (FSFI) Questionnaire and the Female Sexual Distress Scale (FSDS), and by the number of total and successful sexual encounters. Results. The analysis indicates that treatment with HCARE leads to significantly higher improvement, relative to placebo, in the FSFI Total score (p < 0.001), FSFI domain score for “arousal” (p < 0.001), “lubrication” (p < 0.001), “orgasm” (p = 0.004), and “satisfaction” (p < 0.001), and also FSDS score (p < 0.001) and the number of successful sexual encounters (p < 0.001) at the end of the treatment. Conclusions. This study demonstrated that oral administration of HCARE may improve sexual function in healthy women. The present study is registered in the Clinical Trial Registry, Government of India, with a number CTRI/2015/07/006045. PMID:26504795

Effects of indoor gardening on sleep, agitation, and cognition in dementia patients--a pilot study.

PubMed

Lee, Y; Kim, S

2008-05-01

A pilot study was performed to examine the efficacy of indoor gardening on sleep, agitation and cognition of dementia patients. Twenty-three institutionalized dementia patients who had sleep disturbance and/or agitation participated in a 5-week study protocol of 1 week of baseline and 4 weeks of treatment. The study design was a one group repeated measures study. For the first and fifth week of the study period, sleep patterns, agitation, and cognition were evaluated using a sleep diary, Modified Cohen-Mansfield Agitation Inventory and revised Hasegawa Dementia Scale respectively. Significant improvement in wake after sleep onset, nap, nocturnal sleep time, and nocturnal sleep efficiency was identified. On the contrary sleep onset time, wake-up time, total sleep time did not change after indoor gardening. Agitation and cognition score was significantly improved. Indoor gardening was found to be effective for sleep, agitation, and cognition of dementia patients. Randomized controlled studies of larger sample size are needed to confirm treatment effect.

Four-year visual outcomes after photorefractive keratectomy in pilots with low-moderate myopia.

PubMed

Moon, Chan Hee

2016-02-01

The photorefractive keratectomy (PRK) is approved for Air Force pilots in several nations. The occupational environments of pilots in the Air Force are unique, including extremely high altitude, low oxygen tension, high ultraviolet light exposure and high G-force load. The short-term efficacy and safety of PRK for pilots are documented. However, the study for long-term visual and refractive outcomes of PRK in pilots is limited. To investigate the long-term visual and refractive outcomes in a 4-year follow-up period after PRK in pilots with low to moderate myopia. Thirty-eight eyes of 20 subjects that underwent PRK and recruited to Air Force pilot were evaluated preoperatively and at 3, 6, 12, 24, and 48 months postoperatively. The mean patient age was 21.42±0.75 years. The mean preoperative manifest refraction spherical equivalent (SE) was -1.51±1.15 diopters (D). At 4 years postoperatively, the mean SE was -0.29±0.51, 89.5% of eyes achieved 20/20 or better Snellen uncorrected visual acuity, 71.1% of eyes were within ±0.50 D of emmetropia. The refraction stabilised by 6 months and was maintained up to the 4-year follow-up stage. PRK for pilots with low to moderate myopia is safe and effective in the long term. High-altitude environmental stress exposure has no effect on the refractive stability after PRK. ROKAF-ASMC-2015-IRB-002. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/

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

Prospective pilot trial of PerMIT versus standard anticoagulation service management of patients initiating oral anticoagulation.

PubMed

Borgman, Mark P; Pendleton, Robert C; McMillin, Gwendolyn A; Reynolds, Kristen K; Vazquez, Sara; Freeman, Andrew; Wilson, Andrew; Valdes, Roland; Linder, Mark W

2012-09-01

We performed a randomised pilot trial of PerMIT, a novel decision support tool for genotype-based warfarin initiation and maintenance dosing, to assess its efficacy for improving warfarin management. We prospectively studied 26 subjects to compare PerMIT-guided management with routine anticoagulation service management. CYP2C9 and VKORC1 genotype results for 13 subjects randomly assigned to the PerMIT arm were recorded within 24 hours of enrolment. To aid in INR interpretation, PerMIT calculates estimated loading and maintenance doses based on a patient's genetic and clinical characteristics and displays calculated S-warfarin plasma concentrations based on planned or administered dosages. In comparison to control subjects, patients in the PerMIT study arm demonstrated a 3.6-day decrease in the time to reach a stabilised INR within the target therapeutic range (4.7 vs. 8.3 days, p = 0.015); a 12.8% increase in time spent within the therapeutic interval over the first 25 days of therapy (64.3% vs. 55.3%, p = 0.180); and a 32.9% decrease in the frequency of warfarin dose adjustments per INR measurement (38.3% vs. 57.1%, p = 0.007). Serial measurements of plasma S-warfarin concentrations were also obtained to prospectively evaluate the accuracy of the pharmacokinetic model during induction therapy. The PerMIT S-warfarin plasma concentration model estimated 62.8% of concentrations within 0.15 mg/l. These pilot data suggest that the PerMIT method and its incorporation of genotype/phenotype information may help practitioners increase the safety, efficacy, and efficiency of warfarin therapeutic management.

Sources of self-efficacy belief: development and validation of two scales.

PubMed

Liu, Ou Lydia; Wilson, Mark

2010-01-01

Self-efficacy belief has been an instrumental affective factor in predicting student behavior and achievement in academic settings. Although there is abundant literature on efficacy belief per se, the sources of efficacy belief have not been fully researched. Very few instruments exist to quantify the sources of efficacy-beliefs. To fill this void, we developed two scales for the two main sources of self-efficacy belief: past performance and social persuasion. Pilot test data were collected from 255 middle school students. A self-efficacy measure was also administered to the students as a criterion measure. The Rasch rating scale model was used to analyze the data. Information on item fit, item design, content validity, external validity, internal consistency, and person separation reliability was examined. The two scales displayed satisfactory psychometric properties. Applications and limitations of these two scales are also discussed.

A randomized, controlled, single-blind, 6-month pilot study to evaluate the efficacy of MS-Line!: a cognitive rehabilitation programme for patients with multiple sclerosis.

PubMed

Gich, Jordi; Freixanet, Jordi; García, Rafael; Vilanova, Joan Carles; Genís, David; Silva, Yolanda; Montalban, Xavier; Ramió-Torrentà, Lluís

2015-09-01

MS-Line! was created to provide an effective treatment for cognitive impairment in multiple sclerosis (MS) patients. To assess the efficacy of MS-Line!. A randomized, controlled, single-blind, 6-month pilot study. Patients were randomly assigned to an experimental group (cognitive rehabilitation with the programme) or to a control group (no cognitive rehabilitation). Randomization was stratified by cognitive impairment level. Cognitive assessment included: selective reminding test, 10/36 spatial recall test (10/36 SPART), symbol digit modalities test, paced auditory serial addition test, word list generation (WLG), FAS test, subtests of WAIS-III, Boston naming test (BNT), and trail making test (TMT). Forty-three patients (22 in the experimental group, 21 in the control group) were analyzed. Covariance analysis showed significant differences in 10/36 SPART (P=0.0002), 10/36 SPART delayed recall (P=0.0021), WLG (P=0.0123), LNS (P=0.0413), BNT (P=0.0007) and TMT-A (P=0.010) scores between groups. The study showed a significant improvement related to learning and visual memory, executive functions, attention and information processing speed, and naming ability in those patients who received cognitive rehabilitation. The results suggest that MS-Line! is effective in improving cognitive impairment in MS patients. © The Author(s), 2015.

A pilot study with very low-intensity, intermediate-frequency electric fields in patients with locally advanced and/or metastatic solid tumors.

PubMed

Salzberg, Marc; Kirson, Eilon; Palti, Yoram; Rochlitz, Christoph

2008-07-01

The transmission of electric fields using insulated electrodes has demonstrated that very low-intensity, properly tuned, intermediate-frequency electric fields, termed tumor-treating fields (TTFields), selectively stunts tumor cell growth and is accompanied by a decrease in tumor angiogenesis. This open, prospective pilot study was designed to evaluate the safety, tolerability, and efficacy profile of TTFields treatment in patients with locally advanced and/or metastatic solid tumors using the NovoTTF100A(TM) device. All 6 patients were heavily pre-treated with several lines of therapy; no additional standard treatment option was available to them. TTFields treatment using continuous NovoTTF-100A lasted a minimum of 14 days and was very well tolerated. No related serious adverse events occurred. Outcomes showed 1 partial response of a treated skin metastasis from a primary breast cancer, 3 cases where tumor growth was arrested during treatment, and 1 case of disease progression. One mesothelioma patient experienced lesion regression near TTFields with simultaneous tumor stability or progression in distal areas. Although the number of patients in this study is small, the lack of therapy toxicity and the efficacy observed in data gathered to date indicate the potential of TTFields as a new treatment modality for solid tumors, definitely warranting further investigation. (c) 2008 S. Karger AG, Basel

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

The Potential Efficacy of Psychological First Aid on Self-Reported Anxiety and Mood: A Pilot Study.

PubMed

Everly, George S; Lating, Jeffrey M; Sherman, Martin F; Goncher, Ian

2016-03-01

The authors explored the efficacy of a randomized controlled trial to assess the potential benefits of psychological first aid (PFA) compared with a social acknowledgement condition in a sample of 42 participants who spoke about a stressful life event. Demographics and standardized questionnaires, including the state version of the State Trait Anxiety Inventory Scale and the Brief Profile of Mood States, assessed anxiety and mood state. Those in the PFA group evidenced significantly lower anxiety scores at 30-minute postdisclosure than at baseline and, although not significant, showed lowered distressed mood compared with baseline at 30-minute postdisclosure. Those in the social acknowledgment condition evidenced increases in anxiety and distressed mood scores, albeit not significantly, at 30 minutes post disclosure compared with their baseline scores. These results provide preliminary empirical evidence for the efficacy of PFA, and implications for intervention and additional assessment are suggested.

Game-based online antenatal breastfeeding education: A pilot.

PubMed

Grassley, Jane S; Connor, Kelley C; Bond, Laura

2017-02-01

The aim of this study was to evaluate the effect of the Healthy Moms intervention on antenatal breastfeeding self-efficacy and intention and to determine the feasibility of using an online game-based learning platform to deliver antenatal breastfeeding education. The Internet has potential for improving breastfeeding rates through improving women's access to antenatal breastfeeding education. Twelve computer-based breastfeeding education modules were developed using an online learning platform. Changes in participants' breastfeeding self-efficacy and intention pre- and post-intervention were measured using descriptive statistics and a one-way ANOVA. Of the 25 women submitting the pretest, four completed zero quests; seven, orientation only; eight, one to six breastfeeding quests; and six, 10 to 12 breastfeeding quests. No significant differences in breastfeeding self-efficacy and intention were found among the groups. Online antenatal breastfeeding education is feasible; however, further research is warranted to determine if it can affect breastfeeding outcomes. Copyright © 2016 Elsevier Inc. All rights reserved.

A Double Blind, Randomized Study of Safety and Efficacy of OnabotulinumtoxinA (OnaBoNT A) versus Oral Oxybutynin in SCI Patients with NDO (11 09 10 04)

DTIC Science & Technology

2017-10-01

Overactive bladder is a condition resulting from disruption of the normal micturition process. It is a syndrome complex characterized by urinary...from our pilot study in patients with another model of bladder dysfunction (i.e. interstitial cystitis/painful bladder syndrome (IC/PBS)) implanted...increased risk with exposure to ONAboNT-A including diagnosed myasthenia gravis, Eaton-Lambert syndrome or amyotrophic lateral sclerosis. 17

A Pilot Study to Test the Efficacy of Psychologically Based Physical Therapy Training for Treating Deployed U.S. Sailors and Marines with Musculoskeletal Injuries

DTIC Science & Technology

2016-10-01

purpose of this study is to demonstrate the effectiveness of a PBPT intervention for the prevention of disability in ADSM who sustain an MSI during...intervention, pain coping skills, outcome, randomized controlled trial, risk factor, disability , attrition. 16. SECURITY CLASSIFICATION OF: Unclassified 17...help all service members who sustain MSI by improving care, reducing the need for ongoing medical utilization and reducing disability . 2. Keywords

Effectiveness of the Neonatal Discharge Program for Very Low-Birth-Weight Infants on Parental Efficacy and Psychological Distress.

PubMed

Shandra Bos, Lakshmi; Shorey, Shefaly; Kulantaipian, Tamill Salvee; Sng, Jane S P; Tam, Wilson W S; Koh, Serena S L

2018-05-17

This pilot study aimed to (i) evaluate the effectiveness of a neonatal discharge program, (ii) identify relationships between parent and infant factors and parental efficacy and psychological distress, and (iii) identify ways to improve the neonatal discharge program. A quasiexperimental 1-group pretest/posttest design was used. Through consecutive sampling, 42 participants were recruited. Data were collected using self-report questionnaires. Self-administering instruments gathered data on parental efficacy and psychological distress as well as feedback and recommendations on the intervention. A significant increase in parental efficacy and a reduction in psychological distress were observed from pre- to postdischarge intervention. Significant relationships were found between parental efficacy and infants' gestational age, birth weight, gender, and participants' level of education, and a significant relationship was found between psychological distress and number of children from previous pregnancies. Moreover, an Internet-based program, in addition to the face-to-face teaching, was identified as a preferred option to aid in information retention. It is important to evaluate and enhance the neonatal discharge program to suit the parents of today while providing them with informational and emotional support. Future studies should explore parental coping and the long-term effects of their infant's birth and the intervention.

Synthetic Vision Enhanced Surface Operations and Flight Procedures Rehearsal Tool

NASA Technical Reports Server (NTRS)

Arthur, Jarvis J., III; Prinzel, Lawrence J., III; Williams, Steven P.; Kramer, Lynda J.

2006-01-01

Limited visibility has been cited as predominant causal factor for both Controlled-Flight-Into-Terrain (CFIT) and runway incursion accidents. NASA is conducting research and development of Synthetic Vision Systems (SVS) technologies which may potentially mitigate low visibility conditions as a causal factor to these accidents while replicating the operational benefits of clear day flight operations, regardless of the actual outside visibility condition. Two experimental evaluation studies were performed to determine the efficacy of two concepts: 1) head-worn display application of SVS technology to enhance transport aircraft surface operations, and 2) three-dimensional SVS electronic flight bag display concept for flight plan preview, mission rehearsal and controller-pilot data link communications interface of flight procedures. In the surface operation study, pilots evaluated two display devices and four display modes during taxi under unlimited and CAT II visibility conditions. In the mission rehearsal study, pilots flew approaches and departures in an operationally-challenged airport environment, including CFIT scenarios. Performance using the SVS concepts was compared to traditional baseline displays with paper charts only or EFB information. In general, the studies evince the significant situation awareness and enhanced operational capabilities afforded from these advanced SVS display concepts. The experimental results and conclusions from these studies are discussed along with future directions.

The Association between Generalized Anxiety Disorder, Subthreshold Anxiety Symptoms and Fear of Falling among Older Adults: Preliminary Results from a Pilot Study.

PubMed

Payette, Marie-Christine; Bélanger, Claude; Benyebdri, Fethia; Filiatrault, Johanne; Bherer, Louis; Bertrand, Josie-Anne; Nadeau, Alexandra; Bruneau, Marie-Andrée; Clerc, Doris; Saint-Martin, Monique; Cruz-Santiago, Diana; Ménard, Caroline; Nguyen, Philippe; Vu, T T Minh; Comte, Francis; Bobeuf, Florian; Grenier, Sébastien

2017-01-01

A relationship between generalized anxiety disorder (GAD) and fear of falling (FOF) has long been proposed but never specifically studied. This study aimed at analyzing the relationship between FOF and GAD or anxiety symptoms, while controlling for major depressive episodes (MDE), depressive symptoms, fall risk, and sociodemographic variables. Twenty-five older adults participated in this pilot study. Assessments included the following: Anxiety Disorder Interview Schedule, Geriatric Anxiety Inventory, Geriatric Depression Scale, Falls-Efficacy Scale-International. A multidisciplinary team evaluated fall risk. FOF was significantly correlated with GAD, MDE, anxiety and depressive symptoms, and fall risk, but not with sociodemographic variables. Multiple regression analyses indicated that GAD and anxiety symptoms were significantly and independently associated with FOF. Although the results of this pilot study should be replicated with larger samples, they suggest that FOF is associated with GAD and anxiety symptoms even when considering physical factors that increase the risk of falling. Treatment of FOF in patients with GAD may present a particular challenge because of the central role of intolerance of uncertainty, which may prevent patients from regaining confidence despite the reduction of fall risk. Clinicians should screen for GAD and anxiety symptoms in patients with FOF to improve detection and treatment.

Training on domestic violence and child safeguarding in general practice: a mixed method evaluation of a pilot intervention.

PubMed

Lewis, Natalia V; Larkins, Cath; Stanley, Nicky; Szilassy, Eszter; Turner, William; Drinkwater, Jessica; Feder, Gene S

2017-03-04

Children's exposure to domestic violence is a type of child maltreatment, yet many general practice clinicians remain uncertain of their child safeguarding responsibilities in the context of domestic violence. We developed an evidence-based pilot training on domestic violence and child safeguarding for general practice teams. The aim of this study was to test and evaluate its feasibility, acceptability and the direction of change in short-term outcome measures. We used a mixed method design which included a pre-post questionnaire survey, qualitative analysis of free-text comments, training observations, and post-training interviews with trainers and participants. The questionnaire survey used a validated scale to measure participants' knowledge, confidence/ self-efficacy, and beliefs/ attitudes towards domestic violence and child safeguarding in the context of domestic violence. Eleven UK general practices were recruited (response rate 55%) and 88 clinicians attended the pilot training. Thirty-seven participants (42%) completed all pre-post questionnaires and nine were interviewed. All training sessions were observed. All six trainers were interviewed. General practice clinicians valued the training materials and teaching styles, opportunities for reflection and delivery by local trainers from both health and children's social services. The training elicited positive changes in total outcome score and knowledge and confidence/ self-efficacy sub scores which remained at 3-month follow up. However, the mean sub score of beliefs and attitudes did not change and the qualitative results were mixed. Two interviewees described changes in their clinical practice. Participants' suggestions for improving the training included incorporating more ethnic and class diversity in the material, using cases with multiple socio economic disadvantages, and addressing multi-agency collaboration in the context of changing and under-resourced services for children. The pilot training for general practice on child safeguarding in the context of domestic violence was feasible and acceptable. It elicited positive changes in clinicians' knowledge and confidence/ self-esteem. The extent to which clinical behaviour changed is unclear, but there are indications of changes in practice by some clinicians. The pilot training requires further refinement and evaluation before implementation.

Effects of martial arts exercise on body composition, serum biomarkers and quality of life in overweight/obese premenopausal women: a pilot study

PubMed Central

Chyu, Ming-Chien; Zhang, Yan; Brismée, Jean-Michel; Dagda, Raul Y.; Chaung, Eugene; Von Bergen, Vera; Doctolero, Susan; Shen, Chwan-Li

2013-01-01

Various exercise interventions have been shown to benefit weight control and general health in different populations. However, very few studies have been conducted on martial arts exercise (MAE). The objective of this pilot study is to evaluate the efficacy of 12 weeks of MAE intervention on body composition, serum biomarkers and quality of life (QOL) in overweight/obese premenopausal women. We found that subjects in the MAE group did not lose body weight, while they significantly decreased fat-free mass and muscle mass as compared to those in the control group, who demonstrated an increase in these parameters. The MAE group demonstrated an increase in serum IGF-I concentration, but no change in others. MAE may be a feasible and effective approach to improve body composition and QOL in overweight/obese premenopausal women. Our study underscores the need for further studies using larger samples to establish possible benefits of MAE in various populations. PMID:24665215

A randomized controlled pilot study of VO2 max testing: a potential model for measuring relative in vivo efficacy of different red blood cell products.

PubMed

Bennett-Guerrero, Elliott; Lockhart, Evelyn L; Bandarenko, Nicholas; Campbell, Mary L; Natoli, Michael J; Jamnik, Veronika K; Carter, Timothy R; Moon, Richard E

2017-03-01

Randomized trials, for example, RECESS, comparing "young" (median, 7-day) versus "middle-aged" (median, 28-day) red blood cells (RBCs), showed no difference in outcome. These data are important; however, they do not inform us about the safety and effectiveness of the oldest RBCs, which some patients receive. It may not be feasible to conduct a clinical trial randomizing patients to receive the oldest blood. Therefore, we propose strenuous exercise (VO 2 max testing) as a model to study the relative efficacy to increase oxygen delivery to tissue of different RBC products, for example, extremes of storage duration. In this pilot study, eight healthy subjects had 2 units of leukoreduced RBCs collected by apheresis in AS-3 using standard methods. Subjects were randomized to receive both (2) units of their autologous RBCs at either 7 or 42 days after blood collection. VO 2 max testing on a cycle ergometer was performed 2 days before (Monday) and 2 days after (Friday) the transfusion visit (Wednesday). This design avoids confounding effects on intravascular volume from the 2-unit blood transfusion. The primary outcome was the difference in VO 2 max between Friday and Monday (delta VO 2 max). VO 2 max increased more in the 7-day RBC arm (8.7 ± 6.9% vs. 1.9 ± 6.5%, p = 0.202 for comparison between arms). Exercise duration (seconds) increased in the 7-day RBC arm (8.4 ± 1.7%) but actually decreased in the 42-day arm (-2.6 ± 3.6%, p = 0.002). This pilot study suggests that VO 2 max testing has potential as a rigorous and quantitative in vivo functional assay of RBC function. Our preliminary results suggest that 42-day RBCs are inferior to 7-day RBCs at delivering oxygen to tissues. © 2016 AABB.

Tobacco cessation intervention during pregnancy among Alaska Native women.

PubMed

Patten, Christi A

2012-04-01

This paper describes a community-based participatory research program with Alaska Native people addressing a community need to reduce tobacco use among pregnant women and children. Tobacco use during pregnancy among Alaska Native women is described along with development of a community partnership, findings from a pilot tobacco cessation intervention, current work, and future directions. Among Alaska Native women residing in the Yukon Kuskokwim Delta region of western Alaska, the prevalence of tobacco use (cigarette smoking and/or use of smokeless tobacco) during pregnancy is 79%. Results from a pilot intervention study targeting pregnant women indicated low rates of participation and less than optimal tobacco abstinence outcomes. Developing alternative strategies to reach pregnant women and to enhance the efficacy of interventions is a community priority, and future directions are offered.

USE OF NEUROFEEDBACK AND MINDFULNESS TO ENHANCE RESPONSE TO HYPNOSIS TREATMENT IN INDIVIDUALS WITH MULTIPLE SCLEROSIS: Results From a Pilot Randomized Clinical Trial.

PubMed

Jensen, Mark P; Battalio, Samuel L; Chan, Joy F; Edwards, Karlyn A; Day, Melissa A; Sherlin, Leslie H; Ehde, Dawn M

2018-01-01

This pilot study evaluated the possibility that 2 interventions hypothesized to increase slower brain oscillations (e.g., theta) may enhance the efficacy of hypnosis treatment, given evidence that hypnotic responding is associated with slower brain oscillations. Thirty-two individuals with multiple sclerosis and chronic pain, fatigue, or both, were randomly assigned to 1 of 2 interventions thought to increase slow wave activity (mindfulness meditation or neurofeedback training) or no enhancing intervention, and then given 5 sessions of self-hypnosis training targeting their presenting symptoms. The findings supported the potential for both neurofeedback and mindfulness to enhance response to hypnosis treatment. Research using larger sample sizes to determine the generalizability of these findings is warranted.

Tobacco Cessation Intervention During Pregnancy Among Alaska Native Women

PubMed Central

2014-01-01

This paper describes a community-based participatory research program with Alaska Native people addressing a community need to reduce tobacco use among pregnant women and children. Tobacco use during pregnancy among Alaska Native women is described along with development of a community partnership, findings from a pilot tobacco cessation intervention, current work, and future directions. Among Alaska Native women residing in the Yukon Kuskokwim Delta region of western Alaska, the prevalence of tobacco use (cigarette smoking and/or use of smokeless tobacco) during pregnancy is 79%. Results from a pilot intervention study targeting pregnant women indicated low rates of participation and less than optimal tobacco abstinence outcomes. Developing alternative strategies to reach pregnant women and to enhance the efficacy of interventions is a community priority, and future directions are offered. PMID:22311690

Mindfulness for teachers: A pilot study to assess effects on stress, burnout and teaching efficacy

PubMed Central

Flook, Lisa; Goldberg, Simon B.; Pinger, Laura; Bonus, Katherine; Davidson, Richard J.

2013-01-01

Despite the crucial role of teachers in fostering children's academic learning and social-emotional well-being, addressing teacher stress in the classroom remains a significant challenge in education. The present study reports results from a randomized controlled pilot trial of a modified Mindfulness-Based Stress Reduction course (mMBSR) adapted specifically for teachers. Results suggest the course may be a promising intervention, with participants showing significant reductions in psychological symptoms and burnout, improvements in observer-rated classroom organization and performance on a computer task of affective attentional bias, and increases in self-compassion. In contrast, control group participants showed declines in cortisol functioning over time and marginally significant increases in burnout. Furthermore, changes in mindfulness were correlated in the expected direction with changes across several outcomes (psychological symptoms, burnout, sustained attention) in the intervention group. Implications of these findings for the training and support of teachers are discussed. PMID:24324528

A Pilot Study of Mindfulness Meditation for Pediatric Chronic Pain

PubMed Central

Waelde, Lynn C.; Feinstein, Amanda B.; Bhandari, Rashmi; Griffin, Anya; Yoon, Isabel A.; Golianu, Brenda

2017-01-01

Despite advances in psychological interventions for pediatric chronic pain, there has been little research examining mindfulness meditation for these conditions. This study presents data from a pilot clinical trial of a six-week manualized mindfulness meditation intervention offered to 20 adolescents aged 13–17 years. Measures of pain intensity, functional disability, depression and parent worry about their child’s pain were obtained at baseline and post-treatment. Results indicated no significant changes in pain or depression, however functional disability and frequency of pain functioning complaints improved with small effect sizes. Parents’ worry about child’s pain significantly decreased with a large effect size. Participants rated intervention components positively and most teens suggested that the number of sessions be increased. Three case examples illustrate mindfulness meditation effects and precautions. Mindfulness meditation shows promise as a feasible and acceptable intervention for youth with chronic pain. Future research should optimize intervention components and determine treatment efficacy. PMID:28445406

Topical Treatment With Liposomal Sodium Copper Chlorophyllin Complex in Subjects With Facial Redness and Erythematotelangiectatic Rosacea: Case Studies.

PubMed

Vasily, David B

2015-10-01

Physicians are often presented with patients complaining of facial redness and difficult to control rosacea. The water soluble sodium copper chlorophyllin complex has been shown to have anti-oxidant, anti-inflammatory, and anti-bacterial activities in vitro and anti-redness, pore reduction, and anti-acne activities in pilot clinical studies. In these case studies, the safety and efficacy of a topical gel containing a liposomal suspension of sodium copper chlorophyllin complex was assessed in subjects with facial redness and erythematotelangiectatic rosacea.

A Pilot Randomised Controlled Trial of a School-Based Resilience Intervention to Prevent Depressive Symptoms for Young Adolescents with Autism Spectrum Disorder: A Mixed Methods Analysis.

PubMed

Mackay, Bethany A; Shochet, Ian M; Orr, Jayne A

2017-11-01

Despite increased depression in adolescents with Autism Spectrum Disorder (ASD), effective prevention approaches for this population are limited. A mixed methods pilot randomised controlled trial (N = 29) of the evidence-based Resourceful Adolescent Program-Autism Spectrum Disorder (RAP-A-ASD) designed to prevent depression was conducted in schools with adolescents with ASD in years 6 and 7. Quantitative results showed significant intervention effects on parent reports of adolescent coping self-efficacy (maintained at 6 month follow-up) but no effect on depressive symptoms or mental health. Qualitative outcomes reflected perceived improvements from the intervention for adolescents' coping self-efficacy, self-confidence, social skills, and affect regulation. Converging results remain encouraging given this population's difficulties coping with adversity, managing emotions and interacting socially which strongly influence developmental outcomes.

Effects of Fructans from Mexican Agave in Newborns Fed with Infant Formula: A Randomized Controlled Trial

PubMed Central

López-Velázquez, Gabriel; Parra-Ortiz, Minerva; De la Mora-De la Mora, Ignacio; García-Torres, Itzhel; Enríquez-Flores, Sergio; Alcántara-Ortigoza, Miguel Angel; González-del Angel, Ariadna; Velázquez-Aragón, José; Ortiz-Hernández, Rosario; Cruz-Rubio, José Manuel; Villa-Barragán, Pablo; Jiménez-Gutiérrez, Carlos; Gutiérrez-Castrellón, Pedro

2015-01-01

Background: The importance of prebiotics consumption is increasing all over the world due to their beneficial effects on health. Production of better prebiotics from endemic plants raises possibilities to enhance nutritional effects in vulnerable population groups. Fructans derived from Agave Plant have demonstrated their safety and efficacy as prebiotics in animal models. Recently, the safety in humans of two fructans obtained from Agave tequilana (Metlin® and Metlos®) was demonstrated. Methods: This study aimed to demonstrate the efficacy as prebiotics of Metlin® and Metlos® in newborns of a randomized, double blind, controlled trial with a pilot study design. Biological samples were taken at 20 ± 7 days, and three months of age from healthy babies. Outcomes of efficacy include impact on immune response, serum ferritin, C-reactive protein, bone metabolism, and gut bacteria changes. Results: There were differences statistically significant for the groups of infants fed only with infant formula and with formula enriched with Metlin® and Metlos®. Conclusions: Our results support the efficacy of Metlin® and Metlos® as prebiotics in humans, and stand the bases to recommend their consumption. Trial Registration: ClinicalTrials.gov, NCT 01251783. PMID:26529006

Effects of Fructans from Mexican Agave in Newborns Fed with Infant Formula: A Randomized Controlled Trial.

PubMed

López-Velázquez, Gabriel; Parra-Ortiz, Minerva; Mora, Ignacio De la Mora-De la; García-Torres, Itzhel; Enríquez-Flores, Sergio; Alcántara-Ortigoza, Miguel Angel; Angel, Ariadna González-Del; Velázquez-Aragón, José; Ortiz-Hernández, Rosario; Cruz-Rubio, José Manuel; Villa-Barragán, Pablo; Jiménez-Gutiérrez, Carlos; Gutiérrez-Castrellón, Pedro

2015-10-29

The importance of prebiotics consumption is increasing all over the world due to their beneficial effects on health. Production of better prebiotics from endemic plants raises possibilities to enhance nutritional effects in vulnerable population groups. Fructans derived from Agave Plant have demonstrated their safety and efficacy as prebiotics in animal models. Recently, the safety in humans of two fructans obtained from Agave tequilana (Metlin(®) and Metlos(®)) was demonstrated. This study aimed to demonstrate the efficacy as prebiotics of Metlin(®) and Metlos(®) in newborns of a randomized, double blind, controlled trial with a pilot study design. Biological samples were taken at 20 ± 7 days, and three months of age from healthy babies. Outcomes of efficacy include impact on immune response, serum ferritin, C-reactive protein, bone metabolism, and gut bacteria changes. There were differences statistically significant for the groups of infants fed only with infant formula and with formula enriched with Metlin(®) and Metlos(®). Our results support the efficacy of Metlin(®) and Metlos(®) as prebiotics in humans, and stand the bases to recommend their consumption. ClinicalTrials.gov, NCT 01251783.

Pilot study to train dentists to communicate about oral cancer: the impact on dentists' self-reported behaviour, confidence and beliefs.

PubMed

Awojobi, O; Newton, J T; Scott, S E

2016-01-22

To evaluate the effect of a brief, focused training session on the use of an oral cancer communication guide on dentists' intentions, self-efficacy and beliefs with regards to communicating about oral cancer with patients. Pre-post intervention study. The training session took place in a lecture theatre at King's College London. Dentists working in various settings were trained on the use of the oral cancer communication guide via a structured session that included an update on oral cancer, modelling the use of the guide in practice, and role playing. Dentists (n = 39) completed questionnaires pre-training, immediately post-training (n = 31) and after 2 weeks (n = 23). Questionnaires assessed current practice, self-efficacy and barriers to discussing oral cancer. A significantly higher proportion of dentists reported that they informed patients that they were being screened for oral cancer post-training (44%) than pre-training (16%). Significantly fewer perceived barriers and higher self-efficacy to discuss oral cancer were also reported. Training dentists in the use of the guide showed positive impact by reducing perceived barriers and increasing self-efficacy.

A novel approach to training attention and gaze in ASD: A feasibility and efficacy pilot study.

PubMed

Chukoskie, Leanne; Westerfield, Marissa; Townsend, Jeanne

2018-05-01

In addition to the social, communicative and behavioral symptoms that define the disorder, individuals with ASD have difficulty re-orienting attention quickly and accurately. Similarly, fast re-orienting saccadic eye movements are also inaccurate and more variable in both endpoint and timing. Atypical gaze and attention are among the earliest symptoms observed in ASD. Disruption of these foundation skills critically affects the development of higher level cognitive and social behavior. We propose that interventions aimed at these early deficits that support social and cognitive skills will be broadly effective. We conducted a pilot clinical trial designed to demonstrate the feasibility and preliminary efficacy of using gaze-contingent video games for low-cost in-home training of attention and eye movement. Eight adolescents with ASD participated in an 8-week training, with pre-, mid- and post-testing of eye movement and attention control. Six of the eight adolescents completed the 8 weeks of training and all six showed improvement in attention (orienting, disengagement) and eye movement control or both. All game systems remained intact for the duration of training and all participants could use the system independently. We delivered a robust, low-cost, gaze-contingent game system for home use that, in our pilot training sample, improved the attention orienting and eye movement performance of adolescent participants in 8 weeks of training. We are currently conducting a clinical trial to replicate these results and to examine what, if any, aspects of training transfer to more real-world tasks. © 2017 Wiley Periodicals, Inc. Develop Neurobiol 78: 546-554, 2018. © 2017 Wiley Periodicals, Inc.

Treatment of Palmar Plantar Erythrodysesthesia (PPE) with Topical Sildenafil: A Pilot Study

PubMed Central

Meadows, Kellen L.; Rushing, Christel; Honeycutt, Wanda; Latta, Kenneth; Howard, Leigh; Arrowood, Christy A.; Niedzwiecki, Donna; Hurwitz, Herbert I.

2016-01-01

Purpose Palmar-plantar erythrodysethesia (PPE) is a common chemotherapy and anti-VEGF multi-kinase inhibitor class-related toxicity that often results in debilitating skin changes and often limits the use of active anti-cancer regimens. Mechanistic and anecdotal clinical evidence suggested that topical application of sildenafil cream may help reduce the severity of PPE. Therefore, we conducted a randomized, double-blind, placebo-controlled pilot study to evaluate the feasibility, safety and efficacy of topical sildenafil cream for the treatment of PPE. Methods Eligible subjects were required to have grade 1–3 PPE associated with either capecitabine or sunitinib. Subjects were randomized to receive 1% topical sildenafil cream to the left extremities or right extremities and placebo cream on the opposite extremity. 0.5 mL of cream was applied to each affected hand/foot two times per day. The primary endpoint was improvement in PPE grading at any point on study. Clinical assessments were evaluated by NCI-CTC 4.0 grading and patient self-reported pain. Results Ten subjects were enrolled; 9 were evaluable for safety and efficacy. Five of nine subjects reported some improvement in foot pain and 3 of 8 subjects for hand pain improvement. One of these subjects noted specific improvement in tactile function. No treatment-related toxicities were observed. Conclusions In this limited, single center study, topical cream containing 1% sildenafil is feasible to administer, is well-tolerated, and may mitigate PPE-related symptoms due to anti-cancer therapeutic agents. Further validation is necessary. PMID:25341548

A Pilot Study of a Group-Based HIV and STI Prevention Intervention for Lesbian, Bisexual, Queer, and Other Women Who Have Sex with Women in Canada.

PubMed

Logie, Carmen H; Lacombe-Duncan, Ashley; Weaver, James; Navia, Daniela; Este, David

2015-06-01

Limited research has evaluated interventions to reduce HIV and sexually transmitted infection (STI) vulnerability among lesbian, bisexual, and queer (LBQ) women, and other women who have sex with women. The Queer Women Conversations (QWC) study examined the effectiveness of a group-based psycho-educational HIV/STI intervention with LBQ women in Toronto and Calgary, Canada. We conducted a nonrandomized cohort pilot study. Participants completed a pre-test, post-test, and 6-week follow-up. The primary outcome was sexual risk practices, while secondary objectives included intrapersonal (self-esteem, STI knowledge, resilient coping, depression), interpersonal (safer sex self-efficacy), community (community connectedness, social support), and structural (sexual stigma, access to healthcare) factors. The study was registered at http://clinicaltrials.gov. Forty-four women (mean age 28.7 years) participated in a weekend retreat consisting of six consecutive sessions tailored for LBQ women. Sessions covered a range of topics addressing behavioral and social-structural determinants of HIV/STI risk, including STI information, safer sex negotiation skills, and addressing sexual stigma. Adjusted for socio-demographic characteristics, sexual risk practices (β2=-2.96, 95% CI -4.43, -1.50), barrier use self-efficacy (β2=1.52, 95% CI 0.51, 2.53), STI knowledge (β2=4.41, 95% CI 3.52, 5.30), and sexual stigma (β2=-2.62, 95% CI -3.48, -1.75) scores showed statistically significant changes 6 weeks post-intervention. Initial increases in safer sex self-efficacy, social support, and community connectedness were not sustained at 6-week follow up, highlighting the need for booster sessions or alternative approaches to address social factors. Study results may inform HIV/STI prevention interventions, sexual health care provision, and support services tailored for LBQ women.

Comparative randomized pilot study of azithromycin and doxycycline efficacy and tolerability in the treatment of prostate infection caused by Ureaplasma urealyticum.

PubMed

Skerk, Visnja; Mareković, Ivana; Markovinović, Leo; Begovac, Josip; Skerk, Vedrana; Barsić, Neven; Majdak-Gluhinić, Vida

2006-01-01

A total of 1,442 patients with symptoms of chronic prostatitis were examined over a 4-year period at the Outpatient Department for Urogenital Infections, University Hospital for Infectious Diseases Dr. Fran Mihaljević, Zagreb, Croatia. The inclusion criteria for chronic prostatitis caused by Ureaplasma urealyticum were the presence of clinical symptoms, presence of U. urealyticum in expressed prostatic secretion (EPS) or voided urine collected immediately after prostatic massage (VB(3)), absence of U. urealyticum in urethral swabs and absence of other possible pathogens of chronic prostatitis in EPS or VB(3). A total of 63 patients with prostate infection caused by U. urealyticum were available for this pilot study. The patients were randomized according to a computer randomization list to receive a total dose of 4.5 g of azithromycin given as a 3-day therapy of 1 x 500 mg weekly for 3 weeks or doxycyline 100 mg b.i.d. for 21 days. Patients' sexual partners were treated at the same time. Clinical efficacy and tolerability of the administered drug as well as possible adverse events were evaluated during, at the end and 4-6 weeks after completion of therapy. Bacteriological efficacy was evaluated 4-6 weeks after completion of therapy. Treatment groups did not differ regarding age, distribution of urethral, prostatic, sexual and other symptoms, or digitorectal prostatic examination. Five patients treated with doxycycline had nausea. In the group of patients with prostate infection caused by U. urealyticum, the eradication rate was not significantly different with regard to the administered azithromycin (25/32) or doxycycline (23/31). Clinical cure did not significantly differ with regard to the administered azithromycin (22/32) or doxycycline (21/31). Copyright 2006 S. Karger AG, Basel.

Determining the feasibility and preliminary efficacy of a stroke instructional and educational DVD in a multinational context: a randomized controlled pilot study.

PubMed

Jones, Kelly M; Bhattacharjee, Rohit; Krishnamurthi, Rita; Blanton, Sarah; Barker-Collo, Suzanne; Theadom, Alice; Thrift, Amanda G; Wolf, Steven L; Venketasubramanian, Narayanaswamy; Parmar, Priya; Maujean, Annick; Ranta, Annemarei; Cadilhac, Dominique; Sanya, Emmanuel O; MacKay-Lyons, Marilyn; Pandian, Jeyaraj D; Arora, Deepti; Obiako, Reginald O; Saposnik, Gustavo; Balalla, Shivanthi; Bornstein, Natan M; Langhorne, Peter; Norrving, Bo; Brown, Nita; Brainin, Michael; Taylor, Denise; Feigin, Valery L

2018-05-01

To assess the feasibility of conducting a randomized controlled trial of an instructional and educational stroke DVD and determine the feasibility and preliminary efficacy of this intervention in a multinational context. Non-funded, pilot randomized controlled trial of intervention versus usual care. International, multicentre, community-based. Community-living adults up to three years post stroke with moderate to severe disability and their nominated informal caregivers. Intervention patients viewed and practised rehabilitation techniques demonstrated in the DVD over six weeks. Trial feasibility by number of active recruitment sites, recruitment efficiency, randomization and follow-up. Intervention feasibility by patient and caregiver impressions. Preliminary efficacy by the quality of life - 5-level EuroQol-5D (EQ-5D) health status measure, General Health Questionnaire and Centre for Epidemiological Studies-Depression at two months. In total, 14 recruitment sites were established across eight countries. Recruitment was achieved at nine (64%) sites. Over 16 months, 66 participants were recruited (mean (SD) age = 63.5 (12.47) years) and randomized to intervention ( n = 34) and control ( n = 32) groups. In total, 54 (82%) completed a follow-up assessment. Patient and/or caregiver comments about the benefits and barriers to accessing the intervention were mixed. There were no significant between-group differences in outcomes at two months ( P > 0.05). Conducting a multinational trial of a stroke DVD requires full funding. The intervention was acceptable to some patients and their caregivers, yet a generalized education approach did not fully meet their needs and/or expectations. A more individualized method may be required to meet peoples' changing needs during stroke recovery.

Preliminary examination of the efficacy and safety of a standardized chamomile extract for chronic primary insomnia: A randomized placebo-controlled pilot study

PubMed Central

2011-01-01

Background Despite being the most commonly used herbal for sleep disorders, chamomile's (Matricaria recutita) efficacy and safety for treating chronic primary insomnia is unknown. We examined the preliminary efficacy and safety of chamomile for improving subjective sleep and daytime symptoms in patients with chronic insomnia. Methods We performed a randomized, double-blind, placebo-controlled pilot trial in 34 patients aged 18-65 years with DSM-IV primary insomnia for ≥ 6-months. Patients were randomized to 270 mg of chamomile twice daily or placebo for 28-days. The primary outcomes were sleep diary measures. Secondary outcomes included daytime symptoms, safety assessments, and effect size of these measures. Results There were no significant differences between groups in changes in sleep diary measures, including total sleep time (TST), sleep efficiency, sleep latency, wake after sleep onset (WASO), sleep quality, and number of awakenings. Chamomile did show modest advantage on daytime functioning, although these did not reach statistical significance. Effect sizes were generally small to moderate (Cohen's d ≤ 0.20 to < 0.60) with sleep latency, night time awakenings, and Fatigue Severity Scale (FSS), having moderate effect sizes in favor of chamomile. However, TST demonstrated a moderate effect size in favor of placebo. There were no differences in adverse events reported by the chamomile group compared to placebo. Conclusion Chamomile could provide modest benefits of daytime functioning and mixed benefits on sleep diary measures relative to placebo in adults with chronic primary insomnia. However, further studies in select insomnia patients would be needed to investigate these conclusions. Trial Registration ClinicalTrials.gov Identifier NCT01286324 PMID:21939549

A double-blind, randomized pilot trial of chromium picolinate for binge eating disorder: results of the Binge Eating and Chromium (BEACh) study.

PubMed

Brownley, Kimberly A; Von Holle, Ann; Hamer, Robert M; La Via, Maria; Bulik, Cynthia M

2013-07-01

Chromium treatment has been shown to improve mood, appetite, and glucose regulation in various psychiatric and medical patient populations. The authors propose that chromium may be useful in the treatment of binge eating disorder (BED). Twenty-four overweight adults with BED were enrolled in a 6-month double-blind placebo-controlled trial and randomly assigned to receive either 1000mcg chromium/day ("high dose"; n=8) or 600mcg chromium/day ("moderate dose"; n=9) as chromium picolinate or placebo (n=7). Mixed linear regression models were used to estimate mean change in binge frequency and related psychopathology, weight, symptoms of depression, and fasting glucose. Fasting glucose was significantly reduced in both chromium groups compared to the placebo group; similarly, numerically, but not significantly, greater reductions in binge frequency, weight, and symptoms of depression were observed in those treated with chromium versus placebo, although statistical power was limited in this pilot trial. For fasting glucose, the findings suggest a dose response with larger effects in the high dose compared to moderate dose group. These initial findings support further larger trials to determine chromium's efficacy in maintaining normal glucose regulation, reducing binge eating and related psychopathology, promoting modest weight loss, and reducing symptoms of depression in individuals with BED. Studies designed to link the clinical effects of chromium with changes in underlying insulin, serotonin, and dopamine pathways may be especially informative. If efficacious, chromium supplementation may provide a useful, low-cost alternative to or augmentation strategy for selective serotonin reuptake inhibitors, which have partial efficacy in BED. ClinicalTrials.gov NCT00904306. Copyright © 2013 Elsevier Inc. All rights reserved.

A Double-blind, Randomized Pilot Trial of Chromium Picolinate for Binge Eating Disorder: Results of the Binge Eating and Chromium (BEACh) Study

PubMed Central

Brownley, Kimberly A.; Holle, Ann Von; Hamer, Robert M.; Via, Maria La; Bulik, Cynthia M.

2015-01-01

Objective Chromium treatment has been shown to improve mood, appetite, and glucose regulation in various psychiatric and medical patient populations. The authors propose that chromium may be useful in the treatment of binge eating disorder (BED). Method Twenty-four overweight adults with BED were enrolled in a 6-month double-blind placebo-controlled trial and randomly assigned to receive either 1000mcg chromium/day (“high dose”; n=8) or 600mcg chromium/day (“moderate dose”; n=9) as chromium picolinate or placebo (n=7). Mixed linear regression models were used to estimate mean change in binge frequency and related psychopathology, weight, symptoms of depression, and fasting glucose. Results Fasting glucose was significantly reduced in both chromium groups compared to the placebo group; similarly, numerically, but not significantly, greater reductions in binge frequency, weight, and symptoms of depression were observed in those treated with chromium versus placebo, although statistical power was limited in this pilot trial. For fasting glucose, the findings suggest a dose response with larger effects in the high dose compared to moderate dose group. Conclusion These initial findings support further larger trials to determine chromium’s efficacy in maintaining normal glucose regulation, reducing binge eating and related psychopathology, promoting modest weight loss, and reducing symptoms of depression in individuals with BED. Studies designed to link the clinical effects of chromium with changes in underlying insulin, serotonin, and dopamine pathways may be especially informative. If efficacious, chromium supplementation may provide a useful, low-cost alternative to or augmentation strategy for selective serotonin reuptake inhibitors, which have partial efficacy in BED. ClinicalTrials.gov NCT00904306. PMID:23751236

A pilot assessment of relapse prevention for heroin addicts in a Chinese rehabilitation center.

PubMed

Min, Zhao; Xu, Li; Chen, Hanhui; Ding, Xu; Yi, Zhang; Mingyuang, Zhang

2011-05-01

To conduct a pilot assessment of relapse prevention (RP) group therapy for heroin-dependent patients in a drug rehabilitation center in China. A randomized case-control study was conducted to assess the efficacy of RP delivered over a 2-month period to male heroin addicts (n = 50, RP group) in the Shanghai Labor Drug Rehabilitation Center (LDRC) compared with an equal number of participants (n = 50, labor rehabilitation (LR) group) in the LDRC program receiving standard-of-care treatment. Outcomes were assessed by the Beck Depression Inventory (BDI), the Self-Rating Anxiety Scale (SAS), the Self-Efficacy Scale (SE), and the Self-Esteem Scale (SES) after completion of RP, and by the Addiction Severity Index (ASI) and abstinence rates of heroin use at 3-month follow-up post release from the LDRC for both groups. Significant improvements in scores on SAS, SE, and SES were found in the RP group after completion of the 2-month RP group therapy compared with the LR group (SAS 7.85 ± 6.20 vs 1.07 ± 5.42, SE 3.88 ± 3.60 vs .08 ± 2.89, and SES 3.83 ± 3.31 vs .78 ± 2.55). At 3-month follow-up, the RP group participants had more improvements on ASI scores in most domains and had higher abstinence rates than that in the LR group (37.2% vs 16.7%). An RP component can be effective in increasing abstinence rates among post-program heroin-dependent individuals and may help reduce anxiety and improve self-esteem and self-efficacy during and following treatment. This study suggests RP as a potentially effective component of treatment for heroin addicts.

Feasibility, safety, acceptability, and preliminary efficacy of measurement-based care depression treatment for HIV patients in Bamenda, Cameroon.

PubMed

Pence, Brian W; Gaynes, Bradley N; Atashili, Julius; O'Donnell, Julie K; Kats, Dmitry; Whetten, Kathryn; Njamnshi, Alfred K; Mbu, Tabenyang; Kefie, Charles; Asanji, Shantal; Ndumbe, Peter

2014-06-01

Depression affects 18-30 % of HIV-infected patients in Africa and is associated with greater stigma, lower antiretroviral adherence, and faster disease progression. However, the region's health system capacity to effectively identify and treat depression is limited. Task-shifting models may help address this large mental health treatment gap. Measurement-Based Care (MBC) is a task-shifting model in which a Depression Care Manager guides a non-psychiatric (e.g., HIV) provider in prescribing and managing antidepressant treatment. We adapted MBC for depressed HIV-infected patients in Cameroon and completed a pilot study to assess feasibility, safety, acceptability, and preliminary efficacy. We enrolled 55 participants; all started amitriptyline 25-50 mg daily at baseline. By 12 weeks, most remained at 50 mg daily (range 25-125 mg). Median (interquartile range) PHQ-9 depressive severity scores declined from 13 (12-16) (baseline) to 2 (0-3) (week 12); 87 % achieved depression remission (PHQ-9 <5) by 12 weeks. Intervention fidelity was high: HIV providers followed MBC recommendations at 96 % of encounters. Most divergences reflected a failure to increase dose when indicated. No serious and few bothersome side effects were reported. Most suicidality (prevalence 62 % at baseline; 8 % at 12 weeks) was either passive or low-risk. Participant satisfaction was high (100 %), and most participants (89 %) indicated willingness to pay for medications if MBC were implemented in routine care. The adapted MBC intervention demonstrated high feasibility, safety, acceptability, and preliminary efficacy in this uncontrolled pilot study. Further research should assess whether MBC could improve adherence and HIV outcomes in this setting.

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

PubMed

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

2018-06-01

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

High-Frequency (1 kHz) Spinal Cord Stimulation-Is Pulse Shape Crucial for the Efficacy? A Pilot Study.

PubMed

Song, Zhiyang; Meyerson, Björn A; Linderoth, Bengt

2015-12-01

Conflicting data regarding the efficacy of high-frequency spinal cord stimulation (HF SCS) has prompted the issue of the possible importance of the shape of the stimulating pulses. The aim of this pilot study was to compare HF SCS applied with monophasic and biphasic pulses of two different durations with conventional SCS in a rat model of neuropathic pain. Rats were operated with lesions of sciatic nerve branches according to the spared nerve injury procedure (SNI). Animals, which developed pathological tactile hypersensitivity after surgery, were implanted with four-polar miniature SCS leads. SCS was applied during 60 min with either conventional current parameters (monophasic pulse width [PW]: 200 μsec; 50 Hz and amplitude 80% of the motor threshold [MT]), or with high-frequency SCS (1 kHz) with monophasic or biphasic pulses, the latter with pulse widths of either 24 (12 + 12) or 48 (24 + 24) μsec. The outcomes were examined regarding change of tactile hypersensitivity during the one-hour SCS period and with two tests of thermal sensitivity. Conventional monophasic SCS, as well as HF SCS applied with monophasic PW = 24 μsec or with biphasic PW = 48 (24 + 24) μsec, had similar suppressive effects on tactile hypersensitivity. Solely, HF SCS applied with biphasic pulses with a total PW of 24 (12 + 12) μsec demonstrated no effect. Thermal hypersensitivity was unaffected by HF SCS with all pulse varieties. There is no significant difference in efficacy between HF SCS applied with low amplitude ("subparesthetic") monophasic and biphasic pulses. However, short PWs providing only 12 μsec of cathodal stimulation was ineffective, presumably because of insufficient electric charge transfer from the lead contacts to the nervous tissue. © 2015 International Neuromodulation Society.

Using video feedback to improve early father–infant interaction: A pilot study

PubMed Central

Davies, Beverley; Ramchandani, Paul G.

2013-01-01

Preventive interventions with parents of infants have tended to focus on mothers. Recent research focused on fathers suggests that their involvement in interventions might enhance effectiveness. One effective approach with mothers is the brief, home-based Video-feedback Intervention to promote Positive Parenting (VIPP). This paper is a report of a pilot study of VIPP with fathers to assess its feasibility. Five fathers were recruited from an existing longitudinal study of parents. The primary outcome was acceptability, assessed using a semi-structured questionnaire after completion of the intervention. All fathers completed all sessions of the intervention. Fathers rated the intervention as having had a significant impact on their understanding of their child’s thoughts and feelings, and as having improved their communication and relationship with their baby. Fathers’ feedback was generally positive. The flexibility to conduct sessions at home (or at fathers’ places of work) and the flexible timing of sessions were identified as fundamental to successful delivery. The results of this pilot study are encouraging, as VIPP with fathers was feasible. In light of the modest sample size, and the use of a non-clinical sample, the intervention must be evaluated with larger, clinical samples to evaluate its efficacy with fathers. PMID:22434935

Mindfulness training and stress reactivity in substance abuse: results from a randomized, controlled stage I pilot study.

PubMed

Brewer, Judson A; Sinha, Rajita; Chen, Justin A; Michalsen, Ravenna N; Babuscio, Theresa A; Nich, Charla; Grier, Aleesha; Bergquist, Keri L; Reis, Deidre L; Potenza, Marc N; Carroll, Kathleen M; Rounsaville, Bruce J

2009-01-01

Stress is important in substance use disorders (SUDs). Mindfulness training (MT) has shown promise for stress-related maladies. No studies have compared MT to empirically validated treatments for SUDs. The goals of this study were to assess MT compared to cognitive behavioral therapy (CBT) in substance use and treatment acceptability, and specificity of MT compared to CBT in targeting stress reactivity. Thirty-six individuals with alcohol and/or cocaine use disorders were randomly assigned to receive group MT or CBT in an outpatient setting. Drug use was assessed weekly. After treatment, responses to personalized stress provocation were measured. Fourteen individuals completed treatment. There were no differences in treatment satisfaction or drug use between groups. The laboratory paradigm suggested reduced psychological and physiological indices of stress during provocation in MT compared to CBT. This pilot study provides evidence of the feasibility of MT in treating SUDs and suggests that MT may be efficacious in targeting stress.

No-patch 23-gauge vitrectomy under topical anesthesia: A pilot study

PubMed Central

Deka, Satyen; Bhattacharjee, Harsha; Barman, M J; Kalita, Kruto; Singh, Sunil Kumar

2011-01-01

A pilot study was designed to evaluate the safety and efficacy of 23-gauge vitrectomy under topical anesthesia. Five eyes of five patients underwent 23-gauge sutureless vitrectomy under topical anesthesia with a pledget soaked in 0.5% proparacaine hydrochloride anesthetic, for vitreous hemorrhage (four eyes), epiretinal membrane (one eye). Subjective pain and discomfort were graded using a visual analogue chart from 0 (no pain or discomfort) to 4 (severe pain and discomfort). At the end of surgery no patch was applied and patients were given dark glasses. Patients underwent an immediate postoperative assessment, followed by next day and one week postoperative evaluation. Four patients had Grade 0 pain during the surgery. One patient had Grade 1 pain during the placement and withdrawal of the micro cannulas. The surgical outcomes were favorable. 23-gauge vitrectomy under topical anesthesia is safe and effective in selected cases. Further study is recommended to validate the outcome of this study. PMID:21350284

Prophylaxis of acute respiratory infections via improving the immune system in late preterm newborns with E. coli strain Nissle 1917: a controlled pilot trial.

PubMed

Aryayev, Mykola L; Senkivska, Liudmyla I; Bredeleva, Nataliya K; Talashova, Irina V

2018-01-01

Acute respiratory infections (ARIs), caused by the high level of immaturity of the immune system, are a major cause of morbidity in preterm newborns. The probiotic Escherichia coli strain Nissle 1917 (EcN) is well known for its immuno-modulatory properties and may therefore enhance the immune competence. Thus, EcN administration may provide a promising possibility to decrease the risk of ARIs in this vulnerable group of children. However, clinical data supporting or refuting this hypothesis are, to our knowledge, not available. Therefore, the aim of the presented pilot trial was to collect first data on the efficacy and safety of EcN treatment to prevent ARIs in late preterm newborns. Right after birth, 62 late preterm newborns were included into an open-labeled, controlled 4-week trial with two parallel groups and a follow-up phase until the age of 1 year. All children of the treatment group received an EcN suspension orally for 3 weeks, whereas the control group was only observed. Primary efficacy variable was the number of participants with at least one ARI during the first 28 days of life. Secondary efficacy variables were the number of ARIs and the number and duration of hospitalizations caused by ARIs during the first year of life. The number of participants with at least one ARI during the first 28 days of life was significantly lower in the group treated with EcN compared to that in the control group. Although only of exploratory nature, analyses of secondary efficacy variables suggest that EcN treatment may also reduce the average number of ARIs, the average number of hospitalizations caused by ARIs, and the mean duration of such hospitalizations. There is also some evidence that early EcN treatment may have long-term benefits on newborns' health status. The present pilot trial provides first evidence that EcN is able to reduce the incidence of ARIs in the neonatal period of late preterm newborns. Additionally, EcN is characterized by an excellent individual biocompatibility in the absence of adverse drug reactions. Limitations of the current trial are discussed and recommendations for future confirmatory studies are made. ClinicalTrials.gov identifier: NCT01540162; retrospectively registered on 16 February 2012.

Rationale, design and pilot feasibility results of a smartphone-assisted, mindfulness-based intervention for smokers with mood disorders: Project mSMART MIND.

PubMed

Minami, Haruka; Brinkman, Hannah R; Nahvi, Shadi; Arnsten, Julia H; Rivera-Mindt, Monica; Wetter, David W; Bloom, Erika Litvin; Price, Lawrence H; Vieira, Carlos; Donnelly, Remington; McClain, Lauren M; Kennedy, Katherine A; D'Aquila, Erica; Fine, Micki; McCarthy, Danielle E; Graham Thomas, J; Hecht, Jacki; Brown, Richard A

2018-03-01

Although individuals with psychiatric disorders are disproportionately affected by cigarette smoking, few outpatient mental health treatment facilities offer smoking cessation services. In this paper, we describe the development of a smartphone-assisted mindfulness smoking cessation intervention with contingency management (SMI-CM), as well as the design and methods of an ongoing pilot randomized controlled trial (RCT) targeting smokers receiving outpatient psychiatric treatment. We also report the results of an open-label pilot feasibility study. In phase 1, we developed and pilot-tested SMI-CM, which includes a smartphone intervention app that prompts participants to practice mindfulness, complete ecological momentary assessment (EMA) reports 5 times per day, and submit carbon monoxide (CO) videos twice per day. Participants earned incentives if submitted videos showed CO≤6ppm. In phase 2, smokers receiving outpatient treatment for mood disorders are randomized to receive SMI-CM or enhanced standard treatment plus non-contingent CM (EST). The results from the pilot feasibility study (N=8) showed that participants practiced mindfulness an average of 3.4times/day (≥3min), completed 72.3% of prompted EMA reports, and submitted 68.0% of requested CO videos. Participants reported that the program was helpful overall (M=4.85/5) and that daily mindfulness practice was helpful for both managing mood and quitting smoking (Ms=4.50/5). The results from the feasibility study indicated high levels of acceptability and satisfaction with SMI-CM. The ongoing RCT will allow evaluation of the efficacy and mechanisms of action underlying SMI-CM for improving cessation rates among smokers with mood disorders. Copyright © 2017 Elsevier Inc. All rights reserved.

A pilot study examining the effects of priming headache illness schema on attentional engagement towards pain relief medication, in those with high and low medication treatment beliefs.

PubMed

Ahluwalia, Monisha; Hughes, Alicia M; McCracken, Lance M; Chilcot, Joseph

2017-08-01

Few studies have assessed the underlying theoretical components of the Common Sense Model. Past studies have found, through implicit priming, that coping strategies are embedded within illness schema. Our aim was to evaluate the effect priming 'headache' illness schema upon attentional engagement to pain relief medication and to examine the interaction with illness treatment beliefs. Attentional engagement to the pain relief medication ('Paracetamol') was assessed using a 2 (primed vs. control) × 2 (strong belief in medication efficacy vs. weak belief in medication efficacy) design. During a grammatical decision task (identifying verbs/non-verbs), participants were randomised to receive a headache prime or a control. Response latency to the target word, 'Paracetamol' was the dependent variable. 'Paracetamol' treatment beliefs were determined using the brief illness perception questionnaire. Sixty-three participants completed the experiment. There was a significant interaction between illness-primed vs. control and high vs. low treatment efficacy of Paracetamol (p < .001), suggesting an attentional disengagement effect to the coping strategy in illness-primed participants whom held stronger treatment beliefs regarding the efficacy of Paracetamol. In summary, implicit illness schema activation may simultaneously activate embedded coping strategies, which appears to be moderated by specific illness beliefs.

Combined electrical stimulation and exercise for swallow rehabilitation post-stroke: a pilot randomized control trial.

PubMed

Sproson, Lise; Pownall, Sue; Enderby, Pam; Freeman, Jenny

2018-03-01

Dysphagia is common after stroke, affecting up to 50% of patients initially. It can lead to post-stroke pneumonia, which causes 30% of stroke-related deaths, a longer hospital stay and poorer health outcomes. Dysphagia care post-stroke generally focuses on the management of symptoms, via modified oral intake textures and adapted posture, rather than direct physical rehabilitation of the swallowing function. Transcutaneous neuromuscular electrical stimulation (NMES) is a promising rehabilitation technology that can be used to stimulate swallowing; however, findings regarding efficacy have been conflicting. This pilot randomized controlled study involving three UK sites compared the efficacy of the Ampcare Effective Swallowing Protocol (ESP), combining NMES with swallow-strengthening exercises, with usual care in order to clarify evidence on NMES in the treatment of dysphagia post-stroke. A further objective was to pilot recruitment procedures and outcome measures in order to inform the design of a full-scale trial. Thirty patients were recruited and randomized into either (1) usual speech and language therapy dysphagia care; or (2) Ampcare ESP, receiving treatment 5 days/week for 4 weeks. Outcome measures included: the Functional Oral Intake Scale (FOIS), the Rosenbek Penetration-Aspiration Scale (PAS) and patient-reported outcomes (Swallow Related Quality of Life-SWAL-QOL). Thirty patients were recruited; 15 were randomized to the Ampcare ESP intervention arm and 15 to usual care. A greater proportion (75%, or 9/12) of patients receiving Ampcare ESP improved compared with 57% (or 8/14) of the usual-care group. Patients receiving Ampcare ESP also made clinically meaningful change (a comparative benefit of 1.5 on the FOIS, and on the PAS: 1.35 for diet and 0.3 for fluids) compared with usual care. The intervention group also reported much better outcome satisfaction. The pilot demonstrated successful recruitment, treatment safety and tolerability and clinically meaningful outcome improvements, justifying progression to a fully powered study. It also showed clinically meaningful treatment trends for the Ampcare ESP intervention. © 2017 Royal College of Speech and Language Therapists.

Mobile integrated health to reduce post-discharge acute care visits: A pilot study.

PubMed

Siddle, Jennica; Pang, Peter S; Weaver, Christopher; Weinstein, Elizabeth; O'Donnell, Daniel; Arkins, Thomas P; Miramonti, Charles

2018-05-01

Mobile Integrated Health (MIH) leverages specially trained paramedics outside of emergency response to bridge gaps in local health care delivery. To evaluate the efficacy of a MIH led transitional care strategy to reduce acute care utilization. This was a retrospective cohort analysis of a quality improvement pilot of patients from an urban, single county EMS, MIH transitional care initiative. We utilized a paramedic/social worker (or social care coordinator) dyad to provide in home assessments, medication review, care coordination, and improve access to care. The primary outcome compared acute care utilization (ED visits, observation stays, inpatient visits) 90days before MIH intervention to 90days after. Of the 203 patients seen by MIH teams, inpatient utilization decreased significantly from 140 hospitalizations pre-MIH to 26 post-MIH (83% reduction, p=0.00). ED and observation stays, however, increased numerically, but neither was significant. (ED 18 to 19 stays, p=0.98; observation stays 95 to 106, p=0.30) Primary care visits increased 15% (p=0.11). In this pilot before/after study, MIH significantly reduces acute care hospitalizations. Copyright © 2017 Elsevier Inc. All rights reserved.

Pilot evaluation of hypnosis for the treatment of hot flashes in breast cancer survivors.

PubMed

Elkins, Gary; Marcus, Joel; Stearns, Vered; Hasan Rajab, M

2007-05-01

This single arm, pilot study investigated the use of hypnosis to reduce hot flashes in 16 breast cancer survivors. Each patient provided baseline data and received 4 weekly sessions of hypnosis that followed a standardized transcript. Patients were also instructed in self-hypnosis. Throughout the clinical care, patients completed daily diaries of the frequency and severity of their hot flashes. Patients also completed baseline and post-treatment ratings of the degree to which hot flashes interfered with daily activities and quality of life. Results indicated a 59% decrease in total daily hot flashes and a 70% decrease in weekly hot flash scores from their baselines. There was also a significant decrease in the degree to which hot flashes interfered with daily activities for all measures including work, social activities, leisure activities, sleep, mood, concentration, relations with others, sexuality, enjoyment of life, and overall quality of life. This pilot study suggests that clinical hypnosis may be an effective non-hormonal and non-pharmacological treatment for hot flashes. A randomized, controlled clinical trial is planned to more definitively elucidate the efficacy and applicability of hypnosis for reducing hot flashes.

The staying safe intervention: training people who inject drugs in strategies to avoid injection-related HCV and HIV infection.

PubMed

Mateu-Gelabert, Pedro; Gwadz, Marya Viorst; Guarino, Honoria; Sandoval, Milagros; Cleland, Charles M; Jordan, Ashly; Hagan, Holly; Lune, Howard; Friedman, Samuel R

2014-04-01

This pilot study explores the feasibility and preliminary efficacy of the Staying Safe Intervention, an innovative, strengths-based program to facilitate prevention of infection with the human immunodeficiency virus and with the hepatitis C virus among people who inject drugs (PWID). The authors explored changes in the intervention's two primary endpoints: (a) frequency and amount of drug intake, and (b) frequency of risky injection practices. We also explored changes in hypothesized mediators of intervention efficacy: planning skills, motivation/self-efficacy to inject safely, skills to avoid PWID-associated stigma, social support, drug-related withdrawal symptoms, and injection network size and risk norms. A 1-week, five-session intervention (10 hours total) was evaluated using a pre- versus 3-month posttest design. Fifty-one participants completed pre- and posttest assessments. Participants reported significant reductions in drug intake and injection-related risk behavior. Participants also reported significant increases in planning skills, motivation/self-efficacy, and stigma management strategies, while reducing their exposure to drug withdrawal episodes and risky injection networks.

THE STAYING SAFE INTERVENTION: TRAINING PEOPLE WHO INJECT DRUGS IN STRATEGIES TO AVOID INJECTION-RELATED HCV AND HIV INFECTION

PubMed Central

Mateu-Gelabert, Pedro; Gwadz, Marya Viorst; Guarino, Honoria; Sandoval, Milagros; Cleland, Charles M.; Jordan, Ashly; Hagan, Holly; Lune, Howard; Friedman, Samuel R.

2014-01-01

This pilot study explores the feasibility and preliminary efficacy of the Staying Safe Intervention, an innovative, strengths-based program to facilitate prevention of infection with the human immunodeficiency virus and with the hepatitis C virus among people who inject drugs (PWID). The authors explored changes in the intervention's two primary endpoints: (a) frequency and amount of drug intake, and (b) frequency of risky injection practices. We also explored changes in hypothesized mediators of intervention efficacy: planning skills, motivation/self-efficacy to inject safely, skills to avoid PWID-associated stigma, social support, drug-related withdrawal symptoms, and injection network size and risk norms. A 1-week, five-session intervention (10 hours total) was evaluated using a pre- versus 3-month posttest design. Fifty-one participants completed pre- and posttest assessments. Participants reported significant reductions in drug intake and injection-related risk behavior. Participants also reported significant increases in planning skills, motivation/self-efficacy, and stigma management strategies, while reducing their exposure to drug withdrawal episodes and risky injection networks. PMID:24694328

Metformin plus sibutramine for olanzapine-associated weight gain and metabolic dysfunction in schizophrenia: a 12-week double-blind, placebo-controlled pilot study.

PubMed

Baptista, Trino; Uzcátegui, Euderruh; Rangel, Nairy; El Fakih, Yamily; Galeazzi, Tatiana; Beaulieu, Serge; de Baptista, Enma Araujo

2008-05-30

Metformin (850-1700 mg) plus sibutramine (10-20 mg, n=13) or placebo (n=15) was administered for 12 weeks in olanzapine-treated chronic schizophrenia patients. Weight loss was similar in both groups: -2.8+/-3.2 kg vs. -1.4+/-2.6 kg. Except for preventing a triglyceride increase, the drug combination lacked efficacy for metabolic control in this clinical population.

"I Learned to Be Okay with Talking about Sex and Safety": Assessing the Efficacy of a Theatre-Based HIV Prevention Approach for Adolescents in North Carolina

ERIC Educational Resources Information Center

Lightfoot, Alexandra F.; Taboada, Arianna; Taggart, Tamara; Tran, Trang; Burtaine, Amy

2015-01-01

Adolescents are at increased risk of HIV and sexually transmitted infections (STIs) in the Southern states of the USA, where rates among youth are higher than in the rest of the nation. This paper reports on findings from a pilot study of an HIV prevention intervention that uses interactive theatre to educate young people about sexual health. The…

Feasibility of a Grocery Store Tour for Parents and Their Adolescents: A Randomized Controlled Pilot Study.

PubMed

Nikolaus, Cassandra J; Graziose, Matthew M; Nickols-Richardson, Sharon M

To evaluate the feasibility of a grocery store tour for parents and their adolescents being led by adults or adolescent peers. Randomized controlled pilot study with surveys at baseline and post-program, and at 3- and 6-month follow-up. Midwestern midsized grocery stores. Sixty-one parents and their 71 11- to 14-year-old adolescents. Nutrition education during 1 90-minute grocery store tour. Process observations and participants' tour perceptions provided fidelity outcomes. Questionnaires quantitatively assessed participants' knowledge, self-efficacy, and tour strategy use. Chi-square and McNemar tests were used to analyze categorical data, and Kruskal-Wallis, Wilcoxon signed-rank, and Mann-Whitney U tests were employed for continuous variables (significance at P < .05). Over 90% of tour tasks were rated as completed well for adult and peer leaders. Participants had positive tour perceptions but noted deficiencies in teen leaders' knowledge and leadership skills. Overall, parents and adolescents retained increased self-efficacy from pre-tour to post-tour intervals. Despite limited knowledge retention, parents reported they had increased (6.5 ± 4.19) healthful grocery shopping behaviors in the 6 months after the intervention. Peers may feasibly lead grocery store tours but they may need additional resources and support to be highly effective. Copyright © 2017 The Authors. Published by Elsevier Inc. All rights reserved.

Pilot study of safety and efficacy of polyprenols in combination with coenzyme Q10 in patients with statin-induced myopathy.

PubMed

Latkovskis, Gustavs; Saripo, Vita; Sokolova, Emma; Upite, Dana; Vanaga, Ilona; Kletnieks, Ugis; Erglis, Andrejs

2016-01-01

Statin-induced myopathy (SIM) has been partially attributed to deficiency of dolichol and coenzyme Q10 (CoQ10). We aimed to test the safety and efficacy of plant polyprenols in combination with CoQ10 for alleviation of SIM. In an open-label, one-center prospective pilot study patients with SIM received conifer-tree needle polyprenols (4mg/day) and CoQ10 (100mg/day) for 8 weeks. Symptoms and safety were evaluated according to symptom severity score (0-10), creatine kinase (CK) levels, exercise test, dynamometry, complete blood count, clinical biochemistry and electrocardiography. Of the 14 patients, 11 completed the study per protocol. Two patients withdrew consent due to travels abroad, and it was discontinued for one patient with stage 3 chronic kidney disease due to asymptomatic elevations of liver enzymes at week 4. No safety parameters changed significantly in per protocol group. Non-significant increase of CK levels was observed (P=0.231). Muscle pain (n=10) and weakness (n=7) scores improved significantly (P<0.001 and P=0.018, respectively). Muscle pain completely disappeared in 2 patients, weakness resolved in 3 patients and cramps disappeared in two patients. Four patients assessed improvement strong enough to consider increase of statin dose. No changes were observed in exercise test or dynamometry. Conifer-tree polyprenols in combination with CoQ10 may be generally safe in patients with SIM, but caution should be exercised in patients with glomerular filtration rate <60mL/min and routine monitoring of the liver enzymes and CK is advocated in all patients. The observed efficacy provides the rationale for a larger, double-blind controlled study with polyprenols. Copyright © 2016 The Lithuanian University of Health Sciences. Production and hosting by Elsevier Urban & Partner Sp. z o.o. All rights reserved.

A Pilot Study of Apatinib as Third-Line Treatment in Patients With Heavily Treated Metastatic Colorectal Cancer.

PubMed

Liang, Lijun; Wang, Lei; Zhu, Panrong; Xia, Youyou; Qiao, Yun; Wu, Jiang; Zhuang, Wei; Fei, Jiayan; Wen, Yixuan; Jiang, Xiaodong

2018-03-02

Antiangiogenic therapy has shown improved clinical outcome in metastatic colorectal cancer (mCRC). After the failure of standard treatments, regorafenib and TAS-102 would be recommended for patients with mCRC, however, they have not been approved in China during this study period. This pilot study aimed to assess the efficacy and safety of apatinib, a novel oral inhibitor targeting vascular endothelial growth factor receptor 2, as third-line treatment for patients with mCRC refractory to standard therapies. In this retrospective study, all patients received apatinib treatment until progressive disease (PD), death, unacceptable toxicity, and curative surgery. The dose or treatment schedule was modified according to the physician's discretion according to the toxicity profiles. Between March 2015 and June 2017, 36 patients were enrolled and eligible for evaluation of the safety and efficacy. One patient (2.8%) achieved complete response, 3 (8.3%) achieved partial response, 24 (66.7%) achieved stable disease, and 8 (22.2%) PD. The objective response rate and the disease control rate were 11.1% (4 of 36), and 77.8% (28 of 36), respectively. Moreover, the median overall survival (OS) since the initiation of first-line treatment was 33.2 months. The median progression-free survival (PFS) and median OS from apatinib treatment were 4.8 and 10.1 months, respectively. Intergroup analysis showed that there was no significant difference in median PFS and median OS between patients who were previously treated with and without bevacizumab. The most common Grade 3 to 4 adverse reactions were hand-foot syndrome, hypertension, and proteinuria. Our results suggested that apatinib was active as a third-line treatment of refractory mCRC with a manageable tolerability profile. In addition, preliminary data suggested that the efficacy of apatinib would not be affected by previous bevacizumab treatment. Further prospective randomized controlled clinical trials are urgently needed. Copyright © 2018 Elsevier Inc. All rights reserved.

Zonisamide in Brain Tumor-Related Epilepsy: An Observational Pilot Study.

PubMed

Maschio, Marta; Dinapoli, Loredana; Zarabla, Alessia; Maialetti, Andrea; Giannarelli, Diana; Fabi, Alessandra; Vidiri, Antonello; Cantelmi, Tonino

Epilepsy heavily affects the quality of life (QoL) of patients with brain tumor because in addition to taking treatments for the oncological illness, patients are required to live with the long-term taking of antiepileptic drugs (AEDs). The AEDs' adverse effects are common in these patients and can negatively influence their perceptions of their QoL.We conducted an observational pilot study in patients with brain tumor-related epilepsy to verify efficacy, tolerability, and impact on QoL and global neurocognitive performances of zonisamide (ZNS) in add-on. We recruited 13 patients (5 females, 8 males; mean age, 49.6 years) presenting uncontrolled seizures. At first visit and at final follow-up at 6 months, patients underwent neurological examination, evaluation of adverse events, and cognitive and QoL tests. A seizure diary was given. Eight patients underwent chemotherapy, 3 underwent radiotherapy, and 5 had disease progression. Mean dosage of ZNS at final follow-up was 300 mg/d.Of 9 patients who reached the sixth month follow-up, the mean weekly seizure number before ZNS had been 3.2 ± 5.0, and at final follow-up, the mean weekly seizure number was 0.18 ± 0.41 (P = 0.05).Compared with baseline, we observed stability in all cognitive domains, except for verbal fluency that significantly worsened.Results on QoL tests showed that QoL remained unchanged over time, which could indicate that ZNS did not influence the patients' perceived QoL. Zonisamide as add-on in our patients seems to be well tolerated and efficacious in controlling seizures. Despite having limitations represented by the fact that our study is observational, with a small study population and a short follow-up period, our results confirm that when choosing an AED, in addition to efficacy, the drug's effect on patients' QoL also needs to be considered, especially for patients facing many psychosocial challenges, such as those with brain tumor-related epilepsy.

Is Home-Based, High-Intensity Interval Training Cycling Feasible and Safe for Patients With Knee Osteoarthritis?: Study Protocol for a Randomized Pilot Study.

PubMed

Keogh, Justin W L; Grigg, Josephine; Vertullo, Christopher J

2017-03-01

Osteoarthritis (OA) is a degenerative joint disease affecting the knee joint of many middle-aged and older adults. As OA symptoms typically involve knee pain and stiffness, individuals with knee OA are often insufficiently physically active, have low levels of physical function, and are at increased risk of other comorbidities and reduced quality of life. While moderate-intensity continuous training (MICT) cycling is often recommended, little is known about the feasibility, safety, and benefits of high-intensity interval training (HIIT) cycling for this population, even though the feasibility, safety, and benefits of HIIT have been demonstrated in other chronic disease groups. The primary objective of this pilot study was to examine the feasibility and safety of home-based HIIT and MICT cycling in middle-aged and older adults with knee OA. A secondary objective was to gain some insight into the relative efficacy of HIIT and MICT for improving health status (pain, stiffness, and disability), muscle function, and body composition in this population. This study protocol is being published separately to allow a detailed description of the research methods, explain the rationale for choosing the methodological details, and to stimulate consideration of the best means to simulate a research protocol that is relevant to a real-life treatment environment. Randomized pilot study protocol. This trial sought to recruit 40 middle-aged and older adults with knee OA. Participants were randomly allocated to either continuous (MICT) or HIIT home-based cycle training programs, with both programs requiring the performance of 4 cycling sessions (approximately 25 minutes per session) each week. Participants were measured at baseline and postintervention (8 weeks). Feasibility and safety were assessed by adherence rate, dropout rate, and number of adverse events. The relative efficacy of the cycling programs was investigated by 2 knee OA health status questionnaires (Western Ontario and McMaster Universities Osteoarthritis Index scale[WOMAC] and the Lequesne Index) as well as the timed up and go, sit to stand, preferred gait speed, and body composition. This pilot study appears to be the first study assessing the feasibility and safety of a home-based HIIT training program for middle-aged and older adults with knee OA. As HIIT has been demonstrated to be more effective than MICT for improving aspects of health status, body composition, and/or muscular function in other chronic disease groups, the current study has the potential to improve patient outcomes and inform the design of future randomized controlled trials.

Model Checking Verification and Validation at JPL and the NASA Fairmont IV and V Facility

NASA Technical Reports Server (NTRS)

Schneider, Frank; Easterbrook, Steve; Callahan, Jack; Montgomery, Todd

1999-01-01

We show how a technology transfer effort was carried out. The successful use of model checking on a pilot JPL flight project demonstrates the usefulness and the efficacy of the approach. The pilot project was used to model a complex spacecraft controller. Software design and implementation validation were carried out successfully. To suggest future applications we also show how the implementation validation step can be automated. The effort was followed by the formal introduction of the modeling technique as a part of the JPL Quality Assurance process.

Effects of Functional Electrical Stimulation Lower Extremity Training in Myotonic Dystrophy Type I: A Pilot Controlled Study.

PubMed

Cudia, Paola; Weis, Luca; Baba, Alfonc; Kiper, Pawel; Marcante, Andrea; Rossi, Simonetta; Angelini, Corrado; Piccione, Francesco

2016-11-01

Functional electrical stimulation (FES) is a new rehabilitative approach that combines electrical stimulation with a functional task. This pilot study evaluated the safety and effectiveness of FES lower extremity training in myotonic dystrophy type 1. This is a controlled pilot study that enrolled 20 patients with myotonic dystrophy type 1 over 2 years. Eight patients (age, 39-67 years) fulfilled the inclusion criteria. Four participants performed FES cycling training for 15 days (one daily session of 30 minutes for 5 days a week). A control group, matched for clinical and genetic variables, who had contraindications to electrical stimulation, performed 6 weeks of conventional resistance and aerobic training. The modified Medical Research Council Scale and functional assessments were performed before and after treatment. Cohen d effect size was used for statistical analysis. Functional electrical stimulation induced lower extremity training was well tolerated and resulted in a greater improvement of tibialis anterior muscle strength (d = 1,583), overall muscle strength (d = 1,723), and endurance (d = 0,626) than conventional training. Functional electrical stimulation might be considered a safe and valid tool to improve muscle function, also in muscles severely compromised in which no other restorative options are available. Confirmation of FES efficacy through further clinical trials is strongly advised.

Computerized Working-Memory Training for Children Following Arterial Ischemic Stroke: A Pilot Study With Long-Term Follow-Up.

PubMed

Eve, Megan; O'Keeffe, Fiadhnait; Jhuty, Simren; Ganesan, Vijeya; Brown, Gary; Murphy, Tara

2016-01-01

Cognitive deficits in the domains of working memory (WM) and executive function are well documented following childhood arterial ischemic stroke (AIS). However, there are currently no evidence-based cognitive interventions for this population. Computerized, implicit WM training has been demonstrated to generate generalized cognitive gains for children with WM and attention deficits and for adults following brain injury. This study used a pilot design to investigate the efficacy and feasibility of such an intervention program (Cogmed WM Training) for a childhood AIS population. Outcomes were measured via psychometric assessment at preintervention and postintervention and again at 1-year follow-up. At longitudinal follow-up, participants were found to have significant and persistent cognitive difficulties, particularly with attention and response inhibition. Following the computerized, implicit WM intervention, a significant improvement in phonological-loop WM was seen; however, this improvement was not maintained after 12 months. No additional significant improvements on standardized psychometric outcome measures were seen either immediately or at 12-month follow-up. Findings of this pilot study therefore do not currently support Cogmed as an effective intervention for children with AIS but highlight the need for further research, including randomized, controlled trials, to investigate cognitive interventions for the childhood AIS population.

Efficacy of Epidural Perineural Injection of Autologous Conditioned Serum in Unilateral Cervical Radiculopathy: A Pilot Study.

PubMed

Goni, Vijay G; Singh Jhala, Sampat; Gopinathan, Nirmal Raj; Behera, Prateek; Batra, Y K; R H H, Arjun; Guled, Uday; Vardhan, Harsha

2015-08-15

Prospective randomized pilot study. Evaluation of the efficacy of epidural perineural injection of autologous conditioned serum (ACS) versus methylprednisone (MPS) in unilateral cervical radiculopathy patients. Cervical radiculopathy is often treated by nonoperative and operative means. Guided injections of steroids have been used previously. We used ACS, an orthobiologic derived from patients' own blood in patients of unilateral cervical radiculopathy. Forty patients were equally allocated into ACS and MPS groups and were injected with 2.5 to 3 mL of ACS or MPS, respectively, under image guidance into the perineural area of the affected nerve root. They were followed up for 6 months with visual analogue scale for pain, neck pain disability scale in Hindi language, neck disability index, and Short Form of Health Survey-12 (SF-12). Patients who had received injections of ACS and MPS both had improvements in the scores of the evaluation tools. The improvement in the ACS patients was gradual and sustained during the entire study period whereas that in the MPS group had some deterioration over time. No major complications were noted among the 2 groups. Minor complications were noted in both the groups. ACS can be considered an equally good or better modality of nonoperative management in patients of unilateral cervical radiculopathy as MPS. The safety profile is good and the improvement seen is sustained over time. Thus, it may be offered to affected patients before offering them surgery. 2.

STEPPS: Systems Training for Emotional Predictability and Problem Solving in women offenders with borderline personality disorder in prison--a pilot study.

PubMed

Black, Donald W; Blum, Nancee; Eichinger, Leanne; McCormick, Brett; Allen, Jeff; Sieleni, Bruce

2008-10-01

An uncontrolled pilot study of Systems Training for Emotional Predictability and Problem Solving (STEPPS) was conducted with incarcerated women offenders. STEPPS is a promising new cognitive-behavioral group treatment for persons with borderline personality disorder (BPD). Twelve women offenders with Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition BPD were enrolled in the 20-week program at an Iowa prison. Efficacy assessments included the Borderline Evaluation of Severity over Time, the Positive and Negative Affectivity Scale, and the Beck Depression Inventory. Data were collected at baseline, and weeks 4, 8, 12, 16, and 20. A prison therapist was trained to deliver the STEPPS program. The 12 volunteers had a mean age of 34.8+/-8.5 years. Two women discontinued early because they were released from prison; the others attended all sessions. The analysis showed significant improvements in BPD-related symptoms, negative affectivity, and depression. The Borderline Evaluation of Severity over Time total score was highly significant at week 20 (P=.009), indicating overall improvement in BPD-related symptoms. Effect sizes for the efficacy measures were moderate to large. The prison therapist showed excellent adherence to the model. This study demonstrated the successful implementation of the STEPPS program in a women's prison. Participants achieved "real-world" benefits, including a reduction in the negative thoughts and behaviors associated with BPD, negative affectivity, and depression. Implications of the findings are discussed.

Treatment of knee osteoarthritis with autologous mesenchymal stem cells: a pilot study.

PubMed

Orozco, Lluis; Munar, Anna; Soler, Robert; Alberca, Mercedes; Soler, Francesc; Huguet, Marina; Sentís, Joan; Sánchez, Ana; García-Sancho, Javier

2013-06-27

Osteoarthritis is the most prevalent joint disease and a frequent cause of joint pain, functional loss, and disability. Osteoarthritis often becomes chronic, and conventional treatments have demonstrated only modest clinical benefits without lesion reversal. Cell-based therapies have shown encouraging results in both animal studies and a few human case reports. We designed a pilot study to assess the feasibility and safety of osteoarthritis treatment with mesenchymal stromal cells (MSCs) in humans and to obtain early efficacy information for this treatment. Twelve patients with chronic knee pain unresponsive to conservative treatments and radiologic evidence of osteoarthritis were treated with autologous expanded bone marrow MSCs by intra-articular injection (40×10 cells). Clinical outcomes were followed for 1 year and included evaluations of pain, disability, and quality of life. Articular cartilage quality was assessed by quantitative magnetic resonance imaging T2 mapping. Feasibility and safety were confirmed, and strong indications of clinical efficacy were identified. Patients exhibited rapid and progressive improvement of algofunctional indices that approached 65% to 78% by 1 year. This outcome compares favorably with the results of conventional treatments. Additionally, quantification of cartilage quality by T2 relaxation measurements demonstrated a highly significant decrease of poor cartilage areas (on average, 27%), with improvement of cartilage quality in 11 of the 12 patients. MSC therapy may be a valid alternative treatment for chronic knee osteoarthritis. The intervention is simple, does not require hospitalization or surgery, provides pain relief, and significantly improves cartilage quality.

Hydrotherapy in advanced heart failure: the cardio-HKT pilot study.

PubMed

Municinó, Annamaria; Nicolino, Annamaria; Milanese, Manlio; Gronda, Edoardo; Andreuzzi, Bruno; Oliva, Fabrizio; Chiarella, Francesco

2006-12-01

In-water exercise, hydrotherapy, may offer an attractive alternative to conventional training in markedly compromised patients with advanced HF. This Pilot Study evaluates the safety and efficacy of Cardio-Hydrokinesitherapy (Cardio-HKT) in patients with advanced HF on optimal medical therapy. Cardio-HKT is a novel rehabilitation program that includes training sessions in warm water (31 degrees C), integrated by educational and psycho-behavioural sessions to promote healthy life style modifications. We studied 18 adult patients with advanced HF, LVEF < 35%, NYHA functional class > II and peak oxygen uptake (peak VO2) < 18 ml/kg/min. Cardio-HKT consisted of a 3 weeks daily in-water training, combined to educational and psycho-behavioural sessions. Patients underwent a six-minute-walking-test (6mWT), a cardiopulmonary exercise test at baseline and after 3 weeks of Cardio-HKT. Quality of life was assessed with the Minnesota Living with Heart Failure Questionnaire (MLHF). All patients completed the Cardio-HKT rehabilitation program without complications. The 6mWT improved from 453 +/- 172 m to 571 +/- 120 m (p < 0.01), peak VO2 from 13.0 +/- 3.1 to 14.5 +/- 2.9 ml/kg/min (p = 0.03), whereas VE/ CO2 slope declined from 37 +/- 10 to 33 +/- 9 (p = 0.01). MLHF markedly improved from 56 (68-27) to 18 (40-7) (p < 0.01). Our results support the safety and efficacy of the innovative Cardio-HKT rehabilitation program in patients with advanced HF.

Child and parental outcomes of a group parenting intervention for Latino families: A pilot study of the CANNE program.

PubMed

Dumas, Jean E; Arriaga, Ximena B; Begle, Angela Moreland; Longoria, Zayra N

2011-01-01

Criando a Nuestros Niños hacia el Éxito (CANNE) is the Spanish adaptation of Parenting Our Children to Excellence (PACE). A pilot study conducted with 124 parents of preschoolers (mostly recent Mexican immigrants) provides preliminary evidence for the community acceptability and efficacy of CANNE. Eighty-eight of the 124 parents who enrolled in the program attended one or more of the 8 sessions (17% attended 1 session, 11% attended 2-4 sessions, and 72% attended 5 or more sessions), participated actively in sessions, and expressed high degrees of program satisfaction. Over time, parents improved on measures of harsh-inconsistent discipline, and children improved on social competence and social-communication skills. When high-versus-low attenders were compared, high attenders (parents who attended 4 sessions or more) reported greater increases than low attenders in their appropriate-positive parenting practices and clear expectations, and in their children's social competence and communication skills, and they reported greater decreases in their harsh-inconsistent discipline and in their children's aggressiveness and hyperactivity. Some of these changes were evident by the end of the program, whereas others became apparent (or stronger) over a 3-month follow-up period. These encouraging results point to the need for an efficacy study that assesses how well CANNE can help larger numbers of Latino parents in the important task of bringing up their young children in the United States.

A Randomized Controlled Exploratory Pilot Study to Evaluate the Effect of Rotigotine Transdermal Patch on Parkinson's Disease-Associated Chronic Pain.

PubMed

Rascol, Olivier; Zesiewicz, Theresa; Chaudhuri, K Ray; Asgharnejad, Mahnaz; Surmann, Erwin; Dohin, Elisabeth; Nilius, Sigrid; Bauer, Lars

2016-07-01

Pain is a troublesome nonmotor symptom of Parkinson's disease (PD). This double-blind exploratory pilot study (NCT01744496) was the first to specifically investigate the effect of a dopamine agonist on PD-associated pain as primary outcome. Patients with advanced PD (ie, receiving levodopa) and at least moderate PD-associated chronic pain (≥3 months, ≥4 points on 11-point Likert pain scale) were randomized to rotigotine (optimal/maximum dose ≤16 mg/24h) or placebo and maintained for 12 weeks. Primary efficacy variable was change in pain severity (Likert pain scale) from baseline to end of maintenance. Secondary variables included percentage of responders (≥2-point Likert pain scale reduction), King's PD Pain Scale (KPPS) domains, and PD Questionnaire (PDQ-8). Statistical analyses were exploratory. Of 68 randomized patients, 60 (rotigotine, 30; placebo, 30) were evaluable for efficacy. A numerical improvement in pain was observed in favor of rotigotine (Likert pain scale: least-squares mean [95%CI] treatment difference, -0.76 [-1.87 to 0.34]; P = .172), and proportion of responders was 18/30 (60%) rotigotine vs 14/30 (47%) placebo. An ∼2-fold numerical improvement in KPPS domain "fluctuation-related pain" was observed with rotigotine vs placebo. Rotigotine improved PDQ-8 vs placebo (-8.01 [-15.56 to -0.46]; P = .038). These results suggest rotigotine may improve PD-associated pain; a large-scale confirmatory study is needed. © 2015, The American College of Clinical Pharmacology.

Breaking bad news: A communication competency for ophthalmology training programs.

PubMed

Hilkert, Sarah M; Cebulla, Colleen M; Jain, Shelly Gupta; Pfeil, Sheryl A; Benes, Susan C; Robbins, Shira L

As the ophthalmology accreditation system undergoes major changes, training programs must evaluate residents in the 6 core competencies, including appropriately communicating bad news. Although the literature is replete with recommendations for breaking bad news across various non-ophthalmology specialties, no formal training programs exist for ophthalmology. There are many valuable lessons to be learned from our colleagues regarding this important skill. We examine the historic basis for breaking bad news, explore current recommendations among other specialties, and then evaluate a pilot study in breaking bad news for ophthalmology residents. The results of this study are limited by a small number of residents at a single academic center. Future studies from multiple training programs should be conducted to further evaluate the need and efficacy of formal communication skills training in this area, as well as the generalizability of our pilot training program. If validated, this work could serve as a template for future ophthalmology resident training and evaluation in this core competency. Copyright © 2016 Elsevier Inc. All rights reserved.

Breaking bad news: a communication competency for ophthalmology training programs

PubMed Central

Hilkert, Sarah M.; Cebulla, Colleen M.; Jain, Shelly Gupta; Pfeil, Sheryl A.; Benes, Susan C.; Robbins, Shira L.

2016-01-01

As the ophthalmology accreditation system undergoes major changes, training programs must evaluate residents in the 6 core competencies, including appropriately communicating bad news. Although the literature is replete with recommendations for breaking bad news across various non-ophthalmology specialties, no formal training programs exist for ophthalmology. There are many valuable lessons to be learned from our non-ophthalmology colleagues regarding this important skill. We examine the historic basis for breaking bad news, explores current recommendations among other specialties, and then evaluate a pilot study to teach breaking bad news to ophthalmology residents. The results of this study are limited by a small number of residents at a single academic center. Future studies from multiple training programs should be conducted to further evaluate the need and efficacy of formal communication skills training in this area, as well as the generalizability of our pilot training program. If validated, this work could serve as a template for future ophthalmology resident training and evaluation in this core competency. PMID:27134009

Topical treatment of tinea pedis using 6% coriander oil in unguentum leniens: a randomized, controlled, comparative pilot study.

PubMed

Beikert, F C; Anastasiadou, Z; Fritzen, B; Frank, U; Augustin, M

2013-01-01

The antifungal activity of coriander oil has already been demonstrated in vitro. Evaluation of the efficacy and tolerability of 6% coriander oil in unguentum leniens in the treatment of interdigital tinea pedis. Half-side comparative pilot study on subjects with symmetric, bilateral interdigital tinea pedis. Active drug and placebo control were applied twice daily on the affected areas, and follow-up visits were performed on days 14 and 28. 40 participants (mean age 52.5 years, 60% male) were included in the study. For 6% coriander oil in unguentum leniens, a highly significant improvement of the clinical signs (p < 0.0001) was observed during the entire observation period; the number of positive fungal cultures also tended to decrease (p = 0.0654). The tolerability of the tested substances was good. Coriander oil is effective and well tolerated in the treatment of interdigital tinea pedis. Copyright © 2013 S. Karger AG, Basel.

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.

A preclinical evaluation of an autologous living hyaline-like cartilaginous graft for articular cartilage repair: a pilot study.

PubMed

Peck, Yvonne; He, Pengfei; Chilla, Geetha Soujanya V N; Poh, Chueh Loo; Wang, Dong-An

2015-11-09

In this pilot study, an autologous synthetic scaffold-free construct with hyaline quality, termed living hyaline cartilaginous graft (LhCG), was applied for treating cartilage lesions. Implantation of autologous LhCG was done at load-bearing regions of the knees in skeletally mature mini-pigs for 6 months. Over the course of this study, significant radiographical improvement in LhCG treated sites was observed via magnetic resonance imaging. Furthermore, macroscopic repair was effected by LhCG at endpoint. Microscopic inspection revealed that LhCG engraftment restored cartilage thickness, promoted integration with surrounding native cartilage, produced abundant cartilage-specific matrix molecules, and re-established an intact superficial tangential zone. Importantly, the repair efficacy of LhCG was quantitatively shown to be comparable to native, unaffected cartilage in terms of biochemical composition and biomechanical properties. There were no complications related to the donor site of cartilage biopsy. Collectively, these results imply that LhCG engraftment may be a viable approach for articular cartilage repair.

A preclinical evaluation of an autologous living hyaline-like cartilaginous graft for articular cartilage repair: a pilot study

PubMed Central

Peck, Yvonne; He, Pengfei; Chilla, Geetha Soujanya V. N.; Poh, Chueh Loo; Wang, Dong-An

2015-01-01

In this pilot study, an autologous synthetic scaffold-free construct with hyaline quality, termed living hyaline cartilaginous graft (LhCG), was applied for treating cartilage lesions. Implantation of autologous LhCG was done at load-bearing regions of the knees in skeletally mature mini-pigs for 6 months. Over the course of this study, significant radiographical improvement in LhCG treated sites was observed via magnetic resonance imaging. Furthermore, macroscopic repair was effected by LhCG at endpoint. Microscopic inspection revealed that LhCG engraftment restored cartilage thickness, promoted integration with surrounding native cartilage, produced abundant cartilage-specific matrix molecules, and re-established an intact superficial tangential zone. Importantly, the repair efficacy of LhCG was quantitatively shown to be comparable to native, unaffected cartilage in terms of biochemical composition and biomechanical properties. There were no complications related to the donor site of cartilage biopsy. Collectively, these results imply that LhCG engraftment may be a viable approach for articular cartilage repair. PMID:26549401

The role of mitomycin C in surgery of the frontonasal recess: a prospective open pilot study.

PubMed

Amonoo-Kuofi, Kwame; Lund, Valerie J; Andrews, Peter; Howard, David J

2006-01-01

Mitomycin C (MMC) inhibits fibroblast proliferation. The objective of this study was to determine the efficacy of MMC in reducing frontal ostium stenosis after endoscopic sinus surgery. A prospective open pilot study was conducted in 28 patients who had undergone one or more previous surgical interventions for frontal sinusitis. MMC solution was applied to the frontal ostial region via an endoscopic or combined endoscopic and external approach. Patency of the frontal ostium was evaluated endoscopically during regular follow-up. If restenosis was observed further, endoscopic application of MMC was undertaken. There were 17 men and 11 women (mean age, 51.7 years; range, 26-86 years). Mean number of applications was 1.5 (range, 1:3). Mean follow-up was 19 months (range, 6-32 months). Patency rate was 86%. Mitomycin appears to have an important role in reducing postoperative scarring, which may obviate the need for repeated and more extensive surgery.

Mindfulness Training and Stress Reactivity in Substance Abuse: Results from A Randomized, Controlled Stage I Pilot Study

PubMed Central

Brewer, Judson A.; Sinha, Rajita; Chen, Justin A.; Michalsen, Ravenna N.; Babuscio, Theresa A.; Nich, Charla; Grier, Aleesha; Bergquist, Keri L.; Reis, Deidre L.; Potenza, Marc N.; Carroll, Kathleen M.; Rounsaville, Bruce J.

2011-01-01

Background Stress is important in substance use disorders (SUDs). Mindfulness training (MT) has shown promise for stress-related maladies. No studies have compared MT to empirically-validated treatments for SUDs. Goals to assess MT compared to cognitive behavioral therapy (CBT) in substance use and treatment acceptability, and specificity of MT compared to CBT in targeting stress reactivity. Methods 36 individuals with alcohol and/or cocaine use disorders were randomly assigned to receive group MT or CBT in an outpatient setting. Drug use was assessed weekly. After treatment, responses to personalized stress provocation were measured. Results Fourteen individuals completed treatment. There were no differences in treatment satisfaction, or drug use between groups. The laboratory paradigm suggested reduced psychological and physiological indices of stress during provocation in MT compared to CBT. Conclusions This pilot study provides evidence of the feasibility of MT in treating SUDs and suggests that MT may be efficacious in targeting stress. PMID:19904666

Promotoras across the border: a pilot study addressing depression in Mexican women impacted by migration.

PubMed

Edelblute, Heather B; Clark, Sandra; Mann, Lilli; McKenney, Kathryn M; Bischof, Jason J; Kistler, Christine

2014-06-01

The migration of working-aged men from Mexico to the United States fractures the family-centered support structures typical of Latin America and contributes to high levels of depression in women left behind in migratory sending communities in Mexico. Mujeres en Solidaridad Apoyandose (MESA) was developed to improve depression in women through social support in a resource poor setting. MESA is a promotora intervention that trains women in the community to lead social support groups over a five-week period. The MESA curriculum uses a combination of cognitive behavioral theory techniques, psychoeducation, and social support activities aimed at alleviating or preventing depression in women. Results from this pilot efficacy study (n = 39) show that depressed participants at baseline experienced declines in depression as measured by the Center for Epidemiologic Studies Depression Scale at follow-up. Other findings demonstrate the complexity behind addressing social support and depression for women impacted by migration in different ways.

The Girlfriends Project: Results of a pilot study assessing feasibility of an HIV testing and risk reduction intervention developed, implemented, and evaluated in community settings.

PubMed

Hawk, Mary

2013-12-01

African American women in the United States experience significant HIV health disparities. The majority of evidence-based risk reduction interventions do not incorporate HIV testing, and most are targeted only to narrow segments of the population such as women who are pregnant or seen in STI clinics. This pilot study assessed the feasibility and efficacy of The Girlfriends Project (TGP), a community developed and community evaluated HIV risk reduction and testing intervention. A group randomized wait-list design was used to recruit 149 women and to compare findings for intervention group versus control group participants. Women in the intervention group demonstrated statistically-significant increases in HIV knowledge scores and in condom use during vaginal sex. Eighty-seven percent of participants accessed HIV testing with a 100% return rate for results. Study findings suggest that TGP has the potential to be an effective intervention and to increase number of African American women who access HIV testing.

Superficial dermabrasion versus topical tretinoin on early striae distensae: a randomized, pilot study.

PubMed

Hexsel, Doris; Soirefmann, Mariana; Porto, Manoela D; Schilling-Souza, Juliana; Siega, Carolina; Dal'Forno, Taciana

2014-05-01

Striae distensae (SD) is a common skin condition, with a prevalence ranging from 40% to 90%, depending on the population studied. To evaluate the efficacy of superficial dermabrasion and compare it with that of topical tretinoin cream in the treatment of narrow and early SD. Prospective, single-center, randomized, open-label study. Thirty-two women presenting with early, untreated SD (striae rubra) were included in this study. One group received 16 weekly sessions of superficial and localized dermabrasion, and the other used 0.05% tretinoin cream daily. Striae width and length were measured and compared between groups and over time. Global Aesthetic Improvement Scale scores and subject satisfaction were also assessed. Biopsies were performed for subjects who agreed to undergo this procedure, followed by histologic analyses of the skin samples. Both treatments were efficacious, with significant improvement in early SD from baseline, but there was no significant difference between the two treatments. Histologic assessment showed improvement in epidermal and dermal layers for the dermabrasion treatment group. Both treatments had similar efficacy, but superficial dermabrasion had a lower frequency of side effects and better adherence of the patients. © 2014 by the American Society for Dermatologic Surgery, Inc. Published by Wiley Periodicals, Inc.

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.

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

[The efficacy of the exoskeleton ExoAtlet to restore walking in patients with multiple sclerosis].

PubMed

Kotov, S V; Lijdvoy, V Yu; Sekirin, A B; Petrushanskaya, K A; Pismennaya, E V

2017-01-01

To investigate the efficacy and safety of the exoskeleton ExoAtlet in complex therapy of patients with multiple sclerosis (MS). A pilot study within the prospective open controlled program was conducted. Eighteen patients with relapsing-remitting MS (RRMS) in remission and secondary progressive MS (SPMS) with the level of neurological deficit on the EDSS from 3 to 7 points have completed the study. EDSS, MSFC, HADS, MoCA scales were administered and the force measuring insoles F-Scan Tekscan (USA) were used to study the biomechanics of walking. Good tolerability of workload within 30-40 min. was observed. The improvement in the EDSS was detected in 9 patients, in whole, a significant positive trend (p<0.01) was shown. The study of the biomechanics of the walk showed its significant impairment compared to healthy individuals: reduction of parameters of rate, speed and step length, significant instability, pronounced asymmetry, the decrease in support and shock lower limb function, high coefficient of variability of the parameters, the phenomenon of recurrence of the vertical component of support reactions. After a course of exercise of walking in the exoskeleton, the walking speed and stability increased, oscillation of the body decreased, support function increased, the phenomenon of cyclical changes of the vertical component of support reactions reduced. The results of the pilot study showed promising future research opportunities for robotic-assisted walking and maintenance of the vertical posture with the help of the exoskeleton ExoAtlet to restore the abilities of movement in MS patients with locomotor disorders.

Development and evaluation of a risk communication curriculum for medical students.

PubMed

Han, Paul K J; Joekes, Katherine; Elwyn, Glyn; Mazor, Kathleen M; Thomson, Richard; Sedgwick, Philip; Ibison, Judith; Wong, John B

2014-01-01

To develop, pilot, and evaluate a curriculum for teaching clinical risk communication skills to medical students. A new experience-based curriculum, "Risk Talk," was developed and piloted over a 1-year period among students at Tufts University School of Medicine. An experimental study of 2nd-year students exposed vs. unexposed to the curriculum was conducted to evaluate the curriculum's efficacy. Primary outcome measures were students' objective (observed) and subjective (self-reported) risk communication competence; the latter was assessed using an Observed Structured Clinical Examination (OSCE) employing new measures. Twenty-eight 2nd-year students completed the curriculum, and exhibited significantly greater (p<.001) objective and subjective risk communication competence than a convenience sample of 24 unexposed students. New observational measures of objective competence in risk communication showed promising evidence of reliability and validity. The curriculum was resource-intensive. The new experience-based clinical risk communication curriculum was efficacious, although resource-intensive. More work is needed to develop the feasibility of curriculum delivery, and to improve the measurement of competence in clinical risk communication. Risk communication is an important advanced communication skill, and the Risk Talk curriculum provides a model educational intervention and new assessment tools to guide future efforts to teach and evaluate this skill. Copyright © 2013 Elsevier Ireland Ltd. All rights reserved.

The efficacy of laser-assisted hair removal in the treatment of acne keloidalis nuchae; a pilot study.

PubMed

Esmat, Samia M; Abdel Hay, Rania M; Abu Zeid, Ola M; Hosni, Hala N

2012-01-01

Laser-assisted hair removal causes miniaturization of hair shafts which are the principal contributors to inflammation in acne keloidalis nuchae (AKN). To assess the efficacy of hair reduction by long pulsed Nd-YAG laser as a therapeutic modality for AKN. This interventional pilot trial included 16 patients with AKN who received 5 sessions of long pulsed Nd-YAG laser. Lesions were objectively and subjectively assessed at the third and fifth laser sessions, and 1 year after. Global response to treatment was rated using a quartile grading scale regarding the percentage improvement in the count of papules and the size of the plaques. Biopsies were taken before and 2 weeks after the fifth session to evaluate the pathological changes associated with improvement of the treated lesions. All patients showed a significant improvement. The percentage of improvement in the early caseswas significantly higher when compared to late cases.Two weeks after the fifth session, all biopsies showed a significant decrease in the inflammatory infiltrate except one case. Sclerosis was markedly decreased. Complete absence of hair follicles and adenexawas observed, apart from in 2 cases. Laser hair depilation can significantly improve this disfiguring chronic disorder. Starting treatment as early as possible achieves the best results and can stop the disease process if followed by maintenance sessions.

A Brief Peer Support Intervention for Veterans with Chronic Musculoskeletal Pain: A Pilot Study of Feasibility and Effectiveness

PubMed Central

Matthias, Marianne S.; McGuire, Alan B.; Kukla, Marina; Daggy, Joanne; Myers, Laura J.; Bair, Matthew J.

2016-01-01

Objective To pilot test a peer support intervention, involving peer delivery of pain self-management strategies, for veterans with chronic musculoskeletal pain. Design Pre-test/post-test with 4-month intervention period. Methods Ten peer coaches were each assigned 2 patients (n=20 patients). All had chronic musculoskeletal pain. Guided by a study manual, peer coach-patient pairs were instructed to talk bi-weekly for 4 months. Pain was the primary outcome and was assessed with the PEG, a 3-item version of the Brief Pain Inventory, and the PROMIS Pain Interference Questionnaire. Several secondary outcomes were also assessed. To assess change in outcomes, a linear mixed model with a random effect for peer coaches was applied. Results Nine peer coaches and 17 patients completed the study. All were male veterans. Patients’ pain improved at 4 months compared to baseline but did not reach statistical significance (PEG: p = .33, ICC [intra-class correlation] = .28, Cohen's d = −.25; PROMIS: p = .17, d = −.35). Of secondary outcomes, self-efficacy (p = .16, ICC = .56, d = .60) and pain centrality (p = .06, ICC = .32, d = −.62) showed greatest improvement, with moderate effect sizes. Conclusions This study suggests that peers can effectively deliver pain self-management strategies to other veterans with pain. Although this was a pilot study with a relatively short intervention period, patients improved on several outcomes. PMID:25312858

A pilot study on the effects of individually tailored education for MMR vaccine-hesitant parents on MMR vaccination intention

PubMed Central

Gowda, Charitha; Schaffer, Sarah E.; Kopec, Kristin; Markel, Arielle; Dempsey, Amanda F.

2013-01-01

Healthcare providers need strategies to better address the concerns of vaccine-hesitant parents. We studied whether individually tailored education was more effective than untailored education at improving vaccination intention among MMR vaccine-hesitant parents. In an intervention pilot study of parents (n = 77) of children < 6 y who screened as hesitant to vaccinate against MMR (first or second dose), parents were randomly assigned to receive either (1) educational web pages that were individually tailored to address their specific vaccine concerns; or (2) web pages similar in appearance to the intervention but containing untailored information. The main outcome, change in vaccination intention before and after the intervention, was assessed using an 11-pt scale (higher values indicated greater intent). We found that a greater proportion of parents in the tailored than untailored arm had positive vaccination intentions after viewing educational information (58% vs. 46%). Furthermore, parents in the tailored group had a greater magnitude of change in vaccination intention (1.08 vs. 0.49 points) than participants in the untailored group. However, neither of these results was statistically significant. From this pilot study we conclude message tailoring may be an effective way to improve vaccine compliance among vaccine hesitant parents. However, larger studies are warranted to further investigate the efficacy of providing tailored education for increasing vaccine acceptance among parents with diverse beliefs. PMID:23291937

Ostomy creation with fewer sutures using tissue adhesives (cyanoacrylates) in inflammatory bowel disease: a pilot study.

PubMed

Uchino, M; Ikeuchi, H; Bando, T; Sasaki, H; Chohno, T; Horio, Y; Takesue, Y

2018-03-01

Introduction Fistula formation around the ostomy site is a stoma-related complication often requiring surgical intervention. This complication may be caused by sutures or may develop as a complication of inflammatory bowel disease. Before conducting a clinical trial, we set out to investigate the safety of ostomy creation with fewer sutures using tissue adhesives in this pilot study. Methods Patients with inflammatory bowel disease who required surgery with ostomy creation at the Hyogo College of Medicine between January 2014 and December 2015 were enrolled. Safety was assessed by evaluating the incidence of stoma-related complications. Ostomy was restricted to loop ileostomy and was created with two sutures and tissue adhesives. Results A total of 14 patients were enrolled. Mean body mass index was 18.9 ± 2.0 kg/m 2 . There were no cases of ostomy retraction and no severe adverse events were observed. Conclusions This pilot study demonstrates that ostomy creation using tissue adhesives is safe. Although retraction and adverse events were not observed, even in patients with inflammatory bowel disease who generally exhibit delayed wound healing, the body mass index was extremely low in this series. This study does not strongly recommend ostomy creation with tissue adhesives; further studies are needed to clarify the efficacy and safety of the procedure.

A pilot, quasi-experimental, mixed methods investigation into the efficacy of a group psychotherapy intervention for caregivers of outpatients with cancer: the COPE study protocol.

PubMed

Mahendran, Rathi; Tan, Joyce Yi Siang; Griva, Konstadina; Lim, Haikel Asyraf; Ng, Hui Ying; Chua, Joanne; Lim, Siew Eng; Kua, Ee Heok

2015-11-19

Despite the rising trend of cancer prevalence and increase in family caregiving, little attention has been paid to the efficacy of psychosocial interventions among Asian caregiver samples, particularly support groups, given the benefits that have been shown in studies on Western populations. This trial aims to evaluate the effectiveness of a pilot 4-week group psychotherapy for Singaporean family caregivers of patients receiving outpatient care. Facilitated by a clinical psychologist, this intervention is primarily based on the brief integrative psychological therapy with a supportive-expressive intent. Participants will be recruited while they are accompanying their care recipients for outpatient consultations. Since this is a pilot study, a sample size of 120 participants is targeted on the basis of sample sizes of previous studies. The study adopts a quasi-experimental design, as participants are assigned the intervention or control arms based on their availability to attend the intervention. A mixed methods approach is used to evaluate the outcomes of the intervention. A self-administered battery of tests is completed at four time points: baseline, postintervention and follow-up at 1-month and 2-month postinterventions; semi-structured interviews are conducted at baseline and post-intervention. Primary outcomes are quality of life and anxious and depressive symptoms; secondary outcomes are stress and basic psychological needs. Analysis using analysis of covariance would be conducted to determine the effectiveness of the intervention. This study protocol has ethics approval from the National Healthcare Group Domain Specific Review Board (NHG DSRB Ref: 2013/00662). Written informed consent is obtained from every participant. Results will be disseminated through journals and conferences, and will be particularly relevant for clinicians intending to implement similar support groups to address the psychosocial concerns of caregivers, as well as for researchers seeking to refine the structure and evaluate the effectiveness of such programmes. Current Controlled Trials NCT02120183 (https://clinicaltrials.gov/show/NCT02120183). Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/

A pilot, quasi-experimental, mixed methods investigation into the efficacy of a group psychotherapy intervention for caregivers of outpatients with cancer: the COPE study protocol

PubMed Central

Mahendran, Rathi; Tan, Joyce Yi Siang; Griva, Konstadina; Lim, Haikel Asyraf; Ng, Hui Ying; Chua, Joanne; Lim, Siew Eng; Kua, Ee Heok

2015-01-01

Introduction Despite the rising trend of cancer prevalence and increase in family caregiving, little attention has been paid to the efficacy of psychosocial interventions among Asian caregiver samples, particularly support groups, given the benefits that have been shown in studies on Western populations. This trial aims to evaluate the effectiveness of a pilot 4-week group psychotherapy for Singaporean family caregivers of patients receiving outpatient care. Methods and analysis Facilitated by a clinical psychologist, this intervention is primarily based on the brief integrative psychological therapy with a supportive-expressive intent. Participants will be recruited while they are accompanying their care recipients for outpatient consultations. Since this is a pilot study, a sample size of 120 participants is targeted on the basis of sample sizes of previous studies. The study adopts a quasi-experimental design, as participants are assigned the intervention or control arms based on their availability to attend the intervention. A mixed methods approach is used to evaluate the outcomes of the intervention. A self-administered battery of tests is completed at four time points: baseline, postintervention and follow-up at 1-month and 2-month postinterventions; semi-structured interviews are conducted at baseline and post-intervention. Primary outcomes are quality of life and anxious and depressive symptoms; secondary outcomes are stress and basic psychological needs. Analysis using analysis of covariance would be conducted to determine the effectiveness of the intervention. Ethics and dissemination This study protocol has ethics approval from the National Healthcare Group Domain Specific Review Board (NHG DSRB Ref: 2013/00662). Written informed consent is obtained from every participant. Results will be disseminated through journals and conferences, and will be particularly relevant for clinicians intending to implement similar support groups to address the psychosocial concerns of caregivers, as well as for researchers seeking to refine the structure and evaluate the effectiveness of such programmes. Trial registration number Current Controlled Trials NCT02120183 (https://clinicaltrials.gov/show/NCT02120183) PMID:26586322

Randomized Crossover Study of the Natural Restorative Environment Intervention to Improve Attention and Mood in Heart Failure.

PubMed

Jung, Miyeon; Jonides, John; Northouse, Laurel; Berman, Marc G; Koelling, Todd M; Pressler, Susan J

In heart failure (HF), attention may be decreased because of lowered cerebral blood flow and increased attentional demands needed for self-care. Guided by the Attention Restoration Theory, the objective was to test the efficacy of the natural restorative environment (NRE) intervention on improving attention and mood among HF patients and healthy adults. A randomized crossover pilot study was conducted among 20 HF patients and an age- and education-matched comparison group of 20 healthy adults to test the efficacy of the NRE intervention compared with an active control intervention. Neuropsychological tests were administered to examine attention, particularly attention span, sustained attention, directed attention, and attention switching, at before and after the intervention. Mood was measured with the Positive and Negative Affect Schedule. No significant differences were found in attention and mood after the NRE intervention compared with the control intervention among the HF patients and the healthy adults. In analyses with HF patients and healthy adults combined (n = 40), significant differences were found. Compared with the control intervention, sustained attention improved after the NRE intervention (P = .001) regardless of the presence of HF. Compared with the healthy adults, HF patients performed significantly worse on attention switching after the control intervention (P = .045). The NRE intervention may be efficacious in improving sustained attention in HF patients. Future studies are needed to enhance the NRE intervention to be more efficacious and tailored for HF patients and test the efficacy in a larger sample of HF patients.

A comparison of Kneipp hydrotherapy with conventional physiotherapy in the treatment of osteoarthritis: a pilot trial.

PubMed

Schencking, Martin; Wilm, Stefan; Redaelli, Marcus

2013-01-01

An increasingly aging population implies an increasing prevalence of osteoarthritis (OA) of hip or knee. It has been ascertained that unspecific hydrotherapy of OA according to Sebastian Kneipp not only improves the range of mobility but also reduces pain significantly and increases the quality of life of the patients affected. The main aim of this pilot study was to determine the effects of hydrotherapy in comparison to conventional physiotherapy, and to analyze the feasibility of the study design under clinical circumstances. The study design is a prospective randomized controlled three-arm clinical pilot trial, carried out at a specialist clinic for integrative medicine. Thirty patients diagnosed with symptomatic OA of hip or knee and radiologic findings were randomly assigned to one of two intervention groups and a control group: hydrotherapy (group 1), physiotherapy (group 2), and both physiotherapy and hydrotherapy (group 3, control group) of the affected joint. pain intensity of the affected joint in the course of inpatient treatment; secondary outcome: health-related quality of life, joint-specific pain and mobility in the course of the study. Concerning the main outcome, intervention group 1 showed most beneficial effects in the course of inpatient treatment, followed by groups 3 and 2, and also the indirect flexion ability of hip or knee together with the general patient mobility through the "timed up and go" test were mainly improved within group 1 followed by groups 3 and 2. The results of this pilot study demonstrate beneficial effects of hydrotherapy. The study design is feasible. For statistically significant evidence and a robust conclusion of efficacy of Kneipp's hydrotherapy, a larger sample size is necessary. NCT 00950326.

If I do not have enough water, then how could I bring additional water for toilet cleaning?! Addressing water scarcity to promote hygienic use of shared toilets in Dhaka, Bangladesh.

PubMed

Saxton, Ronald E; Yeasmin, Farzana; Alam, Mahbub-Ul; Al-Masud, Abdullah; Dutta, Notan Chandra; Yeasmin, Dalia; Luby, Stephen P; Unicomb, Leanne; Winch, Peter J

2017-09-01

Provision of toilets is necessary but not sufficient to impact health as poor maintenance may impair toilet function and discourage their consistent use. Water in urban slums is both scarce and a prerequisite for toilet maintenance behaviours. We describe the development of behaviour change communications and selection of low-cost water storage hardware to facilitate adequate flushing among users of shared toilets. We conducted nine focus group discussions and six ranking exercises with adult users of shared toilets (50 females, 35 males), then designed and implemented three pilot interventions to facilitate regular flushing and improve hygienic conditions of shared toilets. We conducted follow-up assessments 1 and 2 months post-pilot including nine in-depth interviews and three focus group discussions with adult residents (23 females, 15 males) and three landlords in the pilot communities. Periodic water scarcity was common in the study communities. Residents felt embarrassed to carry water for flushing. Reserving water adjacent to the shared toilet enabled slum residents to flush regularly. Signs depicting rules for toilet use empowered residents and landlords to communicate these expectations for flushing to transient tenants. Residents in the pilot reported improvements in cleanliness and reduced odour inside toilet cubicles. Our pilot demonstrates the potential efficacy of low-cost water storage and behaviour change communications to improve maintenance of and user satisfaction with shared toilets in urban slum settings. © 2017 John Wiley & Sons Ltd.

Use of Electronic Tablets for Patient Education on Flushing Peripherally Inserted Central Catheters.

PubMed

Petroulias, Patricia L

The purpose of this study was to examine the efficacy of using an electronic tablet to provide patient education for flushing peripherally inserted central catheters (PICCs) as a way to reduce the incidence of occlusion. Eleven patients, newly diagnosed with cancer, participated in a pilot study that used a video on PICC flushing and remote coaching using FaceTime (Apple, Cupertino, CA) to teach patients how to maintain their PICCs in their homes. At the end of the 6-week intervention, no adverse outcomes (occlusions or infections) were noted among the patients who participated in the study.

Efficacy and safety of azelaic acid (AzA) gel 15% in the treatment of post-inflammatory hyperpigmentation and acne: a 16-week, baseline-controlled study.

PubMed

Kircik, Leon H

2011-06-01

Although there are few differences in the incidence and pathophysiology of acne across various races and ethnicities, there is some evidence that black patients may have larger sebaceous glands and increased sebum production. Of greater clinical relevance, patients with darker skin types are at increased risk for the development of post-inflammatory hyperpigmentation (PIH), which some find as or more troubling than acne itself. This common and bothersome sequelum of acne can be difficult to manage in this population. Topical azelaic acid gel is recognized to have anti-tyrosinase activity, suggesting it may be a suitable treatment option for mild-to-moderate acne with associated moderate-to-severe PIH. This pilot study demonstrates the efficacy of topical AzA gel 15% when applied twice daily for the reduction of both acne and PIH. J

Acupuncture for treatment of insomnia in patients with traumatic brain injury: a pilot intervention study.

PubMed

Zollman, Felise S; Larson, Eric B; Wasek-Throm, Laura K; Cyborski, Cherina M; Bode, Rita K

2012-01-01

: To assess the efficacy of acupuncture in treating insomnia in traumatic brain injury (TBI) survivors as compared to medication, to determine whether acupuncture has fewer cognitive and affective adverse effects than does medication. : Twenty-four adult TBI survivors, randomized to acupuncture or control arms. : Outpatient rehabilitation clinic. : Insomnia Severity Index (degree of insomnia); actigraphy (sleep time); Hamilton Depression Rating Scale (depression); Repeatable Battery for the Assessment of Neuropsychological Status and Paced Auditory Serial Addition Test (cognitive function) administered at baseline and postintervention. : Sleep time did not differ between the treatment and control groups after intervention, whereas cognition improved in the former but not the latter. : Acupuncture has a beneficial effect on perception of sleep or sleep quality and on cognition in our small sample of patients with TBI. Further studies of this treatment modality are warranted to validate these findings and to explore factors that contribute to treatment efficacy.

Sodium bicarbonate on severe metabolic acidosis during prolonged cardiopulmonary resuscitation: a double-blind, randomized, placebo-controlled pilot study.

PubMed

Ahn, Shin; Kim, Youn-Jung; Sohn, Chang Hwan; Seo, Dong Woo; Lim, Kyoung Soo; Donnino, Michael W; Kim, Won Young

2018-04-01

Sodium bicarbonate administration during cardiopulmonary resuscitation (CPR) is controversial. Current guidelines recommend sodium bicarbonate injection in patients with existing metabolic acidosis, but clinical trials, particularly, those involving patients with acidosis, are limited. We aimed to evaluate the efficacy of sodium bicarbonate administration in out-of-hospital cardiac arrest (OHCA) patients with severe metabolic acidosis during prolonged CPR. Prospective, double-blind, randomized placebo-controlled pilot trial was conducted between January 2015 and December 2015, at a single center emergency department (ED). After 10 minutes of CPR, patients who failed to achieve return of spontaneous circulation (ROSC) and with severe metabolic acidosis (pH<7.1 or bicarbonate <10 mEq/L) were enrolled. Sodium bicarbonate (n=25) or normal saline (n=25) were administered. The primary end point was sustained ROSC. The secondary end points were the change of acidosis and good neurologic survival. Sodium bicarbonate group had significant effect on pH (6.99 vs. 6.90, P=0.038) and bicarbonate levels (21.0 vs. 8.0 mEq/L, P=0.007). However, no significant differences showed between sodium bicarbonate and placebo groups in sustained ROSC (4.0% vs. 16.0%, P=0.349) or good neurologic survival at 1 month (0.0% vs. 4.0%, P=1.000). The use of sodium bicarbonate improved acid-base status, but did not improve the rate of ROSC and good neurologic survival. We could not draw a conclusion, but our pilot data could be used to design a larger trial to verify the efficacy of sodium bicarbonate. NCT02303548 (http://www.ClinicalTrials.gov).

Feasibility, acceptability and preliminary psychological benefits of mindfulness meditation training in a sample of men diagnosed with prostate cancer on active surveillance: results from a randomized controlled pilot trial.

PubMed

Victorson, David; Hankin, Vered; Burns, James; Weiland, Rebecca; Maletich, Carly; Sufrin, Nathaniel; Schuette, Stephanie; Gutierrez, Bruriah; Brendler, Charles

2017-08-01

In a pilot randomized controlled trial, examine the feasibility and preliminary efficacy of an 8-week, mindfulness training program (Mindfulness Based Stress Reduction) in a sample of men on active surveillance on important psychological outcomes including prostate cancer anxiety, uncertainty intolerance and posttraumatic growth. Men were randomized to either mindfulness (n = 24) or an attention control arm (n = 19) and completed self-reported measures of prostate cancer anxiety, uncertainty intolerance, global quality of life, mindfulness and posttraumatic growth at baseline, 8 weeks, 6 months and 12 months. Participants in the mindfulness arm demonstrated significant decreases in prostate cancer anxiety and uncertainty intolerance, and significant increases in mindfulness, global mental health and posttraumatic growth. Participants in the control condition also demonstrated significant increases in mindfulness over time. Longitudinal increases in posttraumatic growth were significantly larger in the mindfulness arm than they were in the control arm. While mindfulness training was found to be generally feasible and acceptable among participants who enrolled in the 8-week intervention as determined by completion rates and open-ended survey responses, the response rate between initial enrollment and the total number of men approached was lower than desired (47%). While larger sample sizes are necessary to examine the efficacy of mindfulness training on important psychological outcomes, in this pilot study posttraumatic growth was shown to significantly increase over time for men in the treatment group. Mindfulness training has the potential to help men cope more effectively with some of the stressors and uncertainties associated with active surveillance. Copyright © 2016 John Wiley & Sons, Ltd. Copyright © 2016 John Wiley & Sons, Ltd.

Design, Implementation, and Wide Pilot Deployment of FitForAll: An Easy to use Exergaming Platform Improving Physical Fitness and Life Quality of Senior Citizens.

PubMed

Konstantinidis, Evdokimos I; Billis, Antonis S; Mouzakidis, Christos A; Zilidou, Vasiliki I; Antoniou, Panagiotis E; Bamidis, Panagiotis D

2016-01-01

Many platforms have emerged as response to the call for technology supporting active and healthy aging. Key requirements for any such e-health systems and any subsequent business exploitation are tailor-made design and proper evaluation. This paper presents the design, implementation, wide deployment, and evaluation of the low cost, physical exercise, and gaming (exergaming) FitForAll (FFA) platform system usability, user adherence to exercise, and efficacy are explored. The design of FFA is tailored to elderly populations, distilling literature guidelines and recommendations. The FFA architecture introduces standard physical exercise protocols in exergaming software engineering, as well as, standard physical assessment tests for augmented adaptability through adjustable exercise intensity. This opens up the way to next generation exergaming software, which may be more automatically/smartly adaptive. 116 elderly users piloted FFA five times/week, during an eight-week controlled intervention. Usability evaluation was formally conducted (SUS, SUMI questionnaires). Control group consisted of a size-matched elderly group following cognitive training. Efficacy was assessed objectively through the senior fitness (Fullerton) test, and subjectively, through WHOQoL-BREF comparisons of pre-postintervention between groups. Adherence to schedule was measured by attendance logs. The global SUMI score was 68.33±5.85%, while SUS was 77.7. Good usability perception is reflected in relatively high adherence of 82% for a daily two months pilot schedule. Compared to control group, elderly using FFA improved significantly strength, flexibility, endurance, and balance while presenting a significant trend in quality of life improvements. This is the first elderly focused exergaming platform intensively evaluated with more than 100 participants. The use of formal tools makes the findings comparable to other studies and forms an elderly exergaming corpus.

Assessment of treatment efficacy and sebosuppressive effect of fractional radiofrequency microneedle on acne vulgaris.

PubMed

Lee, Kyung Real; Lee, Eo Gin; Lee, Hee Jung; Yoon, Moon Soo

2013-12-01

A minimally invasive fractional radiofrequency microneedle (FRM) device has been used in skin rejuvenation and acne scars, and a recent pilot study demonstrated the positive therapeutic effect on acne. We evaluated the efficacy of FRM device for acne vulgaris in Asians and conducted objective measurement to assess its effect on sebum production. Twenty Korean patients with acne vulgaris received a single full-face FRM treatment. Outcome assessments included standardized photography, physician's global assessment, patient's satisfaction scores, acne lesion count, and objective measurements of casual sebum level (CSL) and sebum excretion rate (SER). They were evaluated at baseline and 2, 4, 8 weeks after the treatment. After a single FRM treatment, the CSL and the SER showed 30-60% and 70-80% reduction, respectively, at week 2 (P < 0.01), and remained below the baseline level until week 8. Physician's global improvement scores for acne severity and acne lesion count also revealed clinical improvement with maximum efficacy at week 2, but returned to the baseline in most patients by week 8. Patients' satisfaction scores (0-4) were above 2 on average, and adverse effects were minimal. This prospective study demonstrated the sebosuppressive effect from a single FRM treatment, but its therapeutic efficacy in acne requires further evaluation. © 2013 Wiley Periodicals, Inc.

Does Employment-Related Resilience Affect the Relationship between Childhood Adversity, Community Violence, and Depression?

PubMed

Welles, Seth L; Patel, Falguni; Chilton, Mariana

2017-04-01

Depression is a barrier to employment among low-income caregivers receiving Temporary Assistance for Needy Families (TANF), and adverse childhood experiences (ACEs) and exposure to community violence (ECV) are often associated with depression. Using baseline data of 103 TANF caregivers of young children of the Building Wealth and Health Network Randomized Controlled Trial Pilot, this study investigated associations of two forms of employment-related resilience-self-efficacy and employment hope-with exposure to adversity/violence and depression, measured by the Center for Epidemiologic Studies Depression (CES-D) short form. Using contingency table analysis and regression analysis, we identified associations between ACEs and depression [OR = 1.70 (1.25-2.32), p = 0.0008] and having high levels of ECV with a 6.9-fold increased risk for depression when compared with those without ECV [OR = 6.86 (1.43-33.01), p = 0.02]. While self-efficacy and employment hope were significantly associated with depression, neither resilience factor impacted the association of ACE level and depression, whereas self-efficacy and employment hope modestly reduced the associations between ECV and depression, 13 and 16%, respectively. Results suggest that self-efficacy and employment hope may not have an impact on the strong associations between adversity, violence, and depression.

Levetiracetam versus lorazepam in status epilepticus: a randomized, open labeled pilot study.

PubMed

Misra, U K; Kalita, J; Maurya, P K

2012-04-01

For the management of status epilepticus (SE), lorazepam (LOR) is recommended as the first and phenytoin or fosphenytoin as the second choice. Both these drugs have significant toxicity. Intravenous levetiracetam (LEV) has become available, but its efficacy and safety has not been reported in comparison to LOR. We report a randomized, open labeled pilot study comparing the efficacy and safety of LEV and LOR in SE. Consecutive patients with convulsive or subtle convulsive SE were randomized to LEV 20 mg/kg IV over 15 min or LOR 0.1 mg/kg over 2-4 min. Failure to control SE within 10 min of administration of one study drug was treated by the other study drug. The primary endpoint was clinical seizure cessation and secondary endpoints were 24 h freedom from seizure, hospital mortality, and adverse events. Our results are based on 79 patients. Both LEV and LOR were equally effective. In the first instance, the SE was controlled by LEV in 76.3% (29/38) and by LOR in 75.6% (31/41) of patients. In those resistant to the above regimen, LEV controlled SE in 70.0% (7/10) and LOR in 88.9% (8/9) patients. The 24-h freedom from seizure was also comparable: by LEV in 79.3% (23/29) and LOR in 67.7% (21/31). LOR was associated with significantly higher need of artificial ventilation and insignificantly higher frequency of hypotension. For the treatment of SE, LEV is an alternative to LOR and may be preferred in patients with respiratory compromise and hypotension.

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.

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.

Feasibility and usability of a text message-based program for diabetes self-management in an urban African-American population.

PubMed

Dick, Jonathan J; Nundy, Shantanu; Solomon, Marla C; Bishop, Keisha N; Chin, Marshall H; Peek, Monica E

2011-09-01

We pilot-tested a text message-based diabetes care program in an urban African-American population in which automated text messages were sent to participants with personalized medication, foot care, and appointment reminders and text messages were received from participants on adherence. Eighteen patients participated in a 4-week pilot study. Baseline surveys collected data about demographics, historical cell phone usage, and adherence to core diabetes care measures. Exit interview surveys (using close-coded and open-ended questions) were administered to patients at the end of the program. A 1-month follow-up interview was conducted surveying patients on perceived self-efficacy. Wilcoxon signed-rank tests were used to compare baseline survey responses about self-management activities to those at the pilot's end and at 1-month follow-up. Eighteen urban African-American participants completed the pilot study. The average age was 55 and the average number of years with diabetes was 8. Half the participants were initially uncomfortable with text messaging. Example messages include "Did you take your diabetes medications today" and "How many times did you check your feet for wounds this week?" Participants averaged 220 text messages with the system, responded to messages 80% of the time, and on average responded within 6 minutes. Participants strongly agreed that text messaging was easy to perform and helped with diabetes self-care. Missed medication doses decreased from 1.6 per week to 0.6 (p = .003). Patient confidence in diabetes self-management was significantly increased during and 1 month after the pilot (p = .002, p = .008). Text messaging may be a feasible and useful approach to improve diabetes self-management in urban African Americans. © 2011 Diabetes Technology Society.

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).

A pilot single arm observational study of sofosbuvir/ledipasvir (200 + 45 mg) in 6- to 12- year old children.

PubMed

El-Shabrawi, M H F; Kamal, N M; El-Khayat, H R; Kamal, E M; AbdElgawad, M M A H; Yakoot, M

2018-04-25

No available data on the use of sofosbuvir/ledipasvir combination in treatment of hepatitis C virus (HCV) infection in children 6- to 12- year old. To assess the safety and efficacy of sofosbuvir plus ledipasvir in children 6- to 12- year old with chronic HCV genotype 4 infection. This is a pilot prospective single arm observational open-label multicentre study. A total of 20 consecutive eligible chronic HCV infected children, aged from 6- to 12- years were included in this study and treated with a fixed sofosbuvir/ledipasvir combination in half the adult dose (200/45 mg) once daily for 12 weeks. Laboratory tests including virological markers were measured at baseline, 2, 4, 8 and 12 weeks (end of treatment [EOT]), and 12 weeks after end of treatment for sustained virological response 12 (SVR12). The intention-to-treat (ITT) SVR12 rate was 19/20 (95%; 95% CI: 76.4%-99.1%). SVR12 was not assessed in one patient who was lost to follow-up after showing viral negativity at the EOT12. All the remaining 19 patients (100%, 95% CI: 83.18%-100%) who completed the full protocol and follow-up visits achieved SVR12 with normal liver, haematological, and renal function tests and no side effects or fatalities. This pilot study demonstrated that the fixed dose sofosbuvir/ledipasvir combination could be safe and effective treatment in children 6- to 12- years with chronic hepatitis C genotype 4 infection. Our pilot results might encourage larger and multicentre studies in this age group. © 2018 John Wiley & Sons Ltd.

Wii-Fit for Improving Gait and Balance in an Assisted Living Facility: A Pilot Study

PubMed Central

Padala, Kalpana P.; Padala, Prasad R.; Malloy, Timothy R.; Geske, Jenenne A.; Dubbert, Patricia M.; Dennis, Richard A.; Garner, Kimberly K.; Bopp, Melinda M.; Burke, William J.; Sullivan, Dennis H.

2012-01-01

Objectives. To determine the effects on balance and gait of a Wii-Fit program compared to a walking program in subjects with mild Alzheimer's dementia (AD). Methods. A prospective randomized (1 : 1) pilot study with two intervention arms was conducted in an assisted living facility with twenty-two mild AD subjects. In both groups the intervention occurred under supervision for 30 minutes daily, five times a week for eight weeks. Repeated measures ANOVA and paired t-tests were used to analyze changes. Results. Both groups showed improvement in Berg Balance Scale (BBS), Tinetti Test (TT) and Timed Up and Go (TUG) over 8 weeks. However, there was no statistically significant difference between the groups over time. Intragroup analysis in the Wii-Fit group showed significant improvement on BBS (P = 0.003), and TT (P = 0.013). The walking group showed a trend towards improvement on BBS (P = 0.06) and TUG (P = 0.07) and significant improvement in TT (P = 0.06). Conclusion. This pilot study demonstrates the safety and efficacy of Wii-Fit in an assisted living facility in subjects with mild AD. Use of Wii-Fit resulted in significant improvements in balance and gait comparable to those in the robust monitored walking program. These results need to be confirmed in a larger, methodologically sound study. PMID:22745909

A pilot test of a motivational interviewing social network intervention to reduce substance use among housing first residents.

PubMed

Kennedy, David P; Osilla, Karen Chan; Hunter, Sarah B; Golinelli, Daniela; Maksabedian Hernandez, Ervant; Tucker, Joan S

2018-03-01

This article presents findings of a pilot test of a Motivational Interviewing social network intervention (MI-SNI) to enhance motivation to reduce high risk alcohol and other drug (AOD) use among formerly homeless individuals transitioning to housing. Delivered in-person by a facilitator trained in MI, this four-session computer-assisted intervention provides personalized social network visualization feedback to help participants understand the people in their network who trigger their alcohol and other drug (AOD) use and those who support abstinence. If ready, participants are encouraged to make changes to their social network to help reduce their own high-risk behavior. Participants were 41 individuals (33 male, 7 female, 1 other; 23 African-American, 5 non-Latino White, 6 Latino, 7 other, mean age 48) who were transitioning from homelessness to permanent supportive housing. They were randomly assigned to either the MI-SNI condition or usual care. Readiness to change AOD use, AOD abstinence self-efficacy, and AOD use were assessed at baseline and shortly after the final intervention session for the MI-SNI arm and around 3-months after baseline for the control arm. Acceptability of the intervention was also evaluated. MI-SNI participants reported increased readiness to change AOD use compared to control participants. We also conducted a subsample analysis for participants at one housing program and found a significant intervention effect on readiness to change AOD use, AOD abstinence self-efficacy, and alcohol use compared to control participants. Participants rated the intervention as highly acceptable. We conclude that a brief computer-assisted Motivational Interviewing social network intervention has potential to efficaciously impact readiness to change AOD use, AOD abstinence self-efficacy, and AOD use among formerly homeless individuals transitioning to permanent supportive housing, and warrants future study in larger clinical trials. Copyright © 2017 Elsevier Inc. All rights reserved.

Efficacy of Coming Out Proud to reduce stigma's impact among people with mental illness: pilot randomised controlled trial.

PubMed

Rüsch, Nicolas; Abbruzzese, Elvira; Hagedorn, Eva; Hartenhauer, Daniel; Kaufmann, Ilias; Curschellas, Jan; Ventling, Stephanie; Zuaboni, Gianfranco; Bridler, René; Olschewski, Manfred; Kawohl, Wolfram; Rössler, Wulf; Kleim, Birgit; Corrigan, Patrick W

2014-01-01

Facing frequent stigma and discrimination, many people with mental illness have to choose between secrecy and disclosure in different settings. Coming Out Proud (COP), a 3-week peer-led group intervention, offers support in this domain in order to reduce stigma's negative impact. To examine COP's efficacy to reduce negative stigma-related outcomes and to promote adaptive coping styles (Current Controlled Trials number: ISRCTN43516734). In a pilot randomised controlled trial, 100 participants with mental illness were assigned to COP or a treatment-as-usual control condition. Outcomes included self-stigma, empowerment, stigma stress, secrecy and perceived benefits of disclosure. Intention-to-treat analyses found no effect of COP on self-stigma or empowerment, but positive effects on stigma stress, disclosure-related distress, secrecy and perceived benefits of disclosure. Some effects diminished during the 3-week follow-up period. Coming Out Proud has immediate positive effects on disclosure- and stigma stress-related variables and may thus alleviate stigma's negative impact.

A Pilot Study of Safety and Efficacy of Cranial Electrotherapy Stimulation in Treatment of Bipolar II Depression

PubMed Central

McClure, Deimante; Greenman, Samantha C.; Koppolu, Siva Sundeep; Varvara, Maria; Yaseen, Zimri S.; Galynker, Igor I.

2015-01-01

Abstract This double-blind, sham-controlled study sought to investigate the effectiveness of cranial electrotherapy stimulation (CES) for the treatment of bipolar II depression (BD II). After randomization, the active group participants (n = 7) received 2 mA CES treatment for 20 minutes five days a week for 2 weeks, whereas the sham group (n = 9) had the CES device turned on and off. Symptom non-remitters from both groups received an additional 2 weeks of open-label active treatment. Active CES treatment but not sham treatment was associated with a significant decrease in the Beck Depression Inventory (BDI) scores from baseline to the second week (p = 0.003) maintaining significance until week 4 (p = 0.002). There was no difference between the groups in side effects frequency. The results of this small study indicate that CES may be a safe and effective treatment for BD II suggesting that further studies on safety and efficacy of CES may be warranted. PMID:26414234

A Pilot Study of Safety and Efficacy of Cranial Electrotherapy Stimulation in Treatment of Bipolar II Depression.

PubMed

McClure, Deimante; Greenman, Samantha C; Koppolu, Siva Sundeep; Varvara, Maria; Yaseen, Zimri S; Galynker, Igor I

2015-11-01

This double-blind, sham-controlled study sought to investigate the effectiveness of cranial electrotherapy stimulation (CES) for the treatment of bipolar II depression (BD II). After randomization, the active group participants (n = 7) received 2 mA CES treatment for 20 minutes five days a week for 2 weeks, whereas the sham group (n = 9) had the CES device turned on and off. Symptom non-remitters from both groups received an additional 2 weeks of open-label active treatment. Active CES treatment but not sham treatment was associated with a significant decrease in the Beck Depression Inventory (BDI) scores from baseline to the second week (p = 0.003) maintaining significance until week 4 (p = 0.002). There was no difference between the groups in side effects frequency. The results of this small study indicate that CES may be a safe and effective treatment for BD II suggesting that further studies on safety and efficacy of CES may be warranted.

Contribution of Psychosocial Factors to Physical Activity in Women of Color in the Saving Lives Staying Active (SALSA) Study.

PubMed

Mama, Scherezade K; McNeill, Lorna H; Soltero, Erica G; Orlando Edwards, Raul; Lee, Rebecca E

2017-07-01

Culturally appropriate, innovative strategies to increase physical activity (PA) in women of color are needed. This study examined whether participation in SALSA, an 8-week randomized, crossover pilot study to promote PA, led to improved psychosocial outcomes and whether these changes were associated with changes in PA over time. Women of color (N = 50) completed Internet-based questionnaires on PA, exercise self-efficacy, motivational readiness, stress, and social support at three time points. Women reported high socioeconomic status, decreases in exercise self-efficacy, and increases in motivational readiness for exercise and a number of stressful events (p < .05); changes in motivational readiness for exercise varied by group (p = .043). Changes in psychosocial factors were associated with increases in PA. Latin dance improved motivational readiness for PA. Future studies are needed to determine whether Latin dance improves other psychological measures and quality of life in women of color in an effort to increase PA and reduce health disparities.

Psychological Intervention for Improving Cognitive Function in Cancer Survivors: A Literature Review and Randomized Controlled Trial

PubMed Central

King, Summer; Green, Heather Joy

2015-01-01

Although the impact of cancer and associated treatments on cognitive functioning is becoming an increasingly recognized problem, there are few published studies that have investigated psychological interventions to address this issue. A waitlist randomized controlled trial methodology was used to assess the efficacy of a group cognitive rehabilitation intervention (“ReCog”) that successfully targeted cancer-related cognitive decline in previously published pilot research. Participants were 29 cancer survivors who were randomly allocated to either the intervention group or a waitlist group who received the intervention at a later date, and 16 demographically matched community volunteers with no history of cancer (trial registration ACTRN12615000009516, available at http://www.ANZCTR.org.au/ACTRN12615000009516.aspx). The study was the first to include an adapted version of the Traumatic Brain Injury Self-Efficacy Scale to assess cognitive self-efficacy (CSE) in people who have experienced cancer. Results revealed participating in the intervention was associated with significantly faster performance on one objective cognitive task that measures processing speed and visual scanning. Significantly larger improvements for the intervention group were also found on measures of perceived cognitive impairments and CSE. There was some evidence to support the roles of CSE and illness perceptions as potential mechanisms of change for the intervention. Overall, the study provided additional evidence of feasibility and efficacy of group psychological intervention for targeting cancer-related cognitive decline. PMID:25859431

Novel 755-nm diode laser vs. conventional 755-nm scanned alexandrite laser: Side-by-side comparison pilot study for thorax and axillary hair removal.

PubMed

Paasch, Uwe; Wagner, Justinus A; Paasch, Hartmut W

2015-01-01

Alexandrite (755 nm) and diode lasers (800-810 nm) are commonly used for hair removal. The alexandrite laser technology is somewhat cumbersome whereas new diode lasers are more robust. Recently, alexandrite-like 755 nm wavelength diodes became available. To compare the efficacy, tolerability, and subject satisfaction of a 755 nm diode laser operated in conventional (HR) and non-conventional in-motion (SHR) modes with a conventional scanned alexandrite 755 nm laser for chest and axillary hair removal. A prospective, single-center, proof of principle study was designed to evaluate the safety, efficacy and handling of a 755 nm diode laser system in comparison to a standard alexandrite 755 nm scanning hair removal laser. The new 755 nm diode is suitable to be used in SHR and HR mode and has been tested for its safety, efficacy and handling in a volunteer with success. Overall, both systems showed a high efficacy in hair reduction (88.8% 755 nm diode laser vs. 77.7% 755 nm alexandrite laser). Also, during the study period, no severe adverse effects were reported. The new 755 nm diode laser is as effective and safe as the traditional 755 nm alexandrite laser. Additionally, treatment with the 755 nm diode laser with HR and SHR modes was found to be less painful.

Pilot Study to Assess the Efficacy of Ivermectin and Fenbendazole for Treating Captive-Born Olive Baboons (Papio anubis) Coinfected with Strongyloides fülleborni and Trichuris trichiura.

PubMed

Reichard, Mason V; Thomas, Jennifer E; Chavez-Suarez, Maria; Cullin, Cassandra O; White, Gary L; Wydysh, Emily C; Wolf, Roman F

2017-01-01

In this study, we evaluated the efficacy of combined treatment with ivermectin and fenbendazole (IVM-FBZ) for treating captive olive baboons (Papio anubis) infected with Strongyloides fülleborni and Trichuris trichiura, 2 common nematode parasites of these NHP. Infected baboons were treated for a total of 9 wk with ivermectin (400 μg/kg IM twice weekly) and fenbendazole (50 mg/kg PO once daily for 3 d; 3 rounds of treatment, 21 d apart). Five baboons naturally infected with both S. fülleborni and T. trichiura (n = 4) or S. fülleborni alone (n = 1) received the combination therapy; an additional baboon infected with both parasites served as a nontreated control. The efficacy of IVM-FBZ was measured as the reduction in fecal egg counts of S. fülleborni and T. trichiura as determined by quantitative fecal flotation examination after treatment of baboons with IVM-FBZ. All baboons treated with IVM-FBZ stopped shedding S. fülleborni and T. trichiura eggs by 8 d after treatment and remained negative for at least 161 d. The nontreated control baboon shed S. fülleborni and T. trichiura eggs throughout the study period. Our results indicate that the IVM-FBZ regimen was efficacious for treating olive baboons infected with S. fülleborni and T. trichiura.

COOL-ARREST: Results from a Pilot Multicenter, Prospective, Single-Arm Observational Trial to Assess Intravascular Temperature Management in the Treatment of Cardiac Arrest.

PubMed

Sawyer, Kelly N; Mooney, Michael; Norris, Gregory; Devlin, Thomas; Lundbye, Justin; Doshi, Pratik B; Hewett, Jonathan Kyle; Kono, Alan T; Jorgensen, Jesse P; O'Neil, Brian J

2018-06-08

Targeted temperature management (TTM) is recommended postcardiac arrest. The cooling method with the highest safety and efficacy is unknown. The COOL-ARREST pilot trial aimed to evaluate the safety and efficacy of the most contemporary ZOLL Thermogard XP Intravascular Temperature Management (IVTM) system for providing mild TTM postcardiac arrest. This multicenter, prospective, single-arm, observational pilot trial enrolled patients at eight U.S. hospitals between July 28, 2014, and July 24, 2015. Adult (≥18 years old), out-of-hospital cardiac arrest subjects of presumed cardiac etiology who achieved return of spontaneous circulation (ROSC) were considered for inclusion. Patients were excluded if (1) awake or consistently following commands after ROSC, (2) significant prearrest neurological dysfunction, (3) terminal illness or advanced directives precluding aggressive care, and (4) severe hemodynamic instability or shock. Patient temperature was maintained at 33.0°C ± 0.3°C for a total of 24 hours followed by controlled rewarming (0.1-0.2°C/h). Logistic regressions were used to assess association of good functional outcome (modified Rankin Scale ≤3) measured at the time of hospital discharge with shockable rhythm (yes/no), age, gender, race/ethnicity, lay-rescuer cardiopulmonary resuscitation, time to basic life support (minutes), time to ROSC (minutes), lactate (mg/dL), and pH on admission. The ZOLL IVTM system was effective at inducing TTM (median time to target temperature from initiation, 89 minutes [interquartile range 42-155]). Adverse events most often included electrolyte abnormalities and dysrhythmias. Of patients surviving to hospital discharge, 16/20 patients had a good functional outcome. A total of 18 patients survived through 90-day follow-up, at which time 94% (17/18) of patients had good functional outcome. The COOL-ARREST pilot trial demonstrates high safety and efficacy of the ZOLL Thermogard XP IVTM system in the application of mild TTM postcardiac arrest. This observational trial also revealed noteworthy variability in the management of postcardiac arrest patients, particularly with the use of early withdrawal of life-sustaining therapy.

Collaborative learning about e-health for mental health professionals and service users in a structured anonymous online short course: pilot study.

PubMed

Ashurst, Emily J; Jones, Ray B; Williamson, Graham R; Emmens, Tobit; Perry, Jon

2012-05-31

Professionals are interested in using e-health but implementation of new methods is slow. Barriers to implementation include the need for training and limited awareness or experience. Research may not always convince mental health professionals (MHPs). Adding the 'voice' of mental health service users (MHSUs) in collaborative learning may help. Involving MHSUs in face-face education can be difficult. We had previously been unable to engage MHPs in online discussion with MHSUs. Here we assessed the feasibility of short online courses involving MHSUs and MHPs. We ran three e-health courses, comprising live interactive webcast, week's access to a discussion forum, and final live interactive webcast. We recruited MHPs via posters, newsletters, and telephone from a local NHS trust, and online via mailing lists and personal contacts from NHS trusts and higher education. We recruited MHSUs via a previous project and an independent user involvement service. Participants were presented with research evidence about e-health and asked to discuss topics using professional and lived experience. Feasibility was assessed through recruitment and attrition, participation, and researcher workloads. Outcomes of self-esteem and general self-efficacy (MHSUs), and Internet self-efficacy and confidence (MHPs) were piloted. Online recruiting was effective. We lost 15/41 from registration to follow-up but only 5/31 that participated in the course failed to complete follow-up. Nineteen MHPs and 12 MHSUs took part and engaged with each other in online discussion. Feedback was positive; three-quarters of MHPs indicated future plans to use the Internet for practice, and 80% of MHSUs felt the course should be continued. Running three courses for 31 participants took between 200 to 250 hours. Before and after outcome measures were completed by 26/31 that participated. MHP Internet self-efficacy and general Internet confidence, MHSU self-esteem and general self-efficacy, all seemed reliable and seemed to show some increase. Collaborative learning between MHSUs and MHPs in a structured online anonymous environment over a one-week course is feasible, may be more practical and less costly than face-face methods, and is worthy of further study.

A brain-computer interface based cognitive training system for healthy elderly: a randomized control pilot study for usability and preliminary efficacy.

PubMed

Lee, Tih-Shih; Goh, Siau Juinn Alexa; Quek, Shin Yi; Phillips, Rachel; Guan, Cuntai; Cheung, Yin Bun; Feng, Lei; Teng, Stephanie Sze Wei; Wang, Chuan Chu; Chin, Zheng Yang; Zhang, Haihong; Ng, Tze Pin; Lee, Jimmy; Keefe, Richard; Krishnan, K Ranga Rama

2013-01-01

Cognitive decline in aging is a pressing issue associated with significant healthcare costs and deterioration in quality of life. Previously, we reported the successful use of a novel brain-computer interface (BCI) training system in improving symptoms of attention deficit hyperactivity disorder. Here, we examine the feasibility of the BCI system with a new game that incorporates memory training in improving memory and attention in a pilot sample of healthy elderly. This study investigates the safety, usability and acceptability of our BCI system to elderly, and obtains an efficacy estimate to warrant a phase III trial. Thirty-one healthy elderly were randomized into intervention (n = 15) and waitlist control arms (n = 16). Intervention consisted of an 8-week training comprising 24 half-hour sessions. A usability and acceptability questionnaire was administered at the end of training. Safety was investigated by querying users about adverse events after every session. Efficacy of the system was measured by the change of total score from the Repeatable Battery for the Assessment of Neuropsychological Status (RBANS) before and after training. Feedback on the usability and acceptability questionnaire was positive. No adverse events were reported for all participants across all sessions. Though the median difference in the RBANS change scores between arms was not statistically significant, an effect size of 0.6SD was obtained, which reflects potential clinical utility according to Simon's randomized phase II trial design. Pooled data from both arms also showed that the median change in total scores pre and post-training was statistically significant (Mdn = 4.0; p<0.001). Specifically, there were significant improvements in immediate memory (p = 0.038), visuospatial/constructional (p = 0.014), attention (p = 0.039), and delayed memory (p<0.001) scores. Our BCI-based system shows promise in improving memory and attention in healthy elderly, and appears to be safe, user-friendly and acceptable to senior users. Given the efficacy signal, a phase III trial is warranted. ClinicalTrials.gov NCT01661894.