Contemporary clinical trials最新文献

{"title":"Protocol for a randomized controlled trial comparing phone-based prenatal mindfulness training to usual care for pregnant people at risk for hypertensive disorders of pregnancy","authors":"Nina K. Ayala ,&nbsp;Elena Salmoirago-Blotcher ,&nbsp;Ghada Bourjeily ,&nbsp;Nicole R. Nugent ,&nbsp;Laura Sanapo ,&nbsp;Matthias R. Mehl ,&nbsp;Margaret Bublitz","doi":"10.1016/j.cct.2024.107661","DOIUrl":"10.1016/j.cct.2024.107661","url":null,"abstract":"<div><p>Hypertensive disorders of pregnancy (HDP) are the most common medical conditions in pregnancy and a leading cause of maternal morbidity and mortality in the United States. There are few interventions available to prevent HDP, and those currently available do not target underlying mechanisms of disease. Mindfulness training (MT) is effective at reducing blood pressure in non-pregnant patients with pre-hypertension and hypertension and has proven more effective at blood pressure reduction than other stress management interventions. MT thus holds great promise as a mind-body intervention to prevent HDP. This randomized trial will harness subjective and objective ecological momentary assessment methodology combined with wearable biosensor technology to capture psychological, physiological, and interpersonal processes through which MT may lead to improved maternal cardiovascular parameters. Pregnant women at risk for HDP will be randomized to an 8-week phone-delivered MT intervention or usual care. Through these methods, we will evaluate psychological, physiological, and interpersonal responses to daily experiences linking MT to cardiovascular parameters among women at risk for HDP.</p></div>","PeriodicalId":10636,"journal":{"name":"Contemporary clinical trials","volume":"145 ","pages":"Article 107661"},"PeriodicalIF":2.0,"publicationDate":"2024-08-08","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141912090","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Addressing cost barriers to healthy eating with Eat Well, a prescription produce subsidy, for patients with diabetes and at risk for food insecurity: Study protocol for a type 1 hybrid effectiveness-implementation pragmatic randomized controlled trial","authors":"Connor Drake ,&nbsp;Isa Granados ,&nbsp;Abigail Rader ,&nbsp;Amanda Brucker ,&nbsp;Sam Hoeffler ,&nbsp;Benjamin A. Goldstein ,&nbsp;Ceci Chamorro ,&nbsp;Fred Johnson ,&nbsp;Eugenia McPeek Hinz ,&nbsp;Armando D. Bedoya ,&nbsp;Jashalynn C. German ,&nbsp;Jillian Hauser ,&nbsp;Connie Thacker ,&nbsp;Susan E. Spratt","doi":"10.1016/j.cct.2024.107655","DOIUrl":"10.1016/j.cct.2024.107655","url":null,"abstract":"<div><h3>Background</h3><p>Patients with diabetes at risk of food insecurity face cost barriers to healthy eating and, as a result, poor health outcomes. Population health management strategies are needed to improve food security in real-world health system settings. We seek to test the effect of a prescription produce program, ‘Eat Well’ on cardiometabolic health and healthcare utilization. We will also assess the implementation of an automated, affirmative outreach strategy.</p></div><div><h3>Methods</h3><p>We will recruit approximately 2400 patients from an integrated academic health system in the southeastern United States as part of a two-arm parallel hybrid type 1 pragmatic randomized controlled trial. Patients with diabetes, at risk for food insecurity, and a recent hemoglobin A1c reading will be eligible to participate. The intervention arm receives, ‘Eat Well’, which provides a debit card with $80 (added monthly) for 12 months valid for fresh, frozen, or canned fruits and vegetables across grocery retailers. The control arm does not. Both arms receive educational resources with diabetes nutrition and self-management materials, and information on existing care management resources. Using an intent-to-treat analysis, primary outcomes include hemoglobin A1C levels and emergency department visits in the 12 months following enrollment. Reach and fidelity data will be collected to assess implementation.</p></div><div><h3>Discussion</h3><p>Addressing food insecurity, particularly among those at heightened cardiometabolic risk, is critical to equitable and effective population health management. Pragmatic trials provide important insights into the effectiveness and implementation of ‘Eat Well’ and approaches like it in real-world settings.</p></div><div><h3>Registration</h3><p><span><span>ClinicalTrials.gov</span><svg><path></path></svg></span> Identifier: <span><span>NCT05896644</span><svg><path></path></svg></span>; Clinical Trial Registration Date: 2023-06-09.</p></div>","PeriodicalId":10636,"journal":{"name":"Contemporary clinical trials","volume":"145 ","pages":"Article 107655"},"PeriodicalIF":2.0,"publicationDate":"2024-08-05","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141901171","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"The combination of donepezil and cognitive training for improving treatment outcomes for alcohol use disorder: Design of a randomized controlled trial","authors":"Gihyun Yoon ,&nbsp;Mehmet Sofuoglu ,&nbsp;Ismene L. Petrakis ,&nbsp;Brian Pittman ,&nbsp;Morris D. Bell","doi":"10.1016/j.cct.2024.107657","DOIUrl":"10.1016/j.cct.2024.107657","url":null,"abstract":"<div><h3>Background</h3><p>The development of alcohol use disorder (AUD) is a major concern in public health, and cognitive impairments caused by alcohol are involved in this process. Emerging neurobiological evidence suggests that donepezil, an anticholinesterase agent, may improve AUD treatment outcomes by enhancing neurocognitive functioning. Previous research has also suggested that cognitive remediation therapy (CRT) could potentially improve cognitive function and AUD treatment outcomes. We present the rationale and design of a trial to evaluate the combination of donepezil and cognitive remediation therapy (donepezil + CRT) as an intervention for AUD.</p></div><div><h3>Methods</h3><p>We propose a 13-week, randomized, double-blind, placebo-controlled, between-subjects trial comparing 4 groups (donepezil + CRT vs. donepezil alone vs. CRT alone vs. placebos) as an intervention for AUD. The main goal of the study is to evaluate if donepezil + CRT is superior to placebo in reducing heavy drinking days and improving neurocognitive functioning. A total of 160 patients (4 groups, 40 per each group) with AUD between the ages of 18–80 years will be recruited at Yale University and the VA Connecticut Healthcare System. Primary outcome measures include 1) heavy drinking by Timeline Follow Back (TLFB) over 13 weeks and 2) global neurocognitive functioning by a global index of neurocognitive function score at 7 and 13 weeks.</p></div><div><h3>Discussion</h3><p>This protocol paper describes the rationale and proposed methods for the randomized controlled trial for improving AUD treatment outcomes. This project has significant clinical potential to help patients suffering from AUD by improving their cognition and reducing alcohol consumption.</p><p><em>Trial Registration:</em> <span><span>NCT05042102</span><svg><path></path></svg></span></p></div>","PeriodicalId":10636,"journal":{"name":"Contemporary clinical trials","volume":"145 ","pages":"Article 107657"},"PeriodicalIF":2.0,"publicationDate":"2024-08-05","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141901173","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Protocol of a multisite randomized controlled trial of Bright IDEAS-Young Adults: Problem-solving skills training to reduce distress among young adults with Cancer","authors":"Katie A. Devine ,&nbsp;Pamela Ohman-Strickland ,&nbsp;Marie Barnett ,&nbsp;Kristine A. Donovan ,&nbsp;Lora M.A. Thompson ,&nbsp;Sharon L. Manne ,&nbsp;Julia Kearney ,&nbsp;Kristine Levonyan-Radloff ,&nbsp;Diana Diaz ,&nbsp;Sanjana Dugad ,&nbsp;Olle Jane Z. Sahler","doi":"10.1016/j.cct.2024.107656","DOIUrl":"10.1016/j.cct.2024.107656","url":null,"abstract":"<div><h3>Background</h3><p>Young adults with cancer diagnosed between the ages of 18 to 39 are recognized as a vulnerable group with unique emotional, social, and practical needs that put them at risk of poor psychosocial outcomes and impaired health-related quality of life (HRQOL). This study describes the protocol of a randomized controlled trial to evaluate the efficacy of Bright IDEAS-Young Adults (Bright IDEAS-YA), a problem-solving skills training intervention, on psychosocial outcomes of young adults newly diagnosed with cancer.</p></div><div><h3>Methods</h3><p>Bright IDEAS-YA is a two-arm, parallel, randomized controlled trial. Young adults are eligible if they are 18–39 years of age, within four months of a first cancer diagnosis, and receiving systemic therapy with life expectancy of at least six months. Participants are randomized 1:1 to Bright IDEAS-YA or enhanced usual care. Survey measures are completed at enrollment and 3, 6, 12, and 24 months. The primary endpoint will be the estimated change from baseline to 6 months in symptoms of depression, anxiety, and psychosocial HRQOL. The other time points are secondary endpoints. Mediators and moderators will be examined.</p></div><div><h3>Conclusions</h3><p>This randomized trial will determine the efficacy of Bright IDEAS-YA on psychosocial outcomes for young adults newly diagnosed with cancer. Analyses will also examine mechanisms of action and potentially identify subgroups for whom the intervention is particularly useful.</p></div><div><h3>Trial registration</h3><p><span><span>clinicaltrials.gov</span><svg><path></path></svg></span> #<span><span>NCT04585269</span><svg><path></path></svg></span>.</p></div>","PeriodicalId":10636,"journal":{"name":"Contemporary clinical trials","volume":"145 ","pages":"Article 107656"},"PeriodicalIF":2.0,"publicationDate":"2024-08-05","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141901172","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"A clinical trial inclusion criteria to enrich for patients presenting with canonical symptom structure in bipolar depression","authors":"Seth C. Hopkins,&nbsp;Sasagu Tomioka,&nbsp;Steven T. Szabo,&nbsp;Kenneth S. Koblan","doi":"10.1016/j.cct.2024.107644","DOIUrl":"10.1016/j.cct.2024.107644","url":null,"abstract":"<div><p>Clinical drug development in psychiatry is challenging due to heterogeneous patient populations and the uncertainty of measuring neuropsychiatric constructs with symptom rating scales. Here we describe the development and implementation of an enrichment algorithm that identifies canonical versus anomalous symptom presentations, at the individual subject level, based on MADRS ratings obtained at screening and baseline. Data from 5 randomized, placebo-controlled, phase 3 trials in bipolar I disorder was used (<em>N</em> = 2026 subjects and 15,239 MADRS assessments). A variance-covariance difference (VCD) vector was developed to encode individual symptom structure using the 10 items of MADRS from the two sequential assessments. An anomaly score, calculated from each subject's VCD vector was derived by isolation forest to quantify the degree of disparity from the hypothesized canonical item structure. A retrospective application of the algorithm reliably identified a threshold anomaly score above which the psychometric properties of MADRS deteriorate. Consistent with increasing the certainty of MADRS ratings, subjects with a canonical symptom structure at baseline demonstrated greater effect sizes post-baseline in a phase 2 placebo-controlled trial of non-racemic amisulpride (SEP-4199) for bipolar depression, analyzed retrospectively. Our analyses show that the developed algorithm can reduce the symptom structure heterogeneity at baseline and thus improve the measurement certainty of psychiatric symptoms in clinical trials. This novel enrichment method has been prospectively implemented in a Phase 3 clinical study of SEP-4199 and is consistent with regulatory guidelines aimed at increasing the statistical power and lowering patient-burden in clinical trials.</p><p>Clinical Trials Registry: <span><span>NCT00868452</span><svg><path></path></svg></span>, <span><span>NCT00868699</span><svg><path></path></svg></span>, <span><span>NCT01284517</span><svg><path></path></svg></span>, <span><span>NCT01986101</span><svg><path></path></svg></span>, <span><span>NCT03543410</span><svg><path></path></svg></span>, <span><span>NCT05169710</span><svg><path></path></svg></span></p></div>","PeriodicalId":10636,"journal":{"name":"Contemporary clinical trials","volume":"145 ","pages":"Article 107644"},"PeriodicalIF":2.0,"publicationDate":"2024-08-03","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141888704","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Exercise effects on brain health and learning from minutes to months: The brain EXTEND trial","authors":"Michelle W. Voss ,&nbsp;Chris Oehler ,&nbsp;Will Daniels ,&nbsp;Matthew Sodoma ,&nbsp;Bryan Madero ,&nbsp;James Kent ,&nbsp;Shivangi Jain ,&nbsp;Myungjin Jung ,&nbsp;Virginia R. Nuckols ,&nbsp;Lyndsey E. DuBose ,&nbsp;Kristen G. Davis ,&nbsp;Abby O'Deen ,&nbsp;Chase Hamilton ,&nbsp;Kelsey Baller ,&nbsp;Jenna Springer ,&nbsp;Adriana Rivera-Dompenciel ,&nbsp;Marco Pipoly ,&nbsp;Michael Muellerleile ,&nbsp;Nagalakshmi Nagarajan ,&nbsp;Thorarinn Bjarnason ,&nbsp;Gary L. Pierce","doi":"10.1016/j.cct.2024.107647","DOIUrl":"10.1016/j.cct.2024.107647","url":null,"abstract":"<div><p>Despite evidence that aerobic exercise benefits the aging brain, in particular the hippocampus and memory, controlled clinical trials have not comprehensively evaluated effects of aerobic exercise training on human memory in older adults. The central goal of this study was to determine chronic effects of moderate-to-vigorous intensity aerobic exercise on the hippocampus and memory in non-demented, inactive adults ages 55–80 years. We determine effects of aerobic exercise training with a 6-month randomized controlled trial (RCT) comparing 150 min/week of home-based, light intensity exercise with progressive moderate-to-vigorous intensity aerobic exercise. For the first time in a large trial, we examined temporal mechanisms by determining if individual differences in the rapid, immediate effects of moderate intensity exercise on hippocampal-cortical connectivity predict chronic training-related changes over months in connectivity and memory. We examined physiological mechanisms by testing the extent to which chronic training-related changes in cardiorespiratory fitness are a critical factor to memory benefits. The <em>Exercise Effects on Brain Connectivity and Learning from Minutes to Months</em> (Brain-EXTEND) trial is conceptually innovative with advanced measures of hippocampal-dependent learning and memory processes combined with novel capture of the physiological changes, genetic components, and molecular changes induced by aerobic exercise that change hippocampal-cortical connectivity. Given that hippocampal connectivity deteriorates with Alzheimer's and aerobic exercise may contribute to reduced risk of Alzheimer's, our results could lead to an understanding of the physiological mechanisms and moderators by which aerobic exercise reduces risk of this devastating and costly disease.</p></div>","PeriodicalId":10636,"journal":{"name":"Contemporary clinical trials","volume":"145 ","pages":"Article 107647"},"PeriodicalIF":2.0,"publicationDate":"2024-07-31","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141878506","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Methods for assessing inverse publication bias of adverse events","authors":"Xing Xing ,&nbsp;Chang Xu ,&nbsp;Fahad M. Al Amer ,&nbsp;Linyu Shi ,&nbsp;Jianan Zhu ,&nbsp;Lifeng Lin","doi":"10.1016/j.cct.2024.107646","DOIUrl":"10.1016/j.cct.2024.107646","url":null,"abstract":"<div><p>In medical research, publication bias (PB) poses great challenges to the conclusions from systematic reviews and meta-analyses. The majority of efforts in methodological research related to classic PB have focused on examining the potential suppression of studies reporting effects close to the null or statistically non-significant results. Such suppression is common, particularly when the study outcome concerns the effectiveness of a new intervention. On the other hand, attention has recently been drawn to the so-called inverse publication bias (IPB) within the evidence synthesis community. It can occur when assessing adverse events because researchers may favor evidence showing a similar safety profile regarding an adverse event between a new intervention and a control group. In comparison to the classic PB, IPB is much less recognized in the current literature; methods designed for classic PB may be inaccurately applied to address IPB, potentially leading to entirely incorrect conclusions. This article aims to provide a collection of accessible methods to assess IPB for adverse events. Specifically, we discuss the relevance and differences between classic PB and IPB. We also demonstrate visual assessment through contour-enhanced funnel plots tailored to adverse events and popular quantitative methods, including Egger's regression test, Peters' regression test, and the trim-and-fill method for such cases. Three real-world examples are presented to illustrate the bias in various scenarios, and the implementations are illustrated with statistical code. We hope this article offers valuable insights for evaluating IPB in future systematic reviews of adverse events.</p></div>","PeriodicalId":10636,"journal":{"name":"Contemporary clinical trials","volume":"145 ","pages":"Article 107646"},"PeriodicalIF":2.0,"publicationDate":"2024-07-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141859247","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Design and methods of the StepByStep randomized trial of a mobile health and social media physical activity intervention among adolescent and young adult survivors of childhood cancer: A report from the Children's Oncology Group","authors":"Leah J. Beight ,&nbsp;Jason A. Mendoza ,&nbsp;Wendy M. Leisenring ,&nbsp;Willem Collier ,&nbsp;Margaret E. Olsen ,&nbsp;Wilhelmenia L. Ross ,&nbsp;Yaiomy Santiago-Rivera ,&nbsp;Stacy Bryant ,&nbsp;Jaime Rotatori ,&nbsp;Kirsten K. Ness ,&nbsp;Alejandra Hurtado-de-Mendoza ,&nbsp;K. Scott Baker ,&nbsp;Eric J. Chow ,&nbsp;Nina S. Kadan-Lottick","doi":"10.1016/j.cct.2024.107645","DOIUrl":"10.1016/j.cct.2024.107645","url":null,"abstract":"<div><h3>Background</h3><p>Interventions to increase physical activity are needed in adolescent and young adult survivors of childhood cancer who are largely inactive but at lifelong elevated risk of multiple chronic conditions improved by physical activity. The goals of the StepByStep study are to evaluate the effects of a 48-week distance-based, multi-component mobile health and social media behavioral intervention on physical activity, biomarkers of cardiometabolic health, and health-related quality of life.</p></div><div><h3>Methods</h3><p>This ongoing study is a two-arm, prospective, multi-site randomized controlled trial. 384 childhood cancer survivors age ≥ 15 years and &lt; 21 years who were 3–36 months off therapy and not meeting physical activity guidelines were enrolled. The trial will test the efficacy of a 24-week intensive multi-component physical activity intervention combining a wearable physical activity tracker, social media peer support group, and individualized goal setting followed by a 24-week maintenance phase of the intervention to improve outcomes. The control group receives the wearable physical activity tracker only.</p></div><div><h3>Conclusion</h3><p>There is a growing need for novel, developmentally appropriate interventions to increase physical activity and improve the health trajectory of adolescent and young adult survivors of childhood cancer. If efficacious, this portable and scalable intervention would be a much-needed tool to reduce the morbidity from cancer treatment and improve quality of life among survivors after treatment ends.</p></div><div><h3>Clinical trial registration</h3><p><span><span>ClinicalTrials.gov</span><svg><path></path></svg></span> Identifier: <span><span>NCT04089358</span><svg><path></path></svg></span>; COG Identifier: ALTE2031.</p></div>","PeriodicalId":10636,"journal":{"name":"Contemporary clinical trials","volume":"145 ","pages":"Article 107645"},"PeriodicalIF":2.0,"publicationDate":"2024-07-28","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141845383","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Design of the FRESH-teen study: A randomized controlled trial evaluating an adapted emotion regulation weight loss program for adolescents with overweight or obesity and their parent","authors":"Kerri N. Boutelle ,&nbsp;Michael A. Manzano ,&nbsp;Ellen K. Pasquale ,&nbsp;Rebecca S. Bernard ,&nbsp;David R. Strong ,&nbsp;Kyung E. Rhee ,&nbsp;Dawn M. Eichen ,&nbsp;Scott Engel ,&nbsp;Alec Miller ,&nbsp;Carol B. Peterson","doi":"10.1016/j.cct.2024.107640","DOIUrl":"10.1016/j.cct.2024.107640","url":null,"abstract":"<div><p>Overweight and obesity affect &gt;40% of adolescents. Family-based behavioral treatment (FBT) is the most efficacious behavioral treatment for weight management among youth and consists of nutrition and physical activity education, behavior change skills, and parent skills training. However, the efficacy of FBT decreases for youth as they get older. Increased emotional lability and limited emotion regulation skills may contribute to the reduced efficacy of FBT for adolescents. To date, there are no treatments for overweight or obesity specifically adapted for the needs of adolescents.</p><p>We developed a treatment that integrates components from Dialectical Behavior Therapy and Emotion Focused Therapy with FBT (FBT+ER or FBT-ER) to address the specific needs of adolescents. The current study randomized 166 adolescents (BMI = 32.8; 14.3 years; 57% female; 32% Hispanic, 50% Non-Hispanic White, 18% Non-Hispanic and Non-White) and one of their parents (BMI = 32.9; 45.3 years; 85% female; 27% Hispanic, 57% Non-Hispanic White, 16% Non-Hispanic and Non-White) to 6 months of either standard FBT or FBT+ at 2 sites. Assessments were conducted at baseline, mid-treatment (month 3), post-treatment (month 6), 6-month follow-up (month 12) and 12-month follow-up (month 18). Primary outcomes are adolescent weight (BMIz/%BMIp95), emotion regulation skills, and emotional eating behaviors. Given the public health concern of adolescent obesity, FBT+ could prove extremely useful to provide more targeted and effective intervention for adolescents with overweight or obesity.</p></div><div><h3>Clinical trials</h3><p># NCT03674944</p></div>","PeriodicalId":10636,"journal":{"name":"Contemporary clinical trials","volume":"145 ","pages":"Article 107640"},"PeriodicalIF":2.0,"publicationDate":"2024-07-28","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141846965","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"eMPower: An online Mind-body wellness Program for adults living with chronic health conditions: A three-armed randomized controlled trial protocol","authors":"Emily Johnson ,&nbsp;Kathleen Ismond ,&nbsp;Ashley Hyde ,&nbsp;Justin Ezekowitz ,&nbsp;Gail Wright ,&nbsp;Jude Spiers ,&nbsp;John Spence ,&nbsp;Stephanie Thompson ,&nbsp;Margaret L. McNeely ,&nbsp;Yinggan Zheng ,&nbsp;Jeff Round ,&nbsp;Sarah Tymchuk ,&nbsp;Dayna Lee-Baggley ,&nbsp;Serena Isley ,&nbsp;Shaina Corrick ,&nbsp;Holly Minckler ,&nbsp;Puneeta Tandon","doi":"10.1016/j.cct.2024.107642","DOIUrl":"10.1016/j.cct.2024.107642","url":null,"abstract":"<div><h3>Background</h3><p>Symptoms of depression and anxiety are prevalent among adults with chronic health conditions, contributing to reduced quality of life, morbidity, and mortality. Mind-body wellness interventions (i.e. psychology programming, mindful movement, breathwork, meditation) may impact mental health symptoms, with online delivery offering access and scalability. Whether online mind-body wellness interventions are effective in improving patient outcomes across a broad range of chronic conditions remains uncertain.</p></div><div><h3>Methods</h3><p>This three-armed, pragmatic, randomized controlled trial will use a nested mixed methods approach to assess the effectiveness of an online mind-body wellness intervention (eMPower), offered at two levels of personnel support, on symptoms of anxiety and depression in adults with chronic health conditions. Inclusion criteria require a self-reported chronic condition and access to an internet-connected device. Eligible participants will be randomized 1:1:1 to [1] waitlist control; [2] eMPower; [3] eMPower + weekly 1-to-1 check-in. The primary analysis will compare the Hospital and Anxiety Depression Scale (HADS) total score between eMPower + weekly 1-to-1 check-in versus controls, with secondary and exploratory outcomes including HADS subscales, health-related quality of life, fatigue, program engagement, and frailty.</p></div><div><h3>Conclusion</h3><p>With online intervention delivery, a range of outcomes, mixed method evaluation, and automated intervention tracking, findings are anticipated to enhance our understanding of how individuals living with chronic health conditions engage with and are impacted by online mind-body wellness programming. Six hundred and fifty-six participants have been enrolled as of April 5, 2024, and 598 patients have completed 12-week follow-up.</p></div>","PeriodicalId":10636,"journal":{"name":"Contemporary clinical trials","volume":"145 ","pages":"Article 107642"},"PeriodicalIF":2.0,"publicationDate":"2024-07-28","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"141839680","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}