Contemporary clinical trials最新文献

{"title":"Unequal allocation in randomised phase II trials","authors":"R. Jackson,&nbsp;T. Cox","doi":"10.1016/j.cct.2025.108043","DOIUrl":"10.1016/j.cct.2025.108043","url":null,"abstract":"<div><h3>Background</h3><div>Equal allocation is accepted almost universally in the design of randomised clinical trials and it is often assumed that this approach provides the most efficient use of available resources. The design of a phase II study often depend on a binary endpoint with assessments of efficacy made using an odds ratio. In a trial setting however, precision about this odds ratio will only be optimal under equal allocation when there is no difference in the response rates between two treatment arms. A result which typically is of limited clinical interest.</div></div><div><h3>Methodology</h3><div>For a clinical trial with response rates are p_x and p_y in the experimental and control arm respectively, allocation proportions are derived that seek to maximise the precision about an odds ratio in settings where difference between response rates are expected. Sample size calculations are performed and compared to study designs using equal allocation.</div></div><div><h3>Results</h3><div>Sample size calculations based on the exact methods of Jung and Sargent [<span><span>8</span></span>] show that under the same type 1 error rate and power, the required sample sizes using unequal allocation ratios are smaller than those where equal allocation is used. This discrepancy is greater as the control mean response rate tends towards 0 or 1 while the relative treatment effect remain fixed.</div></div><div><h3>Discussion</h3><div>Trialist involved in the design of phase II studies should take account of possible savings in sample size that may be gained by unequal allocation of patients.</div></div>","PeriodicalId":10636,"journal":{"name":"Contemporary clinical trials","volume":"156 ","pages":"Article 108043"},"PeriodicalIF":1.9,"publicationDate":"2025-08-06","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144798426","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":"Strategies to evaluate treatment effects in clinical trials for emerging infectious diseases","authors":"Kentaro Sakamaki ,&nbsp;Yukari Uemura ,&nbsp;Yosuke Shimizu ,&nbsp;Lori E. Dodd","doi":"10.1016/j.cct.2025.108041","DOIUrl":"10.1016/j.cct.2025.108041","url":null,"abstract":"<div><h3>Background</h3><div>Swift regulatory approval of therapeutic interventions is crucial during emerging infectious disease outbreaks. However, variability in treatment effects based on disease severity or subgroups complicates trial design and endpoint selection. Prioritized composite endpoints can capture treatment effects across diverse clinical courses; however, their performance under heterogeneous treatment effects remains uncertain. This study uses simulation to evaluate trial design strategies in such contexts.</div></div><div><h3>Methods</h3><div>This study examines eight combinations of population and endpoint strategies to optimize trial design in emerging infectious diseases: evaluating treatment in the overall population and subgroups, with various endpoint choices including single, multiple, and prioritized composite endpoints. Simulated data was generated using multistate models based on the ACTT-1 study. Eight treatment effect scenarios, some exhibiting heterogeneity, were considered to evaluate ability to demonstrate efficacy.</div></div><div><h3>Results</h3><div>In scenarios without heterogeneous treatment effects, analyses in the overall population generally showed higher power than subgroup analyses. Time to recovery had relatively high power, while prioritized composite and multiple endpoints were comparable. In scenarios with treatment effect heterogeneity by baseline disease severity, power was higher in effective subgroups than in the overall population. Prioritized composite endpoints showed high power in scenarios where the treatment was effective on distinct endpoints in each subgroup.</div></div><div><h3>Conclusions</h3><div>For drug development in emerging infectious diseases with limited information, it is preferable to focus on evaluating prioritized composite or multiple endpoints in the overall population. Stratified analysis can be more powerful than unstratified analysis and should be considered for the primary analysis in the overall population.</div></div>","PeriodicalId":10636,"journal":{"name":"Contemporary clinical trials","volume":"156 ","pages":"Article 108041"},"PeriodicalIF":1.9,"publicationDate":"2025-08-06","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144798423","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":"Study design and protocol for cognitive anxiety sensitivity treatment for anxiety in adults with mild cognitive impairment or dementia","authors":"Abigail E. Markley ,&nbsp;Kayley M. Stratton ,&nbsp;Grace Y. Cho ,&nbsp;Norman B. Schmidt ,&nbsp;Julie Suhr ,&nbsp;Julia L. Sheffler ,&nbsp;Christopher Nguyen ,&nbsp;Frederick T. Schubert ,&nbsp;Jaime R.G. Quiles ,&nbsp;Miracle R. Potter ,&nbsp;Melissa A. Meynadasy ,&nbsp;Sarah Millisor Irvin ,&nbsp;Nicholas P. Allan","doi":"10.1016/j.cct.2025.108044","DOIUrl":"10.1016/j.cct.2025.108044","url":null,"abstract":"<div><h3>Background</h3><div>Anxiety is prevalent among older adults with mild cognitive impairment (MCI) and mild Alzheimer's disease and related disorders (ADRD) and may contribute to accelerated cognitive decline and increased care partner burden. Computerized Anxiety Sensitivity Treatment (CAST) is a novel, CBT-based intervention targeting anxiety sensitivity, which has not been widely tested in this population.</div></div><div><h3>Methods</h3><div>This randomized controlled trial (<span><span>NCT05748613</span><svg><path></path></svg></span>) will compare CAST to a health education control (HEC) in 194 dyads consisting of older adults with MCI/mild ADRD and their care partners. Primary outcomes include reductions in anxiety sensitivity and anxiety symptoms. Secondary outcomes include measures of mental health and well-being symptoms, improved cognitive performance, and decreased care partner burden. Participants will be assessed at baseline, during two intervention sessions, and follow-ups at 1-, 3-, and 6-months post-intervention.</div></div><div><h3>Expected outcomes</h3><div>CAST will significantly lower anxiety sensitivity (AS) post-intervention and reduce anxiety compared to HEC. Secondary hypotheses propose that CAST will reduce other mental symptoms and improve cognitive functioning more effectively than HEC. Additionally, CAST will alleviate care partner distress and improve their quality of life compared to HEC, with the secondary hypothesis suggesting that these effects will be mediated by reductions in AS in older adults. Furthermore, reductions in AS from pre- to post-intervention will account for the effect of CAST on anxiety, and the secondary hypothesis suggesting that reductions in interoceptive fear conditioning will also contribute to the observed anxiety reduction.</div><div><span><span>Clinicaltrials.gov</span><svg><path></path></svg></span> registration: #NCT05748613.</div></div>","PeriodicalId":10636,"journal":{"name":"Contemporary clinical trials","volume":"156 ","pages":"Article 108044"},"PeriodicalIF":1.9,"publicationDate":"2025-08-06","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144798424","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":"Study protocol for Log2Lose: A randomized controlled trial to evaluate financial incentives for dietary self-monitoring and interim weight loss in adults with obesity","authors":"Corrine I. Voils ,&nbsp;Jennifer M. Gierisch ,&nbsp;Jane F. Pendergast ,&nbsp;Clemontina A. Davenport ,&nbsp;Maren K. Olsen ,&nbsp;Cherie Barnes ,&nbsp;Michelle Bean ,&nbsp;Lisa Cadmus-Bertram ,&nbsp;Jamie Colon ,&nbsp;Felix Elwert ,&nbsp;Katya Garza ,&nbsp;Kara L. Gavin ,&nbsp;Sarah Jackson ,&nbsp;Hailey Miller ,&nbsp;Sarah Morton-Oswald ,&nbsp;Samantha Pabich ,&nbsp;Shelby D. Reed ,&nbsp;William S. Yancy Jr. ,&nbsp;Ryan J. Shaw","doi":"10.1016/j.cct.2025.108042","DOIUrl":"10.1016/j.cct.2025.108042","url":null,"abstract":"<div><div>Although behavioral weight-loss programs are efficacious for achieving clinically significant weight loss, adherence to such programs is variable. Positive reinforcement through small financial incentives has shown promise for increasing adherence to behaviors and clinical outcomes in some domains. Yet, for weight management, it is unknown whether to incent the behavior (calorie logging), the outcome (weight loss), or both. We report the rationale and design for a two-site clinical trial employing a three-phase, 2 × 2 factorial design to evaluate the impact of financial incentives for calorie logging and/or weekly weight loss. Phase I involved a 26-week incentivized weight-loss period with virtual group sessions every two weeks; Phase II involved a 26-week incentivized weight-loss maintenance period with three monthly group sessions and five individual counseling telephone calls; and Phase III involved a 26-week weight-loss maintenance period without incentives with three bimonthly calls. Participants were asked to record their caloric intake on a smartphone application and to weigh themselves regularly on a cellular scale. These data were processed each week to determine if participants qualified for a financial incentive ranging from $0 to $10. The primary outcome was the proportion of participants achieving clinically significant weight loss of at least 5 % at 26 weeks. Secondary outcomes were the same proportions measured at 52 and 78 weeks, and blood pressure and cardiovascular medication use at 78 weeks. Motivation for weight loss will be examined as a potential mediator of the treatment effect. Intervention cost and cost-effectiveness will be calculated to inform implementation.</div><div><span><span>Clinicaltrials.gov</span><svg><path></path></svg></span> registration: <span><span>NCT04770909</span><svg><path></path></svg></span></div></div>","PeriodicalId":10636,"journal":{"name":"Contemporary clinical trials","volume":"156 ","pages":"Article 108042"},"PeriodicalIF":1.9,"publicationDate":"2025-08-05","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144798425","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":"Corrigendum to “The short- and long-term effects of a fall prevention program on the frequency of falls following total knee replacement: A pragmatic single-blinded randomized controlled trial protocol” [Contemporary Clinical Trials 150 (2025) 107837]","authors":"Hadeel Al-Saleh ,&nbsp;Eman Merza ,&nbsp;Bader Al-Adwanie ,&nbsp;Stephen Pearson ,&nbsp;Peter Malliaras","doi":"10.1016/j.cct.2025.108034","DOIUrl":"10.1016/j.cct.2025.108034","url":null,"abstract":"","PeriodicalId":10636,"journal":{"name":"Contemporary clinical trials","volume":"156 ","pages":"Article 108034"},"PeriodicalIF":1.9,"publicationDate":"2025-07-31","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144749754","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":"Optimizing a mHealth physical activity intervention with mindful awareness lessons in breast cancer survivors: Fit2ThriveMIND protocol","authors":"Melanie Wolter ,&nbsp;Jean M. Reading ,&nbsp;Payton Solk ,&nbsp;Julia Starikovsky ,&nbsp;Kristina Hasanaj ,&nbsp;Shirlene D. Wang ,&nbsp;Juned Siddique ,&nbsp;Bruriah Horowitz ,&nbsp;Bonnie Spring ,&nbsp;Lillian B. Carden ,&nbsp;Rina Fox ,&nbsp;Christina Sauer ,&nbsp;Hannah Freeman ,&nbsp;Julia Frey ,&nbsp;David Victorson ,&nbsp;Siobhan M. Phillips","doi":"10.1016/j.cct.2025.108038","DOIUrl":"10.1016/j.cct.2025.108038","url":null,"abstract":"<div><div>Fit2ThriveMIND is a theory-guided moderate to vigorous physical activity (MVPA) promotion trial guided by the Multiphase Optimization Strategy (MOST) framework to evaluate the efficacy of four intervention components for increasing MVPA among inactive, post-treatment breast cancer survivors (BCS; <em>n</em> = 304). All participants receive a core mHealth intervention, including a Fitbit and custom-built self-monitoring Fit2ThriveMIND smartphone application. Participants are randomized to one of 16 intervention conditions, reflecting every possible combination of the four intervention components, each of which has two levels (Yes v. No): 1) Buddy, 2) <em>E</em>-Coach, 3) General Mindfulness (MIND), 4) MVPA-guided mindfulness (PAMIND). The primary aim is to determine the individual and combined effects of the intervention components on accelerometer-assessed MVPA at 24-weeks (post-intervention) and 48-weeks follow-up. The secondary aim is to examine how changes in MVPA influence patient-reported outcomes, other intensity activities (light and sedentary), and sleep duration and quality. All components have a 24-week duration, except <em>E</em>-coaching, which includes “boosters” personalized to an individual's MVPA goal attainment during weeks 25–48. Fit2ThriveMIND represents the first systematic effort to use MOST to design an optimized mHealth MVPA intervention for BCS that incorporates mindfulness and tests a maintenance strategy. This trial will improve understanding of how to effectively and efficiently change and maintain MVPA among BCS to inform more effective and scalable interventions to improve health and disease outcomes. Clinical Trials Registration #<span><span>NCT05931874</span><svg><path></path></svg></span>.</div></div>","PeriodicalId":10636,"journal":{"name":"Contemporary clinical trials","volume":"156 ","pages":"Article 108038"},"PeriodicalIF":1.9,"publicationDate":"2025-07-31","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144768439","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 Chrono-Vax trial protocol: The effect of the time of day of influenza vaccination on immune responses in adults aged 60–85 years","authors":"Koen Vink ,&nbsp;Tamara M.J. Brouwers ,&nbsp;Lisa Beckers ,&nbsp;Debbie Smit ,&nbsp;Martijn Vos ,&nbsp;Teun Guichelaar ,&nbsp;Tobias N. Bonten ,&nbsp;Laura Kervezee ,&nbsp;Debbie van Baarle ,&nbsp;Jacco Wallinga","doi":"10.1016/j.cct.2025.108040","DOIUrl":"10.1016/j.cct.2025.108040","url":null,"abstract":"<div><div>Increasing evidence suggests that timing of vaccine administration affects immune responses, with some studies indicating that morning administration of the influenza vaccine elicits a stronger antibody response than afternoon vaccination in older adults. Existing trials focused on antibody responses, contrasting two time groups (morning versus afternoon), without assessing other immunological parameters, such as T-cell responses, which also play a crucial role in immunity to respiratory viruses and may contribute to the time-of-day dependent response to vaccination. Therefore, the Chrono-Vax trial aims to determine the effect of influenza vaccination timing on antibody and T-cell responses across a continuous time window from 09:00–17:00 to gain novel insights into an optimal administration time. Additionally, this study will investigate how chronotype influences the relationship between vaccination timing and vaccine-induced immune responses and examine the impact of vaccination timing on the incidence of influenza-like illness (ILI) and influenza infection up to six months post-vaccination. A total of 440 adults aged 60–85 years will be included in the trial and receive the seasonal influenza vaccine at a random time between 09:00 and 17:00. Blood samples will be collected at baseline and 28 days post-vaccination to determine vaccine-induced immune responses. ILI symptoms and influenza infection will be monitored by participants up to six months after vaccination using a diary and rapid diagnostic self-tests, respectively. As such, the Chrono-Vax trial aims to determine the optimal time of day for influenza vaccination, thereby contributing to more effective vaccination strategies and increased protection against severe disease in older adults.</div></div>","PeriodicalId":10636,"journal":{"name":"Contemporary clinical trials","volume":"156 ","pages":"Article 108040"},"PeriodicalIF":1.9,"publicationDate":"2025-07-31","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144763660","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":"Theory-based physical activity behavior change intervention in people newly diagnosed with multiple sclerosis: Study protocol for a pilot randomized controlled trial","authors":"Trinh L.T. Huynh ,&nbsp;Robert W. Motl","doi":"10.1016/j.cct.2025.108035","DOIUrl":"10.1016/j.cct.2025.108035","url":null,"abstract":"<div><h3>Background</h3><div>Physical activity (PA) is strongly recommended for people newly diagnosed with multiple sclerosis (MS). Nevertheless, this MS sub-population is physically inactive, and this disease stage might require unique interventions for promoting PA.</div></div><div><h3>Purpose</h3><div>This proposed pilot randomized controlled trial (RCT) examines the effects of a remote-delivered, theory-based behavior change intervention for promoting PA in people newly diagnosed with MS.</div></div><div><h3>Methods/design</h3><div>The intervention was developed using a comprehensive approach guided by the Capability-Opportunity-Motivation-Behavior (COM<img>B) Model and the Behavior Change Wheel (BCW). This two-armed RCT (<span><span>NCT06355804</span><svg><path></path></svg></span>) will enroll 50 people diagnosed with MS within the past two years. Participants will then be randomly assigned, using computer-generated random numbers with allocation concealment, into either the PA intervention or waitlist control (WLC) conditions. Participants randomized into the PA intervention condition will receive the intervention following the baseline assessment, whereas participants in WLC condition will receive the intervention after the follow-up assessment (i.e., after 16 weeks). The primary outcomes of interest include device-measured (light PA [LPA], moderate-to-vigorous PA [MVPA], step counts) and self-reported (i.e., Godin Leisure-Time Exercise Questionnaire and International Physical Activity Questionnaire) PA. Secondary outcomes include fatigue, depression, anxiety, and health-related quality of life (HRQOL). Data will be analyzed with an intent-to-treat approach, using 2 (condition) by 2 (time) mixed-effects ANOVA with effect size estimates of eta-squared (η²) and Cohen's <em>d</em>.</div></div><div><h3>Discussion</h3><div>The findings will inform a full-powered RCT of the intervention for promoting immediate and sustained changes in lifestyle, PA, health outcomes, and HRQOL in people newly diagnosed with MS.</div></div>","PeriodicalId":10636,"journal":{"name":"Contemporary clinical trials","volume":"156 ","pages":"Article 108035"},"PeriodicalIF":1.9,"publicationDate":"2025-07-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144764694","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":"Description of a cruciferous vegetable intervention trial to test the efficacy of a maintenance component to reduce bladder cancer recurrence and progression","authors":"Karen H. Kim Yeary ,&nbsp;Margaret Gates Kuliszewski ,&nbsp;Han Yu ,&nbsp;Qiang Li ,&nbsp;Elizabeth DiCarlo ,&nbsp;Li Tang","doi":"10.1016/j.cct.2025.108036","DOIUrl":"10.1016/j.cct.2025.108036","url":null,"abstract":"<div><h3>Background</h3><div>Bladder cancer is primarily (70–80 %) diagnosed at non-muscle invasive stages (NMIBC), which can be removed but typically recurs (up to 75 %) and progresses, necessitating active surveillance and high cost of care. Treatment options are limited. Built on our preclinical findings on the role of isothiocyanates (ITCs) from cruciferous vegetables (cruciferae) in bladder cancer, we developed and tested an intervention (POW-R Health) that increased cruciferae intake and urinary ITC from 6 to 24 months to the levels hypothesized to inhibit cancer growth. To ensure the intervention's impact on NMIBC prognosis, our goal is to sustain urinary ITC levels from baseline to 24 months, the time window when the majority of NMIBCs recur.</div></div><div><h3>Objectives</h3><div>To develop a maintenance component to our dietary intervention and test its sustained impact on cruciferae intake and urinary ITC levels through 24 months in NMIBC survivors.</div></div><div><h3>Methods</h3><div>After developing the maintenance component, we will conduct a randomized controlled trial with 344 NMIBC survivors to compare our intervention with a maintenance component (POW-R Health + Maintenance) vs. POW-R Health alone (POW-R Health Core). All participants will receive a 6-month dietary intervention, with half randomized to receive an additional 18-month maintenance component. Assessments will occur at baseline, 6, 12, 18, and 24 months.</div></div><div><h3>Discussion</h3><div>POW-R Health is a scalable intervention that could meaningfully impact bladder cancer survivorship. If shown to impact outcomes, POW-R Health would be the first non-pharmacological dietary preventative strategy for cancer recurrence and progression, providing a cost-effective and easily accessible intervention to improve NMIBC survivorship.</div></div>","PeriodicalId":10636,"journal":{"name":"Contemporary clinical trials","volume":"156 ","pages":"Article 108036"},"PeriodicalIF":1.9,"publicationDate":"2025-07-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144763661","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":"Virtually-delivered prenatal yoga to prevent postpartum depression (PRYD) in women with a history of depression: Protocol for an exploratory pilot randomized controlled trial","authors":"Amy M. Loree ,&nbsp;Sara Santarossa ,&nbsp;Paige Coyne ,&nbsp;Erin N. Haley ,&nbsp;Mia Boulay ,&nbsp;Celeste Pappas ,&nbsp;Jordan M. Braciszewski ,&nbsp;Lisa R. Miller-Matero ,&nbsp;Laurel M. Hicks","doi":"10.1016/j.cct.2025.108032","DOIUrl":"10.1016/j.cct.2025.108032","url":null,"abstract":"<div><div>Postpartum depression affects approximately 13 % of women in the United States and contributes to adverse maternal and infant health outcomes. While a range of effective treatment approaches are available, there are substantial barriers to receiving care for postpartum depression. Preventive interventions during pregnancy to reduce the risk of postpartum depression may mitigate some of the barriers experienced in the postpartum period, and approaches that help manage stress and improve wellness are needed. Prenatal yoga, which has a range of physical and mental health benefits and has been shown to improve depressive symptoms in pregnancy, may be a feasible and acceptable alternative to traditional mental health treatment. However, additional research is needed to increase the accessibility of prenatal yoga for high-risk populations and determine whether it can be effectively implemented in healthcare settings to reduce postpartum depression risk. The PRY-D Study is an exploratory pilot randomized controlled trial that optimizes a mindful prenatal yoga intervention to prevent postpartum depression for pregnant patients at high risk of postpartum depression and examines feasibility, acceptability, satisfaction and preliminary effectiveness of the intervention. Results from this pilot randomized controlled trial enrolling a total of 48 pregnant patients at a large healthcare system will inform the development of a future fully powered hybrid type 2 effectiveness-implementation trial.</div><div><strong>Clinical Trial Registration Number:</strong> NCT06004232.</div></div>","PeriodicalId":10636,"journal":{"name":"Contemporary clinical trials","volume":"156 ","pages":"Article 108032"},"PeriodicalIF":1.9,"publicationDate":"2025-07-28","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144738425","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}