Contemporary clinical trials最新文献

{"title":"Protocol of a randomized trial of acceptance and commitment therapy for patient fatigue interference and caregiver burden in advanced gastrointestinal cancer","authors":"Catherine E. Mosher ,&nbsp;Eileen H. Shinn ,&nbsp;Elizabeth L. Addington ,&nbsp;Wei Wu ,&nbsp;Jonathan B. Bricker ,&nbsp;Paul R. Helft ,&nbsp;Anita A. Turk ,&nbsp;Laura B. Vater ,&nbsp;Ashiq Masood ,&nbsp;Shadia I. Jalal ,&nbsp;Patrick J. Loehrer Sr. ,&nbsp;Victoria L. Champion ,&nbsp;Shelley A. Johns","doi":"10.1016/j.cct.2025.108168","DOIUrl":"10.1016/j.cct.2025.108168","url":null,"abstract":"<div><div>Fatigue's interference with activities, mood, and cognition is one of the most prevalent and distressing problems of patients with advanced gastrointestinal cancer. As fatigue interferes with patient functioning, family caregivers often report feeling burdened by increasing demands. Evidence-based interventions for patient fatigue interference and caregiver burden are lacking in advanced gastrointestinal cancer. In a pilot trial, telephone-based Acceptance and Commitment Therapy (ACT) showed potential for reducing patient fatigue interference and caregiver burden in this population. The current Phase II trial seeks to determine the efficacy of this intervention for patients with advanced gastrointestinal cancer and moderate-to-severe fatigue interference and their family caregivers with significant caregiving burden. In this trial, 244 dyads are randomly assigned to either the ACT intervention or an education/support control. Participants in both conditions attend six weekly 50-min telephone sessions, four of which involve both dyad members, and a 30-min booster session. The primary aim is to test the effects of telephone-delivered ACT on patient fatigue interference and caregiver burden. Secondary outcomes include patient sleep interference and patient and caregiver engagement in daily activities and quality of life. Outcomes are assessed at baseline, 2 weeks post-intervention, and 3 months post-intervention. This trial also examines whether increased psychological flexibility, defined as mindful acceptance of present experiences, including challenges, while pursuing actions aligned with personal values, mediates ACT's effects on primary outcomes. Our ability to demonstrate ACT's efficacy will support its adoption in cancer care. Findings will also inform future ACT trials for dyads coping with other serious illnesses.</div><div>Trial Registration ID: <span><span>NCT06532877</span><svg><path></path></svg></span></div></div>","PeriodicalId":10636,"journal":{"name":"Contemporary clinical trials","volume":"160 ","pages":"Article 108168"},"PeriodicalIF":1.9,"publicationDate":"2026-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145630889","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":"Comparison of digital behavioral interventions to prevent alcohol misuse among adolescents ages 12 to 19: A randomized clinical trial protocol","authors":"Erin E. Bonar ,&nbsp;Jason E. Goldstick ,&nbsp;Meredith L. Philyaw-Kotov ,&nbsp;Carrie A. Bourque ,&nbsp;Susan J. Woolford ,&nbsp;Ken Resnicow ,&nbsp;Joanna Quigley ,&nbsp;Golfo Tzilos Wernette ,&nbsp;Sana Ahmed ,&nbsp;Debra M. Langlois ,&nbsp;Maureen A. Walton","doi":"10.1016/j.cct.2025.108172","DOIUrl":"10.1016/j.cct.2025.108172","url":null,"abstract":"<div><div>Prevention of alcohol use and misuse among adolescents is a public health priority. A health care visit provides an opportunity for screening for alcohol use and delivery of early interventions. Digital intervention delivery may reduce barriers to implementation in these settings. Herein, we describe the protocol from an ongoing comparative effectiveness study testing digital interventions to prevent escalation of alcohol use among adolescents (ages 12–19) connected to pediatric healthcare. Adolescents screening positive for past-year alcohol use are eligible to participate. Enrolled participants complete a baseline survey and are randomly assigned [stratified by sex and age group (12–14; 15–17; 18–19)] to an interactive, ∼45-min computerized brief intervention (CBI) alone or combined with 8 weeks of text messages. Outcomes are assessed at 3-, 6-, 9-, and 12-months post-baseline. Primary outcomes include past 3-month alcohol consumption. Secondary outcomes include alcohol and drug consequences, illicit and prescription drug misuse, and depression symptoms. In parallel, caregivers are also invited to participate, which involves referral to download the app “Talk. They Hear You.” and completing surveys at baseline, 3-, 6-, 9- and 12- months to report their use of the app. A novel aspect of this study is that we partnered with adolescents, caregivers, and health care staff and clinicians throughout the study to enhance relevance, effectiveness, and potential for future dissemination. This study will provide critical data to inform implementation of digital interventions for pediatric patients with the potential to prevent negative health outcomes and promote adolescent well-being.</div></div>","PeriodicalId":10636,"journal":{"name":"Contemporary clinical trials","volume":"160 ","pages":"Article 108172"},"PeriodicalIF":1.9,"publicationDate":"2026-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145630817","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":"Randomized trial of delta-9-tetrahydrocannabinol (THC) versus placebo to augment the effects of prolonged exposure therapy on fear extinction learning in post-traumatic stress disorder: Study rationale and protocol","authors":"Christine A. Rabinak ,&nbsp;Paul E. Kilgore ,&nbsp;Mark A. Lumley ,&nbsp;Sheila A.M. Rauch","doi":"10.1016/j.cct.2025.108148","DOIUrl":"10.1016/j.cct.2025.108148","url":null,"abstract":"<div><h3>Background</h3><div>Prolonged exposure (PE) therapy is effective for PTSD, yet dropout and partial response remain concerning. Preclinical and human studies suggest Δ⁹-tetrahydrocannabinol (THC) enhances fear extinction and recall through brain cannabinoid receptor activation in fear processing.</div></div><div><h3>Objective</h3><div>Examine whether synthetic THC (dronabinol) augments PE effectiveness.</div></div><div><h3>Design</h3><div>Double-blind, placebo-controlled, trial with treatment-seeking PTSD patients (ages 18–60) randomized to 7.5 mg THC (<em>n</em> = 30) or placebo (n = 30). Randomization after sessions 1–2 (psychoeducation) ensures covariate-adaptive balance before the first medicated session. THC/placebo administered before PE sessions 3–6 of 10 total sessions so dosing coincided with extinction-learning sessions.</div></div><div><h3>Setting</h3><div>Wayne State University with remote PE delivery via Emory University.</div></div><div><h3>Participants</h3><div>Adults with PTSD (CAPS-5 ≥ 25) excluding for severe mental illness, substance use disorders, or contraindications to THC.</div></div><div><h3>Interventions</h3><div>PE therapy (10 sessions, up to 3 times / week) with THC or placebo administered 120 min before sessions to coincide with peak plasma levels.</div></div><div><h3>Main outcomes</h3><div>Primary: PTSD symptom severity (CAPS-5, PCL-5). Secondary: fMRI brain activation during fear extinction paradigms, skin conductance responses, and extinction retention measures pre/post-treatment.</div></div><div><h3>Statistical analysis</h3><div>Intent-to-treat linear mixed-effects models accounting for therapist clustering. Neuroimaging analyzed via region-of-interest and whole-brain approaches focusing on ventromedial prefrontal cortex, hippocampus, and amygdala.</div></div><div><h3>Discussion</h3><div>THC dosing and timing is based on prior mechanistic studies that demonstrated THC-related enhancement of extinction recall and frontolimbic circuit engagement. Aligning peak THC levels with exposure sessions maximizes potential for CB1-mediated augmentation of extinction learning. If effective, this FDA-approved augmentation strategy could be rapidly implemented to improve PE outcomes.</div></div><div><h3>Trial registration</h3><div><span><span>ClinicalTrials.gov</span><svg><path></path></svg></span> <span><span>NCT04080427</span><svg><path></path></svg></span></div></div>","PeriodicalId":10636,"journal":{"name":"Contemporary clinical trials","volume":"160 ","pages":"Article 108148"},"PeriodicalIF":1.9,"publicationDate":"2026-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145573351","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 telehealth vs. web-based delivered home-based walking for veterans with peripheral artery disease (TREK-PAD) trial","authors":"Elizabeth A. Jackson ,&nbsp;Gustavo Aldama ,&nbsp;Emily Spangler ,&nbsp;Joshua Richman ,&nbsp;Kamal Henderson ,&nbsp;Gareth Dutton ,&nbsp;Donald Dempsey ,&nbsp;Alfredo Guzman ,&nbsp;Jonathan Myers","doi":"10.1016/j.cct.2025.108139","DOIUrl":"10.1016/j.cct.2025.108139","url":null,"abstract":"<div><h3>Background</h3><div>Facility-based exercise such as walking is recommended for adults with peripheral artery disease (PAD). PAD is prevalent among US Veterans; thus, understanding effective methods for delivering home-based PAD exercise programs to Veterans is clinically important.</div></div><div><h3>Methods</h3><div>Veterans with documented PAD will be recruited from three sites (Birmingham, AL, Aurora, CO, and Palo Alto, CA) for a sequential multiple assignment randomized trial (SMART) comparing a web-based delivered walking program to a telehealth delivered walking program or usual care. After 12-weeks of the walking program, participants assigned to one of the walking program intervention arms who do not increase their maximal walking distance will be re-randomized to either receive both web-based and telehealth programs or continue their original assignment till week 24. Follow-up will continue for a third 12-weeks for a total duration of 36-weeks. A total of 225 Veterans will be recruited. The primary outcome of maximal walking distance will be assessed at baseline, 12, 24, and 36-weeks with a standardized treadmill protocol. Additional outcomes include pain-free walking distance and changes in health-related quality of life, measured at the same time points.</div></div><div><h3>Conclusion</h3><div>Determining the efficacy of delivering a home-based walking program can address barriers to facility-based programs which are often not available and create participant burden, particularly to those residing in rural areas distant from healthcare facilities. Veterans are both vulnerable to such barriers and overburdened by PAD. This study will contribute to current evidence related to home-based exercise interventions for Veterans with PAD.</div></div>","PeriodicalId":10636,"journal":{"name":"Contemporary clinical trials","volume":"160 ","pages":"Article 108139"},"PeriodicalIF":1.9,"publicationDate":"2026-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145476673","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 Investigation of Vitamin D and Menstrual Cycles Trial (the inVitD Trial): A clinical trial of vitamin D supplementation on the hypothalamic-pituitary-ovarian axis","authors":"Michelle R. Klawans ,&nbsp;Olivia Kohrman ,&nbsp;W. Braxton Jackson II ,&nbsp;Chandra L. Jackson ,&nbsp;Christine N. Metz ,&nbsp;Ganesa Wegienka ,&nbsp;Alison Motsinger-Reif ,&nbsp;Anne Z. Steiner ,&nbsp;Donna D. Baird ,&nbsp;Dale P. Sandler ,&nbsp;Anne Marie Z. Jukic","doi":"10.1016/j.cct.2025.108176","DOIUrl":"10.1016/j.cct.2025.108176","url":null,"abstract":"<div><h3>Background</h3><div>While there is evidence that vitamin D deficiency is associated with long menstrual cycles, delayed ovulation, and reduced fertility, it is yet unknown if increasing vitamin D levels can regulate menstrual cycles, and thus possibly improve fertility. The primary objective of this randomized clinical trial (RCT) is to test the hypothesis that vitamin D supplementation influences the hypothalamic-pituitary-ovarian axis.</div></div><div><h3>Methods</h3><div>This two-site RCT (<span><span>NCT05050916</span><svg><path></path></svg></span>) required participants to be aged 19–40 years old, having spontaneous menstrual cycles, and without certain chronic diseases or contraindications for vitamin D supplementation. At baseline participants provided information on their demographics and health history. Blood was drawn at the first clinic visit after which participants collected daily urine samples for one menstrual cycle (phase 1). Those with a 25-hydroxyvitamin D level less than 20 ng/ml (“low”) received cholecalciferol supplementation (randomized to either 4200 IU/week or 50,000 IU/week). A random sample of those without low vitamin D received placebo. Supplement (or placebo) was taken for three menstrual cycles which included collection of daily urine samples and home ovulation testing (phase 2). Participants collected self-administered vaginal and oral swabs and a subset collected menstrual effluent samples. Finally, participants kept a daily menstrual diary and weekly behavior diaries. The primary endpoints were mid-luteal progesterone, rate of estrogen rise, and pre-ovulatory luteinizing hormone.</div></div><div><h3>Discussion</h3><div>Findings from this RCT will provide insight into the relationship between vitamin D supplementation and menstrual cycle hormones. Vitamin D shows promise as a low-cost, non-hormonal intervention to regulate menstrual cycles.</div></div>","PeriodicalId":10636,"journal":{"name":"Contemporary clinical trials","volume":"160 ","pages":"Article 108176"},"PeriodicalIF":1.9,"publicationDate":"2026-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145681682","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 comparison of institutional review board models and study efficiency in the Environmental influences on Child Health Outcomes Cohort Consortium","authors":"Taylor Kohlmann ,&nbsp;Angel Chen ,&nbsp;Polly Armsby ,&nbsp;C. Ashley Finlen Copeland ,&nbsp;Tracy Gentry ,&nbsp;Marla Jordan ,&nbsp;Maurine Morris ,&nbsp;Ana Trampe ,&nbsp;Jyoti Angal ,&nbsp;Lauren Sims Taylor ,&nbsp;Annemarie Stroustrup ,&nbsp;Carlos A. Camargo Jr. ,&nbsp;N. David Yanez ,&nbsp;P. Brian Smith ,&nbsp;for the ECHO Cohort Consortium","doi":"10.1016/j.cct.2025.108140","DOIUrl":"10.1016/j.cct.2025.108140","url":null,"abstract":"<div><h3>Background</h3><div>Institutional review board (IRB) approval is a key step in site activation and study initiation. Single IRBs aim to improve the timeliness of IRB review through centralization and standardization, whereas local IRBs conduct reviews only for specific sites. In Cycle 1 of the Environmental influences on Child Health Outcomes (ECHO) Cohort Consortium, 110 sites chose either single or local IRB review, providing the opportunity to compare the efficiency of single versus local IRBs within one multicenter observational study.</div></div><div><h3>Objectives</h3><div>Data were collected from the ECHO Coordinating Center at the Duke Clinical Research Institute. Primary outcomes included: 1) time from IRB submission to approval and 2) time from regulatory pack receipt to first participant enrollment. Secondary outcomes included: 1) time from regulatory pack receipt to IRB submission, 2) time from IRB approval to site activation, and 3) time from site activation to first participant enrollment. We compared these outcomes between sites using local versus single IRBs.</div></div><div><h3>Results</h3><div>No significant differences were identified between the local and single IRB groups for the primary and secondary outcomes. The time from IRB submission to approval was similar for local and single IRBs (median [IQR]: 20 days [10−33]; 19 days [11–27]; <em>p</em> = 0.71, respectively). The time from regulatory pack receipt to first participant enrollment was similar for local and single IRBs (median [IQR]: 243 days [16–309]; 191 days [137–233]; <em>p</em> = 0.50, respectively).</div></div><div><h3>Conclusion</h3><div>Multiple factors influence review timelines. Single IRBs do not guarantee faster review; additional work is needed to evaluate their impact on study timelines.</div></div>","PeriodicalId":10636,"journal":{"name":"Contemporary clinical trials","volume":"160 ","pages":"Article 108140"},"PeriodicalIF":1.9,"publicationDate":"2026-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145511913","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":"SMARTs with treatment preference: Pragmatic SMART design and methods motivated by STAR*D","authors":"Sarah Medley ,&nbsp;Marianthie Wank ,&nbsp;Roy N. Tamura ,&nbsp;Thomas M. Braun ,&nbsp;Kelley M. Kidwell","doi":"10.1016/j.cct.2025.108162","DOIUrl":"10.1016/j.cct.2025.108162","url":null,"abstract":"<div><div>Effective care for chronic conditions with high rates of non-response or relapse requires personalized and adaptive treatment guidelines known as dynamic treatment regimens (DTRs). Sequential, multiple assignment, randomized trials (SMARTs) are the gold standard for estimating DTRs, but SMARTs, like any trial, may struggle with recruitment and retention due to patient treatment preferences. A partially randomized, patient preference SMART (PRPP-SMART) design overcomes these issues by assigning participants with a preference to their preferred treatment and randomizing indifferent participants at each stage of the SMART. The PRPP-SMART design and methods were motivated in part by STAR*D (NCT00021528), which produced second- and third-line treatment recommendations for patients with major depressive disorder (MDD) who tend to have comorbidities, prior treatment history, and treatment preferences. Traditional, randomized clinical trials typically fail to recruit generalizable study populations, and traditional methods are not appropriate to combine data from randomized and non-randomized participants. We have previously shown that weighted and replicated regression models (WRRMs) combining data from all participants in a PRPP-SMART estimate DTR effects given binary outcomes with minimal bias. Here, we evaluate WRRMs to estimate PRPP-SMART DTRs with continuous outcomes and find that the performance of our method is robust to different preference rates and outcome distributions. We illustrate our method using data adapted from STAR*D which considered preferences in treatment assignment but did not compare DTRs. The PRPP-SMART design and methods presented here would have overcome many shortcomings of STAR*D and establish a framework for meaningful DTR estimates in future pragmatic SMARTs.</div></div>","PeriodicalId":10636,"journal":{"name":"Contemporary clinical trials","volume":"160 ","pages":"Article 108162"},"PeriodicalIF":1.9,"publicationDate":"2026-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145615990","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":"Rationale for the Feasibility and Acceptability of Smartwatch Technology in an Exercise Regimen (FASTER) study in older individuals","authors":"Jenna Hauben ,&nbsp;Jacsen Luthy ,&nbsp;Toluwaniose Nafiu ,&nbsp;Alexis Brengartner ,&nbsp;Mohamed Omar ,&nbsp;Donya Nemati ,&nbsp;Songzhu Zhao ,&nbsp;Guy Brock ,&nbsp;Kelly Urse ,&nbsp;John Paro ,&nbsp;Joshua J. Joseph","doi":"10.1016/j.cct.2025.108152","DOIUrl":"10.1016/j.cct.2025.108152","url":null,"abstract":"<div><h3>Background</h3><div>Less than 15 % of individuals 65+ meet physical activity guidelines for aerobic and muscle-strengthening activities. Thus, in this study we will examine the feasibility and acceptability of utilizing smartwatches among Exercise is Medicine (EIM), a physician referral exercise program, for participants aged 65+ to improve physical activity.</div></div><div><h3>Methods</h3><div>We will conduct a single-arm trial. Participants will complete an 11-week exercise program combined with a smartwatch, monthly webinars, and two follow-up sessions at 6 and 12 months. Surveys will measure acceptability of the exercise program and the wearable smartwatch. The number of active participants, participant attendance and program completion rates will assess feasibility of the program.</div></div><div><h3>Setting</h3><div>Ambulatory care clinics affiliated with a medical center and community centers in Central Ohio.</div></div><div><h3>Design</h3><div>Single-arm pilot study.</div></div><div><h3>Interventions</h3><div>FASTER will consist of 3 one-on-one and 16 group sessions over 11 weeks in addition to wellness webinars and two follow-up one-on-one sessions 6 and 12 months after program completion. The one-on-one and group sessions will be led by an American College of Sports Medicine (ACSM) certified exercise physiologist with EIM credentials. All participants will receive a Fitbit smartwatch to use throughout the program.</div></div><div><h3>Outcomes</h3><div>The primary outcome is the feasibility and acceptability of FASTER. Secondary outcomes are change in physical activity, biometric measures, mental health, and quality of life.</div></div><div><h3>Discussion</h3><div>Incorporating wearable smartwatch technology into a physician referral exercise program may be a novel way to improve physical activity and health in older adults.</div><div>Clinical Trial Registration Number: <span><span>NCT06287255</span><svg><path></path></svg></span></div></div>","PeriodicalId":10636,"journal":{"name":"Contemporary clinical trials","volume":"160 ","pages":"Article 108152"},"PeriodicalIF":1.9,"publicationDate":"2026-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145563109","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 PTSD symptoms in first responders and healthcare workers through trauma-focused treatment in Employee Assistance Programs: Protocol for a randomized controlled trial","authors":"Rebecca K. Sripada ,&nbsp;James Garlick ,&nbsp;Naomi Hemphill ,&nbsp;Heather M. Walters ,&nbsp;Dara Ganoczy ,&nbsp;H. Myra Kim ,&nbsp;Kara Zivin ,&nbsp;Andrea L. Nevedal ,&nbsp;Kimberly M. Avallone ,&nbsp;Jeffrey A. Cigrang ,&nbsp;Sheila A.M. Rauch","doi":"10.1016/j.cct.2025.108174","DOIUrl":"10.1016/j.cct.2025.108174","url":null,"abstract":"<div><h3>Background</h3><div>Healthcare workers and first responders are frequently exposed to traumatic events and subsequently are more susceptible to posttraumatic stress disorder (PTSD), but few receive treatment. Although Employee Assistance Programs (EAPs) are available at almost all large-sized companies, they lack the capacity to provide time-intensive first-line treatments for PTSD. To address this problem, our study team adapted a standard first-line PTSD treatment into a brief, 4–6 session format (Processing Emotions in Primary Care; PE-PC) and demonstrated its efficacy in military and veteran populations. This paper describes a study protocol to leverage the existing resource of the EAP to test intervention effectiveness among healthcare workers and first responders with treatment need.</div></div><div><h3>Method</h3><div>We are currently conducting a Hybrid Type 1 Effectiveness-Implementation trial to test the effectiveness of PE-PC, delivered by EAP counselors, versus EAP treatment as usual (TAU) in 360 healthcare workers and first responders with PTSD, and gather data regarding implementation. The specific aims are to compare the effectiveness of PE-PC versus EAP TAU in reducing PTSD symptoms at 6-week (post-treatment), 3-, and 6-month follow-ups, and prepare for future implementation through process evaluation and implementation mapping. We expect the study to yield an implementation strategy that is targeted to address EAP-specific implementation barriers.</div></div><div><h3>Conclusions</h3><div>This project will contribute a point-of-care intervention for frontline healthcare workers and first responders with PTSD, thus improving clinical practice for populations vulnerable to PTSD and increasing preparedness for public health emergencies.</div><div><span><span>ClinicalTrials.gov</span><svg><path></path></svg></span> Identifier: <span><span>NCT05751473</span><svg><path></path></svg></span></div></div>","PeriodicalId":10636,"journal":{"name":"Contemporary clinical trials","volume":"160 ","pages":"Article 108174"},"PeriodicalIF":1.9,"publicationDate":"2026-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145696068","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 for a hybrid type 1 effectiveness-implementation study of mindfulness-based therapy for insomnia in Black women","authors":"Soohyun Nam ,&nbsp;Guangyu Tong ,&nbsp;Joanne Iennaco ,&nbsp;Debbie Humphries ,&nbsp;Monica Ordway ,&nbsp;Minjung Lee ,&nbsp;Siobhan Thompson ,&nbsp;Milagrosa Seguinot ,&nbsp;Fernando Morales ,&nbsp;Kwasheba Harriot ,&nbsp;Nilda Paris ,&nbsp;Katurah A. Bryant ,&nbsp;Kristine Weidner ,&nbsp;Taneha Edwards ,&nbsp;Robin Whittemore","doi":"10.1016/j.cct.2025.108166","DOIUrl":"10.1016/j.cct.2025.108166","url":null,"abstract":"<div><div>Black women in the U.S. disproportionately suffer from insomnia and related cardiometabolic health burdens. However, there is a lack of sleep intervention and implementation research specifically targeting Black women. The aim of this study is to co-design and evaluate equity-focused, community-engaged implementation strategies for an online, group-based mindfulness-based therapy for insomnia (MBTI) tailored for Black women, and to test the effectiveness of MBTI. The study will utilize trained registered nurses to deliver the online MBTI sessions and integrate community health workers (CHWs) to address social determinants of health. This two-phase, study includes: (1) qualitative individual interviews with Black women, CHWs, and clinicians to identify barriers/facilitators to online MBTI (<em>N</em> = 10–40) (2) the development of equity-focused implementation strategies through community engagement process with the Community Advisory Board (clinicians, CHWs, social workers, and community-based organization members), and (3) a Hybrid Type 1 randomized controlled trial comparing online group-based MBTI to a waitlist control (<em>N</em> = 340). Implementation outcomes include acceptability (mean summary score ≥ 3.5 out of 5-point Likert scale), feasibility (≥ 80 %), fidelity (≥ 85 %), cost, and contextual factors; effectiveness outcomes include changes in Insomnia Severity Index scores (≥ 7-point reduction post-intervention) and actigraphy-measured sleep (an increase in total sleep time 20–40 min post-intervention). This study addresses the urgent need for equity-focused intervention and implementation research in sleep health. The study will evaluate how tailoring evidence-based interventions to community needs, leveraging CHWs, and embedding community partnership throughout the process improves access, uptake, and outcomes in Black women with insomnia.</div></div><div><h3>Trial registration</h3><div><span><span>ClinicalTrials.gov</span><svg><path></path></svg></span> Identifier: <span><span>NCT06348082</span><svg><path></path></svg></span></div></div>","PeriodicalId":10636,"journal":{"name":"Contemporary clinical trials","volume":"160 ","pages":"Article 108166"},"PeriodicalIF":1.9,"publicationDate":"2026-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145615981","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}