Contemporary clinical trials最新文献

{"title":"Kinesiologist-delivered mobilization to mitigate inpatient frailty: A study protocol for a randomized controlled trial","authors":"Madeline E. Shivgulam ,&nbsp;Mathieu Dumont ,&nbsp;Shirko Ahmadi ,&nbsp;Molly Courish ,&nbsp;Luc Barrieau ,&nbsp;Luc Cormier ,&nbsp;Olga Theou ,&nbsp;Saïd Mekari ,&nbsp;Myles W. O'Brien","doi":"10.1016/j.cct.2025.108204","DOIUrl":"10.1016/j.cct.2025.108204","url":null,"abstract":"<div><h3>Background</h3><div>Hospitalized older adults spend excessive amounts of time in sedentary postures (sitting/lying while awake). Mobilizing patients may prevent physical deconditioning, exacerbated frailty levels, and worsened hospital outcomes. The purpose of this study will be to test the hypothesis that compared to usual care, patients who receive multiple kinesiologist visits each day will, 1) increase their step counts and upright time, 2) decrease their frailty levels from admission to discharge, and 3) have shorter lengths of stays and decreased readmission rates.</div></div><div><h3>Methods</h3><div>Sixty middle-aged-to-older adult patients (≥50 years) from a general/internal medicine unit will be randomized into a usual care control (visit from the kinesiologist once/day) or intervention group (multiple visits from the kinesiologist/day). Kinesiologist visits will include individualized patient mobilization. All participants will be equipped with three waterproofed activPAL inclinometers positioned on their thigh, torso, and shin for 24-h/day throughout hospitalization to measure physical activity (step counts, physical activity intensity), upright postures, and detailed sedentary postures (bent-legged sitting, straight-legged sitting, lying). Frailty will be assessed via a validated 65-item index and the Clinical Frailty Scale two weeks before admission (retrospectively), at admission, and at discharge. Secondary measures will include length of stay and hospital re-admissions. Mixed models for repeated measures will determine whether daily activity differed between groups, changed throughout hospital stay, and effected frailty levels.</div></div><div><h3>Discussion</h3><div>This randomized controlled trial will aim to refine mobilization strategies and individualize interventions for the prevention of decline in mobility and worsening frailty among hospitalized patients.</div><div>Trial Registration: The protocol has been registered at <span><span>clinicaltrials.gov</span><svg><path></path></svg></span> (identifier: <span><span>NCT06802289</span><svg><path></path></svg></span>).</div></div>","PeriodicalId":10636,"journal":{"name":"Contemporary clinical trials","volume":"161 ","pages":"Article 108204"},"PeriodicalIF":1.9,"publicationDate":"2026-02-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145843541","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":"Sequential choice vs colonoscopy outreach for colorectal cancer screening: Design and rationale of a pragmatic randomized clinical trial","authors":"Shivan J. Mehta ,&nbsp;Pamela A. Shaw ,&nbsp;Catherine Reitz ,&nbsp;Caitlin Brophy ,&nbsp;Evelyn Okorie ,&nbsp;Keyirah Williams ,&nbsp;Abraham Segura ,&nbsp;Jinming Tao ,&nbsp;Christopher K. Snider ,&nbsp;Colin Wollack ,&nbsp;Sadie Friday ,&nbsp;Katharine A. Rendle ,&nbsp;Tamar Klaiman ,&nbsp;Karen Glanz ,&nbsp;Corinne Rhodes ,&nbsp;David A. Asch","doi":"10.1016/j.cct.2025.108188","DOIUrl":"10.1016/j.cct.2025.108188","url":null,"abstract":"<div><h3>Background</h3><div>Colorectal cancer (CRC) screening rates remain limited, and effective methods for offering the choice of colonoscopy or stool testing through outreach have not been identified. We evaluate the effect of sequential choice compared to colonoscopy outreach on screening completion, and further evaluate behavioral nudges in the electronic health record (EHR).</div></div><div><h3>Methods</h3><div>In this pragmatic randomized clinical trial, patients were randomly allocated in a 1:2:2 ratio to 1) usual care (no outreach), 2) colonoscopy only, or 3) sequential choice of colonoscopy, then fecal immunochemical testing (FIT). Patients in arms 2 and 3 were additionally randomized to receive either (a) usual care, or (b) a visit-based, clinician-directed nudge facilitated by the EHR with follow-up texting to the patient. The primary outcome is CRC screening completion within 3 years by either colonoscopy, 2 negative fecal immunochemical tests (FIT), or 1 positive FIT followed by colonoscopy within one year.</div></div><div><h3>Analysis</h3><div>For the patient-directed analysis, the primary outcome will be evaluated by comparing CRC screening completion among patients randomized to either outreach arm (2 or 3) to the no outreach arm (1). We will also compare completion between the colonoscopy only arm (1) and the sequential choice arm (2). For the visit-based analysis, we will compare CRC screening completion among patients between the usual care arms (2a and 3a) and the nudge arms (2b and 3b).</div></div><div><h3>Conclusion</h3><div>This trial is unique in evaluating the long-term effectiveness of offering sequential choice to colonoscopy alone through a multi-level, centralized outreach and visit-based design.</div><div><em>Clinical Trials Identifier:</em> <span><span>NCT05693649</span><svg><path></path></svg></span></div></div>","PeriodicalId":10636,"journal":{"name":"Contemporary clinical trials","volume":"161 ","pages":"Article 108188"},"PeriodicalIF":1.9,"publicationDate":"2026-02-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145780538","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":"STARRS-PC: A stepped approach to reducing suicide in primary care: Design and methods of a hybrid type 1 effectiveness-implementation trial","authors":"Cynthia A. Fontanella ,&nbsp;Jennifer L. Hughes ,&nbsp;Guy Brock ,&nbsp;Donna A. Ruch ,&nbsp;Alex R. Kemper ,&nbsp;Alicia C. Bunger ,&nbsp;Dan M. Walker ,&nbsp;Ann Scheck McAlearney ,&nbsp;Tensing Maa ,&nbsp;Melissa Miller ,&nbsp;Priyanka Desirazu ,&nbsp;Jeremy Obee ,&nbsp;Jeffrey A. Bridge","doi":"10.1016/j.cct.2025.108208","DOIUrl":"10.1016/j.cct.2025.108208","url":null,"abstract":"<div><h3>Background</h3><div>Suicide is the second leading cause of death among youth aged 12–17. Although most at-risk youth receive primary care, routine screening is limited in primary care due to provider discomfort, time constraints, limited training, and inadequate referral sources. Research evaluating and implementing suicide prevention strategies in pediatric primary care is vitally needed.</div></div><div><h3>Purpose</h3><div>We aim to test the effectiveness of the Stepped Approach to Reducing Suicide in Primary Care (STARRS-PC), a population-based quality improvement intervention implementing a structured clinical pathway consisting of risk detection, assessment and triage, and follow-up with transitional care.</div></div><div><h3>Methods</h3><div>A stepped wedge cluster randomized design will evaluate the effectiveness of STARRS-PC compared to treatment as usual (TAU) across 16 primary care sites. 2324 adolescents aged 12–17 screening positive for suicide risk will be enrolled (1033 in the TAU phase; 1291 in the intervention phase). Primary outcomes include suicide attempts and deaths. Secondary outcomes are suicidal ideation, non-suicidal self-injury, and family satisfaction. Youth and parents will complete assessments at baseline, 3, 6, and 12 months. Tests of moderation and mediation will be conducted to understand finding generalizability and identify variables that change as a result of the intervention and are associated with suicide attempts/death. Implementation outcomes (reach, adoption, maintenance, feasibility, and acceptability) will be evaluated through provider surveys and qualitative interviews.</div></div><div><h3>Conclusions</h3><div>This study will provide evidence on the effectiveness and implementation of a quality improvement supported, structured suicide prevention pathway in pediatric primary care, which could transform youth suicide risk identification and management.</div></div>","PeriodicalId":10636,"journal":{"name":"Contemporary clinical trials","volume":"161 ","pages":"Article 108208"},"PeriodicalIF":1.9,"publicationDate":"2026-02-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145838280","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":"iMprovIng the meNtal hEalth of home healTh AiDeS: A study protocol for the MINDSET study","authors":"Madeline R. Sterling ,&nbsp;Michelle Shum ,&nbsp;Ronica Peramsetty ,&nbsp;Joselyne Aucapina ,&nbsp;Faith Wiggins ,&nbsp;Carmen Colon ,&nbsp;Joanna Bryan Ringel ,&nbsp;Ariel C. Avgar ,&nbsp;Nicola Dell ,&nbsp;Bibi N. Habib ,&nbsp;Samprit Banerjee ,&nbsp;Emma Tsui ,&nbsp;Susan J. Andreae ,&nbsp;Elissa Kozlov ,&nbsp;Courtney Landis ,&nbsp;Ian René Solano-Kamaiko ,&nbsp;Monika M. Safford","doi":"10.1016/j.cct.2025.108200","DOIUrl":"10.1016/j.cct.2025.108200","url":null,"abstract":"<div><div>Home health aides and attendants (HHAs) are a fast-growing healthcare workforce who are integral to the rising movement that allows older adults to age in place. However, HHAs themselves are a vulnerable group of caregivers. Mostly middle-aged women of color paid dismally low wages, HHAs' work is physically taxing, emotionally challenging, and socially isolating. Consequently, HHAs have high levels of depressive symptoms and stress. Prior studies suggest that HHAs want to address this, but do not know how and cannot access or afford traditional mental health services. Here we describe the protocol for a pilot randomized control trial (RCT) that aims to improve the mental health of HHAs through peer coaching (PC), an established and effective behavioral health intervention which has never been applied to HHAs or their workplace, the home environment. In collaboration with a labor and management fund of the largest healthcare union in the US (1199SEIU), we will conduct a single-site parallel arm pilot RCT with 100 HHAs to evaluate the feasibility, acceptability, and effectiveness of an adapted <em>Living Healthy Program for HHAs</em> delivered by PCs (intervention arm) vs. a general health promotion program (attention control arm). Primary effectiveness outcome will be a reduction in depressive symptoms; secondary effectiveness outcomes will be a reduction in stress and loneliness. This study offers a novel and potentially scalable way to improve the health of HHAs, an often overlooked, undervalued, but increasingly vital workforce that is needed to care for our rapidly aging population.</div></div>","PeriodicalId":10636,"journal":{"name":"Contemporary clinical trials","volume":"161 ","pages":"Article 108200"},"PeriodicalIF":1.9,"publicationDate":"2026-02-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145818368","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":"Pediatric asthma management via integration of a remote spirometry device into an EHR-based artificial intelligence-powered clinical decision support system: A feasibility pragmatic clinical trial","authors":"Lynnea Myers ,&nbsp;Tracey A. Brereton ,&nbsp;Shauna Overgaard ,&nbsp;Jason D. Greenwood ,&nbsp;Lu Zheng ,&nbsp;Joshua W. Ohde ,&nbsp;Matthew Spiten ,&nbsp;R.N. Kathy Ihrke ,&nbsp;Kristi Lang ,&nbsp;Kevin Peterson ,&nbsp;Stephen Hawley ,&nbsp;Madison Beenken ,&nbsp;M. Malik ,&nbsp;Josh Bublitz ,&nbsp;Taylor Galloway ,&nbsp;Quantia Wilkes ,&nbsp;Danielle Shrader ,&nbsp;Lydia Mercado ,&nbsp;Miguel Park ,&nbsp;Manuel Arteta ,&nbsp;Young Juhn","doi":"10.1016/j.cct.2025.108209","DOIUrl":"10.1016/j.cct.2025.108209","url":null,"abstract":"<div><h3>Background</h3><div>Asthma is the most common chronic disease in children. Suboptimal asthma control is prevalent and causes significant health care costs. Electronic health records (EHRs) contain vast data which pose a major challenge for timely and efficient access to relevant information for clinical decision making. To address this challenge, a machine learning and natural language processing models-powered clinical decision support system (CDS) called Asthma-Guidance Prediction System (A-GPS) was developed. A-GPS automatically extracts and synthesizes pertinent patient data from EHRs for asthma management. To further enhance A-GPS, real-time patient data was added from a home spirometry device and mobile app system (AsthmaTuner), that remotely collected patient-reported outcomes for asthma control and lung function and delivered a clinician-prescribed Asthma Action Plan from EHR to patients. The goal of the study was to assess the feasibility and satisfaction of implementation of an integrated A-GPS with AsthmaTuner for remote asthma management within pediatric primary care.</div></div><div><h3>Methods</h3><div>Study design was a parallel-group, non-blinded, dual-site, 2-arm pragmatic, randomized clinical trial (RCT) with 22 dyads (one clinician and one pediatric patient) at Mayo Clinic Health System and Mayo Clinic, Rochester, Minnesota. The primary endpoint was successful implementation of the integrated A-GPS with AsthmaTuner in primary care and study participants' satisfaction.</div></div><div><h3>Conclusion</h3><div>The technological integration and application of the integrated A-GPS and AsthmaTuner in primary care as a clinical CDS for remote asthma management was feasible. This protocol provides developers with a framework for the best practices for evaluating AI tools and enables digital technology via an RCT.</div><div>Trial Registration: Registered via <span><span>ClinicalTrials.gov</span><svg><path></path></svg></span> <span><span>NCT06062433</span><svg><path></path></svg></span></div></div><div><h3>Significance</h3><div>We anticipate this study will establish a conceptual and operational framework for implementing AI-powered CDS in pediatric asthma management, with the goal that these methodological advancements will be expanded to the management of adults with asthma and other chronic complex diseases. Reporting a clinical trial protocol for the evaluation of an AI tool and following the reporting guidelines are valuable for establishing best practices evaluating AI tools, specifically for the developers and other key stakeholders who plan to evaluate AI models via RCTs in health care settings. We plan to communicate our trial results via publication and reporting in <span><span>ClinicalTrials.gov</span><svg><path></path></svg></span> database (<span><span>NCT06062433</span><svg><path></path></svg></span>). Authorship on publications will follow international standards for authorship (i.e., ICMJE).</div></div>","PeriodicalId":10636,"journal":{"name":"Contemporary clinical trials","volume":"161 ","pages":"Article 108209"},"PeriodicalIF":1.9,"publicationDate":"2026-02-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145843562","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-LC study: Caregivers as the agent of change for childhood obesity and chronic disease risk among Latino families","authors":"Kerri N. Boutelle ,&nbsp;Dawn M. Eichen ,&nbsp;Michael Manzano ,&nbsp;Noe C. Crespo ,&nbsp;Ingrid Rivera-Iñiguez ,&nbsp;Eduardo Castro ,&nbsp;David R. Strong ,&nbsp;Isabella Newell ,&nbsp;Kristie Reed ,&nbsp;Becky Marquez ,&nbsp;Kyung E. Rhee","doi":"10.1016/j.cct.2025.108191","DOIUrl":"10.1016/j.cct.2025.108191","url":null,"abstract":"<div><div>Latino children are disproportionally affected by overweight and obesity (OW/OB). Family-based behavioral treatment (FBT) is the most empirically supported treatment for children with OW/OB and traditionally includes a child and a caregiver. Very few FBT programs have been tested among Latino families, and to date, outcomes are inconsistent and/or show small effects. Familismo is a core value in Latino culture highlighting the importance of family functioning over any individual members, and it is possible that by adapting the treatment and including other family members, FBT outcomes could be enhanced for Latino families. Randomized trials show that parent-only FBT programs (PBT) are similarly effective to FBT and can be easier to disseminate and cost less. The current trial is a two-arm randomized controlled trial comparing the effect of a telehealth PBT program tailored to Latino families (PBT-LC) with a health education (HE) comparator on the child's weight over the 18 months of the study. We randomized 167 Latino families with a child with OW/OB to either six-months of telehealth PBT-LC or HE treatment delivered to the parent and additional caregiver in English or Spanish with 12-months of follow-up. This ongoing study may provide a translatable evidence-based cost-effective program tailored for Latino families with a child with OW/OB.</div><div>Clinical trials # <span><span>NCT05437406</span><svg><path></path></svg></span></div></div>","PeriodicalId":10636,"journal":{"name":"Contemporary clinical trials","volume":"161 ","pages":"Article 108191"},"PeriodicalIF":1.9,"publicationDate":"2026-02-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145780530","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":"Effects of daily low oxygen exposure on weight status, body composition, and metabolic health in adults with obesity: protocol for a randomized, double-blind, controlled-feeding study","authors":"Terrence M. Riley ,&nbsp;Camila Weschenfelder ,&nbsp;Eric Ravussin ,&nbsp;Jennifer C. Rood ,&nbsp;Frank Greenway ,&nbsp;Sarah Taff ,&nbsp;Robert C. Hickner ,&nbsp;Hongyuan Cao ,&nbsp;Angelina R. Sutin ,&nbsp;Gregory Todd ,&nbsp;Stephen R. Hennigar ,&nbsp;Claire E. Berryman","doi":"10.1016/j.cct.2025.108167","DOIUrl":"10.1016/j.cct.2025.108167","url":null,"abstract":"<div><h3>Background</h3><div>Diet and exercise are the cornerstone of obesity prevention and treatment. However, a substantial number of individuals are non-responsive to existing weight-loss interventions and obesity rates continue to rise. Daily exposure to low-oxygen conditions may aid in current weight-loss strategies by increasing resting metabolic rate and decreasing appetite. Whether in-home, overnight, normobaric hypoxic exposure promotes body weight loss in adults with obesity remains unknown.</div></div><div><h3>Methods</h3><div>Fifty adults with obesity (BMI: 30–39.9 kg/m²) will complete this double-blind, parallel-arm, randomized, controlled-feeding clinical trial. Participants will be provided with a weight maintenance diet for 2 weeks while undergoing baseline measurements. Following the weight maintenance phase, an energy restricted diet (500 kcal/day below weight maintenance needs) will be provided in combination with either overnight exposure to normobaric hypoxia (8 h/night, 15% oxygen, elevation ∼2,640 m) or normoxia (8 h/night, 21% oxygen, elevation ∼60 m), using a commercially available, in-home tent system, for 8 weeks. The primary outcome is the difference in body weight change between interventions. Secondary outcomes include measures of body composition, total and resting energy expenditure, energy intake from an ad libitum meal, insulin sensitivity and glycemic control, sympathetic tone, iron absorption and indicators of iron status, stool microbial diversity and composition, appetite, psychosocial factors, and sleep quantity and quality.</div></div><div><h3>Discussion</h3><div>Chronic, overnight, low oxygen exposure may provide a novel intervention to supplement current weight-loss strategies, inform new strategies to accelerate weight loss, and aid long-term weight management efforts in adults with obesity.</div></div><div><h3>Clinical trial registration</h3><div><span><span>Clinicaltrials.gov</span><svg><path></path></svg></span> <span><span>NCT05289310</span><svg><path></path></svg></span></div></div>","PeriodicalId":10636,"journal":{"name":"Contemporary clinical trials","volume":"160 ","pages":"Article 108167"},"PeriodicalIF":1.9,"publicationDate":"2026-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145615978","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 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":"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":"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}