Contemporary Clinical Trials[JOURNAL]
Sun
200 papers
Protocol for a hybrid type 1 effectiveness-implementation trial of a mind-body activity program for older adults with chronic pain in a medically underserved area: The iHOPE study.
Vonderheide C, Kilduff C, McDermott KA … +11 more , Greenberg J, La Camera DE, Giraldo-Santiago N, Kurkul A, Alvarez-Frank N, Kim Y, Pasinski R, Gholston M, iHOPE Study Team, Ritchie CS, Vranceanu AM
Contemp Clin Trials · 2025 Dec · PMID 41326265 · Full text
BACKGROUND: Older adults in medically underserved areas (MUAs) are disproportionately affected by chronic musculoskeletal pain but lack access to safe, evidence-based psychosocial treatments. Staff at community clinics,...
BACKGROUND: Older adults in medically underserved areas (MUAs) are disproportionately affected by chronic musculoskeletal pain but lack access to safe, evidence-based psychosocial treatments. Staff at community clinics, where many disadvantaged older adults receive care, must manage complex pain needs and comorbidities with limited time and resources. Shared medical visits integrate medical care, education, and peer support, offering a feasible, scalable solution to overcome barriers associated with chronic pain management in primary care. We previously developed GetActive+, an intervention delivered through shared medical visits at a community clinic to teach mind-body and activity skills to older adults with chronic pain. Here, we describe the protocol for a fully powered hybrid type 1 effectiveness-implementation randomized controlled trial (RCT) comparing GetActive+ to treatment as usual (TAU). METHODS: We will recruit 200 English and Spanish-speaking older adult patients from two Massachusetts community clinics located in an MUA. We will assess multimodal physical function and psychosocial outcomes at baseline, post-intervention (11 weeks), and follow-up (6 months). Effectiveness will be determined by improvements in self-reported physical function post-intervention compared to TAU. Using mixed methods, we will assess implementation outcomes (feasibility, acceptability, fidelity, and adoption) at patient, provider, and organizational levels. RESULTS: The trial is ongoing. We have enrolled 54 older adults, 21 of whom have completed post-intervention assessments. CONCLUSION: We describe the implementation and evaluation of a mind-body activity intervention for older adults with chronic pain using shared medical visits. Results will inform subsequent implementation and dissemination efforts of GetActive+ in community clinics across the United States. CLINICAL TRIALS REGISTRATION NUMBER: NCT06119698.
A randomized clinical trial of multi-level intervention to improve colorectal cancer screening rates at multiple federally qualified health care centers in New York City.
Shaukat A, Hu J, Zhao Y … +7 more , Faulx G, Augustin A, Murphy S, Stevens E, Ravenell J, Makarov D, Napolitano D
Contemp Clin Trials · 2025 Dec · PMID 41326264 · Publisher ↗
INTRODUCTION: Colorectal cancer (CRC) screening rates among patients receiving care at multiple federally qualified health care centers (FQHCs) in New York city are low. Proactive outreach through mailed fecal immunochem...
INTRODUCTION: Colorectal cancer (CRC) screening rates among patients receiving care at multiple federally qualified health care centers (FQHCs) in New York city are low. Proactive outreach through mailed fecal immunochemical tests (FIT), reminders and navigation are evidence based interventions to improve CRC screening rates but remain untested in this study population. OBJECTIVE: To evaluate the effectiveness, implementation, and cost-effectiveness of a multilevel proactive outreach strategy to improve CRC screening rates among underserved adults in Brooklyn, New York. METHODS: This is a randomized controlled trial across five FQHCs serving predominantly Black and low-income populations. Adults aged 45-75 who are overdue for CRC screening are randomized to usual care or a multi-level proactive intervention. The intervention includes mailed education and FIT kits, patient navigation, and support for colonoscopy scheduling and follow-up. The primary outcome is CRC screening completion (FIT or colonoscopy) within six months. Secondary outcomes include colonoscopy follow-up after a positive FIT, implementation barriers and facilitators, and cost-effectiveness. RESULTS: A total of 1379 participants have been enrolled through May 2025. DISCUSSION: This trial addresses a critical gap in CRC prevention by testing a scalable, multilevel outreach model tailored to underserved populations. Findings will inform future strategies to enhance screening rates while reducing screening disparities through sustainable FQHC-based programs.
Assessment of a novel functional food modulating the microbiota-inflammation-brain axis in patients with heart failure and/or /atrial fibrillation patients (the AMBROSIA study): Protocol for a randomized controlled trial.
Baldi S, Cuffaro F, Russo E … +10 more , Porter K, Cheung W, Coman MM, Vaquero MG, Lingner T, Verdenelli MC, Barceló-Coblijn G, Brownlee I, Fumagalli S, Amedei A
Contemp Clin Trials · 2026 Jan · PMID 41325897 · Publisher ↗
BACKGROUND AND AIMS: Atrial fibrillation (AF), heart failure (HF), and undernutrition represent a complex triad with major clinical and socioeconomic consequences in older adults, often predisposing to frailty. Undernutr...
BACKGROUND AND AIMS: Atrial fibrillation (AF), heart failure (HF), and undernutrition represent a complex triad with major clinical and socioeconomic consequences in older adults, often predisposing to frailty. Undernutrition often remains underdiagnosed due to a reliance on weight-based measures and limited awareness of inflammation-related cachexia. The AMBROSIA study aims to fill these gaps by exploring the response of the microbiota-inflammation-brain axis to a targeted, fortified food product-based intervention, with comprehensive outcome assessments, alongside mechanistic/exploratory -omics analyses and gut microbiota (GM) functional profiling. METHODS AND RESULTS: This single-center, prospective, parallel-group randomized controlled trial aims to enroll 120 older adults with confirmed AF and/or HF. Participants will be randomized 1:1 into an intervention group (n = 60) or control group (n = 60). All participants receive individualized dietary counseling; the intervention group additionally consumes one AMBROSIA nutritional bar daily for six months. The bar contains hydrolyzed proteins, inulin, CoQ₁₀, and probiotics (L. rhamnosus IMC 501® and L. paracasei IMC 502®) in a flavonoid-rich chocolate matrix. Clinical, cognitive, and nutritional data, along with blood, saliva, urine, and stool samples, will be collected at baseline, 3, and 6 months. The primary endpoint is the change in skeletal muscle mass, physical function and frailty, while secondary endpoints include changes in nutritional status, inflammation, GM, metabolomics, and quality of life. CONCLUSION: By integrating cutting-edge omics tools and a multidimensional nutritional strategy, AMBROSIA aims to uncover mechanisms driving undernutrition and identify biomarkers to support personalized interventions for older patients with AF and HF.
Pilot randomized trial of cash transfer interventions to improve health outcomes in low income adults with poorly controlled type 2 diabetes: Study protocol and baseline characteristics.
Campbell JA, Walker RJ, Egede LE
Contemp Clin Trials · 2026 Jan · PMID 41318086 · Full text
BACKGROUND: Monetary interventions, such as cash transfers, have emerged as important intervention approaches to address the complex determinants at the structural and individual level impacting diabetes outcomes. METHOD...
BACKGROUND: Monetary interventions, such as cash transfers, have emerged as important intervention approaches to address the complex determinants at the structural and individual level impacting diabetes outcomes. METHODS: This NIH funded (K01DK131319), pilot randomized controlled trial (RCT) is an ongoing 5 year study to evaluate the efficacy of two diabetes-tailored cash transfer interventions in low-income adults in which 1) cash transfers are conditional on participating in nurse-led, telephone-delivered diabetes education/skills training and stress/coping intervention delivered every 2 weeks for 6 months (DM-CCT); or 2) cash transfers are unconditional (DM-UCT), on clinical outcomes (HbA1c and blood pressure), and quality of life among 100 African Americans aged 18+ years with T2DM and HbA1c ≥8 %. Assessments will be conducted at baseline, 3-, and 6-months with primary outcome at 6 months post-randomization. DISCUSSION: Recruitment began in March 2023 and was completed in February 2024. Average age was 51 years. Most participants were women (71.0 %). Mean HbA1c was 10.1±1.8 for DM-CCT group and 10.2±1.8 for DM-UCT group. Mean systolic and diastolic blood pressure was 128.0±22.7 mmHg and 80.2±13.7 mmHg for DM-CCT group and 133.5±22.2 mmHg and 83.7±13.7 mmHg for DM-UCT group. Mean BMI was 36.2±10.3 kg/m for DM-CCT and 35.7±9.2 kg/m for DM-UCT. This pilot RCT represents a promising intervention to address the underlying poverty driven social risk factors while simultaneously addressing diabetes specific behaviors to improve outcomes. Findings from this study will provide preliminary evidence on efficacy of cash transfer interventions to improve clinical outcomes in low-income adults with poorly controlled T2DM.
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.
Riley TM, Weschenfelder C, Ravussin E … +9 more , Rood JC, Greenway F, Taff S, Hickner RC, Cao H, Sutin AR, Todd G, Hennigar SR, Berryman CE
Contemp Clin Trials · 2026 Jan · PMID 41314599 · Full text
BACKGROUND: 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 r...
BACKGROUND: 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. METHODS: Fifty adults with obesity (BMI: 30-39.9 kg/m) 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. DISCUSSION: 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. CLINICAL TRIAL REGISTRATION: Clinicaltrials.govNCT05289310.
Comparison of digital behavioral interventions to prevent alcohol misuse among adolescents ages 12 to 19: A randomized clinical trial protocol.
Bonar EE, Goldstick JE, Philyaw-Kotov ML … +8 more , Bourque CA, Woolford SJ, Resnicow K, Quigley J, Tzilos Wernette G, Ahmed S, Langlois DM, Walton MA
Contemp Clin Trials · 2026 Jan · PMID 41314598 · Publisher ↗
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 deli...
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.
Protocol of a randomized trial of acceptance and commitment therapy for patient fatigue interference and caregiver burden in advanced gastrointestinal cancer.
Mosher CE, Shinn EH, Addington EL … +10 more , Wu W, Bricker JB, Helft PR, Turk AA, Vater LB, Masood A, Jalal SI, Loehrer PJ, Champion VL, Johns SA
Contemp Clin Trials · 2026 Jan · PMID 41314597 · Full text
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...
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. Trial Registration ID: NCT06532877.
Protocol for a hybrid type 1 effectiveness-implementation study of mindfulness-based therapy for insomnia in Black women.
Nam S, Tong G, Iennaco J … +12 more , Humphries D, Ordway M, Lee M, Thompson S, Seguinot M, Morales F, Harriot K, Paris N, Bryant KA, Weidner K, Edwards T, Whittemore R
Contemp Clin Trials · 2026 Jan · PMID 41308952 · Full text
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. T...
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 (N = 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 (N = 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. TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT06348082.
Comparison of clopidogrel-based antiplatelet therapy versus warfarin as a secondary prevention strategy for AntiPhospholipid Syndrome-related STROKE (APS-STROKE): Rationale and design of a prospective, randomized, open-label, blinded-endpoint trial.
Yang W, Park HK, Koh SH … +35 more , Kim S, Kim Y, Jung KH, Kang HG, Choi JC, Kim HY, Nam HS, Jeong HS, Kim JT, Kim YS, Yu S, Cho KH, Song TJ, Heo SH, Cho HJ, Sohn SI, Chang Y, Park JM, Oh MS, Kim EG, Shin DI, Kim C, Lee J, Ahn SH, Lee YB, Shin JW, Kim BJ, Kim BJ, Park KY, Kwon HM, Jang H, Kim JM, Kim J, Lee SH, APS-STROKE investigators
Contemp Clin Trials · 2026 Jan · PMID 41308951 · Publisher ↗
BACKGROUND: Antiphospholipid syndrome (APS) is closely associated with ischemic stroke. However, optimal treatment for APS-related stroke remains unestablished, as current guidelines are based on outdated studies and exp...
BACKGROUND: Antiphospholipid syndrome (APS) is closely associated with ischemic stroke. However, optimal treatment for APS-related stroke remains unestablished, as current guidelines are based on outdated studies and expert opinion rather than high-quality clinical trials. Evidence on antiplatelet agents other than aspirin, such as clopidogrel, in APS-related stroke is particularly limited. Given the relatively young age of patients with APS and the burden of warfarin use, verifying its necessity is crucial. This study compares clopidogrel-based antiplatelet therapy and warfarin for secondary prevention in APS-related stroke. METHODS: APS-STROKE is an exploratory, multicenter, prospective, randomized, open, blinded-endpoint clinical trial. Adult patients with definite APS and a history of ischemic stroke or transient ischemic attack (TIA) will be included. Patients with high-risk APS (triple positivity or persistently high titers of anti-cardiolipin or anti-β2-glycoprotein I antibodies), systemic lupus erythematosus, or other major indications for continued antiplatelet or anticoagulant therapy will be excluded. Participants will be randomized 1:1 to receive clopidogrel-based antiplatelet therapy or warfarin. More than 200 patients are planned for inclusion across 32 stroke centers. The primary endpoint is a composite of any death, major adverse cardiovascular events, systemic thromboembolic events, and major bleeding during at least 4 years of follow-up. Secondary endpoints include major adverse cardiovascular events, ischemic stroke, any bleeding, major bleeding, intracranial bleeding, clinically relevant non-major bleeding, any death, and thrombosis-related death. CONCLUSION: This study will provide valuable information on the optimal secondary prevention strategy for APS-related stroke. TRIAL REGISTRATION: ClinicalTrials.gov: NCT05995600; CRIS: KCT0008900.
SMARTs with treatment preference: Pragmatic SMART design and methods motivated by STAR*D.
Medley S, Wank M, Tamura RN … +2 more , Braun TM, Kidwell KM
Contemp Clin Trials · 2026 Jan · PMID 41297854 · Publisher ↗
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, random...
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.
Protocol for a pilot RCT investigating a weight loss navigation program for adults.
Silverstein HI, Forman EM, Gilden AH … +4 more , Hagerman CJ, Milliron BJ, Zhang FZ, Butryn ML
Contemp Clin Trials · 2026 Jan · PMID 41297853 · Full text
Millions of adults in the U.S. with overweight or obesity would like to improve their health via weight loss, yet utilization of evidence-based weight loss interventions is low. Instead, adults commonly attempt self-guid...
Millions of adults in the U.S. with overweight or obesity would like to improve their health via weight loss, yet utilization of evidence-based weight loss interventions is low. Instead, adults commonly attempt self-guided weight loss, which has poor efficacy. When adults use evidence-based interventions (i.e., behavioral, dietary, commercial, surgical, and pharmacological options), long-term engagement is suboptimal. The proposed project is a pilot randomized clinical trial to test the use of patient navigators to increase uptake of and persistence with evidence-based weight loss interventions. Navigators have been successful in other areas of healthcare to facilitate engagement with various treatment and prevention services. However, little data are available on the feasibility, acceptability, or efficacy of a weight loss navigator program in adults. In the present study, participants (N = 68 adults with a BMI >27 kg/m2 interested in weight loss) will be randomly assigned for a 12-month period to either usual care or the navigator condition. Participants in usual care will have no intervention contact, while participants in the navigator condition will attend individual sessions and receive personalized emails from a navigator to support uptake and persistence with an evidence-based weight loss intervention. Assessments will be conducted remotely at months 0, 6, and 12. The primary outcome for the preliminary test of efficacy is weight change after 12 months. This study will inform future iterations of a weight loss navigator program and could impact clinical practice and public health by enhancing the utilization of evidence-based weight loss interventions.
Enhanced quality in primary care for elders with diabetes and dementia: Protocol for a multisite randomized controlled trial.
Adeyemi O, Christina W, Arcila-Mesa M … +6 more , Dickson VV, Ferris R, Tarpey T, Fletcher J, Blaum C, Chodosh J
Contemp Clin Trials · 2026 Jan · PMID 41297852 · Full text
BACKGROUND: The Enhanced Quality in Primary Care for Elders with Diabetes-ADRD (EQUIPED-ADRD) is a quality improvement and pragmatic cluster-randomized controlled trial that uses clinical decision guidelines to streamlin...
BACKGROUND: The Enhanced Quality in Primary Care for Elders with Diabetes-ADRD (EQUIPED-ADRD) is a quality improvement and pragmatic cluster-randomized controlled trial that uses clinical decision guidelines to streamline the care of older adults with diabetes mellitus and Alzheimer's disease/Alzheimer's disease-related Dementia (DM-AD/ADRD). This study tests whether the EQUIPED-ADRD intervention will increase the proportion of older adults with DM and AD/ADRD with desirable glycemic ranges, and reduce treatment burden, dementia severity, and healthcare utilization among participants and their care partners in the intervention arm compared to those in the control arm. METHODS: We will recruit older adults (≥65 years) with both DM and AD/ADRD diagnoses, who have care partners, and receive care at the enrolled New York University clinics. The intervention involves the use of panel managers to streamline the integration of clinical decision guidelines among primary care providers and improve the experiences of care partners and patients. Those in the control arm will have no panel management. We will conduct surveys and interviews, and extract data from EMR and Medicare claims to assess the association between the intervention and primary and secondary outcomes. The primary outcome is achieving within-range HbA1c, while the secondary outcomes include measures of healthcare utilization. Patient and care partner treatment burden, dementia symptoms, and care partner diabetes care distress. CONCLUSIONS: The EQUIPED-ADRD intervention (implemented between 2018 and 2021) will assess the effect of an institutional guideline on the quality of life and health outcomes of older adults with DM-AD/ADRD and their care partners. Clinical Trial NumberNCT03723707.
Agile by adaptive design: An algorithm for decentralized trials.
Bakar KS
Contemp Clin Trials · 2026 Jan · PMID 41297851 · Publisher ↗
Decentralized Clinical Trials (DCTs) represent a significant advancement in clinical research, offering greater accessibility, flexibility, and participant engagement through the use of telemedicine, mobile health techno...
Decentralized Clinical Trials (DCTs) represent a significant advancement in clinical research, offering greater accessibility, flexibility, and participant engagement through the use of telemedicine, mobile health technologies, and remote data capture. However, the decentralized nature of data collection introduces challenges related to data reliability and variability, which are often inadequately addressed by conventional statistical methods at the design stage of the trial. This study presents an agile Bayesian design framework tailored to the specific needs of DCTs, integrating adaptive data reliability directly into trial design and analysis. Our approach is based on Bayesian decision rules to guide interim sample size adjustments. By treating data reliability as a model parameter rather than an external factor, our method accounts for uncertainty and improves the robustness of power calculations. Simulation studies demonstrate the effectiveness of this strategy. The proposed framework enables a flexible and agile approach to DCT design that can adapt to varying data quality conditions. This work offers a foundation for extending the proposed adaptive method to other trial contexts, including time-to-event endpoints, and supports the broader adoption of DCTs in real-world clinical research.
Evaluating effectiveness and engagement strategies for asynchronous, messaging, trauma-focused therapy for posttraumatic stress disorder: Study design and methodology for a hybrid effectiveness-implementation randomized controlled trial.
Dondanville KA, Calloway A, Stade EC … +11 more , Hull TD, Jo B, Huang SC, Hall-Clark BN, LoSavio ST, Schuhmann B, Elhusseini S, Fridling-Cook N, Pattee C, Padmanabhan A, Stirman SW
Contemp Clin Trials · 2026 Jan · PMID 41270826 · Publisher ↗
Posttraumatic stress disorder (PTSD) can be a chronic and debilitating condition with significant individual and societal costs. Despite the availability of effective, trauma-focused treatments like Cognitive Processing...
Posttraumatic stress disorder (PTSD) can be a chronic and debilitating condition with significant individual and societal costs. Despite the availability of effective, trauma-focused treatments like Cognitive Processing Therapy (CPT), access and sustained engagement remain limited due to logistical, financial, and stigma-related barriers. The current study utilized a hybrid effectiveness-implementation randomized control trial (N = 300) to evaluate the clinical effectiveness and feasibility of CPT-Text, an asynchronous, therapist-delivered messaging version of CPT, compared to culturally informed treatment-as-usual (CI-TAU) delivered via secure text on the Talkspace platform. Participants were also randomized to receive either standard engagement reminders (RAU) or a novel engagement incentive (RAU + I), which encourages altruism by offering participants the opportunity to "pay forward" credits for free therapy to another PTSD-affected individual through their continued participation. Primary outcomes include PTSD symptom severity (PCL-5) and engagement (e.g., treatment completion and messaging frequency), with secondary outcomes assessing depression, functioning, satisfaction, substance use. We hypothesize that CPT-Text will outperform CI-TAU in symptom reduction, and that RAU + I will enhance engagement and outcomes. Exploratory analyses will examine individual-level moderators and motivation as a mechanism of change. A novel component of this trial includes development of a large language model-based fidelity assessment tool for CPT-Text, allowing scalable evaluation of treatment delivery. Findings will inform scalable, effective, and accessible PTSD interventions that meet the needs of individuals underserved by traditional mental health care, and provide insight into how human-delivered, technology-mediated therapy can be both clinically robust and broadly accessible. Evaluating Asynchronous Messaging Therapy for PTSD.
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.
Rabinak CA, Kilgore PE, Lumley MA … +1 more , Rauch SAM
Contemp Clin Trials · 2026 Jan · PMID 41270825 · Full text
BACKGROUND: Prolonged exposure (PE) therapy is effective for PTSD, yet dropout and partial response remain concerning. Preclinical and human studies suggest Δ-tetrahydrocannabinol (THC) enhances fear extinction and recal...
BACKGROUND: Prolonged exposure (PE) therapy is effective for PTSD, yet dropout and partial response remain concerning. Preclinical and human studies suggest Δ-tetrahydrocannabinol (THC) enhances fear extinction and recall through brain cannabinoid receptor activation in fear processing. OBJECTIVE: Examine whether synthetic THC (dronabinol) augments PE effectiveness. DESIGN: Double-blind, placebo-controlled, trial with treatment-seeking PTSD patients (ages 18-60) randomized to 7.5 mg THC (n = 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. SETTING: Wayne State University with remote PE delivery via Emory University. PARTICIPANTS: Adults with PTSD (CAPS-5 ≥ 25) excluding for severe mental illness, substance use disorders, or contraindications to THC. INTERVENTIONS: PE therapy (10 sessions, up to 3 times / week) with THC or placebo administered 120 min before sessions to coincide with peak plasma levels. MAIN OUTCOMES: 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. STATISTICAL ANALYSIS: 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. DISCUSSION: 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. TRIAL REGISTRATION: ClinicalTrials.govNCT04080427.
Improving CDK4/6 inhibitors adherence in breast cancer using the CONnected CUstomized Treatment Platform (CONCURxP) mobile health intervention: Study protocol for ECOG-ACRIN EAQ221CD.
Sadigh G, Duan F, Gareen IF … +10 more , Hancock J, Sicks JD, Thangarajah M, Meisel JL, Torres MA, Ramsey SD, Wolff AC, Wagner LI, Carlos RC, Graetz I
Contemp Clin Trials · 2026 Jan · PMID 41265834 · Full text
BACKGROUND: Cyclin-dependent kinase 4/6 inhibitors (CDKIs) improves survival when added to endocrine therapy in hormone receptor-positive (HR+), human epidermal growth factor receptor 2-negative (HER2-) breast cancer. Ho...
BACKGROUND: Cyclin-dependent kinase 4/6 inhibitors (CDKIs) improves survival when added to endocrine therapy in hormone receptor-positive (HR+), human epidermal growth factor receptor 2-negative (HER2-) breast cancer. However, their complex schedule, side effects, and cost contribute to non-adherence. METHODS: The EAQ221CD is a two-arm randomized controlled trial that evaluates the effectiveness of the CONnected CUstomized Treatment Platform (CONCURxP), a mobile health intervention, versus enhanced usual care (EUC) on CDKI adherence among 390 patients with breast cancer and a new CDKI prescription. Participants use a smart pouch (Wisebag) to monitor real-time adherence. CONCURxP arm patients: (1) receive text reminders for missed or extra doses; (2) receive text message surveys inquiring reasons for missed or extra doses; and (3) have access to their adherence history on a study web portal. Missed or double doses trigger alerts to the oncology team. Patients citing cost as a barrier are referred to a national non-profit financial navigation program. EUC arm patients receive educational materials on side effect management. Patients complete surveys at baseline, 3, 6, and 12 months after randomization. Our objectives are to: (1) compare 12-month CDKI adherence measured using Wisebag (primary outcome) between the two arms; (2) compare patient-reported outcomes at 12-months between the two arms, including symptom burden, quality of life, patient-provider communication, self-efficacy for managing symptoms, and financial worry; and (3) use mixed methods to describe patients' experience with the CONCURxP intervention. Our multilevel intervention will provide actionable results to improve adherence, health outcomes, and patients' experience. TRIAL REGISTRATION: NCT06112613.
Rationale for the Feasibility and Acceptability of Smartwatch Technology in an Exercise Regimen (FASTER) study in older individuals.
Hauben J, Luthy J, Nafiu T … +8 more , Brengartner A, Omar M, Nemati D, Zhao S, Brock G, Urse K, Paro J, Joseph JJ
Contemp Clin Trials · 2026 Jan · PMID 41265833 · Publisher ↗
BACKGROUND: 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 smartwat...
BACKGROUND: 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. METHODS: 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. SETTING: Ambulatory care clinics affiliated with a medical center and community centers in Central Ohio. DESIGN: Single-arm pilot study. INTERVENTIONS: 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. OUTCOMES: 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. DISCUSSION: Incorporating wearable smartwatch technology into a physician referral exercise program may be a novel way to improve physical activity and health in older adults. CLINICAL TRIAL REGISTRATION NUMBER: NCT06287255.
Food-Body-Mind study protocol: A mindfulness-based lifestyle intervention to promote whole child health among preschoolers from economically marginalized families.
Ling J, Kao TA, Robbins LB … +7 more , Wahman CL, Kerver JM, Resnicow K, Zhang N, Lalonde H, Xie Y, Baumgartner J
Contemp Clin Trials · 2026 Jan · PMID 41265832 · Full text
Socioeconomic, racial/ethnic, and urban/rural disparities in mental, emotional, behavioral, and physical health are evident among U.S. preschoolers. To reduce these disparities, we plan to test our Food-Body-Mind interve...
Socioeconomic, racial/ethnic, and urban/rural disparities in mental, emotional, behavioral, and physical health are evident among U.S. preschoolers. To reduce these disparities, we plan to test our Food-Body-Mind intervention with preschoolers from racially/ethnically diverse, low-income, urban, and rural areas. The aims of the study are to determine the effects of the intervention on improving preschoolers' behavioral (primary outcome is problem behaviors), mental, emotional, and anthropometric health outcomes, as well as their caregivers' mental and cardiometabolic health from baseline to post-intervention to 12-month (Month 16) follow-up. Additionally, we will explore potential mediators (e.g., caregiver mindfulness, physical activity [PA], fruit/vegetable [F/V] intake, caregiver-preschooler relationship, caregiver coping, home environment, and household food insecurity) of the intervention effects. This cluster randomized controlled trial will include 50 daycare centers assigned to intervention (25 centers) or control (25 centers) conditions using a covariate-constrained randomization approach. A total of 400 (on average 8 per center) caregiver-preschooler dyads will be enrolled from 2024 to 2027. The 16-week mindfulness-based intervention includes three components: 1) school-based mindful eating and movement learning for preschoolers; 2) a home-based caregiver skill training on practicing mindful eating, movement, and parenting behaviors at home; and 3) a bridge between school and home in mindfulness learning and practice. Linear mixed-effect models will be used to determine the intervention effects, and structural equation modeling will be performed to examine potential mediators. Trial registration number:NCT06597474.
Combination Therapy of Resilience Intervention with Biologics in Crohn's Disease (CATHARSIS): Study protocol for a randomized controlled trial.
Keefer L, Ungaro R, Lewis A … +7 more , Lee J, de Amorrortu C, Lores T, Siganporia T, Mehandru S, Petralia F, Colombel JF
Contemp Clin Trials · 2026 Jan · PMID 41260461 · Publisher ↗
BACKGROUND: Remission rates in Crohn's disease (CD) with standard therapies have plateaued in recent decades. There is a need to investigate more innovative strategies to raise the "therapeutic ceiling". Combining orthog...
BACKGROUND: Remission rates in Crohn's disease (CD) with standard therapies have plateaued in recent decades. There is a need to investigate more innovative strategies to raise the "therapeutic ceiling". Combining orthogonal treatments that target differing pathways of disease pathogenesis may maximize synergistic therapeutic efficacy. In particular, the addition of interventions that target the gut-brain axis warrant investigation. Our overarching goal is to demonstrate the value of a new "combination therapy" that addresses psychological and physical health simultaneously, targeting the gut-brain axis, to improve CD outcomes. We will test the efficacy of combining brain-gut behavior therapy with biologic treatment in a randomized, controlled clinical trial, following behavioral clinical trial guidelines for gastroenterology. METHODS: We will recruit 170 adults with CD aged between 18 and 80 years starting an anti-tumor necrosis factor or anti-interleukin-23 medication. Participants will be randomized in a 1:1 ratio to receive a program of either brain-gut behavioral therapy (intervention group) or emotional support (time and attention control group). Both programs consist of seven sessions within a 12-week period. Patient-reported outcomes including well-being and disease activity will be measured at weeks 0, 12, 24, 36, and 52, with the primary outcomes reflected at week 24. Outcomes will be evaluated for group X time interactions. CONCLUSIONS: This trial will be the first of its kind to rigorously evaluate the efficacy of a treatment approach that combines brain-gut behavioral therapy and biologics for people with CD.
Increasing timely colonoscopy surveillance for patients with high-risk colorectal polyps: Protocol for a cluster randomized trial.
May FP, McEwan JA, Tuan JJ … +17 more , Crespi CM, Maehara CK, Yang JO, Uy A, Gupta S, Kang Y, Myint A, Naini BV, Elmore JG, Kadiyala S, Ong MK, Bui AAT, Hamilton AB, Chang LC, Gelvezon A, Hsu W, Bastani R
Contemp Clin Trials · 2026 Jan · PMID 41260460 · Publisher ↗
INTRODUCTION: Colorectal cancer (CRC) is largely preventable through the removal of precancerous polyps from the colon and rectum. Polyp surveillance guidelines recommend that individuals with polyps categorized as high-...
INTRODUCTION: Colorectal cancer (CRC) is largely preventable through the removal of precancerous polyps from the colon and rectum. Polyp surveillance guidelines recommend that individuals with polyps categorized as high-risk neoplasia (HRN) undergo surveillance colonoscopy 3 years after HRN diagnosis. However, over half of patients fail to receive their surveillance colonoscopy within this recommended timeframe, highlighting the need for effective interventions to improve 3-year colonoscopy surveillance rates. METHODS: A hybrid type 1 effectiveness-implementation, 2-group cluster-randomized trial is being conducted at 30 primary health care clinics in a large, urban academic health center in Southern California. The study includes two arms: (1) a multilevel intervention arm in which a natural language processing (NLP) algorithm processes electronic health record (EHR) data to facilitate the identification of patients with HRN and providers and patients receive electronic notification when surveillance colonoscopy is due; and (2) a usual care arm, where no intervention is applied. RESULTS: The primary outcome will be completion of surveillance colonoscopy within 3.5 years of the HRN diagnosis. The secondary outcome will be time from the HRN diagnosis to completion of surveillance colonoscopy. CONCLUSIONS: This study evaluates the effectiveness of a multilevel health system intervention designed to improve adherence to surveillance colonoscopy guidelines for patients with a history of high-risk colorectal polyps. The findings are expected to offer valuable insights into strategies for leveraging EHR-informed algorithms to increase surveillance rates and improve CRC outcomes. TRIAL REGISTRATION: NCT06376565.
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