Contemporary clinical trials最新文献

{"title":"Multi-site feasibility and fidelity of remote yoga intervention to improve management of type-2 diabetes: Design and methods of the HA1C (healthy active and in control) study","authors":"Herpreet Thind ,&nbsp;Dorothy Pekmezi ,&nbsp;Shira Dunsiger ,&nbsp;Kate M. Guthrie ,&nbsp;Laura Stroud ,&nbsp;Wen-Chih Wu ,&nbsp;Kristen Walaska ,&nbsp;Beth C. Bock","doi":"10.1016/j.cct.2025.107842","DOIUrl":"10.1016/j.cct.2025.107842","url":null,"abstract":"<div><h3>Introduction</h3><div>Diabetes is a leading cause of death in the United States placing tremendous burden on individuals and the health care system. Yoga could be an attractive option for adults with diabetes with potential benefits for glycemic control and stress reduction.</div></div><div><h3>Methods</h3><div><em>Healthy Active and In Control</em> is a study examining multi-site fidelity and feasibility of remote yoga compared to standard exercise intervention for diabetes management. Adults (N = ∼30 per site) with type II diabetes (T2DM), are recruited from three sites and randomized to receive either a 12-week program of yoga or standard exercise. The yoga intervention is delivered remotely via zoom twice weekly. Participants in the standard exercise group engage in self-paced aerobic exercise with weekly staff check-in. Assessments are conducted at enrollment, end of treatment (week 12), and at 3- and 6-months post-intervention. The primary aim is to assess whether intervention components can be delivered with fidelity across the three sites. Feasibility and acceptability of the yoga and exercise interventions are compared. Data on biological (HbA1c), behavioral (e.g., physical activity, diabetes self-care behaviors), and psychological factors (e.g., mindfulness, diabetes distress) related to diabetes management are also explored along with factors associated with yoga and exercise adherence.</div></div><div><h3>Conclusion</h3><div>This study uses rigorous methodology to establish the feasibility and acceptability of remote-delivered yoga for individuals with T2DM from diverse populations and to assess whether the remote intervention can be delivered with fidelity across sites in preparation for a future multisite efficacy trial.</div></div>","PeriodicalId":10636,"journal":{"name":"Contemporary clinical trials","volume":"151 ","pages":"Article 107842"},"PeriodicalIF":2.0,"publicationDate":"2025-02-10","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143406181","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":"Brief computer MI to motivate sustained tobacco cessation following psychiatric hospital discharge: Study protocol for a randomized controlled trial","authors":"Richard A. Brown ,&nbsp;Abigail Winskowicz ,&nbsp;David H. Johnson ,&nbsp;Jacki Hecht ,&nbsp;Jason Shumake ,&nbsp;Kelly M. Carpenter ,&nbsp;Julie Farrington ,&nbsp;Jasper A.J. Smits","doi":"10.1016/j.cct.2025.107841","DOIUrl":"10.1016/j.cct.2025.107841","url":null,"abstract":"<div><h3>Background</h3><div>Individuals with serious mental illness (SMI) smoke at disproportionately higher rates than those without SMI. We demonstrated, in a randomized controlled trial (RCT) of 342 adult smokers receiving inpatient psychiatric care, that an in-person, motivational interviewing (MI)-based, Sustained Care (SusC) intervention vs. Usual Care (UC) resulted in significantly higher rates of confirmed smoking abstinence at 6-months post-hospital discharge and significantly increased smoking cessation treatment utilization. While successful, this SusC intervention would be challenging to implement broadly in psychiatric hospitals. The current efficacy trial will develop and test an MI-based Sustained Care intervention delivered as a mobile app for iPad and will determine whether this approach can produce higher cessation rates compared to usual care for smokers admitted to a psychiatric inpatient unit.</div></div><div><h3>Methods</h3><div>A total of 250 eligible patients hospitalized for psychiatric illness will be randomized to: Tablet-delivered Sustained Care (T-SusC) or Usual Care (UC), and will be followed for six months after discharge. Participants assigned to UC will receive brief, in-hospital tobacco education. Those assigned to T-SusC will receive the brief tobacco education, plus a 40-min, in-hospital MI intervention delivered via a mobile application (app) for iPad use. They will also receive up to 8 weeks of free nicotine patches and a referral to the Texas Tobacco Quitline. Smoking cessation outcomes will be measured at 1-, 3- and 6-months post hospital discharge.</div></div><div><h3>Conclusion</h3><div>Results from this efficacy trial may add to our understanding of acceptable and effective smoking cessation approaches for patients hospitalized with SMI.</div></div>","PeriodicalId":10636,"journal":{"name":"Contemporary clinical trials","volume":"151 ","pages":"Article 107841"},"PeriodicalIF":2.0,"publicationDate":"2025-02-10","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143406175","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":"Comparative effectiveness of two-way caring contacts texts vs one-way caring contacts texts vs enhanced usual care to reduce suicidal behavior in adolescents and adults: Protocol for the SPRING pragmatic randomized controlled trial","authors":"Anna K. Radin ,&nbsp;Siobhan P. Brown ,&nbsp;Jenny Shaw ,&nbsp;Tara Fouts ,&nbsp;Elizabeth McCue ,&nbsp;Anton Skeie ,&nbsp;Hailey Pierce ,&nbsp;Hilary Flint ,&nbsp;Matthew Biss ,&nbsp;Daniel Sandoval ,&nbsp;Katrina Chase ,&nbsp;Jessi Davis ,&nbsp;George Austin ,&nbsp;Kwun C.G. Chan ,&nbsp;Martina Fruhbauerova ,&nbsp;Anna Ratzliff ,&nbsp;Michael Walton ,&nbsp;Jason Bronner ,&nbsp;Phoebe K. McCutchan ,&nbsp;Katherine Anne Comtois","doi":"10.1016/j.cct.2025.107839","DOIUrl":"10.1016/j.cct.2025.107839","url":null,"abstract":"<div><h3>Background</h3><div>Suicide is a leading cause of death in US adolescents and adults. Caring Contacts — non-demanding messages of care and support — can significantly reduce suicide risk, but important implementation questions remain. Two-way Caring Contacts texts (CC2) (to which recipients can reply) have evidence of efficacy, but in practice health systems typically send one-way Caring Contacts texts (CC1) (to which recipients cannot reply). This manuscript describes the protocol for the Comparing Suicide Prevention Interventions to Guide Follow-up Care (SPRING) Trial.</div></div><div><h3>Methods</h3><div>The SPRING Trial is a pragmatic randomized controlled trial designed to compare the effectiveness of CC2 and CC1 versus UC, and to determine whether CC1 are noninferior to CC2 for preventing suicidal behavior. The sample includes 849 participants 12 years or older who screen positive for suicide risk and receive usual care at a primary care or behavioral health clinic. Participants are randomized 1:1:1 to CC2, CC1, or UC, with participants unaware of the alternative treatments. The state 988 crisis and suicide hotline delivers both active interventions and the feasibility of this model will be described. The primary outcome is suicidal behavior, measured using the Harkavy-Asnis Suicide Scale (HASS). Secondary outcomes include suicide attempts, suicidal ideation, ED utilization, hospitalization, and outpatient mental health treatment. Outcomes are assessed via surveys at baseline, 3, 6, and 12 months.</div></div><div><h3>Discussion</h3><div>CC2 is more operationally complex than CC1. If CC1 is non-inferior to CC2, it could more feasibly be implemented at scale, increasing access to effective suicide prevention care.</div><div><strong>Clinical trial registration</strong></div><div>The SPRING Trial is registered at ClinicalTrials.gov (NCT06128239).</div></div>","PeriodicalId":10636,"journal":{"name":"Contemporary clinical trials","volume":"151 ","pages":"Article 107839"},"PeriodicalIF":2.0,"publicationDate":"2025-02-10","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143406177","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":"Treating seizures faster: The quality improvement in time to treat status epilepticus (QuITT-SE) multicenter randomized stepped wedge clinical trial protocol","authors":"Adam P. Ostendorf ,&nbsp;Tobias Loddenkemper ,&nbsp;Lindsey A. Morgan ,&nbsp;Brian Appavu ,&nbsp;Raquel Farias-Moeller ,&nbsp;Dana Harrar ,&nbsp;Craig Press ,&nbsp;Nicholas S. Abend ,&nbsp;William D. Gaillard ,&nbsp;Shasha Bai ,&nbsp;Mariah Eisner ,&nbsp;Lauren McHenry ,&nbsp;Emily Kroshus ,&nbsp;Kathryn Vannatta ,&nbsp;Howard P. Goodkin","doi":"10.1016/j.cct.2025.107831","DOIUrl":"10.1016/j.cct.2025.107831","url":null,"abstract":"<div><h3>Background</h3><div>Acute seizures may evolve into status epilepticus (SE), prolonged and self-sustaining seizures that may result in brain injury or death. Rapid treatment with a benzodiazepine (BZD) is most effective. However, SE treatment remains delayed in many cases. We previously performed a single-center quality improvement study which resulted in more rapid treatment, decreased intensive care utilization, and decreased cost. Now, we are conducting a multicenter trial to test the hypothesis that pragmatic changes in treating acute inpatient seizures reduce time and are implementable across diverse hospital settings.</div></div><div><h3>Methods/Design</h3><div>We designed a multicenter stepped wedge cluster randomized trial with three unidirectional 12-month steps following one baseline step. After dissemination visits, sites will attempt to implement a standardized bundle consisting of: (1) standardize default BZD to non-IV; (2) target treatment time within 10 min; (3) relocate and bundle items for BZD administration to a single location; (4) prioritize basic seizure first aid as initial assessment; (5) implement SE-specific documentation templates; (6) implement multidisciplinary site QI teams. Our primary outcome is median time from seizure diagnosis to BZD administration. Secondary outcomes are median changes in Pediatric Cerebral Performance Category score, ICU transfer rate, and cost of hospitalization. We will study implementation outcomes using mixed methods based on the Reach, Effectiveness, Adoption, Implementation, Maintenance (RE-AIM) framework.</div></div><div><h3>Discussion</h3><div>QuITT-SE is designed to test the effect and implementation of a pragmatic set of interventions on treatment times in SE. If successful, results will provide a generalizable roadmap for broad implementation through healthcare systems that should improve outcomes in SE.</div><div><strong>Trial registration:</strong> <span><span>Clinicaltrials.gov</span><svg><path></path></svg></span> (NCT06194747). Funded by the National Institutes of Health (R01NS133037).</div></div>","PeriodicalId":10636,"journal":{"name":"Contemporary clinical trials","volume":"151 ","pages":"Article 107831"},"PeriodicalIF":2.0,"publicationDate":"2025-02-08","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143387539","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":"Evaluation of the efficacy and safety of a novel xanthine oxidase inhibitor, tigulixostat, in gout patients with hyperuricemia: Design of the EURELIA 1 and EURELIA 2 studies","authors":"Kenneth G. Saag ,&nbsp;Nicola Dalbeth ,&nbsp;Chi-yuan Hsu ,&nbsp;Chang-Fu Kuo ,&nbsp;George Nuki ,&nbsp;Fernando Perez-Ruiz ,&nbsp;William B. White ,&nbsp;Ali Hariri ,&nbsp;Yunjung Lee ,&nbsp;Younghwan Jang ,&nbsp;Song Han ,&nbsp;Hyon K. Choi","doi":"10.1016/j.cct.2025.107843","DOIUrl":"10.1016/j.cct.2025.107843","url":null,"abstract":"<div><h3>Background</h3><div>Gout is a chronic disease of monosodium urate crystal deposition caused by elevated serum urate (SU). Gout may progress from acute episodic attacks to a disabling chronic deforming arthropathy. Allopurinol and febuxostat are the most widely prescribed urate-lowering drugs, however, these agents have potential adverse events and are seldom titrated to achieve a target SU level. Tigulixostat is a novel non-purine selective xanthine oxidase inhibitor for gout with hyperuricemia which has demonstrated potent <em>in vitro</em> and <em>in vivo</em> urate lowering activity and is being further investigated in humans for regulatory approvals.</div></div><div><h3>Methods</h3><div>The Phase 3 program for tigulixostat consists of two clinical trials: EURELIA 1 and EURELIA 2. EURELIA 1 is a randomized, multi-regional, double-blind, parallel-group, placebo-controlled study to assess the safety and efficacy of 6 months of tigulixostat (100, 200, or 300 mg) in gout patients with hyperuricemia (<em>n</em> = 350).</div><div>EURELIA 2 is a randomized, multi-regional, double-blind, double-dummy, parallel-group, active comparator (allopurinol titrated up to 800 mg) and placebo-controlled study to assess the safety and efficacy of tigulixostat (100, 200, or 300 mg) up to 12 months in gout patients with hyperuricemia (<em>n</em> = 2542).</div><div>The primary endpoint for both studies is to determine the proportion of patients with SU levels &lt;6.0 mg/dL sustained at for 3 months (Months 4, 5, and 6).</div></div><div><h3>Conclusions</h3><div>EURELIA 1 and EURELIA 2 studies will be able to adequately determine the efficacy and safety of tigulixostat compared to both placebo and allopurinol.</div></div><div><h3>Trial registration number</h3><div>For EURELIA 1, the <span><span>clinicaltrials.gov</span><svg><path></path></svg></span> identifier is <span><span>NCT05586958</span><svg><path></path></svg></span>. For EURELIA 2, the <span><span>clinicaltrials.gov</span><svg><path></path></svg></span> identifier is <span><span>NCT05586971</span><svg><path></path></svg></span> and the EU CT number is 2022–501421–20-00. The sponsor for both trials is LG Chem, Ltd. (Seoul, South Korea).</div></div>","PeriodicalId":10636,"journal":{"name":"Contemporary clinical trials","volume":"151 ","pages":"Article 107843"},"PeriodicalIF":2.0,"publicationDate":"2025-02-08","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143390230","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":"Promoting daily engagement in meaningful activity (DEMA) for people with cognitive impairment and their caregivers: Protocol for a randomized clinical trial","authors":"Amy J. Katz ,&nbsp;Pei-Shiu Chang ,&nbsp;Sujuan Gao ,&nbsp;Liana G. Apostolova ,&nbsp;Richard T. Passey ,&nbsp;Ziyi Yang ,&nbsp;Dane Ceniza ,&nbsp;Yvonne Lu","doi":"10.1016/j.cct.2025.107836","DOIUrl":"10.1016/j.cct.2025.107836","url":null,"abstract":"<div><h3>Background</h3><div>Nearly one-third of older American adults have cognitive impairment (mild cognitive impairment or subjective cognitive decline). Cognitive impairment (CI) has an extraordinary impact on older adults, caregivers (CG), and society. Deteriorating life satisfaction in persons with CI (PwCI) and their primary CG is a prevalent problem. However, there is a paucity of research on a strength-based, positive health approach, and supportive care for PwCI and their CG.</div></div><div><h3>Objectives</h3><div>The promoting re-engagement in meaningful activity (PRIMA) study is a randomized controlled trial to test the efficacy of the Daily Engagement in Meaningful Activity (DEMA) intervention for PwCI and their CGs. The primary aim is to test DEMA's efficacy for improving life satisfaction in PwCI and their CGs over time. The second aim evaluates how the intervention improves activity performance, decreases depressive symptoms and anxiety in PwCI and CGs, and reduces CG burden over time. The third aim is to explore the treatment's efficacy among a sub-sample of PwCIs with (and without) depressive symptoms (Patient Health Questionnaire (PHQ)-9 ≥ 5 at baseline) for improvement in health outcomes over time.</div></div><div><h3>Methods</h3><div>The study population consists of dyads, a PwCI and their CG. The PwCI must be 60 years old and have CI. A total of 200 PwCI-CG dyads will be randomized to the DEMA or attention control group. Outcome assessments are conducted over 9-months (baseline, 10 days-, 3- and 6- months post-intervention).</div></div><div><h3>Discussion</h3><div>The DEMA results will inform care for the broader PwCI and CG population in community and home-based settings.</div></div>","PeriodicalId":10636,"journal":{"name":"Contemporary clinical trials","volume":"151 ","pages":"Article 107836"},"PeriodicalIF":2.0,"publicationDate":"2025-02-08","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143390231","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":"Disease progression trajectory curves to estimate saved time in Alzheimer's disease trials","authors":"Guogen Shan ,&nbsp;Yahui Zhang ,&nbsp;Zhixin Tang ,&nbsp;Guoqiao Wang ,&nbsp;Samuel S. Wu","doi":"10.1016/j.cct.2025.107814","DOIUrl":"10.1016/j.cct.2025.107814","url":null,"abstract":"<div><div>With the recent successful disease-modifying therapies against Alzheimer's disease (AD), there have been discussions on easily interpretable measures for treatment effects. Among them, saved time for patients treated with a new drug as compared to patients randomized to the placebo group offers easier interpretation than the reduced percentage in outcome decline at last visit which were commonly used in AD trials. The existing method to calculate saved time utilized the disease progression trajectory of the placebo group and the treatment effect at the last visit. We propose to develop two new methods that use disease progression trajectories of both groups: (1) slope adjusted method; and (2) area under the curve method. We used data from the two donanemab trials and the donepezil trial to illustrate the application of the proposed methods and conducted simulation studies to compare these methods. When a drug has a constant treatment effect over time or early and middle difference in the disease progression, the area under the curve method often has the saved time being longer than the existing method. When the treatment effect is an increasing function of time before the last visit as observed in disease-modifying therapy trials, the slope adjusted method could have a larger saved time as compared to the existing method. In many cases, the area under the curve method often has the smallest standard deviation of saved time.</div></div>","PeriodicalId":10636,"journal":{"name":"Contemporary clinical trials","volume":"151 ","pages":"Article 107814"},"PeriodicalIF":2.0,"publicationDate":"2025-02-07","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143381767","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":"Remote clinical trial to test mechanisms of ‘practice quitting’ treatment: Trial design and methodological report","authors":"Amanda R. Mathew ,&nbsp;Breeann Lynae Hatten ,&nbsp;Maritza Esqueda-Medina ,&nbsp;Karisa Gramajo ,&nbsp;Chen Yeh ,&nbsp;Elizabeth F. Avery ,&nbsp;Sumihiro Suzuki ,&nbsp;Karen Cropsey ,&nbsp;Matthew J. Carpenter","doi":"10.1016/j.cct.2025.107832","DOIUrl":"10.1016/j.cct.2025.107832","url":null,"abstract":"<div><h3>Background</h3><div>Tobacco use disorder is a chronic, relapsing health condition that necessitates a chronic care approach. However, there are limited treatment strategies relevant to individuals who smoke across a continuum of motivation to quit. Further, there is no clear understanding of the mechanisms underlying treatment strategies to engage individuals who are not yet ready to quit smoking.</div></div><div><h3>Methods</h3><div>The current study will enroll 780 individuals who smoke and are unmotivated to quit within the next month through a nationwide remote clinical trial (NCT 05513872). Participants are randomized to receive Practice Quitting or Motivational Interviewing counseling, with or without Nicotine Replacement Therapy product sampling. The primary outcome is incidence of an attempt to quit by 6 months post-treatment. The analytic strategy will examine treatment effects on quit attempts and smoking cessation, along with hypothesized treatment mediators to determine mechanisms of treatment outcomes.</div></div><div><h3>Conclusion</h3><div>Individuals who are not yet ready to quit smoking are a critical group to target in population health management efforts for smoking cessation. We discuss key methodological considerations relevant to the design of future remote and mechanistic clinical trials for smoking cessation.</div></div>","PeriodicalId":10636,"journal":{"name":"Contemporary clinical trials","volume":"151 ","pages":"Article 107832"},"PeriodicalIF":2.0,"publicationDate":"2025-02-07","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143381770","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Study protocol of a hybrid type 1 effectiveness-implementation multisite trial: Dialectical behavior therapy skills group for Veterans at high-risk for suicide attempt","authors":"Suzanne E. Decker ,&nbsp;Aimee Kroll-Desrosiers ,&nbsp;Kristin M. Mattocks ,&nbsp;Frances M. Aunon ,&nbsp;Elizabeth Galliford ,&nbsp;Eric C. DeRycke ,&nbsp;Neal Doran ,&nbsp;Scarlett Baird ,&nbsp;Jennifer K. Rielage ,&nbsp;Josephine Ridley ,&nbsp;Jenny Bannister ,&nbsp;Thorayya S. Giovannelli ,&nbsp;Brian S. Fuehrlein ,&nbsp;Chris Shriver ,&nbsp;Ethan Spana ,&nbsp;Mark Honsberger ,&nbsp;Stacey A. Demirelli ,&nbsp;Elena Shest ,&nbsp;Sara J. Landes ,&nbsp;Marianne Goodman ,&nbsp;Steve Martino","doi":"10.1016/j.cct.2025.107828","DOIUrl":"10.1016/j.cct.2025.107828","url":null,"abstract":"<div><h3>Background</h3><div>Veterans of the United States Armed Forces are at disproportionately high risk for suicide death, requiring indicated strategies to mitigate that risk. Dialectical Behavior Therapy (DBT) is effective for reducing suicide attempts in individuals with emotional dysregulation and repeat suicidal behaviors or self-directed violence, but is a comprehensive, multi-component, resource-intensive treatment. A more resource-efficient component of DBT, the DBT Skills Group as an adjunctive treatment, with therapist consultation team (DBT-SG), has been shown to be as efficacious as comprehensive DBT in non-veteran samples, but its effectiveness and factors affecting its implementation have not been studied in the Veterans Health Administration (VHA). This research aims to assess the effectiveness of DBT-SG among high-risk veterans with recent and repeated suicide attempts and emotion dysregulation while systematically evaluating implementation barriers and facilitators.</div></div><div><h3>Methods</h3><div>This hybrid type 1 effectiveness-implementation study will evaluate DBT-SG effectiveness among veterans at high-risk for suicide attempt with emotion dysregulation using a randomized controlled trial of 18 months duration. Study conditions are 24-session DBT-SG plus full-spectrum VHA mental health treatment-as-usual (TAU), or VHA TAU. Outcomes are assessed at 3-, 6-, 12-, and 18-months post-randomization. Before, during, and after the effectiveness trial, implementation determinants of DBT-SG as an adjunctive treatment in VHA will be assessed using a mixed methods evaluation grounded in the Integrated Promoting Action on Research Implementation in Health Services (i-PARIHS) framework.</div></div><div><h3>Conclusions</h3><div>This study will provide evidence for DBT-SG effectiveness for veterans at high risk for suicide and information about barriers and facilitators to support more widespread facilitation of implementing adjunctive DBT-SG in VHA if it is found effective.</div><div>Clinical trials registration: <span><span>NCT05000749</span><svg><path></path></svg></span></div></div>","PeriodicalId":10636,"journal":{"name":"Contemporary clinical trials","volume":"151 ","pages":"Article 107828"},"PeriodicalIF":2.0,"publicationDate":"2025-02-07","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143381773","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":"Evaluation of risk stratification and problem management plus (PM+) for pregnant women with HIV in Kenya (Tatua study): Protocol paper","authors":"Anna Helova ,&nbsp;Maricianah Onono ,&nbsp;Mercelline Ogolla-Onyando ,&nbsp;Emmah Ouma ,&nbsp;Rabbia Imran ,&nbsp;Laura K. Beres ,&nbsp;Karen Hampanda ,&nbsp;Kevin Owuor ,&nbsp;Jeff M. Szychowski ,&nbsp;Linnet Ongeri ,&nbsp;Lisa L. Abuogi ,&nbsp;Janet M. Turan","doi":"10.1016/j.cct.2025.107838","DOIUrl":"10.1016/j.cct.2025.107838","url":null,"abstract":"<div><h3>Background</h3><div>While many pregnant and postpartum women with HIV (PPWH) in the African Region successfully engage in HIV care, a substantial number still face significant barriers, including poor mental health and HIV stigma. These psychosocial barriers contribute to poor medication and clinic visit adherence, poor health outcomes, including unsuppressed viral load, and increased risk of perinatal transmission of HIV. To efficiently improve health outcomes within a resource-constrained health system, responsive and effective interventions are urgently needed to support women who are at the highest risk of sub-optimal outcomes.</div></div><div><h3>Objective</h3><div>To determine whether risk stratification of PPWH in conjunction with an evidence-based, tailored, lay health worker-delivered psychological intervention can optimize health outcomes for PPWH and their infants.</div></div><div><h3>Methods</h3><div>Using human-centered design, we will adapt Problem Management Plus (PM+) with PPWH for in-person and mobile delivery formats to prevent sub-optimal treatment adherence and HIV care disengagement among PPWH in Kisumu, Kenya. We will test the adapted PM+ intervention among 120 PPWH randomized 1:1:1 to standard of care, in-person PM+, or mobile PM+ in a hybrid type 2 implementation effectiveness pilot trial. Implementation outcomes, including feasibility, acceptability, and intervention satisfaction, as well as preliminary effectiveness outcomes in mental health and HIV, will be evaluated.</div></div><div><h3>Expected study outcomes</h3><div>We anticipate that the adapted PM+ intervention will be highly acceptable and feasible to implement and have the potential to be effective at reducing care disengagement, viremia, and psychological distress in PPWH.</div></div>","PeriodicalId":10636,"journal":{"name":"Contemporary clinical trials","volume":"151 ","pages":"Article 107838"},"PeriodicalIF":2.0,"publicationDate":"2025-02-06","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143374118","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}