Contemporary Clinical Trials Communications最新文献

{"title":"Response variability to exercise (REVISE): Study rationale, design and methods","authors":"Robert Ross ,&nbsp;Andrew G. Day ,&nbsp;Paula J. Stotz ,&nbsp;Samantha Wade ,&nbsp;Robert Cooke ,&nbsp;Erin Miller ,&nbsp;Nick Liberatore ,&nbsp;Benoit Lamarche","doi":"10.1016/j.conctc.2025.101519","DOIUrl":"10.1016/j.conctc.2025.101519","url":null,"abstract":"<div><div>Physical inactivity and low levels of cardiorespiratory fitness (CRF, VO₂peak) are major threats to public health<strong>.</strong> In response, leading health authorities worldwide recommend that all adults accumulate 150 min/wk of moderate to-vigorous physical activity. However, we and others have demonstrated an extraordinary inter-individual variability in CRF response to standardized exercise wherein a substantial number of adults may not improve CRF beyond day-to-day variability. Whether CRF response to first line therapy is a permanent feature of the individual or can be altered by increasing exercise dose is unknown. We will perform a single-centre, two-phased, randomized controlled trial. In Phase I we will randomly assign previously inactive, adult men and women between 25 and 65 years in a 1:9 ratio to a no-exercise wait-list control, or a low amount, low intensity (∼150 min/wk) group for 16 weeks. In Phase II (16 weeks), participants randomized to exercise in phase I will be re-randomized to 1 of 3 exercise groups: 1) the same low amount, low intensity; 2) low amount, high intensity, or 3) high amount, high intensity. The primary outcome is CRF. Our primary question is, after 16 weeks of ∼150 min/wk of moderate intensity exercise, does increasing exercise intensity or exercise amount for an additional 16 weeks improve CRF differently depending on the response to exercise during the first 16 weeks? The findings will provide first evidence and immense opportunity for development of a more personalized approach to exercise that recognizes individual response variability.</div></div><div><h3>Trial registration</h3><div>clinicaltrials. gov identifier: NCT05496751.</div></div>","PeriodicalId":37937,"journal":{"name":"Contemporary Clinical Trials Communications","volume":"46 ","pages":"Article 101519"},"PeriodicalIF":1.4,"publicationDate":"2025-07-05","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144588543","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Corrigendum to “Design and methods of an adaptive trial to test comparative effectiveness of readmission reduction approaches following infection and sepsis hospitalizations (ACCOMPLISH)” [Contemp. Clinic. Trials Commun. 46 (2025) 101504]","authors":"Kristin Mayes ,&nbsp;Victor B. Talisa ,&nbsp;Adelina Malito ,&nbsp;Florian B. Mayr ,&nbsp;Kelly Williams ,&nbsp;Kalpana Char ,&nbsp;Richard Wadas ,&nbsp;Elizabeth Lorenzi ,&nbsp;Kert Viele ,&nbsp;Rana Awdish ,&nbsp;Derek C. Angus ,&nbsp;Chung-Chou Ho Chang ,&nbsp;Sachin Yende","doi":"10.1016/j.conctc.2025.101520","DOIUrl":"10.1016/j.conctc.2025.101520","url":null,"abstract":"","PeriodicalId":37937,"journal":{"name":"Contemporary Clinical Trials Communications","volume":"46 ","pages":"Article 101520"},"PeriodicalIF":1.4,"publicationDate":"2025-07-03","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144679039","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Statistical analysis plan for the 24-week randomised trial of hypoglycaemia prevention, awareness of symptoms, and treatment: HypoPAST","authors":"Sharmala Thuraisingam ,&nbsp;Jennifer A. Halliday ,&nbsp;Uffe Søholm ,&nbsp;Elizabeth Holmes-Truscott ,&nbsp;Christel Hendrieckx ,&nbsp;Timothy C. Skinner ,&nbsp;Vincent L. Versace ,&nbsp;Jane Speight ,&nbsp;HypoPAST study group","doi":"10.1016/j.conctc.2025.101513","DOIUrl":"10.1016/j.conctc.2025.101513","url":null,"abstract":"<div><h3>Background</h3><div>The HypoPAST (Hypoglycaemia Prevention, Awareness of Symptoms, and Treatment) randomised controlled trial aims to examine the effectiveness of an online psycho-educational intervention for reducing fear of hypoglycaemia among adults with type 1 diabetes. This statistical analysis plan provides the framework to assess the primary, secondary, and safety outcomes of the trial. The plan was written prior to database lock and in accordance with the SPIRIT guidelines.</div></div><div><h3>Methods</h3><div>HypoPAST is a 24-week, two-arm, parallel-group, hybrid type 1 randomised controlled trial. The primary outcome is the difference in mean Hypoglycaemia Fear Survey II Worry subscale scores at 24 weeks between intervention and control arms. Secondary outcomes include between-arm differences in psychological, clinical and behavioural measures at mid- and end-trial. Primary and secondary outcomes will be analysed using mixed-effects models under the intention-to-treat principle. A sensitivity analysis will examine assumptions regarding missing data, and a per-protocol analysis will estimate the intervention effect among participants who engage with HypoPAST. Table shells for all prespecified analyses are provided to support transparent reporting.</div></div><div><h3>Conclusion</h3><div>Consistent with best practice, all analyses described were prespecified prior to completion of trial data collection. The analysis methods were developed by statisticians, with input from trial investigators. This analysis plan provides a rigorous framework for the analysis of the HypoPAST trial data, ensuring the results will be robust and reproducible.</div></div><div><h3>Trial registration</h3><div>The trial is registered on the Australian and New Zealand Clinical Trials Registry: ACTRN12623000894695 (August 21, 2023).</div></div>","PeriodicalId":37937,"journal":{"name":"Contemporary Clinical Trials Communications","volume":"46 ","pages":"Article 101513"},"PeriodicalIF":1.4,"publicationDate":"2025-07-02","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144548396","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Trialing addiction neurocircuitry targets and directionality of brain stimulation effects: A deep TMS/fMRI trial in people with alcohol use disorder","authors":"Daniel J. Fehring ,&nbsp;Jordan Morrison-Ham ,&nbsp;Annalee L. Cobden ,&nbsp;Justin Mahlberg ,&nbsp;Mengxia Gao ,&nbsp;Claire E. Kelly ,&nbsp;Arshiya Sangchooli ,&nbsp;Devon Stoliker ,&nbsp;Emily Giddens ,&nbsp;Brody Quinn ,&nbsp;Antonia Cholewick ,&nbsp;Luiza Bonfim Pacheco ,&nbsp;Adeel Razi ,&nbsp;Natalia Albein-Urios ,&nbsp;Antonio Verdejo-Garcia","doi":"10.1016/j.conctc.2025.101515","DOIUrl":"10.1016/j.conctc.2025.101515","url":null,"abstract":"<div><h3>Background</h3><div>Excessive alcohol consumption is a global health concern, with an estimated 400 million people living with alcohol use disorder (AUD). Current treatments for AUD have limited efficacy and fail to address its diverse neurobiological underpinnings. There are at least two cortico-striatal circuits relevant to AUD neurobiology: a weakened dorsolateral prefrontal cortex (dlPFC) pathway, and a heightened ventromedial prefrontal cortex (vmPFC) pathway.</div></div><div><h3>Purpose</h3><div>This trial aims to examine whether deep transcranial magnetic stimulation (dTMS) can recalibrate the neurocircuitry disrupted in AUD as a proof-of-concept for its therapeutic potential. We will assess the capacity of two theta-burst stimulation protocols to modify neuroimaging and behavioral indices of AUD-related neurocircuitry alterations.</div></div><div><h3>Methods</h3><div>We will conduct a randomized, single-blind, sham-controlled crossover trial with 30 adults with moderate to severe AUD (aged 18–49). Participants will receive two doses of active or sham dTMS (for 2 sessions; 7 days apart; order counterbalanced) targeting the dlPFC or vmPFC with intermittent or continuous theta-burst stimulation, respectively.</div></div><div><h3>Results</h3><div>Primary, secondary, and exploratory outcomes (i.e., stimulation-induced changes in neural circuit connectivity, executive control/decision-making, and craving-related emotions, respectively) will be collected before and after each dTMS dose. Additional exploratory outcomes (daily craving experiences and weekly alcohol consumption) will be collected across a 90-day period from the first session.</div></div><div><h3>Discussion</h3><div>This trial innovates by utilizing distinct dTMS approaches to specifically target two functionally segregated neurocircuitries disrupted in AUD. Results will inform the development of a larger-scale trial by establishing optimal therapeutic approaches for AUD.</div></div>","PeriodicalId":37937,"journal":{"name":"Contemporary Clinical Trials Communications","volume":"46 ","pages":"Article 101515"},"PeriodicalIF":1.4,"publicationDate":"2025-06-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144571336","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Tackling burnout in Australian doctors by blending a web-based cognitive-behavioural therapy program with telehealth psychological support – protocol for a three-arm randomised-controlled trial","authors":"M.J. Coleshill ,&nbsp;M.J. Black ,&nbsp;K. Luck ,&nbsp;K. Willis ,&nbsp;N. Smallwood ,&nbsp;H. Stephens ,&nbsp;T. Gillings ,&nbsp;L. Fraser ,&nbsp;M. Putland ,&nbsp;L. Kampel ,&nbsp;A.M. Martin ,&nbsp;N.F. Praharso ,&nbsp;A.D. Joffe ,&nbsp;S. Harvey ,&nbsp;P.A. Baldwin","doi":"10.1016/j.conctc.2025.101514","DOIUrl":"10.1016/j.conctc.2025.101514","url":null,"abstract":"<div><h3>Background</h3><div>Burnout has received limited attention in treatment programs, despite high prevalence among health professionals and the threat burnout places upon the mental health and the long-term sustainability of the Australian healthcare system. As part of The Essential Network (TEN), a blended care mental health support service for Australian health professionals, we developed Navigating Burnout – a digital cognitive-behavioural therapy program for health professional burnout. This three-arm randomised-controlled trial (RCT) will examine the effectiveness, acceptability, and cost-effectiveness of Navigating Burnout in both blended care and digital formats in reducing burnout among doctors.</div></div><div><h3>Methods</h3><div>Doctors (n = 207) with burnout will be randomised to (1) a blended version of Navigating Burnout combining digital resources with five fortnightly telehealth sessions with a clinical psychologist, (2) a digital-only version of Navigating Burnout, or (3) self-care psychoeducation as an active attention control. Burnout, psychosocial wellbeing, workforce engagement and attrition, and service acceptability will be measured at baseline, post-treatment, and 3 months post-treatment.</div></div><div><h3>Results</h3><div>At 3 months post-treatment, we hypothesise reductions in burnout across both treatment arms, with the strongest effect in the blended care arm. Similar trends are expected for psychosocial and occupational outcomes. High service acceptability across both blended care and digital-only versions of Navigating Burnout is also anticipated.</div></div><div><h3>Conclusions</h3><div>With this evidence, Navigating Burnout may be incorporated into TEN's person-to-person components. Further, by demonstrating the effectiveness of blended care for burnout, Navigating Burnout may provide a crucially needed service for Australian doctors and replicable model of care for other organisations and support services.</div></div>","PeriodicalId":37937,"journal":{"name":"Contemporary Clinical Trials Communications","volume":"46 ","pages":"Article 101514"},"PeriodicalIF":1.4,"publicationDate":"2025-06-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144557436","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Improving youth access to behavioral health services through integrated care and task shifting: protocol for a cluster-randomized stepped wedge clinical trial","authors":"Brigid R. Marriott ,&nbsp;Leslie Hulvershorn ,&nbsp;Johnathan Oliver ,&nbsp;Cara Jones ,&nbsp;Lauren M. O'Reilly ,&nbsp;Sarah E. Wiehe ,&nbsp;Patrick O. Monahan ,&nbsp;Sarah Kate Bearman ,&nbsp;Lisa Saldana ,&nbsp;Matthew C. Aalsma","doi":"10.1016/j.conctc.2025.101518","DOIUrl":"10.1016/j.conctc.2025.101518","url":null,"abstract":"<div><h3>Background</h3><div>One promising solution for improving access to mental health services is integrated behavioral health models, in which behavioral health providers address mental health problems within the primary care infrastructure. Additionally, task-shifting, where non-specialists deliver certain services in the place of specialists, may be well-suited to address mental health provider shortages. The current study outlines the protocol for a hybrid type III implementation-effectiveness, cluster-randomized stepped wedge trial to evaluate the implementation of an adapted pediatric integrated behavioral health model (Peds IBH) that includes task-shifting services, explore the facilitators and barriers to the implementation of Peds IBH, and examine connection to behavioral health care pre- and post-implementation.</div></div><div><h3>Methods</h3><div>The trial will include 25 pediatric primary care clinics across 13 counties in a large healthcare system. Clinics will be randomized to one of three cohorts, stepped in at 6-month intervals, with a 12-month implementation period. The Peds IBH program will: 1) incorporate task-shifting to treat mild to moderate anxiety, depression, and conduct problems with flexible, transdiagnostic cognitive-behavior therapy to be delivered by bachelor's level interventionists, 2) leverage existing child psychiatry provider consultation programs, and 3) increase sustainability through a different billing model. Quantitative data collection will include surveys (primary care team members, behavioral health providers, and youth and caregivers) and tracking of implementation strategies. Qualitative interviews will be conducted with primary care providers and staff.</div></div><div><h3>Discussion</h3><div>This trial will evaluate the implementation of the Peds IBH program. While the focus is implementation outcomes, we will assess effectiveness to inform future dissemination efforts.</div></div><div><h3>Trial registration</h3><div>N/A.</div></div>","PeriodicalId":37937,"journal":{"name":"Contemporary Clinical Trials Communications","volume":"46 ","pages":"Article 101518"},"PeriodicalIF":1.4,"publicationDate":"2025-06-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144581092","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"The use of consumer-grade physical activity monitors: Insight into psychosocial determinants and technology acceptance","authors":"Brenda A.J. Berendsen ,&nbsp;Rianne H.J. Golsteijn ,&nbsp;Lilian Lechner ,&nbsp;Catherine Bolman ,&nbsp;Denise A. Peels","doi":"10.1016/j.conctc.2025.101516","DOIUrl":"10.1016/j.conctc.2025.101516","url":null,"abstract":"<div><h3>Background</h3><div>Consumer-grade physical activity (PA) monitors are used to optimize enrollment in clinical trials, to evaluate PA behavior, or to promote PA. Insight is needed into characteristics of people who use PA monitors and who do not, to enhance recruitment and generalizability of trials. We assessed demographics, psychosocial determinants and technology acceptance of (non-)users of PA monitors.</div></div><div><h3>Methods</h3><div>Dutch speaking adults were recruited via social media, email and personal contact. In an online questionnaire 533 participants (70 % women, age 43 ± 14 years) reported PA monitor use, PA and psychosocial determinants, and technology acceptance of PA monitors. Concepts were derived from the theory of planned behavior and the technology acceptance model. Primary outcome of the study was use of a consumer-grade PA monitor in the past month, analyzed with a stepwise logistic regression model, including psychosocial determinants, technology acceptance and PA and past tracking behavior.</div></div><div><h3>Results</h3><div>Of the participants, 40 % reported using a PA monitor in the past month. Demographics and psychosocial determinants of PA explained 12 % of PA monitor use. The odds for using a PA monitor was higher with higher feelings of autonomy (1.772; CI:1.128–2.783). Adding technology acceptance to the regression model increased the explained variance to 66 %, with significant ORs of perceived ease of use (2.403; CI:1.479–3.904), perceived usefulness (0.405; CI:0.224–0.731), attitude towards PA monitors (2.235; CI:1.222–4.087), affective quality (2.293 CI:1.252–4.201), intention to use PA monitors in the near future (4.174; CI:2.320–7.512), and subcultural appeal (0.660; CI:0.455–0.958).</div></div><div><h3>Conclusions</h3><div>This study confirmed the value of integrating consumer-grade PA in clinical trials, since they were used regardless of the amount of leisure time PA, motivation, age, and educational level. This indicates that trials that use people's own PA trackers to recruit and screen participants or in interventions likely includes a generalizable sample. Furthermore, the results provide concrete pointers within technology acceptance that could contribute to recruitment in trials relying on participants' own PA monitors.</div></div>","PeriodicalId":37937,"journal":{"name":"Contemporary Clinical Trials Communications","volume":"46 ","pages":"Article 101516"},"PeriodicalIF":1.4,"publicationDate":"2025-06-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144548395","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Experience and lessons learned relating to investigational product supply in the design and delivery of a paediatric investigator-initiated clinical trial","authors":"Mandy Wan ,&nbsp;Mark A. Turner ,&nbsp;Gilles Cambonie ,&nbsp;Ruth Kemper ,&nbsp;Naouel Bouafia ,&nbsp;Lea Levoyer ,&nbsp;Alpha Diallo ,&nbsp;Mikko Hallman ,&nbsp;Jean-Christophe Rozé","doi":"10.1016/j.conctc.2025.101517","DOIUrl":"10.1016/j.conctc.2025.101517","url":null,"abstract":"<div><div>The management of investigational product (IP) supply is a complex endeavour when designing and delivering clinical trials. In contrast to industry-sponsored trials where IP supplies are coordinated by teams of specialists working together throughout the entire supply chain, investigator initiated clinical trials often face IP-related challenges that can result in substantial trial delays, higher costs, and even early termination of the trial. Despite the challenges faced by investigators, there has been relatively few discussions on this topic in the literature. In this short communication, we describe our experiences and the lessons learned in managing IP supply during the design and execution of a multinational paediatric investigator initiated clinical trial. These experiences are shared to provide researchers with tools and strategies to improve the future implementation of investigator-initiated clinical trials.</div></div>","PeriodicalId":37937,"journal":{"name":"Contemporary Clinical Trials Communications","volume":"46 ","pages":"Article 101517"},"PeriodicalIF":1.4,"publicationDate":"2025-06-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144523639","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Pilot optimization trial of a sexual and reproductive health program for Latina teens and their female caregivers: A study protocol","authors":"Katherine G. Merrill ,&nbsp;Jacqueline Silva ,&nbsp;Wendy Chu ,&nbsp;Gisel Romero ,&nbsp;Vanessa Melgoza ,&nbsp;Blanca Gabino ,&nbsp;Corin Mora ,&nbsp;Sara Vargas ,&nbsp;Jacqueline Fuentes ,&nbsp;Caitlin Kelleher-Montero ,&nbsp;Nicholle Courrejolles ,&nbsp;Kate Guastaferro ,&nbsp;Felicia Scott-Wellington ,&nbsp;Susana Salgado ,&nbsp;Angela Sedeño","doi":"10.1016/j.conctc.2025.101512","DOIUrl":"10.1016/j.conctc.2025.101512","url":null,"abstract":"<div><h3>Background</h3><div>Latina teens experience sexual and reproductive health disparities; however, few effective interventions designed for Latina teens and their families exist. Floreciendo is a sexual and reproductive health intervention for Latina teens (14–18 years) and their female caregivers (e.g., mothers, sisters), delivered by trained staff at community partner organizations (CPOs).</div></div><div><h3>Methods</h3><div>This protocol describes a hybrid type 2 mixed-methods study with a pilot 2³ factorial experimental design which draws on the multiphase optimization strategy (MOST) framework. Small groups of teen-caregiver dyads (target n = 92 dyads/184 participants) will be randomized to 1 of 8 conditions across four CPOs. All will receive the Foundations in Sexual Risk Prevention (i.e., constant) component. Groups of dyads will be randomized to different combinations of three intervention components of Floreciendo, which are either “on” or “off”: 1) Condoms and Contraception, 2) Family Strengthening, and 3) Gender and Relationships. Our aim is to examine the feasibility of using a factorial design and the acceptability of the intervention components. We will also explore effectiveness outcomes—including risky sexual behavior (primary) and incidence of sexually transmitted infections and unplanned pregnancy (secondary)—and implementation outcomes, including appropriateness, feasibility, adoption, sustainability, cost, and fidelity. Qualitative data will build on quantitative data. We will conduct focus group discussions and key informant interviews with Latina teens, female caregivers, facilitators, CPO leadership, and collaborators.</div></div><div><h3>Discussion</h3><div>Results will be used to guide intervention component and implementation refinement and will inform plans to conduct a fully powered optimization trial of Floreciendo.</div></div>","PeriodicalId":37937,"journal":{"name":"Contemporary Clinical Trials Communications","volume":"46 ","pages":"Article 101512"},"PeriodicalIF":1.4,"publicationDate":"2025-06-23","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144517575","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Study protocol for a randomized controlled effectiveness trial of THRIVE group and peer coaching to promote suicide recovery in crisis stabilization centers","authors":"Jennifer D. Lockman ,&nbsp;Anthony R. Pisani ,&nbsp;M. Alexis Kirk ,&nbsp;Kimberly A. Van Orden ,&nbsp;Ian J. Cero ,&nbsp;Margaret E. Balfour ,&nbsp;Kristina Mossgraber ,&nbsp;David Jacobowitz ,&nbsp;Kenneth R. Conner","doi":"10.1016/j.conctc.2025.101511","DOIUrl":"10.1016/j.conctc.2025.101511","url":null,"abstract":"<div><div>Crisis Stabilization Centers (CSCs) offer a person-centered, community-based alternative to Emergency Departments for suicide prevention. CSCs may facilitate the expansion of the 988 Suicide Prevention Lifeline by providing callers with places to go in communities to receive treatment. However, new, recovery-focused psychological interventions for suicide prevention that can be rapidly implemented in CSCs are needed to be effective. This pilot study examines the feasibility, acceptability, and target engagement of the Toward Recovery, Hope, Interpersonal Connection, Values, and Engagement (i.e., THRIVE) for CSCs. THRIVE includes a psychotherapy group and peer-led recovery coaching calls after discharge. This project consists of three phases to adapt, pilot, and test THRIVE in CSCs in preparation for a full-scale effectiveness trial. In phase I, we will use the Model for Implementation Design and Impact (i.e., MADI) to adapt THRIVE to CSCs’ implementation needs (<em>n</em> = 25). In phase II, we will assess the feasibility and acceptability of THRIVE through CSC Stakeholder feedback and completing a pilot trial of THRIVE with CSC guests (<em>n</em> = 20). In phase III, we will complete a pilot randomized effectiveness trial of THRIVE (<em>n</em> = 162) to test the effectiveness of THRIVE on treatment initiation. We will also examine target engagement (i.e., as thwarted belongingness, and perceived burdensomeness) of the THRIVE intervention. Participants will be randomized to (a) Thrive + Discharge &amp; Safety Planning as Usual (i.e., Intervention Arm): or (b) Discharge &amp; Safety Planning as Usual (i.e., Control Arm). Participants complete assessments at baseline, discharge, 1 month, and 3 months. This protocol demonstrates strategies for involving community-based practice partners in research and is the first randomized controlled trial in a CSC sponsored by the National Institute of Mental Health (NIMH).</div></div>","PeriodicalId":37937,"journal":{"name":"Contemporary Clinical Trials Communications","volume":"46 ","pages":"Article 101511"},"PeriodicalIF":1.4,"publicationDate":"2025-06-23","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144536000","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}