Contemporary Clinical Trials Communications最新文献

{"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":"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}

{"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":"Virtual sailing exercise to improve major depressive disorder: A pilot clinical trial protocol","authors":"Radietya Alvarabie ,&nbsp;Yang Yun ,&nbsp;Alexandra Gaillard ,&nbsp;Oren Tirosh ,&nbsp;Gurdeep Sarai ,&nbsp;Elissa Burjawi ,&nbsp;Denny Meyer ,&nbsp;Junhua Xiao","doi":"10.1016/j.conctc.2025.101510","DOIUrl":"10.1016/j.conctc.2025.101510","url":null,"abstract":"<div><h3>Background</h3><div>Major Depressive Disorder (MDD) is a prevalent and chronic psychiatric disorder associated with substantially reduced quality of life. However, current mental health management strategies— particularly for non-pharmacological interventions—to reduce this burden are limited in their efficacy. This pilot trial will, for the first time, assess if simulated sailing, combining virtual reality with recreational exercise, is a promising exercise-based therapeutic approach to reducing depression and improving the quality of life for people with MDD.</div></div><div><h3>Methods</h3><div>To evaluate the effectiveness of virtual sailing on MDD, 58 adults aged between 18 and 64 who have a diagnosis of MDD and can consent and participate in virtual sailing exercises will be recruited for the trial. Exclusion criteria include suicidality, severe mental illness, ongoing psychiatric treatment, and life circumstances that would hinder participation. After the pre-exercise screening, eligible participants will participate in simulated sailing sessions (30 min per session, one session per week) over six weeks. The primary outcome measurements include the evaluation of depression, anxiety, stress, quality of life, clinical improvement, and overall functioning as well as motor coordination. The second aim is to investigate if the virtual sailing program results in neuroplastic changes in the brain that restore altered resting-state functional connectivity and metabolites in MDD using Magnetic Resonance Imaging. Participants will be assessed at baseline and after the last sailing session.</div></div><div><h3>Conclusion</h3><div>The findings of this pilot study will inform a new therapeutic approach aimed at reducing depression and improving the quality of life for people with MDD.</div></div>","PeriodicalId":37937,"journal":{"name":"Contemporary Clinical Trials Communications","volume":"46 ","pages":"Article 101510"},"PeriodicalIF":1.4,"publicationDate":"2025-06-20","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144536001","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":"Design and methods of an adaptive trial to test comparative effectiveness of readmission reduction approaches following infection and sepsis hospitalizations (ACCOMPLISH)","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.2025.101504","DOIUrl":"10.1016/j.conctc.2025.101504","url":null,"abstract":"<div><h3>Background</h3><div>The months following hospitalization for sepsis and lower respiratory tract infection can often be very difficult for patients. Many will have subsequent clinical deterioration, which for some requires hospital readmission while, for others, transition to hospice care may be more appropriate. Unfortunately, there is a lack of high-quality evidence regarding how best to support patients in this period. Remote patient monitoring (RPM) technology can allow patients to remain at home yet be monitored for early signs of clinical deterioration. However, what should be monitored, and how any response should be coordinated, is unclear. We designed a pragmatic adaptive randomized clinical trial to determine the effect of four post-discharge RPM strategies comprising low vs. high intensity monitoring and standard versus enhanced care team response on 90-day hospital readmission rates.</div></div><div><h3>Methods</h3><div>Adults admitted to the hospital with sepsis or lower respiratory tract infection (index admission) are recruited and randomized to usual care (structured telephonic support [STS]) or one of four post-discharge RPM care models in addition to STS. The primary outcome is home days, a composite endpoint of 90-day mortality and the number of days a patient spends at home within 90 days after discharge to home from the index admission. Hospital readmissions will be measured primarily by health insurance claims data. Secondary endpoints, such as functional status and health-related quality of life, will be measured at baseline and 90 days. An adaptive randomization process is run quarterly, improving patients' chances to be randomized to the highest-performing intervention arms.</div></div><div><h3>Discussion</h3><div>The study evaluates different post-discharge monitoring and workforce strategies to increase home days. With a large, representative sample and pragmatic adaptive study design, this research aims to deliver key insights into effective remote discharge monitoring technology and workforce deployment, benefiting patients, providers, and payers.</div></div><div><h3>Trial registration</h3><div>This trial is registered at <span><span>clinicaltrials.gov</span><svg><path></path></svg></span> (NCT04829188). <span><span>https://clinicaltrials.gov/study/NCT04829188</span><svg><path></path></svg></span>. Date of registration: January 4, 2021.</div></div>","PeriodicalId":37937,"journal":{"name":"Contemporary Clinical Trials Communications","volume":"46 ","pages":"Article 101504"},"PeriodicalIF":1.4,"publicationDate":"2025-06-19","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144366916","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 pilot randomized trial building resiliency among caregivers of cancer curvivors and metavivors","authors":"Brett M. Goshe ,&nbsp;Anna Barata ,&nbsp;Lucy Finkelstein-Fox ,&nbsp;Joanna Cloutier ,&nbsp;Emelia Farnam ,&nbsp;Katie Holmbeck ,&nbsp;Elizabeth Waldron ,&nbsp;Giselle K. Perez ,&nbsp;Laura Malloy ,&nbsp;Isabelle Miranda ,&nbsp;Wren Hager ,&nbsp;Nora Horick ,&nbsp;Areej El-Jawahri ,&nbsp;Elyse Park","doi":"10.1016/j.conctc.2025.101506","DOIUrl":"10.1016/j.conctc.2025.101506","url":null,"abstract":"<div><h3>Background</h3><div>Caregivers of cancer survivors experience chronic stress, increasing emotional and physical health risks. Many caregivers report unmet psychosocial needs and maladaptive coping strategies, resulting in high caregiver burden and impaired quality of life. Existing interventions primarily address caregiver needs during active treatment or in relation to end-of-life care, with few providing targeted resources for caregivers coping with the challenges of post-active treatment survivorship – either for those supporting curvivors (cancer survivors who have completed curative therapy) or metavivors (patients living with metastatic disease).</div></div><div><h3>Objective</h3><div>This single-site pilot randomized trial, Forward Together (ForTe), aims to determine the feasibility (e.g., enrollment, survey completion, and group attendance rates), acceptability (e.g., program satisfaction and quality rating), and preliminary effects on resilience and healthcare utilization of the Stress Management and Resiliency Training: The Relaxation Response Resiliency Program (SMART-3RP) compared to Enhanced Usual Care (EUC; referral to <span><span>CanCare.org</span><svg><path></path></svg></span> caregiver and patient virtual support groups). (Clinical Trials ID: NCT05702723)</div></div><div><h3>Methods</h3><div>A multimodal recruitment approach, including both proactive and reactive methods, will be used to identify potential dyads for this study. Dyads (cancer survivor and caregiver) will be randomized 1:1 to SMART-3RP or EUC. Dyads randomized to the SMART-3RP will participate separately but simultaneously in 9 survivor- or caregiver-specific group sessions.</div></div><div><h3>Results</h3><div>This study is funded by the National Cancer Institute. Study procedures were approved by the Dana-Farber Harvard Cancer Center Institutional Review Board. Study procedures are complete; data analysis is ongoing.</div></div>","PeriodicalId":37937,"journal":{"name":"Contemporary Clinical Trials Communications","volume":"46 ","pages":"Article 101506"},"PeriodicalIF":1.4,"publicationDate":"2025-06-12","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144313590","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":"Intranasal insulin for the treatment of alcohol use disorder: design and methodology of an alcohol interaction randomized controlled trial","authors":"Carolina L. Haass-Koffler ,&nbsp;Bhavani Kashyap ,&nbsp;Brian J. Gully ,&nbsp;Sithara S. Nambiar ,&nbsp;Rivkah Hornbacher ,&nbsp;Stephanie L. Foster ,&nbsp;Yuval Silberman ,&nbsp;Robert M. Swift ,&nbsp;Leah R. Hanson ,&nbsp;William H. Frey II","doi":"10.1016/j.conctc.2025.101509","DOIUrl":"10.1016/j.conctc.2025.101509","url":null,"abstract":"<div><div>Despite developments in treatments for alcohol use disorder (AUD), current pharmacotherapies face several limitations, including adverse events. Intranasal (IN) insulin has shown promise for addictive disorders. The overarching hypothesis of this trial is that by increasing brain cell energy and glucose metabolism, while reducing stress hormones, IN insulin may be an ideal approach for treating multiple domains of AUD including memory, executive function and impulsivity. Preclinical and clinical studies of IN insulin demonstrate that it is a safe and effective method for delivering insulin to the central nervous system, circumventing the blood brain barrier, and reducing adverse events associated with insulin use (hypoglycemia). The overarching goal of this Phase I/IIa, within-subject, crossover, double-blind, placebo-controlled, alcohol interaction trial is to test the IN insulin (80IU), compared to placebo (0.9 % saline) as a potential therapy for AUD. The primary aim assesses the safety and tolerability of IN insulin, compared to placebo, in individuals with AUD (<em>N</em> = 40) who are not currently seeking treatment. The secondary aim assesses the safety and tolerability of IN insulin, compared to placebo, when co-administered with alcohol (0.08 g/dL). Tertiary aims include assessing cognitive performance, memory, and impulsivity following IN insulin, or placebo, and alcohol administration. Finally, an alcohol cue reactivity procedure investigates the effect of IN insulin, compared to placebo, in alcohol craving. This is the first study to evaluate IN insulin in an AUD population and this manuscript describes the rationale, design, and methodology of the alcohol interaction trial. This study is designed to accelerate research for the development of novel medications to treat AUD and provide empirical evidence on the safety and efficacy of a neurotherapeutic approach to inform clinical practice.</div></div><div><h3>Clinical trial</h3><div>NCT05988632.</div></div><div><h3>Fda/ind</h3><div>168417.</div></div>","PeriodicalId":37937,"journal":{"name":"Contemporary Clinical Trials Communications","volume":"46 ","pages":"Article 101509"},"PeriodicalIF":1.4,"publicationDate":"2025-06-10","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144271888","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}