Contemporary clinical trials最新文献

{"title":"Bringing veteran mental health promotion and suicide prevention efforts upstream: The THRiVE study protocol","authors":"Shannon M. Blakey ,&nbsp;J. Russ Vandermaas-Peeler ,&nbsp;Jennifer Counts ,&nbsp;Julie Croxford ,&nbsp;Kristine L. Rae Olmsted ,&nbsp;Phil Gant ,&nbsp;Eric B. Elbogen ,&nbsp;Kat Asman","doi":"10.1016/j.cct.2025.108100","DOIUrl":"10.1016/j.cct.2025.108100","url":null,"abstract":"<div><h3>Background</h3><div>Transition from military to civilian life presents both opportunities and challenges. Although existing programs provide newly separated veterans (NSVs) with career transition support, these programs do not fully address psychosocial aspects of reintegrating into civilian life. This is problematic because the military transition is a time during which NSVs are at higher risk for mental health disorders and suicide. Behavioral Activation (BA), an evidence-based psychotherapy that holds potential for optimizing psychosocial well-being during the military transition, could be adapted into an upstream mental health promotion and suicide prevention program to fill this gap. This study involves a one-arm trial to pilot test a BA-based program, called <em>Transition Health and Resilience through Valued Experiences</em> (THRiVE), for NSVs.</div></div><div><h3>Methods</h3><div>Up to 40 NSVs will receive THRiVE delivered virtually to small groups by a veteran peer facilitator. Self-report assessments will be administered at baseline, immediately post-THRiVE, and 3 months after THRiVE. Primary outcomes assess program feasibility and acceptability. Secondary outcomes explore preliminary effects on mental health symptoms, risk factors for suicidal ideation, and psychosocial functioning. Consistent with community-based participatory research models, the investigative team is partnering with a veteran Advisor and a Community Advisory Board composed of veterans and veteran spouses.</div></div><div><h3>Conclusion</h3><div>If successful, this trial would point toward potential means for optimizing mental health outcomes during the military transition. Positive findings would lay groundwork for testing the efficacy of THRiVE in larger and diverse samples. This study is registered in <span><span>ClinicalTrials.gov</span><svg><path></path></svg></span> (<span><span>NCT06778278</span><svg><path></path></svg></span>).</div></div>","PeriodicalId":10636,"journal":{"name":"Contemporary clinical trials","volume":"158 ","pages":"Article 108100"},"PeriodicalIF":1.9,"publicationDate":"2025-10-04","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145238417","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":"Adjusting confidence intervals under covariate-adaptive randomization in non-inferiority and equivalence trials","authors":"Masahiro Kojima,&nbsp;Hirotaka Mano,&nbsp;Kana Yamada,&nbsp;Keisuke Hanada,&nbsp;Yuji Tanaka,&nbsp;Junji Moriya","doi":"10.1016/j.cct.2025.108099","DOIUrl":"10.1016/j.cct.2025.108099","url":null,"abstract":"<div><div>Regulatory authorities guide the use of permutation tests or randomization tests so as not to decrease the Type I error rate when applying covariate-adaptive randomization in randomized clinical trials. For non-inferiority and equivalence trials, this paper derives adjusted confidence intervals using permutation and randomization methods, thus controlling the Type I error to be much closer to the pre-specified nominal significance level. We consider three variable types for the outcome of interest, namely normal, binary, and time-to-event variables for the adjusted confidence intervals. For normal variables, we show that the Type I error for the adjusted confidence interval holds the nominal significance level. However, we highlight a unique theoretical challenge for non-inferiority and equivalence trials: binary and time-to-event variables may not hold the nominal significance level when the model parameters are estimated by models that diverge from the data-generating model under the null hypothesis. To clarify these features, we present simulation results and evaluate the performance of the adjusted confidence intervals.</div><div>In conclusion, this paper highlights that while normal variables can control Type I errors in non-inferiority and equivalence trials, binary and time-to-event variables cannot control Type I errors unless the model is correctly specified.</div></div>","PeriodicalId":10636,"journal":{"name":"Contemporary clinical trials","volume":"158 ","pages":"Article 108099"},"PeriodicalIF":1.9,"publicationDate":"2025-10-03","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145231579","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":"Motivating increases in physical activity to prevent recurrence of weight gain after metabolic bariatric surgery: The Exercise Values of Life and Vitality Everyday (EVOLVE) trial","authors":"Dale S. Bond ,&nbsp;Pavlos K. Papasavas ,&nbsp;Yin Wu ,&nbsp;Michael E. Levin ,&nbsp;Shira I. Dunsiger ,&nbsp;David B. Sarwer ,&nbsp;Leah M. Schumacher ,&nbsp;Dahlia Saad-Pendergrass ,&nbsp;Anna Schwartz ,&nbsp;Jason Lillis","doi":"10.1016/j.cct.2025.108098","DOIUrl":"10.1016/j.cct.2025.108098","url":null,"abstract":"<div><h3>Background</h3><div>Recurrence of significant weight gain after metabolic and bariatric surgery (MBS) is common and can lead to physical and psychological complications. Although patients are encouraged to increase moderate-to-vigorous intensity physical activity (MVPA) to prevent weight recurrence, many report low motivation. This study tests whether targeting autonomous motivation through an Acceptance and Commitment Therapy (ACT)-based intervention can produce durable increases in MVPA to prevent postoperative weight recurrence.</div></div><div><h3>Study design</h3><div>A total of 164 adults who are 6–20 months post-MBS with stable weight (&lt;10 % regain from maximum weight loss) are randomly assigned to one of two 12 months programs: an ACT intervention (Physical Activity [PA]-ACT) or a contact-matched education control (PA-EDU). PA-ACT uses values clarification and acceptance strategies to foster autonomous motivation for self-determined MVPA goals. PA-EDU provides didactic instruction on PA, related health topics, and cognitive-behavioral strategies for prescribed MVPA goals. Both conditions receive group-based workshops and individual counseling delivered via video conferencing and email micro-interventions. The conditions will be compared on changes in MVPA and weight recurrence (primary outcomes) and autonomous motivation and acceptance (secondary outcomes) from baseline to 12 months (end-of-treatment) and 18 months (follow-up). Mediators of MVPA (motivation, acceptance) and weight recurrence (MVPA) will also be explored.</div></div><div><h3>Conclusion</h3><div>This is the first study to examine whether an ACT-based intervention can foster autonomous motivation for sustained MVPA to prevent weight recurrence after MBS. The results may inform more robust guidelines for PA in MBS and support integration of these strategies into clinical practice to prevent significant weight recurrence.</div><div><span><span><strong>ClinicalTrials.gov</strong></span><svg><path></path></svg></span> <strong>Registration:</strong> NCT037604.</div></div>","PeriodicalId":10636,"journal":{"name":"Contemporary clinical trials","volume":"158 ","pages":"Article 108098"},"PeriodicalIF":1.9,"publicationDate":"2025-10-02","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145228488","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":"Protecting households on exposure to newly diagnosed index multidrug-resistant tuberculosis patients: Study protocol for the PHOENIx phase 3 clinical trial","authors":"Michelle A. Kendall ,&nbsp;Michael D. Hughes ,&nbsp;Soyeon Kim ,&nbsp;Lisa A. Aaron ,&nbsp;Linda Naini ,&nbsp;Nishi Suryavanshi ,&nbsp;N. Sarita Shah ,&nbsp;Vanessa Rouzier ,&nbsp;Jeffrey Hafkin ,&nbsp;Thucuma Sise ,&nbsp;Justine Beck ,&nbsp;Barbara E. Heckman ,&nbsp;Jessica E. Haberer ,&nbsp;Mark Harrington ,&nbsp;Kimberly K. Scarsi ,&nbsp;Anneke C. Hesseling ,&nbsp;Susan Swindells ,&nbsp;Gavin J. Churchyard ,&nbsp;Amita Gupta","doi":"10.1016/j.cct.2025.108084","DOIUrl":"10.1016/j.cct.2025.108084","url":null,"abstract":"<div><h3>Introduction</h3><div>Data to guide tuberculosis (TB) preventive treatment (TPT) of close contacts of people with multidrug-resistant tuberculosis (MDR-TB) are limited. While levofloxacin-based TPT has been shown safe and efficacious, alternatives are needed for those exposed to fluoroquinolone-resistant <em>Mycobacterium tuberculosis (M. tb)</em>. The PHOENIx trial evaluates whether using a novel nitroimidazole, delamanid, in high-risk household contacts (HHCs) of patients with MDR-TB reduces their risk of developing active TB.</div></div><div><h3>Methods/Design</h3><div>PHOENIx is a phase 3, open-label, multicenter clinical trial with a cluster-randomized superiority design (households form the clusters). The study objectives are to compare efficacy and safety of 26 weeks of delamanid versus isoniazid for preventing confirmed or probable TB during 96 weeks of follow-up among HHCs of adults with pulmonary MDR-TB. HHCs are defined as young children &lt;5 years, people living with HIV or non-HIV immunosuppression, or people with evidence of <em>M. tb</em> infection. The study was originally designed to enroll 3452 HHCs to provide 90 % power to detect a 50 % reduction in the cumulative proportion of HHCs developing confirmed or probable TB during 96 weeks of follow-up from 5 % in the isoniazid arm to 2.5 % in the delamanid arm. The design included a sample size re-evaluation to address uncertainty in study design assumptions.</div></div><div><h3>Discussion</h3><div>Preventing MDR-TB is a global priority. Alternatives to levofloxacin-based TPT are needed since fluoroquinolone resistance is growing. PHOENIx, a phase 3 trial evaluating delamanid, is poised to inform WHO guidelines.</div></div>","PeriodicalId":10636,"journal":{"name":"Contemporary clinical trials","volume":"158 ","pages":"Article 108084"},"PeriodicalIF":1.9,"publicationDate":"2025-09-22","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145136758","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Design of a cluster randomized multi-level intervention to decrease barriers to minority cancer patient referral and enrollment to cancer clinical trials: The ACT WONDER2S study","authors":"Dana E. Rollison ,&nbsp;Melany A. Garcia ,&nbsp;Rossybelle P. Amorrortu ,&nbsp;Yayi Zhao ,&nbsp;Brian Mittman ,&nbsp;Kea Turner ,&nbsp;Kedar Kirtane ,&nbsp;Hatem Soliman ,&nbsp;Margaret M. Byrne ,&nbsp;Cathy Meade ,&nbsp;Clement K. Gwede ,&nbsp;Steven Eschrich ,&nbsp;Jun Yin ,&nbsp;Nathanael B. Stanley ,&nbsp;Lindsay Fuzzell ,&nbsp;Delilah Hernandez ,&nbsp;Elliott-Tapia-Kwan ,&nbsp;Susan T. Vadaparampil","doi":"10.1016/j.cct.2025.108096","DOIUrl":"10.1016/j.cct.2025.108096","url":null,"abstract":"<div><h3>Introduction</h3><div>Non-Hispanic (NH) Black/African American (AA) and Hispanic cancer patients are underrepresented in cancer clinical trials (CCTs) due to patient, physician, and system-level barriers. Therefore, multi-level approaches are critical to address barriers to CCT participation. Presented here are the study design and baseline characteristics of ACT WONDER²S, a multi-level intervention (MLI) aimed to decrease barriers to NH Black/AA and Hispanic patient referral and enrollment in CCTs.</div></div><div><h3>Methods</h3><div>ACT WONDER²S is an MLI including community outreach and digital interventions for community and Moffitt Cancer Center (MCC) populations. Geospatial analytics were used to identify clusters of census tracts (“priority zones”) with high NH Black/AA and Hispanic populations for intervention deployment. Priority zones were then matched on population characteristics and randomized to receive the intervention (<em>n</em> = 7) or to serve as controls (n = 7). Baseline characteristics of the priority zones were described using US Census data and other public sources.</div></div><div><h3>Results</h3><div>Approximately 16.5 % and 35.8 % of the intervention priority zones are NH Black/AA or Hispanic, respectively. There are no statistically significant differences between groups in total population size (paired <em>t</em>-test <em>p</em>-value = 0.63), proportions of NH Black/AA (<em>p</em> = 0.13) and Hispanic populations (<em>p</em> = 0.17), or distance in miles from MCC (<em>p</em> = 0.64). The estimated number of cancer cases and CCT enrollment rates at baseline are also similar between groups.</div></div><div><h3>Conclusion</h3><div>If shown to be effective in increasing referral and enrollment of NH Black/AA and Hispanic cancer patients to CCTs, ACT WONDER²⁾S can be deployed across other geographic settings, thereby reducing disparities to CCT referral and enrollment on a national scale.</div></div>","PeriodicalId":10636,"journal":{"name":"Contemporary clinical trials","volume":"158 ","pages":"Article 108096"},"PeriodicalIF":1.9,"publicationDate":"2025-09-22","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145136763","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Protocol for a randomized trial of self-management support for people with chronic obstructive pulmonary disease using lay health coaches","authors":"Nikita Agrawal ,&nbsp;Meredith Case ,&nbsp;Peter K. Lindenauer ,&nbsp;Danielle McDermott ,&nbsp;Keith M. Diaz ,&nbsp;Jennifer Oscherician Utkin ,&nbsp;Juan Wisnivesky ,&nbsp;Alex Federman","doi":"10.1016/j.cct.2025.108095","DOIUrl":"10.1016/j.cct.2025.108095","url":null,"abstract":"<div><div>Successful management of chronic obstructive pulmonary disease (COPD) centers on patient self-management behaviors (SMB) such as controller medication adherence, use of action plans, smoking cessation and more. Individuals with COPD face a number of barriers to effective self-management, including medical comorbidities, cognitive and mental health disorders, and socioeconomic factors. Poor self-management contributes significantly to poor health outcomes in patients with COPD. However, prior research has demonstrated that interventions to improve SMB must be multifaceted and tailored to individual patients' specific barriers to be most effective. This randomized control study will test a 6-month self-management support intervention in 300 adults with Global Initiative for Chronic Obstructive Lung Disease (GOLD) classifications B or E. The intervention is called Supporting self-Management Behaviors in Adults with COPD (SAMBA). It uses health coaches to identify and address barriers to SMB, support home-based pulmonary rehabilitation, and promote use of as-needed antibiotics and oral corticosteroids for early treatment of acute COPD exacerbations. SAMBA will be compared to a time and attention matched control treatment consisting of general COPD education. We hypothesize that patients receiving SAMBA will have better COPD medication adherence, greater exercise capacity, more improved COPD symptoms and quality of life, and fewer hospitalizations and ED visits than control patients.</div></div><div><h3>Clinical trial registration number</h3><div><span><span>NCT06634810</span><svg><path></path></svg></span></div></div>","PeriodicalId":10636,"journal":{"name":"Contemporary clinical trials","volume":"158 ","pages":"Article 108095"},"PeriodicalIF":1.9,"publicationDate":"2025-09-22","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145136774","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":"The Telehealth MOM Study: Protocol for a randomized controlled trial of the Telehealth Multi-component Optimal Model (MOM) of postpartum care","authors":"Jennifer A. Callaghan-Koru ,&nbsp;Nirvana Manning ,&nbsp;James P. Selig ,&nbsp;Hari Eswaran ,&nbsp;Stacy Tiemeyer ,&nbsp;Sarah J. Rhoads ,&nbsp;Pearl A. McElfish ,&nbsp;The Telehealth MOM Study Group","doi":"10.1016/j.cct.2025.108085","DOIUrl":"10.1016/j.cct.2025.108085","url":null,"abstract":"<div><h3>Background</h3><div>A substantial proportion of maternal morbidity and mortality occurs in the postpartum period. In 2018, the American College of Obstetricians and Gynecologists (ACOG) published new guidelines recommending that all women have contact with a maternity care provider by 3 weeks postpartum. Although this revised schedule addresses the evident need for enhanced postpartum care, it has not been tested in a clinical trial and implementation has been hampered by logistical and financial constraints. The goal of this study is to evaluate the effect on postpartum outcomes of the Telehealth Multi-Component Optimal Model (MOM) of postpartum care, which delivers the early postpartum visit through telehealth.</div></div><div><h3>Design</h3><div>We will conduct a type 1 hybrid effectiveness-implementation trial of the Telehealth MOM postpartum care model. This randomized-controlled trial will enroll 1500 diverse pregnant women at five obstetric clinics across Arkansas. We will randomize participants 1:1 to receive enhanced standard of care or the Telehealth MOM model, with remote monitoring of blood pressure and temperature for 14 days postpartum and a telehealth screening for complications between 6 and 14 days after birth. Outcomes are obtained from health records (postpartum visit completion, early detection of complications, readmissions) and surveys at 9 weeks, 6 months, and 13 months postpartum. Qualitative interviews with patients, providers, and study staff will inform development of an implementation blueprint.</div></div><div><h3>Conclusion</h3><div>This study will contribute much needed evidence regarding the effectiveness of telehealth and remote monitoring in the early postpartum period and can inform policies and strategies for implementing the 2018 postpartum care guidelines.</div></div>","PeriodicalId":10636,"journal":{"name":"Contemporary clinical trials","volume":"158 ","pages":"Article 108085"},"PeriodicalIF":1.9,"publicationDate":"2025-09-19","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145111452","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":"Feasibility of an ADAPTive intervention to improve food security and Maternal-Child Health (ADAPT-MCH): Protocol for a pilot sequential multiple assignment randomized trial","authors":"Deepak Palakshappa ,&nbsp;Rebecca J. Stone ,&nbsp;Brenda Ramirez ,&nbsp;Sarah E. White ,&nbsp;Joseph Rigdon ,&nbsp;Richa Bundy ,&nbsp;Sally G. Eagleton ,&nbsp;Nicole Caudill ,&nbsp;Heather Martin ,&nbsp;Mayte Grundseth ,&nbsp;Scott Best ,&nbsp;Morgana Mongraw-Chaffin ,&nbsp;Kristina H. Lewis ,&nbsp;Kimberly Montez","doi":"10.1016/j.cct.2025.108086","DOIUrl":"10.1016/j.cct.2025.108086","url":null,"abstract":"<div><h3>Background</h3><div>Food insecurity affects up to 30 % of pregnancies and is associated with worse maternal and infant health. Healthcare systems are implementing interventions to assist patients with food insecurity, but rather than providing a single intervention, adaptively providing interventions could be a more effective strategy. The objective of this study is to determine the feasibility of adaptively providing interventions to assist pregnant patients who report being food-insecure.</div></div><div><h3>Methods/design</h3><div>We will conduct a pilot sequential multiple assignment randomized trial at obstetrics clinics from one health system. Adults (<em>N</em> = 60) who are pregnant and food-insecure will be randomized at their initial prenatal visit to one of two first-stage interventions for 3 months: 1) electronic health record (EHR) referral to WIC or 2) EHR-referral to WIC + care navigation. Participants who do not have ≥2-point improvement in food insecurity after 3 months will be re-randomized to one of two second-stage interventions for an additional 3 months: weekly delivery of 1) produce or 2) medically-tailored meals. In Aim 1, we will determine the feasibility of recruitment, and in Aim 2, we will evaluate the feasibility of re-randomization, retention, and data collection. In Aim 3, we will advance our understanding of how, why, and under what circumstances participants achieved improvements through semi-structured interviews.</div></div><div><h3>Conclusions</h3><div>This will be the first study to test an adaptive intervention to assist pregnant patients with food insecurity and will inform a future fully-powered trial. Given the growing interest among health systems, an efficacious, adaptive food insecurity intervention could be broadly disseminated.</div></div><div><h3>Trial registration</h3><div>The study was registered with <span><span>ClinicalTrials.gov</span><svg><path></path></svg></span> (<span><span>NCT06942598</span><svg><path></path></svg></span>) on April 23, 2025.</div></div>","PeriodicalId":10636,"journal":{"name":"Contemporary clinical trials","volume":"158 ","pages":"Article 108086"},"PeriodicalIF":1.9,"publicationDate":"2025-09-18","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145102796","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":"The psychosocial pain management to improve opioid use disorder treatment outcomes study: Protocol for a randomized controlled trial","authors":"Mark Ilgen ,&nbsp;Frederic Blow ,&nbsp;John D. Piette ,&nbsp;Jason Goldstick ,&nbsp;Mandy Lewis ,&nbsp;William Priest ,&nbsp;Harshpreet Matharu ,&nbsp;Michael Bourgoise ,&nbsp;Chelsea Young ,&nbsp;Doctor Ashe ,&nbsp;Amanda Price ,&nbsp;Lewei (Allison) Lin","doi":"10.1016/j.cct.2025.108081","DOIUrl":"10.1016/j.cct.2025.108081","url":null,"abstract":"<div><h3>Background</h3><div>People with opioid use disorder (OUD) often experience comorbid chronic pain, which complicates treatment of both conditions. Medications for opioid use disorders (MOUD), specifically buprenorphine, are the standard of care for OUD and can be helpful for pain; however, a major challenge to sustaining effectiveness has been limited retention in buprenorphine treatment. Prior research has highlighted the efficacy of psychosocial treatments for pain management; although, research remains limited on integrated approaches to improve OUD outcomes among people/patients with chronic pain. This randomized controlled trial, called the Persist Study, investigated whether a psychosocial pain management intervention (PPMI) was more effective than Enhanced Usual Care (EUC) for MOUD patients with chronic pain.</div></div><div><h3>Methods</h3><div>This was a randomized trial of remotely delivered PPMI vs EUC for adults receiving MOUD who have chronic pain. Our study recruited nationally from MOUD clinics and through targeted online advertisements. Target enrollment was 200 participants randomly assigned to either PPMI (<em>n</em> = 100) or EUC (n = 100) conditions. The PPMI consisted of eight 1-h sessions and the EUC included two 15-min sessions conducted over a 6-week timespan. Primary outcomes measured retention on buprenorphine over 3 months, whereas secondary outcomes measured longer-term MOUD retention, pain level, pain-related functioning, and frequency of substance use over 12 months.</div></div><div><h3>Discussion</h3><div>The Persist Study tested a remotely delivered, manualized, psychosocial intervention for co-occurring chronic pain in patients prescribed buprenorphine treatment for OUD. Study results will inform efforts to improve retention and treatment outcomes among patients receiving MOUD who also have chronic pain.</div><div><strong>Trial registration:</strong> This clinical trial has been registered with <span><span>ClincialTrials.gov</span><svg><path></path></svg></span> under ID <span><span>NCT04433975</span><svg><path></path></svg></span>.</div></div>","PeriodicalId":10636,"journal":{"name":"Contemporary clinical trials","volume":"158 ","pages":"Article 108081"},"PeriodicalIF":1.9,"publicationDate":"2025-09-17","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145091421","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":"NutriConnect: Enhancing health and food security through sustainable solutions and partnerships: Design and protocol of a pragmatic comparative effectiveness trial","authors":"Sang Gune K. Yoo ,&nbsp;Rachel G. Tabak ,&nbsp;Stephanie Mazzucca-Ragan ,&nbsp;Allison Primo ,&nbsp;Doneisha Bohannon ,&nbsp;Derek Hashimoto ,&nbsp;Charles W. Goss ,&nbsp;Jason HY Wu ,&nbsp;Eghonghon Eromosele ,&nbsp;Ihab Hassanieh ,&nbsp;Adam Hively ,&nbsp;Abygail Martinez ,&nbsp;Jinli Wang ,&nbsp;Mark D. Huffman ,&nbsp;Jing Li","doi":"10.1016/j.cct.2025.108083","DOIUrl":"10.1016/j.cct.2025.108083","url":null,"abstract":"<div><h3>Background</h3><div>Food insecurity and poor dietary intake contribute to health disparities, particularly among socioeconomically disadvantaged populations. Produce prescription programs aim to improve access to fruits and vegetables (F&amp;V) for those with diet-sensitive conditions, but comparative effectiveness data are limited.</div></div><div><h3>Objective</h3><div>To compare the impact of two produce prescription strategies, NutriConnect Credit (grocery coupons) and NutriConnect Delivery (home-delivered F&amp;V boxes), on dietary intake, food security, and health outcomes among socioeconomically disadvantaged populations who have been recently hospitalized with diet-sensitive conditions.</div></div><div><h3>Methods</h3><div>In this three-arm pilot trial, recently hospitalized adults with food or financial insecurity and elevated cardiovascular risk were randomized (1:1:1) to Credit, Delivery, or enhanced usual care. The primary outcome is between group difference in change in F&amp;V intake at 6 months. Secondary outcomes include food security and self-reported health-related quality of life. Implementation outcomes are assessed using the PRISM/RE-AIM framework.</div></div><div><h3>Conclusion</h3><div>NutriConnect seeks to provide evidence on the effectiveness and feasibility of two produce prescription strategies to inform scalable “Food is Medicine” programs targeting nutrition-related health disparities.</div><div><strong>Trial registration number:</strong> <span><span>NCT06263751</span><svg><path></path></svg></span></div></div>","PeriodicalId":10636,"journal":{"name":"Contemporary clinical trials","volume":"158 ","pages":"Article 108083"},"PeriodicalIF":1.9,"publicationDate":"2025-09-17","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"145091327","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}