Contemporary clinical trials最新文献

{"title":"Design of a randomized controlled trial to test the efficacy of interrupting sitting on type 2 diabetes risk factors in children with overweight/obesity: The sedentary behavior study 3 protocol","authors":"B.R. Belcher Ph.D., M.P.H. ,&nbsp;K.L. McAlister Ph.D., M.S. ,&nbsp;J. Zink Ph.D. ,&nbsp;T.M. Chapman M.P.H. ,&nbsp;K.N. Moore ,&nbsp;S. Castillo ,&nbsp;M. Hewus M.P.H. ,&nbsp;J.N. Kaslander ,&nbsp;C.M. Dieli-Conwright Ph.D., M.P.H. ,&nbsp;J. Huh Ph.D. ,&nbsp;K.A. Page M.D., M.S.","doi":"10.1016/j.cct.2025.107862","DOIUrl":"10.1016/j.cct.2025.107862","url":null,"abstract":"<div><h3>Background</h3><div>Sedentary behaviors are pervasive in children. We found acute 3-h improvements in metabolic and affective outcomes by interrupting sitting. It is unknown whether acute responses translate to sustained or improved responses over multiple days. This paper describes the rationale, study design, recruitment, data collection, and data analytic protocols for the Sedentary Behavior Study 3 (SBS3).</div></div><div><h3>Methods</h3><div>This is a 3-arm parallel-group randomized controlled trial of <em>N</em> = 150 (50 per group) 8–11-year-old children with overweight/obesity. Following screening and 7–10 day baseline free-living assessment, children are randomly assigned to complete one of three in-lab conditions for 3 h/day for 7 consecutive days: (1) continuous sitting (SIT); (2) sitting interrupted by 3-min bouts of moderate-intensity walking every 30 min (SIT+WALK); or (3) a single 18-min bout of moderate-intensity walking followed by continuous sitting (EX). Three-hour oral glucose tolerance tests are conducted on Days 1 and 7. Participants also wear continuous glucose monitors and accelerometers for the duration of the study, and complete daily 24-h dietary recalls and affective assessments.</div></div><div><h3>Conclusions</h3><div>The overall aim of this study is to evaluate the effectiveness of interrupting sitting over one week on glucose homeostasis (primary outcome) and secondary (cognitive and affective) outcomes in children. If successful, it will provide novel intervention strategies that can be translated to other settings, and age and weight groups, thereby contributing to efforts at reducing type 2 diabetes risk in U.S. youth.</div></div><div><h3>Trial registration</h3><div><span><span>ClinicalTrials.gov</span><svg><path></path></svg></span> <span><span>NCT04469790</span><svg><path></path></svg></span>, registered July 14, 2020.</div></div>","PeriodicalId":10636,"journal":{"name":"Contemporary clinical trials","volume":"152 ","pages":"Article 107862"},"PeriodicalIF":2.0,"publicationDate":"2025-02-21","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143482461","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":"Intervention to reduce barriers to type 1 diabetes self-management: Diabetes Journey study design and participant characteristics","authors":"Kimberly A. Driscoll ,&nbsp;Paige J. Trojanowski ,&nbsp;Desireé N. Williford ,&nbsp;Holly K. O'Donnell ,&nbsp;Erin Flynn ,&nbsp;Constance A. Mara ,&nbsp;Sara E. Wetter ,&nbsp;Alexandra C. Himelhoch ,&nbsp;Hannah Manis ,&nbsp;Alicia Pardon ,&nbsp;Cheyenne M. Reynolds ,&nbsp;Emily R. Shaffer ,&nbsp;Bailey Tanner ,&nbsp;Jessica Kichler ,&nbsp;Laura Smith ,&nbsp;Sarah Westen ,&nbsp;Anastasia Albanese-O'Neill ,&nbsp;Sarah D. Corathers ,&nbsp;Laura M. Jacobsen ,&nbsp;Amy Poetker ,&nbsp;Avani C. Modi","doi":"10.1016/j.cct.2025.107849","DOIUrl":"10.1016/j.cct.2025.107849","url":null,"abstract":"<div><div>Most adolescents with type 1 diabetes (T1D) encounter barriers to achieving optimal glycemia, including effective planning and monitoring their T1D and problem-solving, and following through with T1D treatment decisions. Thus, the overall aim of Diabetes Journey, a randomized controlled clinical trial, was to assess the feasibility, acceptability, and preliminary efficacy of a novel, amusement park-themed, web-based mobile health (mHealth) intervention tailored for adolescents who experienced barriers to T1D self-management. Secondary aims included examining post-intervention changes in T1D health-related quality of life, T1D self-management behaviors, and hemoglobin A1c (HbA1c). This article describes the study rationale, recruitment, design, and baseline characteristics of the adolescents (aged 12–17 years) who were randomized to one of two groups: Diabetes Journey or Enhanced Standard of Care. Diabetes Journey focused on reducing challenges related to stress, burnout, time pressure, and planning through the delivery of 5–8 intervention sessions using a problem-solving framework. Enhanced Standard of Care participants attended 4 education sessions focused on similar topics through the T1D Toolkit© website (educational content and brief videos about T1D). Adolescents (<em>N</em> = 195) were recruited with <em>n</em> = 162 randomized (M_age = 14.8 ± 1.6 years; 50 % female, 88 % White; HbA1c% = 8.2 ± 1.8; 86 % on insulin pumps). Diabetes Journey was impacted by COVID-19 and modifications to the study design were warranted. Future directions include examining the impact of Diabetes Journey on primary and secondary outcomes, while accounting for the impact of COVID-19.</div></div>","PeriodicalId":10636,"journal":{"name":"Contemporary clinical trials","volume":"152 ","pages":"Article 107849"},"PeriodicalIF":2.0,"publicationDate":"2025-02-20","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143476419","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":"Boost your health (Refuerza tu Salud): Design of a randomized controlled trial of a community health worker intervention to reduce inequities in COVID-19 and influenza vaccinations.","authors":"Lisa S Meredith, Jonathan N Tobin, Andrea Cassells, Khadesia Howell, Helin Hernandez, Courtney Gidengil, Stephanie Williamson, Lu Dong, George Timmins, Gabriela Alvarado, Tameir Holder, T J Lin, Marielena Lara","doi":"10.1016/j.cct.2025.107848","DOIUrl":"https://doi.org/10.1016/j.cct.2025.107848","url":null,"abstract":"<p><strong>Introduction: </strong>Low-income and underserved populations, especially racial and ethnic minorities, experience health disparities linked to social determinants. The COVID-19 pandemic amplified these disparities, necessitating effective strategies to address structural racism and related factors. Vaccination, crucial for mitigating infectious diseases, including COVID-19 and influenza, remains challenging among underserved populations. Community health worker (CHW) interventions show promise in addressing these disparities but have not undergone rigorous evaluation with a randomized controlled trial to increase vaccination uptake among underserved populations. This study develops and evaluates a CHW vaccination behavior (CHW-VB) intervention to increase COVID-19 and influenza vaccination among adult patients in primary care settings.</p><p><strong>Methods: </strong>Tailoring of the Boost Your Health (Refuerza tu Salud) intervention is grounded in behavior change theory and integrates input from a Community Advisory Board. The study employs a patient randomized controlled trial design to test the effectiveness the CHW-VB intervention compared with usual care across six Federally Qualified Health Centers (FQHCs) in New York. Patients are being screened for eligibility (vaccinated but not up to date with the COVID-19 vaccine and have at least one of seven common chronic illnesses) and 800 are assessed at baseline, three, and six months. Outcomes include COVID-19 vaccine (primary) and influenza vaccine (secondary) uptake. The study also evaluates intervention implementation using the RE-AIM model.</p><p><strong>Conclusion: </strong>Boost Your Health aims to increase COVID-19 and influenza vaccination among racially/ethnically diverse, underserved populations with chronic illness through the CHW-VB intervention, targeting critical gaps in vaccination uptake to reduce health disparities and increase health equity.</p><p><strong>Trial registration: </strong>(ClinicalTrials.govNCT06156254).</p>","PeriodicalId":10636,"journal":{"name":"Contemporary clinical trials","volume":" ","pages":"107848"},"PeriodicalIF":2.0,"publicationDate":"2025-02-16","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143448079","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":"Is exergaming a viable exercise option for obese black women?","authors":"Jennifer Hicks ,&nbsp;Chiranjeev Dash ,&nbsp;Danyel Smith ,&nbsp;James Hagberg ,&nbsp;Kepher Makambi ,&nbsp;Lucile Adams-Campbell","doi":"10.1016/j.cct.2025.107846","DOIUrl":"10.1016/j.cct.2025.107846","url":null,"abstract":"<div><h3>Background</h3><div>Physical inactivity and obesity, which are disproportionately higher in Black women, are known risk factors of breast cancer. Novel methods to address this public health concern involve leveraging screen-viewing activities to reduce sedentary behavior and increase energy expenditure levels. Exergaming has demonstrated efficacy in increasing physical activity levels, yet no studies have examined exergaming in overweight/obese Black women. The primary objective of this study was to examine the effect of exergaming on anthropometric markers among overweight/obese Black women.</div></div><div><h3>Methods</h3><div>This study was a 2-arm, 6-month randomized controlled trial examining the efficacy of exergaming in improving obesity-related anthropometric markers among overweight and obese Black women (n = 100). Participants randomized to the exergaming condition (<em>n</em> = 50) engaged in supervised exergaming activities (i.e., Nintendo Wii Fit/X-box Kinect for 3 days/week; 60-min), while the control group (<em>n</em> = 50) maintained current physical activity levels. Assessments on anthropometric variables, physical activity, medical history and sociodemographic variables were completed at baseline, 3-, and 6-months. Two-sample <em>t-</em>tests were used to examine group differences in outcome variables at 6 months.</div></div><div><h3>Results</h3><div>There were no significant between-group differences observed in waist circumference (108.7(14.6) cm vs 107.2(14.8) cm), fat mass (44.3(12.8) kg vs 46.1(12.5) kg) or lean mass (47.0(6.9) kg vs 48.2(4.7) kg) at 6-months.</div></div><div><h3>Conclusions</h3><div>Exergaming did not demonstrate efficacy in improving obesity-related anthropometric markers in overweight/obese Black women. Exergaming is not a viable exercise for obese women. Future studies should consider pairing exergaming with traditional exercises (i.e., variety support) and exploring other factors related to energy expenditure (e.g., motivation, enjoyment).</div></div>","PeriodicalId":10636,"journal":{"name":"Contemporary clinical trials","volume":"151 ","pages":"Article 107846"},"PeriodicalIF":2.0,"publicationDate":"2025-02-12","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143425038","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":"A randomised controlled trial of a multidisciplinary TEAM-based approach to guide secondary cardiovascular risk reduction for patients with Peripheral Artery Disease (TEAM-PAD) study protocol","authors":"Ritesh Chimoriya ,&nbsp;Sophie James ,&nbsp;Leonard Kritharides ,&nbsp;Janani Thillainadesan ,&nbsp;Samim Behdasht ,&nbsp;Shaundeep Sen ,&nbsp;Avinash Suryawanshi ,&nbsp;Huw Davie ,&nbsp;Amy Kitajima ,&nbsp;Sarah Joy Aitken","doi":"10.1016/j.cct.2025.107844","DOIUrl":"10.1016/j.cct.2025.107844","url":null,"abstract":"<div><h3>Background</h3><div>Peripheral arterial disease (1) is a vascular condition associated with significant cardiovascular morbidity and mortality. Effective secondary prevention strategies are essential to improve cardiovascular outcomes in patients with PAD. The TEAM-PAD study aims to determine if a centralised virtual multidisciplinary team (MDT) model of care is effective in improving guideline-recommended secondary cardiovascular risk reduction for outpatients with PAD.</div></div><div><h3>Methods</h3><div>TEAM-PAD is a multicentre, randomised controlled trial involving patients with PAD. Participants will be randomised into two groups: the intervention group, who will receive care supported by cardiovascular risk reduction recommendations from a centralised MDT; and the control group, who will receive usual care by their vascular surgeon. The MDT will consist of the following clinicians: vascular surgeon, cardiologist, endocrinologist, nephrologist, geriatrician, drug health physician and clinical pharmacist. The primary outcome is the change in a composite measure of an individual's 10-year cardiovascular risk between baseline to 9-months follow-up. Secondary outcomes include control of modifiable cardiovascular risk factors and medication optimisation, cardiovascular and limb outcomes, PAD symptom control, quality of life outcomes, and health-service use outcomes.</div></div><div><h3>Conclusion</h3><div>This article details the TEAM-PAD trial protocol, which will provide robust evidence on the benefits of an MDT-based approach to cardiovascular risk reduction in PAD patients. TEAM-PAD has the potential to inform clinical practice by demonstrating whether coordinated, personalised care recommendations can improve cardiovascular risk and potentially reduce cardiovascular events in this high-risk population.</div><div><strong>Trial Registration:</strong> This study has been registered at the Australia New Zealand Clinical Trial Registry (Registration number: ACTRN12623000995673).</div></div>","PeriodicalId":10636,"journal":{"name":"Contemporary clinical trials","volume":"151 ","pages":"Article 107844"},"PeriodicalIF":2.0,"publicationDate":"2025-02-12","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143425034","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Design of the Continuous Glucose Monitoring (CGM) Study in the Dietary Approaches to Stop Hypertension for Diabetes Trial (DASH4D-CGM)","authors":"Dan Wang ,&nbsp;Scott Z. Mu ,&nbsp;Olive Tang ,&nbsp;Justin B. Echouffo-Tcheugui ,&nbsp;Christine M. Mitchell ,&nbsp;Michael Fang ,&nbsp;Mary R. Rooney ,&nbsp;Hsin-Chieh Yeh ,&nbsp;Casey M. Rebholz ,&nbsp;Scott J. Pilla ,&nbsp;Lawrence J. Appel ,&nbsp;Elizabeth Selvin","doi":"10.1016/j.cct.2025.107845","DOIUrl":"10.1016/j.cct.2025.107845","url":null,"abstract":"<div><h3>Background</h3><div>The Dietary Approaches to Stop Hypertension (DASH) diet is recommended for adults with diabetes. However, the effects of the DASH diet on glucose control and variability have not been thoroughly investigated.</div></div><div><h3>Study aim</h3><div>To study the effects of a modified DASH diet on glycemic control and glucose variability assessed by continuous glucose monitoring (CGM) in individuals with hypertension and type 2 diabetes.</div></div><div><h3>Methods</h3><div>We conducted an ancillary study to add CGM to the Dietary Approaches to Stop Hypertension for Diabetes (DASH4D) Trial. The DASH4D Trial was designed to determine the effects, alone and combined, of a modified DASH diet (vs a diet typical of what Americans with diabetes eat) and lower (vs higher) sodium intake on systolic blood pressure among people with type 2 diabetes and elevated blood pressure. Participants were fed each of the 4 study diets for 5 weeks in a random order. We invited all participants enrolling in the DASH4D Trial to wear a masked CGM sensor for up to 14 days during screening and during each of the four 5-week feeding periods. The DASH4D-CGM Study primarily aimed to evaluate the effects of the modified DASH diet (vs comparison diet) on glycemic control (mean glucose and time-in-range) and glucose variability (coefficient of variation).</div></div><div><h3>Conclusion</h3><div>Combining CGM technology and a controlled feeding design, the DASH4D-CGM Study will generate robust data on the effects of diet on glycemic control and variability. These findings will inform dietary recommendations for adults with type 2 diabetes.</div></div>","PeriodicalId":10636,"journal":{"name":"Contemporary clinical trials","volume":"151 ","pages":"Article 107845"},"PeriodicalIF":2.0,"publicationDate":"2025-02-12","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143425035","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 controlled dose response trial to combat accelerated summer BMI gain in children: The determining the optimal amount of structured environments (DOSE) study","authors":"Keagan P. Kiely ,&nbsp;Michael W. Beets ,&nbsp;Elizabeth L. Adams ,&nbsp;Russell R. Pate ,&nbsp;Chen Brian ,&nbsp;Armstrong Bridget ,&nbsp;Burkart Sarah ,&nbsp;Aliye B. Cepni ,&nbsp;Anthony J. Holmes ,&nbsp;James W. White ,&nbsp;Finnegan Olivia ,&nbsp;Savidge Meghan ,&nbsp;Parker Hannah ,&nbsp;Griffin A.T. Randolph ,&nbsp;Zhu Xuanxuan ,&nbsp;R. Glenn Weaver","doi":"10.1016/j.cct.2025.107840","DOIUrl":"10.1016/j.cct.2025.107840","url":null,"abstract":"<div><h3>Background</h3><div>Summer is a period of accelerated body mass index (BMI) gain for elementary school-aged children. Summer day camps may provide a structured environment, which has been shown to mitigate accelerated summer BMI gain. Many of these programs have a fee-for-service structure, creating a financial barrier for families with low-income. Providing vouchers to pay for these programs may be an effective strategy for addressing this barrier and mitigating accelerated summer BMI gain but requires further investigation on the optimal dose - the minimum exposure needed to see meaningful results while not overextending resources.</div></div><div><h3>Methods</h3><div>This study will use a multi-arm randomized controlled trial with three treatment levels. Children (<em>n</em> = 360) ages 5–12 years from participating schools (<em>n</em> = 4) will be randomly assigned to either summer as usual (comparison group) or to receive a voucher to attend an existing summer day camp for 4-, 6-, or 8-, weeks. BMI will be objectively measured at baseline (i.e., ∼May), 3-months (i.e., ∼August), and 12-months (i.e., ∼May of following school year). Obesogenic behaviors (e.g., physical activity, diet, screen time, and sleep) will be assessed in spring (i.e., late May) and summer (i.e., late June and July). Implementation factors, such as content, attendance frequency, duration, and coverage, relationship with children's summer BMI gain and obesogenic behaviors will also be evaluated. The study will also evaluate the cost-effectiveness of each duration.</div></div><div><h3>Discussion</h3><div>The study's findings will identify the optimal dose of summer programming to mitigate excess summer BMI gain, informing effective public health initiatives to combat childhood obesity.</div><div>Trial Registration: NCT06158594</div><div><span><span>https://clinicaltrials.gov/study/NCT06158594?titles=determining%20optimal%20amount%20of%20structured%20environments&amp;rank=1</span><svg><path></path></svg></span>.</div></div>","PeriodicalId":10636,"journal":{"name":"Contemporary clinical trials","volume":"151 ","pages":"Article 107840"},"PeriodicalIF":2.0,"publicationDate":"2025-02-10","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143403708","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":"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}