Contemporary Clinical Trials Communications最新文献

{"title":"Evaluation of the effect of acupuncture on weight loss in postpartum obese women: a study protocol for a randomized controlled trial","authors":"Han Zhang ,&nbsp;Xinyu Zhang ,&nbsp;Yuejiao Wang ,&nbsp;Ran Yang ,&nbsp;Yanan Zhen ,&nbsp;Yang Zhang ,&nbsp;Qi Zhao ,&nbsp;Yinping Xu ,&nbsp;Zhishun Liu ,&nbsp;Shulan Wang","doi":"10.1016/j.conctc.2025.101528","DOIUrl":"10.1016/j.conctc.2025.101528","url":null,"abstract":"<div><h3>Background</h3><div>Pregnant women gain an average weight of 16.6 ± 4.8 kg during pregnancy, with weight retention of 4 kg at 6 months, 4 kg at 12 months, and 2.9 kg at 18 months postpartum. At 3, 6, 9 and 12 months after delivery, 61.92 %, 68.73 %, 78.18 % and 84.24 % of women whose BMI returned to the normal range, respectively. Obesity has negative effects on postpartum women's physical and mental health. Prior research has suggested that acupuncture may be beneficial for weight loss. This study investigates the effectiveness of manual acupuncture (MA) for treating postpartum obesity (PO), compared to sham acupuncture (SA).</div></div><div><h3>Methods</h3><div>This is a multicenter, randomized, single-blind controlled trial. A total of 82 eligible PO participants will be randomly assigned to either MA (n = 41) or SA (n = 41) group using a 1:1 ratio. The MA group received acupuncture treatment and the control group received sham acupuncture treatment. Both groups received diet and exercise instructions and were treated for 30 min each session, three times a week, for a total of 8 weeks. The primary outcome measure was the change in body mass index (BMI) after 8 weeks of treatment, compared to baseline. Secondary outcome measures include changes in BMI from baseline to 4 weeks of treatment, changes in waist circumference, waist-to-hip ratio (WHR), blood glucose, lipid levels, thyroid function and other serological measures from baseline to 8 weeks of treatment. Secondary measures also included dietary and exercise guidance compliance scales, as well as assessments of depression and anxiety status. The safety of acupuncture was continuously evaluated throughout the study. Follow-up was performed at 14 and 20 weeks after treatment.</div></div><div><h3>Discussion</h3><div>This prospective randomized trial will help evaluate the efficacy and safety of acupuncture in treating PO. The results of this study will provide evidence of the therapeutic effectiveness of acupuncture on PO.</div></div><div><h3>Trial registration</h3><div>chictr.org.cn: ChiCTR2300067658, registered on January 17, 2023.</div></div>","PeriodicalId":37937,"journal":{"name":"Contemporary Clinical Trials Communications","volume":"47 ","pages":"Article 101528"},"PeriodicalIF":1.4,"publicationDate":"2025-07-23","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144703293","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 feasibility of a financial and health-related social needs navigation intervention (AYA-NAV) for adolescents and young adults with Cancer: Study protocol for a prospective, single-arm study","authors":"Rhea K. Khurana ,&nbsp;Kathryn Valera ,&nbsp;Rohit Raghunathan ,&nbsp;Kathleen D. Gallagher ,&nbsp;Rebekah SM. Angove ,&nbsp;Erin Bradshaw ,&nbsp;Janet Patton ,&nbsp;Sabrina Alvarado ,&nbsp;Stephen Crespo ,&nbsp;Kimberly Judon ,&nbsp;Katie DiCola ,&nbsp;Dara M. Steinberg ,&nbsp;Shikun Wang ,&nbsp;Dawn L. Hershman ,&nbsp;Melissa P. Beauchemin","doi":"10.1016/j.conctc.2025.101523","DOIUrl":"10.1016/j.conctc.2025.101523","url":null,"abstract":"<div><h3>Background</h3><div>Adolescent and young adult (AYA: 15–39 years) cancer survivors face high financial toxicity risk. Addressing unmet health-related social needs (HRSN: financial strain, food, housing, transportation, or utility difficulties) may reduce health and financial disparities. This pilot study examines the feasibility and preliminary impact of a needs navigation intervention (AYA-NAV) for AYAs with cancer who screen positive for financial toxicity or unmet HRSN.</div></div><div><h3>Methods</h3><div>This single-arm study involves 30 AYAs receiving cancer treatment at a large, diverse academic institution. After a baseline assessment to determine eligibility, those screening positive for financial toxicity or unmet HRSN will receive AYA-NAV, including resource provision and hybrid needs navigation via a referral to the Patient Advocate Foundation (PAF) and a digital platform, <span><span>findhelp.org</span><svg><path></path></svg></span>. Data will be collected at baseline (preintervention), monthly check-ins (months 2–5), and 6-month follow-up (postintervention) through surveys using validated scales to measure financial toxicity, HRSN, quality of life, and implementation outcomes. Feasibility will be evaluated with predetermined acceptability measures.</div></div><div><h3>Discussion</h3><div>This protocol assesses the feasibility of AYA-NAV, a hybrid needs navigation intervention for AYAs with cancer. Findings will inform future randomized studies on efficacy and impact. Additionally, this study may guide sustainable community-partnered navigation research to improve cancer care delivery and patient outcomes.</div></div><div><h3>Trial registration</h3><div>Clinicaltrials.gov registry: NCT06072833. The study was registered on October 3, 2023.</div></div>","PeriodicalId":37937,"journal":{"name":"Contemporary Clinical Trials Communications","volume":"47 ","pages":"Article 101523"},"PeriodicalIF":1.4,"publicationDate":"2025-07-16","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144656014","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":"Patient-centered medical tools for sustained motivation in cardiac rehabilitation of patients with heart failure: protocol of a multicenter randomized controlled trial (EXERCISE-HF trial)","authors":"Koki Yamaoka ,&nbsp;Yoshinori Katsumata ,&nbsp;Shun Kohsaka ,&nbsp;Yasuyuki Shiraishi ,&nbsp;Masahiro Kondo ,&nbsp;Kengo Nagashima ,&nbsp;Takeshi Onoue ,&nbsp;Masaharu Kataoka ,&nbsp;Takatomo Watanabe ,&nbsp;Daisuke Nakashima ,&nbsp;Yuki Muramoto ,&nbsp;Yasunori Sato ,&nbsp;Kazuki Sato ,&nbsp;Masaya Nakamura ,&nbsp;Masaki Ieda","doi":"10.1016/j.conctc.2025.101522","DOIUrl":"10.1016/j.conctc.2025.101522","url":null,"abstract":"<div><h3>Introduction</h3><div>Heart failure substantially affects the quality of life of patients and imposes notable social and economic burdens. Despite the beneficial effects of cardiac rehabilitation, global participation rates remain low. Recent advances in wearable biometric technologies may improve patient adherence through real-time monitoring and personalized feedback. This study aimed to develop and evaluate an exercise-support program that integrates wearable devices to enhance rehabilitation outcomes in patients with heart failure.</div></div><div><h3>Methods</h3><div>An innovative and practical cardiac rehabilitation program combined with a wearable device was developed based on patients and physicians’ feedback. A multicenter randomized controlled clinical trial was designed to evaluate the safety and effectiveness of the application in patients with heart failure in Japan from October 2022 to January 2025. Compared with traditional exercise-monitoring applications, the developed application offers an array of features that are designed to foster patient engagement and promote long-term adherence. These features include (1) individualized goal setting, (2) direct communication with healthcare providers, (3) education on heart failure through instructional videos, (4) automated motivational feedback, and (5) a curated library of research summaries on cardiac rehabilitation and self-care. Patients who meet the inclusion criteria (including those aged ≥18 years with a clinical diagnosis of heart failure) will be randomly assigned to one of two groups as follows: the integrated exercise-support app group or the standard care group, in which only a wearable device was implemented. The change in peak VO₂ at 12 weeks, adjusted for baseline and allocation factors, will be analyzed as the primary endpoint. The secondary outcomes include quality-of-life measures and re-hospitalization rates. Data analysis will follow the intention-to-treat principle, with results reported as two-tailed 95 % confidence intervals and corresponding <em>p</em>-values.</div><div>This study was approved by the relevant institutional ethics committee (approval number: DB23-001; iRCT: 2032230388). Informed consent will be obtained from all participants before study participation. The results of the study will be disseminated through peer-reviewed publications and presented at relevant scientific meetings.</div></div>","PeriodicalId":37937,"journal":{"name":"Contemporary Clinical Trials Communications","volume":"47 ","pages":"Article 101522"},"PeriodicalIF":1.4,"publicationDate":"2025-07-15","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144656015","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 feasibility of the Community health worker Outreach and Navigation Network for Enhancing representation in Clinical Trials (CONNECT) model: A community-physician engagement approach for increasing representation in clinical trials","authors":"Mindy Feldman Hecht ,&nbsp;Mara Minguez ,&nbsp;Alejandra Aguirre ,&nbsp;Melissa Fajardo ,&nbsp;Olajide Williams","doi":"10.1016/j.conctc.2025.101521","DOIUrl":"10.1016/j.conctc.2025.101521","url":null,"abstract":"<div><h3>Background</h3><div>Despite efforts to increase racial and ethnic representation in clinical trials (CT), inclusion of minoritized participants remains inadequate. To address the barriers of ineffective outreach and reduced opportunities, we developed a program called <u>C</u>ommunity health worker <u>O</u>utreach and <u>N</u>avigation <u>N</u>etwork for <u>E</u>nhancing representation in <u>C</u>linical <u>T</u>rials (CONNECT). This article describes CONNECT and its feasibility of implementation over a 3-month period.</div></div><div><h3>Methods</h3><div>At the core of CONNECT is a dedicated culturally and language concordant CT-trained Community Health Worker (CHW) and local community physician. The CHW was embedded in a local community physician's practice, where they educated patients about CTs during one-on-one encounters. The CHW then followed up with patients to assist with referral to a CT that fit patients' interests. Our primary outcome was patient openness and fit for CTs as demonstrated by a CHW referral to a CT.</div></div><div><h3>Results</h3><div>The CHW met with 74 of ∼150 patients (49 %) one-on-one and referred 62 of the 74 participants (84 %) to CTs that fit their preferences.</div></div><div><h3>Conclusion</h3><div>Our study demonstrates the feasibility of the CONNECT model for increasing openness and fit to CT referrals for underrepresented populations. Strengthening relationships with community physicians serving wide-ranging patient populations and embedding a CHW in their practice to educate patients about CTs may be an important pathway for increasing openness to and support for CT participation. We found that CHWs can bridge the research trust gaps, facilitate openness to CT participation and create accessible opportunities to participate in CTs that fit participant preferences.</div></div>","PeriodicalId":37937,"journal":{"name":"Contemporary Clinical Trials Communications","volume":"46 ","pages":"Article 101521"},"PeriodicalIF":1.4,"publicationDate":"2025-07-07","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144633391","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":"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}