Trials最新文献

{"title":"Randomized, controlled trial comparing the efficacy of intercostal nerve block in thoracoscopic surgery by timing: study protocol for a randomized clinical trial.","authors":"Yasuharu Sekine, Hideo Ichimura, Sho Ueda, Shinsuke Kitazawa, Naohiro Kobayashi, Yuya Murata, Kumiko Yamada, Shinichi Inomata, Kazushi Maruo, Yukio Sato","doi":"10.1186/s13063-025-09059-3","DOIUrl":"https://doi.org/10.1186/s13063-025-09059-3","url":null,"abstract":"<p><strong>Background: </strong>Even minimally invasive thoracic surgeries carry a postoperative cost in pain. While regional anesthesia may alleviate this anticipated pain, especially intercostal nerve blocks (ICNB), the timing of block administration for optimal effect (at the beginning of surgery vs. before wound closure) remains controversial. Here, we plan (1) to test the hypothesis that performing ICNB at the beginning of surgery provides superior postoperative analgesic effects compared to before wound closure and (2) to observe perioperative outcomes to determine whether the timing affects acute and chronic postoperative pain, or intraoperative patient management.</p><p><strong>Methods: </strong>This single-blinded, single-center, randomized, controlled trial will be conducted at the Department of Thoracic Surgery, University of Tsukuba Hospital from Sep 29, 2024, to June 30, 2026. Patients 16-79 years old within the regular population of patients undergoing lung wedge resection via video-assisted thoracoscopic surgery (VATS) without a utility window approach and who are ASA-PS classes 1-3 will be enrolled to receive ICNB either pre-operatively or before wound closure. Groups will be single-blinded (patient only) at random, and the primary outcome will be assessment by Numerical Rating Scale (NRS) pain scores during movement, measured 4 h after returning to the ward. Secondary outcomes will be (1) any additional analgesic use within the 4-h return window, (2) intraoperative measurements (including amounts of remifentanil used, time from surgery completion to extubation, occurrence of shivering or nausea after extubation, use of antiemetics, and maximum blood pressure/heart rate), (3) acute pain during hospitalization (using routinely administered NRS), (4) postoperative analgesic use, and (5) quality of life (QOL) scores on EQ-5D and SF-36 questionnaires at preoperative and 3-month postoperative timepoints. Chronic pain at 3 months post-surgery will also be determined by NRS.</p><p><strong>Discussion: </strong>A complete evaluation of ICNB efficacy as a preemptive analgesic approach will contribute to the development of improved perioperative pain management techniques. A reduction in the duration of surgery-related symptoms and an improvement in postoperative QOL will be the result.</p><p><strong>Trial registration: </strong>Japan Registry of Clinical Trials: identifier jRCT1031240358. Registered on 29 Sep 2024.  https://jrct.niph.go.jp/latest-detail/jRCT1031240358 .</p>","PeriodicalId":23333,"journal":{"name":"Trials","volume":"26 1","pages":"301"},"PeriodicalIF":2.0,"publicationDate":"2025-08-23","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12375271/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144970745","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Effect of tirzepatide-induced weight loss on adipose tissue in obesity: rationale and design of the randomized placebo-controlled Tirzepatide Brown and Beige Adipose Tissue Activation (TABFAT) trial.","authors":"Rok Herman, Mojca Jensterle, Simon Horvat, Luka Lezaic, Ziga Snoj, Igor Pusnik, Katja Goricar, Andrej Cör, Luka Pusnik, Vid Mlacnik, Lara Hanzelic, Andrej Janez","doi":"10.1186/s13063-025-09045-9","DOIUrl":"https://doi.org/10.1186/s13063-025-09045-9","url":null,"abstract":"<p><strong>Background: </strong>Obesity is a complex disease marked by excessive, dysfunctional adipose tissue accumulation. Recent research underscores the pivotal role of brown adipose tissue (BAT) in metabolic health and its potential as a therapeutic target for obesity management. Emerging preclinical and clinical evidence suggests that second-generation anti-obesity drugs, especially dual agonists such as tirzepatide, may enhance BAT activity. Additionally, beige adipose tissue, derived from white adipose tissue (WAT), may contribute significantly to whole-body thermogenesis, yet its role remains underexplored.</p><p><strong>Methods: </strong>This investigator-initiated, randomized, placebo-controlled clinical trial aims to evaluate the effects of tirzepatide on BAT activity and WAT browning in premenopausal women with obesity. Thirty-four participants will be randomized 1:1 to receive either tirzepatide or a placebo for 24 weeks. Primary outcomes include changes in BAT volume and activity, assessed using 18F-FDG-PET/CT, MRI, and infrared thermography, as well as the induction of WAT browning, evaluated through changes in mRNA expression patterns and histomorphometric alterations in subcutaneous adipose tissue samples. Secondary outcomes will involve the assessment of whole-body composition, resting energy expenditure, and various metabolic health markers, correlated with thermogenic adipose tissue changes. Comparative analysis of BAT assessment methods will refine protocols for research and clinical use.</p><p><strong>Discussion: </strong>This study is the first to systematically explore the potential of pharmacological obesity management to enhance BAT activity and induce WAT browning. Results may establish thermogenic adipose tissue augmentation as a novel mechanism of action for second-generation anti-obesity medications.</p><p><strong>Trial registration: </strong>ClinicalTrials.gov NCT06893211. Registered on 2025 March 25.</p>","PeriodicalId":23333,"journal":{"name":"Trials","volume":"26 1","pages":"300"},"PeriodicalIF":2.0,"publicationDate":"2025-08-22","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12374325/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144970574","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"A randomized, controlled, 12-month trial on the effects of an interdisciplinary treatment approach in ESRD patients: study protocol of the smart and fit for kidney transplantation trial (S&F4KTx).","authors":"Helge Krusemark, Judith Kleemann, Julian Weigand, Dennis Kannenkeril, Katharina Heller, Tobias Hepp, Marc Albersmeyer, Doris Gerbig, Mario Schiffer","doi":"10.1186/s13063-025-09022-2","DOIUrl":"https://doi.org/10.1186/s13063-025-09022-2","url":null,"abstract":"<p><strong>Background: </strong>A prolonged waiting time for a kidney transplant leads to a significant decline in the general health status of many patients with chronic kidney disease (CKD). This deterioration may cause these patients to be classified as unsuitable for transplantation during the waiting period owing to frailty, poor body composition, or the development of new comorbidities. Studies have shown that physical exercise and tailored nutrition can maintain and improve physical performance and overall health status.</p><p><strong>Methods: </strong>This study is a 1:1 controlled, randomized trial. The control group will receive standard care along with an app designed for dialysis patients, which provides information on topics such as nutrition, vital signs, blood parameters, and details about their condition. In addition, the intervention group will receive individualized nutritional and exercise recommendations, along with a 3-week inpatient rehabilitation program. At 0, 6, and 12 months, body composition (body mass index, skeletal muscle mass, body fat mass, and waist circumference) and physical performance (6-min walk test, timed up and go test, sit-to-stand test, one-legged stance test, stair climbing test, and frailty), blood values (e.g., potassium and phosphate), and quality of life (KDQOL) will be evaluated. Bone density (tibia and radius) will be measured at 0 and 12 months.</p><p><strong>Discussion: </strong>Studies have demonstrated that physical activity and tailored nutrition have positive effects on the general health of dialysis patients. However, pretransplantation preparation programs (prehabilitation) aimed at preserving transplant eligibility have not yet been evaluated. This study aims to address this gap by investigating a potential care program for patients on the transplant waiting list.</p><p><strong>Trial registration: </strong>ClinicalTrials.gov NCT06040281. Registered on September 15, 2023.</p><p><strong>Trials status: </strong>Protocol version number: 4 (30.07.2025). Recruitment start: 18.09.2023. Recruitment completed: 30.06.2025.</p>","PeriodicalId":23333,"journal":{"name":"Trials","volume":"26 1","pages":"298"},"PeriodicalIF":2.0,"publicationDate":"2025-08-21","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12369097/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144970665","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"PRO-DIALOG-the effect of a novel dialogue-based parent-teacher conference on mental health in kindergarten children: a cluster randomized controlled trial.","authors":"Ingvar Bjelland, Gro Janne Wergeland, Christopher Gillberg, Rolf Gjestad, Adrijana Višnjić-Jevtić, Veronica Kibbe Lisæth, Carmela Miniscalco, Amanda Louise Flygel Tufta, Ida Lygre Vermeer, Alicja Renata Sadownik, Philip Wilson, Maj-Britt Posserud","doi":"10.1186/s13063-025-08980-x","DOIUrl":"10.1186/s13063-025-08980-x","url":null,"abstract":"<p><strong>Background: </strong>Mental health difficulties in preschool children often go unnoticed and may result in delayed access to potentially beneficial services. In Norwegian kindergartens, teachers get to know the children well over time and have parent-teacher conferences once or twice a year. Kindergarten is thus a well-suited arena for early identification and intervention of mental health difficulties. To address the need for a kindergarten-specific method for secondary prevention, we have developed Dialogue-Based Early Detection (DBED) in close collaboration with educators and parents in eight different kindergartens. Results from a feasibility study indicate that DBED works well as a parent-teacher collaborative screening method and is well accepted by the users. In the PRO-DIALOG project, we will examine the potential of DBED and explore its possible long-term effects in a randomized controlled trial.</p><p><strong>Methods: </strong>Ten kindergartens will be randomly selected to implement DBED, while ten will act as controls, offering ordinary parent-teacher conferences. Parents of at least 100 + 100 children will be recruited. The primary outcome will be children's mental health in the intervention group as assessed by the Strengths and Difficulties Questionnaire (SDQ), during the 5-year follow-up, compared to the control group. Secondary outcomes will be (i) the effect of DBED on parental stress as measured by the Parental Stress Scale (PSS) and (ii) time to activation of support, as measured by the duration from the first parent-teacher conference to activation of any support, comparing the two groups. We will also assess (iii) socio-demographic predictors for mental health development, parent and teacher concern for the child, parental stress, and parent satisfaction with DBED, (iv) screening properties of DBED compared to SDQ, and (v) social validity of DBED as measured by user-satisfaction questionnaires and interviews with both parents and teachers.</p><p><strong>Discussion: </strong>This complex intervention study includes a wide range of outcomes beyond the mental health scores of kindergarten children. If the intervention is well accepted and has a positive influence on the children's mental health, the DBED method has a potential for a wide dissemination. This study will produce new knowledge on kindergarten as an arena for the promotion of mental health among young children.</p><p><strong>Trial registration: </strong>ClinicalTrials.gov NCT06471816. Registered on 2024-06-22 16:06. Retrospectively registered.</p>","PeriodicalId":23333,"journal":{"name":"Trials","volume":"26 1","pages":"299"},"PeriodicalIF":2.0,"publicationDate":"2025-08-21","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12372322/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144970688","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Randomized adaptive assessment of post COVID syndrome treatments (RAPID): a study protocol for a multicenter, randomized, controlled adaptive platform trial of treatment options for Post Covid Syndrome (PCS) on patients physical function including the first intervention specific appendix RAPID_REVIVE (reducing inflammatory activity in patients with PCS).","authors":"Lisa Weipert, Ralph G Telgmann, Gabriele Anton, Thomas Asendorf, Irina Chaplinskaja-Sobol, Sandra Ciesek, Oliver A Cornely, Sonja Drescher, Carsten Finke, Tim Friede, Julia Groth, Sabine Hanß, Wolfgang Hoffmann, Cynthia Huber, Thomas Illig, Monika Kraus, Dagmar Krefting, Sebastian Kuhn, Andreas Muehler, Matthias Nauck, Jens Schaller, Ann-Cathrin Schmidt, Georg Schmidt, Birgit Sawitzki, Ralf Tostmann, Heike Valentin, Maria Vehreschild","doi":"10.1186/s13063-025-09008-0","DOIUrl":"10.1186/s13063-025-09008-0","url":null,"abstract":"<p><strong>Background: </strong>The majority of patients recovers from severe acute respiratory syndrome coronavirus type 2 (SARS-CoV-2) coronavirus disease 2019 (COVID-19) without obvious sequelae, but a significant proportion suffers long-term consequences which have been termed post COVID syndrome (PCS). Despite a wide range of considerations on treatment options in PCS and a significant number of trials initiated, only very few results from randomized controlled trials are currently available. In conclusion, there is an evident medical need to identify treatments for patients with PCS.</p><p><strong>Methods: </strong>The primary objective of the platform trial RAPID is to assess the impact of different PCS treatments on the overall physical function of patients. Designed as a master protocol, RAPID contains all information that is generic to this adaptive platform trial. Current and future study treatments are specified in intervention-specific appendices (ISA). The first ISA, RAPID_REVIVE is presented in this manuscript. General sections of the master protocol are named as such. RAPID_REVIVE is a double-blind, placebo-controlled, phase II clinical trial evaluating antiviral PCS treatment with vidofludimus calcium (IMU-838). Patients are randomized at a 1:1 ratio to 45 mg/day vidofludimus calcium (22.5 mg for the first 7 days) or placebo during an initialization phase and thereafter using a response-adaptive randomization procedure. The trial includes a screening period of 7 days, a double-blind treatment period of 56 days and a follow-up period of 28 days. The primary outcome is the intra-patient change in physical function measured by the Short Form-36 Physical Function (SF-36-PF) from baseline to day 56. Secondary endpoints include mental and physical health, intensity of fatigue, severity of mental disorder symptoms, and cognitive function.</p><p><strong>Discussion: </strong>PCS is a major problem for global health care and the identification of treatment options is urgently needed. Currently, PCS patients are in a situation without evidence-based treatment options, and quality of life, and often mental health are significantly impaired. The purpose of RAPID is to establish an adaptive platform trial protocol which will concert and quicken clinical trials to evaluate the efficacy and safety of different potential treatments for PCS with the aim to expand the very limited evidence base for the treatment of PCS.</p><p><strong>Trial registration: </strong>EU Clinical Trials Register (CTIS) ID: 2024-511628-16-00 (RAPID_REVIVE). Registered on 18.03.2024.</p>","PeriodicalId":23333,"journal":{"name":"Trials","volume":"26 1","pages":"297"},"PeriodicalIF":2.0,"publicationDate":"2025-08-19","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12366011/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144883842","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Non-inferiority of sleep position therapy compared to positive airway pressure therapy with regard to daytime sleepiness in patients with mild to moderate position-dependent obstructive sleep apnoea (POSA): study protocol for a multicentre randomised cross-over trial.","authors":"Nina Timmesfeld, Anja Neumann, Frederik Valbert, Jürgen Wasem, Alexandra Spillner, Christoph Schöbel","doi":"10.1186/s13063-025-09007-1","DOIUrl":"10.1186/s13063-025-09007-1","url":null,"abstract":"<p><strong>Background: </strong>First-line therapy for patients with clinically relevant obstructive sleep apnoea (OSA) is positive airway pressure therapy (PAP). At least one half of patients with mild to moderate OSA (apnoea-hypopnoea-index (AHI) 5-30/h) have positional OSA (POSA), where apnoea occurs mostly in supine sleep. These patients might benefit from sleep-position therapy (SPT) which should reduce sleeping time spent in a supine position. Until now, it is unclear whether SPT is non-inferior to PAP therapy for symptom relief in these patients.</p><p><strong>Methods: </strong>This is a multicentre, non-inferiority, open-label randomised, cross-over clinical trial. Patients with mild to moderate POSA and daytime sleepiness (according to Epworth Sleepiness Scale (ESS) > 10 points) will be randomised with a 1:1 allocation ratio, stratified by centre and AHI, to start with either PAP therapy or SPT and treated for 12 weeks. After a wash-out period of two weeks, they will switch to the other therapy for 12 weeks. The primary outcome is daytime sleepiness measured by the ESS at the end of each treatment phase. Analysis will be done in the intention-to-treat population using a linear mixed-effects model containing the intervention, the phase, the interaction between therapy and phase (including the carry-over effect) and the baseline measurement of the ESS and AHI as fixed effect, and centre and patient as random effects. A one-sided test at significant level of 2.5% will be used to test the non-inferiority of SPT with a non-inferiority margin of 1.35. Based on a sample size calculation with a one-sided one-sample t-test at significant level of 2.5%, assuming a standard deviation of 4, a total of 418 patients should be included to reach 80% power when SPT is only slightly inferior to PAP therapy (difference 0.8 resulting in a delta of 0.55 (1.35-0.8)). Assuming a 5% drop-out rate, 220 patients per sequence should be included. Possible futility stopping is planned at an interim analysis after 300 patients.</p><p><strong>Discussion: </strong>The recruitment of patients with mild to moderate POSA is feasible with the planned centres. Both certified interventions (PAP and SPT) are covered by the statutory health insurance companies as part of the trial guideline.</p><p><strong>Trial registration: </strong>DRKS00033048 registered 17. June 2024, http://www.drks.de .</p>","PeriodicalId":23333,"journal":{"name":"Trials","volume":"26 1","pages":"295"},"PeriodicalIF":2.0,"publicationDate":"2025-08-18","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12363012/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144875321","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Reablement in Residential Aged Care (Re-RAC): study protocol for a multi-center pragmatic randomized controlled open-label trial.","authors":"Anna Philipson, Mialinn Arvidsson Lindvall, Cecilia Pettersson, Lena Strålman, Kajsa Lidström Holmqvist","doi":"10.1186/s13063-025-08999-0","DOIUrl":"10.1186/s13063-025-08999-0","url":null,"abstract":"<p><strong>Background: </strong>Living in residential aged care (RAC) facilities can be passivating and negatively impact residents' well-being and quality of life. With a growing global population of older adults and an increasing number residing in RAC facilities, it is crucial to address these concerns. Person-centered reablement, which enhances activity and participation through tailored, multidisciplinary strategies, has shown promising results in home settings. However, its implementation in RAC facilities, especially in Sweden, requires further evaluation. This research project will examine whether the reablement intervention in RAC (Re-RAC) impacts activity performance and satisfaction, participation, quality of life, and well-being, in older adults living in RAC facilities. Additionally, the project will evaluate the health-economic effects of the intervention and explore potential associations with the outcomes. A further aim is to describe the experiences of both the participating older adults and RAC facility staff involved in Re-RAC.</p><p><strong>Methods: </strong>This is a multi-center prospective pragmatic randomized controlled trial has two parallel groups comparing the Re-RAC intervention with usual care. A total of 86 participants are planned to be enrolled. The 8-week intervention will be evaluated using quantitative, qualitative, and health-economic methods. Data will be collected at baseline and after the intervention. Health-economic data will also be gathered 3 months before and after intervention. Primary outcomes are activity performance and satisfaction with performance captured using the Canadian Occupational Performance Measure; secondary outcomes, i.e., health-related quality of life, psychological well-being, and physical activity levels will also be evaluated. Experiences of participants and staff will be captured through individual and focus-group interviews. Cost-effectiveness will be estimated by calculating the cost per quality-adjusted life year gained. Quantitative data will be analyzed using descriptive and comparative statistics; qualitative data will be analyzed using thematic analysis and focus-group methodology.</p><p><strong>Discussion: </strong>This study evaluates the Re-RAC intervention for older adults in RAC through a real-world pragmatic trial, examining activity performance, satisfaction, quality of life, well-being, and health outcomes for older adults in RAC facilities. The study also explores participant and staff experiences and evaluates cost-effectiveness. The results will offer valuable insights informing the future implementation and assessment of reablement interventions in RAC settings.</p><p><strong>Trial registration: </strong>ClinicalTrials.gov, ID: NCT06793501 . Registered on 20 January 2025.</p>","PeriodicalId":23333,"journal":{"name":"Trials","volume":"26 1","pages":"294"},"PeriodicalIF":2.0,"publicationDate":"2025-08-18","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12363129/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144875322","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Implementing routine sexual and reproductive health screening into an Australian child and youth mental health service: study protocol for a cluster randomised controlled trial.","authors":"Julie A Blake, Joseph Debattista, Isabella Andersen, Shuohui Rao, Emma Hart, Nicole Gorden, Scott Harden, Meenakshi S Shanmugam, Mia Molan, Dallas Pitt, Nidhi Krishnan, Kannan Kallapiran, James G Scott","doi":"10.1186/s13063-025-09019-x","DOIUrl":"10.1186/s13063-025-09019-x","url":null,"abstract":"<p><strong>Background: </strong>Adolescents living with mental illness are more likely than their peers to engage in risky sexual behaviours such as unsafe sexual practices or drug misuse, which can result in sexually transmitted infections (STIs), unplanned pregnancies and sexual coercion or violence. One barrier to these adolescents receiving sexual and reproductive health (SRH) care is a lack of skills and confidence of mental health clinicians to discuss SRH concerns. Integrating SRH care for adolescents attending mental health services may facilitate access to timely screening and treatment.</p><p><strong>Methods: </strong>This pragmatic cluster randomised controlled trial involves an educational intervention to train mental health clinicians to conduct brief SRH screening with adolescents (12-17 years) with complex mental health needs attending a child and youth mental health service (CYMHS). The educational intervention is complemented with a referral pathway for a nurse-led SRH consultation where indicated through screening. The study aims to examine the preliminary feasibility and effectiveness of the educational intervention by measuring the number of referrals by clinicians who receive the training for SRH nurse-led consultations compared to untrained clinicians and to measure changes after training in clinician knowledge, skills and confidence to discuss SRH needs of young people accessing the CYMHS. The acceptability of SRH screening and nurse-led SRH consultations in CYMHS will be assessed through qualitative interviews with clinicians, adolescents accessing CYMHS, and their parents.</p><p><strong>Discussion: </strong>There is an unmet need for care for adolescents living with mental illness who have SRH concerns. This trial seeks to assess the preliminary feasibility, effectiveness and acceptability of a service-wide SRH educational intervention which aims to improve access to SRH care for adolescents accessing CYMHS.</p><p><strong>Trial registration: </strong>Australian New Zealand Clinical Trials Registry (ANZCTR) ACTRN12624001462572. Registered on 16 December 2024. https://anzctr.org.au/ACTRN12624001462572.aspx .</p>","PeriodicalId":23333,"journal":{"name":"Trials","volume":"26 1","pages":"296"},"PeriodicalIF":2.0,"publicationDate":"2025-08-18","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12362875/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144875412","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Optimizing a community-based intervention to improve help-seeking for depression care: study protocol for a randomized factorial trial.","authors":"Nagendra P Luitel, Brandon A Kohrt, Bishnu Lamichhane, Anvita Bhardwaj, Kamal Gautam, Mark Jd Jordans","doi":"10.1186/s13063-025-09014-2","DOIUrl":"10.1186/s13063-025-09014-2","url":null,"abstract":"<p><strong>Background: </strong>Depression is a common mental health issue that can be effectively managed in primary and community health care settings. However, there is a significant gap between the number of individuals in need of care and those who actually receive treatment, with the greatest gap in low- and middle-income countries (LMICs). Although efforts have been made in LMICs to improve access to mental health services by addressing supply-side barriers, there has been less attention to demand-side obstacles. On the demand side, factors such as stigma, negative attitudes, and limited awareness of available services lead to underutilization of mental health services. This protocol describes a study of active ingredients of a community-based intervention aimed at enhancing help-seeking for depression care in Nepal, a LMIC with low rates of mental health treatment seeking.</p><p><strong>Methods: </strong>The study will take place in two municipalities in eastern Nepal, utilizing the Multiphase Optimization Strategy (MOST) with a 2 × 3 factorial randomized controlled trial design. Female Community Health Volunteers will be trained to identify individuals with depression using the Community Informant Detection Tool, a proven community-based strategy for proactive case detection, and subsequently implement the Gain Life intervention, which aims to promote help-seeking for depression care. The Gain Life intervention comprises four components: (i) information about depression, (ii) awareness of available services, (iii) stigma reduction by dispelling myths and facts about depression, and (iv) a life transformation story. The study will target the adult population, with eligibility criteria including being 18 years or older, residing in specific municipalities, meeting the CIDT threshold for depression, providing consent, and having proficiency in Nepali. The sample size will be 288, with the primary outcome being help-seeking behaviour.</p><p><strong>Discussion: </strong>In this protocol paper, we outline how the MOST framework can optimize a community-based intervention aimed at improving help-seeking for depression care. The findings from this study will guide decisions on whether to proceed with a fully randomized controlled trial or conduct an additional optimization study to finalize the intervention components.</p><p><strong>Trial registration: </strong>ClinicalTrials.gov NCT06574074. Registered on 27 August 2024.</p>","PeriodicalId":23333,"journal":{"name":"Trials","volume":"26 1","pages":"293"},"PeriodicalIF":2.0,"publicationDate":"2025-08-16","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12358067/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144862502","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}

{"title":"Digitally delivered cognitive behavioral therapy for insomnia (CBT-I) for patients with chronic pain and insomnia (The Back2Sleep Trial): study protocol for a randomized controlled trial.","authors":"Maria Louise Stage Olsen, Jonas Bloch Thorlund, Robert Zachariae, Werner Vach, Laila Bendix, Julie Jespersen, Preben Kidmose, Christine Parsons, Kristian Kidholm, Henrik Bjarke Vægter","doi":"10.1186/s13063-025-09013-3","DOIUrl":"10.1186/s13063-025-09013-3","url":null,"abstract":"<p><strong>Background: </strong>More than half of individuals with chronic pain also experience insomnia. Cognitive behavioral therapy for insomnia (CBT-I) is an effective and safe first-line treatment; however, access remains a major barrier to widespread implementation. This study aims to evaluate the effectiveness of a 9-week app-delivered CBT-I intervention, compared to an app-delivered sleep hygiene education program (active control), in reducing insomnia and pain severity in patients with disabling chronic pain and comorbid insomnia.</p><p><strong>Methods: </strong>The trial is a 1:1 randomized, single-blind, superiority trial randomizing 160 patients with disabling chronic pain and comorbid insomnia to either app-delivered CBT-I for 9 weeks or app-delivered sleep hygiene education for 9 weeks. Primary outcomes are the between-group differences in change in Insomnia Severity Index (ISI) and average pain intensity assessed using a 0-10 numeric rating scale (NRS) from baseline to post-interventions. Short-term secondary outcomes post-intervention include perceived effects on sleep and pain (Global Perceived Effect scales), sleep quality, thoughts and beliefs about sleep and pain, physical and mental health, and EQ5D-5L. Medium-term and long-term secondary outcomes (ISI, pain intensity, EQ5D-5L, health care costs, and use of sleep and pain medication) will be collected after 24 and 52 weeks. Exploratory physiological sleep metrics from at-home ear-electroencephalography (EEG) will be collected for five nights at baseline and for five nights during week 8.</p><p><strong>Discussion: </strong>This planned study addresses a critical need for identifying effective, safe, and easily accessible alternatives to the current treatments for patients with chronic pain and insomnia.</p><p><strong>Trial registration: </strong>ClinicalTrials.gov NCT06361914. Registered on April 17, 2024.</p>","PeriodicalId":23333,"journal":{"name":"Trials","volume":"26 1","pages":"292"},"PeriodicalIF":2.0,"publicationDate":"2025-08-15","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12357470/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144859667","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":4,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"OA","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}