Trials最新文献

{"title":"Investigating the effect of intermittent fasting (time-restricted eating) with and without calorie restriction compared to calorie restriction on anthropometric parameters, depression score, and metabolic factors in patients with major depression disorder and obesity: a study protocol for a randomized controlled trial.","authors":"Alireza Bagherzadeh-Karimi, Naimeh Mesri Alamdari, Leila Hosseini, Leila Maghsoumi-Norouzabad","doi":"10.1186/s13063-026-09860-8","DOIUrl":"10.1186/s13063-026-09860-8","url":null,"abstract":"<p><strong>Background: </strong>It is suggested that intermittent fasting, specifically time-restricted eating (TRE), may have potential impact on depression in obese patients with major depression disorder (MDD). This study will aim to evaluate the effects of TRE with and without calorie restriction, compared to the traditional calorie restriction in patients suffering from MDD and obesity.</p><p><strong>Methods/design: </strong>This single-center, single-blinded, prospective, randomized trial will be conducted on 90 obese patients with major depression over 24 weeks. Participants were randomly divided into three groups in a 1:1:1 ratio. Group 1: recipients of TRE with 8-h food intake restriction (fixed 8-h time period), 2: recipients of TRE (fixed 8-h time period) and calorie restriction (75% of required calories), and 3: group receiving calorie restriction (75% of required calories).</p><p><strong>Main outcomes measure(s): </strong>The primary objective is assessment of changes in depression severity scores, alongside secondary outcomes including changes in parameters such as body weight, body mass index (BMI), waist circumference, fat mass, fat-free mass, circadian rhythm score, quality of life, physical activity, and key metabolic factors such as fasting glucose levels, serum insulin, hemoglobin A1C, insulin resistance and sensitivity, lipid profile, and blood pressure.</p><p><strong>Discussion: </strong>While calorie restriction can promote weight loss, its long-term adherence and mental health effects remain inconsistent. Emerging approaches like TRE have shown promise in improving body weight and metabolic parameters, but their impact on mental health is less understood. This study aims to fill this gap by comparing time-restricted eating with a fixed 8-h eating window plus and minus calorie restriction, against standard calorie restriction, in obese patients with major depressive disorder. The findings could have significant clinical implications for integrated management of obesity and depression.</p><p><strong>Trial registration: </strong>Iran Clinical Trials Registry, IRCTID: ( https://irct.behdasht.gov.ir/IRCT20241029063543N1 ). Registered on 26-11-2024.</p>","PeriodicalId":23333,"journal":{"name":"Trials","volume":" ","pages":""},"PeriodicalIF":2.1,"publicationDate":"2026-06-27","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13321579/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148340201","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":"Imaging-based versus threshold assessment-based deep brain stimulation programming in Parkinson's disease: study protocol for a randomized controlled trial {1a}.","authors":"Annabel van der Weide, Yarit Wiggerts, Martijn Beudel, Jeroen Hoogland, Maarten Bot, Rick Schuurman, Rob de Bie","doi":"10.1186/s13063-026-09870-6","DOIUrl":"10.1186/s13063-026-09870-6","url":null,"abstract":"<p><strong>Background: </strong>Deep brain stimulation (DBS) of the subthalamic nucleus (STN) effectively treats motor fluctuations in Parkinson's disease. The clinical outcome depends on optimal programming, which involves selecting active contacts and adjusting stimulation parameters to maximize clinical benefit while minimizing adverse effects. The conventional clinically guided approach, the monopolar review (MPR), is complex and time-consuming due to numerous parameter combinations, interindividual anatomical variability, and differences in DBS lead placement. Recent advances in neuroimaging offer the potential to guide contact selection based on patient-specific anatomy.</p><p><strong>Methods: </strong>A single-centre, prospective, randomized, open-label trial with blinded endpoint assessment (PROBE design) is being conducted in patients with Parkinson's disease undergoing STN-DBS to determine whether imaging-based contact selection is non-inferior to the current standard MPR for contact selection in treating motor symptoms. A total of 132 patients are randomized to either imaging-based programming (Imaging group) or threshold-assessment-based programming (i.e., MPR, Threshold group). In the Imaging group, contacts are selected using patient-specific 3D anatomical models derived from preoperative 7 T MRI and postoperative CT, visualizing the STN and simulating volumes of tissue activated (VTA) aligned with the motor subdivision. The primary outcome is the mean change from baseline to 6 months in the Movement Disorder Society - Unified Parkinson's Disease Rating Scale (MDS-UPDRS) part III score during the off-drug phase. Secondary outcomes include motor symptoms in the on-medication phase, duration of off-medication time, dyskinesia severity and duration, non-motor symptoms, motor aspects of daily living, physical disability, disease-specific quality of life, (severe) adverse effects, treatment satisfaction and burden, crossover to the alternate programming arm, use of care, programming duration, final DBS settings, and concordance between 6-months stimulation contacts and initial selections. Follow-up is 6 months after initial programming.</p><p><strong>Discussion: </strong>The trial evaluates whether imaging-based DBS programming can achieve motor improvements comparable to clinical threshold-assessment-based programming, while potentially offering greater efficiency, speed, and stability of stimulation settings. Although the study is designed as a non-inferiority trial, we hypothesize that imaging-based contact selection may ultimately provide a superior approach by enabling faster optimization with fewer parameter adjustments.</p><p><strong>Trial registration: </strong>The DBS-ITAP trial was registered at clinicaltrials.gov (NCT06223399) on January 23, 2024, https://clinicaltrials.gov/study/NCT06223399 .</p>","PeriodicalId":23333,"journal":{"name":"Trials","volume":" ","pages":""},"PeriodicalIF":2.1,"publicationDate":"2026-06-26","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13563839/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148340162","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":"Navigating Advanced Illness Goals And Treatment with Digital Engagement (NAVIGATE): a protocol for a randomised controlled trial of a website for caregivers of patients with serious illness.","authors":"Vinh Anh Huynh, Gerald Choon Huat Koh, Mervyn Jun Rui Lim, Tau Ming Liew, Vincent Diong Weng Nga, Tseng Tsai Yeo, Noreen Chan, Jia Neng Tan, Foong Pin Sym","doi":"10.1186/s13063-026-09876-0","DOIUrl":"10.1186/s13063-026-09876-0","url":null,"abstract":"<p><strong>Background: </strong>Surrogate decision-makers (SDMs) of patients with serious illnesses (PSI) face significant challenges in making end-of-life decisions, including feeling unprepared and uncertain due to lack of clarity on what patients and they themselves value. We developed a digital SDM-focused intervention (Careverse) that provides educational materials and tools for SDMs to initiate and discuss values conversation with patients and clinicians. The aims of this study are (i) to test the impact of Careverse on SDMs self-reported engagement in care planning behaviours and (ii) to evaluate whether Careverse increases caregivers' and patients' self-reported satisfaction with care and improves patient outcomes.</p><p><strong>Methods: </strong>This is a two-armed, parallel-design, single-blinded, participant-level randomised controlled trial of 100 identified decision-makers for patients with serious illness, along with their patients in a public university hospital in Singapore. Participants are English-speaking adult SDMs (21 years and older) of PSIs, including brain tumours, spontaneous intracerebral haemorrhage, and late-stage chronic kidney disease. Physicians in charge must assess that the patient is an appropriate candidate for advance care planning (ACP). Eligible caregivers of these patients with serious illness are then assigned to the intervention or control group using randomisation stratified by patients' conditions. We will assess SDM outcomes (engagement in care planning behaviours as a surrogate decision maker within 6 weeks-primary outcome; satisfaction with care; goals of care congruence, wellbeing) and patient outcomes (healthcare utilisation at end-of-life).</p><p><strong>Discussion: </strong>This trial will provide much-needed empirical evidence about a SDM-focused digital care planning intervention to empower caregivers to engage more effectively in care planning behaviours and be better prepared for their SDM role. This trial will also test the effect of Careverse on improving both SDM's- and patient-centred outcomes, and inform clinicians, payers and health systems seeking to adopt and scale effective and efficient digital strategies for supporting SDMs in real-world serious illness care settings.</p><p><strong>Trial registration: </strong>ClinicalTrial.gov NCT07134881. Registered on 21 August 2025, https://clinicaltrials.gov/study/NCT07134881 .</p>","PeriodicalId":23333,"journal":{"name":"Trials","volume":" ","pages":""},"PeriodicalIF":2.1,"publicationDate":"2026-06-25","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13555948/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148333213","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":"Coracoclavicular ligament reconstruction versus hook plate treatment in patients with Rockwood III-VI acute acromioclavicular dislocation: a multicentre randomized controlled trial.","authors":"Qihang Fang, Qi Zhu, Shengdi Lu, Lei Shao, Wenjun Zhang, Qinggang Sun, Wenqi Song, Youshui Gao, Pei Liu","doi":"10.1186/s13063-026-09846-6","DOIUrl":"10.1186/s13063-026-09846-6","url":null,"abstract":"<p><strong>Background: </strong>In 9-12% of shoulder girdle injuries in athletes, acromioclavicular (AC) joint dislocations disproportionately affect young adults who are engaged in contact sports. Surgical reconstruction has emerged as the gold standard for Rockwood III-VI lesions, particularly in professional athletes, where conservative management is correlated with high recurrence rates according to recent meta-analyses. However, the optimal surgical management for acute Rockwood type III-VI AC dislocations remains controversial, with no consensus on the most effective technique. This study aims to evaluate the efficacy of two prevalent surgical techniques: hook plate fixation and coracoclavicular ligament reconstruction using a ligament augmentation and reconstruction system (LARS).</p><p><strong>Methods: </strong>This study is designed as a multicentre, single-blinded, two-arm, parallel-group randomized controlled superiority trial with a 1:1 allocation ratio. Hook plate (arm 1) and LARS ligament (arm 2) will be compared. The primary outcome will be the Disability Arm Shoulder and Hand (DASH) score. The secondary outcomes will include imaging evaluations of re-dislocation, the quality of life 12-item survey questionnaire (SF-12), the visual analog scale (VAS), the Constant-Murley-Shoulder joint score, and complications. Since treatment allocation involves surgery and X-ray access for patients and surgeons, only researchers who analyze the outcome data after 1 year of follow-up will be blinded to the allocation. A total of 72 participants will be included, and the estimated time to complete this trial will be approximately 2 years. All the work will be conducted at the National Orthopedic Medical Center and its partner trauma healthcare network.</p><p><strong>Discussion: </strong>As the optimal surgical method for severe AC joint dislocation remains uncertain, this study highlights the differences in short-term and middle-term outcomes between hook plate and LARS ligament surgical treatments, which may hopefully reveal the most effective surgical interventions.</p><p><strong>Trial registration: </strong>This study is registered at the Chinese Clinical Trial Registry (ChiCTR2400082168) and was granted permission by the institutional ethics committee of Shanghai Sixth People's Hospital on 02-29-2024. https://www.chictr.org.cn/showproj.html?proj=222307.</p>","PeriodicalId":23333,"journal":{"name":"Trials","volume":" ","pages":""},"PeriodicalIF":2.1,"publicationDate":"2026-06-24","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13551753/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148319233","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":"Controlled local air-balloon compression chest belt on postoperative seroma in breast cancer: study protocol for a randomised controlled trial in Zunyi, China.","authors":"Yan Yang, Li Yang, Nana Zhang, Liwen Kang, Yongmei Zhang","doi":"10.1186/s13063-026-09847-5","DOIUrl":"10.1186/s13063-026-09847-5","url":null,"abstract":"&lt;p&gt;&lt;strong&gt;Background: &lt;/strong&gt;Seroma formation is a common postoperative complication of breast cancer surgery, leading to delayed wound healing, infection, patient discomfort, and repeated outpatient visits. In severe cases, it can cause skin flap necrosis, imposing physical, psychological, and financial burdens on patients. Applying compression bandaging to the patient's postoperative wound with a chest strap is an effective measure to prevent seroma formation. However, the commonly used elastic chest straps cannot provide specific compression values, limiting their use. Therefore, we aim to compare the efficacy of standard elastic chest straps versus controlled localised air-balloon compression chest straps in preventing seroma formation following breast cancer surgery.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Methods: &lt;/strong&gt;This is a superiority, single-blind randomised controlled trial conducted at a tertiary hospital in Guizhou Province, China, involving female breast cancer patients undergoing mastectomy. Eligible participants will be recruited by attending surgeons during routine preoperative consultations. Patients aged 18 years or older diagnosed with unilateral breast cancer who meet the criteria for mastectomy (including modified radical mastectomy and/or simple mastectomy) and provide informed consent will be eligible for inclusion. Exclusion criteria include patients with severe concomitant diseases before surgery, those with chest deformities or trauma, those with chest strap allergies, and those with psychiatric disorders who are unable to cooperate. Sixty patients were randomly assigned to two groups (control group and intervention group) in a 1:1 ratio, without stratification. Patients in the control group received postoperative compression bandaging with standard elastic chest bandages. In contrast, those in the intervention group received postoperative compression bandaging with a controlled-pressure local air-balloon chest bandage, with pressure sensors measuring the air-balloon inflation level. The air-balloon inflation period lasted one week, with inflation values ranging from 4 to 8 kPa. Both sets of chest straps were worn for one month. Safety measures to be collected include adverse events, postoperative complications (seroma, wound infection), and device-related skin reactions or discomfort. Primary outcomes included seroma incidence, postoperative drainage volume, and drainage tube retention time. Secondary outcomes encompassed quality of life, comfort, and satisfaction with the chest straps.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Discussion: &lt;/strong&gt;Postoperative wound compression dressing is essential for promoting flap-to-chest wall adhesion, reducing cavities, preventing seroma formation, and facilitating wound healing. By applying the Controlled Local Air-Balloon Compression Chest Belt, we aim to reduce postoperative complications, improve postoperative comfort, and promote patient recovery.&lt;/p&gt;&lt;p&gt;&lt;strong&gt;Trial registration: &lt;/strong&gt;Chinese Clinical Trial Re","PeriodicalId":23333,"journal":{"name":"Trials","volume":" ","pages":""},"PeriodicalIF":2.1,"publicationDate":"2026-06-24","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13551750/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148319188","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 early dexamethasone on major complications and all-cause mortality in severe burns (DEXA-BURN): study protocol for a multicenter, randomized, placebo-controlled, double-blind trial.","authors":"Alexandre Bourdiol, Nicolas Bruder, François Dépret, Delphine Flattres, Laurent Flet, June Fortin, Anne-Emmanuelle Gaufichon, Boris Glavnik, Matthieu Jeanne, Alexandra Jobert, Boris Jung, Anne-Claire Lukaszewicz, Noéline Mathelier, Morgane Péré, Xavier Pichon, Hugues Ravaux, Pierre-Joachim Mahé, Karim Asehnoune","doi":"10.1186/s13063-026-09869-z","DOIUrl":"10.1186/s13063-026-09869-z","url":null,"abstract":"<p><strong>Background: </strong>Severe burns lead to intense and prolonged systemic inflammation and high rates of organ failure and major complications such as acute respiratory distress syndrome (ARDS), acute kidney injury (AKI) and mortality. Although corticosteroids have shown benefits in various critical care settings, no adequately powered randomized controlled trial has yet evaluated their effect in burn patients.</p><p><strong>Objectives: </strong>The DEXA-BURN trial aims to assess whether early administration of dexamethasone reduces the incidence of major complications (moderate-to-severe ARDS or stage 2-3 AKI) and all-cause mortality in adults with severe burns.</p><p><strong>Methods: </strong>DEXA-BURN is a multicenter, randomized, placebo-controlled, double-blind trial conducted in 10 French intensive care units. Adult patients with ≥ 20% total body surface area (TBSA) burns, admitted within 24 h of injury and requiring mechanical ventilation, will be randomized (1:1) to receive either dexamethasone (0.2 mg/kg/day IV for 5 days) or placebo. Two endpoints are pre-specified and evaluated using a hierarchical testing strategy: (1) major complications within 28 days (moderate-to-severe ARDS or AKI KDIGO stages ≥ 2); and, if statistically significant, (2) all-cause mortality at day 90. Secondary endpoints include nosocomial infections, ventilator-free days, intensive care unit /hospital stay, CRP trajectory, and steroid-related adverse events. A total of 478 patients will be enrolled. Analyses will follow the intention-to-treat and modified intention-to-treat principle.</p><p><strong>Discussion: </strong>This trial will provide high-quality evidence on the effectiveness and safety of corticosteroid therapy in the acute management of severely burned patients. Findings may inform future guidelines and improve critical care practices for this understudied population with a high risk of mortality.</p><p><strong>Trial registration: </strong>EudraCT: 2024-517708-12-00; ClinicalTrials.gov: NCT06968559. Registered on April 22, 2025.</p>","PeriodicalId":23333,"journal":{"name":"Trials","volume":" ","pages":""},"PeriodicalIF":2.1,"publicationDate":"2026-06-24","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13548467/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148309671","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":"CHIP-AML22: a complex clinical trial in de novo pediatric AML patients, including a gemtuzumab ozogamicin randomization and targeted therapy with quizartinib in eligible subgroups, within the NOPHO-DB-SHIP consortium.","authors":"Gertjan J L Kaspers, Merlijn van Hamel, Jonas Abrahamsson, Nira Arad-Cohen, Renske Benedictus, Nastassja Scheidegger, Luis Castillo, Daniel Ka Leung Cheuk, Vitor Costa, Yvonne Duong, Jose Maria Fernandez Navarro, Linda Fogelstrand, Bianca F Goemans, Sae Ishimaru, Olafur Gisli Jonsson, Kristian L Juul-Dam, Maarja Karu, Joost B Koedijk, Zhanna Kovalova, Barbara De Moerloose, Monica Cheng Munthe-Kaas, Sauli Palmu, Ramune Pasauliene, Anne Tierens, Harm van Tinteren, Dominik Turkiewicz, Daria G Valerio, Noa Wijnen, C Michel Zwaan, Cornelis Jan Pronk","doi":"10.1186/s13063-026-09855-5","DOIUrl":"10.1186/s13063-026-09855-5","url":null,"abstract":"<p><strong>Background: </strong>The overall survival of children with newly diagnosed acute myeloid leukemia (AML) in high-income countries has increased to 80% over the past decades. Nevertheless, a significant subset of patients experiences relapse and treatment is associated with both short- and long-term toxicities. The CHIP-AML22 protocol includes an updated standard-of-care treatment for children with AML within the NOPHO-DB-SHIP consortium. Targeted therapies are offered to specific subsets of patients and measures to reduce toxicity are being investigated.</p><p><strong>Methods: </strong>CHIP-AML22 is a multinational complex clinical trial in newly diagnosed de novo AML patients up to and including 18 years of age, sponsored by the Princess Máxima Center. The primary aim is to improve event-free survival. To achieve this, (1) FLT3-ITD+/NPM1wt patients can participate in a linked-trial assessing safety and efficacy of quizartinib, in addition to conventional chemotherapy during induction and consolidation therapy and as continuation monotherapy after allogeneic hematopoietic stem cell transplantation; (2) a randomization study is incorporated on the use of two doses of 3 mg/m² gemtuzumab ozogamicin during induction therapy in CD33-positive patients; and (3) updated criteria are used for the identification of high-risk patients, based both on flow measurable residual disease (MRD) and (cyto)genetic profiling. The design allows for introduction of new treatment options in the future. Furthermore, a randomization is included aiming to demonstrate non-inferiority in disease-free survival after two versus three consolidation courses in standard-risk patients. Additionally, the use of the cardioprotective drug dexrazoxane is recommended in all patients. Interim analyses will be conducted to assess safety and efficacy in the linked trial and randomization studies. Based on power calculations, we aim to recruit a total of 905 patients in the Master protocol and 60 patients in the linked Quizartinib trial.</p><p><strong>Discussion: </strong>The risk-based approach and use of targeted therapies in CHIP-AML22 illustrate a shift toward more personalized treatment. Besides improving event-free survival, this study aims to contribute to the international consensus on strategies to reduce toxicity for all patients. The design of this study provides a dynamic framework, allowing for the potential introduction of emerging therapeutic options in the future.</p><p><strong>Trial registration: </strong>CHIP-AML22 Master protocol: EU CT 2023-504999-25-00, Clinicaltrials.gov NCT05994690. Registered on 16-08-2023 Quizartinib linked-trial: EU CT 2023-505000-27-01, Clinicaltrials.gov NCT06262438. Registered on 16-02-2024.</p>","PeriodicalId":23333,"journal":{"name":"Trials","volume":" ","pages":""},"PeriodicalIF":2.1,"publicationDate":"2026-06-20","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13528083/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148284424","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":"Impact and implementation evaluation of Stress First Aid for the Substance Use Outreach Workforce (SFA/SUOW): protocol of a hybrid type I cluster randomized control trial.","authors":"Anmol Desai, Katie A McCormick, Juliette Rau, Haresh Rochani, Patrick Chang, Richard J Westphal, Patricia J Watson, Kasey R Claborn, Justin K Benzer, Suzannah K Creech","doi":"10.1186/s13063-026-09856-4","DOIUrl":"10.1186/s13063-026-09856-4","url":null,"abstract":"<p><strong>Background: </strong>Stress First Aid (SFA), an evidence-informed peer support intervention to address occupational stress, has been adapted to the needs of the substance use outreach workforce (SUOW) (SFA/SUOW) and pilot tested with initial positive outcomes. The goal of this study is to test and evaluate the effectiveness, implementation and sustainability of SFA/SUOW compared to a no treatment control condition in a hybrid-type I cluster-randomized controlled trial (RCT).</p><p><strong>Methods: </strong>Approximately 500 substance use outreach workers (SUOWs) and leaders from approximately 90 substance use outreach (SUO) organizations, Community Health Worker programs, and peer support programs arranged in 10 regions based on geographic co-location across Texas, Louisiana, Arkansas, Oklahoma, New Mexico, and tribal areas will be 50:50 randomized to the intervention group or the control group. Treatment will consist of a 2-hour virtual SFA training and up to six virtual 30-minute monthly learning collaboratives. All participants will be asked to complete a baseline assessment prior to randomization, and 2 follow-up assessments at 2-month and 6-month to assess occupational stress primary outcomes: 1) supervisor and coworker social support and 2) burnout. We will also assess use of SFA, job-related affective well-being, secondary traumatic stress, use of coping strategies, general self-efficacy, work engagement, turnover intention, and moral injury symptoms. Additionally, we will conduct interviews and focus groups with RCT participants, RCT non-participants, and addiction professional staff to evaluate the reach, effectiveness, adoption, implementation, and maintenance of SFA/SUOW.</p><p><strong>Discussion: </strong>This RCT provides a robust trial of SFA/SUOW that has not been done before. The aim of the study will result in a national implementation plan to improve SUOWs well-being and subsequently improve quality care for persons who use drugs.</p><p><strong>Trial registration: </strong>The study NCT07177014 is registered on clinicaltrials.gov https://clinicaltrials.gov/study/NCT07177014 . Registered on September 09, 2025.</p>","PeriodicalId":23333,"journal":{"name":"Trials","volume":" ","pages":""},"PeriodicalIF":2.1,"publicationDate":"2026-06-20","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13531861/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148296441","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":"Effectiveness of abdominal hollowing and piriformis stretching exercises in spondylolisthesis patients: a study protocol for a randomized controlled trial.","authors":"Ganesh Dey, Mohammad Anwar Hossain, Polok Halder, Md Nazmul Huda, Mithun Adhikari, Fabiha Alam","doi":"10.1186/s13063-026-09873-3","DOIUrl":"10.1186/s13063-026-09873-3","url":null,"abstract":"<p><strong>Background: </strong>Lumbar spondylolisthesis is a clinically important cause of chronic low back pain, activity limitation, and reduced functional capacity. Exercise-based physiotherapy is widely recommended for conservative management, yet uncertainty remains regarding the added value of targeted core stabilization and hip-related stretching strategies in this population. Abdominal hollowing is intended to improve deep trunk muscle activation and lumbopelvic control, whereas piriformis stretching may reduce posterior hip tightness and movement-related discomfort. This trial aims to evaluate whether adding abdominal hollowing and piriformis stretching exercises to a standardized conventional physiotherapy programme improves pain, functional disability, and kinesiophobia in adults with low-grade lumbar spondylolisthesis.</p><p><strong>Methods: </strong>This study is a two-arm, parallel group, assessor-blinded randomized controlled superiority trial. Seventy-two participants aged 18 to 65 years with radiologically confirmed lumbar spondylolisthesis of Meyerding grade I or II, chronic localized low back pain of more than 3 months, and a baseline pain intensity of more than 3 on a 10-point Visual Analogue Scale will be recruited from the Musculoskeletal Physiotherapy Unit of the Centre for the Rehabilitation of the Paralysed, Savar, Bangladesh. Recruitment is planned from April 2026 to June 2026. Participants will be allocated in a 1:1 ratio using a computer-generated block randomization sequence with concealed allocation. Both groups will receive a standardized conventional physiotherapy programme three times weekly for 6 weeks. The experimental group will additionally receive abdominal hollowing and piriformis stretching exercises. The primary outcome will be pain intensity measured by the 10-cm Visual Analogue Scale immediately after the 6-week intervention. Secondary outcomes will include functional disability measured by the Oswestry Disability Index, kinesiophobia measured by the Tampa Scale for Kinesiophobia, and all outcome measures assessed at 4-week follow-up. Data will be analysed according to the intention-to-treat principle using linear mixed effects models, with effect estimates reported alongside 95% confidence intervals.</p><p><strong>Discussion: </strong>This trial will determine whether adding targeted core stabilization and piriformis stretching to a standardized physiotherapy programme produces superior short-term clinical outcomes in people with lumbar spondylolisthesis. The findings may inform conservative rehabilitation strategies for this population, particularly in resource-limited clinical settings.</p><p><strong>Trial registration: </strong>Clinical Trial Registry India (CTRI), CTRI/2025/07/089927. Registered prospectively on 01 July 2025.</p>","PeriodicalId":23333,"journal":{"name":"Trials","volume":" ","pages":""},"PeriodicalIF":2.1,"publicationDate":"2026-06-20","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13527944/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148284484","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":"Long-term evaluation of a comprehensive bullying prevention program starting in preschool: study protocol for a randomized controlled trial.","authors":"Antoinette Dewandre, Ophélie Courbet, Quentin Daviot, Marc Gurgand, Elise Huillery, Rebecca Shankland, Marianne Habib, Thomas Villemonteix","doi":"10.1186/s13063-026-09799-w","DOIUrl":"10.1186/s13063-026-09799-w","url":null,"abstract":"<p><strong>Background: </strong>Promoting mental health and psychological well-being from early childhood is a growing priority in global education policy. Bullying has emerged as a major threat to children's well-being, and while most school-based interventions begin in late childhood or adolescence, research suggests that bullying-related behaviors and peer exclusion emerge as early as preschool. Yet, to date, no bullying prevention program has been rigorously evaluated from the beginning of schooling. This study aims to fill this gap by evaluating Vivre Ensemble-Fri for Mobberi (VE-FFM), a comprehensive, developmentally tailored bullying prevention and social-emotional learning (SEL) program implemented in French primary schools from preschool through elementary school.</p><p><strong>Methods: </strong>We will conduct a two-arm cluster-randomized controlled trial involving 210 French public schools and approximately 5250 children, recruited at age 3 and followed for 7 years. Schools will be randomly allocated to either the intervention group (VE-FFM) or a wait-list control group continuing with teaching-as-usual. VE-FFM is a universal, whole-school program targeting students, professionals, and families. It focuses on building inclusive peer communities and strengthening children's social-emotional skills through structured group discussions, well-being activities, and SEL workshops. Primary outcomes include bullying and peer victimization. Secondary outcomes include psychological well-being, mental health difficulties, empathy, social skills, academic performance, teacher-child relationship quality, school belonging, subjective unsafety, perception of school kindness, and teacher job satisfaction. Data will be collected at six timepoints using teacher- and child-rated measures. Implementation fidelity will be monitored through teacher logs and recorded classroom sessions.</p><p><strong>Discussion: </strong>This trial is the first to evaluate the long-term impact of a bullying prevention and SEL program beginning at preschool level. By embedding the intervention into the full span of early schooling, VE-FFM may produce stronger and more lasting effects than shorter-term interventions implemented at later stages. Results will inform educational and mental health policy by providing evidence on the effectiveness of early, community-based approaches to preventing bullying and promoting mental well-being.</p><p><strong>Trial registration: </strong>DRKS; DRKS00037553. Registered on 2025/09/11.</p>","PeriodicalId":23333,"journal":{"name":"Trials","volume":" ","pages":""},"PeriodicalIF":2.1,"publicationDate":"2026-06-19","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13576281/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148284493","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}