Trials最新文献

{"title":"ABCD-Trial: study protocol for a randomized, double-blind, placebo-controlled study in patients with Amyotrophic lateral sclerosis for the evaluation of efficacy and safety of B-Cell Depletion with rituximab (ABCD).","authors":"Friederike Ufer, Rosa Rössling, Annika Spottke, Robert Németh, Tamara Schaprian, Nadja Kemmerling-de Coninck, Anna Gamez, Rebecca Sterl, Pia Naumann, Nikolaus Behr, André Maier, Thomas Meyer, Patrick Weydt, Harald Prüss","doi":"10.1186/s13063-026-10022-z","DOIUrl":"10.1186/s13063-026-10022-z","url":null,"abstract":"<p><strong>Background: </strong>The exact disease-causing mechanisms in ALS remain incompletely understood. A possible cause is inflammation of neurons. Compared to other neurodegenerative diseases, neuroinflammation is pronounced in ALS, presumably leading to disease progression and neuronal death. Patients with ALS can have neuronal autoantibodies and most notably antibody-producing cells in the cerebrospinal fluid. The CD20-binding therapeutic antibody rituximab targets these antibody-producing B-cells. Rituximab is a medication commonly used in neurology. Single patients with ALS have already been treated with rituximab, which was well tolerated. We therefore want to evaluate safety and efficacy of a treatment with rituximab in ALS patients in a double-blind placebo-controlled trial. With this trial we aim for slower disease progression and unveiling disease-causing mechanisms in ALS.</p><p><strong>Methods: </strong>A total of 52 male and female patients older than 18 years with active sporadic ALS and disease duration of less than 24 months who are on a stable dose of riluzole (50 mg BID) should be included. Patients requiring assisted ventilation of any kind or have a known intolerance to the study medication rituximab are excluded. The study medication rituximab or placebo should be administered over a period of 52 weeks at 4 distinct time points, followed by a follow-up period of 79 weeks with 4 visits. Treatment efficacy should be evaluated using the ALS functioning scale ALSFRS-R-SE at every study visit (except safety visits). Safety will be assessed through regular laboratory analyses, adverse event (AE) and serious adverse event (SAE) monitoring, and CD20+ B-cell kinetics. The primary endpoint is the change in the ALS Functional Rating Scale-Revised (ALSFRS-R-SE) from baseline to week 79. Trial sites will be at Charité/DZNE Berlin and DZNE Bonn.</p><p><strong>Discussion: </strong>ALS is a rapidly progressive neurodegenerative disease with limited treatment options. Recent preclinical in vivo studies suggest that B-cell-mediated autoimmunity contributes to disease progression. This trial will evaluate whether rituximab, which specifically depletes CD20+ B-cells, can slow ALS progression and provide insights into disease mechanisms.</p><p><strong>Trial registration: </strong>The trial was registered in the German WHO-recognized primary register Deutsches Register Klinische Studien DRKS (German Clinical Trials Register) on 3/07/2023 under registration number DRKS00030948.</p>","PeriodicalId":23333,"journal":{"name":"Trials","volume":"27 1","pages":""},"PeriodicalIF":2.1,"publicationDate":"2026-10-20","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13681759/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"149228729","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":"Correction: Efficacy of five-step shoulder manipulation for rotator cuff-related shoulder pain: protocol for a multicenter randomized controlled trial.","authors":"Shuang Liu, Jin-Tao Liu, Lin Chen, Tian-You Fan, Xue-Jun Cui, Shao-Dan Cheng, Yan-Jiao Chen, Qi Shi, Chun-Chun Xue, Xiao-Feng Li","doi":"10.1186/s13063-026-10049-2","DOIUrl":"10.1186/s13063-026-10049-2","url":null,"abstract":"","PeriodicalId":23333,"journal":{"name":"Trials","volume":"27 1","pages":""},"PeriodicalIF":2.1,"publicationDate":"2026-10-18","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13679025/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"149220825","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":"Correction: Protocol for a randomized controlled trial comparing saturated and unsaturated fat sources of a ketogenic diet (KETO-IM) investigating cardiovascular, inflammatory and immune function outcomes in adults living with overweight and prediabetes or type 2 diabetes in Edmonton, Canada.","authors":"Jodie L Fulton, Trina Gartke, Paulina Blanco Cervantes, Yasaman Mojibi, Alexander Makarowski, Laurie Mereu, Roseanne O Yeung, Caroline Richard, Catherine B Chan","doi":"10.1186/s13063-026-10050-9","DOIUrl":"10.1186/s13063-026-10050-9","url":null,"abstract":"","PeriodicalId":23333,"journal":{"name":"Trials","volume":"27 1","pages":""},"PeriodicalIF":2.1,"publicationDate":"2026-10-14","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13670854/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"149184696","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":"Advantage of cerebellar intermittent theta-burst stimulation in Alzheimer's disease (ACT-AD): study protocol for a multicenter, randomized, double-blind, sham-controlled trial.","authors":"Xin Zhang, Wen Li, Zhongqing Sun, Xiaomu Wang, Changgeng Song, Xiaorui Wang, Yinuo Niu, Dong Wei, Wei Zhang, Gejuan Zhang, Bei Zhang, Ling Wang, Zhirong Liu, Jingjing Zhao, Wen Jiang","doi":"10.1186/s13063-026-10009-w","DOIUrl":"10.1186/s13063-026-10009-w","url":null,"abstract":"<p><strong>Introduction: </strong>The cerebellum plays a crucial role in cognitive processing and thus presents a promising therapeutic target for Alzheimer's disease (AD). This trial aims to evaluate the efficacy and safety of long-term, neuronavigated cerebellar intermittent theta burst stimulation (iTBS) in patients with AD.</p><p><strong>Methods and analysis: </strong>The ACT-AD trial is a multicenter, randomized, double-blind, sham-controlled study involving 100 participants with mild-to-moderate AD across 4 centers in China. Participants will be randomized to receive either cerebellar iTBS or sham stimulation for 4 weeks (daily sessions), followed by 8 weeks of weekly maintenance sessions. The primary outcome is the change in the Clinical Dementia Rating Scale Sum of Boxes (CDR-SB) score from baseline to week 12. Secondary outcomes include additional clinical scales. Exploratory outcomes include electroencephalogram (EEG), blood biomarkers and magnetic resonance imaging (MRI). Statistical analysis will follow intention-to-treat principles using mixed models for repeated measures (MMRM).</p><p><strong>Discussion: </strong>The ACT-AD trial will assess the efficacy and safety of long-term, neuronavigated cerebellar iTBS in treating patients with mild-to-moderate AD.</p><p><strong>Trial registration: </strong>ClinicalTrials.gov, NCT06669182. Registered on 31 October 2024.</p>","PeriodicalId":23333,"journal":{"name":"Trials","volume":"27 1","pages":""},"PeriodicalIF":2.1,"publicationDate":"2026-10-09","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13651309/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"149148646","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":"Emotion-focused therapy in the treatment of prolonged grief disorder: study protocol for a randomized controlled trial.","authors":"José Gamoneda, José Manuel Caperos, Pablo F Cáncer, Rafael Jódar","doi":"10.1186/s13063-026-10005-0","DOIUrl":"https://doi.org/10.1186/s13063-026-10005-0","url":null,"abstract":"<p><strong>Background: </strong>Prolonged grief disorder (PGD) impacts various dimensions of the bereaved person's life, such as psychological, social, and/or health domains. Psychological interventions, particularly those beyond the cognitive-behavioral approach, are essential to address these difficulties. This is especially relevant given that not all interventions are effective for all bereaved individuals, leaving a subset of people without adequate help. Emotion-Focused therapy (EFT) offers a promising alternative to support individuals suffering from PGD.</p><p><strong>Methods/design: </strong>This protocol describes a two-arm randomized controlled trial designed to evaluate the efficacy of EFT compared to a self-help control group for grief complications. The study will recruit 128 adults who meet eligibility criteria through the Clinical Psychology Unit of Pontifical Comillas University (UNINPSI) and the university's networks. Participants will be randomly assigned to one of the two conditions. The EFT condition will include between eight and ten face-to-face weekly sessions. The self-help control group will consist of ten sessions of a self-help intervention based on EFT. Grief symptoms, anxiety, depression, trauma, and psychological distress will be measured using validated instruments (e.g., PG-13-R or CORE-10) before the intervention, during (at 3 weeks after the start), at the end of the intervention (at 12 weeks after the start, post-treatment), at 5 months, and at 12 months after the beginning of the intervention as follow-up assessments. In addition, grief and psychological distress will be assessed in all sessions (using the PG-13-R and CORE-10), and the therapeutic alliance will be measured in sessions 3 and 8 (using the WAI-S). A pilot study will precede the trial in order to adjust procedures and ensure adherence to the assessment protocol.</p><p><strong>Discussion: </strong>This study aims to establish the feasibility and comparative efficacy of EFT versus the self-help control group for PGD, hypothesizing that the EFT condition will demonstrate superior effectiveness at the different assessment points. The findings will expand the evidence base on therapeutic approaches to effectively support individuals with PGD.</p><p><strong>Trial registrations: </strong>ClinicalTrials.gov NCT07207512. Registered on 3 October 2025.</p>","PeriodicalId":23333,"journal":{"name":"Trials","volume":"27 1","pages":""},"PeriodicalIF":2.1,"publicationDate":"2026-09-21","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13625471/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"149115420","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":"Children's participation in assent to paediatric oncology research: experiences of children, siblings and parents.","authors":"Kajsa Norberg Wieslander, Sara Frygner-Holm, Stefan Nilsson, Malin Lövgren, Anna Höglund, Tove Godskesen","doi":"10.1186/s13063-026-10011-2","DOIUrl":"10.1186/s13063-026-10011-2","url":null,"abstract":"<p><strong>Background: </strong>Research is essential for improving outcomes in paediatric oncology, yet decisions about research participation often occur during emotionally vulnerable periods for families. Although children's assent is ethically required, it is not always meaningfully implemented in practice. Understanding how children, siblings and parents experience the child's involvement in the assent process, including their attitudes towards research, is crucial for promoting ethically sound research and supporting genuine child participation. The aim of this study was to describe how children with cancer, siblings and parents experience the child's assent process during research recruitment in paediatric oncology, with particular attention to its motivational and relational dimensions.</p><p><strong>Methods: </strong>A descriptive qualitative study design. Interviews were undertaken with children with cancer (n = 11), siblings (n = 17) and parents (n = 9) regarding their experiences of recruitment to various types of research in Sweden. Data was analysed using reflexive thematic analysis.</p><p><strong>Results: </strong>Two main themes were identified: a moral and emotional commitment to research, and relational assent-trust, loyalty and parental mediation. Children, siblings and parents described research participation as meaningful and morally significant in a vulnerable situation. Children's involvement in assent ranged from active participation to limited influence, with some decisions made primarily by parents. Decisions about research participation were shaped by relational dynamics, in which trust, loyalty, and emotional vulnerability and parental mediation played central roles.</p><p><strong>Conclusions: </strong>Families are strongly motivated to contribute to research in paediatric oncology. However, sustaining trust and safeguarding research integrity require consistent and meaningful implementation of children's assent. Child-centred, flexible, and context-sensitive assent processes are key, alongside ethical awareness of how relational dynamics shape children's autonomy. Recognising parents as key partners is essential for upholding both ethical standards and children's rights in paediatric research.</p>","PeriodicalId":23333,"journal":{"name":"Trials","volume":"27 1","pages":""},"PeriodicalIF":2.1,"publicationDate":"2026-09-21","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13591860/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"149017558","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":"Beyond antibiotic duration in acute cholangitis: system-level determinants after biliary drainage.","authors":"Linda Pasta, Fabrizio Bronte, Emma Aragona","doi":"10.1186/s13063-026-09975-y","DOIUrl":"10.1186/s13063-026-09975-y","url":null,"abstract":"<p><strong>Background: </strong>The COBRA trial addresses whether antibiotic exposure can be safely reduced after adequate biliary drainage in acute cholangitis. We argue that antibiotic duration should be interpreted within the broader care pathway in which treatment is delivered, because source control, device management, host susceptibility, local microbiological ecology, and reliability of care processes may modify clinical outcomes.</p><p><strong>Main body: </strong>Drawing on the Medical Research Council framework for complex interventions, we propose a system-level interpretation that complements, rather than replaces, the randomized comparison of antibiotic duration. A 24-month single-center quasi-experimental study in a gastroenterology unit, recently accepted for publication, provides hypothesis-generating support for this perspective: implementation of a standardized and traceable work-support intervention was associated with reductions in healthcare-associated infections, ward microbial pressure, and clinically expressed microbial burden. These findings do not establish causality or determine optimal antibiotic duration in acute cholangitis. To make care-pathway variability more explicit in future studies, we propose a Bundle Deviation Score based on six domains: timely diagnosis, timing of biliary drainage, adequacy of drainage and source control, antimicrobial strategy, device management, and standardized high-contact care. This contextual process measure could complement patient-centered outcome frameworks such as Desirability of Outcome Ranking by distinguishing treatment effects from variability in how care is delivered.</p><p><strong>Conclusions: </strong>The COBRA trial provides important evidence for antimicrobial stewardship after biliary drainage. Its interpretation and transferability may be strengthened by measuring the reliability of the broader care pathway alongside antibiotic duration. Prospective validation is required before the proposed Bundle Deviation Score can be used for clinical or research applications.</p>","PeriodicalId":23333,"journal":{"name":"Trials","volume":"27 1","pages":""},"PeriodicalIF":2.1,"publicationDate":"2026-09-16","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13584251/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148983632","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":"Study protocol for a multicenter prospective randomized-controlled trial to test a systematic remote and app-based prehabilitation program in comparison to education-only before major surgery: the LUMOS Study.","authors":"Svenja Sliwinski, Franziska J Stickl, S Fatima Faqar-Uz-Zaman, Charlotte Detemble, Colin Maurer, Ramona Moldovan Diaremes, Alexander Buia, Marco Niedergethmann, Christoph Reissfelder, Gregor A Stavrou, Rizky Widyaningsih, Dora Zmuc, Armin Wiegering, Johannes Fleckenstein, Andreas A Schnitzbauer","doi":"10.1186/s13063-026-09977-w","DOIUrl":"10.1186/s13063-026-09977-w","url":null,"abstract":"<p><strong>Background: </strong>Recent studies have demonstrated significant benefits associated with prehabilitation prior to major surgery. However, digital solutions in this domain are currently lacking. Our previous study, the Protego Maxima trial, reported positively assessed usability, validity, and safety of a prehabilitation application. In this randomized-controlled multicenter study, we aim to ascertain whether a digital prehabilitation program can reduce perioperative morbidity and costs in patients undergoing major surgery.</p><p><strong>Methods: </strong>The LUMOS trial is a multicenter prospective randomized-controlled trial comparing a 3-to-6-week interventional digital prehabilitation program with a digitized informational app, against a control group receiving only the informational application. The trial seeks to enroll 382 participants who will be block-randomized based on diagnosis into either the intervention or control group. The primary endpoint is the reduction of 90-day morbidity from 60 to 45% (Dindo-Clavien I-V). Secondary objectives include the 1-year overall survival, quality of life, length of hospital stay (including ICU, IMC, and general ward), readmission rates, compliance, and program adherence, product malfunction, vigilance reporting, improvement of the 6-min walking test by at least 20%, and hospital cost assessment.</p><p><strong>Discussion: </strong>The LUMOS trial aims to evaluate the effectiveness of a digital prehabilitation program compared to an informational app only, prior to major surgery. The objective is to demonstrate the significant value of a digitized remote prehabilitation program in reducing perioperative morbidity, as well as addressing cost considerations.</p><p><strong>Trial registration: </strong>Trial registered in the European Database on Medical Devices (EUDAMED) (CIV-24-02-046162) and German Clinical Trial Registry (DRKS00033612, 13.05.2024), DMIDS-Number: 00015083, https://drks.de/search/en/trial/DRKS00033612 . Goethe University Frankfurt: 024-1681-MDR/MPDG-zuständig multizentrisch, 06.05.2024.</p>","PeriodicalId":23333,"journal":{"name":"Trials","volume":"27 1","pages":""},"PeriodicalIF":2.1,"publicationDate":"2026-09-10","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13560359/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148931182","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":"PrEgabalin for Treatment Resistant generalised Anxiety disorder (PETRA): study protocol for a double-blind randomised controlled trial set in the UK.","authors":"Larisa Duffy, Carolyn A Chew-Graham, Brian C F Ching, Beverley Chipp, Charlotte Clarke, Liz Deane, Hakim-Moulay Dehbi, Nicholas Freemantle, Rafael Gafoor, Lauren Harding-Brown, Rachael Hunter, Berry Jude, David Kessler, David Lewis, Gemma Lewis, Louise Marston, Oliver J Robinson, Jonathan P Roiser, David Taylor, Kate Walters, Nicola Wiles, Glyn Lewis","doi":"10.1186/s13063-026-09949-0","DOIUrl":"10.1186/s13063-026-09949-0","url":null,"abstract":"<p><strong>Background: </strong>Generalised anxiety disorder (GAD) is common and increasingly recognised in primary care. Although antidepressants and psychological therapies are first-line treatments, many patients have residual anxiety and limited access to therapy. Evidence for effective next-step pharmacological options for treatment resistant anxiety remains limited. This paper describes the protocol for the PETRA trial, which will evaluate the clinical and cost-effectiveness of adding pregabalin to antidepressant treatment, compared with placebo, for people with GAD who have not responded or partially responded to antidepressant treatment.</p><p><strong>Methods: </strong>PETRA is a multicentre, individually randomised, double-blind, placebo-controlled superiority trial conducted in UK primary care. Participants are recruited by the study team from approximately 150 General Practices and randomised in a 1:1 ratio, using minimisation, to either pregabalin or a matching placebo for 26 weeks (followed by a tapering period where their dosage is reduced over approximately 4 weeks). Sample size is 498. Eligible participants are adults aged 18-74 years, who have been taking antidepressant medication for at least 8 weeks, received treatment with at least one other antidepressant before their current antidepressant and meet ICD-11 criteria for GAD and score ≥ 12 on the revised clinical interview schedule (CIS-R) total score. Follow-up assessments are at 3, 6, 12, 26 and ~ 30 weeks. Our primary outcome measure will be anxiety symptoms measured with GAD-7 at 12 weeks (continuous score). Secondary outcomes are anxiety (GAD-7) at other time points, depressive and panic symptoms, suicidal thoughts, self-rated global improvement, adherence to study medication, serious adverse events, adverse effects, alcohol consumption and benzodiazepine use, quality of life and resources and costs used. The ~ 30-week assessment will investigate symptoms during the withdrawal from pregabalin. Exploratory analyses will include cognitive tasks. A cost-effectiveness analysis and a nested qualitative study will evaluate the implementation and intervention acceptability.</p><p><strong>Discussion: </strong>The trial findings will inform primary care prescribing practice by providing an accurate and generalisable estimate of the clinical and cost-effectiveness of prescribing pregabalin to individuals with generalised anxiety who have not responded or only partially responded to antidepressant treatment.</p><p><strong>Trial registration: </strong>Controlled Trials ISRCTN Registry, ISRCTN 16993990, registered on 19/09/2023. First participant enrolled in January 2024.</p>","PeriodicalId":23333,"journal":{"name":"Trials","volume":"27 1","pages":""},"PeriodicalIF":2.1,"publicationDate":"2026-09-03","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13555984/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148921030","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":"Efficacy and cost-effectiveness of Internet-delivered cognitive-behavior therapy for children and adolescents with body dysmorphic disorder: study protocol for a randomized controlled trial.","authors":"Lorena Fernández de la Cruz, Anita Birovecz, Per Andrén, Karin Melin, Kristina Aspvall, Matti Cervin, Erik Andersson, Maria Silverberg-Mörse, Martina Gumpert, Frida Wickberg, Matteo Bottai, Eva Serlachius, Daniel Rautio, David Mataix-Cols","doi":"10.1186/s13063-026-09974-z","DOIUrl":"10.1186/s13063-026-09974-z","url":null,"abstract":"<p><strong>Background: </strong>Body dysmorphic disorder (BDD) is a prevalent and impairing mental disorder that typically onsets in adolescence. Cognitive-behavior therapy (CBT) may be effective for adolescent BDD, although the supporting evidence is currently limited. CBT for BDD is a highly specialized treatment, creating a considerable gap in access to care for young people. Therapist-guided Internet-delivered CBT (ICBT) may help bridge this gap. The primary aim of this study is to determine the efficacy of a therapist-guided ICBT program for children and adolescents with BDD versus an active comparator. Secondary aims are to examine the 6-month durability of the treatment effects and to evaluate its relative cost-effectiveness from multiple perspectives.</p><p><strong>Methods: </strong>This is a 3-site superiority randomized controlled trial including 154 young people (12-17 years) with BDD recruited throughout Sweden. Participants are randomized 1:1 to 12 weekly modules of either therapist-supported ICBT primarily based on exposure with response prevention or an active comparator consisting of therapist-supported Internet-delivered relaxation training. Data will be collected at baseline, mid-treatment, post-treatment, and 1 month (primary endpoint), 3 months, and 6 months post-treatment. The primary outcome is BDD symptom severity measured with the Yale-Brown Obsessive-Compulsive Scale Modified for Body Dysmorphic Disorder, Adolescent version. All study personnel who can be blinded to study aims/hypotheses and group allocation will be blinded. Assessors conducting post-treatment and follow-up assessments will be external to the research team and blinded to study aims/hypotheses and group allocation at all assessment points. Analyses will be conducted according to the intention-to-treat principle and will follow a pre-specified statistical and health economic analysis plan.</p><p><strong>Discussion: </strong>Participant recruitment started on 22 February 2024 and is currently ongoing. Data analysis for the primary aim will commence after the last participant reaches the primary endpoint.</p><p><strong>Trial registration: </strong>ClinicalTrials.gov NCT06262412. Registered on 16 February 2024, https://clinicaltrials.gov/study/NCT06262412 .</p>","PeriodicalId":23333,"journal":{"name":"Trials","volume":"27 1","pages":""},"PeriodicalIF":2.1,"publicationDate":"2026-08-31","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC13527960/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"148866770","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}