Trials最新文献

{"title":"Master protocol for a series of cohort-based randomized controlled trials to test tools to communicate research results to study participants and others with relevant lived experience: the SPIN-CLEAR Trials.","authors":"Brett D Thombs, Claire Adams, Elsa-Lynn Nassar, Marie-Eve Carrier, Meira Golberg, Kanika Bharthi, Amanda Wurz, Annabelle South, Linda Kwakkenbos, Sabrina Hoa, Danielle B Rice, Geneviève Guillot, Amanda Lawrie-Jones, Maureen Sauvé, Susan J Bartlett, Catherine Fortune, Amy Gietzen, Karen Gottesman, Marie Hudson, Laura K Hummers, Vanessa L Malcarne, Maureen D Mayes, Michelle Richard, James Stempel, Robyn K Wojeck, Kathleen Blagrave, Jill T Boruff, Vanessa Cook, Nicole Culos-Reed, Ole Fröbert, Katie Gillies, Vera Granikov, Lars G Hemkens, Elizabeth Yakes Jimenez, Agnes Kocher, Catarina Leite, Mathew A W T Lim, Nancy Maltez, John Michalski, Tracy Mieszczak, Mwidimi Ndosi, Janet Pope, François Rannou, Ken Rozee, Sharon E Straus, Matthew R Sydes, Lehana Thabane, John Varga, Tami Yap, Merrick Zwarenstein, Luc Mouthon, Andrea Benedetti","doi":"10.1186/s13063-025-08846-2","DOIUrl":"10.1186/s13063-025-08846-2","url":null,"abstract":"<p><strong>Background: </strong>Research results are often not communicated to study participants or others with relevant lived experience. Effective communication of research results would help study participants understand their contribution to research and could improve trust in research and likelihood of research participation. Few randomized controlled trials (RCTs), however, have compared the effectiveness of research communication tools, and it is not known which tools work best for different people. We will conduct the Scleroderma Patient-centered Intervention Network-Communicating Latest Evidence and Results (SPIN-CLEAR) trial series via the multi-national SPIN Cohort to compare tool effectiveness. Primary objectives of each RCT will be to compare tools based on (1) information completeness, (2) understandability, and (3) ease of use. We will additionally evaluate comprehension of key aspects of disseminated research; likelihood that participants would enroll in a similar future study; and, for all primary and secondary outcomes, outcomes by participant characteristics (gender, age, race or ethnicity, country, language, education level, health literacy).</p><p><strong>Methods: </strong>An advisory team of people with systemic sclerosis (SSc, also known as scleroderma) participated in developing research questions, selecting outcomes, and designing the series of parallel-arm RCTs that will each compare two or more tools or tool variations to a plain-language summary comparator; the common comparator will facilitate across-trial comparisons. In each RCT, people with SSc and researchers will select a recent SSc research study to disseminate. Tools will be developed by experienced tool developers and people with SSc. SPIN Cohort participants (current N eligible = 1522 from 50 SPIN sites in Australia, Canada, France, UK, USA) and additional participants recruited via social media and patient organization partners who consent to participate will be randomized to a dissemination tool or plain-language summary comparator and complete outcomes. Analyses will be intent-to-treat and use linear regression models.</p><p><strong>Discussion: </strong>Each trial in the planned series of trials will build upon knowledge from previous trials. Results will contribute to the evidence base on how to best disseminate results to study participants and others with relevant lived experience.</p><p><strong>Trial registration: </strong>ClinicalTrials.gov NCT06373263. Registered on April 17, 2024 (first trial in series).</p>","PeriodicalId":23333,"journal":{"name":"Trials","volume":"26 1","pages":"149"},"PeriodicalIF":2.0,"publicationDate":"2025-05-08","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12060389/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144039646","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 of the aldehyde dehydrogenase 2 (ALDH2) gene testing on alcohol drinking behaviors among the Chinese Han population: study protocol of a single-center, open-label, randomized, controlled clinical trial.","authors":"Dongli Lu, Yingneng Wen, Kaijun Liao, Qiulian Lu, Shiqin Wu, Lin Fang, Zhenghua Jiang, Zhaochun Wu","doi":"10.1186/s13063-025-08851-5","DOIUrl":"10.1186/s13063-025-08851-5","url":null,"abstract":"<p><strong>Background: </strong>Alcohol consumption may induce multiple disorders, and decreased alcohol consumption has been proved to be effective to reduce the incidence of alcohol-associated diseases and mortality. Pharmacotherapy is the most common option for the management of alcohol problems; however, it suffers from multiple problems. Non-pharmaceutical interventions are therefore of urgent need to change alcohol intake among alcohol users. Aldehyde dehydrogenase 2 (ALDH2), which encodes the ALDH2 gene, is an important enzyme in ethanol metabolism. Previous studies have demonstrated that individuals harboring ALDH2 gene mutations are more likely to present discomfort symptoms and are more susceptible to multiple cancers. It is hypothesized that ALDH2 gene testing may reduce alcohol consumption and the incidence of alcohol-associated disorders among unhealthy alcohol users.</p><p><strong>Methods: </strong>A single-center, open-label, randomized, controlled clinical trial was designed, aiming to recruit 940 unhealthy alcohol users at ages of 18 to 60 years. All participants are randomized into the interventional and control groups, and both groups are given alcohol consumption health education. In addition, blood samples are collected from participants in the interventional group for ALDH2 gene testing, with testing reports issued, while ALDH2 gene testing is not performed in the control group. Changes in alcohol intake, hazardous drinking days, and alcohol-associated adverse events are recorded prior to and post-interventions. The primary outcome is alcohol intake, and the secondary outcomes are hazardous drinking days and alcohol-associated adverse events.</p><p><strong>Discussion: </strong>This trial will provide strong evidence regarding the impact of ALDH2 gene testing on alcohol use behaviors.</p><p><strong>Trial registration: </strong>The study has been registered in the Chinese Clinical Trial Registry (registration no. ChiCTR2400087726) on 2 August 2024.</p>","PeriodicalId":23333,"journal":{"name":"Trials","volume":"26 1","pages":"147"},"PeriodicalIF":2.0,"publicationDate":"2025-05-07","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12057152/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144025161","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":"Assessing the influence of Katana™ Cleaner on the clinical performance of bulk-fill restorations in endodontically treated teeth: study protocol for a randomized clinical study.","authors":"Jacqueline Vitória do Nascimento Azevedo, Ceci Nunes Carvalho, Hadda Lyzandra Austriaco Leite, Suellen Nogueira Linares Lima, Wallace Vieira Mendes, Sebastião Marinho Pinheiro Neto, Andrés Felipe Millian Cardenas, Fabiana Suellen Figueredo Siqueira, Rossana Aboud Matos de Almeida, Etevaldo Matos Maia Filho","doi":"10.1186/s13063-025-08790-1","DOIUrl":"https://doi.org/10.1186/s13063-025-08790-1","url":null,"abstract":"<p><strong>Background: </strong>Complete cleaning of the pulp chamber interior is a mandatory step before the restorative process. Ethanol is the most commonly used substance for cleaning the dentin surface; however, studies report that ethanol is ineffective at completely removing residues. Although Katana™ is recommended for prosthetic purposes, in vitro studies have shown it delivers results equal to or better than ethanol. The study aims to evaluate the influence of Katana™ Cleaner on cleaning the pulp chamber of teeth treated endodontically with an epoxy or bioceramic sealer and on the clinical performance of bulk-fill resin restorations over an 18-month follow-up period, using two clinical performance criteria: World Dental Federation (FDI) and United States Public Health Service (USPHS).</p><p><strong>Methods: </strong>The study will be a blinded randomized clinical trial conducted according to the Consolidated Standards of Reporting Trials (CONSORT) statement. Selected patients (n = 224) will undergo pulp chamber cleaning following endodontic obturation with epoxy and bioceramic sealers, divided into four treatment groups (Katana and AH Plus, Katana and Bioceramic, Ethanol and AH Plus, Ethanol and Bioceramic), followed by bulk-fill resin restorations. The clinical performance of the restorations will be evaluated at the following intervals: 1 week, 3, 6, 9, 12, 15, and 18 months, using two evaluation criteria: FDI and USPHS. Results will be analyzed using survival analysis with the Kaplan-Meier estimator to assess failure occurrence over time for the two treatments. A Cox regression analysis will be conducted to evaluate the risk of failure. A 5% significance level will be adopted for all tests.</p><p><strong>Discussion: </strong>The proposed study will be the first to examine the clinical effects of a new cleaning protocol on the removal of endodontic sealer residues. We will also explore potential improvements that Katana may provide in the bond strength of a self-etch adhesive to dentin in teeth restored with composite resin. If promising results are observed in clinical trials, this would suggest that individuals could benefit from the intervention using the proposed protocol, highlighting the potential for improved outcomes in the restorations of endodontically treated teeth. Additionally, it could pave the way for future studies in this field.</p><p><strong>Trial registration: </strong>Registered in the Brazilian Registry of Clinical Trials (REBEC: RBR-86ycwq7) on February 29, 2024.</p>","PeriodicalId":23333,"journal":{"name":"Trials","volume":"26 1","pages":"148"},"PeriodicalIF":2.0,"publicationDate":"2025-05-07","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12060364/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144062181","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 proprioceptive neuromuscular facilitation pattern on upper extremity and scapula in patients with adhesive capsulitis: a single-centre assessor-blinded randomised controlled trial (RCT).","authors":"Abid Hasan Khan, Md Saruar Hossain Bhuiyan, Md Feroz Kabir, Md Zahid Hossain, Sharmila Jahan, K M Amran Hossain, Ehsanur Rahman","doi":"10.1186/s13063-025-08848-0","DOIUrl":"https://doi.org/10.1186/s13063-025-08848-0","url":null,"abstract":"<p><strong>Background: </strong>Adhesive capsulitis (AC) is a progressive inflammatory condition of the shoulder that causes functional limitations and leads to long-term disability. The study aimed to elicit the effectiveness of proprioceptive neuromuscular facilitation (PNF) compared to standard physiotherapy approaches on AC.</p><p><strong>Methods: </strong>An assessor-blinded single-centre randomised control trial (RCT) was carried out on 80 AC patients between May 2022 and December 2023 in Bangladesh. Random assigned and concealed allocated patients were recruited equally (n = 40) to each PNF and conventional capsular stretching group. The experimental group received a PNF approach, and the control group received capsular stretching to the affected shoulder for 24 sessions in 6 weeks. Both groups received electrical modalities as standard treatment. The primary outcome was pain measured by the numeric pain rating scale (NPRS) and range of motion in a universal goniometer. The secondary outcome was functional limitation measured by the shoulder pain and disability index (SPADI). As per the distribution of data, non-parametric tests were employed to analyse the superiority between and within groups with intention-to-treat analysis.</p><p><strong>Results: </strong>Baseline compatibility was noted in all the key variables (p > 0.05). Both PNF and capsular stretching had a decrease in pain compared to baseline in all capsular pattern positions (p < 0.001), and PNF had more significant improvement compared to control (p < 0.001). Both groups had equal improvement in shoulder ROM (p < 0.001) except abduction (p < 0.05). Both groups had improvements in disability (p < 0.05), and PNF had statistical superiority of improvement (p < 0.001).</p><p><strong>Conclusions: </strong>The findings of this study support the potential of PNF intervention for 6 weeks as a treatment for shoulder adhesive capsulitis, showing improvements in pain, ROM and functional disability. However, further multicentre trials with a follow-up design are needed to fully understand the superiority of PNF on shoulder AC, encouraging continued engagement in this area of research.</p><p><strong>Trial registration: </strong>The Australian New Zealand Clinical Trial Registry (ACTRN12621001299897). Registered on 27 September 2021, prospectively registered.</p>","PeriodicalId":23333,"journal":{"name":"Trials","volume":"26 1","pages":"146"},"PeriodicalIF":2.0,"publicationDate":"2025-05-03","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12048982/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"143988338","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":"Statistical analysis plan for the \"empirical treatment against cytomegalovirus and tuberculosis in HIV-infected infants with severe pneumonia\" clinical trial.","authors":"Sara Domínguez-Rodríguez, David Lora, Alfredo Tagarro, Cinta Moraleda, Álvaro Ballesteros, Lola Madrid, Lilit Manukyan, Olivier Marcy, Valeriane Leroy, Alessandra Nardone, David Burger, Quique Bassat, Matthew Bates, Raoul Moh, Pui-Ying Iroh Tam, Tisungane Mvalo, Justina Magallhaes, W Chris Buck, Jahit Sacarlal, Victor Mussime, Chishala Chabala, Hilda Angela Mujuru, Pablo Rojo","doi":"10.1186/s13063-025-08841-7","DOIUrl":"https://doi.org/10.1186/s13063-025-08841-7","url":null,"abstract":"<p><strong>Background: </strong>The EMPIRICAL trial aims to assess safety and efficacy of an empirical treatment against cytomegalovirus (CMV) and tuberculosis (TB) compared to standard of care (SoC), on adverse events and 15-day and 1-year mortality among infants living with HIV hospitalized with severe pneumonia in Africa.</p><p><strong>Methods and design: </strong>The EMPIRICAL trial (NCT03915366) is an international multicenter phase II-III, open-label randomized factorial clinical trial conducted in six African countries. The trial has four randomization arms in a 1:1:1:1 fashion with patients allocated to (i) TB-Treatment plus SoC, (ii) valganciclovir plus SoC, (iii) both TB-Treatment and valganciclovir plus SoC, and (iv) SoC only.</p><p><strong>Discussion: </strong>This paper describes the statistical analysis plan (SAP) for the trial which, per the study publication plan, needs to be published prior to the database lock and final analysis results. The SAP includes details of the analyses to be undertaken and unpopulated tables that will be reported to address primary and secondary endpoints. The database will be locked on 31st January 2025.</p><p><strong>Trial registration: </strong>ClinicalTrials.gov: NCT03915366 (registered on April 16, 2019), Universal Trial Number: U111-1231-4736, Pan African Clinical Trial Registry: PACTR201994797961340.</p>","PeriodicalId":23333,"journal":{"name":"Trials","volume":"26 1","pages":"144"},"PeriodicalIF":2.0,"publicationDate":"2025-04-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12044806/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144047114","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":"Statistical analysis plan for the ARtificially Intelligent image fusion system versus standard treatment to guide endovascular Aortic aneurysm repair (ARIA): a multi-centre randomised controlled trial.","authors":"Hatem A Wafa, James Budge, Tom Carrell, Medeah Yaqub, Matt Waltham, Izabela Pilecka, Joanna Kelly, Caroline Murphy, Stephen Palmer, Rachel E Clough, Yanzhong Wang","doi":"10.1186/s13063-025-08770-5","DOIUrl":"https://doi.org/10.1186/s13063-025-08770-5","url":null,"abstract":"<p><strong>Background: </strong>Aortic aneurysms, a significant cause of mortality, particularly in individuals aged 55 years and older, have witnessed a transformative shift in treatment strategies with the advent of endovascular surgery. Cydar-EV is an innovative image fusion technology that can augment preoperative planning and surgical guidance of endovascular aneurysm repair (EVAR). The ARIA trial aims to evaluate the efficacy of using Cydar-EV with EVAR procedures to reduce operating time while enhancing procedural precision, patient outcomes, and cost-effectiveness. This paper describes the statistical analysis plan for the study.</p><p><strong>Methods/design: </strong>The ARIA trial, a phase III, multi-centre, open-label, two-armed, parallel groups randomised controlled surgical trial, seeks to recruit 340 patients diagnosed with abdominal or thoraco-abdominal aortic aneurysms. Participants are randomly assigned to receive either standard endovascular repair or an endovascular repair assisted by Cydar-EV for planning and surgical guidance. Primary and secondary outcomes are assessed at baseline, 4-12 weeks, and 52 weeks. The primary outcome measure is procedure duration at baseline, while additional secondary outcomes are recorded at various time points and include indicators for technical effectiveness, patient outcomes, procedure efficiency, and cost-effectiveness. We plan to analyse the patient outcome data according to the treatment they received regardless of initial allocation. The statistical analysis plan outlines methods for handling missing data, covariates for adjusted analyses, and planned sensitivity analyses to ensure robust evaluation of treatment effects.</p><p><strong>Trial registration: </strong>The trial was registered with the ISRCTN register on 03/12/2021, number ISRCTN13832085.</p>","PeriodicalId":23333,"journal":{"name":"Trials","volume":"26 1","pages":"143"},"PeriodicalIF":2.0,"publicationDate":"2025-04-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12042510/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144053253","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":"Clinical Study Reports-a systematic review with thematic synthesis: Part 1. History, contents and structure, definitions, and terminology.","authors":"J K Aronson, I J Onakpoya","doi":"10.1186/s13063-024-08710-9","DOIUrl":"10.1186/s13063-024-08710-9","url":null,"abstract":"<p><strong>Background: </strong>Clinical study reports (CSRs) are standardized full reports of the protocols, results, and other pertinent details of clinical studies that are typically submitted by pharmaceutical companies to regulatory authorities, as part of the drug approval process. Their recommended contents and structure were described in 1995 in a document of the International Conference on Harmonisation, ICH E3, although companies can choose how to present the data. Until 2015, such reports were not readily available to the public, but since then some regulatory authorities have made them available, as have some pharmaceutical companies, albeit often in abbreviated or redacted versions. The apparent benefits of pharmacological interventions are not as impressive when they are calculated using data from clinical study reports compared with published trial reports, and more information emerges about harms the interventions can cause.</p><p><strong>Results: </strong>Our methods are described in Part 2 of this systematic review with thematic synthesis, in which we have summarized the uses of CSRs, as described in 349 publications of various sorts, including analyses of clinical trials, data analyses, commentaries, and official documents. We have specifically concentrated on how CSRs affect assessments of benefits, harms, and the benefit-to-harm balance, and other factors that affect it. In Part 1, we discuss the history of the development of CSRs, their contents and structure, definitions of CSRs and qualifying terms, and relevant terminology (including the availability of CSRs, data sharing systems, and transparency and confidentiality).</p><p><strong>Conclusions: </strong>Our conclusions are listed in Part 2 of this review.</p>","PeriodicalId":23333,"journal":{"name":"Trials","volume":"26 1","pages":"141"},"PeriodicalIF":2.0,"publicationDate":"2025-04-29","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12042613/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144035933","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":"Radial extracorporeal shock wave therapy for pain and function in adults with knee osteoarthritis: protocol for a placebo-controlled, randomized clinical trial.","authors":"Peng Ren, Ziliang Wang, Zihui Liang, Shenglin Xia, Xiangnan Yuan, Fenghua Zhou, Xueyong Liu","doi":"10.1186/s13063-025-08844-4","DOIUrl":"https://doi.org/10.1186/s13063-025-08844-4","url":null,"abstract":"<p><strong>Background: </strong>Knee osteoarthritis (KOA) is the most common degenerative joint disease. It is characterized by pain, stiffness, reduced joint motion, and muscle weakness. It also has the potential for long-term disability. Radial extracorporeal shock wave therapy (rESWT) is a noninvasive therapeutic modality widely used for the treatment of musculoskeletal disorders. However, the role of rESWT in the treatment of knee osteoarthritis remains controversial in previous clinical trials. This trial will investigate the efficacy of rESWT in improving the symptoms, function, and bone metabolic status of participants with knee osteoarthritis.</p><p><strong>Methods: </strong>The study is a randomized, double-blind, controlled trial. Thirty participants with knee osteoarthritis will be randomized to receive either rESWT or sham rESWT on the affected knee once per week for 4 weeks. All participants will undergo professional physiotherapy once a week during the treatment period. The primary outcome is the visual analogue scale score for pain. Secondary outcomes include the Western Ontario and McMaster Universities Osteoarthritis Index score, knee range of motion, the 10-m walk test results, and bone metabolism biochemical indicators. Outcomes will be measured at baseline (T0), 5 weeks post-intervention (T1), and 8 weeks post-intervention (T2).</p><p><strong>Discussion: </strong>This study will investigate the effects of rESWT on pain, physical function, and bone metabolism biochemical indicators in participants with knee osteoarthritis, which is expected to reduce the pain of participants, improve the function of participants, and improve bone metabolism biochemical indicators. The information obtained will enhance our understanding of rESWT for the treatment of knee osteoarthritis and may be used to standardize clinical treatment protocols for knee osteoarthritis.</p><p><strong>Trial registration: </strong>Chinese Clinical Trial Registry ChiCTR2300069997. Registered on 30 March 2023.</p>","PeriodicalId":23333,"journal":{"name":"Trials","volume":"26 1","pages":"139"},"PeriodicalIF":2.0,"publicationDate":"2025-04-25","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12023600/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144064824","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":"Respiratory biofeedback and psycho-education for patients with post COVID- 19 symptoms and bodily distress: study protocol of the randomized, controlled explorative intervention trial POSITIV.","authors":"Hannah Dinse, Eva-Maria Skoda, Adam Schweda, Christoph Jansen, Kira Schmidt, Margarethe Konik, Hana Rohn, Oliver Witzke, Mark Stettner, Christoph Kleinschnitz, Alexander Bäuerle, Martin Teufel","doi":"10.1186/s13063-025-08842-6","DOIUrl":"https://doi.org/10.1186/s13063-025-08842-6","url":null,"abstract":"<p><strong>Background: </strong>A high number of individuals report suffering from physical and psychological sequelae symptoms after COVID-19-the so-called post COVID-19 condition. Commonly reported complaints include physical symptoms such as fatigue, headache, attention and concentration deficits or dyspnea and anxiety, symptoms of post-traumatic stress, or depression. Evidence-based treatment recommendations are still lacking up to this point. Associations between physical and psychological symptoms in chronic diseases are known for a long time. Support in coping with the disease and improvement of self-efficacy can have a positive effect on the course of diseases. For this reason, we designed a randomized, controlled explorative intervention trial as a treatment of bodily distress disorder in COVID-19 recovered persons.</p><p><strong>Methods: </strong>Patients with a post COVID-19 condition meeting to the criteria of the WHO, along with a bodily distress disorder, are randomized in an intervention and control arm (TAU). Randomization takes place after a diagnostic interview, screening, and informed consent. In total, 60 patients will be included in the trial (30 per group). The intervention group receives a cognitive behavioral therapy as a video-conference-based group therapy (6 weeks) and mobile, respiratory biofeedback treatment (for 4 weeks). At several time points, both groups are assessed in terms of psychological and physical health status, treatment expectation, and satisfaction with the intervention. Furthermore, they will get biofeedback examination appointments. The primary outcome is the change in self-efficacy; secondary outcomes include assessed parameters of mental health, somatic symptoms, and satisfaction with the intervention. Data will be analyzed primarily using R and SPSS.</p><p><strong>Discussion: </strong>The randomized, controlled, explorative intervention trial POSITIV is one of the very first interventions for patients with post COVID-19 condition and psychological burden due to their different symptoms. The aim of the study is to generate new evidence and help patients to cope with the disease and thus, increase their quality of life and reduce symptomatology. We expect with a high probability that the patients' self-efficacy and health status will improve as a result of the intervention.</p><p><strong>Trial registration: </strong>German Clinical Trial Register (DRKS); DRKS-ID: DRKS00030565. Registered on December 22, 2022.</p>","PeriodicalId":23333,"journal":{"name":"Trials","volume":"26 1","pages":"140"},"PeriodicalIF":2.0,"publicationDate":"2025-04-25","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12032681/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144019728","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 acupuncture on cognitive function in poststroke depression: study protocol for a randomized, placebo-controlled trial.","authors":"Ling Chen, Yi Chen, Lihua Wu, Wen Fu, Luanmian Wu, Wenbin Fu","doi":"10.1186/s13063-025-08796-9","DOIUrl":"https://doi.org/10.1186/s13063-025-08796-9","url":null,"abstract":"","PeriodicalId":23333,"journal":{"name":"Trials","volume":"26 1","pages":"135"},"PeriodicalIF":2.0,"publicationDate":"2025-04-18","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12007299/pdf/","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"144015065","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}