The clinical effectiveness of a self-management intervention for patients with persistent depressive disorder and their partners/caregivers: results from a multicenter, pragmatic randomized controlled trial
Persistent depressive disorder (PDD) is prevalent and debilitating. For patients with PDD, psychiatric rehabilitation using self-management interventions is advised as the next therapeutic step after multiple ... (Source: Trials)
Source: Trials - March 13, 2024 Category: General Medicine Authors: Ericka C. Solis, Ingrid V. E. Carlier, No ëlle G. A. Kamminga, Erik J. Giltay and Albert M. van Hemert Tags: Research Source Type: research
The clinical effectiveness of a self-management intervention for patients with persistent depressive disorder and their partners/caregivers: results from a multicenter, pragmatic randomized controlled trial
ConclusionAlthough depressive symptoms did not improve relative to CAU, this only confirmed that treatment for patients with treatment-resistant PDD should move from symptom reduction to functional recovery. Also, functional recovery may be reflected in other outcomes than psychosocial burden, such as self-empowerment, in patients with treatment-resistant PDD. Future research on PPEP4All-PDD could focus on a longer-term program and/or online program that may also be offered earlier in the treatment process as an empowerment intervention. Trial registrationNetherlands Trial Register Identifier NL5818. Registered on 20 Jul...
Source: Trials - March 13, 2024 Category: Research Source Type: clinical trials
Efficacy of a virtual reality-based cognitive interactive training program for children with traumatic brain injuries: study protocol for a parallel-group randomized controlled trial
DiscussionCognitive rehabilitation is among the top healthcare needs for pediatric TBI patients. Virtual reality-based training is promising due to its versatile content, flexibility, and potential cost savings for both patients and providers. Findings of this trial will provide data on the efficacy of the VICT program on core executive functions, attention problems, and health-related quality of life and serve as the empirical foundation for future larger multi-site effectiveness trials.Trial registrationClinicalTrials.govNCT04526639. Registered on August 18, 2020. (Source: Trials)
Source: Trials - March 13, 2024 Category: Research Source Type: clinical trials
Correction: Statistical analysis plan and protocol updates for Gestational diabetes in Uganda and India: Design and Evaluation of Educational Films for Improving Screening and Self-management (GUIDES) trial
(Source: Trials)
Source: Trials - March 13, 2024 Category: Research Source Type: clinical trials
Trial Forge Guidance 4: a guideline for reporting the results of randomised Studies Within A Trial (SWATs)
Evidence to support decisions on trial processes is minimal. One way to generate this evidence is to use a Study Within A Trial (SWAT) to test trial processes or explore methodological uncertainties. SWAT evid... (Source: Trials)
Source: Trials - March 12, 2024 Category: General Medicine Authors: C. E. Arundel, L. K. Clark, A. Parker, D. Beard, E. Coleman, C. Cooper, D. Devane, S. Eldridge, S. Galvin, K. Gillies, C. E. Hewitt, C. Sutton, D. J. Torgerson and S. Treweek Tags: Methodology Source Type: research
The effectiveness of therapeutic craft-making activities in treating lower-third forearm fracture: study protocol for a randomized controlled trial
ConclusionThis study is ongoing.Trial registrationANZCTR, ACTRN12622000150741. Retrospectively registered on 28 January 2022https://anzctr.org.au/Trial/Registration/TrialReview.aspx?id=382676&isReview=true.. (Source: Trials)
Source: Trials - March 12, 2024 Category: Research Source Type: clinical trials
The scientific rationale and study protocol for the DPP3, Angiotensin II, and Renin Kinetics in Sepsis (DARK-Sepsis) randomized controlled trial: serum biomarkers to predict response to angiotensin II versus standard-of-care vasopressor therapy in the treatment of septic shock
DiscussionWith an armamentarium of mechanistically distinct vasopressor agents now available, sub-phenotyping patients using biomarkers has the potential to improve septic shock outcomes by enabling treatment of the correct patient with the correct vasopressor at the correct time. However, this approach requires validation in a large definitive multicenter trial. The data generated through the DARK-Sepsis study will prove crucial to the optimal design and patient enrichment of such a pivotal trial.Trial registrationClinicalTrials.gov NCT05824767. Registered on April 24, 2023. (Source: Trials)
Source: Trials - March 12, 2024 Category: Research Source Type: clinical trials
Trial Forge Guidance 4: a guideline for reporting the results of randomised Studies Within A Trial (SWATs)
ConclusionsThe SWAT reporting guideline will aid authors, reviewers, and journal editors to produce and review clear, structured reports of randomised SWATs, whilst also adhering to the CONSORT guideline.Trial registrationEQUATOR Network – Guidelines Under Development (https://www.equator-network.org/library/reporting-guidelines-under-development/reporting-guidelines-under-development-for-clinical-trials/#SWAT). Registered on 25 March 2021. (Source: Trials)
Source: Trials - March 12, 2024 Category: Research Source Type: clinical trials
Estimands for clinical endpoints in tuberculosis treatment randomized controlled trials: a retrospective application in a completed trial
Randomized trials for the treatment of tuberculosis (TB) rely on a composite primary outcome to capture unfavorable treatment responses. However, variability between trials in the outcome definition and estima... (Source: Trials)
Source: Trials - March 12, 2024 Category: General Medicine Authors: Isabelle R. Weir, Suzanne M. Dufault and Patrick P. J. Phillips Tags: Methodology Source Type: research
The efficacy and safety of deucravacitinib compared to methotrexate, in patients with vulvar lichen planus who have failed topical therapy with potent corticosteroids: a study protocol for a single-centre double-blinded randomised controlled trial
Vulvar lichen planus (VLP) is a chronic vulvar dermatosis that is difficult to treat and can severely impair quality of life in the absence of adequate treatment. There is a lack of high-quality evidence to di... (Source: Trials)
Source: Trials - March 12, 2024 Category: General Medicine Authors: Marlene Wijaya, Gayle Fischer and Rebecca Bronwyn Saunderson Tags: Study protocol Source Type: research
Estimands for clinical endpoints in tuberculosis treatment randomized controlled trials: a retrospective application in a completed trial
ConclusionsOur application of estimands defined by the ICH E9 (R1) addendum offers a formalized framework for addressing the primary TB treatment trial objective and can promote uniformity in future trials by limiting heterogeneity in trial outcome definitions. We demonstrated the utility of our proposal using data from the REMoxTB randomized trial. We outlined methods for estimating each estimand and found consistent conclusions across estimands. We recommend future late-phase TB treatment trials to implement some or all of our estimands to promote rigorous outcome definitions and reduce variability between trials.Trial r...
Source: Trials - March 12, 2024 Category: Research Source Type: clinical trials
The efficacy and safety of deucravacitinib compared to methotrexate, in patients with vulvar lichen planus who have failed topical therapy with potent corticosteroids: a study protocol for a single-centre double-blinded randomised controlled trial
DiscussionHigh-quality evidence guiding the management of women with VLP is lacking. Once completed, this will be the first double-blinded RCT to compare systemic treatments in VLP. The results of this study will provide valuable, high-quality data to guide second-line therapy options for VLP that is recalcitrant to potent topical corticosteroids.Trial registrationAustralian New Zealand Clinical Trials Registry ACTRN12623000682640. Registered on 26 June 2023. (Source: Trials)
Source: Trials - March 12, 2024 Category: Research Source Type: clinical trials
Measuring the Effect of the Early assessment Team (MEET) for patients referred to outpatient mental health care: a study protocol for a randomised controlled trial
This study will examine an intervention designed to determine early on which patients will benefit from parallel or other measures than assessment and treatment in CMHC and whether these will facilitate their recovery. Findings may potentially contribute to the development of the organisation of mental health services.Trial registrationClinicalTrials.gov NCT05087446. Registered on 21 October 2021. (Source: Trials)
Source: Trials - March 11, 2024 Category: Research Source Type: clinical trials
Measuring the Effect of the Early assessment Team (MEET) for patients referred to outpatient mental health care: a study protocol for a randomised controlled trial
Referrals to specialised mental health care (such as community mental health centres; CMHC) have increased over the last two decades. Patients often have multifaceted problems, which cannot only be solved by s... (Source: Trials)
Source: Trials - March 11, 2024 Category: General Medicine Authors: Camilla Angelsen Kvestad, Ingvild R ønneberg Holte, Solveig Klæbo Reitan, Charlotte S. Chiappa, Gunn Karin Helle, Anne E. Skjervold, Anne Marit A. Rosenlund, Øyvind Watne, Heidi Brattland, Jon Helle, Turid Follestad, Karen Walseth Hara and Katrine Høy Tags: Study protocol Source Type: research
EFFects of Exposure and Cognitive behavioral Therapy for chronic BACK pain ( “EFFECT-BACK”): study protocol for a randomized controlled trial
ConclusionThis study will be the first RCT to compare CBT and EXP in chronic back pain in a large sample, including patients from different care structures due to psychological and medical recruitment centers. By identifying and exploring potential predictors of symptom improvement in each treatment group, this study will contribute to enable a more individualized assignment to treatment modalities and thus improves the care situation for chronic back pain and helps to create a customized treatment program for subgroups of pain patients. If our findings confirm EXP to be an efficacious and efficient treatment concept, it s...
Source: Trials - March 11, 2024 Category: Research Source Type: clinical trials
