Study protocol for a single-blind, parallel-group, randomised, controlled non-inferiority trial of 4-day intensive versus standard cognitive behavioural therapy for adults with obsessive-compulsive disorder.

Autor:	Ivanova E; Centre for Psychiatry Research, Department of Clinical Neuroscience, Karolinska Institutet & Stockholm Health Care Services, Stockholm, Sweden ekaterina.ivanova@ki.se., Fondberg R; Centre for Psychiatry Research, Department of Clinical Neuroscience, Karolinska Institutet, Stockholm, Sweden., Flygare O; Centre for Psychiatry Research, Department of Clinical Neuroscience, Karolinska Institutet & Stockholm Health Care Services, Stockholm, Sweden., Sannemalm M; Centre for Psychiatry Research, Department of Clinical Neuroscience, Karolinska Institutet & Stockholm Health Care Services, Stockholm, Sweden., Asplund S; Stockholm Health Care Services, Region Stockholm, Stockholm, Sweden., Dahlén S; Stockholm Health Care Services, Region Stockholm, Stockholm, Sweden., Sampaio F; Department of Public Health and Caring Sciences, Uppsala University, Uppsala, Sweden., Andersson E; Division of Psychology, Department of Clinical Neuroscience, Karolinska Institutet, Stockholm, Sweden., Mataix-Cols D; Centre for Psychiatry Research, Department of Clinical Neuroscience, Karolinska Institutet & Stockholm Health Care Services, Stockholm, Sweden.; Department of Clinical Sciences, Lund University, Lund, Sweden., Ivanov VZ; Centre for Psychiatry Research, Department of Clinical Neuroscience, Karolinska Institutet & Stockholm Health Care Services, Stockholm, Sweden., Rück C; Centre for Psychiatry Research, Department of Clinical Neuroscience, Karolinska Institutet & Stockholm Health Care Services, Stockholm, Sweden.
Jazyk:	angličtina
Zdroj:	BMJ open [BMJ Open] 2023 Dec 14; Vol. 13 (12), pp. e076361. Date of Electronic Publication: 2023 Dec 14.
DOI:	10.1136/bmjopen-2023-076361
Abstrakt:	Introduction: Individual cognitive behavioural therapy (CBT) with exposure and response prevention is an effective treatment for obsessive-compulsive disorder (OCD). However, individual CBT is costly and time-consuming, requiring weekly therapy sessions for 3-4 months. A 4-day intensive version of CBT for OCD delivered in group format has been recently developed in Norway (Bergen 4-day treatment, B4DT). B4DT has shown promising results in several uncontrolled and one small, randomised trial, but its non-inferiority to the gold standard treatment has not been established. Methods and Analysis: This single-blind, randomised controlled trial including 120 patients (60 per arm) will compare B4DT to individual CBT. The primary outcome is the blind assessor-rated Yale-Brown Obsessive Compulsive Scale (Y-BOCS). We hypothesise that B4DT will be non-inferior to gold standard CBT 15 weeks after treatment start. The non-inferiority margin is set at four points on the Y-BOCS. Secondary outcomes include time to treatment response, cost-effectiveness, response and remission rates, drop-out rates and adverse events. Ethics and Dissemination: This study has been approved by the Swedish Ethical Review Authority. Hypotheses were specified and analysis code published before data collection started. Results from all analyses will be reported in accordance with the Consolidated Standards of Reporting Trials statement for non-pharmacological trials and Consolidated Health Economic Evaluation Reporting Standards irrespective of outcome. Trial Registration Number: NCT05608278. Competing Interests: Competing interests: OF has received speaking fees from the Swedish OCD Association, Insight Events AB and Kry International AB, as well as reimbursement for writing articles for Inside Practice Psychiatry; all outside the submitted work. EI has received speaking fees from the Swedish OCD Association outside the submitted work. Prof Mataix-Cols receives royalties for contributing articles to UpToDate, outside the submitted work. EA and SA receive royalties from Natur & Kultur for books, all outside the submitted work. CR receives royalties from Natur & Kultur, Studentlitteratur and Albert Bonniers Förlag and has received speaking fees from various sources, all outside the submitted work. (© Author(s) (or their employer(s)) 2023. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)
Databáze:	MEDLINE
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