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BMJ Open ; 13(12): e076361, 2023 12 14.
Artigo em Inglês | MEDLINE | ID: mdl-38101824

RESUMO

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.


Assuntos
Terapia Cognitivo-Comportamental , Transtorno Obsessivo-Compulsivo , Adulto , Humanos , Terapia Cognitivo-Comportamental/métodos , Análise Custo-Benefício , Transtorno Obsessivo-Compulsivo/terapia , Ensaios Clínicos Controlados Aleatórios como Assunto , Método Simples-Cego , Resultado do Tratamento , Estudos de Equivalência como Asunto
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