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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

Ivanova, Ekaterina ; Fondberg, Robin ; Flygare, Oskar ; Sannemalm, Max ; Asplund, Sofia ; Dahlén, Sofia ; Sampaio, Filipa ; Andersson, Erik ; Mataix-Cols, David LU and Ivanov, Volen Z. , et al. (2023) In BMJ Open 13(12).
Abstract

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... (More)

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.

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organization
publishing date
type
Contribution to journal
publication status
published
subject
keywords
adult psychiatry, anxiety disorders, psychiatry
in
BMJ Open
volume
13
issue
12
article number
e076361
publisher
BMJ Publishing Group
external identifiers
  • pmid:38101824
  • scopus:85179905100
ISSN
2044-6055
DOI
10.1136/bmjopen-2023-076361
language
English
LU publication?
yes
id
1a46978a-71f1-4e15-88c7-f38e8ed7f1b7
date added to LUP
2024-01-03 13:04:08
date last changed
2024-04-18 10:25:27
@article{1a46978a-71f1-4e15-88c7-f38e8ed7f1b7,
  abstract     = {{<p>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.</p>}},
  author       = {{Ivanova, Ekaterina and Fondberg, Robin and Flygare, Oskar and Sannemalm, Max and Asplund, Sofia and Dahlén, Sofia and Sampaio, Filipa and Andersson, Erik and Mataix-Cols, David and Ivanov, Volen Z. and Rück, Christian}},
  issn         = {{2044-6055}},
  keywords     = {{adult psychiatry; anxiety disorders; psychiatry}},
  language     = {{eng}},
  number       = {{12}},
  publisher    = {{BMJ Publishing Group}},
  series       = {{BMJ Open}},
  title        = {{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}},
  url          = {{http://dx.doi.org/10.1136/bmjopen-2023-076361}},
  doi          = {{10.1136/bmjopen-2023-076361}},
  volume       = {{13}},
  year         = {{2023}},
}