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Study protocol for ...
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
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- Ivanova, Ekaterina (author)
- Karolinska Institutet,Karolinska Institute,Karolinska Inst, Ctr Psychiat Res, Dept Clin Neurosci, Stockholm, Sweden.;Stockholm Hlth Care Serv, Stockholm, Sweden.
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- Fondberg, Robin (author)
- Karolinska Institutet,Karolinska Institute,Karolinska Inst, Ctr Psychiat Res, Dept Clin Neurosci, Stockholm, Sweden.
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- Flygare, Oskar (author)
- Karolinska Institutet,Karolinska Institute,Karolinska Inst, Ctr Psychiat Res, Dept Clin Neurosci, Stockholm, Sweden.;Stockholm Hlth Care Serv, Stockholm, Sweden.
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- Sannemalm, Max (author)
- Karolinska Institutet,Karolinska Institute,Karolinska Inst, Ctr Psychiat Res, Dept Clin Neurosci, Stockholm, Sweden.;Stockholm Hlth Care Serv, Stockholm, Sweden.
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- Asplund, Sofia (author)
- Karolinska Institutet
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- Dahlén, Sofia (author)
- Stockholm Hlth Care Serv, Reg Stockholm, Stockholm, Sweden.
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- Sampaio, Filipa, PhD, 1985- (author)
- Uppsala universitet,Uppsala University,Socialmedicin/CHAP
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- Andersson, Erik (author)
- Karolinska Institutet,Karolinska Institute,Karolinska Inst, Dept Clin Neurosci, Div Psychol, Stockholm, Sweden.
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- Mataix-Cols, David (author)
- Karolinska Institutet,Karolinska Institute,Lund University,Lunds universitet,Innovations in pediatric mental health,Forskargrupper vid Lunds universitet,Lund University Research Groups,Karolinska Inst, Ctr Psychiat Res, Dept Clin Neurosci, Stockholm, Sweden.;Stockholm Hlth Care Serv, Stockholm, Sweden.;Lund Univ, Dept Clin Sci, Lund, Sweden.
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- Ivanov, Volen Z. (author)
- Karolinska Institutet,Karolinska Institute,Karolinska Inst, Ctr Psychiat Res, Dept Clin Neurosci, Stockholm, Sweden.;Stockholm Hlth Care Serv, Stockholm, Sweden.
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- Rück, Christian (author)
- Karolinska Institutet,Karolinska Institute,Karolinska Inst, Ctr Psychiat Res, Dept Clin Neurosci, Stockholm, Sweden.;Stockholm Hlth Care Serv, Stockholm, Sweden.
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Karolinska Institute Karolinska Inst, Ctr Psychiat Res, Dept Clin Neurosci, Stockholm, Sweden;Stockholm Hlth Care Serv, Stockholm, Sweden. (creator_code:org_t)
- BMJ Publishing Group Ltd, 2023
- 2023
- English.
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In: BMJ Open. - : BMJ Publishing Group Ltd. - 2044-6055. ; 13:12
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https://doi.org/10.1...
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https://doi.org/10.1...
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http://kipublication...
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Abstract
Subject headings
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- 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.
Subject headings
- MEDICIN OCH HÄLSOVETENSKAP -- Klinisk medicin -- Psykiatri (hsv//swe)
- MEDICAL AND HEALTH SCIENCES -- Clinical Medicine -- Psychiatry (hsv//eng)
Keyword
- adult psychiatry
- anxiety disorders
- psychiatry
- adult psychiatry
Publication and Content Type
- art (subject category)
- ref (subject category)
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BMJ Open
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- By the author/editor
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Ivanova, Ekateri ...
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Fondberg, Robin
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Flygare, Oskar
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Sannemalm, Max
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Asplund, Sofia
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Dahlén, Sofia
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Sampaio, Filipa, ...
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Andersson, Erik
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Mataix-Cols, Dav ...
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Ivanov, Volen Z.
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Rück, Christian
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- About the subject
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- MEDICAL AND HEALTH SCIENCES
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MEDICAL AND HEAL ...
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and Clinical Medicin ...
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and Psychiatry
- Articles in the publication
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BMJ Open
- By the university
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Lund University
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Karolinska Institutet
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Uppsala University