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. 2018 Sep 5;8(9):e022254.
doi: 10.1136/bmjopen-2018-022254.

Study protocol for a single-blind, randomised controlled, non-inferiority trial of internet-based versus face-to-face cognitive behaviour therapy for obsessive-compulsive disorder

Christian Rück  1   2 , Lina Lundström  1   2 , Oskar Flygare  1 , Jesper Enander  1   2 , Matteo Bottai  3 , David Mataix-Cols  1   2 , Erik Andersson  1
Affiliations

Study protocol for a single-blind, randomised controlled, non-inferiority trial of internet-based versus face-to-face cognitive behaviour therapy for obsessive-compulsive disorder

Christian Rück et al. BMJ Open. .

Abstract

Introduction: Expert guidelines recommend cognitive-behavioural therapy (CBT) as a first-line treatment for obsessive-compulsive disorder (OCD), but the majority of patients with OCD do not have access to CBT. Internet-delivered CBT (ICBT) has the potential to make this evidence-based treatment more accessible while requiring less therapist time than traditional face-to-face (f2f) CBT. Data from six clinical trials suggest that ICBT for OCD is both efficacious and cost-effective, but whether ICBT is non-inferior to traditional f2f CBT for OCD is yet unknown.

Methods and analysis: A single-blind, randomised, controlled, non-inferiority trial comparing therapist-guided ICBT, unguided ICBT and individual (f2f) CBT for adult OCD patients. The primary objective is to investigate whether ICBT is non-inferior to gold standard f2f CBT. Secondary objectives are to investigate if ICBT is equally effective when delivered unguided, to establish the cost-effectiveness of ICBT and to investigate if the treatment outcome differs between self-referred and clinically referred patients. Participants will be recruited at two specialist OCD clinics in Stockholm and also through online self-referral. Participants will be randomised to one of three treatment conditions: F2f CBT, ICBT with therapist support or unguided ICBT. The total number of participants will be 120, and masked assessments will be administered at baseline, biweekly during treatment, at post-treatment and at 3-month and 12-month follow-ups. The main outcome measure is the clinician-rated Yale-Brown Obsessive Compulsive Scale (Y-BOCS) at 3-month follow-up. The margin of non-inferiority is set to 3 points on the Y-BOCS using a 90% CI.

Ethics and dissemination: The study has been approved by the Regional Ethics Board of Stockholm (REPN 2015/1099-31/2) and registered at Clinicaltrials.gov (NCT02541968). The study will be reported in accordance with the Consolidated Standards of Reporting Trials statement for non-pharmacological trials. The results will be published in peer-reviewed academic journals and disseminated to patient organisations and media.

Trial registration number: NCT02541968; Pre-results.

Keywords: adult psychiatry; clinical randomized controlled trial; internet delivered cognitive behaviour theraphy; non-inferiority study; obsessive compulsive disorder.

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Conflict of interest statement

Competing interests: None declared.

Figures

Figure 1
Figure 1
CONSORT-flow diagram. CBT, cognitive–behavioural therapy; CONSORT, Consolidated Standards of Reporting Trials; ICBT, internet-delivered CBT.
See this image and copyright information in PMC

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