Abstract

Cognitive behavioral therapy (CBT) for obsessive-compulsive disorder (OCD) is a highly specialized treatment that is in short supply worldwide. To investigate whether both therapist-guided and unguided internet-based CBT (ICBT) are noninferior to face-to-face CBT for adults with OCD, to conduct a health economic evaluation, and to determine whether treatment effects were moderated by source of participant referral. This study is a single-blinded, noninferiority, randomized clinical trial, with a full health economic evaluation, conducted between September 2015 and January 2020, comparing therapist-guided ICBT, unguided ICBT, and individual face-to-face CBT for adults with OCD. Follow-up data were collected up to 12 months after treatment. The study was conducted at 2 specialist outpatient OCD clinics in Stockholm, Sweden. Participants included a consecutive sample of adults with a primary diagnosis of OCD, either self-referred or referred by a clinician. Data analysis was performed from June 2019 to January 2022. Guided ICBT, unguided ICBT, and face-to-face CBT delivered over 14 weeks. The primary end point was the change in OCD symptom severity from baseline to 3-month follow-up. The noninferiority margin was 3 points on the masked assessor-rated Yale-Brown Obsessive Compulsive Scale. A total of 120 participants were enrolled (80 women [67%]; mean [SD] age, 32.24 [9.64] years); 38 were randomized to the face-to-face CBT group, 42 were randomized to the guided ICBT group, and 40 were randomized to the unguided ICBT group. The mean difference between therapist-guided ICBT and face-to-face CBT at the primary end point was 2.10 points on the Yale-Brown Obsessive Compulsive Scale (90% CI, -0.41 to 4.61 points; P = .17), favoring face-to-face CBT, meaning that the primary noninferiority results were inconclusive. The difference between unguided ICBT and face-to-face CBT was 5.35 points (90% CI, 2.76 to 7.94 points; P < .001), favoring face-to-face CBT. The health economic analysis showed that both guided and unguided ICBT were cost-effective compared with face-to-face CBT. Source of referral did not moderate treatment outcome. The most common adverse events were anxiety (30 participants [25%]), depressive symptoms (20 participants [17%]), and stress (11 participants [9%]). The findings of this randomized clinical trial of ICBT vs face-to-face CBT for adults with OCD do not conclusively demonstrate noninferiority. Therapist-guided ICBT could be a cost-effective alternative to in-clinic CBT for adults with OCD in scenarios where traditional CBT is not readily available; unguided ICBT is probably less efficacious but could be an alternative when providing remote clinician support is not feasible. ClinicalTrials.gov Identifier: NCT02541968.

Highlights

  • Cognitive behavioral therapy (CBT) is a first-line treatment for obsessive-compulsive disorder (OCD),[1] but only a minority of patients receive it.[2]

  • The health economic analysis showed that both guided and unguided internet-based CBT (ICBT) were costeffective compared with face-to-face CBT

  • The health economic evaluation indicated that both therapistguided and unguided ICBT were costeffective compared with faceto-face CBT. Meaning These findings suggest that ICBT can be a cost-effective alternative for the treatment of OCD in health care contexts where access to traditional CBT is in short supply

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Summary

Introduction

Cognitive behavioral therapy (CBT) is a first-line treatment for obsessive-compulsive disorder (OCD),[1] but only a minority of patients receive it.[2]. ICBT is effective compared with a waiting list or active control condition in adults with OCD,[3-5] with gains sustained up to 2 years after treatment.[4]. ICBT for OCD has shown promising results across cultures[6-8] and in children and adolescents.[9,10]. This randomized clinical trial (RCT) was designed to address several critical questions that remain before ICBT for OCD can be recommended for implementation in health care. Whether guided ICBT is noninferior to individual face-to-face CBT for OCD has not been evaluated. The cost-effectiveness of ICBT vs individual face-to-face CBT for OCD needs to be evaluated to guide rational clinical service development. Because most previous ICBT studies have relied on selfreferred participants, it is important to establish whether the treatment outcomes can be generalized to clinic-referred participants (see the complete trial protocol in Supplement 1)

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