Effect of Internet-Based vs Face-to-Face Cognitive Behavioral Therapy for Adults With Obsessive-Compulsive Disorder: A Randomized Clinical Trial

Abstract

Importance: Cognitive behavioral therapy (CBT) for obsessive-compulsive disorder (OCD) is a highly specialized treatment that is in short supply worldwide.

Objectives: 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.

Design, setting, and participants: 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.

Interventions: Guided ICBT, unguided ICBT, and face-to-face CBT delivered over 14 weeks.

Main outcomes and measures: 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.

Results: 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%]).

Conclusions and relevance: 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.

Trial registration: ClinicalTrials.gov Identifier: NCT02541968.

Figure 1.. Participant Flow Through the Trial

Dropouts were participants who did not complete any assessments from week 6 on. Missing at follow-up refers to participants who completed treatment but did not provide data at the follow-up time point. C indicates clinical referral; CBT, cognitive behavioral therapy; ICBT, internet-based cognitive behavioral therapy; ITT, intention to treat; OCD, obsessive-compulsive disorder; S, self-referral.

Figure 2.. Yale-Brown Obsessive Compulsive Scale (Y-BOCS) Scores Over Time

Panel A shows clinician-rated observed (solid lines) and estimated (dashed lines) Y-BOCS scores from before treatment to the 3-month follow-up. Panel B shows estimated differences between face-to-face cognitive behavioral therapy (CBT) and the 2 internet-based cognitive behavioral therapy (ICBT) treatments at the 3-month follow-up. The dotted line indicates the prespecified noninferiority margin of 3 points on the Y-BOCS.

Figure 3.. Cost-effectiveness Planes at the 3-Month Follow-up

Graphs show before treatment to 3-month follow-up cost-effectiveness planes of therapist guided internet-based cognitive behavioral therapy (ICBT) (A) and unguided ICBT (B) compared with face-to-face CBT for obsessive-compulsive disorder. Costs are from a societal perspective and based on the Trimbos and Institute of Medical Technology Assessment Cost Questionnaire on Costs Associated with Psychiatric Illness using Swedish health care tariff listings. The effect is shown as the rate of response, defined as a 35% or more reduction in the Yale-Brown Obsessive Compulsive Scale from before treatment and a Clinical Global Impression–Improvement score of 1 or 2.