Abstract
Internet-delivered cognitive behavior therapy is an effective treatment for children and adolescents with obsessive-compulsive disorder and has the potential to markedly increase access to treatment for patients while being cost-effective for health care organizations. To investigate whether internet-delivered cognitive behavior therapy implemented within a stepped care model is noninferior to, and cost-effective compared with, the gold standard of face-to-face cognitive behavior therapy for pediatric obsessive-compulsive disorder. Multicenter, single-blind, randomized clinical noninferiority trial implemented at 2 specialist pediatric obsessive-compulsive disorder clinics in Stockholm and Gothenburg, Sweden. Participants are 152 children and adolescents aged 7 to 17 years with obsessive compulsive disorder, recruited through the 2 clinics and online self-referral. Patients will be randomized 1:1 to the stepped care intervention or face-to-face therapy. Blind evaluations will be conducted after treatment and at 3-month and 6-month follow-ups. At the 6-month follow-up (primary end point), noninferiority will be tested and resource use will be compared between the 2 treatment groups. Data will be analyzed according to intention-to-treat principles. Patients randomized to stepped care will first receive internet-delivered cognitive behavior therapy for 16 weeks; patients who are classified as nonresponders 3 months after treatment completion will receive additional face-to-face therapy. The control group will receive 16 weeks of face-to-face cognitive behavior therapy immediately following randomization and nonresponders at the 3-month follow-up will, as in the stepped care group, receive additional face-to-face therapy. Noninferiority is defined as a 4-point difference on the primary outcome measure (Children's Yale-Brown Obsessive Compulsive Scale). Recruitment started October 6, 2017, and was completed May 24, 2019. Results from the primary end point will be available by May 2020. The naturalistic follow-ups (1, 2, and 5 years after the end of treatment) will continue to 2025. There are no interim analyses planned or stopping rules for the trial. ClinicalTrials.gov identifier: NCT03263546.
Highlights
Participants are 152 children and adolescents aged 7 to 17 years. Meaning This trial will add to the current knowledge base by evaluating a stepped care approach to the treatment of pediatric obsessivecompulsive disorder in which patients are first offered internet-delivered cognitive behavior therapy as a low-intensity intervention, reserving higher-intensity treatments such as face-to-face therapy for those who do not benefit from the first step
Cognitive behavior therapy (CBT) is regarded as the gold-standard treatment for pediatric obsessivecompulsive disorder (OCD)[1,2] and has consistently shown large effect sizes compared with both wait-list (g = 1.53) and various active comparators (g = 0.93)[3] as well as sustained long-term effects.[4]
Suitably trained CBT therapists specializing in OCD are scarce and typically concentrated in large urban areas, and it is estimated that many patients do not have access to CBT.[7,8,9,10]
Summary
A subsequent randomized clinical trial including 67 patients demonstrated superiority and cost-effectiveness of BIP OCD against a wait-list control.[14,15] Interestingly, the effects of ICBT were slightly weaker than expected but continued beyond the primary end point, with patients experiencing additional symptom improvement at the 3-month follow-up This delayed improvement phenomenon has been observed in other ICBT trials.[16,17] As participants in these trials were primarily self-referred[12,13,14] and may constitute a selected group of individuals (eg, highly educated, more motivated), the generalizability of these findings to regular clinic-referred patients is currently unclear
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