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Aspvall K, Andersson E, Lenhard F, et al. Stepped Care Internet-Delivered vs Face-to-Face Cognitive-Behavior Therapy for Pediatric Obsessive-Compulsive Disorder: A Trial Protocol for a Randomized Noninferiority Trial. JAMA Netw Open. 2019;2(10):e1913810. doi:https://doi.org/10.1001/jamanetworkopen.2019.13810
Is internet-delivered cognitive behavior therapy implemented within a stepped care model noninferior to, and cost-effective compared with, face-to-face cognitive behavior therapy for pediatric obsessive-compulsive disorder?
This protocol describes a multicenter randomized clinical noninferiority trial conducted in a health care setting. Participants are 152 children and adolescents aged 7 to 17 years.
This trial will add to the current knowledge base by specifically evaluating a stepped care approach to the treatment of pediatric obsessive-compulsive 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.
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.
Design, Setting, and Participants
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.
Main Outcomes and Measures
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
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