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    Original Investigation
    Psychiatry
    October 23, 2019

    Stepped Care Internet-Delivered vs Face-to-Face Cognitive-Behavior Therapy for Pediatric Obsessive-Compulsive Disorder: A Trial Protocol for a Randomized Noninferiority Trial

    Author Affiliations
    • 1Centre for Psychiatry Research, Department of Clinical Neuroscience, Karolinska Institutet
    • 2Stockholm Health Care Services, Stockholm County Council, Stockholm, Sweden
    • 3Division of Psychology, Department of Clinical Neuroscience, Karolinska Institutet, Stockholm, Sweden
    • 4Institute of Neuroscience and Physiology, the Sahlgrenska Academy, University of Gothenburg, Gothenburg, Sweden
    • 5Department of Child and Adolescent Psychiatry, Child and Adolescent Psychiatry Specialized Unit, Sahlgrenska University Hospital, Gothenburg, Sweden
    • 6Department of Women's and Children's Health, Uppsala Universitet, Uppsala, Sweden
    • 7Institute of Environmental Medicine, Biostatistics, Karolinska Institutet, Stockholm, Sweden
    JAMA Netw Open. 2019;2(10):e1913810. doi:10.1001/jamanetworkopen.2019.13810
    Key Points español 中文 (chinese)

    Question  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?

    Findings  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.

    Meaning  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.

    Abstract

    Importance  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.

    Objective  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.

    Intervention  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).

    Discussion  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.

    Trial Registration  ClinicalTrials.gov identifier: NCT03263546

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