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Stepped Care Intern...
Stepped Care Internet-Delivered vs Face-to-Face Cognitive-Behavior Therapy for Pediatric Obsessive-Compulsive Disorder A Trial Protocol for a Randomized Noninferiority Trial
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- Aspvall, K. (author)
- Karolinska Institutet
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- Andersson, E. (author)
- Karolinska Institutet
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- Lenhard, F. (author)
- Karolinska Institutet
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- Melin, Karin, 1964 (author)
- Gothenburg University,Göteborgs universitet,Institutionen för neurovetenskap och fysiologi,Institute of Neuroscience and Physiology,Univ Gothenburg, Sahlgrenska Acad, Inst Neurosci & Physiol, Gothenburg, Sweden;Sahlgrens Univ Hosp, Dept Child & Adolescent Psychiat, Child & Adolescent Psychiat Specialized Unit, Gothenburg, Sweden
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- Wallin, Lena (author)
- Gothenburg University,Göteborgs universitet,Institutionen för neurovetenskap och fysiologi,Institute of Neuroscience and Physiology,Univ Gothenburg, Sahlgrenska Acad, Inst Neurosci & Physiol, Gothenburg, Sweden;Sahlgrens Univ Hosp, Dept Child & Adolescent Psychiat, Child & Adolescent Psychiat Specialized Unit, Gothenburg, Sweden
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- Silverberg-Morse, M. (author)
- Stockholm Cty Council, Stockholm Hlth Care Serv, Stockholm, Sweden
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- Feldman, Inna, Docent, 1951- (author)
- Uppsala universitet,Socialmedicin/CHAP
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- Bottai, M. (author)
- Karolinska Institutet
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- Mataix-Cols, D. (author)
- Karolinska Institutet
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- Serlachius, E. (author)
- Karolinska Institutet
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- Norlin, Lisa (author)
- Sahlgrens Univ Hosp, Dept Child & Adolescent Psychiat, Child & Adolescent Psychiat Specialized Unit, Gothenburg, Sweden
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(creator_code:org_t)
- 2019-10-23
- 2019
- English.
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In: Jama Network Open. - : American Medical Association (AMA). - 2574-3805. ; 2:10
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Abstract
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- 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.
Subject headings
- MEDICIN OCH HÄLSOVETENSKAP -- Medicinska och farmaceutiska grundvetenskaper -- Neurovetenskaper (hsv//swe)
- MEDICAL AND HEALTH SCIENCES -- Basic Medicine -- Neurosciences (hsv//eng)
- MEDICIN OCH HÄLSOVETENSKAP -- Klinisk medicin -- Psykiatri (hsv//swe)
- MEDICAL AND HEALTH SCIENCES -- Clinical Medicine -- Psychiatry (hsv//eng)
Keyword
- children
- ocd
- adolescents
- scale
- reliability
- General & Internal Medicine
Publication and Content Type
- ref (subject category)
- art (subject category)
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Aspvall, K.
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Andersson, E.
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Lenhard, F.
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Melin, Karin, 19 ...
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Wallin, Lena
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Silverberg-Morse ...
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Feldman, Inna, D ...
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Bottai, M.
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Mataix-Cols, D.
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Serlachius, E.
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Norlin, Lisa
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- MEDICAL AND HEALTH SCIENCES
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MEDICAL AND HEAL ...
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and Basic Medicine
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University of Gothenburg
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Uppsala University
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Karolinska Institutet