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- Title
Effect of an Internet-Delivered Stepped-Care Program vs In-Person Cognitive Behavioral Therapy on Obsessive-Compulsive Disorder Symptoms in Children and Adolescents: A Randomized Clinical Trial.
- Authors
Aspvall, Kristina; Andersson, Erik; Melin, Karin; Norlin, Lisa; Eriksson, Viktor; Vigerland, Sarah; Jolstedt, Maral; Silverberg-Mörse, Maria; Wallin, Lena; Sampaio, Filipa; Feldman, Inna; Bottai, Matteo; Lenhard, Fabian; Mataix-Cols, David; Serlachius, Eva
- Abstract
<bold>Importance: </bold>In most countries, young people with obsessive-compulsive disorder have limited access to specialist cognitive behavioral therapy (CBT), a first-line treatment.<bold>Objective: </bold>To investigate whether internet-delivered CBT implemented in a stepped-care model is noninferior to in-person CBT for pediatric obsessive-compulsive disorder.<bold>Design, Setting and Participants: </bold>A randomized clinical noninferiority trial conducted at 2 specialist child and adolescent mental health clinics in Sweden. Participants included 152 individuals aged 8 to 17 years with obsessive-compulsive disorder. Enrollment began in October 2017 and ended in May 2019. Follow-up ended in April 2020.<bold>Interventions: </bold>Participants randomized to the stepped-care group (n = 74) received internet-delivered CBT for 16 weeks. Nonresponders at the 3-month follow-up were then offered a course of traditional face-to-face treatment. Participants randomized to the control group (n = 78) immediately received in-person CBT for 16 weeks. Nonresponders at the 3-month follow-up received additional face-to-face treatment.<bold>Main Outcomes and Measures: </bold>The primary outcome was the masked assessor-rated Children's Yale-Brown Obsessive-Compulsive Scale (CY-BOCS) score at the 6-month follow-up. The scale includes 10 items rated from 0 (no symptoms) to 4 (extreme symptoms), yielding a total score range of 0 to 40, with higher scores indicating greater severity. Assessors were masked to treatment allocation at pretreatment, posttreatment, 3-month follow-up, and 6-month follow-up assessments. The predefined noninferiority margin was 4 points on the CY-BOCS.<bold>Results: </bold>Among the 152 randomized participants (mean age, 13.4 years; 94 [62%] females), 151 (99%) completed the trial. At the 3-month follow-up, 34 participants (46%) in the stepped-care group and 23 (30%) in the in-person CBT group were nonresponders. At the 6-month follow-up, the CY-BOCS score was 11.57 points in the stepped-care group vs 10.57 points in the face-to-face treatment group, corresponding to an estimated mean difference of 0.91 points ([1-sided 97.5% CI, -∞ to 3.28]; P for noninferiority = .02). Increased anxiety (30%-36%) and depressive symptoms (20%-28%) were the most frequently reported adverse events in both groups. There were 2 unrelated serious adverse events (1 in each group).<bold>Conclusions and Relevance: </bold>Among children and adolescents with obsessive-compulsive disorder, treatment with an internet-delivered CBT program followed by in-person CBT if necessary compared with in-person CBT alone resulted in a noninferior difference in symptoms at the 6-month follow-up. Further research is needed to understand the durability and generalizability of these findings.<bold>Trial Registration: </bold>ClinicalTrials.gov Identifier: NCT03263546.
- Subjects
SWEDEN; OBSESSIVE-compulsive disorder; INTERNET in medicine; MEDICAL care; BEHAVIOR therapy; COGNITIVE therapy; RANDOMIZED controlled trials; MENTAL depression; BLIND experiment; ANXIETY; STATISTICAL sampling
- Publication
JAMA: Journal of the American Medical Association, 2021, Vol 325, Issue 18, p1863
- ISSN
0098-7484
- Publication type
journal article
- DOI
10.1001/jama.2021.3839