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

Abstract

Importance: In most countries, young people with obsessive-compulsive disorder have limited access to specialist cognitive behavioral therapy (CBT), a first-line treatment.

Objective: To investigate whether internet-delivered CBT implemented in a stepped-care model is noninferior to in-person CBT for pediatric obsessive-compulsive disorder.

Design, setting and participants: 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.

Interventions: 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.

Main outcomes and measures: 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.

Results: 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).

Conclusions and relevance: 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.

Trial registration: ClinicalTrials.gov Identifier: NCT03263546.

Conflict of interest statement

Conflict of Interest Disclosures: Dr Jolstedt reported receiving grants from The Swedish Research Council for Health, Working Life and Welfare (Forte 2014-4052) and from Stockholm County Council (HNSV 14099) during the conduct of the study. Dr Mataix-Cols reported receiving personal fees from UpToDate, Wolters Kluwer Health, and Elsevier outside the submitted work. No other disclosures were reported.

Figures

Figure 1.. Patient Flow in a Study of the Effect of Internet-Delivered Stepped Care vs In-Person Cognitive Behavioral Therapy (CBT) on Obsessive-Compulsive Disorder Symptoms in Children and Adolescents

See eResult 3 in Supplement 2 for detailed reasons on not receiving face-to-face CBT when being classified as a nonresponder at the 3-month follow-up assessment.

Figure 2.. Primary Outcome in a Study of the Effect of Internet-Delivered vs In-Person Cognitive Behavioral Therapy (CBT) on Obsessive-Compulsive Disorder Symptoms in Children and Adolescents

A, Boxes represent the interquartile range of the 25th and 75th percentiles, the middle line represents the median, the circles with connecting lines represent the mean values, the whiskers extend to the highest and lowest values within 1.5 times the interquartile range, and dots represent outliers. Children’s Yale-Brown Obsessive-Compulsive Scale (CY-BOCS) scores range from 0 to 40, with higher scores indicating more severe symptoms. The posttreatment assessment was 16 weeks after the pretreatment assessment, and the follow-up assessments were 3 months and 6 months after the posttreatment assessment. Nonresponders at the 3-month follow-up were offered additional in-person CBT between the 3-month follow-up and the 6-month follow-up. B, Stepped-care treatment was considered noninferior to in-person CBT because the 1-sided 97.5% CI of the mean difference was below the prespecified margin of 4 points (dotted line) on the CY-BOCS.

Figure 3.. Individual Participant CY-BOCS Outcomes in a Study of the Effect of Internet-Delivered vs In-Person Cognitive Behavioral Therapy (CBT) on Obsessive-Compulsive Disorder Symptoms in Children and Adolescents

Children’s Yale-Brown Obsessive-Compulsive Scale (CY-BOCS) scores range from 0 to 40, with higher scores indicating more severe symptoms. The boxplots indicate the interquartile range of the 25th and 75th percentiles, the middle line represents the median, circles represent the mean value, and the whiskers extend to the highest and lowest values within 1.5 times the interquartile range. C, The light blue vertical lines represent the nonresponders at the 3-month follow-up who received additional in-person treatment.