Abstract
Social anxiety disorder (SAD) is a prevalent childhood-onset disorder associated with lifelong adversity and high costs for the individual and society at large. Cognitive behavioral therapy (CBT) is an established evidence-based treatment for SAD, but its availability is limited. To assess the efficacy and cost-effectiveness of therapist-guided internet-delivered cognitive behavioral therapy (ICBT) for SAD in youths vs an active comparator, internet-delivered supportive therapy (ISUPPORT). This single-masked, superiority randomized clinical trial enrolled participants at a clinical research unit integrated within the child and adolescent mental health services in Stockholm, Sweden, from September 1, 2017, to October 31, 2018. The final participant reached the 3-month follow-up (primary end point) in May 2019. Children and adolescents 10 to 17 years of age with a principal diagnosis of SAD and their parents were included in the study. ICBT and ISUPPORT, both including 10 online modules, 5 separate parental modules, and 3 video call sessions with a therapist. The Clinician Severity Rating (CSR), derived from the Anxiety Disorder Interview Schedule, rated by masked assessors 3 months after the end of treatment. The CSR ranges from 0 to 8, with scores of 4 or higher indicating caseness. Secondary outcomes included masked assessor-rated diagnostic status of SAD and global functioning, child- and parent-reported social anxiety and depressive symptoms, and health-related costs. Of the 307 youths assessed for eligibility, 103 were randomized to 10 weeks of therapist-guided ICBT (n = 51) or therapist-guided ISUPPORT (n = 52) for SAD. The sample consisted of 103 youths (mean [SD] age, 14.1 [2.1] years; 79 [77%] female). Internet-delivered cognitive behavioral therapy was significantly more efficacious than ISUPPORT in reducing the severity of SAD symptoms. Mean (SD) CSR scores for ICBT at baseline and at the 3-month follow-up were 5.06 (0.95) and 3.96 (1.46), respectively, compared with 4.94 (0.94) and 4.48 (1.30) for ISUPPORT. There was a significant between-group effect size of d = 0.67 (95% CI, 0.21-1.12) at the 3-month follow-up. Similarly, all of the secondary outcome measures demonstrated significant differences with small to large effect sizes, except for child-rated quality of life (nonsignificant). The cost-effectiveness analyses indicated cost savings associated with ICBT compared with ISUPPORT, with the main drivers of the savings being lower medication costs (z = 2.38, P = .02) and increased school productivity (z = 1.99, P = .047) in the ICBT group. There was 1 suicide attempt in the ISUPPORT group; no other serious adverse events occurred in either group. In this randomized clinical trial, internet-delivered cognitive behavioral therapy was an efficacious and cost-effective intervention for children and adolescents with SAD. Implementation in clinical practice could markedly increase the availability of effective interventions for SAD. ClinicalTrials.gov Identifier: NCT03247075.
Highlights
Question Is internet-delivered cognitive behavioral therapy (ICBT) an efficacious and cost-effective treatment for youths with social anxiety disorder (SAD)?. In this randomized clinical trial of 103 children and adolescents with a principal diagnosis of Social anxiety disorder (SAD) and their parents, a 10-week course of ICBT was efficacious and cost-effective compared with an active comparator
We observed a statistically significant time × group interaction effect (β [SE] = −0.27 [0.09]; P = .005), with a model-implied between-group effect size of moderate strength for the primary outcome measure (CSR) (d = 0.67; 95% CI, 0.21-1.12) at the primary end point, favoring ICBT (Figure 2)
Results favored ICBT, and most between-group effect sizes at 3-month follow-up were in the moderate range (d = 0.64; 95% CI, 0.27-1.01 for child-reported SAD symptoms; d = 0.83; 95% CI, 0.43-1.22 for parent-reported SAD symptoms; d = 0.47; 95% CI, 0.07-0.88 for child-reported depressive symptoms; d = 0.78; 95% CI, 0.38-1.17 for parent-reported anxiety and depressive symptoms; d = 0.39; 95% CI, 0.03-0.74 for masked assessor–reported global functioning; and d = 0.48; 95% CI, 0.08-0.89 for parent-reported general functioning) (Table 2)
Summary
Study Design This single-masked randomized clinical trial (RCT) compared therapist-guided ICBT with therapist-guided internetdelivered supportive therapy (ISUPPORT) for children and adolescents (10-17 years of age) with a principal diagnosis of SAD. The trial was conducted at a clinical research unit integrated within the Child and Adolescent Mental Health Services in Stockholm, Sweden. Recruitment took place from September 1, 2017, to October 31, 2018. Participants (N = 103) were randomized to 10 weeks of ICBT (n = 51) or ISUPPORT (n = 52). The primary end point was set to 3 months after the treatment period (May 2019) because of a previously observed tendency for participants in ICBT trials to report continued improvement beyond treatment termination.[14,15]
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