Therapist-Guided Internet-Delivered Cognitive Behavioural Therapy Versus Internet-Delivered Supportive Therapy for Children and Adolescents with Social Anxiety Disorder: A Randomised Controlled Trial

Abstract

Background: This single-masked randomised controlled superiority trial evaluated the efficacy and cost-effectiveness of therapist guided internet-delivered cognitive behavioural therapy (ICBT) for social anxiety disorder (SAD) in youth compared with an active comparator, internet-delivered supportive therapy (ISUPPORT). Methods: Participants were 103 children and adolescents aged 10-17 years with a principal diagnosis of SAD, and their parents. Participants were randomly allocated to 10 weeks of ICBT (n=51) or ISUPPORT (n=52). Both interventions included three video call sessions with a therapist. The primary outcome measure was the Clinician Severity Rating (CSR), derived from the Anxiety Disorder Interview Schedule (ADIS-C), rated by masked clinicians post treatment and three months after the end of treatment (primary endpoint). Secondary outcomes included clinician-rated diagnostic status of SAD and global functioning, as well as child- and parent-reported social anxiety and comorbid depression. Findings: ICBT was significantly more efficacious than ISUPPORT in reducing the severity of SAD symptoms with a significant between-group effect size of d=0·66 (95% CI [0·27, 1·11]) at the 3-month follow-up. Similarly, most of the secondary outcome measures demonstrated moderate effect sizes favouring ICBT. The cost-effectiveness analyses indicated cost savings associated with ICBT compared to ISUPPORT. One suicide attempt was reported and managed in the ISUPPORT condition. No other serious adverse events were reported in either condition. Interpretation: ICBT is 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. Trial Registration: The trial was registered at ClinicalTrials.gov with id NCT03247075 Funding: This work was funded by the Swedish Research Council for Health, Working Life and Welfare (Forte 2014-4052) and Region Stockholm (HNSV 14099). JH was supported by Region Stockholm (Dnr: K0173-2016; clinical postdoctoral appointment: 2017-2020). ES was supported by Region Stockholm (clinical research appointment; 2017-0605). Declaration of Interests: All authors have completed the ICMJE uniform disclosure form at www.icmje.org/coi_disclosure.pdf. Dr. Mataix-Cols reports personal fees from Elsevier, personal fees from UpToDate, Inc., outside the submitted work. None of the other authors declare any conflict of interests. Ethics Approval Statement: The trial was approved by the Stockholm regional ethical review board (2017/1027-31/2).