Prevention and Treatment of Social Anxiety Disorder in Adolescents: Protocol for a Randomized Controlled Trial of the Online Guided Self-Help Intervention SOPHIE.

BACKGROUND Social anxiety symptoms are highly prevalent among adolescents and are associated with poor quality of life and low psychosocial functioning. If untreated, social anxiety often persists into adulthood and increases the risk for comorbid disorders. Therefore, early interventions for social anxiety to prevent negative long-term consequences are critical. However, adolescents rarely seek help and often avoid face-to-face psychotherapeutic interventions due to the perceived lack of autonomy and anonymity. Thus, online interventions represent a promising opportunity to reach adolescents who have social anxiety but do not seek help yet. OBJECTIVE This study aims to evaluate the efficacy, moderators, and mediators of an online intervention developed to reduce social anxiety in adolescents. METHODS A total of 222 adolescents aged 11-17 years with subclinical social anxiety (N=166) or with a diagnosis of social anxiety disorder (N=56) are randomly assigned to the online intervention or a care-as-usual control group. The 8-week guided online intervention is based on the Cognitive Model of Social Phobia and evidence-based online interventions for social anxiety adapted to the specific needs of adolescents. The care-as-usual group will be given access to the online intervention after the follow-up assessment. Participants are assessed at baseline, at 4 and 8 weeks post intervention, and at 3-month follow-up assessment on the primary outcome, that is, social anxiety, on secondary outcomes (eg, level of functioning, fear and avoidance, general anxiety, depression, quality of life, self-esteem, and negative effects of the intervention), on potential moderators (eg, therapy motivation, therapy expectancy, and satisfaction with the intervention), and potential mediators (eg, therapeutic alliance and adherence to the intervention). Data will be analyzed based on an intention-to-treat approach and both groups (intervention and care-as-usual) will be compared at each assessment time point. Furthermore, potential mechanisms of change and generalization of intervention effects on daily life are assessed using an ecological momentary assessment procedure that includes items on maintaining mechanisms of social anxiety, social context, and affect. Participants are prompted 3 times a day during the first 8 weeks of the study and again for 2 weeks following the follow-up assessment. RESULTS Recruitment is ongoing; initial results are expected in 2024. CONCLUSIONS Results are discussed considering the potential of online interventions as a low-threshold prevention and treatment option for adolescents with social anxiety and in light of current advances in dynamic modeling of change processes and mechanisms in early intervention and psychotherapy in adolescents. TRIAL REGISTRATION ClinicalTrials.gov NCT04782102; https://clinicaltrials.gov/ct2/show/NCT04782102. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID) DERR1-10.2196/44346