NCT07464561

RESCCUE4 - Group CBT for Social Anxiety in Adolescents

REcover Spaces for Traumatized Children in CommUnity sEttings Post COVID-19 (RESCCUE4): A Double-Blind Controlled Trial Comparing Group Cognitive Behavioral Therapy Versus Treatment as Usual in Adolescents With Social Anxiety Disorder

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 34 (actual)
• Sponsor: Bambino Gesù Hospital and Research Institute · Academic / Other
• Sex: All
• Age: 12 Years – 17 Years
• Healthy volunteers: Not accepted

Summary

This randomized controlled trial aims to evaluate the efficacy of a 2-month group Cognitive Behavioral Therapy (CBT) intervention compared to a structured psychoeducational treatment as usual (TAU) in adolescents diagnosed with Social Anxiety Disorder. Participants aged 12 to 17 years will be recruited from the Child and Adolescent Neuropsychiatry Day Hospital at Bambino Gesù Children's Hospital (Rome, Italy). The primary objective is to assess the reduction of social anxiety symptoms following the CBT intervention compared to TAU. Secondary objectives include improvement in global functioning, interpersonal relationships, emotional regulation, and reduction of social withdrawal. Assessments will be conducted at baseline, post-treatment (2 months), and 1-month follow-up.

Detailed description

This monocentric, no-profit randomized controlled trial will enroll 34 adolescents aged 12-17 years with a DSM-5 diagnosis of Social Anxiety Disorder. Participants will be randomly assigned in a 1:1 ratio to either a group Cognitive Behavioral Therapy (CBT) intervention or a structured psychoeducational treatment as usual (TAU). Randomization will be stratified by age (12-14 years; 15-17 years). Both interventions will consist of eight weekly group sessions (90 minutes each) delivered over a 2-month period. The CBT intervention includes psychoeducation about social anxiety, identification of maladaptive automatic thoughts, cognitive restructuring, breathing techniques, imaginal and in vivo exposure exercises based on a subjective distress hierarchy (SUDs), social skills training, metacognitive exercises, and relapse prevention strategies. The active comparator (TAU) consists of structured group psychoeducational sessions focused on emotional literacy, understanding emotional processes, recognition of somatic components of anxiety, and development of emotion regulation strategies. Outcome assessments will be conducted at baseline (T0), post-treatment (T2), and at 1-month follow-up (T3) by blinded evaluators. The primary outcome is the change in social anxiety symptoms measured through validated self-report scales. Secondary outcomes include changes in global functioning, interpersonal difficulties, emotional regulation, and general psychopathology. The study aims to determine whether group CBT provides superior clinical improvement compared to structured psychoeducational treatment in adolescents with Social Anxiety Disorder.

Conditions

• Social Anxiety Disorder

Interventions

Type	Name	Description
BEHAVIORAL	Group Cognitive Behavioral Therapy	A structured 8-session group Cognitive Behavioral Therapy program delivered weekly over 2 months. Sessions include psychoeducation, identification of maladaptive automatic thoughts, cognitive restructuring, exposure techniques based on a subjective distress hierarchy (SUDs), breathing techniques, social skills training, and relapse prevention.
BEHAVIORAL	Psychoeducational Group Intervention	A structured 8-session group psychoeducational program delivered weekly over 2 months. Sessions focus on emotional literacy, understanding emotional processes, awareness of somatic manifestations of anxiety, and development of emotion regulation strategies.

Timeline

• Start date: 2024-05-01
• Primary completion: 2026-02-15
• Completion: 2026-02-15
• First posted: 2026-03-11
• Last updated: 2026-03-11

Locations

1 site across 1 country: Italy