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

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.

Study Overview

• Status: Completed
• Conditions: Social Anxiety Disorder
• Intervention / Treatment: Behavioral: Group Cognitive Behavioral Therapy; Behavioral: Psychoeducational Group Intervention

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.

• Study Type: Interventional
• Enrollment (Actual): 34
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Italy
  • Roma, Italy
    • IRCCS Ospedale Pediatrico Bambino Gesù

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Age between 12 and 17 years
• DSM-5 diagnosis of Social Anxiety Disorder
• Access to the Child and Adolescent Neuropsychiatry Day Hospital
• Willingness of the participant and family to participate in the study
• Written informed consent provided by parents or legal guardians

Exclusion Criteria:

• Age below 12 years
• Intellectual disability
• Lack of family compliance with treatment
• Withdrawal of informed consent

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Group Cognitive Behavioral Therapy; Participants assigned to this arm will receive an 8-week group Cognitive Behavioral Therapy (CBT) intervention consisting of weekly 90-minute sessions. The intervention includes psychoeducation about social anxiety, cognitive restructuring, breathing techniques, imaginal and in vivo exposure exercises, social skills training, metacognitive exercises, and relapse prevention strategies.	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.
Active Comparator: Structured Psychoeducational Treatment (TAU); Participants assigned to this arm will receive an 8-week structured group psychoeducational intervention consisting of weekly 90-minute sessions focused on emotional literacy, understanding emotional processes, recognition of somatic components of anxiety, and development of emotion regulation strategies.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Social Anxiety Symptoms (MASC-2)	Change from baseline to post-treatment in social anxiety symptoms measured by the Multidimensional Anxiety Scale for Children (MASC-2) Social Anxiety T-score. The MASC-2 is a self-report questionnaire assessing anxiety symptoms in youth. T-scores range from 0 to 100, with higher scores indicating greater anxiety severity.	Baseline to 2 months and 3 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Social Anxiety Symptoms (LSAS)	Change from baseline to post-treatment in social anxiety symptoms measured by the Liebowitz Social Anxiety Scale (LSAS). The LSAS assesses fear/anxiety and avoidance across social situations. Scores range from 0 to 144, with higher scores indicating greater social anxiety severity.	Baseline to 2 months and 3 months
Change in Global Functioning	Change from baseline to post-treatment and 1-month follow-up in global functioning measured by the Children's Global Assessment Scale (C-GAS). Higher scores indicate better functioning.	Baseline to 2 months and 3 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Interpersonal Difficulties (CDI-2 Interpersonal Problems)	Change from baseline to post-treatment and 1-month follow-up in interpersonal difficulties measured by the Children's Depression Inventory, Second Edition (CDI-2) Interpersonal Problems subscale. The CDI-2 is a self-report questionnaire assessing depressive symptoms in children and adolescents. Scores on the Interpersonal Problems subscale range from 0 to 12, with higher scores indicating greater interpersonal difficulties.	Baseline to 2 months and 3 months
Change in Emotional Regulation	Change from baseline to post-treatment and 1-month follow-up in emotional regulation difficulties measured by the Difficulties in Emotion Regulation Scale (DERS). Higher scores indicate greater difficulties in emotion regulation.	Baseline to 2 months and 3 months
Change in Peer and School Functioning (HONOSCA)	Change from baseline to post-treatment and 1-month follow-up in peer and school functioning measured by selected items of the Health of the Nation Outcome Scales for Children and Adolescents (HONOSCA), specifically the items assessing peer relationship problems and school attendance difficulties. Each item is rated on a scale from 0 to 4, with higher scores indicating greater severity of problems.	Baseline to 2 months and 3 months
Change in Emotional and Peer Problems (SDQ)	Change from baseline to post-treatment and 1-month follow-up in emotional and peer difficulties measured by the Strengths and Difficulties Questionnaire (SDQ) Emotional Symptoms and Peer Problems subscales. Each subscale score ranges from 0 to 10, with higher scores indicating greater emotional and peer difficulties.	Baseline to 2 months and 3 months

Collaborators and Investigators

• Sponsor: Bambino Gesù Hospital and Research Institute
• Collaborators: European Union

Publications and helpful links

General Publications

• Walter HJ, Bukstein OG, Abright AR, Keable H, Ramtekkar U, Ripperger-Suhler J, Rockhill C. Clinical Practice Guideline for the Assessment and Treatment of Children and Adolescents With Anxiety Disorders. J Am Acad Child Adolesc Psychiatry. 2020 Oct;59(10):1107-1124. doi: 10.1016/j.jaac.2020.05.005. Epub 2020 May 18.
• Qiu JJ, Yang RZ, Tang YJ, Lin YY, Xu HJ, Zhang N, Liang M, Cai HD, Zeng K, Wu XD. BRD4 and PIN1 gene polymorphisms are associated with high pulse pressure risk in a southeastern Chinese population. BMC Cardiovasc Disord. 2020 Nov 4;20(1):475. doi: 10.1186/s12872-020-01757-x.

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2024
• Primary Completion (Actual): February 15, 2026
• Study Completion (Actual): February 15, 2026

Study Registration Dates

• First Submitted: February 19, 2026
• First Submitted That Met QC Criteria: March 6, 2026
• First Posted (Actual): March 11, 2026

Study Record Updates

• Last Update Posted (Actual): March 11, 2026
• Last Update Submitted That Met QC Criteria: March 6, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: Adolescents; Cognitive Behavioral Therapy; Psychoeducation; Group Therapy; Anxiety Symptoms; Social Withdrawal
• Additional Relevant MeSH Terms: Mental Disorders; Phobic Disorders; Phobia, Social; Anxiety Disorders
• Other Study ID Numbers: RESCCUE4

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No