RESCCUE4 - Group CBT for Social Anxiety in Adolescents

NCT07464561 | Completed

• 1 other identifier: RESCCUE4
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Social Anxiety Disorder

Keywords

Cognitive Behavioral Therapy; Adolescents; Group Therapy; Social Withdrawal; Psychoeducation; Anxiety Symptoms

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Change in Social Anxiety Symptoms (LSAS)

  Baseline to 2 months and 3 months

• Change in Global Functioning

  Baseline to 2 months and 3 months

Other Outcomes (4)

• Change in Interpersonal Difficulties (CDI-2 Interpersonal Problems)

  Baseline to 2 months and 3 months

• Change in Emotional Regulation

  Baseline to 2 months and 3 months

• Change in Peer and School Functioning (HONOSCA)

  Baseline to 2 months and 3 months

Study Arms (2)

Group Cognitive Behavioral Therapy

EXPERIMENTAL

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

Structured Psychoeducational Treatment (TAU)

ACTIVE COMPARATOR

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

Interventions

Psychoeducational Group Intervention BEHAVIORAL

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.

Structured Psychoeducational Treatment (TAU)

Group Cognitive Behavioral Therapy BEHAVIORAL

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.

Group Cognitive Behavioral Therapy

Eligibility Criteria

• Age: 12 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Bambino Gesù Hospital and Research Institute: lead
• European Union: collaborator

Study Sites (1)

IRCCS Ospedale Pediatrico Bambino Gesù

Roma, Italy

Location

Related Publications (2)

• 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.

  PMID: 32439401 BACKGROUND

• 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.

  PMID: 33148187 BACKGROUND

MeSH Terms

Conditions

Phobia, Social; Anxiety Disorders

Condition Hierarchy (Ancestors)

Phobic Disorders; Mental Disorders

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Participants and outcome assessors will be blinded to treatment allocation. Therapists delivering the interventions will not be blinded due to the nature of the behavioral treatments.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Paola De Rose, MD, Child and Adolescent Neuropsychiatrist

Study Record Dates

• First Submitted: February 19, 2026
• First Posted: March 11, 2026
• Study Start: May 1, 2024
• Primary Completion: February 15, 2026
• Study Completion: February 15, 2026
• Last Updated: March 11, 2026

Record last verified: 2026-03

Locations

IT (1)