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Completed

NCT Number: NCT07464561

RESCCUE4 - Group CBT for Social Anxiety in Adolescents

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.

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Key information

Conditions

Social Anxiety Disorder Anxiety Disorders Mental Disorders Phobia, Social Phobic Disorders

Age range

12 year–17 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

IRCCS Ospedale Pediatrico Bambino Gesù

Roma, Italy

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

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.

Primary outcomes

  1. Change in Social Anxiety Symptoms (MASC-2)

    Time frame: Baseline to 2 months and 3 months

    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.

Secondary outcomes

  1. Change in Social Anxiety Symptoms (LSAS)

    Time frame: Baseline to 2 months and 3 months

    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.

  2. Change in Global Functioning

    Time frame: Baseline to 2 months and 3 months

    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.

Other outcomes

  1. Change in Interpersonal Difficulties (CDI-2 Interpersonal Problems)

    Time frame: Baseline to 2 months and 3 months

    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.

  2. Change in Emotional Regulation

    Time frame: Baseline to 2 months and 3 months

    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.

  3. Change in Peer and School Functioning (HONOSCA)

    Time frame: Baseline to 2 months and 3 months

    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.

  4. Change in Emotional and Peer Problems (SDQ)

    Time frame: Baseline to 2 months and 3 months

    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.

Sponsors and collaborators

Lead sponsor

Bambino Gesù Hospital and Research Institute

Other

Collaborators

  • European Union

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Mar 11, 2026
Registry last updated
Mar 11, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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