Ignite Creation Date:
2026-03-26 @ 3:14 PM
Ignite Modification Date:
2026-03-30 @ 9:31 PM
Study NCT ID:
NCT07464561
Status:
COMPLETED
Last Update Posted:
2026-03-11
First Post:
2026-02-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
RESCCUE4 - Group CBT for Social Anxiety in Adolescents
Sponsor:
Bambino Gesù Hospital and Research Institute
Organization:
Study Overview
Official 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
Status:
COMPLETED
Status Verified Date:
2026-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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.
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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: