Social Anxiety Disorder
Conditions
Keywords
Cognitive Behavioral Therapy, Adolescents, Group Therapy, Social Withdrawal, Psychoeducation, Anxiety Symptoms
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.
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.
Interventions
BEHAVIORALGroup 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.
BEHAVIORALPsychoeducational 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.
Sponsors
Bambino Gesù Hospital and Research Institute
European Union
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Masking description
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.
Eligibility
Sex/Gender
ALL
Age
12 Years to 17 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Social Anxiety Symptoms (MASC-2) | 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
| Measure | Time frame | Description |
|---|---|---|
| Change in Social Anxiety Symptoms (LSAS) | 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. |
| Change in Global Functioning | 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. |
Countries
Italy
Outcome results
None listed