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
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 34
- 试验地点
- 1
- 主要终点
- Change in Social Anxiety Symptoms (MASC-2)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
盲法说明
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.
入排标准
- 年龄范围
- 12 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •Age below 12 years
- •Intellectual disability
- •Lack of family compliance with treatment
- •Withdrawal of informed consent
研究组 & 干预措施
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.
干预措施: Group Cognitive Behavioral Therapy (Behavioral)
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.
干预措施: Psychoeducational Group Intervention (Behavioral)
结局指标
主要结局
Change in Social Anxiety Symptoms (MASC-2)
时间窗: 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.
次要结局
- Change in Social Anxiety Symptoms (LSAS)(Baseline to 2 months and 3 months)
- Change in Global Functioning(Baseline to 2 months and 3 months)
研究者
Paola De Rose
Paola De Rose, MD, Child and Adolescent Neuropsychiatrist
Bambino Gesù Hospital and Research Institute