Comparative Trial of a Mindfulness-based Intervention Versus Cognitive Behavior Therapy for Social Anxiety Disorder
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 97
- 试验地点
- 4
- 主要终点
- Liebowitz Social Anxiety Scale
研究概览
简要总结
To conduct a prospective, randomized trial to compare the efficacy of a group mindfulness-based intervention adapted for social anxiety disorder (MBI-SAD) versus cognitive behavior group therapy (CBGT).
详细描述
The main aim of this comparative trial is to determine if the MBI-SAD will be noninferior to CBGT in improving core symptoms of social anxiety disorder, depressive symptoms, self, esteem, disability and quality of life. A secondary aim is to examine whether treatment gains are maintained over a 6-month period. Exploratory aims of the study are to: 1) determine if the MBI-SAD enhances self-compassion and mindfulness relative to CBGT; 2) determine if changes in self-compassion and mindfulness mediate the clinical response to the MBI-SAD; and 3) explore moderators of treatment response.
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •DSM-5 diagnosis of social anxiety disorder (SAD) of at least moderate severity
- •Montgomery Asberg Depression Rating Scale score ≤ 25
- •Comorbid depressive disorders, panic disorder, agoraphobia, generalized anxiety disorder, specific phobias, eating disorders are allowed as long as the SAD is primary and predominates the clinical picture.
排除标准
- •Coexisting Axis I disorders excluding those listed in the inclusion criteria
- •Coexisting medical conditions that can alter the clinical presentation of SAD (e.g. Parkinson's disease)
- •Lifetime history of bipolar disorder or psychotic symptoms
- •Substance-related disorders in the last 12 months
- •Acutely suicidal or history of suicide attempt in the past five years
- •History of non-suicidal self-injurious behavior in the last 12 months
- •Currently receiving psychotherapy
- •Currently engaged in a regular meditation or yoga practice
- •Unable to attend weekly group sessions
研究组 & 干预措施
Mindfulness-Based Intervention
Participants in the mindfulness-based intervention arm will receive 12 weekly sessions of 2 to 2.5 hours duration. The intervention will be delivered in a group format. Participants will be assigned weekly homework.
干预措施: Mindfulness-based Intervention (Behavioral)
Cognitive Behavior Group Therapy
Participants in the cognitive behavior group therapy arm will receive 12 weekly sessions of 2 to 2.5 hours in duration. Participants will be assigned weekly homework.
干预措施: Cognitive Behavior Group Therapy (Behavioral)
结局指标
主要结局
Liebowitz Social Anxiety Scale
时间窗: Change from baseline to week 12 and 6-month follow-up
A 24-item clinician-rated scale that assesses fear and avoidance of social performance and social situations.
次要结局
- Beck Depression Inventory(Change from baseline to week 12 and 6-month-follow-up)
- Social Adjustment Scale-Self Report Revised(Change from baseline to week 12 and 6-month follow-up)
- Satisfaction with Life Questionnaire(Change from baseline to week 12 and 6-month follow-up)
- Clinical Global Impression Improvement Ratings(Change from baseline to week 12 and 6-month follow-up)
- Rosenberg Self-Esteem Scale(Change from baseline to week 12 and 6-month follow-up)
- Social Phobia Inventory(Change from baseline to week 12 and 6-month follow-up)
研究者
Diana Koszycki
Professor and Research Chair in Mental Health
Hopital Montfort