Efficacy of an Enhanced Mindfulness-based Intervention for Social Anxiety Disorder: A Pilot Feasibility Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 39
- 试验地点
- 1
- 主要终点
- Social Phobia Inventory
研究概览
简要总结
The aim of this study is to evaluate the feasibility and initial efficacy of an enhanced mindfulness-based program that includes "mindful exposure" to reduce anxiety and avoidance of social situations, and the Buddhist practice of self-compassion aimed at reducing harsh judgment and self-criticism that is characteristic of people with social anxiety disorder.
详细描述
The purpose of this pilot study is to evaluate the feasibility and initial efficacy of an enhanced mindfulness-based intervention for SAD (MIND-SAD) that incorporates the following components: training in classical mindfulness, including concentration and insight (vipassana) meditation; training in self-compassion; and mindful exposure. An exploratory aim of the study is to evaluate the effects of the mindfulness intervention on biological markers of stress reactivity, including salivary cortisoland salivary alpha-amylase. The study is a two-arm, parallel design, prospective study comparing 12 weekly sessions of MIND-SAD delivered in a group format versus a wait-list control (WLC).
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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Primary diagnosis of Social Anxiety Disorder; Baseline score of 30 or higher on the Liebowitz Social Anxiety Scale; Baseline score of 4 or higher on the Clinical Global Impression of Severity
排除标准
- •Lifetime history of psychosis or bipolar disorder; substance abuse in the past 12 months; diagnosis of borderline or antisocial personality disorder; serious suicide risk; currently in psychotherapy; regular meditation or yoga practice in the past 12 months
研究组 & 干预措施
Mindfulness Meditation
12 weekly sessions in group format
干预措施: Mindfulness Meditation (Behavioral)
Wait-list
Patients will receive the mindfulness intervention after a 12-week wait period
结局指标
主要结局
Social Phobia Inventory
时间窗: change from baseline at weeks 6, 12 and 3 months follow-up
Clinician-rated Liebowitz Social Phobia Scale
时间窗: change from baseline at weeks 6, 12 and 3 months follow-up
次要结局
- CGI-Severity of Illness(change from baseline at weeks 6, 12 and 3 months follow-up)
- Self-Compassion Scale(change from baseline at weeks 6, 12 and 3-months follow-up)
- Beck Depression Inventory(change from baseline at weeks 6, 12 and 3 months follow-up)
- Social Adjustment Scale-Self-Report(change from baseline at weeks 6 and 12 and 3 months follow-up)
- Five Facet Mindfulness Questionnaire(change from baseline at weeks 6, 12 and 3 months follow-up)
研究者
Diana Koszycki
Research Chair In Mental Health/Senior Scientist
Hopital Montfort