Effect of Mindfulness and Loving Kindness Meditation on Symptoms of Social Anxiety Disorder
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 80
- 试验地点
- 2
- 主要终点
- Change from Baseline in the Liebowitz Social Anxiety Scale (LSAS)
研究概览
简要总结
The purpose of this study is to develop and test a mindfulness and loving-kindness based intervention, Positive Affect Training (PAT), to enhance positive affect such as compassion, love, and gratitude and reduce symptoms of social anxiety disorder (SAD). PAT involves a combination of practicing mindfulness meditation and loving kindness meditation in groups. Although PAT has been shown to be effective for dysthymic disorder, one area that remains unclear is whether the PAT protocol for SAD can address the social anxiety symptoms in Japanese adults with SAD. The goal of the research is to test the initial feasibility and efficacy in increasing positive affect and decreasing negative affect in individuals recruited from the general community who are social anxious. If PAT is also effective for Japanese SAD patients, it could be more cost-effective and noninvasive option to address social anxiety disorder.
详细描述
Mindfulness based stress reduction (MBSR) and mindfulness based cognitive therapy (MBCT), which are based on Buddhist tradition, has been shown to be effective for many psychological disorders including anxiety disorders. Buddhist tradition, however, has many kinds of meditation which would be able to address psychological distress but MBSR and MBCT has not focused. Loving kindness meditation (LKM) is one of promising meditation to be effective for psychological disorders because it is designed to increase feelings of social connection and compassion for one's self and others, whose focus is different from mindfulness meditation. Since mindfulness meditation is designed to observe and accept current internal experiences as they are while maintaining a primary focus on the breath sensations, it would cultivate less compassion than LKM would. Because patients with SAD tend to be self-critical, cultivating compassion for self and others with LKM would be more effective to reduce symptoms of SAD than MBSR and MBCT. In support of the view that KM increases positive mood and a sense of connection and positivity towards others, previous studies with non-clinical samples, schizophrenia, dysthymia, and PTSD had decreased the mental illness. The intervention protocol that the investigators plan to use was developed by Dr. Kearney and Dr. Hofmann. The PAT protocol has been shown to generate positive, and attenuating negative affect in patients with PTSD and mood disorder. The investigators aim to test the initial efficacy of PAT in individuals with SAD. The investigators hypothesize the intervention would show significant improvement in subjects' self-reported ratings of negative and positive affect and the brain asymmetry. Dr. Hofmann, a prominent researcher and clinical psychologist who is the foremost expert in LKM will serve as a collaborator. Dr. Kaiya, a Japanese CBT therapist for anxiety disorders will serve as an outside consultant for the study.
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 (Investigator)
入排标准
- 年龄范围
- 20 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 20 years or older.
- •Positive response to the recruitment question: "Have you been feeling anxious or distressed in social situations?"
- •Meets DSM-5 diagnostic criteria for Social Anxiety Disorder based on the Structured Clinical Interview for DSM-5 Disorders (SCID-5).
- •Social Anxiety Disorder is the primary diagnosis.
- •Liebowitz Social Anxiety Scale (LSAS) total score of 30 or higher.
排除标准
- •Current risk of self-harm or suicide, assessed by clinical interview and the suicide item of the Beck Depression Inventory-II (BDI-II).
- •Current or past psychiatric disorders that may impose a safety risk, such as bipolar disorder, schizophrenia spectrum disorders, or other psychotic disorders, as assessed by the SCID-
- •Current psychiatric or psychological treatment for any psychological disorder at the time of assessment.
- •Initiation of psychiatric or psychological treatment during the study; such participants will be monitored and may be excluded from sensitivity analyses.
研究组 & 干预措施
Positive Affect Training for SAD
Participants randomized to the intervention arm will receive Positive Affect Training, a 12-week face-to-face group loving-kindness meditation program. The groups will meet once a week for 12 successive weeks, and each session will be approximately 60 minutes long. Each group will include approximately 4-6 participants and will be led by two trained facilitators/therapists. Participants will also be asked to complete approximately 30 minutes of daily home practice using recorded guided meditations and informal practice assignments.
干预措施: Positive Affect Training for SAD (Behavioral)
Wait-list Control
Participants randomized to the waitlist control arm will receive no study intervention during the 12-week waiting period. After completing the post-waitlist assessment, they will be offered the same 12-week face-to-face group loving-kindness meditation program as the intervention arm.
结局指标
主要结局
Change from Baseline in the Liebowitz Social Anxiety Scale (LSAS)
时间窗: Baseline and 6 months
A self-report measure that assesses symptoms of distress experienced when socializing with others.
Change from Baseline in the Liebowitz Social Anxiety Scale (LSAS)
时间窗: Baseline, 12 weeks, and 6 months
The LSAS assesses fear/anxiety and avoidance across social interaction and performance situations. Higher scores indicate greater social anxiety severity.
次要结局
- Change from Baseline in compassion subscale of Differential Positive Emotions Scale(Baseline and 6 months)
- Change from Baseline in Self-Compassion Scale (SCS)(Baseline and 6 months)
- Change from Baseline in Positive and Negative Affect Scale (PANAS)(Baseline and 6 months)
- Change from Baseline in Self-Compassion Scale (SCS)(Baseline, 12 weeks, and 6 months)
- Change from Baseline in Positive and Negative Affect Scale (PANAS)(Baseline, 12 weeks, and 6 months)
- Change from Baseline in the Dispositional Positive Emotion Scales (DPES)(Baseline, 12 weeks, and 6 months)