A Randomized Controlled Trial of the Effectiveness of Breathing Focused Yoga (BFY) in Improving Symptoms of Social Anxiety Disorder
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Change in Liebowitz Social Anxiety Scale (LSAS) Total Score
研究概览
简要总结
The goal of this study is to determine the safety and effectiveness of Breathing Focused Yoga (BFY) in improving symptoms of social anxiety disorder (SAD). Patients with SAD will be randomized to 8 weeks of yoga or 8 weeks of wait-list. Symptom severity and quality of life will be compared between the two groups before and after the 8 weeks.
详细描述
This is an exploratory 8-week study with a randomized controlled, parallel group design, and will be carried out in two phases: 1) 8-week treatment phase and 2) a 3-month follow-up phase.
60 patients meeting Diagnostic and Statistical Manual IV Text Revision, (DSM-IV-TR), diagnostic criteria for social anxiety disorder will be recruited. Patients who have provided written consent, have met study criteria, and are stabilized on pharmacotherapy will be enrolled into the study.
In the treatment phase, patients will be randomized, to one of two groups 1) Breathing Focused Yoga (BFY); or 2) wait-list group.
A sub-set of 15 drug- naïve patients and matched healthy controls will undergo functional magnetic resonance imaging (fMRI) scans before and after yoga treatment.
A blood sample for genetic analysis will be taken from all SAD patients, to investigate to presence of genes linked to SAD and t 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
- None
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
- •Male or female patients aged 18-65 years
- •Primary diagnosis of SAD, per the DSM-IV-TR (APA, 2000)
- •LSAS score of ≥50
- •Absence of serious medical illness
- •Not on any psychotropic medications currently, or on stable medications for at least 8 weeks prior to starting treatment
- •Short-acting benzodiazepines (e.g. lorazepam 1 mg prn) and sleep medications (e.g. zopiclone 7.5 mg prn) may be used, but not within 12 hours prior to a study visit
排除标准
- •Current primary diagnosis of major depressive episode, mania or psychosis
- •A score of ≥15 on the first 17 items of the HAM-D at Screening or Baseline
- •Diagnosis of a substance abuse disorder within the prior 6 months
- •Presence of medical or mental health conditions that would inhibit the patient's ability to participate in the study
- •Currently receiving any structured formal psychotherapy (supportive therapy is allowed)
研究组 & 干预措施
Yoga Treatment Group
BFY will be taught by a trained yoga instructor. Group sessions will be offered twice a week for 60 minutes each (i.e., a total of 2 hours per week), for 8 weeks.
干预措施: Yoga Treatment Group (Behavioral)
Waitlist Group
Waitlisted participants will receive BFY at the next available group after their waitlist period is completed
结局指标
主要结局
Change in Liebowitz Social Anxiety Scale (LSAS) Total Score
时间窗: Baseline to study endpoint (Week 8)
次要结局
- Change in Hamilton Depression Rating Scale (HAM-D) Total Score(Baseline to study endpoint (Week 8))
- Change in Clinical Global Impression Scale(Baseline to study endpoint (Week 8))
- Change in Quality of Life Enjoyment and Satisfaction Scale (QLESQ) Total Score(Baseline to study endpoint (Week 8))
- Change in Quick Inventory of Depressive Symptomatology (QIDS) Total Score(Baseline to study endpoint (Week 8))
研究者
Arun Ravindran
Principal Investigator
Centre for Addiction and Mental Health