Smartphone Cognitive Behavioral Therapy for Social Anxiety Disorder: A Randomized, Waitlist-control Trial
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 试验地点
- 2
- 主要终点
- Difference in SAD severity (LSAS) at the end of treatment/waitlist period.
研究概览
简要总结
The investigators are testing the efficacy of Smartphone-delivered cognitive behavioral therapy (CBT) treatment for social anxiety disorder (SAD). The investigators hypothesize that participants receiving app-CBT will have greater reduction in LSAS scores than those in the waitlist condition at treatment endpoint (week 12).
详细描述
The primary aims of this study are to test the efficacy of a Smartphone-based CBT treatment for adults with SAD recruited nationally. Eligible subjects (N=80) will be randomly assigned to 12 weeks of Smartphone-delivered CBT for SAD either immediately, or after a 12-week long waiting period (50-50 chance). The investigators hypothesize that Smartphone-delivered CBT for SAD will be feasible and acceptable to individuals with SAD, and that it will lead to greater reductions in SAD symptom severity compared to the passage of time (waitlist control).
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •At least 18 years of age
- •Current diagnosis of primary DSM-5 SAD, based on MINI
- •Currently living in the United States
排除标准
- •Psychotropic medication changes within 2 months prior to enrollment i. Participants taking psychotropic medication must have been on a stable dose for at least 2 months prior to enrollment and not change medication during study period
- •Past participation in ≥ 4 sessions of CBT for SAD
- •Current severe substance use disorder
- •Lifetime bipolar disorder or psychosis
- •Current severe comorbid major depression, as indicated by clinical judgment and/or a QIDS-SR total score ≥ 21 ***EDIT***
- •Acute, active suicidal ideation as indicated by clinical judgment and/or a score ≥ 2 on the suicidal ideation subscale of the C-SSRS
- •Concurrent psychological treatment
- •Does not own a supported mobile Smartphone with a data plan
- •Lack of technology literacy that would interfere with ability to engage with smartphone treatment
研究组 & 干预措施
Experimental: Smartphone-delivered CBT for SAD
12-week Smartphone delivered CBT for SAD.
干预措施: Smartphone-delivered CBT for SAD (Device)
12 Week Waitlist Control
12-week waitlist control. (Note: participants will be crossed over to 12-week Smartphone-delivered CBT for SAD following the 12-week waitlist control).
干预措施: Smartphone-delivered CBT for SAD (Device)
结局指标
主要结局
Difference in SAD severity (LSAS) at the end of treatment/waitlist period.
时间窗: Endpoint (week 12)
The Liebowitz Social Anxiety Scale (LSAS) is a clinician-administered measure of social anxiety symptom severity. It contains 24 social situations likely to elicit social anxiety, and items are scored on a Likert scale ranging from 0 to 3. Higher scores indicate more severe SAD symptoms. The LSAS will be used to assess change in social anxiety symptoms from baseline to endpoint.
次要结局
- Difference in functional impairment as measured by change in The Work and Social Adjustment Scale (WSAS) total scores from baseline to week 12.(Endpoint (week 12))
- Difference in quality of life as assessed by change in The Quality of Life, Enjoyment, and Satisfaction Questionnaire-Short Form (QLESQ-SR) total scores from baseline to week 12.(Endpoint (week 12))
- Difference in depression severity as assessed by change in The Center for Epidemiologic Studies Depression Scale - Revised (CESD-R) total scores from baseline to week 12.(Endpoint (week 12))
研究者
Sabine Wilhelm, PhD
Chief of Phycology
Massachusetts General Hospital