Arousal Detection and Training for Social Anxiety Disorder (SAD)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- Satisfaction and Immersion Questionnaire
研究概览
简要总结
The primary objective of the study is to examine the safety, usability and preliminary efficacy of a novel arousal-based biofeedback system in alleviating social anxiety. The investigators hypothesize that after 4 weeks of hour-long interventions, participants will show reductions pre- and post-intervention in their Liebowitz Social Anxiety Scale scores.
详细描述
The investigators plan to conduct a waitlist control trial.
Intervention consists of a combination of computerized cognitive behavioral therapy and arousal-based Virtual Reality Exposure Therapy. During the latter component, the physiological variables of participants, such as pulse rate and EEG, will be continuously monitored and presented as feedback to them. Participants will have to deliver speeches to videotaped audiences while striving to regulate their physiological arousal.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 21 Years 至 35 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Literate in English
- •Computer literate
- •Able to travel independently
- •Agreeable to being video-recorded when going through study protocol
- •Liebowitz Social Anxiety Scale score of 31 or more
- •Public Speaking Anxiety Scale score of 60 or more
- •Alcohol Use Disorders Identification Test (AUDIT) of 8 and below
排除标准
- •Has gross visual or hearing impairments
- •Has irregular heart rhythm
- •On any psychoactive medication
- •Involved in any other long-term research study
- •Current or previous history of neuropsychiatric disorders (other than depression, which will be assessed by BDI-II)
- •Suicide ideation
- •Concurrent psychotherapy for any disorder
- •Non-responding to a previous psychotherapy
研究组 & 干预措施
Intervention
Participants will undergo a 4-week intervention (once per week, 1 hour each session). Each intervention session consists of approximately 30 minutes of computerized cognitive behavioral therapy, and 30 minutes of Virtual Reality Exposure Therapy with our novel arousal-based biofeedback system. For Virtual Reality Exposure Therapy, the physiological variables of participants will be continuously monitored and presented to them as feedback. Participants will have to deliver speeches to videotaped audiences while striving to regulate their physiological arousal.
干预措施: Arousal-based biofeedback system (Device)
Waitlist Control
Participants in Waitlist Control will receive no intervention in the first 4 weeks of the study. After the Intervention group has completed treatment, participants in the Waitlist Control will then undergo the same intervention as the Intervention group.
结局指标
主要结局
Satisfaction and Immersion Questionnaire
时间窗: Week 4 (post-intervention) for Intervention group and Week 9 (post-intervention) for Waitlist Control group
A 22-item questionnaire that examines how effective, enjoyable and realistic the intervention is to participants.
Safety Measure: After each intervention session (once a week), participants will be queried on whether they have experienced any physical or psychological adverse events during the study
时间窗: Week 1 to Week 4 for Intervention and Week 6 to Week 9 for Waitlist Control
The total number and severity rating of all adverse events reported will be collated at the end of the study.
Change in Liebowitz Social Anxiety Scale scores from Week 0 to Week 5
时间窗: Week 0 (Pre-intervention) and Week 5 (Post-intervention)
A validated 24-item scale that is commonly used in social anxiety studies.
次要结局
- Change in Self-Statements during Public Speaking (SSPS) scores(Week 0 (pre-intervention) and Week 5 (post-intervention))
- Change in Public Speaking Anxiety Scale scores from Week 0 to Week 5(Week 0 (pre-intervention) and Week 5 (post-intervention))
- Change in Fear of Negative Evaluation-Brief (FNE-B) scores(Week 0 (pre-intervention) and Week 5 (post-intervention))
研究者
Lee Tih Shih
Associate Professor
Duke-NUS Graduate Medical School