Arousal Training for Social Anxiety Disorder
- Conditions
- Social Anxiety
- Interventions
- Device: Arousal-based biofeedback system
- Registration Number
- NCT02493010
- Lead Sponsor
- Duke-NUS Graduate Medical School
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 50
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Intervention Arousal-based biofeedback system 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.
- Primary Outcome Measures
Name Time Method Satisfaction and Immersion Questionnaire 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 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 Week 0 (Pre-intervention) and Week 5 (Post-intervention) A validated 24-item scale that is commonly used in social anxiety studies.
- Secondary Outcome Measures
Name Time Method Change in Self-Statements during Public Speaking (SSPS) scores Week 0 (pre-intervention) and Week 5 (post-intervention) A 10-item Likert-scale instrument measuring extent of negative and positive thoughts about oneself during public speaking.
Change in Public Speaking Anxiety Scale scores from Week 0 to Week 5 Week 0 (pre-intervention) and Week 5 (post-intervention) A 17-item self-rating scale that measures public speaking anxiety.
Change in Fear of Negative Evaluation-Brief (FNE-B) scores Week 0 (pre-intervention) and Week 5 (post-intervention) According to the American Psychiatric Association's Diagnostic and Statistical Manual of Mental Disorders 5th edition (DSM-V), fear of negative evaluation is at the core of Social Anxiety Disorder. This 12-item self-report scale is a commonly used outcome measure in social anxiety studies.
Trial Locations
- Locations (1)
Duke-NUS Graduate Medical School
🇸🇬Singapore, Singapore