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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
50
Duke-NUS Graduate Medical School
Singapore, Singapore
Change in Liebowitz Social Anxiety Scale scores from Week 0 to Week 5
A validated 24-item scale that is commonly used in social anxiety studies.
Time frame: Week 0 (Pre-intervention) and Week 5 (Post-intervention)
Satisfaction and Immersion Questionnaire
A 22-item questionnaire that examines how effective, enjoyable and realistic the intervention is to participants.
Time frame: Week 4 (post-intervention) for Intervention group and Week 9 (post-intervention) for Waitlist Control group
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
The total number and severity rating of all adverse events reported will be collated at the end of the study.
Time frame: Week 1 to Week 4 for Intervention and Week 6 to Week 9 for Waitlist Control
Change in Fear of Negative Evaluation-Brief (FNE-B) scores
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.
Time frame: Week 0 (pre-intervention) and Week 5 (post-intervention)
Change in Self-Statements during Public Speaking (SSPS) scores
A 10-item Likert-scale instrument measuring extent of negative and positive thoughts about oneself during public speaking.
Time frame: Week 0 (pre-intervention) and Week 5 (post-intervention)
Change in Public Speaking Anxiety Scale scores from Week 0 to Week 5
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A 17-item self-rating scale that measures public speaking anxiety.
Time frame: Week 0 (pre-intervention) and Week 5 (post-intervention)