Social Anxiety
Conditions
Keywords
Virtual Reality Exposure Therapy, Computerized Cognitive Behavioral Therapy, Public Speaking, Social Phobia, Biofeedback
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.
Interventions
DEVICEArousal-based biofeedback system
Sponsors
Agency for Science, Technology and Research
Singapore General Hospital
Duke-NUS Graduate Medical School
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
21 Years to 35 Years
Healthy volunteers
Yes
Inclusion criteria
* 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
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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. |
Countries
Singapore
Outcome results
None listed