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| Name | Class |
|---|---|
| Agency for Science, Technology and Research | OTHER |
| Singapore General Hospital | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention | Experimental | 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. |
|
| Waitlist Control | No Intervention | 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Arousal-based biofeedback system | Device |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. | 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. | Week 1 to Week 4 for Intervention and Week 6 to Week 9 for Waitlist Control |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Week 0 (pre-intervention) and Week 5 (post-intervention) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Tih-Shih Lee, MD PHD | Duke-NUS Graduate Medical School | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Duke-NUS Graduate Medical School | Singapore | 169857 | Singapore |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31199347 | Derived | Lin XB, Lee TS, Cheung YB, Ling J, Poon SH, Lim L, Zhang HH, Chin ZY, Wang CC, Krishnan R, Guan C. Exposure Therapy With Personalized Real-Time Arousal Detection and Feedback to Alleviate Social Anxiety Symptoms in an Analogue Adult Sample: Pilot Proof-of-Concept Randomized Controlled Trial. JMIR Ment Health. 2019 Jun 14;6(6):e13869. doi: 10.2196/13869. |
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| ID | Term |
|---|---|
| D013060 | Speech |
| D000072861 | Phobia, Social |
| ID | Term |
|---|---|
| D014705 | Verbal Behavior |
| D003142 | Communication |
| D001519 | Behavior |
| D010698 | Phobic Disorders |
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| 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. | Week 0 (pre-intervention) and Week 5 (post-intervention) |
| Change in Public Speaking Anxiety Scale scores from Week 0 to Week 5 | A 17-item self-rating scale that measures public speaking anxiety. | Week 0 (pre-intervention) and Week 5 (post-intervention) |
| D001008 |
| Anxiety Disorders |
| D001523 | Mental Disorders |