Arousal Training for Social Anxiety Disorder

Study Overview
=================
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.

Official Title
-----------------
Arousal Detection and Training for Social Anxiety Disorder (SAD)

Conditions
-----------------
Social Anxiety

Intervention / Treatment
-----------------
* Device: Arousal-based biofeedback system


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 21 Years
Maximum Age: 35 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention<br>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. | Device: Arousal-based biofeedback system<br> <br> |
| No Intervention: Waitlist Control<br>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. | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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) | 
| 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) | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Virtual Reality Exposure Therapy, Computerized Cognitive Behavioral Therapy, Public Speaking, Social Phobia, Biofeedback