Back to resultsArousal Training for Social Anxiety Disorder
Primary Purpose
Social Anxiety
Status
Completed
Phase
Not Applicable
Locations
Singapore
Study Type
Interventional
Intervention
Arousal-based biofeedback system
Sponsored by
About this trial
This is an interventional treatment trial for Social Anxiety focused on measuring Virtual Reality Exposure Therapy, Computerized Cognitive Behavioral Therapy, Public Speaking, Social Phobia, Biofeedback
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
Sites / Locations
- Duke-NUS Graduate Medical School
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Intervention
Waitlist Control
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
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.
Satisfaction and Immersion Questionnaire
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
The total number and severity rating of all adverse events reported will be collated at the end of the study.
Secondary Outcome Measures
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.
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.
Change in Public Speaking Anxiety Scale scores from Week 0 to Week 5
A 17-item self-rating scale that measures public speaking anxiety.
Full Information
NCT ID
NCT02493010
First Posted
July 24, 2014
Last Updated
December 18, 2017
Sponsor
Duke-NUS Graduate Medical School
Collaborators
Agency for Science, Technology and Research, Singapore General Hospital
1. Study Identification
Unique Protocol Identification Number
NCT02493010
Brief Title
Arousal Training for Social Anxiety Disorder
Official Title
Arousal Detection and Training for Social Anxiety Disorder (SAD)
Study Type
Interventional
2. Study Status
Record Verification Date
December 2017
Overall Recruitment Status
Completed
Study Start Date
February 2016 (Actual)
Primary Completion Date
July 2017 (Actual)
Study Completion Date
July 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Duke-NUS Graduate Medical School
Collaborators
Agency for Science, Technology and Research, Singapore General Hospital
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Social Anxiety
Keywords
Virtual Reality Exposure Therapy, Computerized Cognitive Behavioral Therapy, Public Speaking, Social Phobia, Biofeedback
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
50 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Intervention
Arm Type
Experimental
Arm Description
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.
Arm Title
Waitlist Control
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Arousal-based biofeedback system
Primary Outcome Measure Information:
Title
Change in Liebowitz Social Anxiety Scale scores from Week 0 to Week 5
Description
A validated 24-item scale that is commonly used in social anxiety studies.
Time Frame
Week 0 (Pre-intervention) and Week 5 (Post-intervention)
Title
Satisfaction and Immersion Questionnaire
Description
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
Title
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
Description
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
Secondary Outcome Measure Information:
Title
Change in Fear of Negative Evaluation-Brief (FNE-B) scores
Description
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)
Title
Change in Self-Statements during Public Speaking (SSPS) scores
Description
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)
Title
Change in Public Speaking Anxiety Scale scores from Week 0 to Week 5
Description
A 17-item self-rating scale that measures public speaking anxiety.
Time Frame
Week 0 (pre-intervention) and Week 5 (post-intervention)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tih-Shih Lee, MD PHD
Organizational Affiliation
Duke-NUS Graduate Medical School
Official's Role
Principal Investigator
Facility Information:
Facility Name
Duke-NUS Graduate Medical School
City
Singapore
ZIP/Postal Code
169857
Country
Singapore
12. IPD Sharing Statement
Citations:
PubMed Identifier
31199347
Citation
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.
Results Reference
derived
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Arousal Training for Social Anxiety Disorder
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