Arousal Training for Social Anxiety Disorder
Arousal Detection and Training for Social Anxiety Disorder (SAD)
1 other identifier
interventional
50
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Feb 2016
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 24, 2014
CompletedFirst Posted
Study publicly available on registry
July 9, 2015
CompletedStudy Start
First participant enrolled
February 1, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2017
CompletedDecember 19, 2017
December 1, 2017
1.4 years
July 24, 2014
December 18, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
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 Outcomes (3)
Change in Fear of Negative Evaluation-Brief (FNE-B) scores
Week 0 (pre-intervention) and Week 5 (post-intervention)
Change in Self-Statements during Public Speaking (SSPS) scores
Week 0 (pre-intervention) and Week 5 (post-intervention)
Change in Public Speaking Anxiety Scale scores from Week 0 to Week 5
Week 0 (pre-intervention) and Week 5 (post-intervention)
Study Arms (2)
Intervention
EXPERIMENTALParticipants 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 INTERVENTIONParticipants 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.
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Duke-NUS Graduate Medical Schoollead
- Agency for Science, Technology and Researchcollaborator
- Singapore General Hospitalcollaborator
Study Sites (1)
Duke-NUS Graduate Medical School
Singapore, 169857, Singapore
Related Publications (1)
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.
PMID: 31199347DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Tih-Shih Lee, MD PHD
Duke-NUS Graduate Medical School
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate Professor
Study Record Dates
First Submitted
July 24, 2014
First Posted
July 9, 2015
Study Start
February 1, 2016
Primary Completion
July 1, 2017
Study Completion
July 1, 2017
Last Updated
December 19, 2017
Record last verified: 2017-12