Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
50 participants
INTERVENTIONAL
2016-02-29
2017-07-31
Brief Summary
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Detailed Description
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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.
Conditions
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Keywords
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
NONE
Study Groups
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Intervention
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.
Arousal-based biofeedback system
Waitlist Control
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.
No interventions assigned to this group
Interventions
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Arousal-based biofeedback system
Eligibility Criteria
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Inclusion Criteria
* 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 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
21 Years
35 Years
ALL
Yes
Sponsors
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Agency for Science, Technology and Research
OTHER
Singapore General Hospital
OTHER
Duke-NUS Graduate Medical School
OTHER
Responsible Party
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Lee Tih Shih
Associate Professor
Principal Investigators
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Tih-Shih Lee, MD PHD
Role: PRINCIPAL_INVESTIGATOR
Duke-NUS Graduate Medical School
Locations
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Duke-NUS Graduate Medical School
Singapore, , Singapore
Countries
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References
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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.
Other Identifiers
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B-14-098
Identifier Type: -
Identifier Source: org_study_id