Clinical trial NCT02493010: Arousal Training for Social Anxiety Disorder
Official title: Arousal Detection and Training for Social Anxiety Disorder (SAD)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Social Anxiety
Keywords: Virtual Reality Exposure Therapy
Computerized Cognitive Behavioral Therapy
Public Speaking
Social Phobia
Biofeedback
Lead sponsor: Duke-NUS Graduate Medical School
Sponsor class: OTHER
Collaborators: name: Agency for Science, Technology and Research
name: Singapore General Hospital
First posted: 2015-07-09
Enrollment: 50
Sex: ALL
Minimum age (years): 21
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Change in Liebowitz Social Anxiety Scale scores from Week 0 to Week 5
timeFrame: Week 0 (Pre-intervention) and Week 5 (Post-intervention)
measure: Satisfaction and Immersion Questionnaire
timeFrame: Week 4 (post-intervention) for Intervention group and Week 9 (post-intervention) for Waitlist Control group
measure: 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
timeFrame: Week 1 to Week 4 for Intervention and Week 6 to Week 9 for Waitlist Control
Secondary outcomes:
measure: Change in Fear of Negative Evaluation-Brief (FNE-B) scores
timeFrame: Week 0 (pre-intervention) and Week 5 (post-intervention)
measure: Change in Self-Statements during Public Speaking (SSPS) scores
timeFrame: Week 0 (pre-intervention) and Week 5 (post-intervention)
measure: Change in Public Speaking Anxiety Scale scores from Week 0 to Week 5
timeFrame: Week 0 (pre-intervention) and Week 5 (post-intervention)
Other outcomes:
Locations:
city: Singapore
country: Singapore
facility: Duke-NUS Graduate Medical School
Study officials:
affiliation: Duke-NUS Graduate Medical School
name: Tih-Shih Lee, MD PHD
role: PRINCIPAL_INVESTIGATOR
References:
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.