Arousal Training for Social Anxiety Disorder

Arousal Detection and Training for Social Anxiety Disorder (SAD)

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.

Study Overview

• Status: Completed
• Conditions: Social Anxiety
• Intervention / Treatment: Device: Arousal-based biofeedback system

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.

• Study Type: Interventional
• Enrollment (Actual): 50
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Singapore
  • Singapore, Singapore, 169857
    • Duke-NUS Graduate Medical School

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years to 35 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Device: Arousal-based biofeedback system
No Intervention: 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.

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)

Collaborators and Investigators

• Sponsor: Duke-NUS Graduate Medical School
• Collaborators: Singapore General Hospital; Agency for Science, Technology and Research
• Investigators: Principal Investigator: Tih-Shih Lee, MD PHD, Duke-NUS Graduate Medical School

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2016
• Primary Completion (Actual): July 1, 2017
• Study Completion (Actual): July 1, 2017

Study Registration Dates

• First Submitted: July 24, 2014
• First Submitted That Met QC Criteria: July 8, 2015
• First Posted (Estimate): July 9, 2015

Study Record Updates

• Last Update Posted (Actual): December 19, 2017
• Last Update Submitted That Met QC Criteria: December 18, 2017
• Last Verified: December 1, 2017

More Information

Terms related to this study

• Keywords: Social Phobia; Biofeedback; Virtual Reality Exposure Therapy; Computerized Cognitive Behavioral Therapy; Public Speaking
• Additional Relevant MeSH Terms: Mental Disorders; Phobic Disorders; Anxiety Disorders; Phobia, Social
• Other Study ID Numbers: B-14-098