Arousal Training for Social Anxiety Disorder

Social Anxiety Clinical Trial

Official title:

Arousal Detection and Training for Social Anxiety Disorder (SAD)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02493010
• Other study ID #: B-14-098
• Status: Completed
• Phase: N/A
• First received: July 24, 2014
• Last updated: December 18, 2017
• Start date: February 2016
• Est. completion date: July 2017

Study information

• Verified date: December 2017
• Source: Duke-NUS Graduate Medical School
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: July 2017
• Est. primary completion date: July 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 21 Years to 35 Years

Eligibility

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

Related Conditions & MeSH terms

• Anxiety Disorders
• Phobia, Social
• Social Anxiety

Intervention

Device:
• Arousal-based biofeedback system

Locations

Country	Name	City	State
Singapore	Duke-NUS Graduate Medical School	Singapore

Sponsors (3)

Lead Sponsor	Collaborator
Duke-NUS Graduate Medical School	Agency for Science, Technology and Research, Singapore General Hospital

Country where clinical trial is conducted

Singapore, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)
Primary	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
Primary	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	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)
Secondary	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)
Secondary	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)