Arousal Training for Social Anxiety Disorder

Duke University

Status: Completed

Conditions: Social Anxiety

Treatments: Device: Arousal-based biofeedback system

Study type: Interventional

Funder types: Other

Identifiers

NCT02493010

B-14-098

Details and patient eligibility

About

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.

Full 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.

Enrollment: 50 patients

Sex: All

Ages: 21 to 35 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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50 participants in 2 patient groups

Intervention

Experimental group

Description:

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.

Treatment:

Device: Arousal-based biofeedback system

Waitlist Control

No Intervention group

Description:

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.