Using Virtual Reality in Exposure-Based Treatment for Social Anxiety in Youth
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|ClinicalTrials.gov Identifier: NCT03135990|
Recruitment Status : Recruiting
First Posted : May 2, 2017
Last Update Posted : May 7, 2018
Anxiety disorders are the most common mental health diagnosis in the US and are associated with avoidance that causes functional impairments and decreases quality of life. Social anxiety disorder is among the most prevalent anxiety disorders, with most common age of onset being in adolescence. The frontline treatment for social anxiety disorder is cognitive behavioral therapy with exposure. However, a significant number of adolescent patients do not get better after completing cognitive behavioral therapy or experience relapse. This could be explained by findings in both mice and humans suggesting that cue-based extinction learning occurs less readily in adolescents than in children and adults. Studies using mouse-models have overcome this age disparity by enhancing contextual cues when fear extinction learning takes place. Providing realistic learning contexts for exposure could be the key to enhancing treatment effects in adolescents. This is often challenging for a variety of reasons, including difficulty realistically mimicking anxiety-provoking social situations due to limited resources, clinician training, time, or motivation. Virtual reality environments could provide contextual exposures for social anxiety.
This pilot study will test the feasibility of integrating virtual reality technology in exposure-based treatment in youth ages 13-23 diagnosed with social anxiety disorder with the goal of approximating equivalent efficacy with traditional cognitive behavioral therapy, and assessing feasibility of virtual reality technology with this population. We will also pilot a fear conditioning and extinction learning paradigm to explore the relationship between extinction learning and efficacy of virtual reality exposure therapy, using physiological assessment indicators to mark changes in fear response. These markers will also be used prior to the initiation of the therapy to assess the degree to which virtual reality environments invoke a true fear response, comparing the 12 participants with social phobia to 12 age matched, non-anxious control participants. The aims of this study are threefold: to assess feasibility of using virtual reality in treatment of social anxiety in youth, to examine whether virtual reality invokes arousal similar to anxiety and test the physiological assessment protocol, and to evaluate whether exposure using virtual reality environments reduces symptoms of social anxiety and related functional impairment.
|Condition or disease||Intervention/treatment||Phase|
|Social Anxiety Social Anxiety Disorder Social Anxiety Disorder of Childhood||Behavioral: Cognitive Behavioral Therapy with Virtual Reality Technology||Not Applicable|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||24 participants|
|Intervention Model:||Single Group Assignment|
|Intervention Model Description:||Cognitive Behavioral Therapy|
|Masking:||None (Open Label)|
|Official Title:||Using Virtual Reality in Exposure-Based Treatment for Social Anxiety in Youth|
|Estimated Study Start Date :||June 1, 2018|
|Estimated Primary Completion Date :||December 1, 2019|
|Estimated Study Completion Date :||December 1, 2019|
Experimental: CBT + VR
Cognitive Behavioral Therapy with Virtual Reality technology.
Behavioral: Cognitive Behavioral Therapy with Virtual Reality Technology
Cognitive Behavioral Therapy Intervention: This manualized intervention is a modified version of the Unified Protocol for Emotional Disorders in Youth, a modular Cognitive Behavioral Therapy protocol for anxiety disorders and depression with demonstrated efficacy in youth. The 10-session intervention includes psychoeducation about anxiety disorders and their treatment (1 session), emotion awareness and regulation (2 sessions), exposure therapy using virtual reality environments (6 sessions), and review and relapse prevention (1 session). All treatment sessions will be videotaped to ensure fidelity to treatment manual and modules.
- CGI [ Time Frame: Week 12 ]Clinical Global Impressions Scale
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03135990
|Contact: Michelle Pelcovitzfirstname.lastname@example.org|
|Contact: Jennifer S Schild, BSemail@example.com|
|United States, New York|
|New York, New York, United States, 10065|
|Contact: Michelle Pelcovitz, PhD 212-821-0789 firstname.lastname@example.org|
|Contact: Jennifer Schild, BS 212-746-5930 email@example.com|
|Principal Investigator:||Michelle Pelcovitz, PhD||Weill Cornell Medicine|