Using Virtual Reality in Exposure-Based Treatment for Social Anxiety in Youth

NCT03135990 | Terminated

• 1 other identifier: 1701017878
• Study Type: interventional
• Target: 19
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Social Anxiety; Social Anxiety Disorder; Social Anxiety Disorder of Childhood

Keywords

Virtual Reality; Exposure Therapy; Cognitive Behavioral Therapy; Extinction Learning

Outcome Measures

Primary Outcomes (1)

• Change in diagnostic in diagnostic status and severity of social anxiety symptoms measured by ADIS

  Anxiety Disorders Interview Schedule is used to assess change in diagnostic status and severity of social anxiety symptoms. A low score of a 3 or below would be a sub-clinical representation of the disorder, a 4 represent moderate severity and a high score of 5-8 would be a clinically severe representation of the disorder.

  Initial Visit,Immediately after the intervention, and Three Month Follow Up Visit

Secondary Outcomes (1)

• Change in depression and suicidality as measured by CESD-R

  Initial Visit, Immediately after the intervention, and Three Month Follow Up Visit

Study Arms (1)

CBT + VR

EXPERIMENTAL

Cognitive Behavioral Therapy with Virtual Reality technology.

Behavioral: Cognitive Behavioral Therapy with Virtual Reality Technology

Interventions

Cognitive Behavioral Therapy with Virtual Reality Technology BEHAVIORAL

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.

CBT + VR

Eligibility Criteria

• Age: 13 Years - 23 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Ages 13-23 with a primary diagnosis of social anxiety disorder.
• Anxiety Disorders Interview Schedule-5 Clinician Severity Rating greater than 4
• IQ estimate of 70 or higher.
• Comorbid disorder (e.g., Attention Deficit Hyperactivity Disorder, Obsessive Compulsive Disorder, Oppositional Defiant Disorder) will be allowed provided that the anxiety symptoms are of primary concern to parents and comorbid symptoms are not of sufficient severity to require immediate treatment other than that provided by the current study.
• Sufficient command of the English language to comply with study protocol.
• Ages 13-23.
• Does not meet criteria for anxiety or mood disorder on Anxiety Disorders Interview Schedule-5.

You may not qualify if:

• Unable to consent.
• A prior or present diagnosis of receptive and expressive language disorder and/or pervasive developmental disorder or severe mental retardation.
• Current substance use disorder or dependence as primary diagnosis.
• Recent suicide behavior (last month) or any other psychiatric condition that requires more intensive care (e.g., psychotic episode, manic episode).
• Youth or parent/third party not fluent in English.

Sponsors & Collaborators

• Weill Medical College of Cornell University: lead
• Brain & Behavior Research Foundation: collaborator

Study Sites (1)

Weill Cornell Medicine

New York, New York, 10065, United States

Location

MeSH Terms

Conditions

Phobia, Social

Interventions

Cognitive Behavioral Therapy

Condition Hierarchy (Ancestors)

Phobic Disorders; Anxiety Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Michelle Pelcovitz, PhD

  Weill Medical College of Cornell University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Cognitive Behavioral Therapy

Study Record Dates

• First Submitted: March 21, 2017
• First Posted: May 2, 2017
• Study Start: August 14, 2018
• Primary Completion: March 23, 2020
• Study Completion: March 23, 2020
• Last Updated: March 11, 2022

Record last verified: 2022-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)