ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03135990
Recruitment Status : Recruiting
First Posted : May 2, 2017
Last Update Posted : May 7, 2018
Sponsor:
Information provided by (Responsible Party):
Weill Medical College of Cornell University

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.


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)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anxiety

Arm Intervention/treatment
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.




Primary Outcome Measures :
  1. CGI [ Time Frame: Week 12 ]
    Clinical Global Impressions Scale



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   13 Years to 23 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria for Virtual Reality/CBT Group:

  1. Ages 13-23 with a primary diagnosis of social anxiety disorder.
  2. Anxiety Disorders Interview Schedule-5 Clinician Severity Rating greater than 4
  3. IQ estimate of 70 or higher.
  4. 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.
  5. Sufficient command of the English language to comply with study protocol.
  6. Participants on psychiatric medication must be on a stable dose for at least 2 months prior to study participation and remain symptomatic to the level identified for study inclusion (Anxiety Disorders Interview Schedule-5 less than or equal to 4). Family agrees to refrain from med changes over the course of the study if at all possible.

Inclusion Criteria for Control Group:

  1. Ages 13-23.
  2. Does not meet criteria for anxiety or mood disorder on Anxiety Disorders Interview Schedule-5.

Exclusion Criteria:

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

Information from the National Library of Medicine

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


Contacts
Contact: Michelle Pelcovitz 212-821-0789 mip2051@med.cornell.edu
Contact: Jennifer S Schild, BS 212-746-5930 jss3003@med.cornell.edu

Locations
United States, New York
Michelle Pelcovitz Recruiting
New York, New York, United States, 10065
Contact: Michelle Pelcovitz, PhD    212-821-0789    mip2051@med.cornell.edu   
Contact: Jennifer Schild, BS    212-746-5930    jss3003@med.cornell.edu   
Sponsors and Collaborators
Weill Medical College of Cornell University
Investigators
Principal Investigator: Michelle Pelcovitz, PhD Weill Cornell Medicine

Responsible Party: Weill Medical College of Cornell University
ClinicalTrials.gov Identifier: NCT03135990     History of Changes
Other Study ID Numbers: 1701017878
First Posted: May 2, 2017    Key Record Dates
Last Update Posted: May 7, 2018
Last Verified: May 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Weill Medical College of Cornell University:
Virtual Reality
Exposure Therapy
Cognitive Behavioral Therapy
Extinction Learning

Additional relevant MeSH terms:
Disease
Anxiety Disorders
Phobia, Social
Pathologic Processes
Mental Disorders
Phobic Disorders