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Virtual Reality (VR) Therapy for Post-Traumatic Stress Disorder (PTSD)

This study has been completed.
Sponsor:
Collaborators:
Naval Hospital Camp Pendleton
Virtual Reality Medical Center
United States Naval Medical Center, San Diego
Information provided by:
United States Naval Medical Center, San Diego
ClinicalTrials.gov Identifier:
NCT00992953
First received: October 8, 2009
Last updated: NA
Last verified: October 2009
History: No changes posted
  Purpose

It is proposed that using Virtual Reality as part of therapy will result in improvements in Post Traumatic Stress Disorder for Service Members with PTSD related to service in Iraq and/or Afghanistan.


Condition Intervention Phase
Post-Traumatic Stress Disorder
 Behavioral: Treatment as Usual
Behavioral: Virtual Reality Exposure with Stimulus Control
 Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: The Efficacy of Virtual Reality (VR) as an Adjunct Therapy for Acute Combat-related Post-Traumatic Stress Disorder (PTSD) in Non-Combatants

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by United States Naval Medical Center, San Diego:

Estimated Enrollment: 136
Study Start Date: January 2005
Study Completion Date: October 2009
Primary Completion Date: October 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Virtual Reality Therapy
10 Weeks of Virtual Reality Exposure with Stimulus Control, with up to twice a week, 90 min sessions
 Behavioral: Virtual Reality Exposure with Stimulus Control
10 weeks of therapy, up to twice a week, 90 min sessions involving Virtual Reality Exposure with Stimulus Control
Other Names:
  • Virtual Reality Gradual Exposure Treatment
  • VRGET
  • Virtual Reality Exposure
  • VRE
Active Comparator: Treatment As Usual
Traditional Therapy and Psychiatric Medication
 Behavioral: Treatment as Usual
10 weeks of therapy and/or psychiatric medication as available
Other Name: TAU

Detailed Description:

In the treatment development phase, participants will be enrolled in Virtual Reality therapy. The therapy will be based on principals of exposure therapy, but will also incorporate aspects of physiological monitoring, and cognitive restructuring. The therapy will be modified as indicated by clinical feedback, with a fixed protocol to be developed (with length of treatment and exact methods to be used to be determined). After a fixed protocol is agreed upon, the project will enter the randomized phase. In this portion, subjects will be randomly assigned to receive either the Virtual Reality Treatment, or sent back to a waiting list during which time they will receive usual treatment. Participants will be assessed to determine which treatment (VR or treatment as usual) results in the greatest improvements in PTSD, as measured by independent assessors using the Clinician Administered PTSD scale.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Diagnosed with Post Traumatic Stress Disorder related to military service in Iraq or Afghanistan by a Military Medical Provider.

Willing and able to give informed consent to participate Willing to give up intoxicating substances on the days of therapy

Exclusion Criteria:

  • Actively suicidal, homicidal, psychotic, or having a diagnosis of alcohol dependence that does not show signs of at least early remission
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00992953

Locations
United States, California
Naval Hosptial Camp Pendleton
Camp Pendlton, California, United States, 92134
Naval Medical Center San Diego (NMCSD)
San Diego, California, United States, 92134
Sponsors and Collaborators
Office of Naval Research
Naval Hospital Camp Pendleton
Virtual Reality Medical Center
United States Naval Medical Center, San Diego
Investigators
Principal Investigator: Brenda Wiederhold, PhD Virtual Reality Medical Center
  More Information

No publications provided

Responsible Party: Robert Neil McLay, Site Primary Investigator, Naval Medical Center San Diego
ClinicalTrials.gov Identifier: NCT00992953     History of Changes
Other Study ID Numbers: S-05-005
Study First Received: October 8, 2009
Last Updated: October 8, 2009
Health Authority: United States: Federal Government
United States: Institutional Review Board

Keywords provided by United States Naval Medical Center, San Diego:
Virtual Reality
Post Traumatic Stress Disorder
Combat
Military
 Major Depressive Disorder
Anxiety
Virtual Reality Exposure with Stimulus Control
Treatment as Usual

Additional relevant MeSH terms:
Stress Disorders, Post-Traumatic
Stress Disorders, Traumatic
Anxiety Disorders
Mental Disorders

ClinicalTrials.gov processed this record on May 19, 2013