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

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ClinicalTrials.gov Identifier: NCT00992953
Recruitment Status : Completed
First Posted : October 9, 2009
Last Update Posted : October 9, 2009
Information provided by:

Study Description
Brief Summary:
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 or disease Intervention/treatment Phase
Post-Traumatic Stress Disorder Behavioral: Treatment as Usual Behavioral: Virtual Reality Exposure with Stimulus Control Phase 1 Phase 2

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.

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 136 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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
Study Start Date : January 2005
Primary Completion Date : October 2009
Study Completion Date : October 2009

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
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
  • 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

Outcome Measures

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

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): NCT00992953

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 (ONR)
Naval Hospital Camp Pendleton
Virtual Reality Medical Center
United States Naval Medical Center, San Diego
Principal Investigator: Brenda Wiederhold, PhD Virtual Reality Medical Center
More Information

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
First Posted: October 9, 2009    Key Record Dates
Last Update Posted: October 9, 2009
Last Verified: October 2009

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

Additional relevant MeSH terms:
Stress Disorders, Traumatic
Stress Disorders, Post-Traumatic
Pathologic Processes
Trauma and Stressor Related Disorders
Mental Disorders