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

Post-Traumatic Stress Disorder Clinical Trial

Official title:

The Efficacy of Virtual Reality (VR) as an Adjunct Therapy for Acute Combat-related Post-Traumatic Stress Disorder (PTSD) in Non-Combatants

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00992953
• Other study ID #: S-05-005
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: October 8, 2009
• Last updated: October 8, 2009
• Start date: January 2005
• Est. completion date: October 2009

Study information

• Verified date: October 2009
• Source: United States Naval Medical Center, San Diego
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal GovernmentUnited States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 136
• Est. completion date: October 2009
• Est. primary completion date: October 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Disease
• Post-Traumatic Stress Disorder
• Stress Disorders, Post-Traumatic
• Stress Disorders, Traumatic

Intervention

Behavioral:
• Treatment as Usual
10 weeks of therapy and/or psychiatric medication as available
• 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

Locations

Country	Name	City	State
United States	Naval Hosptial Camp Pendleton	Camp Pendlton	California
United States	Naval Medical Center San Diego (NMCSD)	San Diego	California

Sponsors (4)

Lead Sponsor	Collaborator
Office of Naval Research (ONR)	Naval Hospital Camp Pendleton, United States Naval Medical Center, San Diego, Virtual Reality Medical Center

Country where clinical trial is conducted

United States,