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

Phase 1

Completed

• Conditions: Post-Traumatic Stress Disorder
• Interventions: Behavioral: Virtual Reality Exposure with Stimulus Control; Behavioral: Treatment as Usual

• Registration Number: NCT00992953
• Lead Sponsor: Office of Naval Research (ONR)

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.

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 Timeline

• Study Start: 2005-01
• Status Verified: 2009-10
• Primary Completion: 2009-10
• Study Completion: 2009-10
• Study First Submitted: 2009-10-08
• Study First Submitted QC: 2009-10-08
• Last Update Submitted: 2009-10-08
• Study First Posted: 2009-10-09
• Last Update Posted: 2009-10-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 136

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Virtual Reality Therapy	Virtual Reality Exposure with Stimulus Control	10 Weeks of Virtual Reality Exposure with Stimulus Control, with up to twice a week, 90 min sessions
Treatment As Usual	Treatment as Usual	Traditional Therapy and Psychiatric Medication

Trial Locations

Locations (2)

Naval Hosptial Camp Pendleton; 🇺🇸 Camp Pendlton, California, United States

Naval Medical Center San Diego (NMCSD); 🇺🇸 San Diego, California, United States