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

Office of Naval Research (ONR)

Status and phase: Completed; Phase 2; Phase 1

Conditions: Post-Traumatic Stress Disorder

Treatments: Behavioral: Virtual Reality Exposure with Stimulus Control; Behavioral: Treatment as Usual

Study type: Interventional

Funder types: Other U.S. Federal agency; Other

Identifiers

NCT00992953

S-05-005

Details and patient eligibility

About

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.

Full 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.

Enrollment: 136 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

136 participants in 2 patient groups

Virtual Reality Therapy

Experimental group

Description:

10 Weeks of Virtual Reality Exposure with Stimulus Control, with up to twice a week, 90 min sessions

Treatment:

Behavioral: Virtual Reality Exposure with Stimulus Control

Treatment As Usual

Active Comparator group

Description:

Traditional Therapy and Psychiatric Medication

Treatment:

Behavioral: Treatment as Usual