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OpenTrials
Completed

NCT Number: NCT00992953

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

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.

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Naval Hosptial Camp Pendleton, Camp Pendlton, California, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Treatment as Usual

Behavioral

10 weeks of therapy and/or psychiatric medication as available

Other names: TAU

Virtual Reality Exposure with Stimulus Control

Behavioral

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

Sponsors and collaborators

Lead sponsor

Office of Naval Research (ONR)

Fed

Collaborators

  • Naval Hospital Camp Pendleton
  • United States Naval Medical Center, San Diego
  • Virtual Reality Medical Center

Registry information

Official study title

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

Important dates

Study start
2005
Primary completion
2009
Study completion
2009
First posted
Oct 9, 2009
Registry last updated
Oct 9, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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