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

NCT ID: NCT00992953

Last Updated: 2009-10-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

136 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-01-31

Study Completion Date

2009-10-31

Brief Summary

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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

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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.

Conditions

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Post-Traumatic Stress Disorder

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Virtual Reality Therapy

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

Group Type EXPERIMENTAL

Virtual Reality Exposure with Stimulus Control

Intervention Type BEHAVIORAL

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

Treatment As Usual

Traditional Therapy and Psychiatric Medication

Group Type ACTIVE_COMPARATOR

Treatment as Usual

Intervention Type BEHAVIORAL

10 weeks of therapy and/or psychiatric medication as available

Interventions

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Treatment as Usual

10 weeks of therapy and/or psychiatric medication as available

Intervention Type 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

Intervention Type BEHAVIORAL

Other Intervention Names

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TAU Virtual Reality Gradual Exposure Treatment VRGET Virtual Reality Exposure VRE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Naval Hospital Camp Pendleton

FED

Sponsor Role collaborator

Virtual Reality Medical Center

UNKNOWN

Sponsor Role collaborator

United States Naval Medical Center, San Diego

FED

Sponsor Role collaborator

Office of Naval Research (ONR)

FED

Sponsor Role lead

Responsible Party

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Naval Medical Center San Diego

Principal Investigators

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Brenda Wiederhold, PhD

Role: PRINCIPAL_INVESTIGATOR

Virtual Reality Medical Center

Locations

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Naval Hosptial Camp Pendleton

Camp Pendlton, California, United States

Site Status

Naval Medical Center San Diego (NMCSD)

San Diego, California, United States

Site Status

Countries

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United States

Other Identifiers

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S-05-005

Identifier Type: -

Identifier Source: org_study_id

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