- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00167804
Comparing Virtual Reality Therapy to Usual Treatment for PTSD
December 2, 2011 updated by: US Department of Veterans Affairs
Combat related Posttraumatic Stress Disorder (PTSD) is the most common chronic psychiatric disorder in the veteran population.
Unfortunately, outcome studies of VA PTSD programs have failed to show efficacy.
VA PTSD patients have been significantly less responsive to conventional therapies than other PTSD populations.
Virtual Reality based exposure therapy (VRE) allows patients to feel immersed in highly interactive computer-generated environments.
Within these environments patients can be exposed to anxiety-provoking stimuli in a gradual and controlled manner so that they can become desensitized to these stimuli and, in the case of PTSD, the traumatic memories evoked by these stimuli.
The advantages of VRE include less reliance on the patient's ability to visualize traumatic memories and making it more difficult for patients to avoid memories during exposure therapy.
It is also safer and more convenient than in vivo exposure.
In this study twenty Vietnam veterans are randomly assign to either VRE or to a Treatment as Usual (TAU) control condition.
Treatment would consist of ten ninety-minute individual psychotherapy sessions for both groups.
Assessments would occur at pre-treatment, immediate post-treatment and at six months post-treatment.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
Combat related Posttraumatic Stress Disorder (PTSD) is the most common chronic psychiatric disorder in the veteran population.
PTSD is often disabling and is characterized by intrusive re-experiencing of traumatic memories, avoidance/numbing, and increased arousal.
An estimated 830,000 veterans currently have chronic PTSD symptoms.
The VA has set up 145 specialized PTSD programs.
Unfortunately, outcome studies of VA PTSD programs have failed to show efficacy.
VA PTSD patients have been significantly less responsive to conventional therapies than other PTSD populations including traditional Imaginal Exposure Therapy.
Virtual Reality based exposure therapy (VRE) allows patients to feel immersed in highly interactive computer-generated environments.
Within these environments patients can be exposed to anxiety-provoking stimuli in a gradual and controlled manner so that they can become desensitized to these stimuli and, in the case of PTSD, the traumatic memories evoked by these stimuli.
VRE therapy produced significant and lasting reductions in PTSD symptoms with Vietnam veterans (N=14) in two open trials at the Atlanta VA.
Two case studies of successful PTSD treatment (one at the Boston VA and the other of a 9/11 survivor) provide additional support for VRE.
The advantages of VRE include less reliance on the patient's ability to visualize traumatic memories and making it more difficult for patients to avoid memories during exposure therapy.
It is also safer and more convenient than in vivo exposure.
The proposed study would randomly assign twenty Vietnam veterans to either VRE or to a Treatment as Usual (TAU) control condition.
Treatment would consist of ten ninety-minute individual psychotherapy sessions for both groups.
Assessments would occur at pre-treatment, immediate post-treatment and at six months post-treatment.
VRE would use Virtual Vietnam computer generated environments to desensitize patients to one or two of their most traumatic combat related memories.
VRE patients would wear a Head Mounted Display (HMD) that fits over their eyes and ears.
While in the HMD patients look into a stereoscopic computer display and receive audio input through a set of headphones.
Patients have reported a strong sense of being present in a Vietnam-like place when in these environments.
The therapist is in constant contact with the patient through a microphone connected to the HMD.
Patients recount their traumatic experiences while the therapist augments these descriptions with visual and auditory combat-related stimuli at the appropriate moments in time.
The therapist can control, on a moment-by-moment basis, the type and intensity of the VR exposure.
The goal is to provide the necessary level of stimuli to help the patient become engaged enough, long enough, to desensitize to a traumatic memory without becoming overwhelmed by either the external stimuli provided by the VR or the internal stimulus of the traumatic memory.
In the TAU condition therapy will focus on "here-and-now" issues with a problem solving focus of the type that VA PTSD patients usually receive.
The primary outcome measure will be the Clinician Administered PTSD Scale.
An Independent Assessor who will be blind to patients' treatment conditions will conduct assessments.
To insure patient safety, the Scale of Suicide Ideation will be administered in both conditions once a week.
Patients will be paid $75 for each of the two post-treatment assessments.
The hypotheses are: (1) VRE will produce significant reductions in PTSD symptoms; (2) VRE will be significantly more effective than TAU; (3) VRE symptom reduction will be maintained on six-month follow-up assessment.
VRE may be a powerful new tool in the treatment of PTSD.
Controlled studies, like the one proposed, are needed to explore its utility.
Study Type
Interventional
Enrollment (Actual)
20
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Georgia
-
Decatur, Georgia, United States, 30033
- VA Medical Center, Decatur
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Vietnam Veterans with combat related Posttraumatic Stress Disorder
Exclusion Criteria:
- Active Substance Abuse
- Psychosis
- Bipolar Disorder
- Dementia
- Significant Cognitive Impairment
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Other: 1
Present Centered Therapy focuses on the veterans problems in the here and now.
It uses a problem solving approach and avoids discussion of war related traumatic events.
|
VRE uses computer generated environments to conduct exposure therapy.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Clinician Administered PTSD Scale
Time Frame: Pre Tx, Post TX and 6 months Post Tx
|
Pre Tx, Post TX and 6 months Post Tx
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Mississippi-R Scale
Time Frame: Pre Tx, Post TX and 6 months Post Tx
|
Pre Tx, Post TX and 6 months Post Tx
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: David Ready, PhD MS, VA Medical Center, Decatur
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
September 1, 2004
Primary Completion (Actual)
August 1, 2006
Study Completion (Actual)
August 1, 2006
Study Registration Dates
First Submitted
September 9, 2005
First Submitted That Met QC Criteria
September 12, 2005
First Posted (Estimate)
September 14, 2005
Study Record Updates
Last Update Posted (Estimate)
December 6, 2011
Last Update Submitted That Met QC Criteria
December 2, 2011
Last Verified
December 1, 2011
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- D3520P
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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