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Comparing Virtual Reality Therapy to Usual Treatment for PTSD

Primary Purpose

Posttraumatic Stress Disorder

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Virtual Reality Exposure
Sponsored by
US Department of Veterans Affairs
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Posttraumatic Stress Disorder focused on measuring Exposure Therapy, Post Traumatic Stress Disorder, Treatment Outcome, Veterans, Virtual Reality

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Vietnam Veterans with combat related Posttraumatic Stress Disorder Exclusion Criteria: Active Substance Abuse Psychosis Bipolar Disorder Dementia Significant Cognitive Impairment

Sites / Locations

  • VA Medical Center, Decatur

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

1

Arm Description

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.

Outcomes

Primary Outcome Measures

Clinician Administered PTSD Scale

Secondary Outcome Measures

Mississippi-R Scale

Full Information

First Posted
September 9, 2005
Last Updated
December 2, 2011
Sponsor
US Department of Veterans Affairs
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1. Study Identification

Unique Protocol Identification Number
NCT00167804
Brief Title
Comparing Virtual Reality Therapy to Usual Treatment for PTSD
Official Title
Comparing Virtual Reality Therapy to Usual Treatment for PTSD
Study Type
Interventional

2. Study Status

Record Verification Date
December 2011
Overall Recruitment Status
Completed
Study Start Date
September 2004 (undefined)
Primary Completion Date
August 2006 (Actual)
Study Completion Date
August 2006 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
US Department of Veterans Affairs

4. Oversight

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Posttraumatic Stress Disorder
Keywords
Exposure Therapy, Post Traumatic Stress Disorder, Treatment Outcome, Veterans, Virtual Reality

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
20 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Other
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Virtual Reality Exposure
Intervention Description
VRE uses computer generated environments to conduct exposure therapy.
Primary Outcome Measure Information:
Title
Clinician Administered PTSD Scale
Time Frame
Pre Tx, Post TX and 6 months Post Tx
Secondary Outcome Measure Information:
Title
Mississippi-R Scale
Time Frame
Pre Tx, Post TX and 6 months Post Tx

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Vietnam Veterans with combat related Posttraumatic Stress Disorder Exclusion Criteria: Active Substance Abuse Psychosis Bipolar Disorder Dementia Significant Cognitive Impairment
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David Ready, PhD MS
Organizational Affiliation
VA Medical Center, Decatur
Official's Role
Principal Investigator
Facility Information:
Facility Name
VA Medical Center, Decatur
City
Decatur
State/Province
Georgia
ZIP/Postal Code
30033
Country
United States

12. IPD Sharing Statement

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Comparing Virtual Reality Therapy to Usual Treatment for PTSD

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