Posttraumatic Stress DisorderNCT00167804
Comparing Virtual Reality Therapy to Usual Treatment for PTSD
A study testing Virtual Reality Exposure in people with Posttraumatic Stress Disorder, run by US Department of Veterans Affairs at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Posttraumatic Stress Disorder
- What is being tested?
- Virtual Reality Exposure
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2004to Aug 2006
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Vietnam Veterans with combat related Posttraumatic Stress Disorder
Who cannot join
- Active Substance Abuse
- Psychosis
- Bipolar Disorder
- Dementia
- Significant Cognitive Impairment
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Posttraumatic Stress Disorder
- Being tested
- Virtual Reality Exposure
- Keywords
- Exposure Therapy, Post Traumatic Stress Disorder, Treatment Outcome, Veterans, Virtual Reality
- Medical subject headings
- Stress Disorders, Post-Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Virtual Reality ExposureBehavioural
VRE uses computer generated environments to conduct exposure therapy.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Other | 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. Receives: Behavioral: Virtual Reality Exposure |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinician Administered PTSD Scale
Measured: Pre Tx, Post TX and 6 months Post Tx
Secondary outcomes (1)
Mississippi-R Scale
Measured: Pre Tx, Post TX and 6 months Post Tx
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Sep 2005 (estimated)
- Study startSep 2004
- Primary completionAug 2006
- Study completionAug 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Posttraumatic Stress DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- US Department of Veterans Affairs
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- David Ready, PhD MS, Principal investigator, VA Medical Center, Decatur
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00167804
- Sponsor's protocol ID
- D3520P
- Status last verified
- Dec 2011
- First submitted
- 9 Sep 2005
- Last updated
- 6 Dec 2011
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Dec 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparing Virtual Reality Therapy to Usual Treatment for PTSD
- ClinicalTrials.gov ID
- NCT00167804
- Acronym / sponsor ID
- D3520P
- Conditions
- Posttraumatic Stress Disorder
- Keywords
- Exposure Therapy, Post Traumatic Stress Disorder, Treatment Outcome, Veterans, Virtual Reality
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- US Department of Veterans AffairsUS federal agency
- Study start
- Sep 2004
- Primary completion
- Aug 2006 (actual)
- Study completion
- Aug 2006 (actual)
- First posted
- 14 Sep 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | Other | Behavioral: Virtual Reality ExposurePresent 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. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Vietnam Veterans with combat related Posttraumatic Stress Disorder
Key exclusion criteria (5 listed)
- Active Substance Abuse
- Psychosis
- Bipolar Disorder
- Dementia
- Significant Cognitive Impairment
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Virtual Reality ExposureVRE uses computer generated environments to conduct exposure therapy. | Behavioural | 1 |
Primary outcome
Clinician Administered PTSD Scale
Time frame: Pre Tx, Post TX and 6 months Post Tx
1 secondary outcome
Mississippi-R Scale
Time frame: Pre Tx, Post TX and 6 months Post Tx
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Dec 2011.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
David Ready, PhD MS principal investigator
VA Medical Center, Decatur
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Virtual Reality Exposure in people with Posttraumatic Stress Disorder, run by US Department of Veterans Affairs at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Dec 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinician Administered PTSD Scale (time frame: Pre Tx, Post TX and 6 months Post Tx). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Dec 2011.