Post Traumatic Stress DisorderPhase 3NCT00978484
A Head-to-head Comparison of Virtual Reality Treatment for Post Traumatic Stress Disorder
A Phase 3 study testing Virtual Reality Exposure Therapy - Dynamic and Augmented Exposure Therapy in people with Post Traumatic Stress Disorder, run by United States Naval Medical Center, San Diego at 2 sites in United States.
Trial summary
Therapy that uses Virtual Reality (VR) has been shown to help in the treatment of Post Traumatic Stress Disorder (PTSD). It is unclear what role the VR simulator itself plays in recovery. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Post Traumatic Stress Disorder
- What is being tested?
- Virtual Reality Exposure Therapy - Dynamic and Augmented Exposure Therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 2 sitesUnited States
- Study dates
- Sep 2009to Oct 2014
- Phase
- Phase 3
- 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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects must be eligible to receive care at NMCSD or Camp Pendleton, willing and able to give informed consent, aged 18 to 60, have a PTSD diagnosis from combat operations in Iraq or Afghanistan based on DSM-IV criteria and Clinician Administered PTSD Scale (CAPS) score greater than 40, have an index trauma that occurred in Iraq or Afghanistan, be medically able to tolerate exposure treatment and physically able to don virtual reality headset and physiological monitoring equipment as assed by their medical provider, be willing and able to give up alcohol and/or other intoxicating substances within 12 hours of a VR treatment session, and be able to see, hear, and smell
Who cannot join
- Subjects would be excluded or dropped from the study if they exhibit psychosis, mania, epilepsy, have current suicidal intent, are less than 30 days from a psychiatric hospitalization or suicide attempt, meet criteria for current, active substance dependence, use an intoxicating substance within 12 hours of a treatment session, or have another condition or event that the treating provider or medical monitor consider to be a safety hazard within the study. Subjects may also drop out of the study at any point with the assurance that they will be referred to other care as needed.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Camp Pendlton
Camp Pendlton, California
Naval Medical Center San Diego (NMCSD)
San Diego, California, 92134
About this study
Therapy that uses Virtual Reality (VR) has been shown to help in the treatment of Post Traumatic Stress Disorder (PTSD). It is unclear what role the VR simulator itself plays in recovery. This study is examining if full-immersion in VR causes greater improvement in PTSD symptoms than does similar therapy that uses a simple, static, computer image.
Read the detailed description
Exposure Therapy (ET) is the current gold standard for treating Post Traumatic Stress Disorder (PTSD). Although ET has the best evidence in its favor, it is also clear that the treatment is less than perfect in achieving remission of PTSD. Attempts have been made to improve on traditional ET by augmenting the exposure using Virtual Reality (VR). Open label trials of VR assisted ET (VRET) showed this method to be safe and effective, and suggested remission rates that were higher than normally seen with ET alone. For the treatment of phobias, head to head comparison with traditional ET has shown VRET to be superior. For PTSD, trials that directly pit VRET against traditional ET, and against other traditional therapy, are ongoing, but it is already clear that some individuals who fail to respond to traditional ET do get better once VR is added. Lost in the rush to develop VRET, however, has been any direct testing of its signature aspect, the VR itself. There are theoretical reasons to believe that VR might enhance ET in special ways. However there are other reasons to believe that any form of Augmented Exposure Therapy (AET) that introduced sights and sounds from the trauma would do just as well. VR, although exciting, is expensive, cumbersome, and not available at most treatment facilities. If similar effects could be achieved using more primitive technology, it would open up the possibility of enhanced ET to a much wider range of patients. Conversely, if VRET were shown to be superior to simplified AET, it would argue for a unique role of VR in psychotherapy. Not only would this be theoretically important for neuroscientists, it would indicate VRET as a "platinum" standard for treating PTSD. For the past four years, programs at Naval Medical Center San Diego (NMCSD) and Naval Hospital Camp Pendleton have collaborated with VR companies and researcher to build and test VR systems to treat PTSD in Service Members returning from Iraq and Afghanistan. NMCSD thus has the experience to perform the necessary experiments. The existing equipment also means that NMCSD has the unique ability to carry out such a test without any additional input from the companies that make VR systems. We propose to perform a randomized, head-to-head study that compares VRET to AET. We propose to perform a randomized, head-to-head study that compares VRET to AET. Up to 300 patients would be recruited with the goal of treating 40 patients with VR and 40 patients with the control (AET) therapy. The same techniques, measures, and controls would be used that NMCSD has already put in place to develop VRET for PTSD. Also, a cost-benefit analysis would be used to determine the benefits of VRET.
- Conditions
- Post Traumatic Stress Disorder
- Being tested
- Virtual Reality Exposure Therapy - Dynamic, Augmented Exposure Therapy
- Keywords
- PTSD, Depression, Anxiety, Virtual Reality, Computer Therapy, Exposure Therapy, Prolonged Exposure, Military Medicine, Combat, Iraq, Afghanistan, Air Force Personnel, Armed Forces Personnel, Army Personnel, Coast Guard, psychology, military psychiatry, combat disorders, combat neurosis, Marines
- Medical subject headings
- Stress Disorders, Post-Traumatic, Depression, Anxiety Disorders, Combat Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Virtual Reality Exposure Therapy - DynamicBehavioural
Also called VRE, VRET
10 weeks of Virtual Reality Exposure using full, immersive VR
Augmented Exposure TherapyBehavioural
Also called AET, Static VRE, Prolonged Exposure, PE
Exposure Therapy augmented with a still computer image
| Study group | Role | What they receive |
|---|---|---|
| Static Virtual Reality | Active comparator | Exposure Therapy using a still computer image Receives: Behavioral: Augmented Exposure Therapy |
| Dynamic Virtual Reality | Experimental | Virtual Reality Exposure Therapy using full, immersive Virtual Reality Receives: Behavioral: Virtual Reality Exposure Therapy - Dynamic |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinician Administered PSTD Scale (CAPS)
Measured: Post Tx, and 3 month follow up
Secondary outcomes (7)
PTSD Checklist, Military Version (PCL-M):
Measured: Post Tx, and 3 month follow up
The Patient Health Questionnaire 9 (PHQ-9):
Measured: same
Beck Anxiety Inventory (BAI):
Measured: same
Behavioral Reactivity Test (BRT)
Measured: same
Automated Neuropsychological Assessment Metric (ANAM)
Measured: same
Mini International Neuropsychiatric Interview (MINI)
Measured: same
Shehan Disability Scale (SDS)
Measured: same
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Sep 2009 (estimated)
- Study startSep 2009
- Primary completionSep 2014 (estimated)
- Study completionOct 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Post Traumatic 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- United States Naval Medical Center, San Diego
- Sponsor type
- US federal agency
- Collaborators
- Defense Centers of Excellence for Psychological Health and Traumatic Brain Injury, The Geneva Foundation, Marine Corps Base Camp Pendleton, Naval Hospital Camp Pendleton
- Responsible party
- Principal investigator, Robert McLay, United States Naval Medical Center, San Diego
- Investigators
- Robert N McLay, MD/PhD, Principal investigator, United States Naval Medical Center, San Diego
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00978484
- Sponsor's protocol ID
- W81XWH-08-1-0755
- Other IDs
- W81XWH-08-1-0755
- Status last verified
- Jun 2014
- First submitted
- 16 Sep 2009
- Last updated
- 30 Jun 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 30 Jun 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Head-to-head Comparison of Virtual Reality Treatment for Post Traumatic Stress Disorder
- ClinicalTrials.gov ID
- NCT00978484
- Acronym / sponsor ID
- W81XWH-08-1-0755
- Conditions
- Post Traumatic Stress Disorder
- Keywords
- PTSD, Depression, Anxiety, Virtual Reality, Computer Therapy, Exposure Therapy, Prolonged Exposure, Military Medicine
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (actual)
- Lead sponsor
- United States Naval Medical Center, San DiegoUS federal agency
- Collaborators
- Defense Centers of Excellence for Psychological Health and Traumatic Brain Injury, The Geneva Foundation, Marine Corps Base Camp Pendleton, Naval Hospital Camp Pendleton
- Study start
- Sep 2009
- Primary completion
- Sep 2014 (estimated)
- Study completion
- Oct 2014 (estimated)
- First posted
- 17 Sep 2009 (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.
Therapy that uses Virtual Reality (VR) has been shown to help in the treatment of Post Traumatic Stress Disorder (PTSD). It is unclear what role the VR simulator itself plays in recovery. This study is examining if full-immersion in VR causes greater improvement in PTSD symptoms than does similar therapy that uses a simple, static, computer image.
Detailed description
Exposure Therapy (ET) is the current gold standard for treating Post Traumatic Stress Disorder (PTSD). Although ET has the best evidence in its favor, it is also clear that the treatment is less than perfect in achieving remission of PTSD. Attempts have been made to improve on traditional ET by augmenting the exposure using Virtual Reality (VR). Open label trials of VR assisted ET (VRET) showed this method to be safe and effective, and suggested remission rates that were higher than normally seen with ET alone. For the treatment of phobias, head to head comparison with traditional ET has shown VRET to be superior. For PTSD, trials that directly pit VRET against traditional ET, and against other traditional therapy, are ongoing, but it is already clear that some individuals who fail to respond to traditional ET do get better once VR is added. Lost in the rush to develop VRET, however, has been any direct testing of its signature aspect, the VR itself. There are theoretical reasons to believe that VR might enhance ET in special ways. However there are other reasons to believe that any form of Augmented Exposure Therapy (AET) that introduced sights and sounds from the trauma would do just as well. VR, although exciting, is expensive, cumbersome, and not available at most treatment facilities. If similar effects could be achieved using more primitive technology, it would open up the possibility of enhanced ET to a much wider range of patients. Conversely, if VRET were shown to be superior to simplified AET, it would argue for a unique role of VR in psychotherapy. Not only would this be theoretically important for neuroscientists, it would indicate VRET as a "platinum" standard for treating PTSD. For the past four years, programs at Naval Medical Center San Diego (NMCSD) and Naval Hospital Camp Pendleton have collaborated with VR companies and researcher to build and test VR systems to treat PTSD in Service Members returning from Iraq and Afghanistan. NMCSD thus has the experience to perform the necessary experiments. The existing equipment also means that NMCSD has the unique ability to carry out such a test without any additional input from the companies that make VR systems. We propose to perform a randomized, head-to-head study that compares VRET to AET. We propose to perform a randomized, head-to-head study that compares VRET to AET. Up to 300 patients would be recruited with the goal of treating 40 patients with VR and 40 patients with the control (AET) therapy. The same techniques, measures, and controls would be used that NMCSD has already put in place to develop VRET for PTSD. Also, a cost-benefit analysis would be used to determine the benefits of VRET.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Static Virtual Reality | Active comparator | Behavioral: Augmented Exposure TherapyExposure Therapy using a still computer image |
| Dynamic Virtual Reality | Experimental | Behavioral: Virtual Reality Exposure Therapy - DynamicVirtual Reality Exposure Therapy using full, immersive Virtual Reality |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Subjects must be eligible to receive care at NMCSD or Camp Pendleton, willing and able to give informed consent, aged 18 to 60, have a PTSD diagnosis from combat operations in Iraq or Afghanistan based on DSM-IV criteria and Clinician Administered PTSD Scale (CAPS) score greater than 40, have an index trauma that occurred in Iraq or Afghanistan, be medically able to tolerate exposure treatment and physically able to don virtual reality headset and physiological monitoring equipment as assed by their medical provider, be willing and able to give up alcohol and/or other intoxicating substances within 12 hours of a VR treatment session, and be able to see, hear, and smell
Key exclusion criteria (1 listed)
- Subjects would be excluded or dropped from the study if they exhibit psychosis, mania, epilepsy, have current suicidal intent, are less than 30 days from a psychiatric hospitalization or suicide attempt, meet criteria for current, active substance dependence, use an intoxicating substance within 12 hours of a treatment session, or have another condition or event that the treating provider or medical monitor consider to be a safety hazard within the study. Subjects may also drop out of the study at any point with the assurance that they will be referred to other care as needed.
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 Exposure Therapy - DynamicAlso: VRE, VRET10 weeks of Virtual Reality Exposure using full, immersive VR | Behavioural | Dynamic Virtual Reality |
| Augmented Exposure TherapyAlso: AET, Static VRE, Prolonged Exposure, PEExposure Therapy augmented with a still computer image | Behavioural | Static Virtual Reality |
Primary outcome
Clinician Administered PSTD Scale (CAPS)
Time frame: Post Tx, and 3 month follow up
7 secondary outcomes
PTSD Checklist, Military Version (PCL-M):
Time frame: Post Tx, and 3 month follow up
The Patient Health Questionnaire 9 (PHQ-9):
Time frame: same
Beck Anxiety Inventory (BAI):
Time frame: same
Behavioral Reactivity Test (BRT)
Time frame: same
Automated Neuropsychological Assessment Metric (ANAM)
Time frame: same
Mini International Neuropsychiatric Interview (MINI)
Time frame: same
Shehan Disability Scale (SDS)
Time frame: same
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jun 2014.
Related trials for Post Traumatic Stress Disorder
Recruiting
NightWare and Cardiovascular Health in Women With PTSD
Post Traumatic Stress Disorder, Cardiovascular Diseases
Not yet recruiting
A Transdiagnostic Sleep Health Intervention for Veterans With PTSD
Stress Disorders, Post-Traumatic, Sleep Initiation and Maintenance Disorders
Not yet recruitingPhase 3
Women Who Are Victims of Violence: Treatment of PTSD Through Reactivation of Traumatic Memories Using Propranolol
Post-Traumatic Stress Disorder, PTSD
RecruitingPhase 4
The Effects of Orexin Antagonism on Fear Extinction in PTSD
Insomnia, PTSD
Recruiting
Advancing Skills Through Consultation, Education, and Novel Technologies
PTSD - Post Traumatic Stress Disorder
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.
Robert N McLay, MD/PhD principal investigator
United States Naval Medical Center, San Diego
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Virtual Reality Exposure Therapy - Dynamic and Augmented Exposure Therapy in people with Post Traumatic Stress Disorder, run by United States Naval Medical Center, San Diego at 2 sites 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 1 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: status not confirmed, as of the sponsor's last update on 30 Jun 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
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 PSTD Scale (CAPS) (time frame: Post Tx, and 3 month follow up). 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 30 Jun 2014.