Post-Traumatic Stress DisorderPhase 1/2NCT00992953
Virtual Reality (VR) Therapy for Post-Traumatic Stress Disorder (PTSD)
A Phase 1/2 study testing Treatment as Usual in people with Post-Traumatic Stress Disorder, run by Office of Naval Research (ONR) at 2 sites in United States.
Trial summary
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. 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?
- Treatment as Usual
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 136 participants
- Where
- 2 sitesUnited States
- Study dates
- Jan 2005to Oct 2009
- Phase
- Phase 1/2
- 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
- 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
Who cannot join
- Actively suicidal, homicidal, psychotic, or having a diagnosis of alcohol dependence that does not show signs of at least early remission
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Naval Hosptial Camp Pendleton
Camp Pendlton, California, 92134
Naval Medical Center San Diego (NMCSD)
San Diego, California, 92134
About this study
Official title: The Efficacy of Virtual Reality (VR) as an Adjunct Therapy for Acute Combat-related Post-Traumatic Stress Disorder (PTSD) in Non-Combatants
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.
Read the detailed description
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
- Post-Traumatic Stress Disorder
- Being tested
- Treatment as Usual, Virtual Reality Exposure with Stimulus Control
- Keywords
- Virtual Reality, Post Traumatic Stress Disorder, Combat, Military, Major Depressive Disorder, Anxiety, Virtual Reality Exposure with Stimulus Control, Treatment as Usual
- Medical subject headings
- Stress Disorders, Post-Traumatic, Depressive Disorder, Major, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Treatment as UsualBehavioural
Also called TAU
10 weeks of therapy and/or psychiatric medication as available
Virtual Reality Exposure with Stimulus ControlBehavioural
Also called Virtual Reality Gradual Exposure Treatment, VRGET, Virtual Reality Exposure, VRE
10 weeks of therapy, up to twice a week, 90 min sessions involving Virtual Reality Exposure with Stimulus Control
| Study group | Role | What they receive |
|---|---|---|
| Virtual Reality Therapy | Experimental | 10 Weeks of Virtual Reality Exposure with Stimulus Control, with up to twice a week, 90 min sessions Receives: Behavioral: Virtual Reality Exposure with Stimulus Control |
| Treatment As Usual | Active comparator | Traditional Therapy and Psychiatric Medication Receives: Behavioral: Treatment as Usual |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Oct 2009 (estimated)
- Study startJan 2005
- Primary completionOct 2009
- Study completionOct 2009
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 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 136 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Office of Naval Research (ONR)
- Sponsor type
- US federal agency
- Collaborators
- Naval Hospital Camp Pendleton, Virtual Reality Medical Center, United States Naval Medical Center, San Diego
- Investigators
- Brenda Wiederhold, PhD, Principal investigator, Virtual Reality Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00992953
- Sponsor's protocol ID
- S-05-005
- Status last verified
- Oct 2009
- First submitted
- 8 Oct 2009
- Last updated
- 9 Oct 2009
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 9 Oct 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Efficacy of Virtual Reality (VR) as an Adjunct Therapy for Acute Combat-related Post-Traumatic Stress Disorder (PTSD) in Non-Combatants
- ClinicalTrials.gov ID
- NCT00992953
- Acronym / sponsor ID
- S-05-005
- Conditions
- Post-Traumatic Stress Disorder
- Keywords
- Virtual Reality, Post Traumatic Stress Disorder, Combat, Military, Major Depressive Disorder, Anxiety, Virtual Reality Exposure with Stimulus Control, Treatment as Usual
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 136 participants (estimated)
- Lead sponsor
- Office of Naval Research (ONR)US federal agency
- Collaborators
- Naval Hospital Camp Pendleton, Virtual Reality Medical Center, United States Naval Medical Center, San Diego
- Study start
- Jan 2005
- Primary completion
- Oct 2009 (actual)
- Study completion
- Oct 2009 (actual)
- First posted
- 9 Oct 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.
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
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Virtual Reality Therapy | Experimental | Behavioral: Virtual Reality Exposure with Stimulus Control10 Weeks of Virtual Reality Exposure with Stimulus Control, with up to twice a week, 90 min sessions |
| Treatment As Usual | Active comparator | Behavioral: Treatment as UsualTraditional Therapy and Psychiatric Medication |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (1 listed)
- Actively suicidal, homicidal, psychotic, or having a diagnosis of alcohol dependence that does not show signs of at least early remission
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 |
|---|---|---|
| Treatment as UsualAlso: TAU10 weeks of therapy and/or psychiatric medication as available | Behavioural | Treatment As Usual |
| Virtual Reality Exposure with Stimulus ControlAlso: Virtual Reality Gradual Exposure Treatment, VRGET, Virtual Reality Exposure, VRE10 weeks of therapy, up to twice a week, 90 min sessions involving Virtual Reality Exposure with Stimulus Control | Behavioural | Virtual Reality Therapy |
Primary outcome
Not reported in the source record.
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 9 Oct 2009.
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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.
Brenda Wiederhold, PhD principal investigator
Virtual Reality Medical Center
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Treatment as Usual in people with Post-Traumatic Stress Disorder, run by Office of Naval Research (ONR) 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 2 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: finished, as of the sponsor's last update on 9 Oct 2009. 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 combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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.
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 9 Oct 2009.