PTSDVRETNCT03000478
Virtual Reality Exposure Therapy for Combat
A study testing Prolonged Exposure and Virtual Reality Exposure Therapy in people with PTSD, run by Bar-Ilan University, Israel at 1 site in Israel.
Trial summary
This non inferiority trial will compare Prolonged Exposure with Virtual Reality Exposure Therapy in adult patients with combat related PTSD. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- PTSD
- What is being tested?
- Prolonged Exposure and Virtual Reality Exposure Therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteIsrael
- Study dates
- Dec 2016to Jan 2019
- 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 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- combat related PTSD; Hebrew first language
Who cannot join
- suicidality, other psychiatric diagnosis requiring treatment, concurrent treatment,
Trial locations and contacts
1 site in 1 country.
Israel1 site, 1 recruiting
- Recruiting
Bar Ilan University
Ramat Gan, 52900
Sara Freedman, PhD, 544704636, sarafreedman@gmail.com
About this study
Official title: Virtual Reality Treatment for Combat Related PTSD: Is Virtual Azza More Effective Than Traditional Exposure Treatment?
This non inferiority trial will compare Prolonged Exposure with Virtual Reality Exposure Therapy in adult patients with combat related PTSD.
Read the detailed description
Posttraumatic stress disorder (PTSD) affects a significant number of combat soldiers, with some studies suggesting 20% have PTSD. PTSD is related to a number of other detrimental effects, on the individual, such as mood disorders and alcohol abuse, on family members, and on society at large. Although effective treatments for PTSD exist, primarily types of cognitive behavior therapy, their uptake is very low. Studies have shown that a variety of factors act as barriers to care. These include not having the time for therapy, no therapy being locally available, and general stigma about therapy. In military populations, this stigma includes worries about the attitudes of unit members and commanding officers. As a result, many combat veterans do not seek therapy. Recently, it has been suggested that providing therapy in non-conventional settings might overcome some of these barriers. Studies over the last decade have shown that using Virtual Reality is a potential option. Virtual reality is a computer based environment that allows the therapist complete control over its multimedia components. VR is easily adaptable to exposure based treatments, where patients gradually come into contact with feared situations. VR for PTSD following combat, terror and motor vehicle accidents have all shown to be effective treatments. The studies so far are few, involve a small number of patients, and have often not adhered to gold standards of controlled trials. In addition, VR for combat in Israel has never been developed or tested.
The current study is a randomized controlled trial, that will compare traditional face-to-face treatment with Virtual Reality, for combat related PTSD. Blind assessors will examine levels of PTSD and other disorders before treatment, immediately after treatment, and at 6 month follow up.
- Conditions
- PTSD
- Being tested
- Prolonged Exposure, Virtual Reality Exposure Therapy
- 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.
Prolonged ExposureBehavioural
Virtual Reality Exposure TherapyBehavioural
| Study group | Role | What they receive |
|---|---|---|
| Prolonged Exposure | Active comparator | 12 sessions of PE as per protocol Receives: Behavioral: Prolonged Exposure |
| VRET | Experimental | 12 sessions of Virtual Reality Exposure Therapy Receives: Behavioral: Virtual Reality Exposure Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
PTSD symptoms
PTSD as measured by the CAPS
Measured: 6 months post treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Dec 2016 (estimated)
- Study startDec 2016
- Primary completionDec 2018 (estimated)
- Study completionJan 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PTSDStudies 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
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Bar-Ilan University, Israel
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sara Freedman, Bar-Ilan University, Israel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03000478
- Sponsor's protocol ID
- BIU201216
- Acronym
- VRET
- Status last verified
- Feb 2018
- First submitted
- 20 Dec 2016
- Last updated
- 19 Feb 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Virtual Reality Treatment for Combat Related PTSD: Is Virtual Azza More Effective Than Traditional Exposure Treatment?
- ClinicalTrials.gov ID
- NCT03000478
- Acronym / sponsor ID
- VRET / BIU201216
- Conditions
- PTSD
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Bar-Ilan University, IsraelUniversity, hospital or other
- Study start
- Dec 2016
- Primary completion
- Dec 2018 (estimated)
- Study completion
- Jan 2019 (estimated)
- First posted
- 22 Dec 2016 (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.
This non inferiority trial will compare Prolonged Exposure with Virtual Reality Exposure Therapy in adult patients with combat related PTSD.
Detailed description
Posttraumatic stress disorder (PTSD) affects a significant number of combat soldiers, with some studies suggesting 20% have PTSD. PTSD is related to a number of other detrimental effects, on the individual, such as mood disorders and alcohol abuse, on family members, and on society at large. Although effective treatments for PTSD exist, primarily types of cognitive behavior therapy, their uptake is very low. Studies have shown that a variety of factors act as barriers to care. These include not having the time for therapy, no therapy being locally available, and general stigma about therapy. In military populations, this stigma includes worries about the attitudes of unit members and commanding officers. As a result, many combat veterans do not seek therapy. Recently, it has been suggested that providing therapy in non-conventional settings might overcome some of these barriers. Studies over the last decade have shown that using Virtual Reality is a potential option. Virtual reality is a computer based environment that allows the therapist complete control over its multimedia components. VR is easily adaptable to exposure based treatments, where patients gradually come into contact with feared situations. VR for PTSD following combat, terror and motor vehicle accidents have all shown to be effective treatments. The studies so far are few, involve a small number of patients, and have often not adhered to gold standards of controlled trials. In addition, VR for combat in Israel has never been developed or tested.
The current study is a randomized controlled trial, that will compare traditional face-to-face treatment with Virtual Reality, for combat related PTSD. Blind assessors will examine levels of PTSD and other disorders before treatment, immediately after treatment, and at 6 month follow up.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Prolonged Exposure | Active comparator | Behavioral: Prolonged Exposure12 sessions of PE as per protocol |
| VRET | Experimental | Behavioral: Virtual Reality Exposure Therapy12 sessions of Virtual Reality Exposure Therapy |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- combat related PTSD; Hebrew first language
Key exclusion criteria (1 listed)
- suicidality, other psychiatric diagnosis requiring treatment, concurrent treatment,
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 |
|---|---|---|
| Prolonged Exposure | Behavioural | Prolonged Exposure |
| Virtual Reality Exposure Therapy | Behavioural | VRET |
Primary outcome
PTSD symptoms
Time frame: 6 months post treatment
PTSD as measured by the CAPS
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Feb 2018.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Prolonged Exposure and Virtual Reality Exposure Therapy in people with PTSD, run by Bar-Ilan University, Israel at 1 site in Israel.
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 19 Feb 2018. 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 Israel. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Sara Freedman, PhD (544704636, sarafreedman@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
PTSD symptoms (time frame: 6 months post treatment). 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 19 Feb 2018; AzTrials last refreshed its copy on 1 Nov 2026.