TraumaPhase 2NCT02246972
BraveMind: Advancing the Virtual Iraq/Afghanistan PTSD Exposure Therapy
A Phase 2 study testing Virtual Reality Exposure Therapy (VRET) in people with Trauma and Post-Traumatic Stress Disorder, run by Emory University at 1 site in United States.
Trial summary
The proposed study is designed to test the clinical efficacy of the BRAVEMIND military sexual trauma (MST) system in an initial feasibility and wait list clinical trial of 45 users. The following hypotheses will be tested: 1. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Trauma, Post-Traumatic Stress Disorder
- What is being tested?
- Virtual Reality Exposure Therapy (VRET)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteUnited States
- Study dates
- May 2015to Jul 2017
- Phase
- Phase 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
- Participants will be 45 males and females between ages of 18 and 65
- Participants must meet DSM-V criteria for PTSD due to military sexual trauma (MST)
- Patients must be literate in English
- Patients must be medically stable
- Participants must comprehend his or her role in the study and the risks involved
Who cannot join
- Patients with a history of mania, schizophrenia, or other psychoses
- Patients with active suicidal risk
- Patients with current alcohol or drug dependence
- Patients unable to wear the VR head mounted display
- Patients on psychotropic medications must have been on a stable dose for at least 2 months prior to beginning the study and must agree not to change their current medication regimen throughout the course of the study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: BRAVEMIND: Advancing the Virtual Iraq/Afghanistan PTSD Exposure Therapy System for MST
The proposed study is designed to test the clinical efficacy of the BRAVEMIND military sexual trauma (MST) system in an initial feasibility and wait list clinical trial of 45 users.
The following hypotheses will be tested:
- Virtual Reality Exposure Therapy (VRET) will be safely deliverable to persons with posttraumatic stress disorder (PTSD) due to MST as evidenced by treatment dropout rates that are similar to existing Prolonged Exposure (PE) therapy delivered in military samples (20-40%) and by the absence of any critical incidents.
- Participants in the VRET group will show statistically and clinically meaningful reductions in PTSD and depression (PTSD Checklist-Military (PCL-M), Clinician Administered PTSD Scale (CAPS), and Patient Health Questionnaire (PHQ-9) scores and psychophysiological measures) following treatment.
- Participants in the VRET group will show statistically and clinically meaningful reductions in PTSD and depression (PCL-M, CAPS, PHQ-9 scores and psychophysiological measures) compared to wait-list results.
Read the detailed description
Pre-Treatment Assessment:
Potential subjects will be asked to provide a copy of their DD214 to verify their military service record. Once a potential participant has met all screening inclusion and exclusion criteria and consented to participate, the CAPS will be administered to determine current PTSD status.
Randomization:
Following pre-treatment assessment, patients will be randomized to receive VRET (Virtual Reality Exposure Therapy) immediately or wait 6 weeks during which time they will continue to receive usual care. Wait-listed participants will be reassessed prior to beginning their course of treatment with the Clinician Administered PTSD Scale (CAPS), PTSD Checklist-Military (PCL-M), Beck Depression Inventory-II (BDI-II), and psychophysiological measures. This pre-treatment assessment visit will last about 2-3 hours.
Therapy:
Participants will be treated once or twice per week for 6-12 sessions. VRET treatment will be limited to a minimum of 6 sessions and a maximum of 12 sessions, based upon reaching criterion of 70% symptom improvement as indicated on the PCL-M from baseline or an agreement between clinician and participant that maximum treatment response has been achieved. All sessions will be individual and weekly or twice weekly. The first session will last approximately 90 minutes and will be spent in information gathering, treatment planning, and explaining the treatment rationale to the patient. Information gathering will review the history of PTSD and their military service and will include a brief psychosocial history, including review of prior treatment.
Session 2 will discuss in vivo exposure and construct the hierarchy for in vivo exposure. The VRET sessions will last 90 minutes each. During VRET sessions patients will wear a head-mounted display with stereo earphones that will provide visual and audio cues consistent with Iraqi or Afghan military scenarios or other base-related scenarios as appropriate for the individual patient. The therapist will make appropriate comments and encourage continued exposure to the identified index trauma until anxiety has habituated. During exposure, information will be gathered on the participant's anxiety level through the use of a 0-100 Subjective Units of Discomfort (SUDs) scale. All therapists will have been trained in Prolonged Imaginal Exposure therapy (PE) followed by training in VRET by Drs. Rothbaum and Gerardi. Drs. Rothbaum and Gerardi will supervise all therapy.
- Conditions
- Trauma, Post-Traumatic Stress Disorder
- Being tested
- Virtual Reality Exposure Therapy (VRET)
- Keywords
- PTSD, Military sexual trauma, Veterans, Women in the military, Sexual assault
- Medical subject headings
- Wounds and Injuries, Stress Disorders, Post-Traumatic, Military Sexual Trauma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Virtual Reality Exposure Therapy (VRET)Behavioural
Also called VRET
6 to 12 90-minute individual treatment sessions. During VRET sessions patients will wear a head-mounted display with stereo earphones that will provide visual and audio cues consistent with Iraqi or Afghan military scenarios or other base-related scenarios as appropriate for the individual patient.
| Study group | Role | What they receive |
|---|---|---|
| VRET Immediate treatment | Experimental | Participants will be randomized to receive Virtual Reality Exposure Therapy (VRET) immediately Receives: Behavioral: Virtual Reality Exposure Therapy (VRET) |
| Waitlist | Active comparator | 6 weeks standard of care, then Virtual Reality Exposure Therapy (VRET) treatment. Receives: Behavioral: Virtual Reality Exposure Therapy (VRET) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safely deliverable
Treatment dropout rates that are similar to existing PE delivered in military samples (20-40%) and by the absence of any critical incidents.
Measured: 2 years
Reduction in PTSD and depression
Participants in the VRET group will show statistically and clinically meaningful reductions in PTSD and depression (PCL-M, CAPS, PHQ-9 scores and psychophysiological measures) following treatment.
Measured: 3 months
Reduction in PTSD and depression: wait-list comparator
Participants in the VRET group will show statistically and clinically meaningful reductions in PTSD and depression (PCL-M, CAPS, PHG-9 scores and psychophysiological measures) compared to wait-list results.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Sep 2014 (estimated)
- Study startMay 2015
- Primary completionJul 2017
- Study completionJul 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for TraumaStudies of the same condition, open and under way.
- More trials run by Emory UniversityThe sponsor's other registered studies.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Emory University
- Sponsor type
- University, hospital or other
- Collaborators
- Telemedicine & Advanced Technology Research Center, University of Southern California
- Responsible party
- Principal investigator, Barbara O. Rothbaum, PhD, Emory University
- Investigators
- Barbara O Rothbaum, PhD/ABPP, Principal investigator, Emory University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02246972
- Sponsor's protocol ID
- IRB00072196
- Status last verified
- Aug 2017
- First submitted
- 19 Sep 2014
- Last updated
- 9 Aug 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- BRAVEMIND: Advancing the Virtual Iraq/Afghanistan PTSD Exposure Therapy System for MST
- ClinicalTrials.gov ID
- NCT02246972
- Acronym / sponsor ID
- IRB00072196
- Conditions
- Trauma, Post-Traumatic Stress Disorder
- Keywords
- PTSD, Military sexual trauma, Veterans, Women in the military, Sexual assault
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Emory UniversityUniversity, hospital or other
- Collaborators
- Telemedicine & Advanced Technology Research Center, University of Southern California
- Study start
- May 2015
- Primary completion
- Jul 2017 (actual)
- Study completion
- Jul 2017 (actual)
- First posted
- 23 Sep 2014 (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.
The proposed study is designed to test the clinical efficacy of the BRAVEMIND military sexual trauma (MST) system in an initial feasibility and wait list clinical trial of 45 users.
The following hypotheses will be tested:
- Virtual Reality Exposure Therapy (VRET) will be safely deliverable to persons with posttraumatic stress disorder (PTSD) due to MST as evidenced by treatment dropout rates that are similar to existing Prolonged Exposure (PE) therapy delivered in military samples (20-40%) and by the absence of any critical incidents.
- Participants in the VRET group will show statistically and clinically meaningful reductions in PTSD and depression (PTSD Checklist-Military (PCL-M), Clinician Administered PTSD Scale (CAPS), and Patient Health Questionnaire (PHQ-9) scores and psychophysiological measures) following treatment.
- Participants in the VRET group will show statistically and clinically meaningful reductions in PTSD and depression (PCL-M, CAPS, PHQ-9 scores and psychophysiological measures) compared to wait-list results.
Detailed description
Pre-Treatment Assessment:
Potential subjects will be asked to provide a copy of their DD214 to verify their military service record. Once a potential participant has met all screening inclusion and exclusion criteria and consented to participate, the CAPS will be administered to determine current PTSD status.
Randomization:
Following pre-treatment assessment, patients will be randomized to receive VRET (Virtual Reality Exposure Therapy) immediately or wait 6 weeks during which time they will continue to receive usual care. Wait-listed participants will be reassessed prior to beginning their course of treatment with the Clinician Administered PTSD Scale (CAPS), PTSD Checklist-Military (PCL-M), Beck Depression Inventory-II (BDI-II), and psychophysiological measures. This pre-treatment assessment visit will last about 2-3 hours.
Therapy:
Participants will be treated once or twice per week for 6-12 sessions. VRET treatment will be limited to a minimum of 6 sessions and a maximum of 12 sessions, based upon reaching criterion of 70% symptom improvement as indicated on the PCL-M from baseline or an agreement between clinician and participant that maximum treatment response has been achieved. All sessions will be individual and weekly or twice weekly. The first session will last approximately 90 minutes and will be spent in information gathering, treatment planning, and explaining the treatment rationale to the patient. Information gathering will review the history of PTSD and their military service and will include a brief psychosocial history, including review of prior treatment.
Session 2 will discuss in vivo exposure and construct the hierarchy for in vivo exposure. The VRET sessions will last 90 minutes each. During VRET sessions patients will wear a head-mounted display with stereo earphones that will provide visual and audio cues consistent with Iraqi or Afghan military scenarios or other base-related scenarios as appropriate for the individual patient. The therapist will make appropriate comments and encourage continued exposure to the identified index trauma until anxiety has habituated. During exposure, information will be gathered on the participant's anxiety level through the use of a 0-100 Subjective Units of Discomfort (SUDs) scale. All therapists will have been trained in Prolonged Imaginal Exposure therapy (PE) followed by training in VRET by Drs. Rothbaum and Gerardi. Drs. Rothbaum and Gerardi will supervise all therapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| VRET Immediate treatment | Experimental | Behavioral: Virtual Reality Exposure Therapy (VRET)Participants will be randomized to receive Virtual Reality Exposure Therapy (VRET) immediately |
| Waitlist | Active comparator | Behavioral: Virtual Reality Exposure Therapy (VRET)6 weeks standard of care, then Virtual Reality Exposure Therapy (VRET) treatment. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Participants will be 45 males and females between ages of 18 and 65
- Participants must meet DSM-V criteria for PTSD due to military sexual trauma (MST)
- Patients must be literate in English
- Patients must be medically stable
- Participants must comprehend his or her role in the study and the risks involved
Key exclusion criteria (5 listed)
- Patients with a history of mania, schizophrenia, or other psychoses
- Patients with active suicidal risk
- Patients with current alcohol or drug dependence
- Patients unable to wear the VR head mounted display
- Patients on psychotropic medications must have been on a stable dose for at least 2 months prior to beginning the study and must agree not to change their current medication regimen throughout the course of the study
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 (VRET)Also: VRET6 to 12 90-minute individual treatment sessions. During VRET sessions patients will wear a head-mounted display with stereo earphones that will provide visual and audio cues consistent with Iraqi or Afghan military scenarios or other base-related scenarios as appropriate for the individual patient. | Behavioural | VRET Immediate treatment, Waitlist |
Primary outcome
Safely deliverable
Time frame: 2 years
Treatment dropout rates that are similar to existing PE delivered in military samples (20-40%) and by the absence of any critical incidents.
Reduction in PTSD and depression
Time frame: 3 months
Participants in the VRET group will show statistically and clinically meaningful reductions in PTSD and depression (PCL-M, CAPS, PHQ-9 scores and psychophysiological measures) following treatment.
Reduction in PTSD and depression: wait-list comparator
Time frame: 6 months
Participants in the VRET group will show statistically and clinically meaningful reductions in PTSD and depression (PCL-M, CAPS, PHG-9 scores and psychophysiological measures) compared to wait-list results.
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 Aug 2017.
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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.
Barbara O Rothbaum, PhD/ABPP principal investigator
Emory University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Virtual Reality Exposure Therapy (VRET) in people with Trauma and Post-Traumatic Stress Disorder, run by Emory University 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 5 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 9 Aug 2017. 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.
What does this phase mean?
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.
What does the primary outcome measure?
Safely deliverable (time frame: 2 years). The study lists 3 primary outcomes in all. 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 9 Aug 2017.