BraveMind: Advancing the Virtual Iraq/Afghanistan PTSD Exposure Therapy

August 8, 2017 updated by: Barbara O. Rothbaum, PhD, Emory University

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:

  1. 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.
  2. 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.
  3. 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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

15

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Georgia
      • Atlanta, Georgia, United States, 30322
        • Emory University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: VRET Immediate treatment
Participants will be randomized to receive Virtual Reality Exposure Therapy (VRET) immediately
Behavioral: Virtual Reality Exposure Therapy (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.
Other Names:
  • VRET
Active Comparator: Waitlist
6 weeks standard of care, then Virtual Reality Exposure Therapy (VRET) treatment.
Behavioral: Virtual Reality Exposure Therapy (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.
Other Names:
  • VRET

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
2 years
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.
3 months
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.
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Emory University

Collaborators

University of Southern California
Telemedicine & Advanced Technology Research Center

Investigators

  • Principal Investigator: Barbara O Rothbaum, PhD/ABPP, Emory University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2015

Primary Completion (Actual)

July 1, 2017

Study Completion (Actual)

July 1, 2017

Study Registration Dates

First Submitted

September 19, 2014

First Submitted That Met QC Criteria

September 19, 2014

First Posted (Estimate)

September 23, 2014

Study Record Updates

Last Update Posted (Actual)

August 9, 2017

Last Update Submitted That Met QC Criteria

August 8, 2017

Last Verified

August 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRB00072196

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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