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BraveMind: Advancing the Virtual Iraq/Afghanistan PTSD Exposure Therapy

This study is currently recruiting participants. (see Contacts and Locations)
Verified January 2017 by Emory University
Sponsor:
Collaborators:
Telemedicine & Advanced Technology Research Center
University of Southern California
Information provided by (Responsible Party):
Barbara O. Rothbaum, PhD, Emory University
ClinicalTrials.gov Identifier:
NCT02246972
First received: September 19, 2014
Last updated: January 12, 2017
Last verified: January 2017
  Purpose

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.

Condition Intervention Phase
Trauma
Post-Traumatic Stress Disorder
Behavioral: Virtual Reality Exposure Therapy (VRET)
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: BRAVEMIND: Advancing the Virtual Iraq/Afghanistan PTSD Exposure Therapy System for MST

Further study details as provided by Emory University:

Primary Outcome Measures:
  • 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.


Estimated Enrollment: 45
Study Start Date: May 2015
Estimated Study Completion Date: June 2017
Estimated Primary Completion Date: June 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: 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 Name: VRET

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.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02246972

Contacts
Contact: Laura Loucks, PhD 404-712-9788 lloucks@emory.edu
Contact: Robin E Gross 404-727-3662 regross@emory.edu

Locations
United States, Georgia
Emory University Recruiting
Atlanta, Georgia, United States, 30322
Contact: Robin Gross    404-727-3662    regross@emory.edu   
Contact: Kathryn Breazeale       kbreaze@emory.edu   
Principal Investigator: Barbara O Rothbaum, PhD/ABPP         
Sponsors and Collaborators
Emory University
Telemedicine & Advanced Technology Research Center
University of Southern California
Investigators
Principal Investigator: Barbara O Rothbaum, PhD/ABPP Emory University
  More Information

Responsible Party: Barbara O. Rothbaum, PhD, Professor, Emory University
ClinicalTrials.gov Identifier: NCT02246972     History of Changes
Other Study ID Numbers: IRB00072196
Study First Received: September 19, 2014
Last Updated: January 12, 2017

Keywords provided by Emory University:
PTSD
Military sexual trauma
Veterans
Women in the military
Sexual assault

Additional relevant MeSH terms:
Stress Disorders, Traumatic
Stress Disorders, Post-Traumatic
Trauma and Stressor Related Disorders
Mental Disorders

ClinicalTrials.gov processed this record on April 21, 2017