NCT02246972

Brief 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. 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. 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. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
15

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started May 2015

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 19, 2014

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 23, 2014

Completed
7 months until next milestone

Study Start

First participant enrolled

May 1, 2015

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2017

Completed
Last Updated

August 9, 2017

Status Verified

August 1, 2017

Enrollment Period

2.2 years

First QC Date

September 19, 2014

Last Update Submit

August 8, 2017

Conditions

TraumaPost-Traumatic Stress Disorder

Keywords

PTSDMilitary sexual traumaVeteransWomen in the militarySexual assault

Outcome Measures

Primary Outcomes (3)

  • 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.

    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.

    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.

    6 months

Study Arms (2)

VRET Immediate treatment

EXPERIMENTAL

Participants will be randomized to receive Virtual Reality Exposure Therapy (VRET) immediately

Behavioral: Virtual Reality Exposure Therapy (VRET)

Waitlist

ACTIVE COMPARATOR

6 weeks standard of care, then Virtual Reality Exposure Therapy (VRET) treatment.

Behavioral: Virtual Reality Exposure Therapy (VRET)

Interventions

Virtual Reality Exposure Therapy (VRET)BEHAVIORAL

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.

Also known as: VRET
VRET Immediate treatmentWaitlist

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Emory University

Atlanta, Georgia, 30322, United States

Location

MeSH Terms

Conditions

Wounds and InjuriesStress Disorders, Post-TraumaticMilitary Sexual Trauma

Interventions

Virtual Reality Exposure Therapy

Condition Hierarchy (Ancestors)

Stress Disorders, TraumaticTrauma and Stressor Related DisordersMental DisordersSexual Trauma

Intervention Hierarchy (Ancestors)

Desensitization, PsychologicBehavior TherapyPsychotherapyBehavioral Disciplines and Activities

Study Officials

  • Barbara O Rothbaum, PhD/ABPP

    Emory University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

September 19, 2014

First Posted

September 23, 2014

Study Start

May 1, 2015

Primary Completion

July 1, 2017

Study Completion

July 1, 2017

Last Updated

August 9, 2017

Record last verified: 2017-08

Locations

US(1)