Innovative Delivery of Evidence Based Psychotherapy to Women With Military Sexual Trauma
Do You Really Expect Me to Get MST Care in a VA Where Everyone is Male? Innovative Delivery of Evidence Based Psychotherapy to Women With Military Sexual Trauma (MST)
1 other identifier
interventional
136
1 country
1
Brief Summary
The purpose of this study is to determine whether a scientifically validated treatment for Posttraumatic Stress Disorder (PTSD) called Prolonged Exposure (PE) can be delivered effectively to Veterans with Military Sexual Trauma (MST) related PTSD using videoconferencing technology, which allows a therapist and patient who are not in the same room as one another to communicate. The investigators are interested in learning if this form of mental health service delivery is an acceptable alternative to traditional face-to-face therapy delivered with the therapist in the same room as the patient. This study is being conducted at the Charleston VA Medical Center and surrounding Community-Based Outpatient Clinics (CBOCs), and will involve approximately 100 female participants.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Aug 2014
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2014
CompletedFirst Submitted
Initial submission to the registry
December 15, 2014
CompletedFirst Posted
Study publicly available on registry
April 15, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 29, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
November 29, 2019
CompletedDecember 24, 2019
December 1, 2019
5.3 years
December 15, 2014
December 23, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Number of Participants Receiving Prolonged Exposure Treatment via Telemedicine with significantly decreased PTSD symptoms Compared to Number of Participants Receiving Prolonged Exposure Treatment with Standard In-Person Delivery
36 weeks
Secondary Outcomes (40)
Veteran (VR) Short Form (SF) -12 Health Survey (VR-12)
Baseline
Veteran (VR) Short Form (SF) -12 Health Survey (VR-12)
13 weeks
Veteran (VR) Short Form (SF) -12 Health Survey (VR-12)
24 weeks
Veteran (VR) Short Form (SF) -12 Health Survey (VR-12)
36 weeks
Index of Functional Impairment (IFI)
Baseline
- +35 more secondary outcomes
Study Arms (2)
PE-HBT
EXPERIMENTALProlonged Exposure via home-based telehealth (i.e., completed using videoconferencing technology)
PE-SD
ACTIVE COMPARATORProlonged Exposure via standard delivery (i.e., completed in person at the therapist's office)
Interventions
Eligibility Criteria
You may qualify if:
- MST-related index event
- Diagnosis of PTSD-related MST
- Female
You may not qualify if:
- Having a household member of spouse who is already enrolled in the study
- Active psychosis or dementia
- Suicidal and/or homicidal ideation with clear intent
- Current substance dependence
- Concurrent enrollment in another clinical trial for PTSD or depression
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Ralph H. Johnson VAMC
Charleston, South Carolina, 29401, United States
Related Publications (1)
Acierno R, Jaffe AE, Gilmore AK, Birks A, Denier C, Muzzy W, Lopez CM, Tuerk P, Grubaugh AL. A randomized clinical trial of in-person vs. home-based telemedicine delivery of Prolonged Exposure for PTSD in military sexual trauma survivors. J Anxiety Disord. 2021 Oct;83:102461. doi: 10.1016/j.janxdis.2021.102461. Epub 2021 Aug 8.
PMID: 34391978DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Ronald E Acierno, PhD
Ralph H. Johnson VA Medical Center
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 15, 2014
First Posted
April 15, 2015
Study Start
August 1, 2014
Primary Completion
November 29, 2019
Study Completion
November 29, 2019
Last Updated
December 24, 2019
Record last verified: 2019-12