Status:
COMPLETED
A Novel Posttraumatic Stress Disorder Treatment for Veterans With Moral Injury
Lead Sponsor:
VA Office of Research and Development
Conditions:
Moral Injury
Eligibility:
All Genders
18-82 years
Phase:
NA
Brief Summary
The objective of this project is to test the efficacy of an individual treatment for post-traumatic stress disorder (PTSD) stemming from moral injury called Impact of Killing (IOK), compared to a pres...
Detailed Description
Post-traumatic stress disorder (PTSD) is now the most common mental health diagnosis among the youngest generation of Veterans receiving treatment from the Veterans Health Administration (VHA), necess...
Eligibility Criteria
Inclusion
- Veterans 18-82 years of age
- Veterans who meet Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) criteria for Post-traumatic Stress Disorder (PTSD) or score 23 or higher on the Clinician-Administered PTSD Scale for DSM-5 (CAPS) screening interview.
- Veterans who endorsed killing or being responsible for the death of another in a war zone and report continued distress regarding these events
- Distress will be operationalized by a positive response to one or more of the nine self-directed moral injury items on the Expressions of Moral Injury Scale-Military Version (EMIS-M) or item #4 on the Moral Injury Events Scale (MIES)
- Veterans who have initiated or completed an evidence-based treatment for PTSD, such as Cognitive Processing Therapy (CPT) or Prolonged Exposure (PE)
- If receiving CPT or PE, Veterans must complete treatment and wait two weeks prior to screening
- If receiving prescription medication for PTSD, Veterans must be one month stable on medication and not make any changes to medication during the course of the active treatment phase of the study
Exclusion
- Veterans with current or lifetime diagnosis of a psychotic disorder or current untreated/unmanaged mania.
- Veterans with recent suicidal or homicidal behaviors (chronic suicidal ideation is not exclusionary)
- Veterans with recent psychiatric hospitalizations
- Veterans with moderate or severe alcohol or drug dependence within the past three months
- Veterans receiving individual therapy for PTSD or those planning to start skills-based or trauma-focused group psychotherapy will be excluded
- However, these Veterans will be offered the opportunity to be screened again after completion of individual PTSD therapy or once they are three months stable in group treatment, with no plans to discontinue this treatment
Key Trial Info
Start Date :
August 12 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 31 2024
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT03764033
Start Date
August 12 2019
End Date
December 31 2024
Last Update
November 20 2025
Active Locations (3)
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1
San Francisco VA Medical Center, San Francisco, CA
San Francisco, California, United States, 94121-1563
2
James J. Peters VA Medical Center, Bronx, NY
The Bronx, New York, United States, 10468
3
Durham VA Medical Center, Durham, NC
Durham, North Carolina, United States, 27705