A Novel Posttraumatic Stress Disorder Treatment for Veterans With Moral Injury (NCT03764033) | Clinical Trial Compass
CompletedNot Applicable
A Novel Posttraumatic Stress Disorder Treatment for Veterans With Moral Injury
United States100 participantsStarted 2019-08-12
Plain-language 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 present-centered therapy (PCT) control condition, and to determine the rehabilitative utility of IOK for Veterans with PTSD. The first aim is to test whether IOK can help improve psychosocial functioning for Veterans, as well as PTSD symptoms. The second aim is to determine whether IOK gains made by Veterans in treatment are durable, as measured by a six-month follow-up assessment. Veterans who kill in war are at increased risk for functional difficulties, PTSD, alcohol abuse, and suicide. Even after current PTSD psychotherapies, most Veterans continue to meet diagnostic criteria for PTSD, highlighting the need for expanding treatments for PTSD and functioning. IOK is a treatment that can be provided following existing PTSD treatments, filling a critical gap for Veterans with moral injury who continue to suffer from mental health symptoms and functional difficulties.
Who can participate
Age range
18 Years – 82 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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 Criteria:
* 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 mo…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
World Health Organization Quality of Life-BREF
Timeframe: Change from baseline (Week 0) and post-treatment (Week 11)
2
World Health Organization Quality of Life-BREF
Timeframe: Change from post-treatment (Week 11) to 6 month follow-up (6 months after post-treatment)