Implementation of Innovative Treatment for Moral Injury Syndrome: A Hybrid Type 2 Study (NCT06230887) | Clinical Trial Compass
By InvitationNot Applicable
Implementation of Innovative Treatment for Moral Injury Syndrome: A Hybrid Type 2 Study
United States200 participantsStarted 2024-07-30
Plain-language summary
Moral Injury Syndrome (MIS) affects up to 35-60% of Veterans managing combat-related PTSD; it results from experiences that challenge deeply held values or spiritual beliefs. Symptoms of MIS may include hopelessness, helplessness, loss of spiritual beliefs, difficulty with forgiveness, loss of meaning or purpose, reduced trust in self or others, or intractable guilt, shame or anger.
Veterans managing MIS have difficulty responding to mental health treatment, and are at increased risk for suicide ideation or attempts. To date evidence-based interventions for MIS are not widely available in VA. This study will implement an evidence-based intervention for MIS in four VA facilities, collect data on the effectiveness of the intervention, and develop an implementation toolkit. This data will inform national dissemination in collaboration with the Office of Mental Health and Suicide Prevention and the National Chaplain Service.
Who can participate
Age range
18 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:
Veteran status and:
* (a) validation of any of the first three items on the Moral Injury and Distress Scale, which is consistent with probable MIS
* (b) willingness to be randomized to either treatment condition
* (c) stability on mental health medications for at least 8 weeks
* (d) age of 18 years or older
Exclusion Criteria:
* (a) insufficient capacity to consent
* (b) active psychosis or substance use at levels that would interfere with treatment, assessed via chart review, the Alcohol Use Disorders Identification Test - Concise (AUDIT-C) score, and the Mini International Neuropsychiatric Interview (MINI)
* (c) currently involved in evidence-based psychotherapy for MIS, or evidence-based psychotherapy for PTSD, assessed via chart review and intake interview
* (d) managing any severe psychopathology that, in the opinion of the investigative team, requires immediate clinical attention, such as imminent suicide risk, assessed via the MINI and supplemental homicide risk questions.
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
Change in Moral Injury and Distress Scale
Timeframe: 8 weeks (end of treatment) and 20 weeks (long-term follow-up)
2
Change in Moral Injury Outcomes Scale
Timeframe: 8 weeks (end of treatment) and 20 weeks (long-term follow-up)
3
Change in Expressions of Moral Injury Scale
Timeframe: 8 weeks (end of treatment) and 20 weeks (long-term follow-up)
4
Change in Religious and Spiritual Struggles Scale
Timeframe: 8 weeks (end of treatment) and 20 weeks (long-term follow-up)