Implementation of Innovative Treatment for Moral Injury Syndrome: A Hybrid Type 2 Study

Enrolling by invitation · Not applicable

Conditions studied: Moral Injury Syndrome

In brief

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.

Key facts

Study ID

NCT06230887

Run by

VA Office of Research and Development

People needed

200

Starts

2024-07-30

Expected to finish

2028-07-31

Last updated by the study team

2026-07-20

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• (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.

Where it is running

• Central Arkansas Veterans Healthcare System , Little Rock, AR — Little Rock, Arkansas, United States
• Atlanta VA Medical and Rehab Center, Decatur, GA — Decatur, Georgia, United States
• Maine VA Medical Center, Augusta, ME — Augusta, Maine, United States
• Minneapolis VA Health Care System, Minneapolis, MN — Minneapolis, Minnesota, United States
• Michael E. DeBakey VA Medical Center, Houston, TX — Houston, Texas, United States

Full record on ClinicalTrials.gov

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