Implementation of Innovative Treatment for Moral Injury Syndrome: A Hybrid Type 2 Study
Part of paid clinical trials in Little Rock, Arkansas.
- Sponsor
- VA Office of Research and Development
- Study ID
- NCT06230887
- Status
- Enrolling By Invitation
Conditions
- Moral Injury Syndrome
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - N/A
- Healthy Volunteers
- Not accepted
Interventions
- Building Spiritual Strength — BEHAVIORALSpiritually Integrated group intervention for moral injury
- Present Centered Group Therapy — BEHAVIORALActive control, manualized evidence-based coping skills intervention for PTSD
Study Details
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 Dates
- Start date
- Jul 30, 2024
- Status verified
- Jul 2025
- Primary completion
- Jan 1, 2028
- Completion
- Jul 31, 2028
Study Design
- Enrollment
- 200 participants (estimated)
- Allocation
- RANDOMIZED
- Intervention model
- PARALLEL
- Primary purpose
- HEALTH_SERVICES_RESEARCH
Arms
- Experimental: Building Spiritual StrengthSpiritually integrated group intervention for moral injury.
- Active Comparator: Present Centered Group TherapyCoping strategies group intervention addressing broad spectrum trauma symptoms
Primary Outcome Measure
Change in Moral Injury and Distress Scale [ Time Frame: 8 weeks (end of treatment) and 20 weeks (long-term follow-up) ]
Locations (5)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Central Arkansas Veterans Healthcare System , Little Rock, AR | Little Rock | Arkansas | 72205 | - |
| Atlanta VA Medical and Rehab Center, Decatur, GA | Decatur | Georgia | 30033-4004 | - |
| Maine VA Medical Center, Augusta, ME | Augusta | Maine | 04330 | - |
| Minneapolis VA Health Care System, Minneapolis, MN | Minneapolis | Minnesota | 55417-2309 | - |
| Michael E. DeBakey VA Medical Center, Houston, TX | Houston | Texas | 77030-4211 | - |