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 — BEHAVIORAL
    Spiritually Integrated group intervention for moral injury
  • Present Centered Group Therapy — BEHAVIORAL
    Active 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 Strength
    Spiritually integrated group intervention for moral injury.
  • Active Comparator: Present Centered Group Therapy
    Coping 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)

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