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

Background: Moral injury syndrome (MIS) consists of the psychological and behavioral sequelae of experiences that challenge moral, spiritual, or values related beliefs. Symptoms of MIS may include hopelessness, helplessness, loss of previously held spiritual beliefs, struggle with a Higher Power, difficulty with forgiveness, lack of meaning or purpose, reduced trust in self or others, or intractable guilt, shame or anger. Individuals managing MIS are up to twice as likely as their peers to consider and attempt suicide, and derive less benefit from psychotherapy. There are few evidence-based interventions for moral injury; one such intervention is a manualized, group intervention called "Building Spiritual Strength (BSS)." In previous randomized controlled trials BSS has been shown to reduce both symptoms of PTSD and spiritual distress.

This clinical trial will be one of the first to measure symptoms of MIS as a primary outcome. Hypotheses are:

1. Compared to Present Centered Group Therapy (PCGT), BSS will significantly decrease symptoms of MIS. 2. Compared to PCGT, BSS will significantly decrease symptoms of PTSD, depression, and suicidal ideation.

Significance: To date there are not standard procedures for assessing and treating MIS, so it is likely that untreated MIS is contributing to poor outcomes, including suicides. Developing an implementation toolkit so that BSS is widely available in VA facilities could reduce the impact of MIS on Veterans' mental health.

Innovation and Impact: To date there have not been funded implementation studies on treatments for MIS in Veterans, and very few VA facilities provide evidence-based care for MIS. This study can clear the way to make evidence-based care for MIS more accessible in the VA system.

Specific Aims:

1. Conduct a mixed methods pre-implementation evaluation to identify barriers and facilitators for BSS implementation at each site, and to develop local implementation strategies. Specific implementation variables assessed, based on the Proctor and EBQI models include acceptability, appropriateness, and feasibility. Specific variables to be assessed will include a) acceptability of BSS to stakeholders, b) available implementation resources, and c) organizational openness to adding a new EBP. 2. Conduct a randomized controlled trial comparing BSS to Present Centered Group Therapy (PCGT) for Veterans who score above cutoff on the Moral Injury Outcomes Scale. Effectiveness and functional outcomes will be informed by the psychospiritual developmental model of MIS. 3. Conduct a mixed methods post-implementation evaluation to compare outcomes across chaplaincy managed vs. mental health managed BSS programs. Proctor model outcomes will include adoption, fidelity, penetration, and sustainability. Specific outcomes related to this framework include a) successful BSS implementation, b) fidelity in implementation of BSS, c) percentage of eligible, referred Veterans who access BSS services, and d) qualitative reports of intent to maintain the BSS program when the study is complete.

Methodology: This will be a type 2 hybrid study, combining pre- and post-implementation evaluations with a randomized clinical trial at 4 culturally diverse VA sites.

Next Steps and Implementation: Data on barriers and facilitators will be used to develop a toolkit and collaborate with study partners at the Office of Mental Health and Suicide Prevention and the National Chaplain Service to develop a national dissemination plan for BSS. The investigators will work with existing clinical staffing at the study sites, so that those sites can continue to provide BSS services after the study. Furthermore, after completing this study, BSS leaders will be qualified to train BSS leaders at other sites, creating resources for training and national dissemination.

• Change in Patient Health Questionnaire-9 [Time frame: 8 weeks (end of treatment) and 20 weeks (long-term follow-up)]
• Change in Sheehan Disability Scale [Time frame: 8 weeks (end of treatment) and 20 weeks (long-term follow-up)]
• Change in Beck Scale for Suicide Ideation [Time frame: 8 weeks (end of treatment) and 20 weeks (long-term follow-up)]
• Change in Reasons for Living Inventory [Time frame: 8 weeks (end of treatment) and 20 weeks (long-term follow-up)]
• PTSD Checklist for DSM-5 [Time frame: 8 weeks (end of treatment) and 20 weeks (long-term follow-up)]
• Client Satisfaction Questionnaire-8 [Time frame: 8 weeks (end of treatment)]
• Psychospiritual Development Scale [Time frame: 8 weeks (end of treatment) and 20 weeks (long-term follow-up)]
• Spiritual Fortitude Questionnaire [Time frame: 8 weeks (end of treatment) and 20 weeks (long-term follow-up)]