Clinical trial NCT06230887: Implementation of Innovative Treatment for Moral Injury Syndrome: A Hybrid Type 2 Study
Official title: Implementation of Innovative Treatment for Moral Injury Syndrome: A Hybrid Type 2 Study
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Moral Injury Syndrome
Keywords: Moral Injury
Posttraumatic Stress Disorder
Spirituality
chaplains
Lead sponsor: VA Office of Research and Development
Sponsor class: FED
Collaborators: name: VA Central Alabama Health Care System
name: VA Atlanta Healthcare System
name: Michael E. DeBakey VA Medical Center
name: Minneapolis Veterans Affairs Medical Center
First posted: 2024-01-30
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Participants will be randomized to either the experimental condition (Building Spiritual Strength, an evidence-based, manualized, spiritually integrated group counseling program for moral injury/spiritual distress/values related distress associated with trauma) or the control condition (Present Centered Group Therapy, an evidence-based, manualized group treatment for PTSD.)
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief 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.

Detailed description: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Change in Moral Injury and Distress Scale
timeFrame: 8 weeks (end of treatment) and 20 weeks (long-term follow-up)
measure: Change in Moral Injury Outcomes Scale
timeFrame: 8 weeks (end of treatment) and 20 weeks (long-term follow-up)
measure: Change in Expressions of Moral Injury Scale
timeFrame: 8 weeks (end of treatment) and 20 weeks (long-term follow-up)
measure: Change in Religious and Spiritual Struggles Scale
timeFrame: 8 weeks (end of treatment) and 20 weeks (long-term follow-up)
Secondary outcomes:
measure: Change in Patient Health Questionnaire-9
timeFrame: 8 weeks (end of treatment) and 20 weeks (long-term follow-up)
measure: Change in Sheehan Disability Scale
timeFrame: 8 weeks (end of treatment) and 20 weeks (long-term follow-up)
measure: Change in Inventory of Community Participation
timeFrame: 8 weeks (end of treatment) and 20 weeks (long-term follow-up)
measure: Change in Beck Scale for Suicide Ideation
timeFrame: 8 weeks (end of treatment) and 20 weeks (long-term follow-up)
measure: Change in Reasons for Living Inventory
timeFrame: 8 weeks (end of treatment) and 20 weeks (long-term follow-up)
measure: Change in Multiscale Measure for Postconventional Religious Functioning
timeFrame: 8 weeks (end of treatment) and 20 weeks (long-term follow-up)
measure: Client Satisfaction Questionnaire-8
timeFrame: 8 weeks (end of treatment)
Other outcomes:
Locations:
city: Little Rock
country: United States
facility: Central Arkansas Veterans Healthcare System , Little Rock, AR
state: Arkansas
city: Decatur
country: United States
facility: Atlanta VA Medical and Rehab Center, Decatur, GA
state: Georgia
city: Augusta
country: United States
facility: Maine VA Medical Center, Augusta, ME
state: Maine
city: Minneapolis
country: United States
facility: Minneapolis VA Health Care System, Minneapolis, MN
state: Minnesota
city: Houston
country: United States
facility: Michael E. DeBakey VA Medical Center, Houston, TX
state: Texas
Study officials:
affiliation: Maine VA Medical Center, Augusta, ME
name: Jeanette Irene Harris, PhD MS MS
role: PRINCIPAL_INVESTIGATOR
References: