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

NCT06230887 | Enrolling By Invitation DMC

• 1 other identifier: IIR 22-132
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 5

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.

Conditions

Moral Injury Syndrome

Keywords

Moral Injury; Posttraumatic Stress Disorder; Spirituality; chaplains

Outcome Measures

Primary Outcomes (4)

• Change in Moral Injury and Distress Scale

  Full Scale Name: Moral Injury and Distress Scale Score Range: 0-90, with higher scores indicating more symptoms.

  8 weeks (end of treatment) and 20 weeks (long-term follow-up)

• Change in Moral Injury Outcomes Scale

  Full Scale Name: Moral Injury and Distress Scale Score Range: 0-56, with higher scores indicating more symptoms.

  8 weeks (end of treatment) and 20 weeks (long-term follow-up)

• Change in Expressions of Moral Injury Scale

  Full Scale Name: Expressions of Moral Injury Scale Score Range: 10-100, with higher scores indicating more symptoms.

  8 weeks (end of treatment) and 20 weeks (long-term follow-up)

• Change in Religious and Spiritual Struggles Scale

  Full Scale Name: Religions and Spiritual Struggles Scale Score Range: 0=4 with higher scores indicating more symptoms

  8 weeks (end of treatment) and 20 weeks (long-term follow-up)

Secondary Outcomes (7)

• Change in Patient Health Questionnaire-9

  8 weeks (end of treatment) and 20 weeks (long-term follow-up)

• Change in Sheehan Disability Scale

  8 weeks (end of treatment) and 20 weeks (long-term follow-up)

• Change in Inventory of Community Participation

  8 weeks (end of treatment) and 20 weeks (long-term follow-up)

• Change in Beck Scale for Suicide Ideation

  8 weeks (end of treatment) and 20 weeks (long-term follow-up)

• Change in Reasons for Living Inventory

  8 weeks (end of treatment) and 20 weeks (long-term follow-up)

Study Arms (2)

Building Spiritual Strength

EXPERIMENTAL

Spiritually integrated group intervention for moral injury.

Behavioral: Building Spiritual Strength

Present Centered Group Therapy

ACTIVE COMPARATOR

Coping strategies group intervention addressing broad spectrum trauma symptoms

Behavioral: Present Centered Group Therapy

Interventions

Building Spiritual Strength BEHAVIORAL

Spiritually Integrated group intervention for moral injury

Building Spiritual Strength

Present Centered Group Therapy BEHAVIORAL

Active control, manualized evidence-based coping skills intervention for PTSD

Present Centered Group Therapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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.

Sponsors & Collaborators

• VA Office of Research and Development: lead
• VA Central Alabama Health Care System: collaborator
• VA Atlanta Healthcare System: collaborator
• Michael E. DeBakey VA Medical Center: collaborator
• Minneapolis Veterans Affairs Medical Center: collaborator

Study Sites (5)

Central Arkansas Veterans Healthcare System , Little Rock, AR

Little Rock, Arkansas, 72205, United States

Location

Atlanta VA Medical and Rehab Center, Decatur, GA

Decatur, Georgia, 30033-4004, United States

Location

Maine VA Medical Center, Augusta, ME

Augusta, Maine, 04330, United States

Location

Minneapolis VA Health Care System, Minneapolis, MN

Minneapolis, Minnesota, 55417-2309, United States

Location

Michael E. DeBakey VA Medical Center, Houston, TX

Houston, Texas, 77030-4211, United States

Location

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic

Condition Hierarchy (Ancestors)

Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders

Study Officials

• Jeanette Irene Harris, PhD MS MS

  Maine VA Medical Center, Augusta, ME

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Outcomes assessor will not have access to shared files, and will not be at any team meetings in which individual participants are discussed, so she will not know to what condition the participants have been assigned.
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: SPONSOR

Model Details: 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.)

Study Record Dates

• First Submitted: January 19, 2024
• First Posted: January 30, 2024
• Study Start: July 30, 2024
• Primary Completion (Estimated): January 1, 2028
• Study Completion (Estimated): July 31, 2028
• Last Updated: July 4, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: Study protocols will be shared across all sites in preparation for data collection across sites; individual sites will not be permitted to collect any data until they have met with lead site personnel in Maine for instruction and review of study procedures. The independent evaluator will be located in Maine; other sites will be expected to transmit IPD for participants scheduled for assessments within the 14 days preceding anticipated date of assessment. Data analysis will take place in Little Rock. When data collected at each individual site is complete for each Aim, the site will transmit their data to the lead statistician in Little Rock. The lead statistician may or may not transmit part or all of the data to the assistant statistician in Maine for assistance with the analysis.
• Access Criteria: Only the study team will have access to this data during the study. Should the investigators receive a request for access to the data after the completion of the study, the investigators will consult with the IRB and the Privacy Officer, and if approved, share a de-identified data set as needed for verification of the research.

Locations

US (5)