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

NCT06230887 · Status: ENROLLING_BY_INVITATION · Phase: NA · Type: INTERVENTIONAL · Enrollment: 200

Last updated 2025-07-04

No results posted yet for this study

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

Interventions

BEHAVIORAL

Building Spiritual Strength

Spiritually Integrated group intervention for moral injury

BEHAVIORAL

Present Centered Group Therapy

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

Sponsors & Collaborators

  • VA Central Alabama Health Care System

    collaborator UNKNOWN

  • VA Atlanta Healthcare System

    collaborator UNKNOWN

  • Michael E. DeBakey VA Medical Center

    collaborator FED

  • Minneapolis Veterans Affairs Medical Center

    collaborator FED

  • VA Office of Research and Development

    lead FED

Principal Investigators

  • Jeanette Irene Harris, PhD MS MS · Maine VA Medical Center, Augusta, ME

Study Design

Allocation
RANDOMIZED
Purpose
HEALTH_SERVICES_RESEARCH
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-07-30
Primary Completion
2028-01-01
Completion
2028-07-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06230887 on ClinicalTrials.gov