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Search / Trial NCT06230887

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

Launched by VA OFFICE OF RESEARCH AND DEVELOPMENT · Jan 19, 2024

Trial Information

Current as of September 12, 2025

Enrolling by invitation

Keywords

Moral Injury Posttraumatic Stress Disorder Spirituality Chaplains

ClinConnect Summary

This study tests two group therapies for Moral Injury Syndrome (MIS) in Veterans. MIS is distress that can happen after war experiences that clash with personal beliefs or spiritual values. The researchers are comparing Building Spiritual Strength (BSS), a spiritual, manualized group program designed for MIS, with Present Centered Group Therapy (PCGT), a standard PTSD-focused coping-skills group. Participants are randomly assigned to one of the two therapies and attend sessions for about 8 weeks, with follow-up assessments at 20 weeks to see how MIS and related symptoms change over time. The study uses questionnaires to measure MIS symptoms, PTSD, depression, suicide risk, daily functioning, and engagement with the community.

Who can participate and what to expect: Veterans aged 18 or older who have MIS symptoms and are willing to be randomly assigned to either therapy, and who have been stable on mental health medications for at least 8 weeks, may be eligible. Exclusions include not being able to consent, serious active psychosis or substance problems that would interfere with treatment, currently receiving MIS or PTSD therapies through the study, or severe immediate risk (like high suicide risk). The trial is being conducted at several VA centers across the U.S. with the aim of learning whether BSS can be implemented more widely if it helps, ultimately informing national VA care for MIS. Enrollment is currently ongoing (not results) with an estimated 200 participants.

Gender

ALL

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.

About Va Office Of Research And Development

The VA Office of Research and Development (ORD) is dedicated to advancing the health and well-being of veterans through innovative research initiatives. As a pivotal sponsor of clinical trials, ORD focuses on a broad spectrum of health-related topics, including mental health, rehabilitation, and chronic disease management, ensuring that findings are directly applicable to the unique needs of the veteran population. With a commitment to scientific excellence and collaboration, ORD promotes rigorous study designs and ethical standards, facilitating the translation of research discoveries into improved clinical practices and policies that enhance veteran care.

Locations

North Little Rock, Arkansas, United States

Augusta, Maine, United States

Houston, Texas, United States

Minneapolis, Minnesota, United States

Decatur, Georgia, United States

Little Rock, Arkansas, United States

Little Rock, Arkansas, United States

Patients applied

0 patients applied

Trial Officials

Jeanette Irene Harris, PhD MS MS

Principal Investigator

Maine VA Medical Center, Augusta, ME

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported