NCT07579143

Brief Summary

The goal of this clinical trial is to learn if the intervention can be delivered by VA chaplains and if it is acceptable for veterans who have symptoms of moral injury (guilt, shame, isolation) and are receiving VA mental health treatment. The main questions it aims to answer are: Can the study team enroll veterans for this intervention and complete data collection? Will veterans complete the intervention? There is no comparison group. Participants will will complete a baseline and 6-month interview and participate in up to 12 intervention sessions with a VA chaplain. The intervention will focus on facilitating forgiveness and community connection.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
1mo left

Started Apr 2025

Geographic Reach
1 country

2 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress98%
Apr 2025Jun 2026

Study Start

First participant enrolled

April 14, 2025

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

December 10, 2025

Completed
5 months until next milestone

First Posted

Study publicly available on registry

May 11, 2026

Completed
21 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2026

Last Updated

May 11, 2026

Status Verified

April 1, 2026

Enrollment Period

1.1 years

First QC Date

December 10, 2025

Last Update Submit

May 6, 2026

Conditions

Keywords

feasibilityacceptabilitysingle arm trial

Outcome Measures

Primary Outcomes (2)

  • Number referred, enrolled, baseline and 6-month

    referral, enrollment, and baseline and 6-month data collection

    6 months

  • intervention retention

    number of sessions completed

    6 months

Secondary Outcomes (10)

  • moral injury distress

    baseline and 6 months

  • Religious and spiritual struggles

    baseline and 6 months

  • Forgiving others

    baseline and 6-months

  • Self forgiveness

    baseline and 6-months

  • PTSD symptom severity

    baseline and 6-months

  • +5 more secondary outcomes

Study Arms (1)

Intervention focused on facilitating forgiveness and community connection

EXPERIMENTAL

Intervention is delivered by VA chaplains to facilitate forgiveness and community connection in collaboration with mental health clinicians

Behavioral: facilitate forgiveness and community connection to address symptoms of moral injury

Interventions

VA chaplain delivered intervention to facilitate forgiveness and community connection in collaboration with mental health clinicians

Intervention focused on facilitating forgiveness and community connection

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • age 18 to 80 years
  • plan to follow-up with a VA mental health clinician for PTSD or SUD treatment within the next three months (therefore allowing for collaboration)
  • positive screen using the 6-item Moral Injury Distress Scale (MIDS) screener. A positive MIDS screen will be defined as being bothered at least moderately by exposure to at least one potentially morally injurious event (witnessing, omission, commission).

You may not qualify if:

  • diagnosis of schizophrenia, bipolar disorder, borderline personality disorder, or severe neurocognitive disorder (e.g., dementia, severe TBI). Veterans with borderline personality disorder will be eligible for participation in this study following DBT completion.
  • Planning to start or current participation in a moral injury treatment group or evidence-based psychotherapy (e.g., Prolonged Exposure or Cognitive Processing Therapy).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Central Arkansas Veterans Healthcare System

Little Rock, Arkansas, 72114, United States

COMPLETED

VA Pittsburgh Healthcare System

Pittsburgh, Pennsylvania, 15240, United States

RECRUITING

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic

Condition Hierarchy (Ancestors)

Stress Disorders, TraumaticTrauma and Stressor Related DisordersMental Disorders

Central Study Contacts

Jeff M Pyne, MD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: single arm study
Sponsor Type
FED
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Physician/Research Scientist

Study Record Dates

First Submitted

December 10, 2025

First Posted

May 11, 2026

Study Start

April 14, 2025

Primary Completion (Estimated)

June 1, 2026

Study Completion (Estimated)

June 1, 2026

Last Updated

May 11, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will share

De-identified data and limited data set data will be shared in consultation with the local research privacy officer and follow strict privacy protocols and approvals, e.g., upon written request and a signed data use agreement from a non-VA investigator. These requests could be to confirm conclusions made in publications, to duplicate statistical analyses or perform additional analysis.

Shared Documents
STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
Time Frame
one year after data collection is complete until protocol is closed
Access Criteria
De-identified data and limited data set data will be shared in consultation with the local research privacy officer and follow strict privacy protocols and approvals, e.g., upon written request and a signed data use agreement from a non-VA investigator. These requests could be to confirm conclusions made in publications, to duplicate statistical analyses or perform additional analysis.

Locations