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Recruiting NCT07579143

Mental Health Clinician / Chaplain Collaboration

No phase Interventional Moral Injury

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: facilitate forgiveness and community connection to address symptoms of moral injury.
Who it may be relevant to
Registry conditions: Moral Injury. Basic parameters: 18 years — 80 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

Mental Health Clinician / Chaplain Collaboration (MC3): A Pilot Study

Overview

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.

Detailed description

Moral injury symptoms include guilt, shame, and self-isolation. Moral injury is also associated with increased suicide risk. Moral injury symptoms are common in Veterans being treated for posttraumatic stress disorder (PTSD) or substance use disorder (SUD) and current treatments do not always improve these symptoms. The Mental Health Clinician / Chaplain Collaboration (MC3) intervention is delivered by VA chaplains who facilitate forgiveness and community reintegration. MC3 is a collaboration between resources in the mental health clinic, chaplain service, and community to support moral injury symptom recovery.

Specific Aims:

1. Pre-implementation: Adapt the intervention that was originally delivered by community clergy for delivery by VA chaplains. Stakeholders in this process will include VA chaplains and mental health clinicians at the Little Rock and Pittsburgh VAMCs. 2. Conduct a single arm pilot study (total N = 20 across 2 sites) of the MC3 intervention to assess feasibility, acceptability, and fidelity (primary outcomes). 3. Post-implementation: Conduct a formative evaluation with stakeholders of the recruitment methods, MC3 intervention, and outcome measures. This information will be used to refine the MC3 intervention and study procedures for a subsequent RCT.

Methodology: The study design is a two site one arm trial. The population is Veterans being treated in specialty mental health or substance use disorder clinics who have symptoms of moral injury. MC3 will be delivered by VA chaplains who will facilitate forgiveness and community reintegration. The primary outcomes are feasibility and acceptability. Quantitative and qualitative data will be collected at baseline and 6-months (end of intervention). Evidence-based quality improvement methods will be used to implement MC3 at the Little Rock and Pittsburgh VA Medical Centers.

Interventions

  • Behavioral facilitate forgiveness and community connection to address symptoms of moral injury
    VA chaplain delivered intervention to facilitate forgiveness and community connection in collaboration with mental health clinicians

Primary outcome measures

  • Number referred, enrolled, baseline and 6-month [Time frame: 6 months]
  • intervention retention [Time frame: 6 months]
Secondary outcome measures (10)
  • moral injury distress [Time frame: baseline and 6 months]
  • Religious and spiritual struggles [Time frame: baseline and 6 months]
  • Forgiving others [Time frame: baseline and 6-months]
  • Self forgiveness [Time frame: baseline and 6-months]
  • PTSD symptom severity [Time frame: baseline and 6-months]
  • Depression symptom serverity [Time frame: baseline and 6-months]
  • Functioning [Time frame: baseline and 6-months]
  • Post-traumatic growth [Time frame: baseline and 6-months]
  • Social satisfaction [Time frame: baseline and 6-months]
  • Loneliness [Time frame: baseline and 6-months]

Eligibility criteria

Inclusion criteria

  • 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).

Exclusion criteria

  • 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).

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

United States · 2 centers
  • Central Arkansas Veterans Healthcare System — Little Rock
  • VA Pittsburgh Healthcare System — Pittsburgh

Identifiers

NCT: NCT07579143 · 1750298 · PPO 22-211

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗