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Mental Health Clinician / Chaplain Collaboration (MC3)

6 mei 2026 bijgewerkt door: Jeffrey M Pyne, Central Arkansas Veterans Healthcare System

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

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.

Studie Overzicht

Toestand

Werving

Conditie

Interventie / Behandeling

Gedetailleerde beschrijving

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.

Studietype

Ingrijpend

Inschrijving (Geschat)

20

Fase

  • Niet toepasbaar

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studiecontact

Studie Locaties

  • Verenigde Staten
    • Arkansas
      • Little Rock, Arkansas, Verenigde Staten, 72114
        • Voltooid
        • Central Arkansas Veterans Healthcare System
    • Pennsylvania
      • Pittsburgh, Pennsylvania, Verenigde Staten, 15240
        • Werving
        • VA Pittsburgh Healthcare System
        • Contact:
        • Contact:
        • Onderonderzoeker:
          • Gretchen Hulse, MDiv
        • Onderonderzoeker:
          • Stephanie Gannon, MDiv

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

  • Volwassen
  • Oudere volwassene

Accepteert gezonde vrijwilligers

Nee

Beschrijving

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).

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Behandeling
  • Toewijzing: NVT
  • Interventioneel model: Opdracht voor een enkele groep
  • Masker: Geen (open label)

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Experimenteel: Intervention focused on facilitating forgiveness and community connection
Intervention is delivered by VA chaplains to facilitate forgiveness and community connection in collaboration with mental health clinicians
Gedragsmatig: 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

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Number referred, enrolled, baseline and 6-month
Tijdsspanne: 6 months
referral, enrollment, and baseline and 6-month data collection
6 months
intervention retention
Tijdsspanne: 6 months
number of sessions completed
6 months

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
moral injury distress
Tijdsspanne: baseline and 6 months
Moral Injury Distress Scale: 18 items, minimum score is 0, maximum score is 72, higher score means greater moral distress severity
baseline and 6 months
Religious and spiritual struggles
Tijdsspanne: baseline and 6 months
Religious and Spiritual Struggles Scale: 5-item Divine subscale, minimum score is 5, maximum score is 25, higher score means greater struggle with relationship with Divine and 4-item Ultimate Meaning subscale, minimum score is 0, maximum score is 20, higher score means greater struggle with meaning/purpose of life
baseline and 6 months
Forgiving others
Tijdsspanne: baseline and 6-months
Decision to Forgive Scale: 6 items, minimum score is 6, maximum score is 30, higher score means stronger decision to forgive
baseline and 6-months
Self forgiveness
Tijdsspanne: baseline and 6-months
Self Forgiveness Dual Process Scale: 10 items, minimum score is 10, maximum score is 50, higher score means greater self-forgiveness
baseline and 6-months
PTSD symptom severity
Tijdsspanne: baseline and 6-months
Post Traumatic Stress Disorder Checklist for DSM-5: 20 items, minimum score is 0, maximum score is 80, higher score means greater post-traumatic stress disorder symptom severity
baseline and 6-months
Depression symptom serverity
Tijdsspanne: baseline and 6-months
Patient Health Questionnaire - 9: 9 items, minimum score is 0, maximum score is 27, higher score means greater depression symptom severity
baseline and 6-months
Functioning
Tijdsspanne: baseline and 6-months
Brief Inventory of Psychosocial Functioning: 7 items, one item for each domain and domains include romantic relationships, family relationships, work, friendships and socializing, parenting, education, and self-care. minimum score is 0, maximum score is 6 for each domain, higher score means more trouble in each domain
baseline and 6-months
Post-traumatic growth
Tijdsspanne: baseline and 6-months
Post-traumatic Growth Inventory: 15 items, 5 domains include appreciation of life, personal strength, new possibilities, relating to others, spiritual and existential change, minimum score is 0, maximum score is 75, higher score means more post-traumatic growth
baseline and 6-months
Social satisfaction
Tijdsspanne: baseline and 6-months
Social Satisfaction: 3 items, minimum score is 1, maximum score is 5, higher score means more satisfaction
baseline and 6-months
Loneliness
Tijdsspanne: baseline and 6-months
UCLA Loneliness Scale: 20 items, minimum score is 1, maximum score is 60, higher score means more loneliness
baseline and 6-months

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

Central Arkansas Veterans Healthcare System

Medewerkers

VA Pittsburgh Healthcare System

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Werkelijk)

14 april 2025

Primaire voltooiing (Geschat)

1 juni 2026

Studie voltooiing (Geschat)

1 juni 2026

Studieregistratiedata

Eerst ingediend

10 december 2025

Eerst ingediend dat voldeed aan de QC-criteria

6 mei 2026

Eerst geplaatst (Werkelijk)

11 mei 2026

Updates van studierecords

Laatste update geplaatst (Werkelijk)

11 mei 2026

Laatste update ingediend die voldeed aan QC-criteria

6 mei 2026

Laatst geverifieerd

1 april 2026

Meer informatie

Termen gerelateerd aan deze studie

Trefwoorden

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • 1750298
  • PPO 22-211 (Ander subsidie-/financieringsnummer: Veterans Affairs Health Services Research and Development)

Plan Individuele Deelnemersgegevens (IPD)

Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?

JA

Beschrijving IPD-plan

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.

IPD-tijdsbestek voor delen

one year after data collection is complete until protocol is closed

IPD-toegangscriteria voor delen

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.

IPD delen Ondersteunend informatietype

  • LEERPROTOCOOL
  • SAP
  • ICF
  • ANALYTIC_CODE
  • MVO

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Nee

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Nee

Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .

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