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Mental Health Clinician / Chaplain Collaboration (MC3)

6. Mai 2026 aktualisiert von: 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.

Studienübersicht

Status

Rekrutierung

Bedingungen

Intervention / Behandlung

Detaillierte Beschreibung

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.

Studientyp

Interventionell

Einschreibung (Geschätzt)

20

Phase

  • Unzutreffend

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienkontakt

Studienorte

  • Vereinigte Staaten
    • Arkansas
      • Little Rock, Arkansas, Vereinigte Staaten, 72114
        • Abgeschlossen
        • Central Arkansas Veterans Healthcare System
    • Pennsylvania
      • Pittsburgh, Pennsylvania, Vereinigte Staaten, 15240
        • Rekrutierung
        • VA Pittsburgh Healthcare System
        • Kontakt:
        • Kontakt:
        • Unterermittler:
          • Gretchen Hulse, MDiv
        • Unterermittler:
          • Stephanie Gannon, MDiv

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

  • Erwachsene
  • Älterer Erwachsener

Akzeptiert gesunde Freiwillige

Nein

Beschreibung

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).

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

  • Hauptzweck: Behandlung
  • Zuteilung: N / A
  • Interventionsmodell: Einzelgruppenzuweisung
  • Maskierung: Keine (Offenes Etikett)

Waffen und Interventionen

Teilnehmergruppe / Arm
Intervention / Behandlung
Experimental: 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
Verhalten: 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

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Number referred, enrolled, baseline and 6-month
Zeitfenster: 6 months
referral, enrollment, and baseline and 6-month data collection
6 months
intervention retention
Zeitfenster: 6 months
number of sessions completed
6 months

Sekundäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
moral injury distress
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Sponsor

Central Arkansas Veterans Healthcare System

Mitarbeiter

VA Pittsburgh Healthcare System

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn (Tatsächlich)

14. April 2025

Primärer Abschluss (Geschätzt)

1. Juni 2026

Studienabschluss (Geschätzt)

1. Juni 2026

Studienanmeldedaten

Zuerst eingereicht

10. Dezember 2025

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

6. Mai 2026

Zuerst gepostet (Tatsächlich)

11. Mai 2026

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

11. Mai 2026

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

6. Mai 2026

Zuletzt verifiziert

1. April 2026

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Schlüsselwörter

Zusätzliche relevante MeSH-Bedingungen

Andere Studien-ID-Nummern

  • 1750298
  • PPO 22-211 (Andere Zuschuss-/Finanzierungsnummer: Veterans Affairs Health Services Research and Development)

Plan für individuelle Teilnehmerdaten (IPD)

Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?

JA

Beschreibung des IPD-Plans

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-Sharing-Zeitrahmen

one year after data collection is complete until protocol is closed

IPD-Sharing-Zugriffskriterien

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.

Art der unterstützenden IPD-Freigabeinformationen

  • STUDIENPROTOKOLL
  • SAFT
  • ICF
  • ANALYTIC_CODE
  • CSR

Arzneimittel- und Geräteinformationen, Studienunterlagen

Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt

Nein

Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt

Nein

Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .

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