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Mental Health Clinician / Chaplain Collaboration (MC3)

6 de mayo de 2026 actualizado por: 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.

Descripción general del estudio

Estado

Reclutamiento

Condiciones

Intervención / Tratamiento

Descripción detallada

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.

Tipo de estudio

Intervencionista

Inscripción (Estimado)

20

Fase

  • No aplica

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

Estudio Contacto

  • Nombre: Jeff M Pyne, MD
  • Número de teléfono: 501-442-6019
  • Correo electrónico: jeffrey.pyne@va.gov

Ubicaciones de estudio

  • Estados Unidos
    • Arkansas
      • Little Rock, Arkansas, Estados Unidos, 72114
        • Terminado
        • Central Arkansas Veterans Healthcare System
    • Pennsylvania
      • Pittsburgh, Pennsylvania, Estados Unidos, 15240
        • Reclutamiento
        • VA Pittsburgh Healthcare System
        • Contacto:
        • Contacto:
        • Sub-Investigador:
          • Gretchen Hulse, MDiv
        • Sub-Investigador:
          • Stephanie Gannon, MDiv

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

  • Adulto
  • Adulto Mayor

Acepta Voluntarios Saludables

No

Descripción

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).

Plan de estudios

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿Cómo está diseñado el estudio?

Detalles de diseño

  • Propósito principal: Tratamiento
  • Asignación: N / A
  • Modelo Intervencionista: Asignación de un solo grupo
  • Enmascaramiento: Ninguno (etiqueta abierta)

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
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
Conductual: 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

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Number referred, enrolled, baseline and 6-month
Periodo de tiempo: 6 months
referral, enrollment, and baseline and 6-month data collection
6 months
intervention retention
Periodo de tiempo: 6 months
number of sessions completed
6 months

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
moral injury distress
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Patrocinador

Central Arkansas Veterans Healthcare System

Colaboradores

VA Pittsburgh Healthcare System

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio (Actual)

14 de abril de 2025

Finalización primaria (Estimado)

1 de junio de 2026

Finalización del estudio (Estimado)

1 de junio de 2026

Fechas de registro del estudio

Enviado por primera vez

10 de diciembre de 2025

Primero enviado que cumplió con los criterios de control de calidad

6 de mayo de 2026

Publicado por primera vez (Actual)

11 de mayo de 2026

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

11 de mayo de 2026

Última actualización enviada que cumplió con los criterios de control de calidad

6 de mayo de 2026

Última verificación

1 de abril de 2026

Más información

Términos relacionados con este estudio

Palabras clave

Términos MeSH relevantes adicionales

Otros números de identificación del estudio

  • 1750298
  • PPO 22-211 (Otro número de subvención/financiamiento: Veterans Affairs Health Services Research and Development)

Plan de datos de participantes individuales (IPD)

¿Planea compartir datos de participantes individuales (IPD)?

SÍ

Descripción del plan IPD

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.

Marco de tiempo para compartir IPD

one year after data collection is complete until protocol is closed

Criterios de acceso compartido de IPD

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.

Tipo de información de apoyo para compartir IPD

  • PROTOCOLO DE ESTUDIO
  • SAVIA
  • CIF
  • CÓDIGO_ANALÍTICO
  • RSC

Información sobre medicamentos y dispositivos, documentos del estudio

Estudia un producto farmacéutico regulado por la FDA de EE. UU.

No

Estudia un producto de dispositivo regulado por la FDA de EE. UU.

No

Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .

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