Mental Health Clinician / Chaplain Collaboration (MC3)
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.
Studieoversikt
Status
Forhold
Intervensjon / Behandling
Detaljert beskrivelse
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:
- 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.
- Conduct a single arm pilot study (total N = 20 across 2 sites) of the MC3 intervention to assess feasibility, acceptability, and fidelity (primary outcomes).
- 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
Registrering (Antatt)
Fase
- Ikke aktuelt
Kontakter og plasseringer
Studiekontakt
- Navn: Jeff M Pyne, MD
- Telefonnummer: 501-442-6019
- E-post: jeffrey.pyne@va.gov
Studiesteder
-
-
Arkansas
-
Little Rock, Arkansas, Forente stater, 72114
- Fullført
- Central Arkansas Veterans Healthcare System
-
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Pennsylvania
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Pittsburgh, Pennsylvania, Forente stater, 15240
- Rekruttering
- VA Pittsburgh Healthcare System
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Ta kontakt med:
- Maribeth Wesesky
- Telefonnummer: 412-295-7017
- E-post: maribeth.wesesky@va.gov
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Ta kontakt med:
- Jin Cheng, MD
- E-post: jin.cheng@va.gov
-
Underetterforsker:
- Gretchen Hulse, MDiv
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Underetterforsker:
- Stephanie Gannon, MDiv
-
-
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Voksen
- Eldre voksen
Tar imot friske frivillige
Beskrivelse
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).
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: N/A
- Intervensjonsmodell: Enkeltgruppeoppdrag
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Eksperimentell: 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
|
VA chaplain delivered intervention to facilitate forgiveness and community connection in collaboration with mental health clinicians
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Number referred, enrolled, baseline and 6-month
Tidsramme: 6 months
|
referral, enrollment, and baseline and 6-month data collection
|
6 months
|
|
intervention retention
Tidsramme: 6 months
|
number of sessions completed
|
6 months
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
moral injury distress
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
|
Samarbeidspartnere og etterforskere
Samarbeidspartnere
Studierekorddatoer
Studer hoveddatoer
Studiestart (Faktiske)
Primær fullføring (Antatt)
Studiet fullført (Antatt)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- 1750298
- PPO 22-211 (Annet stipend/finansieringsnummer: Veterans Affairs Health Services Research and Development)
Plan for individuelle deltakerdata (IPD)
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IPD-planbeskrivelse
IPD-delingstidsramme
Tilgangskriterier for IPD-deling
IPD-deling Støtteinformasjonstype
- STUDY_PROTOCOL
- SEVJE
- ICF
- ANALYTIC_CODE
- CSR
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