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Mental Health Clinician / Chaplain Collaboration (MC3)

2026年5月6日 更新者：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.

調査の概要

状態

募集

条件

介入・治療

詳細な説明

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.

研究の種類

介入

入学 (推定)

20

段階

  • 適用できない

連絡先と場所

このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。

研究連絡先

研究場所

  • アメリカ
    • Arkansas
      • Little Rock、Arkansas、アメリカ、72114
        • 完了
        • Central Arkansas Veterans Healthcare System
    • Pennsylvania
      • Pittsburgh、Pennsylvania、アメリカ、15240
        • 募集
        • VA Pittsburgh Healthcare System
        • コンタクト：
        • コンタクト：
        • 副調査官：
          • Gretchen Hulse, MDiv
        • 副調査官：
          • Stephanie Gannon, MDiv

参加基準

研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。

適格基準

就学可能な年齢

  • 大人
  • 高齢者

健康ボランティアの受け入れ

いいえ

説明

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).

研究計画

このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。

研究はどのように設計されていますか？

デザインの詳細

  • 主な目的：処理
  • 割り当て：なし
  • 介入モデル：単一グループの割り当て
  • マスキング：なし（オープンラベル）

武器と介入

参加者グループ / アーム
介入・治療
実験的：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
行動：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

この研究は何を測定していますか？

主要な結果の測定

結果測定
メジャーの説明
時間枠
Number referred, enrolled, baseline and 6-month
時間枠：6 months
referral, enrollment, and baseline and 6-month data collection
6 months
intervention retention
時間枠：6 months
number of sessions completed
6 months

二次結果の測定

結果測定
メジャーの説明
時間枠
moral injury distress
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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

協力者と研究者

ここでは、この調査に関係する人々や組織を見つけることができます。

スポンサー

Central Arkansas Veterans Healthcare System

協力者

VA Pittsburgh Healthcare System

研究記録日

これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。

主要日程の研究

研究開始 (実際)

2025年4月14日

一次修了 (推定)

2026年6月1日

研究の完了 (推定)

2026年6月1日

試験登録日

最初に提出

2025年12月10日

QC基準を満たした最初の提出物

2026年5月6日

最初の投稿 (実際)

2026年5月11日

学習記録の更新

投稿された最後の更新 (実際)

2026年5月11日

QC基準を満たした最後の更新が送信されました

2026年5月6日

最終確認日

2026年4月1日

詳しくは

本研究に関する用語

キーワード

追加の関連 MeSH 用語

その他の研究ID番号

  • 1750298
  • PPO 22-211 (その他の助成金/資金番号：Veterans Affairs Health Services Research and Development)

個々の参加者データ (IPD) の計画

個々の参加者データ (IPD) を共有する予定はありますか?

はい

IPD プランの説明

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 共有時間枠

one year after data collection is complete until protocol is closed

IPD 共有アクセス基準

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 共有サポート情報タイプ

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • ANALYTIC_CODE
  • CSR

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米国FDA規制医薬品の研究

いいえ

米国FDA規制機器製品の研究

いいえ

この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。

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