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「アライアンス180プログラム」が健康に与える影響

2026年9月18日 更新者：University of North Carolina, Chapel Hill

「アライアンス180プログラム」が心身の健康に与える影響

The goal of this clinical trial is to evaluate the effects of the Alliance180 Program on physical and psychological well-being on adults who are/were US Veterans, First Responders and/or Front Line Healthcare Workers.

The study aims are:

  • Aim #1: to evaluate the effect of the Alliance180 Program on physical and psychological well-being in adults who are/were US Veterans, First Responders and/or Front Line Healthcare Workers;
  • Aim #2: to evaluate the relationship between between feelings of safety and well-being, autonomic functioning, and mental health indices (depression, anxiety, trauma response) before and after the intervention.

Participants will be asked to complete self-report measures of feelings of safety and well-being, autonomic functioning, and mental health indices (depression, anxiety, trauma response) before participating in the Alliance180 Program (i.e., baseline research session) and 1 week, 1 month, 3 months and 6 months after completing the Alliance180 Program. Demographic information will be documented during the baseline research session.

調査の概要

状態

募集

条件

介入・治療

詳細な説明

All data collection will occur remotely using REDCap (via University of North Carolina, Chapel Hill). As this is a single-arm, feasibility/pilot study, all participants will follow the same protocol.

  1. Baseline Research Session: self-report completion of demographic information, perception of safety (Neuroception of Psychological Safety, NPSS) and trauma experience (Posttraumatic Stress Disorder Checklist DSM-5, PCL-5), autonomic reactivity (Body Perception Questionnaire, BPQ), anxiety/depression (Hospital Anxiety and Depression Scale, HADS), and perception of events and goals related to purpose in life (Purpose in Life Scale).
  2. Participate in the 3-day Alliance180 Program (intervention), which includes the Transformative Equine Experience.
  3. Post-intervention Research Sessions: 1 week, 1 month, 3 months and 6 months after completing the Alliance180 Program, self-report completion of perception of safety and trauma experience (NPSS, PCL-5), autonomic reactivity (BPQ), anxiety/depression (HADS) and purpose of events and goals related to purpose in life (Purpose in Life Scale).

研究の種類

介入

入学 (推定)

50

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
    • New York
      • Saratoga Springs、New York、アメリカ、12866
        • 募集
        • Alliance180
        • コンタクト：
          • Janelle Huggard
          • 電話番号：518-225-8353
        • 副調査官：
          • Bob Nevins
        • 副調査官：
          • Janelle Huggard
    • North Carolina
      • Chapel Hill、North Carolina、アメリカ、27599-7160
        • 募集
        • University of North Carolina at Chapel Hill
        • コンタクト：
          • Keri J Heilman, PhD

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

18年～99年 (大人、高齢者)

健康ボランティアの受け入れ

いいえ

受講資格のある性別

全て

説明

Inclusion Criteria:

  • 18 years or older
  • Enrollment in an upcoming "Alliance180 Program". (Enrollment is limited to adults who currently or formerly serve as US Veterans, First Responders and/or Front Line Healthcare Workers and are currently experiencing symptoms related to trauma exposure)

Exclusion Criteria:

- Individuals who have previously completed the "Alliance180 Program"

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：基礎科学
  • 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：Alliance180 Program

Participants will attend the 3-day Alliance180 Program.
他の：Alliance180 Program

The Alliance180 Program promotes feelings of neuropsychological safety and trust in the context of a 3-day program, which includes the transformative equine experience.

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
Change in the Anxiety Subscale of the Hospital Anxiety and Depression Scale
時間枠：Baseline, 1 month

The Anxiety Subscale of the Hospital Anxiety and Depression Scale (HADS) is a 7-item self-report questionnaire measuring the frequency of anxiety over the prior week. The anxiety subscale ranges from 0 to 21, with higher scores indicating higher anxiety complaints. Repeated measures ANOVA will be used to evaluate significant differences in change scores using a 0.05 significance level.
Baseline, 1 month
Change in the Depression Subscale of the Hospital Anxiety and Depression Scale
時間枠：Baseline, 1 month

The Depression Subscale of the Hospital Anxiety and Depression Scale (HADS) is a 7-item self-report questionnaire measuring the frequency of depression over the prior week. The depression subscale ranges from 0 to 21, with higher scores indicating higher depression complaints. Repeated measures ANOVA will be used to evaluate significant differences in change scores using a 0.05 significance level.
Baseline, 1 month

二次結果の測定

結果測定
メジャーの説明
時間枠
Change in the Body Perception Questionnaire
時間枠：Baseline, 1 month

Body Perception Questionnaire (BPQ) is a self-report questionnaire, which includes a 20-item subscale for Autonomic Nervous System Reactivity. Only the Autonomic Nervous System Reactivity subscale will be administered. Raw scores range from 0-100, with higher scores indicating greater level of symptoms associated with autonomic activity (poorer outcome). Repeated measures ANOVA will be used to evaluate significant differences in change scores using a 0.05 significance level.
Baseline, 1 month
Change in the Neuroception of Psychological Safety Scale
時間枠：Baseline, 1 month

Neuroception of Psychological Safety Scale (NPSS) is a self-report questionnaire, which contains 29-items. Raw scores range from 29-145, with higher scores indicating stronger feelings of psychological safety. Repeated measures ANOVA will be used to evaluate significant differences in change scores using a 0.05 significance level.
Baseline, 1 month
Change in the Posttraumatic Stress Disorder Checklist (DSM-5)
時間枠：Baseline, 1 month

Posttraumatic Stress Disorder Checklist (DSM-5) (PCL-5) is a self-report questionnaire, which contains 20-items. Raw scores range from 0-80, with higher scores indicating more symptoms of PTSD. Repeated measures ANOVA will be used to evaluate significant differences in change scores using a 0.05 significance level.
Baseline, 1 month
Change in the Purpose in Life Questionnaire
時間枠：Baseline, 1 month

Purpose in Life Questionnaire is a self-report questionnaire, which contains 12-items. Raw scores range from 0-60, with higher scores indicating a greater sense of purpose in life. Repeated measures ANOVA will be used to evaluate significant differences in change scores using a 0.05 significance level.
Baseline, 1 month
Change in the Anxiety Subscale of the Hospital Anxiety and Depression Scale
時間枠：Baseline, 6 months

The Anxiety Subscale of the Hospital Anxiety and Depression Scale (HADS) is a 7-item self-report questionnaire measuring the frequency of anxiety over the prior week. The anxiety subscale ranges from 0 to 21, with higher scores indicating higher anxiety complaints. Repeated measures ANOVA will be used to evaluate significant differences in change scores using a 0.05 significance level.
Baseline, 6 months
Change in the Depression Subscale of the Hospital Anxiety and Depression Scale
時間枠：Baseline, 6 months

The Depression Subscale of the Hospital Anxiety and Depression Scale (HADS) is a 7-item self-report questionnaire measuring the frequency of depression over the prior week. The depression subscale ranges from 0 to 21, with higher scores indicating higher depression complaints. Repeated measures ANOVA will be used to evaluate significant differences in change scores using a 0.05 significance level.
Baseline, 6 months
Change in the Body Perception Questionnaire
時間枠：Baseline, 6 months

Body Perception Questionnaire (BPQ) is a self-report questionnaire, which includes a 20-item subscale for Autonomic Nervous System Reactivity. Only the Autonomic Nervous System Reactivity subscale will be administered. Raw scores range from 0-100, with higher scores indicating greater level of symptoms associated with autonomic activity (poorer outcome). Repeated measures ANOVA will be used to evaluate significant differences in change scores using a 0.05 significance level.
Baseline, 6 months
Change in the Neuroception of Psychological Safety Scale
時間枠：Baseline, 6 months

Neuroception of Psychological Safety Scale (NPSS) is a self-report questionnaire, which contains 29-items. Raw scores range from 29-145, with higher scores indicating stronger feelings of psychological safety. Repeated measures ANOVA will be used to evaluate significant differences in change scores using a 0.05 significance level.
Baseline, 6 months
Change in the Posttraumatic Stress Disorder Checklist (DSM-5)
時間枠：Baseline, 6 months

Posttraumatic Stress Disorder Checklist (DSM-5) (PCL-5) is a self-report questionnaire, which contains 20-items. Raw scores range from 0-80, with higher scores indicating more symptoms of PTSD. Repeated measures ANOVA will be used to evaluate significant differences in change scores using a 0.05 significance level.
Baseline, 6 months
Change in the Purpose in Life Questionnaire
時間枠：Baseline, 6 months

Purpose in Life Questionnaire is a self-report questionnaire, which contains 12-items. Raw scores range from 0-60, with higher scores indicating a greater sense of purpose in life. Repeated measures ANOVA will be used to evaluate significant differences in change scores using a 0.05 significance level.
Baseline, 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

University of North Carolina, Chapel Hill

協力者

Alliance180, Inc.

捜査官

  • 主任研究者：Keri J Heilman, PhD、University of North Carolina, Chapel Hill

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)

2024年6月24日

一次修了 (推定)

2027年9月1日

研究の完了 (推定)

2027年9月1日

試験登録日

最初に提出

2024年6月4日

QC基準を満たした最初の提出物

2024年6月4日

最初の投稿 (実際)

2024年6月11日

学習記録の更新

投稿された最後の更新 (実際)

2026年9月21日

QC基準を満たした最後の更新が送信されました

2026年9月18日

最終確認日

2026年9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

  • 23-2072

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

Deidentified individual data that supports the results will be shared beginning 9 to 36 months following publication provided the investigator who proposes to use the data has approval from an Institutional Review Board (IRB), Independent Ethics Committee (IEC), or Research Ethics Board (REB), as applicable, and executes a data use/sharing agreement with the University of North Carolina, Chapel Hill (UNC).

IPD 共有時間枠

Beginning 9 and continuing for 36 months after publication

IPD 共有アクセス基準

Investigator has approved IRB, IEC, or REB and an executed data use/sharing agreement with the University of North Carolina, Chapel Hill (UNC).

IPD 共有サポート情報タイプ

  • STUDY_PROTOCOL
  • ICF

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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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