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Effekter av "Alliance180-programmet" på välbefinnande

18 september 2026 uppdaterad av: University of North Carolina, Chapel Hill

Effekter av "Alliance180-programmet" på psykologiskt och fysiskt välbefinnande

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.

Studieöversikt

Status

Rekrytering

Betingelser

Intervention / Behandling

Detaljerad beskrivning

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).

Studietyp

Interventionell

Inskrivning (Beräknad)

50

Fas

  • Inte tillämpbar

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studiekontakt

Studieorter

  • Förenta staterna
    • New York
      • Saratoga Springs, New York, Förenta staterna, 12866
        • Rekrytering
        • Alliance180
        • Kontakt:
          • Janelle Huggard
          • Telefonnummer: 518-225-8353
        • Underutredare:
          • Bob Nevins
        • Underutredare:
          • Janelle Huggard
    • North Carolina
      • Chapel Hill, North Carolina, Förenta staterna, 27599-7160
        • Rekrytering
        • University of North Carolina at Chapel Hill
        • Kontakt:
          • Keri J Heilman, PhD

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

18 år till 99 år (Vuxen, Äldre vuxen)

Tar emot friska volontärer

Nej

Kön som är behöriga för studier

Allt

Beskrivning

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"

Studieplan

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

  • Primärt syfte: Grundläggande vetenskap
  • Tilldelning: N/A
  • Interventionsmodell: Enskild gruppuppgift
  • Maskning: Ingen (Open Label)

Vapen och interventioner

Deltagargrupp / Arm
Intervention / Behandling
Experimentell: Alliance180 Program

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

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Change in the Anxiety Subscale of the Hospital Anxiety and Depression Scale
Tidsram: 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
Tidsram: 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

Sekundära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Change in the Body Perception Questionnaire
Tidsram: 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
Tidsram: 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)
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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)
Tidsram: 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
Tidsram: 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

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Sponsor

University of North Carolina, Chapel Hill

Samarbetspartners

Alliance180, Inc.

Utredare

  • Huvudutredare: Keri J Heilman, PhD, University of North Carolina, Chapel Hill

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart (Faktisk)

24 juni 2024

Primärt slutförande (Beräknad)

1 september 2027

Avslutad studie (Beräknad)

1 september 2027

Studieregistreringsdatum

Först inskickad

4 juni 2024

Först inskickad som uppfyllde QC-kriterierna

4 juni 2024

Första postat (Faktisk)

11 juni 2024

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

21 september 2026

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

18 september 2026

Senast verifierad

1 september 2026

Mer information

Termer relaterade till denna studie

Nyckelord

Ytterligare relevanta MeSH-villkor

Andra studie-ID-nummer

  • 23-2072

Plan för individuella deltagardata (IPD)

Planerar du att dela individuella deltagardata (IPD)?

JA

IPD-planbeskrivning

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).

Tidsram för IPD-delning

Beginning 9 and continuing for 36 months after publication

Kriterier för IPD Sharing Access

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

IPD-delning som stöder informationstyp

  • STUDY_PROTOCOL
  • ICF

Läkemedels- och apparatinformation, studiedokument

Studerar en amerikansk FDA-reglerad läkemedelsprodukt

Nej

Studerar en amerikansk FDA-reglerad produktprodukt

Nej

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