Clinical trial NCT06451523: Effects of "Alliance180 Program" on Well-Being
Official title: Effects of "Alliance180 Program" on Psychological and Physical Well-Being
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Trauma and Stressor Related Disorders
Keywords: Anxiety Depression
Autonomic Reactivity
Polyvagal Theory
Lead sponsor: University of North Carolina, Chapel Hill
Sponsor class: OTHER
Collaborators: name: ALLIANCE180, INC
First posted: 2024-06-11
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: All participants will follow the same procedures.
Primary purpose: BASIC_SCIENCE

Brief summary: 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.

Detailed description: 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).

Eligibility criteria: 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"

Primary outcomes:
measure: Change in the Anxiety Subscale of the Hospital Anxiety and Depression Scale
timeFrame: Baseline, 1 month
measure: Change in the Depression Subscale of the Hospital Anxiety and Depression Scale
timeFrame: Baseline, 1 month
Secondary outcomes:
measure: Change in the Body Perception Questionnaire
timeFrame: Baseline, 1 month
measure: Change in the Neuroception of Psychological Safety Scale
timeFrame: Baseline, 1 month
measure: Change in the Posttraumatic Stress Disorder Checklist (DSM-5)
timeFrame: Baseline, 1 month
measure: Change in the Purpose in Life Questionnaire
timeFrame: Baseline, 1 month
measure: Change in the Anxiety Subscale of the Hospital Anxiety and Depression Scale
timeFrame: Baseline, 6 months
measure: Change in the Depression Subscale of the Hospital Anxiety and Depression Scale
timeFrame: Baseline, 6 months
measure: Change in the Body Perception Questionnaire
timeFrame: Baseline, 6 months
measure: Change in the Neuroception of Psychological Safety Scale
timeFrame: Baseline, 6 months
measure: Change in the Posttraumatic Stress Disorder Checklist (DSM-5)
timeFrame: Baseline, 6 months
measure: Change in the Purpose in Life Questionnaire
timeFrame: Baseline, 6 months
Other outcomes:
Locations:
city: Saratoga Springs
country: United States
facility: Alliance180
state: New York
city: Chapel Hill
country: United States
facility: University of North Carolina at Chapel Hill
state: North Carolina
Study officials:
affiliation: University of North Carolina, Chapel Hill
name: Keri J Heilman, PhD
role: PRINCIPAL_INVESTIGATOR
References: