Effects of "Alliance180 Program" on Well-Being
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Alliance180 Program.
- Who it may be relevant to
- Registry conditions: Trauma and Stressor Related Disorders. Basic parameters: 18 years — 99 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Effects of "Alliance180 Program" on Psychological and Physical Well-Being
Overview
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).
Interventions
- Other 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.
Primary outcome measures
- Change in the Anxiety Subscale of the Hospital Anxiety and Depression Scale [Time frame: Baseline, 1 month]
- Change in the Depression Subscale of the Hospital Anxiety and Depression Scale [Time frame: Baseline, 1 month]
Secondary outcome measures (10)
- Change in the Body Perception Questionnaire [Time frame: Baseline, 1 month]
- Change in the Neuroception of Psychological Safety Scale [Time frame: Baseline, 1 month]
- Change in the Posttraumatic Stress Disorder Checklist (DSM-5) [Time frame: Baseline, 1 month]
- Change in the Purpose in Life Questionnaire [Time frame: Baseline, 1 month]
- Change in the Anxiety Subscale of the Hospital Anxiety and Depression Scale [Time frame: Baseline, 6 months]
- Change in the Depression Subscale of the Hospital Anxiety and Depression Scale [Time frame: Baseline, 6 months]
- Change in the Body Perception Questionnaire [Time frame: Baseline, 6 months]
- Change in the Neuroception of Psychological Safety Scale [Time frame: Baseline, 6 months]
- Change in the Posttraumatic Stress Disorder Checklist (DSM-5) [Time frame: Baseline, 6 months]
- Change in the Purpose in Life Questionnaire [Time frame: Baseline, 6 months]
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"
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Basic science
Study locations
United States · 2 centers
- Alliance180 — Saratoga Springs
- University of North Carolina at Chapel Hill — Chapel Hill
Identifiers
NCT: NCT06451523 · 23-2072