Effects of "Alliance180 Program" on Well-Being

NCT06451523 | Recruiting

• 1 other identifier: 23-2072
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 2

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.

Conditions

Trauma and Stressor Related Disorders

Keywords

Anxiety Depression; Autonomic Reactivity; Polyvagal Theory

Outcome Measures

Primary Outcomes (2)

• Change in the Anxiety Subscale of the Hospital Anxiety and Depression Scale

  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

  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

Secondary Outcomes (10)

• Change in the Body Perception Questionnaire

  Baseline, 1 month

• Change in the Neuroception of Psychological Safety Scale

  Baseline, 1 month

• Change in the Posttraumatic Stress Disorder Checklist (DSM-5)

  Baseline, 1 month

• Change in the Purpose in Life Questionnaire

  Baseline, 1 month

• Change in the Anxiety Subscale of the Hospital Anxiety and Depression Scale

  Baseline, 6 months

Study Arms (1)

Alliance180 Program

EXPERIMENTAL

Participants will attend the 3-day Alliance180 Program.

Other: Alliance180 Program

Interventions

Alliance180 Program OTHER

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

Alliance180 Program

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• \- Individuals who have previously completed the "Alliance180 Program"

Sponsors & Collaborators

• University of North Carolina, Chapel Hill: lead
• ALLIANCE180, INC: collaborator

Study Sites (2)

Alliance180

Saratoga Springs, New York, 12866, United States

RECRUITING

University of North Carolina at Chapel Hill

Chapel Hill, North Carolina, 27599-7160, United States

RECRUITING

MeSH Terms

Conditions

Trauma and Stressor Related Disorders

Condition Hierarchy (Ancestors)

Mental Disorders

Study Officials

• Keri J Heilman, PhD

  University of North Carolina, Chapel Hill

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Keri J Heilman, PhD

CONTACT

913-802-2168; keri_heilman@med.unc.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: All participants will follow the same procedures.

Study Record Dates

• First Submitted: June 4, 2024
• First Posted: June 11, 2024
• Study Start: June 24, 2024
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): September 1, 2026
• Last Updated: February 18, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF
• Time Frame: Beginning 9 and continuing for 36 months after publication
• Access Criteria: Investigator has approved IRB, IEC, or REB and an executed data use/sharing agreement with the University of North Carolina, Chapel Hill (UNC).

Locations

US (2)