Effects of "Alliance180 Program" on Well-Being

Trauma and Stressor Related Disorders Clinical Trial

Official title:

Effects of "Alliance180 Program" on Psychological and Physical Well-Being

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06451523
• Other study ID #: 23-2072
• Status: Recruiting
• Phase: N/A
• Start date: June 2024
• Est. completion date: October 2025

Study information

• Verified date: June 2024
• Source: University of North Carolina, Chapel Hill
• Contact: Keri J Heilman, PhD
• Phone: 913-802-2168
• Email: keri_heilman[@]med.unc.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: October 2025
• Est. primary completion date: October 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

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"

Related Conditions & MeSH terms

• Trauma and Stressor Related Disorders

Intervention

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.

Locations

Country	Name	City	State
United States	University of North Carolina at Chapel Hill	Chapel Hill	North Carolina
United States	Alliance180	Saratoga Springs	New York

Sponsors (2)

Lead Sponsor	Collaborator
University of North Carolina, Chapel Hill	ALLIANCE180, INC

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	Change in the Body Perception Questionnaire	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
Secondary	Change in the Neuroception of Psychological Safety Scale	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
Secondary	Change in the Posttraumatic Stress Disorder Checklist (DSM-5)	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
Secondary	Change in the Purpose in Life Questionnaire	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
Secondary	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, 6 months
Secondary	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, 6 months
Secondary	Change in the Body Perception Questionnaire	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
Secondary	Change in the Neuroception of Psychological Safety Scale	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
Secondary	Change in the Posttraumatic Stress Disorder Checklist (DSM-5)	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
Secondary	Change in the Purpose in Life Questionnaire	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