Ignite Creation Date:
2024-06-16 @ 11:52 AM
Last Modification Date:
2024-10-26 @ 3:31 PM
Study NCT ID:
NCT06451523
Status:
RECRUITING
Last Update Posted:
2024-06-14
First Post:
2024-06-04
Brief Title:
Effects of Alliance180 Program on Well-Being
Sponsor:
University of North Carolina Chapel Hill
Organization:
University of North Carolina Chapel Hill
Study Overview
Official Title:
Effects of Alliance180 Program on Psychological and Physical Well-Being
Status:
RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 arewere US Veterans First Responders andor 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 arewere US Veterans First Responders andor 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 ie 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
The study aims are
Aim 1 to evaluate the effect of the Alliance180 Program on physical and psychological well-being in adults who arewere US Veterans First Responders andor 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 ie 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 feasibilitypilot 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 anxietydepression 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 anxietydepression HADS and purpose of events and goals related to purpose in life Purpose in Life Scale
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 anxietydepression 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 anxietydepression HADS and purpose of events and goals related to purpose in life Purpose in Life Scale
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None