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| Name | Class |
|---|---|
| Alliance180, Inc. | INDUSTRY |
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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:
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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Alliance180 Program | Experimental | Participants will attend the 3-day Alliance180 Program. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
- Individuals who have previously completed the "Alliance180 Program"
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Keri J Heilman, PhD | Contact | 913-802-2168 | keri_heilman@med.unc.edu |
| Name | Affiliation | Role |
|---|---|---|
| Keri J Heilman, PhD | University of North Carolina, Chapel Hill | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Alliance180 | Recruiting | Saratoga Springs | New York | 12866 | United States |
Deidentified individual data that supports the results will be shared beginning 9 to 36 months following publication provided the investigator who proposes to use the data has approval from an Institutional Review Board (IRB), Independent Ethics Committee (IEC), or Research Ethics Board (REB), as applicable, and executes a data use/sharing agreement with the University of North Carolina, Chapel Hill (UNC).
Beginning 9 and continuing for 36 months after publication
Investigator has approved IRB, IEC, or REB and an executed data use/sharing agreement with the University of North Carolina, Chapel Hill (UNC).
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| ID | Term |
|---|---|
| D000068099 | Trauma and Stressor Related Disorders |
| ID | Term |
|---|---|
| D001523 | Mental Disorders |
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All participants will follow the same procedures.
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| Baseline, 1 month |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| University of North Carolina at Chapel Hill | Recruiting | Chapel Hill | North Carolina | 27599-7160 | United States |
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