Trauma and Stressor Related DisordersNCT06451523
Effects of "Alliance180 Program" on Well-Being
A study testing Alliance180 Program in people with Trauma and Stressor Related Disorders, run by University of North Carolina, Chapel Hill at 2 sites in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Trauma and Stressor Related Disorders
- What is being tested?
- Alliance180 Program
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 2 sitesUnited States
- Study dates
- 24 Jun 2024to Sep 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- Individuals who have previously completed the "Alliance180 Program"
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites, 2 recruiting
- Recruiting
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, 27599-7160
Keri J Heilman, PhD
- Recruiting
Alliance180
Saratoga Springs, New York, 12866
Janelle Huggard, 518-225-8353
Bob Nevins
About this study
Official title: Effects of "Alliance180 Program" on Psychological and Physical Well-Being
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:
Read more
- 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.
Read the 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.
- 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).
- Participate in the 3-day Alliance180 Program (intervention), which includes the Transformative Equine Experience.
- 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).
- Conditions
- Trauma and Stressor Related Disorders
- Being tested
- Alliance180 Program
- Keywords
- Anxiety Depression, Autonomic Reactivity, Polyvagal Theory
- Medical subject headings
- Trauma and Stressor Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Alliance180 ProgramOther
The Alliance180 Program promotes feelings of neuropsychological safety and trust in the context of a 3-day program, which includes the transformative equine experience.
| Study group | Role | What they receive |
|---|---|---|
| Alliance180 Program | Experimental | Participants will attend the 3-day Alliance180 Program. Receives: Other: Alliance180 Program |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Baseline, 1 month
Secondary outcomes (10)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline, 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jun 2024
- Study start24 Jun 2024
- Primary completionSep 2027 (estimated)
- Study completionSep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Trauma and Stressor Related DisordersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- All participants will follow the same procedures.
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of North Carolina, Chapel Hill
- Sponsor type
- University, hospital or other
- Collaborators
- Alliance180, Inc.
- Responsible party
- Sponsor
- Investigators
- Keri J Heilman, PhD, Principal investigator, University of North Carolina, Chapel Hill
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06451523
- Sponsor's protocol ID
- 23-2072
- Status last verified
- Sep 2026
- First submitted
- 4 Jun 2024
- Last updated
- 21 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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).
Study at a glance
From the registry record, last updated by the sponsor on 21 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of "Alliance180 Program" on Psychological and Physical Well-Being
- ClinicalTrials.gov ID
- NCT06451523
- Acronym / sponsor ID
- 23-2072
- Conditions
- Trauma and Stressor Related Disorders
- Keywords
- Anxiety Depression, Autonomic Reactivity, Polyvagal Theory
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- University of North Carolina, Chapel HillUniversity, hospital or other
- Collaborators
- Alliance180, Inc.
- Study start
- 24 Jun 2024 (actual)
- Primary completion
- Sep 2027 (estimated)
- Study completion
- Sep 2027 (estimated)
- First posted
- 11 Jun 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
- 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).
- Participate in the 3-day Alliance180 Program (intervention), which includes the Transformative Equine Experience.
- 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).
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- All participants will follow the same procedures.
| Arm | Type | Receives |
|---|---|---|
| Alliance180 Program | Experimental | Other: Alliance180 ProgramParticipants will attend the 3-day Alliance180 Program. |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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)
Key exclusion criteria (1 listed)
- Individuals who have previously completed the "Alliance180 Program"
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Alliance180 ProgramThe Alliance180 Program promotes feelings of neuropsychological safety and trust in the context of a 3-day program, which includes the transformative equine experience. | Other | Alliance180 Program |
Primary outcome
Change in the Anxiety Subscale of the Hospital Anxiety and Depression Scale
Time frame: Baseline, 1 month
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.
Change in the Depression Subscale of the Hospital Anxiety and Depression Scale
Time frame: Baseline, 1 month
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.
10 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Sep 2026.
- Individual participant dataSharing planned: Yes. 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).
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Keri J Heilman, PhD principal investigator
University of North Carolina, Chapel Hill
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Alliance180 Program in people with Trauma and Stressor Related Disorders, run by University of North Carolina, Chapel Hill at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 21 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Keri J Heilman, PhD (913-802-2168, keri_heilman@med.unc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in the Anxiety Subscale of the Hospital Anxiety and Depression Scale (time frame: Baseline, 1 month). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Sep 2026.