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Effects of "Alliance180 Program" on Well-Being

StatusRecruiting
PhaseNot applicable
Started
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary completion moved at least 11 months later Sep 2026 → Sep 2027
See other at-risk trials from University of North Carolina, Chapel Hill

Record History

  1. Notable Primary and study completion pushed from Sep 2026 to Sep 2027 Secondary endpoints: details revised at 10 of 10 entries · Eligibility criteria expanded, about 2 words · Study description expanded, about 3 words Show 3 more changesShow less
    • Secondary endpoints: details revised at 10 of 10 entries
    • Eligibility criteria expanded, about 2 words
    • Study description expanded, about 3 words
  2. Notable Primary and study completion dates: Jan 2026 to Sep 2026v5
  3. Minor Primary and study completion dates: Oct 2025 to Jan 2026v4
  4. Minor Start date changed from estimate of Jun 2024 to Jun 24, 2024v3
  5. Notable Trial status: Not Yet Recruiting to Recruiting Start date: Jul 2024 to Jun 2024 · Site details revised at 2 of 2 sitesv2 Show 2 more changesShow less
    • Start date: Jul 2024 to Jun 2024
    • Site details revised at 2 of 2 sites
  6. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT06451523
Lead Sponsor University of North Carolina, Chapel Hill
Collaborators: Alliance180, Inc.
Conditions Trauma and Stressor Related Disorders
Enrollment 50 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov