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Clinician Supported Mobile App to Reduce Mental Health Symptoms Among World Trade Center Responders in Florida

Study acronym: PTSDCoach911
StatusEnrolling by Invitation
PhaseNot applicable
Started
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary completion moved at least 7 months later Jun 2026 → Feb 2027
See other at-risk trials from Florida International University

Record History

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  1. Notable Primary completion pushed from Jun 2026 to Feb 2027
    • Study completion pushed from Jul 2026 to Jul 2027
    • Publications expanded, about 54 words
    v7
  2. Minor Eligibility criteria revised
    • Study description shortened, about 544 words
    v6
  3. Minor Start date changed from estimate of Feb 2025 to Feb 21, 2025v5
  4. Notable Trial status: Not Yet Recruiting to Enrolling by Invitation
    • Site contact updated
    v4
  5. Notable Start date: Dec 2024 to Feb 2025
    • Primary completion date: May 2026 to Jun 2026
    v3
  6. Minor Start date: Nov 2024 to Dec 2024v2
  7. 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
3,263 trials monitored
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3,055 trials monitored
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889 trials monitored
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This study examines mental health challenges among World Trade Center (WTC) General Responders, who continue to experience significant psychological trauma from the WTC collapse. PTSD and depression remain common, and nearly six percent of the WTC Health Program (WTCHP) cohort now resides in Florida. Many identify as Hispanic, underscoring the need for linguistically appropriate services. Research shows that remotely delivered, clinician-supported mobile applications can reduce mental health symptoms. PTSD Coach, developed by the Veterans Administration, is a free self-managed mobile app designed to help users manage PTSD symptoms through tools such as relaxation exercises, calming self-talk, and sleep hygiene practices. Reviews of the app have found it feasible, acceptable, and effective in reducing PTSD symptoms. Clinician-Supported PTSD Coach was designed for individuals unlikely to use the app independently. This model pairs the PTSD Coach app with four remote 20-30-minute clinician sessions over eight weeks. Studies with Veterans demonstrate reductions in PTSD and depression, higher satisfaction, and increased treatment engagement compared with usual care. However, these interventions have not yet been tested with WTC General Responders or Hispanic populations. This study will evaluate the feasibility, acceptability, and effectiveness of Clinician-Supported PTSD Coach in reducing PTSD, depression, anxiety, and sleep disturbances among English- and Spanish-speaking WTC General Responders in Florida. Participants will be randomly assigned to one of three conditions: (1) Clinician-Supported PTSD Coach, (2) Self-Managed PTSD Coach, or (3) Waitlist Control. Assessments at 8 and 12 weeks will measure symptom reductions and examine engagement, satisfaction, and barriers within the app-based conditions. It is expected that both interventions will reduce symptoms, with greater improvements in the clinician-supported condition. This project addresses a critical gap in evidence-based mental health treatments for dispersed WTC Responders and responds to the WTCHP Scientific/Technical Advisory Committee's call for more research on mental health interventions. By focusing on Hispanic and Spanish-speaking Responders-an understudied group-this study may support the development of scalable, app-based interventions that can be deployed nationally to meet the mental health needs of WTC responders and survivors.
Trial Details
NCT Number NCT06648928
Lead Sponsor Florida International University
Collaborators: Centers for Disease Control and Prevention, National Institute for Occupational Safety and Health (NIOSH/CDC)
Conditions
(from sponsor)
PTSD Symptoms, Anxiety Symptoms, Depression Symptoms, Sleep Disturbance
Related terms Anxiety Disorders, Depression, Parasomnias, Psychological Well-Being
Enrollment 120 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov