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

Part of paid clinical trials in Miami, Florida.

Sponsor
Florida International University
Study ID
NCT06648928
Status
Enrolling By Invitation

Conditions

  • Anxiety Symptoms
  • Depression Symptoms
  • PTSD Symptoms
  • Sleep Disturbance

Eligibility Criteria

Sex
ALL
Age
N/A - N/A
Healthy Volunteers
Not accepted

Interventions

  • Clinician Supported PTSD Coach — BEHAVIORAL
    Combines self-managed PTSD Coach application with four 20-30 minute sessions delivered by a clinician. The app includes modules on learning about PTSD, self-assessment, symptom management, and finding support.
  • Self Managed PTSD Coach — BEHAVIORAL
    A widely available mobile application designed to help individuals manage PTSD symptoms available in English and Spanish.

Study Details

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.

Key Dates

Start date
Feb 21, 2025
Status verified
Feb 2026
Primary completion
Jun 30, 2026
Completion
Jul 31, 2026

Study Design

Enrollment
120 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Clinician Supported PTSD Coach
    PTSD Coach application combined with remotely delivered clinician support, focusing on app use, symptom monitoring, and management strategies.
  • Active Comparator: Self Managed PTSD Coach application
    Participant remotely receives basic instructions on using the PTSD Coach application but receives no further clinician support
  • No Intervention: Wait list control
    No intervention until after the follow-up assessment when they have a choice of receiving either CS PTSD Coach or SM PTSD Coach.

Primary Outcome Measure

PTSD Checklist for DSM-5 (PCL-5) [ Time Frame: Evaluate changes in PTSD symptoms from pretest to posttest (8 weeks) and follow-up four weeks later (12 weeks). ]

Locations (1)

FacilityCityStateZIPSite coordinators
Florida International UniversityMiamiFlorida33199-

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By research site
Florida International University· Miami, FL

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