Clinician Supported Mobile App to Reduce Mental Health Symptoms Among World Trade Center Responders in Florida
PTSDCoach911
2 other identifiers
interventional
120
1 country
1
Brief Summary
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 Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Feb 2025
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 17, 2024
CompletedFirst Posted
Study publicly available on registry
October 18, 2024
CompletedStudy Start
First participant enrolled
February 21, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
July 1, 2026
February 18, 2026
February 1, 2026
1.3 years
October 17, 2024
February 16, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
PTSD Checklist for DSM-5 (PCL-5)
A self-report measure used to assess the presence and severity of PTSD symptoms. It consists of 20 items that correspond to the DSM-5 criteria for PTSD.
Evaluate changes in PTSD symptoms from pretest to posttest (8 weeks) and follow-up four weeks later (12 weeks).
Secondary Outcomes (3)
Patient Health Questionnaire-9 (PHQ-9).
Evaluate changes in depression symptoms from pretest to posttest (8 weeks) and follow-up four weeks later (12 weeks).
Generalized Anxiety Disorder-7 (GAD-7)
Evaluate changes in anxiety symptoms from pretest to posttest (8 weeks) and follow-up four weeks later (12 weeks).
Insomnia Severity Index (ISI)
Evaluate changes in sleep disturbance symptoms from pretest to posttest (8 weeks) and follow-up four weeks later (12 weeks).
Study Arms (3)
Clinician Supported PTSD Coach
EXPERIMENTALPTSD Coach application combined with remotely delivered clinician support, focusing on app use, symptom monitoring, and management strategies.
Self Managed PTSD Coach application
ACTIVE COMPARATORParticipant remotely receives basic instructions on using the PTSD Coach application but receives no further clinician support
Wait list control
NO INTERVENTIONNo intervention until after the follow-up assessment when they have a choice of receiving either CS PTSD Coach or SM PTSD Coach.
Interventions
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.
A widely available mobile application designed to help individuals manage PTSD symptoms available in English and Spanish.
Eligibility Criteria
You may qualify if:
- World Trade Center General Responders (GRs) currently living in Florida.
- Any age.
- Must have a smartphone device capable of using the PTSD Coach app.
- Must be fluent in either English or Spanish.
You may not qualify if:
- Active or recent (past month) suicidal ideation or attempt.
- Low levels of distress as measured by the PCL-5 (score below 27).
- Severe alcohol use measured by an AUDIT score of 20 or above.
- Use of illicit or unprescribed drugs (except for cannabis) in the last 2 weeks, as indicated on the Modified ASSIST Measure.
- Presence of neurologic or neurodegenerative conditions associated with significant cognitive impairment (e.g., Parkinson's, Alzheimer's diseases) or current severe cognitive impairment measured using the Montreal Cognitive Assessment (MoCA).
- Current mental health treatment for PTSD.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Florida International University
Miami, Florida, 33199, United States
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Mark Macgowan, PhD
Florida International University
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 17, 2024
First Posted
October 18, 2024
Study Start
February 21, 2025
Primary Completion (Estimated)
June 1, 2026
Study Completion (Estimated)
July 1, 2026
Last Updated
February 18, 2026
Record last verified: 2026-02
Data Sharing
- IPD Sharing
- Will not share
Protecting the privacy of these World Trade Center General Responders is paramount. Sharing IPD could risk exposing sensitive personal information, even if anonymized, which might lead to re-identification.