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App plus therapist sessions may help WTC responders with PTSD

NCT ID NCT06648928

Symptom relief Sponsor: Florida International University Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only This study
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Sep 11, 2026 · Updated 2 times

Summary

This study tests whether a mobile app called PTSD Coach, with or without brief clinician support, can reduce PTSD, anxiety, depression, and sleep problems in World Trade Center responders living in Florida. About 120 English- or Spanish-speaking responders will be randomly assigned to use the app alone, the app plus four remote therapy sessions, or a waitlist. The goal is to see if these app-based approaches are practical and effective for this group, especially Hispanic responders.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Clinician-supported PTSD Coach mobile app
What this could lead to
If it works, this could provide a scalable, remotely delivered treatment option for PTSD and related symptoms in WTC responders, especially Hispanic and Spanish-speaking groups.
What could go wrong
This is a small, early-stage feasibility study (120 participants) with no blinding, and results may not generalize to all populations. The app is not a substitute for in-person care for severe cases.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 120 people

The number the study aims to enrol. It can still change while the study runs.

Started

Feb 2025

Expected to finish

Jul 2027

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

Children (under 18), adults (18 to 64) and older adults (65 and over)

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * 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. Exclusion Criteria: * 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.

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Conditions

The condition(s) this trial relates to.

anxiety anxiety disorder Depression depressive disorder Parasomnias post-traumatic stress disorder Psychological Well-Being sleep disorder

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Anxiety symptoms Depression symptoms PTSD symptoms Sleep disturbance

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    The full official record for this study. This one lists no contact details, but it is the first place any would appear.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Florida International University

    Miami, Florida, 33199, United States

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