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Depression Symptoms / Clinician Supported PTSD Coach / Self Managed PTSD Coach · Interventional Study
ClinicalTrials.gov · September 10, 2026
Early or partial results. Treat as a signal, not a conclusion.
This is a registration for an ongoing randomized controlled trial examining a clinician-supported mobile app (PTSD Coach) for mental health symptoms in World Trade Center responders in Florida. The study is currently enrolling by invitation and has not yet reported results; the design includes a three-arm comparison (clinician-supported app, self-managed app, and waitlist control) with assessments at 8 and 12 weeks.
Interventional, Randomized, Parallel, Single masking, Treatment purpose. PTSD Symptoms, Anxiety Symptoms, Depression Symptoms, Sleep Disturbance. Intervention: Clinician Supported PTSD Coach. Compared with: Self Managed PTSD Coach application — Active Comparator; Wait list control — No Intervention. n = 120. 1 site: United States.
This is a registration for an ongoing randomized controlled trial examining a clinician-supported mobile app (PTSD Coach) for mental health symptoms in World Trade Center responders in Florida. The study is currently enrolling by invitation and has not yet reported results; the design includes a three-arm comparison (clinician-supported app, self-managed app, and waitlist control) with assessments at 8 and 12 weeks.
This is a registry record with no results posted; no efficacy or safety outcomes are available for evaluation.
No clinical impact can be assessed until results are posted. This trial addresses a gap in evidence for app-based mental health interventions in an understudied population (Hispanic WTC responders) and may inform scalable, remotely delivered treatment options if positive results are found.
This is a registry record for an ongoing interventional trial with no results posted; enrollment is in progress and the study design is sound but results are not yet available to assess.
As stated by the source record.
Quoted from the source exactly as published.
No clinical impact can be assessed until results are posted. This trial addresses a gap in evidence for app-based mental health interventions in an understudied population (Hispanic WTC responders) and may inform scalable, remotely delivered treatment options if positive results are found.
Graded across the dimensions that decide whether you should act, each from what the source actually supports. There is no single score, and where a dimension was not assessed it says so.
What is missing. This record has no key findings. That is a gap in the analysis, not a judgement about the study.
Registry record from ClinicalTrials.gov (NCT06648928). This is a study registration, not published results. Lead sponsor: Florida International University. Recruitment status: ENROLLING_BY_INVITATION. Phase: NA. Study type: INTERVENTIONAL. Enrollment: 120 participants (ESTIMATED). Conditions: PTSD Symptoms, Anxiety Symptoms, Depression Symptoms, Sleep Disturbance. Interventions: BEHAVIORAL: Clinician Supported PTSD Coach; BEHAVIORAL: Self Managed PTSD Coach. Primary outcome measures: PTSD Checklist for DSM-5 (PCL-5) , Evaluate changes in PTSD symptoms from pretest to posttest (8 weeks) and follow-up four weeks later (12 weeks).. 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.
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