NCT lookup
Pull any trial record directly from ClinicalTrials.gov.
Sponsor: Florida International University
Conditions: PTSD Symptoms, Anxiety Symptoms, Depression Symptoms, Sleep Disturbance
Interventions: Clinician Supported PTSD Coach, Self Managed PTSD Coach
Countries: United States
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.
Sex: ALL
Healthy volunteers: No
Study type: INTERVENTIONAL
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.
- Miami, Florida, United States