Mobile App Support for Post-Traumatic Stress Disorder
(PTSDCoach911 Trial)
Trial Summary
Do I have to stop taking my current medications for this trial?
The trial protocol does not specify whether you need to stop taking your current medications. However, if you are currently receiving mental health treatment for PTSD, you may not be eligible to participate.
What data supports the effectiveness of the treatment Clinician Supported PTSD Coach, Self Managed PTSD Coach for Post-Traumatic Stress Disorder?
Research shows that the PTSD Coach app, used for self-managing PTSD symptoms, is well-received by users and perceived as helpful. While studies indicate high user satisfaction and potential benefits in managing PTSD symptoms, more research is needed to confirm its effectiveness, especially in diverse populations and settings.12345
Is the PTSD Coach app safe for use in humans?
How is the Clinician Supported PTSD Coach treatment different from other PTSD treatments?
The Clinician Supported PTSD Coach treatment is unique because it uses a mobile app to provide psycho-education and self-management tools for PTSD, making it accessible to those who may not have access to traditional therapy due to barriers like stigma or lack of providers. This app-based approach allows for self-management of symptoms and has been adapted for use in multiple countries, offering a flexible and widely accessible option for individuals with PTSD.12347
What is the purpose of this trial?
This study focuses on the mental health challenges faced by the World Trade Center's (WTC) General Responders due to the severe psychological trauma from the WTC collapse. PTSD and depression are among the top mental health conditions affecting these responders. Many members of the WTC Health Program (WTCHP) have relocated to Florida, making up nearly six percent of the cohort. Furthermore, many identify as Latinx, highlighting the need for services in their preferred language to promote health equity. Studies have shown that remotely-delivered, clinician-supported applications (apps) can reduce adverse MH symptoms.PTSD Coach was developed by the Veteran's Administration as a self-managed mobile app and is available at no cost for Android and Apple devices. The primary focus of PTSD Coach is on managing PTSD symptoms. The app offers coping tools such as relaxation exercises and calming self-talk and effective sleep hygiene practices when needed. A recent review evaluated the self-managed PTSD Coach app and found it to be feasible, acceptable, and effective in reducing PTSD symptoms.Clinician-Supported PTSD Coach was developed as a brief intervention for Veterans who were unlikely to use a mobile app on their own. Clinician Supported PTSD Coach combines PTSD Coach mobile app with four remotely-delivered 20-30 minute sessions over 8 weeks with a clinician. Studies with Veterans have reported significant reductions in PTSD and depression symptoms, treatment satisfaction and more treatment sessions attended, when compared with typical mental health care. While promising, none of these studies included WTC General Responders or focused on Latinx populations.Given the promise of these interventions, and the need to provide support for geographically dispersed General Responders in Florida, this study aims to evaluate the feasibility, acceptability, and effectiveness of Clinician Supported PTSD Coach in reducing symptoms of PTSD, depression, anxiety, and sleep disturbances among English and Spanish-speaking WTC General Responders. Participants will be randomly assigned to one of three conditions:1. Clinician-Supported PTSD Coach2. Self-Managed PTSD Coach3. Waitlist Control (no treatment until after follow-up)Assessments will be conducted at the end of treatment (8 weeks) and at follow-up (12 weeks). The study will measure reductions in PTSD, depression, anxiety, and sleep disturbances at 8 weeks and 12 weeks. It is expected that both Clinician Supported PTSD Coach and Self-Managed PTSD Coach will reduce symptoms, with Clinician Supported PTSD Coach showing larger reductions. In addition, to assess feasibility and acceptability, the study will assess engagement, satisfaction, and barriers in both PTSD Coach app conditions.This project aims to fill a significant gap in evidence-based mental health treatments for WTC General Responders. It responds to the WTCHP Scientific Technical Advisory Committee's call for more research on mental health interventions and addresses the critical shortage of rigorously tested app-based remote interventions for dispersed General Responders with PTSD. The study also focuses on Spanish-speaking Latinx General Responders, a group that has not been specifically targeted in previous interventions. The study's findings could lead to the development of readily deployable interventions nationally to meet the mental health needs of WTC responders and survivors, providing a valuable resource for treatment researchers and health care providers.
Research Team
Mark Macgowan, PhD
Principal Investigator
Florida International University
Eligibility Criteria
This trial is for World Trade Center General Responders now living in Florida, who have smartphones and are fluent in English or Spanish. It's not for those with recent suicidal thoughts, low distress levels, severe alcohol use, recent illicit drug use (except cannabis), or significant cognitive impairment.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive either Clinician-Supported PTSD Coach or Self-Managed PTSD Coach over 8 weeks
Follow-up
Participants are monitored for changes in PTSD, depression, anxiety, and sleep disturbances
Treatment Details
Interventions
- Clinician Supported PTSD Coach
- Self Managed PTSD Coach
Find a Clinic Near You
Who Is Running the Clinical Trial?
Florida International University
Lead Sponsor
National Institute for Occupational Safety and Health (NIOSH/CDC)
Collaborator
Centers for Disease Control and Prevention
Collaborator