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Behavioral Intervention
Mobile App Support for Post-Traumatic Stress Disorder (PTSDCoach911 Trial)
N/A
Waitlist Available
Led By Mark Macgowan, PhD
Research Sponsored by Florida International University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Must not have
Current mental health treatment for PTSD
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)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up evaluate changes in sleep disturbance symptoms from pretest to posttest (8 weeks) and follow-up four weeks later (12 weeks).
Awards & highlights
No Placebo-Only Group
Summary
This trial focuses on helping World Trade Center General Responders who are facing mental health challenges like PTSD and depression. Many of these responders have moved to Florida and identify as Latinx. The study will test
Who is the study for?
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.
What is being tested?
The study tests a mobile app called PTSD Coach to manage PTSD symptoms. Participants will either use the app on their own (Self-Managed) or with clinician support over eight weeks. A third group waits without treatment initially. The effectiveness of reducing mental health symptoms is measured after 8 and 12 weeks.
What are the potential side effects?
Since this intervention involves a mobile application designed to help manage PTSD symptoms rather than medication, traditional side effects are not expected. However, users may experience discomfort if memories are triggered during usage.
Eligibility Criteria
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I am receiving treatment for PTSD.
Select...
I have a condition like Parkinson's or Alzheimer's that affects my thinking.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ evaluate changes in ptsd symptoms from pretest to posttest (8 weeks) and follow-up four weeks later (12 weeks).
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~evaluate changes in ptsd symptoms from pretest to posttest (8 weeks) and follow-up four weeks later (12 weeks).
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
PTSD Checklist for DSM-5 (PCL-5)
Secondary study objectives
Generalized Anxiety Disorder-7 (GAD-7)
Insomnia Severity Index (ISI)
Patient Health Questionnaire-9 (PHQ-9).
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
3Treatment groups
Experimental Treatment
Active Control
Group I: Clinician Supported PTSD CoachExperimental Treatment1 Intervention
PTSD Coach application combined with remotely delivered clinician support, focusing on app use, symptom monitoring, and management strategies.
Group II: Self Managed PTSD Coach applicationActive Control1 Intervention
Participant remotely receives basic instructions on using the PTSD Coach application but receives no further clinician support
Group III: Wait list controlActive Control1 Intervention
No intervention until after the follow-up assessment when they have a choice of receiving either CS PTSD Coach or SM PTSD Coach.
Find a Location
Who is running the clinical trial?
National Institute for Occupational Safety and Health (NIOSH/CDC)FED
43 Previous Clinical Trials
49,908 Total Patients Enrolled
1 Trials studying Depression
17 Patients Enrolled for Depression
Florida International UniversityLead Sponsor
106 Previous Clinical Trials
18,820 Total Patients Enrolled
6 Trials studying Depression
978 Patients Enrolled for Depression
Centers for Disease Control and PreventionFED
891 Previous Clinical Trials
22,000,174 Total Patients Enrolled
10 Trials studying Depression
1,895 Patients Enrolled for Depression
Mark Macgowan, PhDPrincipal InvestigatorFlorida International University