Evaluation of the PE Coach Mobile Application Among Veterans With PTSD
Randomized Trial of Prolonged Exposure (PE) vs. PE With PE Coach Among Veterans With PTSD
VA Office of Research and Development
124 participants
Jul 29, 2022
INTERVENTIONAL
Conditions
Summary
Thousands of mental health mobile applications (apps) are available but limited research has been conducted on their effectiveness. VA has been a leader in mental health mobile app development and must research whether these apps work, and if so, how? PE Coach is a well-designed treatment companion app to one of the most researched, efficacious psychotherapies for PTSD (prolonged exposure), a treatment that has been broadly disseminated throughout VA mental health clinics. Research suggests that VA therapists find the app helpful in supporting patients. Preliminary results suggest that Veteran patients prefer to receive therapy with PE Coach and Veterans complete more recovery-oriented homework when they do. This study will randomize 124 Veterans with PTSD to treatment with or without PE Coach. The project will evaluate the effect of the app on PTSD-related functioning, quality of life, and PTSD symptoms. The investigators will test whether the app improves functioning and symptoms, increases homework, and reduces drop out.
Eligibility
Inclusion Criteria5
- Veterans aged 18-65
- enrolled in VA healthcare and eligible for VA PTSD psychotherapy
- current diagnosis of PTSD based on CAPS-5, Minimum total severity score of 26 or higher
- English language fluency
- willingness to participate in individual, in-person or telemental health PE psychotherapy including use of a mobile device
Exclusion Criteria10
- neurological conditions (based on review of the volunteer's medical record) that are severe enough to interfere with PE treatment and assessments (i.e., diagnosed Major Neurocognitive Disorder, severe neurological disorders (e.g., ALS), and those with severe TBI history). Neurological disorders that may result in mildly impaired cognitive function (such as multiple sclerosis or those with history of mild or moderate severity TBI) will be eligible, pending a score of 6 or higher on the Short Portable Mental Status Questionnaire
- current intent to suicide
- behavioral patient record flag in the VA medical record
- a history of a serious mental health condition listed in their medical record problem list that is known to include psychotic symptoms, such as schizophrenia or a depressive disorder with psychotic features. We will also ask for self -reported indicators of psychosis, using an existing interview template
- in an ongoing threatening situation (e.g. domestic violence)
- positive screen for severe alcohol use disorder, as indicated by an AUDIT score equal to or higher than 13 or 15 for women and men, respectively
- prior history of 3 or more sessions of PE therapy for PTSD
- other current psychotherapy for PTSD that is recommended (with at least weak strength) in the VA/DoD Clinical Practice Guideline for the treatment of PTSD
- a physical condition that interferes with the proper use of a mobile device.
- not stable on psychotropic medications for at least 6 weeks prior to enrollment
Interventions
PE Coach is a treatment companion mobile application designed with features to support the tasks of prolonged exposure psychotherapy and the homework between sessions.
Standard PE treatment protocol without PE Coach
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT04959695