Using a mobile app to help Veterans with PTSD
Randomized Trial of Prolonged Exposure (PE) vs. PE With PE Coach Among Veterans With PTSD
This study is testing whether a mobile app can help Veterans with PTSD stick to their therapy and feel better compared to those who only receive therapy.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 124 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | VA Office of Research and Development Federal |
| Locations | 1 site (Seattle, Washington) |
| Trial ID | NCT04959695 on ClinicalTrials.gov |
What this trial studies
This study evaluates the effectiveness of the PE Coach mobile application in assisting Veterans with Posttraumatic Stress Disorder (PTSD) during prolonged exposure therapy. It aims to determine if the app enhances treatment adherence and improves PTSD-related functioning, quality of life, and symptoms. A total of 124 Veterans will be randomized to receive either the app alongside therapy or therapy alone, allowing researchers to assess the app's impact on treatment outcomes. The study is significant as it addresses the high dropout rates in PTSD therapy and seeks to provide cognitive support to improve recovery.
Who should consider this trial
Good fit: Ideal candidates for this study are Veterans aged 18-65 who are enrolled in VA healthcare and have a current diagnosis of PTSD.
Not a fit: Patients with severe neurological conditions or those currently at risk of suicide may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved treatment adherence and outcomes for Veterans suffering from PTSD.
How similar studies have performed: Other studies have shown promise in using mobile applications to support mental health treatments, but this specific approach is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 Criteria: * 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
Where this trial is running
Seattle, Washington
- VA Puget Sound Health Care System Seattle Division, Seattle, WA — Seattle, Washington, United States (Recruiting)
Study contacts
- Principal investigator: Greg M. Reger, PhD — VA Puget Sound Health Care System Seattle Division, Seattle, WA
- Study coordinator: Greg M Reger, PhD
- Email: Greg.Reger@va.gov
- Phone: (253) 583-1677
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.