NCT04959695 · VA Office of Research and Development
Evaluation of the PE Coach Mobile Application Among Veterans With PTSD
What this study is about
Thousands of mental health mobile applications (apps) are available but limited research has been conducted on their effectiveness.
View original scientific description
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.
Interventions
BEHAVIORAL
PE Coach
PE Coach is a treatment companion mobile application designed with features to support the tasks of prolonged exposure psychotherapy and the homework between sessions.
BEHAVIORAL
Prolonged exposure without PE Coach
Standard PE treatment protocol without PE Coach
Primary outcome measures
Change in Posttraumatic Stress Related Functioning Inventory (PRFI) from baseline to mid-treatment, post-treatment, 1-month post-treatment f/up, 4-month post-treatment f/up
Time frame: Pre-treatment (Baseline), approx week 8 (mid-treatment), approx. week 16 (post-treatment), approx week 20 (1-month f/up), approx week 32 (4-month f/up)
The PRFI is a 33-item, self -report measure of,functioning related to three domains: work and school, relationships, and lifestyle. Each domain is assessed with two subscales, including a Symptom Cluster Impact scale, which assess the impact of each DSM-5 PTSD symptom cluster on functioning in that domain, and a Total Symptom Impact subscale, which assesses the impact of all PTSD symptoms.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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
- Seattle, Washington
Collaborators
Defense Centers of Excellence for Psychological Health and Traumatic Brain Injury
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jan 15, 2026 · Source of record for eligibility and locations