Using a mobile app to help Veterans with PTSD

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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• Multi‑Mode Cognitive Processing Therapy for adults with PTSD

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• Improving thinking, daily functioning, mood, and sleep after mild traumatic brain injury and PTSD

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• Combined MDMA and psilocybin treatment for Veterans with PTSD

  This trial tests whether giving MDMA followed 30 minutes later by psilocybin can be safely used to reduce symptoms in military veterans with long-standing PTSD.

  Recruiting Phase 1 Johns Hopkins University · Baltimore, Maryland · NCT06989957

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.