Recruiting

PE Coach

Sponsor:

VA Office of Research and Development

Code:

NCT04959695

Conditions

Posttraumatic Stress Disorder

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Not accepted

Interventions

PE Coach

Prolonged exposure without PE Coach

Study Details

Brief 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.

Conditions

Posttraumatic Stress Disorder

Study ID

NCT04959695

Start date

Jul 29, 2022

Status verified date

Jan, 2026

Completion date

Sep 30, 2027

Anticipated

Primary completion date

Jun 30, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

124 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Prolonged exposure with PE Coach

The mobile application will be incorporated into each PE psychotherapy session and used to support homework between sessions.

active comparator: Prolonged exposure without PE Coach

Standard PE treatment protocol without PE Coach

Interventions

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.

Prolonged exposure without PE Coach

Standard PE treatment protocol without PE Coach

Primary outcome measure

  • 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) ]

Central Contacts and Locations

Central contacts

Greg M Reger, PhD

(253) 583-1677Greg.Reger@va.gov

Eric R Kuhn, PhD

(650) 493-5000Eric.Kuhn@va.gov

Locations

VA Puget Sound Health Care System Seattle Division, Seattle, WA

Recruiting

Seattle, Washington, United States, 98108-1532

Contacts

Amy Marsh

206-764-2670amy.marsh@va.gov

Christopher Click

(206) 277-2155christopher.click@va.gov

Principal Investigator:

Greg M. Reger, PhD

More Information

Sponsor

VA Office of Research and Development

Last update posted

Jan 15, 2026

Last verified

Jan, 2026

Keywords

  • posttraumatic stress disorder
  • prolonged exposure
  • exposure therapy
  • mobile applications
  • PE Coach
  • cognitive behavioral therapy

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by VA Office of Research and Development on 2026-01-15.