Evaluation of the PE Coach Mobile Application Among Veterans With PTSD

Part of paid clinical trials in Seattle, Washington.

Sponsor
VA Office of Research and Development
Study ID
NCT04959695
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 65 Years
Healthy Volunteers
Not accepted

Interventions

  • PE Coach — BEHAVIORAL
    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 — BEHAVIORAL
    Standard PE treatment protocol without PE Coach

Study Details

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.

Key Dates

Start date
Jul 29, 2022
Status verified
Jan 2026
Primary completion
Jun 30, 2027
Completion
Sep 30, 2027

Study Design

Enrollment
124 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

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

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

Locations (1)

FacilityCityStateZIPSite coordinators
VA Puget Sound Health Care System Seattle Division, Seattle, WASeattleWashington98108-1532
Amy Marsh
[email protected]
206-764-2670
Christopher Click
[email protected]
(206) 277-2155
Greg M. Reger, PhD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Seattle, WA

By condition
PTSD (post-traumatic stress disorder)
By specialty
PsychiatryMental healthBehavioral health
By research site
VA Puget Sound Health Care System Seattle Division, Seattle, WA· Seattle, WA

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