Evaluation of the PE Coach Mobile Application Among Veterans With PTSD

NCT04959695 | Recruiting DMC

• 1 other identifier: D3503-R
• Study Type: interventional
• Target: 124
• Locations: 1 country
• Sites: 1

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

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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

  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.

  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)

Secondary Outcomes (13)

• Change in World Health Organization Disability Assessment Schedule 2.0 (WHODAS 2.0) from baseline to mid-treatment, post-treatment, 1-month post-treatment f/up, and 4-month post-treatment f/up

  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)

• Change in World Health Organization Quality of Life Instrument, Abbreviated Version (WHOQOL-BREF) from baseline to mid-treatment, post-treatment, 1-month post-treatment f/up, and 4-month post-treatment f/up

  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)

• Change in Clinical Global Impression of Change - Symptoms and Improvement (CGI-Symptoms) from mid-treatment to post-treatment, 1-month post-treatment f/up, and 4-month post-treatment f/up

  approx week 8 (mid-treatment), approx. week 16 (post-treatment), approx week 20 (1-month f/up), approx week 32 (4-month f/up)

• Change in Beck Depression Inventory-II (BDI-II) from baseline to mid-treatment, post-treatment, 1-month post-treatment f/up, 4-month post-treatment f/up

  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)

• Change in Columbia-Suicide Severity Rating Scale (C-SSRS) from baseline to mid-treatment, post-treatment, 1-month post-treatment f/up, and 4-month post-treatment f/up

  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)

Study Arms (2)

Prolonged exposure with PE Coach

EXPERIMENTAL

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

Behavioral: PE Coach

Prolonged exposure without PE Coach

ACTIVE COMPARATOR

Standard PE treatment protocol without PE Coach

Behavioral: Prolonged exposure without PE Coach

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 with PE Coach

Prolonged exposure without PE Coach BEHAVIORAL

Standard PE treatment protocol without PE Coach

Prolonged exposure without PE Coach

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• VA Office of Research and Development: lead
• Defense Centers of Excellence for Psychological Health and Traumatic Brain Injury: collaborator

Study Sites (1)

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

Seattle, Washington, 98108-1532, United States

RECRUITING

Related Publications (1)

• Reger GM, Smolenski D, Williams R, Norr AM, Foa E, Kuhn E, Schnurr PP, Weathers F, Zoellner L. Design and methods of a randomized controlled trial evaluating the effects of the PE Coach mobile application on prolonged exposure among veterans with PTSD. Contemp Clin Trials. 2023 Apr;127:107115. doi: 10.1016/j.cct.2023.107115. Epub 2023 Feb 8.

  PMID: 36758935 DERIVED

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic

Condition Hierarchy (Ancestors)

Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders

Study Officials

• Greg M. Reger, PhD

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

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Greg M Reger, PhD

CONTACT

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

Eric R Kuhn, PhD

CONTACT

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Data analyst will be blind to the coding of assigned treatment intervention in the data set until analyses are complete.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 3, 2021
• First Posted: July 13, 2021
• Study Start: July 29, 2022
• Primary Completion (Estimated): June 30, 2027
• Study Completion (Estimated): September 30, 2027
• Last Updated: January 15, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: Data will be available after release to a local or national VA research data repository and subsequent to all required approvals. Data will be de-identified as required by VHA Hbk 1605.1, Appendix B. All 18 HIPAA identifiers will be removed from the data, including any unique study identifier(s). If random number assigned to de-identified data set, VA will not retain crosswalk, link or other method to re-identify subjects. Proprietary information to be excluded. Subject to IRB approval, data released to VA research data repository. DUA prohibits requestor from re-identifying subjects. Privacy office approval required.
• Access Criteria: The VA research data repository administrator will be responsible for reviewing and responding to requests to release data to non-VA requestors. A data use agreement compliant with VHA Handbooks 1200.12 and 1605.1 will be required between VHA and the requestor. Review and approval by VA privacy officer is required prior to disclosure.

Locations

US (1)