RECRUITING

Evaluation of the PE Coach Mobile Application Among Veterans With PTSD

Conditions

Posttraumatic Stress Disorder prolonged exposure exposure therapy mobile applications PE Coach cognitive behavioral therapy

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

Official Title

Randomized Trial of Prolonged Exposure (PE) vs. PE With PE Coach Among Veterans With PTSD

Quick Facts

Study Start:2022-07-29

Study Completion:2027-09-30

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT04959695

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 65 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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	* 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

Inclusion Criteria

Exclusion 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

* 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

Contacts and Locations

Study Contact

Greg M Reger, PhD

CONTACT

(253) 583-1677

Greg.Reger@va.gov

Eric R Kuhn, PhD

CONTACT

(650) 493-5000

Eric.Kuhn@va.gov

Principal Investigator

Greg M. Reger, PhD

PRINCIPAL_INVESTIGATOR

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

Study Locations (Sites)

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

Seattle, Washington, 98108-1532

United States

Collaborators and Investigators

Sponsor: VA Office of Research and Development

Greg M. Reger, PhD, PRINCIPAL_INVESTIGATOR, VA Puget Sound Health Care System Seattle Division, Seattle, WA

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2022-07-29

Study Completion Date2027-09-30

Study Record Updates

Study Start Date2022-07-29

Study Completion Date2027-09-30

Terms related to this study

Keywords Provided by Researchers

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

Additional Relevant MeSH Terms

Posttraumatic Stress Disorder