Clinical trial NCT04959695: Evaluation of the PE Coach Mobile Application Among Veterans With PTSD
Official title: Randomized Trial of Prolonged Exposure (PE) vs. PE With PE Coach Among Veterans With PTSD
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Posttraumatic Stress Disorder
Keywords: posttraumatic stress disorder
prolonged exposure
exposure therapy
mobile applications
PE Coach
cognitive behavioral therapy
Lead sponsor: VA Office of Research and Development
Sponsor class: FED
Collaborators: name: Defense Centers of Excellence for Psychological Health and Traumatic Brain Injury
First posted: 2021-07-13
Enrollment: 124
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 withPE 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.

Detailed description: Veterans are at increased risk of posttraumatic stress disorder (PTSD), which negatively impacts social and occupational functioning and quality of life. Prolonged exposure (PE) is an evidence-based psychotherapy for PTSD that is effective in the treatment of Veterans. However, many Veterans drop out of psychotherapy for PTSD and many of those who complete PE still meet criteria for PTSD or do not achieve clinically meaningful change. The vast majority of Veterans with PTSD report neurobehavioral cognitive symptoms and may be at particular risk given that problems with executive functioning and prospective memory are related to PTSD treatment drop out and poorer treatment outcomes. The mechanisms of functioning and symptom change in PE include emotional activation during exposure, between-session habituation, and changes in PTSD-related negative cognitions. These mechanisms occur via verbally recounting and processing trauma memories (imaginal exposure) and approaching anxiety provoking situations in day-to-day life (in vivo exposure) and are achieved by daily homework exercises. Increased homework adherence predicts improved PTSD symptoms and functioning. To support patients participating in PE, the DoD/VA developed the mobile application (app) 'PE Coach'. The features of PE Coach were designed to enhance patients' ability to adhere with the homework critical to recovery. PE Coach may provide the cognitive and organizational support that Veterans with PTSD need to successfully complete treatment and maximize outcomes. However, little is known about the effectiveness of most mental health technology augmentations and this is true of PE Coach as well. Although the app is used in routine VA care and the VA recently invested in the software development required for an updated version of the app, no study has evaluated the impact of PE Coach on clinically relevant treatment outcomes. This study will conduct a randomized, controlled clinical trial to determine the efficacy of PE Coach and its impact on PTSD-related social and occupational functioning, PTSD symptoms, and homework adherence and dropout. The project will randomize 124 Veterans with PTSD to either PE +PE Coach or Usual PE (without PE Coach). Participants in both conditions will have identical homework activities assigned, but those with PE + PE Coach will receive all of their homework activities through the PE Coach app, while those in Usual PE will receive their homework through separate, standard workbook handouts and digital audio recording device. Veterans will participate in 8-15 weekly individual PE psychotherapy sessions, based on defined termination criteria and delivered consistent with the published treatment manual. Outcome assessments will be conducted at baseline, half-way through treatment, post-treatment, and at 1- and 4- month follow-ups. The primary outcome measure will be the Posttraumatic Stress Related Functioning Inventory (PRFI). PTSD symptoms will be assessed using the gold-standard Clinician Administered PTSD Scale for DSM-5, which will be conducted by independent assessors blind to treatment condition. Functioning, quality of life, self-reported PTSD, and depression will be monitored every-other PE session, throughout treatment. An external PE expert will code 15% of PE sessions to monitor the fidelity of psychotherapy to the treatment protocol, and homework adherence will be reported at each session to test the impact of PE Coach on adherence. VA has been a leader in mental health mobile app development and must respond to the call for research on whether these apps work, and if so, how? This study addresses that need by testing the efficacy of PE Coach, a treatment companion to one of the most researched, efficacious psychotherapies for PTSD, and a treatment that has been broadly disseminated throughout VA mental health clinics. Results can help inform whether VA should invest in systematic implementation and dissemination of PE Coach as a routine part of PE training in VA.

Eligibility criteria: 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

Primary outcomes:
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
timeFrame: 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:
measure: 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
timeFrame: 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)
measure: 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
timeFrame: 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)
measure: 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
timeFrame: approx week 8 (mid-treatment), approx. week 16 (post-treatment), approx week 20 (1-month f/up), approx week 32 (4-month f/up)
measure: 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
timeFrame: 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)
measure: 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
timeFrame: 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)
measure: Change in PTSD Checklist for DSM-5 (PCL-5) from baseline to mid-treatment, post-treatment, 1-month post-treatment f/up, 4-month post-treatment f/up, and every other approximately weekly treatment session
timeFrame: 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)
measure: Sum of Utility of Techniques Inventory (UTI) at each weekly treatment session starting treatment session 2
timeFrame: Weekly treatment Sessions 2-15 (approx weeks 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16)
measure: PE Homework Daily Diary
timeFrame: Weekly treatment Sessions 2-15 (approx weeks 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16)
measure: Change in Neurobehavioral Symptom Inventory from baseline to mid-treatment, post-treatment, 1-month post-treatment f/up, 4-month post-treatment f/up
timeFrame: 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)
measure: Change in Posttraumatic Stress Related Functioning Inventory (PRFI) across treatment, measured every other treatment session
timeFrame: Session 2 (approx week 3), Session 4 (approx week 5), Session 6 (approx week 7), Session 8 (approx week 9), Session 10 (approx week 11), Session 12 (approx week 13), Session 14 (approx week 15)
measure: Change in Beck Depression Inventory-II (BDI-II) across treatment, measured every other treatment session
timeFrame: Session 2 (approx week 3), Session 4 (approx week 5), Session 6 (approx week 7), Session 8 (approx week 9), Session 10 (approx week 11), Session 12 (approx week 13), Session 14 (approx week 15)
measure: Change in PTSD Checklist for DSM-5 (PCL-5) across treatment, measured every other treatment session
timeFrame: Session 2 (approx week 3), Session 4 (approx week 5), Session 6 (approx week 7), Session 8 (approx week 9), Session 10 (approx week 11), Session 12 (approx week 13), Session 14 (approx week 15)
measure: Change in Clinician Administered PTSD Scale for DSM-5, Revised (CAPS-5-R) from baseline to mid-treatment, post-treatment, 1-month post-treatment f/up, and 4-month post-treatment f/up
timeFrame: 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)
Other outcomes:
Locations:
city: Seattle
country: United States
facility: VA Puget Sound Health Care System Seattle Division, Seattle, WA
state: Washington
Study officials:
affiliation: VA Puget Sound Health Care System Seattle Division, Seattle, WA
name: Greg M. Reger, PhD
role: PRINCIPAL_INVESTIGATOR
References: