Evaluation of the PE Coach Mobile Application Among Veterans With PTSD

January 13, 2026 updated by: VA Office of Research and Development

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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, Revised 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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
124

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

  • Name: Eric R Kuhn, PhD
  • Phone Number: 23160 (650) 493-5000
  • Email: Eric.Kuhn@va.gov

Study Locations

  • United States
    • Washington
      • Seattle, Washington, United States, 98108-1532
        • Recruiting
        • VA Puget Sound Health Care System Seattle Division, Seattle, WA
        • Contact:
        • Contact:
        • Principal Investigator:
          • Greg M. Reger, PhD

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.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Prolonged exposure with PE Coach
The mobile application will be incorporated into each PE psychotherapy session and used to support homework between sessions.
Behavioral: 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.
Active Comparator: Prolonged exposure without PE Coach
Standard PE treatment protocol without PE Coach
Behavioral: Prolonged exposure without PE Coach
Standard PE treatment protocol without PE Coach

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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)
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 Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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
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)
The WHODAS 2.0 is a 36-item self -report measure that assesses disability in the past 30 days related to general medical and psychiatric disorders across six domains of functioning (cognition, mobility, self -care, getting along, life activities, participation) and provides subscale scores and an overall disability score ranting from 0 (no disability) to 100 (full disability).
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
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)
The WHOQOL-BREF is a well-validated, 26-item self -report measure that assesses quality of life across four domains: physical health, psychological, social relationship, and environment. Patients report on a 5-point Likert scale their experience/satisfaction across various life domains over the prior two weeks.
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
Time Frame: approx week 8 (mid-treatment), approx. week 16 (post-treatment), approx week 20 (1-month f/up), approx week 32 (4-month f/up)
CGI-Symptoms will be measured using a 7-point Likert scale asking participants (at post-treatment and at f/u) to rate their perception of change in PTSD symptoms as a result of treatment as "very much improved," 2 or "much improved," 3 or "minimally improved," 4 or "no change," 5 or "slightly worse," 6 or "much worse," and 7 or "very much worse" . The same scale/anchors will be used to have patients rate any change in their ability to "participate meaningfully in life activities" (Improvement).
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
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)
The BDI-II is a 21-item self -report measure of the severity of depressive symptoms. Patients rate each item using a 4-point Likert-type scale ranging from 0 (least severe) to 3 (most severe). Ratings are summed to yield a total severity score, in which higher scores indicate higher levels of depressive 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)
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
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)
The C-SSRS is a gold-standard, clinician assessment of suicidal ideation and suicidal behavior. The C-SSRS measures four separate constructs: severity of ideation, intensity of ideation, behavior, and lethality. The patient is rated by the assessor as to the experience of the highest level experienced of each construct over the specified period.
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 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
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)
The PCL-5 is a widely used and well-validated self -report measure of PTSD symptoms, and comprises 20 items corresponding to each of the DSM-5 symptom criteria for PTSD. The PCL-5 assesses the patient's experience of symptoms over the past month, or week, and each item is rated on how bothersome the patient has found that particular symptom (0 = not at all; 1 = a little bit; 2 = moderately; 3 = quite a bit; 4 = extremely). Thus, scores on the PCL-5 range from 0-80, with higher scores indicating more severe 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)
Sum of Utility of Techniques Inventory (UTI) at each weekly treatment session starting treatment session 2
Time Frame: Weekly treatment Sessions 2-15 (approx weeks 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16)
The UTI is a self -report measure that asks patients to retrospectively report the frequency and perceived helpfulness of assigned PE homework. Frequency of homework adherence is rated from 0 (not at all) to 5 (more than 10 times). Perceived helpfulness responses range from 1 (not helpful at all) to 5 (extremely helpful).
Weekly treatment Sessions 2-15 (approx weeks 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16)
PE Homework Daily Diary
Time Frame: Weekly treatment Sessions 2-15 (approx weeks 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16)
A calendar documenting the raw count of days of self-reported adherence to assigned imaginal and in vivo homework (typically, 0-7 for each) in the week prior to each PE session.
Weekly treatment Sessions 2-15 (approx weeks 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16)
Change in Neurobehavioral Symptom Inventory 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)
The NSI is a 22-item, self-report measure of neurobehavioral symptoms that includes four symptom clusters: Cognitive, Somatosensory, Affective, and Vestibular.
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 Posttraumatic Stress Related Functioning Inventory (PRFI) across treatment, measured every other treatment session
Time Frame: 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)
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.
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)
Change in Beck Depression Inventory-II (BDI-II) across treatment, measured every other treatment session
Time Frame: 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)
The BDI-II is a 21-item self -report measure of the severity of depressive symptoms. Patients rate each item using a 4-point Likert-type scale ranging from 0 (least severe) to 3 (most severe). Ratings are summed to yield a total severity score, in which higher scores indicate higher levels of depressive symptoms.
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)
Change in PTSD Checklist for DSM-5 (PCL-5) across treatment, measured every other treatment session
Time Frame: 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)
The PCL-5 is a widely used and well-validated self -report measure of PTSD symptoms, and comprises 20 items corresponding to each of the DSM-5 symptom criteria for PTSD. The PCL-5 assesses the patient's experience of symptoms over the past month, or week, and each item is rated on how bothersome the patient has found that particular symptom (0 = not at all; 1 = a little bit; 2 = moderately; 3 = quite a bit; 4 = extremely). Thus, scores on the PCL-5 range from 0-80, with higher scores indicating more severe PTSD symptoms.
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)
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
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)
The CAPS-5-R is a recent revision of the CAPS-5. CAPS-5-R assesses for the frequency and intensity of DSM-5 symptoms. Frequency is assessed per the patient report (e.g, times per month or percentage of the time the symptom is present). Intensity of symptoms is scored as absent, minimal, clearly present, pronounced, and extreme. Two intermediate intensity ratings are available for clearly present/pronounced, and pronounced/extreme. The combination of frequency and intensity ratings determine the 0 to 10 severity score for each item. Although the range for item severity scores has expanded from 0-4 on the CAPS-5 to 0-10 on the CAPS-5-R, CAPS-5 scores are nested in the CAPS-5-R scoring grid, so either scoring method can be used. Although we will administer the CAPS-5-R, we will use CAPS-5 scoring for the inclusion criterion.
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)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
VA Office of Research and Development

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Defense Centers of Excellence for Psychological Health and Traumatic Brain Injury

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Greg M. Reger, PhD, VA Puget Sound Health Care System Seattle Division, Seattle, WA

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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 Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 29, 2022

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 30, 2027

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 30, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 3, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 1, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 13, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 15, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 13, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • D3503-R

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

The data sets include research involving human subjects. A de-identified, anonymized dataset will be created and shared. Subject to IRB approval, de-identified data will be released to a local VAPSHCS and/or national VA research data repository for release to non-VA protocols. 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.

IPD Sharing 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.

IPD Sharing 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.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • ANALYTIC_CODE
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings