CORE (Cognitive Optimization Through Rehabilitation and Education) Study
CORE
A Comparison of Two Interventions for Chronic Cognitive Difficulties After mTBI
2 other identifiers
interventional
354
1 country
2
Brief Summary
Mild traumatic brain injury (mTBI) affects millions of individuals worldwide every year. It has long been thought that the vast majority of individuals who sustain a mTBI experience natural recovery with little or no intervention and return to baseline functioning within days to weeks of injury. However, recent large studies have demonstrated that a substantial number of individuals experience prolonged symptoms (e.g., cognitive impairment, headaches, affective symptoms). These symptoms, termed "Persistent Post-concussive Symptoms" (PPCS) are associated with significant functional disability and reduced quality of life (QOL) and can last for years post-injury. While PPCS can include affective, cognitive, and somatosensory/vestibular symptoms, objective and subjective cognitive symptoms - particularly in the domains of attention, memory, processing speed, and executive function - are among the most commonly reported following mTBI. There is currently no gold-standard intervention to address these symptoms. To address this gap, our research group developed a brief cognitive rehabilitation intervention called Tools for Rehabilitation and Cognitive Care (or On-TRACC). The goals of this clinical trial are: AIM 1: Compare the efficacy of On-TRACC to a psychoeducation control on reduction of self-reported cognitive post-concussive symptoms (Aim 1.1) and overall neurobehavioral post concussive symptoms and (Aim 1.2) following treatment and at 3-month follow-up (Aim 1.3) in a randomized clinical trial of community-dwelling adults with mTBI. AIM 2: Compare the efficacy of On-TRACC and psychoeducation on change in secondary outcomes, including cognitive self-efficacy, compensatory strategy use, self-management skills, and quality of life at post-treatment and 3-month follow-up. Exploratory AIM 3: Compare the efficacy of On-TRACC and psychoeducation on: primary and secondary outcomes at 6-months post-treatment and (Aim 3.1) explore whether engaging in On-TRACC leads to subsequent engagement in care by assessing whether there is a different level of participation in optional intervention booster sessions in the post-intervention period (Aim 3.2). All participants will:
- Complete a series of assessments
- Complete 6 treatment sessions via telehealth (either On-TRACC or psychoeducation) All participants will have the option of:
- Attending weekly "Booster Sessions" between 3 and 6-months post-treatment
- Completing neuropsychological assessments at 2 timepoints during the study
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Oct 2025
Longer than P75 for not_applicable
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 27, 2025
CompletedFirst Posted
Study publicly available on registry
March 5, 2025
CompletedStudy Start
First participant enrolled
October 27, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2029
ExpectedStudy Completion
Last participant's last visit for all outcomes
September 1, 2029
April 20, 2026
January 1, 2026
3.6 years
February 27, 2025
April 14, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Neurobehavioral Symptom Inventory Total Score
Measure of post-concussive symptoms. Minimum value=0; maximum value=88; higher scores indicate worse outcomes.
Pre-treatment, Immediately post-treatment, 3-months post-treatment
Neurobehavioral Symptom Inventory Cognitive Subscale Score
Cognitive post-concussive symptoms. Minimum value=0; maximum value=16; higher scores indicate worse outcomes.
Pre-treatment, Immediately post-treatment, 3-months post-treatment
Secondary Outcomes (5)
Cognitive Concerns Self-Efficacy Scale
Pre-treatment, Immediately post-treatment, 3-months post-treatment
Compensatory Cognitive Strategies Scale
Pre-treatment, Immediately post-treatment, 3-months post-treatment
Patient Global Impression of Change
Pre-treatment, Immediately post-treatment, 3-months post-treatment
Quality of Life After Brain Injury
Pre-treatment, Immediately post-treatment, 3-months post-treatment
Self-Management Assessment Scale
Pre-treatment, Immediately post-treatment, 3-months post-treatment
Study Arms (2)
On-TRACC
EXPERIMENTALBrain Health Psychoeducation
ACTIVE COMPARATORInterventions
The On-TRACC intervention is administered one-on-one with a skilled clinician via telehealth and consists of an introductory session followed by 5 treatment sessions. Participants in the On-TRACC intervention will review various health and lifestyle factors that can affect cognitive functioning, learn and practice skills for managing cognitive and emotional symptoms, and develop personalized goals to support optimal cognitive functioning.
The Brain Health intervention is administered one-on-one with a skilled clinician via telehealth and consists of an introductory session followed by 5 treatment sessions. Participants in the Brain Health psychoeducation treatment will learn about various health and lifestyle factors that can affect brain health and cognitive functioning. In addition, they will be provided with resources and strategies for managing relevant factors and supporting optimal cognitive functioning.
Eligibility Criteria
You may qualify if:
- \>18 years of age
- Evidence of self-reported mTBI sustained in adulthood at least 3 months prior to the date of study enrollment (clinical discretion allowed for mTBI in late adolescence) AND documentation of diagnosed or suspected mTBI as defined by American Congress of Rehabilitation Medicine (ACRM) criteria in the medical record (e.g., on the problem list, has a diagnosis, encounter for a TBI, diagnosis via a TBI evaluation, or documented in a clinical note, etc).
- Endorsement of at least moderate symptoms (score of 3 or higher) on at least one of the cognitive items (forgetfulness, poor concentration, taking longer to think) from the Rivermead Postconcussion Symptom Questionnaire.
- Ability to read, speak and understand English enough to participate in healthcare in English without a translator.
- Willingness to participate in audio-recorded treatment sessions.
- Willingness to be randomized to treatment condition.
- Willingness to use clinical video teleconferencing (CVT) for research appointments (including be on camera for treatment sessions).
- Able to use and have access to a smart phone, tablet, or computer with internet access in private setting for treatment sessions.
- Willingness to refrain from participation in any other clinical trial or interventional study while participating in this study
You may not qualify if:
- Active suicidal ideation/intent indicating significant risk, per PI discretion.
- Unstable medical or psychiatric condition (e.g., mania, psychotic symptoms) that would interfere with study participation, per PI discretion.
- Behavioral issues noted in the record or observed during the screening process that would interfere with appropriate or safe CVT participation or study procedures, per PI discretion.
- Prior participation in the On-TRACC intervention.
- Significant cognitive impairment that would limit ability to engage in treatment (as indicated by more than 1 error on a 6-item screener).
- Planned life events that would interfere with study participation during active treatment phase (e.g., major surgery, moving out of state, extended travel).
- Current participation in another clinical trial or interventional study.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
VA Puget Sound Health Care System
Seattle, Washington, 98108, United States
University of Washington
Seattle, Washington, 98195, United States
Related Publications (1)
Pagulayan KF, Rau HK, Sheppard DP, Shulein OM, Onstad-Hawes E, Hoffman JM, Williams RM. On-TRACC Pilot Study: A Novel Intervention for Persistent Post-Concussive Cognitive Symptoms. J Head Trauma Rehabil. 2025 Jul-Aug 01;40(4):E308-E319. doi: 10.1097/HTR.0000000000001014. Epub 2024 Sep 29.
PMID: 39853212BACKGROUND
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Kathleen Pagulayan, PhD
University of Washington
- PRINCIPAL INVESTIGATOR
Rhonda Williams, PhD
VA Puget Sound Health Care System
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate Professor, Department of Rehabilitation Medicine
Study Record Dates
First Submitted
February 27, 2025
First Posted
March 5, 2025
Study Start
October 27, 2025
Primary Completion (Estimated)
June 1, 2029
Study Completion (Estimated)
September 1, 2029
Last Updated
April 20, 2026
Record last verified: 2026-01
Data Sharing
- IPD Sharing
- Will share
We will submit all deidentified data from this study to the Inter-university Consortium for Political and Social Research (ICPSR) data repository for other researchers to use in future studies.