Actively Recruiting
CORE (Cognitive Optimization Through Rehabilitation and Education) Study
Led by University of Washington · Updated on 2026-04-20
354
Participants Needed
2
Research Sites
200 weeks
Total Duration
On this page
Sponsors
U
University of Washington
Lead Sponsor
N
National Institute on Disability, Independent Living, and Rehabilitation Research
Collaborating Sponsor
AI-Summary
What this Trial Is About
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
CONDITIONS
Official Title
CORE (Cognitive Optimization Through Rehabilitation and Education) Study
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Over 18 years of age
- Self-reported mild traumatic brain injury (mTBI) sustained in adulthood at least 3 months before enrollment, with medical documentation meeting American Congress of Rehabilitation Medicine criteria
- Moderate or higher symptoms (score of 3 or more) on at least one cognitive symptom (forgetfulness, poor concentration, slower thinking) on the Rivermead Postconcussion Symptom Questionnaire
- Ability to read, speak, and understand English without a translator
- Willingness to participate in audio-recorded treatment sessions
- Willingness to be randomly assigned to a treatment group
- Willingness to use clinical video teleconferencing for research visits, including being on camera
- Access to and ability to use a smartphone, tablet, or computer with internet in a private setting for treatment
- Willingness to avoid participation in other clinical trials or interventional studies during this study
You will not qualify if you...
- History of neurological injury or illness other than mTBI that affects cognitive function, including severe traumatic brain injury, seizure disorder, multiple sclerosis, or neurodegenerative disorders
- Diagnosed moderate traumatic brain injury unless clinical discretion allows
- Alcohol abuse or high-risk illicit drug use in past 3 months based on screening tools or medical records
- Active suicidal thoughts or intent that pose significant risk
- Unstable medical or psychiatric conditions that interfere with participation
- Behavioral issues that prevent safe or appropriate participation in video teleconferencing or study procedures
- Prior participation in the On-TRACC intervention
- Significant cognitive impairment limiting ability to engage in treatment
- Planned major life events during treatment phase that interfere with participation
- Current participation in another clinical trial or interventional study
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 2 locations
1
VA Puget Sound Health Care System
Seattle, Washington, United States, 98108
Actively Recruiting
2
University of Washington
Seattle, Washington, United States, 98195
Actively Recruiting
Research Team
A
Anna Frauenheim, MPH
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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