Mild Traumatic Brain Injury; ConcussionCORENCT06859996
CORE (Cognitive Optimization Through Rehabilitation and Education) Study
A study testing Tools for Rehabilitation and Cognitive Care (On-TRACC) and Brain Health psychoeducation in people with Mild Traumatic Brain Injury; Concussion, run by University of Washington at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Mild Traumatic Brain Injury; Concussion
- What is being tested?
- Tools for Rehabilitation and Cognitive Care (On-TRACC) and Brain Health psychoeducation
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 354 participants
- Where
- 2 sitesUnited States
- Study dates
- 27 Oct 2025to Sep 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- >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.
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- 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
Who cannot join
- History of neurologic injury or illness other than mTBI that can affect cognitive functioning (e.g., any lifetime severe TBI [Glasgow Coma Score (GCS)<=8; loss of consciousness (LOC)> 1 hour; posttraumatic amnesia (PTA)>1 week], seizure disorder, multiple sclerosis, neurodegenerative disorder). Any definitively diagnosed moderate TBI is exclusionary, but injuries that are in the mild to moderate range are eligible pending clinical discretion. If available records and/or self-reported information do not allow for a definitive determination of whether an injury is mild or moderate, then clinician discretion will be used to determine eligibility.
- Alcohol abuse (operationalized as scoring 15 or more if male or 13 or more if female on the Alcohol Use Disorders Identification Test), or high-risk illicit drug use (as defined by modified Tobacco, Alcohol, Prescription Medications and Substance Use/Misuse (TAPS) Tool subscale scores > 2) in the past 3 months. Indication of alcohol/drug abuse or dependence in medical record is also sufficient to meet this exclusion criteria, per PI discretion.
- 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.
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- 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.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites, 2 recruiting
- Recruiting
VA Puget Sound Health Care System
Seattle, Washington, 98108
Anna Frauenheim, MPH, (206) 543-7731, afrauen@uw.edu
Rhonda Williams, PhD
- Recruiting
University of Washington
Seattle, Washington, 98195
Anna Frauenheim, MPH, (206) 543-7731, afrauen@uw.edu
Kathleen Pagulayan, PhD
About this study
Official title: A Comparison of Two Interventions for Chronic Cognitive Difficulties After mTBI
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:
Read more
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
- Mild Traumatic Brain Injury; Concussion
- Being tested
- Tools for Rehabilitation and Cognitive Care (On-TRACC), Brain Health psychoeducation
- Keywords
- cognitive training, self-management, Veterans, concussion, psychoeducation, clinical trial
- Medical subject headings
- Brain Concussion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tools for Rehabilitation and Cognitive Care (On-TRACC)Behavioural
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.
Brain Health psychoeducationBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| On-TRACC | Experimental | Not described Receives: Behavioral: Tools for Rehabilitation and Cognitive Care (On-TRACC) |
| Brain Health Psychoeducation | Active comparator | Not described Receives: Behavioral: Brain Health psychoeducation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Neurobehavioral Symptom Inventory Total Score
Measure of post-concussive symptoms. Minimum value=0; maximum value=88; higher scores indicate worse outcomes.
Measured: 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.
Measured: Pre-treatment, Immediately post-treatment, 3-months post-treatment
Secondary outcomes (5)
Cognitive Concerns Self-Efficacy Scale
Measure of perceived ability to effectively manage cognitive concerns and their impact on daily life. Minimum value=0; maximum value=60; higher scores indicate better outcomes.
Measured: Pre-treatment, Immediately post-treatment, 3-months post-treatment
Compensatory Cognitive Strategies Scale
Measure of frequency of compensatory strategy use. Minimum value=0; maximum value=96; higher scores indicate better outcomes.
Measured: Pre-treatment, Immediately post-treatment, 3-months post-treatment
Patient Global Impression of Change
Measure of symptoms and overall quality of life. Minimum value=1; maximum value=7; higher scores indicate worse outcomes.
Measured: Pre-treatment, Immediately post-treatment, 3-months post-treatment
Quality of Life After Brain Injury
Measure of health-related quality of life after brain injury. Minimum value=0; maximum value=100; higher scores indicate better outcomes.
Measured: Pre-treatment, Immediately post-treatment, 3-months post-treatment
Self-Management Assessment Scale
Measure of ability to self-manage health. Minimum value=10; maximum value=60; higher scores indicate better outcomes.
Measured: Pre-treatment, Immediately post-treatment, 3-months post-treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Mar 2025
- Study start27 Oct 2025
- Primary completionJun 2029 (estimated)
- Study completionSep 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Mild Traumatic Brain Injury; ConcussionStudies of the same condition, open and under way.
- More trials run by University of WashingtonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 354 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Washington
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Disability, Independent Living, and Rehabilitation Research, VA Puget Sound Health Care System
- Responsible party
- Principal investigator, Kathleen Pagulayan, University of Washington
- Investigators
- Kathleen Pagulayan, PhD, Principal investigator, University of WashingtonRhonda Williams, PhD, Principal investigator, VA Puget Sound Health Care System
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06859996
- Sponsor's protocol ID
- STUDY00022262
- Other IDs
- 90DPHF0015-01-00
- Acronym
- CORE
- Status last verified
- Jan 2026
- First submitted
- 27 Feb 2025
- Last updated
- 20 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Publications
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.
PubMed 39853212
Study at a glance
From the registry record, last updated by the sponsor on 20 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparison of Two Interventions for Chronic Cognitive Difficulties After mTBI
- ClinicalTrials.gov ID
- NCT06859996
- Acronym / sponsor ID
- CORE / STUDY00022262
- Conditions
- Mild Traumatic Brain Injury; Concussion
- Keywords
- cognitive training, self-management, Veterans, concussion, psychoeducation, clinical trial
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 354 participants (estimated)
- Lead sponsor
- University of WashingtonUniversity, hospital or other
- Collaborators
- National Institute on Disability, Independent Living, and Rehabilitation Research, VA Puget Sound Health Care System
- Study start
- 27 Oct 2025 (actual)
- Primary completion
- Jun 2029 (estimated)
- Study completion
- Sep 2029 (estimated)
- First posted
- 5 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| On-TRACC | Experimental | Behavioral: Tools for Rehabilitation and Cognitive Care (On-TRACC) |
| Brain Health Psychoeducation | Active comparator | Behavioral: Brain Health psychoeducation |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- >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.
Key exclusion criteria (9 listed)
- History of neurologic injury or illness other than mTBI that can affect cognitive functioning (e.g., any lifetime severe TBI [Glasgow Coma Score (GCS)<=8; loss of consciousness (LOC)> 1 hour; posttraumatic amnesia (PTA)>1 week], seizure disorder, multiple sclerosis, neurodegenerative disorder). Any definitively diagnosed moderate TBI is exclusionary, but injuries that are in the mild to moderate range are eligible pending clinical discretion. If available records and/or self-reported information do not allow for a definitive determination of whether an injury is mild or moderate, then clinician discretion will be used to determine eligibility.
- Alcohol abuse (operationalized as scoring 15 or more if male or 13 or more if female on the Alcohol Use Disorders Identification Test), or high-risk illicit drug use (as defined by modified Tobacco, Alcohol, Prescription Medications and Substance Use/Misuse (TAPS) Tool subscale scores > 2) in the past 3 months. Indication of alcohol/drug abuse or dependence in medical record is also sufficient to meet this exclusion criteria, per PI discretion.
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Tools for Rehabilitation and Cognitive Care (On-TRACC)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. | Behavioural | On-TRACC |
| Brain Health psychoeducationThe 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. | Behavioural | Brain Health Psychoeducation |
Primary outcome
Neurobehavioral Symptom Inventory Total Score
Time frame: Pre-treatment, Immediately post-treatment, 3-months post-treatment
Measure of post-concussive symptoms. Minimum value=0; maximum value=88; higher scores indicate worse outcomes.
Neurobehavioral Symptom Inventory Cognitive Subscale Score
Time frame: Pre-treatment, Immediately post-treatment, 3-months post-treatment
Cognitive post-concussive symptoms. Minimum value=0; maximum value=16; higher scores indicate worse outcomes.
5 secondary outcomes
Cognitive Concerns Self-Efficacy Scale
Time frame: Pre-treatment, Immediately post-treatment, 3-months post-treatment
Compensatory Cognitive Strategies Scale
Time frame: Pre-treatment, Immediately post-treatment, 3-months post-treatment
Patient Global Impression of Change
Time frame: Pre-treatment, Immediately post-treatment, 3-months post-treatment
Quality of Life After Brain Injury
Time frame: Pre-treatment, Immediately post-treatment, 3-months post-treatment
Self-Management Assessment Scale
Time frame: Pre-treatment, Immediately post-treatment, 3-months post-treatment
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Apr 2026.
- Background: PubMed 39853212Pagulayan 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.
- Dr. Pagulayan's Research WebsiteLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Kathleen Pagulayan, PhD principal investigator
University of Washington
Rhonda Williams, PhD principal investigator
VA Puget Sound Health Care System
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Tools for Rehabilitation and Cognitive Care (On-TRACC) and Brain Health psychoeducation in people with Mild Traumatic Brain Injury; Concussion, run by University of Washington at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 20 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Anna Frauenheim, MPH ((206) 543-7731, afrauen@uw.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Neurobehavioral Symptom Inventory Total Score (time frame: Pre-treatment, Immediately post-treatment, 3-months post-treatment). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06859996, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Apr 2026.