CORE (Cognitive Optimization Through Rehabilitation and Education) Study

NCT ID: NCT06859996

Last Updated: 2025-03-05

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 354 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-04-01
• Study Completion Date: 2029-09-30

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

Conditions

Mild Traumatic Brain Injury; Concussion

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

On-TRACC

Group Type: EXPERIMENTAL

Tools for Rehabilitation and Cognitive Care (On-TRACC)

Intervention Type: BEHAVIORAL

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 Psychoeducation

Group Type: ACTIVE_COMPARATOR

Brain Health psychoeducation

Intervention Type: BEHAVIORAL

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.

Interventions

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.

Intervention Type: BEHAVIORAL

Brain Health psychoeducation

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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• >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.

Exclusion Criteria

• 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).
• 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.
• Behavioral issues noted in the record or observed during the screening process that would interfere with appropriate or safe CVT participation or study procedures.
• 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).

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institute on Disability, Independent Living, and Rehabilitation Research

FED

Sponsor Role: collaborator

VA Puget Sound Health Care System

FED

Sponsor Role: collaborator

University of Washington

OTHER

Sponsor Role: lead

Responsible Party

Kathleen Pagulayan

Associate Professor, Department of Rehabilitation Medicine

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Kathleen Pagulayan, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Washington

Rhonda Williams, PhD

Role: PRINCIPAL_INVESTIGATOR

VA Puget Sound Health Care System

Locations

VA Puget Sound Health Care System

Seattle, Washington, United States

University of Washington

Seattle, Washington, United States

Countries

United States

Central Contacts

Anna C Frauenheim, MPH

Role: CONTACT

afrauen@uw.edu

(206) 543-7731

Facility Contacts

Sydney Drever

Role: primary

drevers@uw.edu

(206) 616-7671

Anna C Frauenheim, MPH

Role: primary

afrauen@uw.edu

(206) 543-7731

References

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.

Reference Type: BACKGROUND

PMID: 39853212 (View on PubMed)

Related Links

https://sites.uw.edu/farkat/

Dr. Pagulayan's Research Website

Other Identifiers

90DPHF0015-01-00

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

STUDY00022262

Identifier Type: -

Identifier Source: org_study_id