CORE: Cognitive Optimization Through Rehabilitation and Education for persistent concussion symptoms

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This interventional, randomized program enrolls adults with a documented mild traumatic brain injury at least three months earlier who continue to report cognitive symptoms. Participants are randomized to receive Tools for Rehabilitation and Cognitive Care (On-TRACC) combined with Brain Health psychoeducation, with treatment sessions audio-recorded and delivered in person or by clinical video teleconferencing. Eligibility requires at least moderate cognitive complaints on the Rivermead Postconcussion Symptom Questionnaire and the ability to participate in English. The study is conducted at the University of Washington and the VA Puget Sound Health Care System in Seattle.

Why it matters

Who can join: the full rules

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.
* Willingness to refrain from participation in any other clinical trial or interventional study while participating in this study

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). 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.
* 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.

Where it's running

• VA Puget Sound Health Care System
  Seattle, Washington, United States Recruiting
• University of Washington
  Seattle, Washington, United States Recruiting

Study contacts

• Principal investigator: Kathleen Pagulayan, PhD — University of Washington
• Study coordinator: Anna Frauenheim, MPH
• Email: afrauen@uw.edu
• Phone: (206) 543-7731

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.