NCT06859996

CORE (Cognitive Optimization Through Rehabilitation and Education) Study

A Comparison of Two Interventions for Chronic Cognitive Difficulties After mTBI

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 354 (estimated)
• Sponsor: University of Washington · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
BEHAVIORAL	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.
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.

Timeline

• Start date: 2025-04-01
• Primary completion: 2029-06-01
• Completion: 2029-09-01
• First posted: 2025-03-05
• Last updated: 2025-03-05

Locations

2 sites across 1 country: United States