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| ID | Type | Description | Link |
|---|---|---|---|
| 90DPHF0015-01-00 | Other Grant/Funding Number | NIDILRR |
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| Name | Class |
|---|---|
| National Institute on Disability, Independent Living, and Rehabilitation Research | FED |
| VA Puget Sound Health Care System | FED |
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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:
All participants will have the option of:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| On-TRACC | Experimental |
| |
| Brain Health Psychoeducation | Active Comparator |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tools for Rehabilitation and Cognitive Care (On-TRACC) | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Neurobehavioral Symptom Inventory Total Score | Measure of post-concussive symptoms. Minimum value=0; maximum value=88; higher scores indicate worse outcomes. | 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. | Pre-treatment, Immediately post-treatment, 3-months post-treatment |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Pre-treatment, Immediately post-treatment, 3-months post-treatment |
| Compensatory Cognitive Strategies Scale |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Anna Frauenheim, MPH | Contact | (206) 543-7731 | afrauen@uw.edu |
| Name | Affiliation | Role |
|---|---|---|
| Kathleen Pagulayan, PhD | University of Washington | Principal Investigator |
| Rhonda Williams, PhD | VA Puget Sound Health Care System | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| VA Puget Sound Health Care System | Recruiting | Seattle | Washington | 98108 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39853212 | Background | 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. |
| Label | URL |
|---|---|
| Dr. Pagulayan's Research Website | View source |
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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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| ID | Term |
|---|---|
| D001924 | Brain Concussion |
| ID | Term |
|---|---|
| D000070642 | Brain Injuries, Traumatic |
| D001930 | Brain Injuries |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
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| ID | Term |
|---|---|
| D012046 | Rehabilitation |
| ID | Term |
|---|---|
| D000359 | Aftercare |
| D003266 | Continuity of Patient Care |
| D005791 | Patient Care |
| D013812 | Therapeutics |
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| Brain Health psychoeducation | 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. |
|
Measure of frequency of compensatory strategy use. Minimum value=0; maximum value=96; higher scores indicate better outcomes. |
| 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. | 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. | 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. | Pre-treatment, Immediately post-treatment, 3-months post-treatment |
| University of Washington | Recruiting | Seattle | Washington | 98195 | United States |
|
| D009422 | Nervous System Diseases |
| D006259 | Craniocerebral Trauma |
| D020196 | Trauma, Nervous System |
| D016489 | Head Injuries, Closed |
| D014947 | Wounds and Injuries |
| D014949 | Wounds, Nonpenetrating |
| D006296 |
| Health Services |
| D005159 | Health Care Facilities Workforce and Services |