Brief Telehealth Cognitive Rehabilitation Following Mild TBI (On-TRACC)

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University of Washington

Status

Completed

Conditions

Cognitive Impairment
Mild Traumatic Brain Injury

Treatments

Behavioral: Brief Cognitive Rehabilitation

Study type

Interventional

Funder types

Other
Other U.S. Federal agency

Identifiers

NCT05315453
STUDY00013494

Details and patient eligibility

About

In the United States, more than a million people sustain a mild traumatic brain injury (mTBI) every year. Although many recover fully, emerging literature suggests a high number of individuals report chronic, and functionally disabling, cognitive difficulties. Among Veterans, a nationwide survey found that more than 75% of 55,000 Veterans with a history of mTBI reported persistent moderate to severe levels of forgetfulness and poor concentration. Reduced cognitive functioning following mTBI contributes to significant functional impairment, including underemployment, relationship difficulties, and reduced community integration for years post injury. Despite the significant individual and societal impact, evidence to guide interventions and treatment for this population remains limited. Even more limited are validated telehealth options for these symptoms, a critical means by which access to care can be improved, especially during the COVID-19 pandemic. The proposed pilot study will address this gap by evaluating the feasibility, acceptability, and preliminary effectiveness of a brief (5-session) cognitive rehabilitation intervention that was developed for individuals with mTBI and that will be administered over video-based telehealth technology. The development of this intervention was supported by a grant from the Department of Defense, with critical elements identified through surveys completed by clinicians and veterans with a history of mTBI, and also the clinical expertise of the team.

Enrollment

28 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Age 18+;
  • Read, speak, understand English;
  • History of at least one mTBI;
  • Endorses moderate to severe cognitive difficulties in one or more of Neurobehavioral Symptom Inventory items M-P;
  • Ability and willingness to participate in audio recorded sessions over video telehealth platform in a private setting, including equipment and internet access;
  • Lives within 2 hours of VA Puget Sound or affiliated clinics/University of Washington;
  • Will be in Washington State when engaging in treatment sessions

Exclusion criteria

  • Significant cognitive impairment that would limit ability to engage on treatment;
  • Neurologic injury or illness that affects cognitive functioning, including history of moderate or severe TBI;
  • History of TBI in the past 3 months, from the date of screening;
  • History of serious mental illness involving psychotic symptoms;
  • Current psychotic or manic symptoms;
  • Current or active flag, or documentation in medical record, for behavior or suicide risk;
  • Current (within the past 3 months) Substance Use Disorder (not including caffeine or nicotine disorder)

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

28 participants in 1 patient group

Brief Cognitive Rehabilitation
Experimental group
Description:
5-session Cognitive Rehabilitation intervention administered over telehealth
Treatment:
Behavioral: Brief Cognitive Rehabilitation

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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