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OpenTrials
Completed

NCT Number: NCT05315453

Brief Telehealth Cognitive Rehabilitation Following Mild TBI

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.

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Key information

Conditions

Mild Traumatic Brain Injury Brain Concussion Brain Diseases Brain Injuries Brain Injuries, Traumatic Central Nervous System Diseases Cognition Disorders Cognitive Dysfunction Cognitive Impairment Craniocerebral Trauma Head Injuries, Closed Mental Disorders Nervous System Diseases Neurocognitive Disorders Trauma, Nervous System Wounds and Injuries Wounds, Nonpenetrating

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

VA Puget Sound Health Care System

Seattle, Washington, 98108, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Brief Cognitive Rehabilitation

Behavioral

5-session Cognitive Rehabilitation intervention that can be administered over telehealth.

Primary outcomes

  1. Feasibility of administering the On-TRACC intervention to individuals with mTBI

    Time frame: At the completion of 5 week intervention

    Feasibility measures will include rate of enrollment of eligible individuals as well as dropout rate for enrolled participants. We will also evaluate participant adherence, including proportion of treatment sessions attended and number of days that homework was completed.

Secondary outcomes

  1. Participant satisfaction with On-TRACC intervention

    Time frame: End of each treatment session and at treatment completion, 5 weeks total.

    Participants will provide feedback on individual treatment sessions and at the end of treatment regarding intervention content. Participants will complete a Weekly Therapy Rating form after each treatment session and an End of Treatment Patient Feedback Form at the end of treatment to provide satisfaction ratings.

  2. Preliminary effectiveness of On-TRACC intervention in decreasing post-concussive symptoms

    Time frame: Baseline (pre-treatment) and at the end of the 5-week On-TRACC intervention, 5 week time-frame on average

    Pre-post treatment change in post-concussive symptoms (Neurobehavioral Symptom Inventory) will be evaluated.

  3. Preliminary effectiveness of On-TRACC intervention at decreasing self-reported cognitive difficulties

    Time frame: Baseline (pre-treatment) and at the end of the 5-week On-TRACC intervention, 5 week time-frame on average

    Pre-post treatment change in self-reported cognitive difficulties (NeuroQol Item Bank Cognitive Function SF) will be evaluated.

  4. Preliminary effectiveness of On-TRACC intervention at improving self-efficacy

    Time frame: Baseline (pre-treatment) and at the end of the 5-week On-TRACC intervention, 5 week time-frame on average

    Pre-post treatment change in self-efficacy (Cognitive Concerns Self-Efficacy Scale) will be evaluated.

Sponsors and collaborators

Lead sponsor

University of Washington

Other

Collaborators

  • VA Puget Sound Health Care System

Registry information

Official study title

Brief Telehealth Cognitive Rehabilitation Following Mild Traumatic Brain Injury: A Pilot Study

Acronym: On-TRACC

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Apr 7, 2022
Registry last updated
Mar 24, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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