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

Primary Purpose

Mild Traumatic Brain Injury, Cognitive Impairment

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Brief Cognitive Rehabilitation
Sponsored by
University of Washington
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Mild Traumatic Brain Injury

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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)

Sites / Locations

  • VA Puget Sound Health Care System

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Brief Cognitive Rehabilitation

Arm Description

5-session Cognitive Rehabilitation intervention administered over telehealth

Outcomes

Primary Outcome Measures

Feasibility of administering the On-TRACC intervention to individuals with mTBI
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 Outcome Measures

Participant satisfaction with On-TRACC intervention
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.
Preliminary effectiveness of On-TRACC intervention in decreasing post-concussive symptoms
Pre-post treatment change in post-concussive symptoms (Neurobehavioral Symptom Inventory) will be evaluated.
Preliminary effectiveness of On-TRACC intervention at decreasing self-reported cognitive difficulties
Pre-post treatment change in self-reported cognitive difficulties (NeuroQol Item Bank Cognitive Function SF) will be evaluated.
Preliminary effectiveness of On-TRACC intervention at improving self-efficacy
Pre-post treatment change in self-efficacy (Cognitive Concerns Self-Efficacy Scale) will be evaluated.

Full Information

First Posted
December 13, 2021
Last Updated
March 22, 2023
Sponsor
University of Washington
Collaborators
VA Puget Sound Health Care System
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1. Study Identification

Unique Protocol Identification Number
NCT05315453
Brief Title
Brief Telehealth Cognitive Rehabilitation Following Mild TBI
Acronym
On-TRACC
Official Title
Brief Telehealth Cognitive Rehabilitation Following Mild Traumatic Brain Injury: A Pilot Study
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Completed
Study Start Date
December 13, 2021 (Actual)
Primary Completion Date
October 10, 2022 (Actual)
Study Completion Date
October 13, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Washington
Collaborators
VA Puget Sound Health Care System

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Mild Traumatic Brain Injury, Cognitive Impairment

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
28 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Brief Cognitive Rehabilitation
Arm Type
Experimental
Arm Description
5-session Cognitive Rehabilitation intervention administered over telehealth
Intervention Type
Behavioral
Intervention Name(s)
Brief Cognitive Rehabilitation
Intervention Description
5-session Cognitive Rehabilitation intervention that can be administered over telehealth.
Primary Outcome Measure Information:
Title
Feasibility of administering the On-TRACC intervention to individuals with mTBI
Description
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.
Time Frame
At the completion of 5 week intervention
Secondary Outcome Measure Information:
Title
Participant satisfaction with On-TRACC intervention
Description
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.
Time Frame
End of each treatment session and at treatment completion, 5 weeks total.
Title
Preliminary effectiveness of On-TRACC intervention in decreasing post-concussive symptoms
Description
Pre-post treatment change in post-concussive symptoms (Neurobehavioral Symptom Inventory) will be evaluated.
Time Frame
Baseline (pre-treatment) and at the end of the 5-week On-TRACC intervention, 5 week time-frame on average
Title
Preliminary effectiveness of On-TRACC intervention at decreasing self-reported cognitive difficulties
Description
Pre-post treatment change in self-reported cognitive difficulties (NeuroQol Item Bank Cognitive Function SF) will be evaluated.
Time Frame
Baseline (pre-treatment) and at the end of the 5-week On-TRACC intervention, 5 week time-frame on average
Title
Preliminary effectiveness of On-TRACC intervention at improving self-efficacy
Description
Pre-post treatment change in self-efficacy (Cognitive Concerns Self-Efficacy Scale) will be evaluated.
Time Frame
Baseline (pre-treatment) and at the end of the 5-week On-TRACC intervention, 5 week time-frame on average

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kathleen Pagulayan, PhD
Organizational Affiliation
VA Puget Sound Health Care System/University of Washington
Official's Role
Principal Investigator
Facility Information:
Facility Name
VA Puget Sound Health Care System
City
Seattle
State/Province
Washington
ZIP/Postal Code
98108
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Brief Telehealth Cognitive Rehabilitation Following Mild TBI

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