Brief Telehealth Cognitive Rehabilitation Following Mild TBI

NCT05315453 | Completed

• 1 other identifier: STUDY00013494
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 1

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.

Conditions

Mild Traumatic Brain Injury; Cognitive Impairment

Outcome Measures

Primary Outcomes (1)

• 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.

  At the completion of 5 week intervention

Secondary Outcomes (4)

• Participant satisfaction with On-TRACC intervention

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

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

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

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

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

• Preliminary effectiveness of On-TRACC intervention at improving self-efficacy

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

Study Arms (1)

Brief Cognitive Rehabilitation

EXPERIMENTAL

5-session Cognitive Rehabilitation intervention administered over telehealth

Behavioral: Brief Cognitive Rehabilitation

Interventions

Brief Cognitive Rehabilitation BEHAVIORAL

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

Brief Cognitive Rehabilitation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• University of Washington: lead
• VA Puget Sound Health Care System: collaborator

Study Sites (1)

VA Puget Sound Health Care System

Seattle, Washington, 98108, United States

Location

MeSH Terms

Conditions

Brain Concussion; Cognitive Dysfunction

Condition Hierarchy (Ancestors)

Brain Injuries, Traumatic; Brain Injuries; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Head Injuries, Closed; Wounds and Injuries; Wounds, Nonpenetrating; Cognition Disorders; Neurocognitive Disorders; Mental Disorders

Study Officials

• Kathleen Pagulayan, PhD

  VA Puget Sound Health Care System/University of Washington

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor, School of Medicine: Psychiatry

Study Record Dates

• First Submitted: December 13, 2021
• First Posted: April 7, 2022
• Study Start: December 13, 2021
• Primary Completion: October 10, 2022
• Study Completion: October 13, 2022
• Last Updated: March 24, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)