Brief Telehealth Cognitive Rehabilitation Following Mild TBI

NCT ID: NCT05315453

Last Updated: 2023-03-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 28 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-12-13
• Study Completion Date: 2022-10-13

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Brief Cognitive Rehabilitation

5-session Cognitive Rehabilitation intervention administered over telehealth

Group Type: EXPERIMENTAL

Brief Cognitive Rehabilitation

Intervention Type: BEHAVIORAL

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

Interventions

Brief Cognitive Rehabilitation

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

Intervention Type: BEHAVIORAL

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)

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

VA Puget Sound Health Care System

FED

Sponsor Role: collaborator

University of Washington

OTHER

Sponsor Role: lead

Responsible Party

Kathleen Pagulayan

Associate Professor, School of Medicine: Psychiatry

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Kathleen Pagulayan, PhD

Role: PRINCIPAL_INVESTIGATOR

VA Puget Sound Health Care System/University of Washington

Locations

VA Puget Sound Health Care System

Seattle, Washington, United States

Countries

United States

Other Identifiers

STUDY00013494

Identifier Type: -

Identifier Source: org_study_id