Clinical trial NCT05315453: Brief Telehealth Cognitive Rehabilitation Following Mild TBI
Official title: Brief Telehealth Cognitive Rehabilitation Following Mild Traumatic Brain Injury: A Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Mild Traumatic Brain Injury
Cognitive Impairment
Lead sponsor: University of Washington
Sponsor class: OTHER
Collaborators: name: VA Puget Sound Health Care System
First posted: 2022-04-07
Enrollment: 28
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


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)

Primary outcomes:
measure: Feasibility of administering the On-TRACC intervention to individuals with mTBI
timeFrame: At the completion of 5 week intervention
Secondary outcomes:
measure: Participant satisfaction with On-TRACC intervention
timeFrame: End of each treatment session and at treatment completion, 5 weeks total.
measure: Preliminary effectiveness of On-TRACC intervention in decreasing post-concussive symptoms
timeFrame: Baseline (pre-treatment) and at the end of the 5-week On-TRACC intervention, 5 week time-frame on average
measure: Preliminary effectiveness of On-TRACC intervention at decreasing self-reported cognitive difficulties
timeFrame: Baseline (pre-treatment) and at the end of the 5-week On-TRACC intervention, 5 week time-frame on average
measure: Preliminary effectiveness of On-TRACC intervention at improving self-efficacy
timeFrame: Baseline (pre-treatment) and at the end of the 5-week On-TRACC intervention, 5 week time-frame on average
Other outcomes:
Locations:
city: Seattle
country: United States
facility: VA Puget Sound Health Care System
state: Washington
Study officials:
affiliation: VA Puget Sound Health Care System/University of Washington
name: Kathleen Pagulayan, PhD
role: PRINCIPAL_INVESTIGATOR
References: