An interventional study of Brief Cognitive Rehabilitation in Mild Traumatic Brain Injury and Cognitive Impairment, sponsored by University of Washington. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-03-24.
Sponsored by University of Washington · Not applicable, Interventional, and Treatment
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.
2,113 studies on the registry are indexed under Brain Injuries; 385 are open to participants now.
This study's enrollment of 28 is below the median of 48 across 1,331 interventional studies indexed under Brain Injuries.
Browse Brain Injuries studies →University of Washington is the lead sponsor of 1,397 studies on the registry; 225 are open to participants now.
Of its 154 completed or terminated interventional studies of FDA-regulated products, 132 (86%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
5-session Cognitive Rehabilitation intervention administered over telehealth
Behavioral: Brief Cognitive Rehabilitation
5-session Cognitive Rehabilitation intervention that can be administered over telehealth.
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.
Time frame: At the completion of 5 week intervention
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.
Time frame: End of each treatment session and at treatment completion, 5 weeks total.
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.
Time frame: 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
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
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.
Time frame: Baseline (pre-treatment) and at the end of the 5-week On-TRACC intervention, 5 week time-frame on average
Plan to share: No
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This study is completed, as verified in Mar 2023. You cannot join it, but the record below documents what was studied.
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