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| Name | Class |
|---|---|
| VA Puget Sound Health Care System | FED |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Brief Cognitive Rehabilitation | Experimental | 5-session Cognitive Rehabilitation intervention administered over telehealth |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Brief Cognitive Rehabilitation | Behavioral | 5-session Cognitive Rehabilitation intervention that can be administered over telehealth. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | End of each treatment session and at treatment completion, 5 weeks total. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Kathleen Pagulayan, PhD | VA Puget Sound Health Care System/University of Washington | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| VA Puget Sound Health Care System | Seattle | Washington | 98108 | United States |
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| ID | Term |
|---|---|
| D001924 | Brain Concussion |
| D060825 | Cognitive Dysfunction |
| ID | Term |
|---|---|
| D000070642 | Brain Injuries, Traumatic |
| D001930 | Brain Injuries |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
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| 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. | 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. | 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. | Baseline (pre-treatment) and at the end of the 5-week On-TRACC intervention, 5 week time-frame on average |
| D009422 | Nervous System Diseases |
| D006259 | Craniocerebral Trauma |
| D020196 | Trauma, Nervous System |
| D016489 | Head Injuries, Closed |
| D014947 | Wounds and Injuries |
| D014949 | Wounds, Nonpenetrating |
| D003072 | Cognition Disorders |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |