Maximizing Energy After Traumatic Brain Injury (NCT04238910) | Clinical Trial Compass
CompletedNot Applicable
Maximizing Energy After Traumatic Brain Injury
41 participantsStarted 2011-05
Plain-language summary
Traumatic brain injury (TBI) is the signature injury of the wars in Iraq and Afghanistan. Up to 73% of TBI patients endorse fatigue as their most challenging symptom.
Fatigue leads to decreased participation in everyday life and return to work. The Maximizing Energy (MAX) intervention trains individuals with TBI to manage their fatigue.
The intervention individualizes the Occupational Therapist delivered Energy Conservation Strategies education by using the framework of Problem Solving Therapy. The purpose of this single-blind randomized clinical trial was to test the effect of the Maximizing Energy (MAX) intervention for decreasing the impact and severity of post-TBI fatigue, increasing participation in everyday life and physical activity, and decreasing work disability.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. Age: 18 years or older
✓. Patient lives within a 50 miles radius of the University of Pittsburgh in Oakland
✓. Diagnosis of TBI atleast 6 months ago: Individuals need time to determine if they have chronic fatigue after CA.
✓. Community dwelling: Community dwelling participants are more likely to be able to make environmental changes than those in institutions
✓. Vision to operate a computer:
✓. Presence of fatigue: Fatigue Severity Scale is a valid and reliable test used to measure the severity of fatigue on 9 fatigue-related statements on a 7 point ordinal scale. A score ≥ 4 signifies fatigue severe enough to limit daily activities.
✓. No cognitive impairment
✓. Functional English fluency and literacy
Exclusion criteria
✕. Physical impairment: Individuals scoring \< 65 on the 13 Functional Independence Measure (FIM) motor items will be excluded from the study;
What they're measuring
1
Change in Fatigue Scores (Patient-Reported Outcomes Measurement Information System - Fatigue) Between Groups At 16 Weeks
✕. Mood and mental health history: Individuals with a recent (less than 3 months) history of major depressive disorder, mania, hypomania, psychosis, or substance abuse as diagnosed by the PRIME-MD and the MiniInternational Neuropsychiatric Interview (MINI) unless treated or in partial remission will be excluded because their self-reports of participation in everyday life may not be reliable; and
✕. Disability due to other diagnoses: history of neurologic, traumatic, or psychiatric conditions.