Clinical trial NCT04238910: Maximizing Energy After Traumatic Brain Injury
Official title: Maximizing Energy After Traumatic Brain Injury: Feasibility and Effectiveness of Combined Problem Solving Therapy and Occupational Therapist Delivered Education
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Traumatic Brain Injury
Fatigue
Keywords: traumatic brain injury
fatigue
self-management
Lead sponsor: University of Pittsburgh
Sponsor class: OTHER
Collaborators: name: U.S. Army Medical Research and Development Command
First posted: 2020-01-23
Enrollment: 41
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed description: A significant proportion (50-80%) of individuals with traumatic brain injury (TBI) experience persistent fatigue and endorse it as the most distressing and challenging symptom that affects daily life. Chronic fatigue has a devastating impact on individuals because it leads to reduced participation in everyday life. Despite the high incidence of post-TBI fatigue and its impact on everyday life, these is a dearth of studies examining the effectiveness of non-pharmacological interventions for the treatment of post-TBI fatigue. This study is unique in that it will examine the effectiveness of a non-pharmacological intervention to manage post-TBI fatigue. The Maximizing Energy (MAX) Intervention, individuals with post-TBI fatigue will reduce the impact of fatigue on everyday life by actively seeking and implementing solutions for their fatigue-related problems, thus promoting their reintegration into the community.

Eligibility criteria: Inclusion Criteria:

1. Age: 18 years or older
2. Patient lives within a 50 miles radius of the University of Pittsburgh in Oakland
3. Diagnosis of TBI atleast 6 months ago: Individuals need time to determine if they have chronic fatigue after CA.
4. Community dwelling: Community dwelling participants are more likely to be able to make environmental changes than those in institutions
5. Vision to operate a computer:
6. 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.
7. No cognitive impairment
8. Functional English fluency and literacy

Exclusion Criteria:

1. Physical impairment: Individuals scoring \< 65 on the 13 Functional Independence Measure (FIM) motor items will be excluded from the study;
2. 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
3. Disability due to other diagnoses: history of neurologic, traumatic, or psychiatric conditions.

Primary outcomes:
measure: Change in Fatigue Scores (Patient-Reported Outcomes Measurement Information System - Fatigue) Between Groups At 16 Weeks
timeFrame: Baseline, Week 16
Secondary outcomes:
measure: Change in Fatigue Impact Scores (Modified Fatigue Impact Scale) Between Groups At 16 Weeks
timeFrame: Baseline, Week 16
measure: Change in Fatigue Severity Scores (Fatigue Severity Scale) Between Groups At 16 Weeks
timeFrame: Baseline, Week 16
measure: Change in Participation Scores (Participation Objective, Participation Subjective) Between Groups At 16 Weeks
timeFrame: Baseline, Week 16
measure: Change in Physical Activity Between Groups At 16 Weeks
timeFrame: Baseline, Week 16
measure: Change in Perceived Work Disability (Work Role Functioning Questionnaire) Between Groups At 16 Weeks
timeFrame: Baseline, Week 16
Other outcomes:
Locations:
Study officials:
affiliation: University of Pittsburgh
name: Ketki Raina, PhD, OTR/L
role: PRINCIPAL_INVESTIGATOR
References:
citation: Raina KD, Morse JQ, Chisholm D, Leibold ML, Shen J, Whyte E. Feasibility of a Cognitive Behavioral Intervention to Manage Fatigue in Individuals With Traumatic Brain Injury: A Pilot Study. J Head Trauma Rehabil. 2016 Sep-Oct;31(5):E41-9. doi: 10.1097/HTR.0000000000000196.