NCT04238910|Completed
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Sponsor study identifier
Secondary identifiers
OTHER_GRANT · US Army Medical Research and Development Command
interventional
41
0 countries
N/A
Study Start
May 2011
Actual (reported)Primary Completion
January 2015
Actual (reported)Study Completion
January 2015
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
January 2015
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
May 2011
Actual (reported)January 2015
Actual (reported)January 2015
Actual (reported)January 15, 2020
Actual (reported)January 23, 2020
Actual (reported)Change in Fatigue Scores (Patient-Reported Outcomes Measurement Information System - Fatigue) Between Groups At 16 Weeks
The PROMIS Fatigue item banks assess a range of self-reported fatigue symptoms that likely decreases one's ability to execute daily activities and function normally in family or social roles. The computerized adaptive test version provides a mean fatigue score. The Scale uses a T-score metric in which 50 is the mean for the population and 10 is the standard deviation of that population. Higher scores equal more fatigue. Scores were obtained at baseline, Week 8, Week 12, and Week 16 for each participant, and mean scores were calculated for each group at each time point.
Baseline, Week 16
Change in Fatigue Impact Scores (Modified Fatigue Impact Scale) Between Groups At 16 Weeks
Baseline, Week 16
Change in Fatigue Severity Scores (Fatigue Severity Scale) Between Groups At 16 Weeks
Baseline, Week 16
Change in Participation Scores (Participation Objective, Participation Subjective) Between Groups At 16 Weeks
Baseline, Week 16
Change in Physical Activity Between Groups At 16 Weeks
Baseline, Week 16
Change in Perceived Work Disability (Work Role Functioning Questionnaire) Between Groups At 16 Weeks
Baseline, Week 16
The Maximizing Energy (MAX) intervention consists of two weekly 30-minute sessions delivered live via the Internet using web-camera technology for 8 weeks. The interventions are delivered by occupational therapists. The MAX intervention was developed by combining two active ingredients - Problem Solving Therapy and energy conservation strategy education. Participants engage in two introductory sessions during the first week of the intervention. During the first session in a week, participants practice the steps of MAX Intervention with a fatigue-related problem. At the end of the session, the participants identify a clearly defined action plan for solution implementation. Participants are asked to implement the solution over the next few days. The second session takes place later in the week. The interventionist reviews the problem, the identified solution, and its implementation. Participants use a workbook to support their application of the MAX Intervention.
consists of two weekly 30-minute sessions delivered live via the Internet using web-camera technology for 8 weeks. The interventionist delivered health education using a variety of health related topics relevant to individuals with TBI (e.g., characteristics and prevalence of fatigue after TBI, diet and nutrition, importance of exercise, energy conservation strategies).Participants use a workbook to follow along with the interventionist during the weekly sessions.
The intent of the MAX intervention is to personalize OT delivered education to facilitate the implementation of Energy Conservation strategies using the PST framework to address specific fatigue-related problems and then to generalize from these solutions to both similar and new situations in daily life.
The intent of the health education intervention is to control for the non-specific effects of interactions with an interventionist. Participants received education on a variety of health related topics relevant to individuals with TBI.
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.
Ketki Raina, PhD, OTR/L
University of Pittsburgh
41 participants (actual enrollment reported by the registry).
First Submitted
January 15, 2020
First Posted
January 23, 2020
Study Start
May 2011
Actual (reported)Non-invasive Clinical Imaging of Cerebral Metabolism Following Brain Injury Using 13C Magnetic Resonance Spectroscopy.
Amino Acid Supplementation in Recovery From Traumatic Brain Injury
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
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Primary Completion
January 2015
Actual (reported)Study Completion
January 2015
Actual (reported)Last Updated
May 23, 2025
Record last verified: 2020-01
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