Maximizing Energy After Traumatic Brain Injury

NCT04238910 | Completed

• 2 other identifiers: PRO09010275W81XWH-10-1-0
• Study Type: interventional
• Target: 41
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Traumatic Brain Injury; Fatigue

Keywords

traumatic brain injury; fatigue; self-management

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (5)

• 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

Study Arms (2)

Maximizing Energy

EXPERIMENTAL

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.

Behavioral: Maximizing Energy

Health Education

ACTIVE COMPARATOR

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.

Behavioral: Health Education

Interventions

Maximizing Energy BEHAVIORAL

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.

Maximizing Energy

Health Education BEHAVIORAL

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.

Health Education

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Physical impairment: Individuals scoring \< 65 on the 13 Functional Independence Measure (FIM) motor items will be excluded from the study;
• 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.

Sponsors & Collaborators

• University of Pittsburgh: lead
• U.S. Army Medical Research and Development Command: collaborator

Related Publications (1)

• 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.

  PMID: 26580691 BACKGROUND

MeSH Terms

Conditions

Brain Injuries, Traumatic; Fatigue

Condition Hierarchy (Ancestors)

Brain Injuries; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Ketki Raina, PhD, OTR/L

  University of Pittsburgh

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: January 15, 2020
• First Posted: January 23, 2020
• Study Start: May 1, 2011
• Primary Completion: January 1, 2015
• Study Completion: January 1, 2015
• Last Updated: May 23, 2025

Record last verified: 2020-01

Data Sharing

• IPD Sharing: Will not share