Maximizing Energy After Traumatic Brain Injury

NCT ID: NCT04238910

Last Updated: 2025-05-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 41 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-05-31
• Study Completion Date: 2015-01-31

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.

Conditions

Traumatic Brain Injury; Fatigue

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Maximizing Energy

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.

Group Type: EXPERIMENTAL

Maximizing Energy

Intervention Type: 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.

Health Education

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.

Group Type: ACTIVE_COMPARATOR

Health Education

Intervention Type: 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.

Interventions

Maximizing Energy

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.

Intervention Type: BEHAVIORAL

Health Education

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.

Intervention Type: BEHAVIORAL

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

U.S. Army Medical Research and Development Command

FED

Sponsor Role: collaborator

University of Pittsburgh

OTHER

Sponsor Role: lead

Responsible Party

Ketki Raina

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Ketki Raina, PhD, OTR/L

Role: PRINCIPAL_INVESTIGATOR

University of Pittsburgh

References

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.

Reference Type: BACKGROUND

PMID: 26580691 (View on PubMed)

Other Identifiers

W81XWH-10-1-0

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

PRO09010275

Identifier Type: -

Identifier Source: org_study_id