Traumatic Brain InjuryNCT04238910
Maximizing Energy After Traumatic Brain Injury
A study testing Maximizing Energy and Health Education in people with Traumatic Brain Injury and Fatigue, run by University of Pittsburgh.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Traumatic Brain Injury, Fatigue
- What is being tested?
- Maximizing Energy and Health Education
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 41 participants
- Where
- No sites listed yet
- Study dates
- May 2011to Jan 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
About this study
Official title: Maximizing Energy After Traumatic Brain Injury: Feasibility and Effectiveness of Combined Problem Solving Therapy and Occupational Therapist Delivered Education
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.
Read the 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
- Being tested
- Maximizing Energy, Health Education
- Keywords
- traumatic brain injury, fatigue, self-management
- Medical subject headings
- Brain Injuries, Traumatic, Fatigue
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Maximizing EnergyBehavioural
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 EducationBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: Health Education |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline, Week 16
Secondary outcomes (5)
Change in Fatigue Impact Scores (Modified Fatigue Impact Scale) Between Groups At 16 Weeks
The Modified Fatigue Impact Scale is a self-report instrument that assesses the impact of fatigue on performance of everyday activities. The Scale has 21 items in three subscales: physical, cognitive, and psychosocial. A 5-point scale ranging from 0 (never) to 4 (almost always) is used for rating each item; items are summed to obtain a total score. Higher scores indicate greater impact of fatigue on performance of everyday activities. Total 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.
Measured: Baseline, Week 16
Change in Fatigue Severity Scores (Fatigue Severity Scale) Between Groups At 16 Weeks
The Modified Fatigue Severity Scale is a self-report instrument that assesses the severity of fatigue. The Scale has 9 items. A 7-point scale ranging from 1 (strong disagreement) to 7 (strong agreement) is used for rating each item; mean of the items yield a total score. Higher scores indicate greater fatigue severity. Total 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.
Measured: Baseline, Week 16
Change in Participation Scores (Participation Objective, Participation Subjective) Between Groups At 16 Weeks
Participation Objective, Participation Subjective (POPS) evaluates participation in everyday life in persons with TBI. The scale consists of 26 items sorted into five categories: Domestic life; Major life activities; Transportation; Interpersonal interactions and relationships; and Community, recreational and civic life. Scores on the objective questions are converted into standardized z scores ranging from -3 to +3. Higher scores indicate greater frequency of participation in everyday life. Scores on the subjective questions range from +4, indicating a "most important" area of life that the person is engaging in at a satisfactory level, to -4, indicating an equally important area of life that the person wants to do either less of or more of. Total 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.
Measured: Baseline, Week 16
Change in Physical Activity Between Groups At 16 Weeks
Physical activity data was collected with the Actical device. The Actical is a wireless, wearable body monitor that collects and analyzes raw physiological and lifestyle data. It was worn at the wrist for 3 days. Physical activity data was derived in terms of metabolic equivalents (METs) when participants engaged in physical activity. Total energy expenditure over 3 days were obtained at at baseline, Week 8, Week 12, and Week 16 for each participant, and mean scores were calculated for each group at each time point.
Measured: Baseline, Week 16
Change in Perceived Work Disability (Work Role Functioning Questionnaire) Between Groups At 16 Weeks
The Work Role Functioning Questionnaire (WRFQ) assesses the degree of perceived work disability due to a chronic health problem. The questionnaire consists of 27 items divided into five subscales: Work scheduling demands, Physical demands, Mental demands, Social demands, and Output demands. The participant scores each item on a 5 point ordinal scale (0 = difficult all the time, 4 = difficult none of the time). Each subscale is scored separately, by adding the response of each item, and converting the score from 0 (limited all the time) to 100 (never limited).
Measured: Baseline, Week 16
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jan 2020
- Study startMay 2011
- Primary completionJan 2015
- Study completionJan 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Traumatic Brain InjuryStudies of the same condition, open and under way.
- More trials run by University of PittsburghThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 41 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pittsburgh
- Sponsor type
- University, hospital or other
- Collaborators
- U.S. Army Medical Research and Development Command
- Responsible party
- Principal investigator, Ketki Raina, University of Pittsburgh
- Investigators
- Ketki Raina, PhD, OTR/L, Principal investigator, University of Pittsburgh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04238910
- Sponsor's protocol ID
- PRO09010275
- Other IDs
- W81XWH-10-1-0
- Status last verified
- Jan 2020
- First submitted
- 15 Jan 2020
- Last updated
- 23 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 26580691
Study at a glance
From the registry record, last updated by the sponsor on 23 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Maximizing Energy After Traumatic Brain Injury: Feasibility and Effectiveness of Combined Problem Solving Therapy and Occupational Therapist Delivered Education
- ClinicalTrials.gov ID
- NCT04238910
- Acronym / sponsor ID
- PRO09010275
- Conditions
- Traumatic Brain Injury, Fatigue
- Keywords
- traumatic brain injury, fatigue, self-management
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 41 participants (actual)
- Lead sponsor
- University of PittsburghUniversity, hospital or other
- Collaborators
- U.S. Army Medical Research and Development Command
- Study start
- May 2011 (actual)
- Primary completion
- Jan 2015 (actual)
- Study completion
- Jan 2015 (actual)
- First posted
- 23 Jan 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Maximizing Energy | Experimental | Behavioral: Maximizing EnergyThe 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. |
| Health Education | Active comparator | Behavioral: Health Educationconsists 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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:
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Maximizing EnergyThe 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. | Behavioural | Maximizing Energy |
| Health EducationThe 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. | Behavioural | Health Education |
Primary outcome
Change in Fatigue Scores (Patient-Reported Outcomes Measurement Information System - Fatigue) Between Groups At 16 Weeks
Time frame: Baseline, Week 16
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.
5 secondary outcomes
Change in Fatigue Impact Scores (Modified Fatigue Impact Scale) Between Groups At 16 Weeks
Time frame: Baseline, Week 16
Change in Fatigue Severity Scores (Fatigue Severity Scale) Between Groups At 16 Weeks
Time frame: Baseline, Week 16
Change in Participation Scores (Participation Objective, Participation Subjective) Between Groups At 16 Weeks
Time frame: Baseline, Week 16
Change in Physical Activity Between Groups At 16 Weeks
Time frame: Baseline, Week 16
Change in Perceived Work Disability (Work Role Functioning Questionnaire) Between Groups At 16 Weeks
Time frame: Baseline, Week 16
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 May 2025.
- Background: PubMed 26580691Raina 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.
- Individual participant dataSharing planned: No
Related trials for Traumatic Brain Injury
Enrolling by invitationObservational study
Assessment of Traumatic Brain Injury Using Transcranial Magnetic Stimulated Evoked Potentials
Traumatic Brain Injury
RecruitingObservational study
CoMind Early Feasibility Study
Intracranial Pressure, Intracranial Pressure Changes
Enrolling by invitation
Improving In-hospital and Post-discharge Patient Education for Mild Traumatic Brain Injury
Concussion, Mild, Traumatic Brain Injury
Not yet recruitingObservational study
Description of Clinicians' Predictive Abilities Before and After a Diffusion Tensor Imaging (DTI)
Diffusion Tensor Imaging Prognosis, Brain Injury, Traumatic
Enrolling by invitation
Risk Assessment of Mild Traumatic Brain Injury in Military Training
Trauma, Brain
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ketki Raina, PhD, OTR/L principal investigator
University of Pittsburgh
Questions about this trial
What is this clinical trial studying?
A study testing Maximizing Energy and Health Education in people with Traumatic Brain Injury and Fatigue, run by University of Pittsburgh.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 May 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Fatigue Scores (Patient-Reported Outcomes Measurement Information System - Fatigue) Between Groups At 16 Weeks (time frame: Baseline, Week 16). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04238910, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 May 2025.