J Head Trauma Rehabil c 2015 Wolters Kluwer Health, Inc. All rights reserved. Copyright
Feasibility of a Cognitive Behavioral Intervention to Manage Fatigue in Individuals With Traumatic Brain Injury: A Pilot Study Ketki D. Raina, PhD, OTR/L; Jennifer Q. Morse, PhD; Denise Chisholm, PhD, OTR/L; Mary Lou Leibold, PhD, OTR/L; Jennifer Shen, MD; Ellen Whyte, MD Objective: To evaluate the feasibility of conducting a randomized clinical trial of an Internet-based manualized intervention to teach individuals with traumatic brain injury to manage their fatigue. Setting: Community dwelling. Participants: Forty-one participants randomized to Maximizing Energy (MAX) intervention group (n = 20) and Health Education group (n = 21). Intervention: The experimental group (MAX intervention) received an 8-week program that combined education and Problem-Solving Therapy to teach individuals to manage fatigue-related problems. The attention control group received health education. Measures: Primary outcome measures pertained to the feasibility of conducting the trial. Secondary outcomes were fatigue impact and fatigue severity assessed at baseline and postintervention. Results: Of the 65 participants referred, 41 were enrolled (63% recruitment rate), of which 3 withdrew (92% retention rate). Participants in the experimental and control groups completed their homework 75% and 85% of the time, respectively, and were equally engaged in the sessions. Participants in the experimental group were able to learn and implement the MAX intervention steps. Effect sizes for all measures ranged from small (−0.17) to medium (−0.58) in favor of the intervention group. Conclusion: Findings from the study suggest that the MAX intervention is feasible to administer to individuals with post–traumatic brain injury fatigue. Key words: behavioral, energy conservation, fatigue, problem solving, traumatic brain injury
A
SIGNIFICANT PROPORTION (50%-80%) of individuals with traumatic brain injury (TBI) experience persistent and significant fatigue that affects their daily life.1–7 The chronic pathologic fatigue experienced by individuals with TBI is different from normal “everyday” fatigue experienced occasionally by most people. Chronic pathologic fatigue is defined as “the self-recognized state in which the person experiences an overwhelming sustained sense of exhaustion and deAuthor Affiliations: Department of Occupational Therapy, School of Health and Rehabilitation Sciences (Drs Raina, Chisholm, and Leibold), Department of Physical Medicine and Rehabilitation, School of Medicine (Dr Shen), and Department of Psychiatry, School of Medicine (Dr Whyte), University of Pittsburgh, Pittsburgh, Pennsylvania; and Department of Counseling Psychology, School of Health Sciences, Chatham University, Pittsburgh, Pennsylvania (Dr Morse). The study was funded by the US Army Medical Research and Material Command (award no. W81XWH-10-1-0920). The authors declare no conflicts of interest. Corresponding Author: Ketki D. Raina, PhD, OTR/L, Department of Occupational Therapy, School of Health and Rehabilitation Sciences, University of Pittsburgh, 5012 Forbes Tower, Pittsburgh, PA 15260 ([email protected]). DOI: 10.1097/HTR.0000000000000196
creased capacity for physical and mental work that is not relieved by rest.”8(p309) Chronic pathologic fatigue often accompanies medical illness, has multiple or unknown causes, and is disproportionate to the individual’s level of actual physical or mental exertion. While fatigue frequently co-occurs with other post-TBI conditions, such as depression, pain, and disturbed sleep, evidence suggests that fatigue is a disabling syndrome distinct from these comorbid conditions and that these conditions do not account for the fatigue.9 It is critical for clinician to reduce post-TBI fatigue because it has a devastating impact on the individual. Numerous studies report an inverse relationship between fatigue and participation in everyday life.10–14 Post-TBI fatigue is a barrier to return to work.15 Even for patients who return to work, fatigue is a common complaint.16,17 Pharmacologic and exercise-based interventions have not been successful in reducing fatigue severity.18,19 However, several studies suggested that rehabilitation after TBI should include patient education to (a) stress the awareness of fatigue as a natural consequence of TBI20 ; (b) identify triggers leading to fatigue and learn strategies to manage these triggers to optimize 1
Copyright © 2015 Wolters Kluwer Health, Inc. Unauthorized reproduction of this article is prohibited.
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JOURNAL OF HEAD TRAUMA REHABILITATION
participation in everyday life21 ; and (c) teach compensatory methods that include the monitoring of fatigue, pacing activities by alternating work and rest, and establishing regular sleep patterns.22,23 These recommendations for managing fatigue have yet to be empirically tested in individuals with post-TBI fatigue. Occupational therapists (OTs) have expertise in providing education to facilitate successful management of chronic fatigue with various clinical populations.24 Through energy conservation strategy education, individuals learn to modify their daily activities by (a) evaluating and monitoring their energy expenditure for daily activities, (b) breaking activities down into their subcomponents and performing each subcomponent separately, (c) evaluating rest-activity ratios, (d) using their bodies efficiently to perform activities, (e) pacing their daily routine, and (f) using equipment and community resources.24–27 Using the principles of Behavior Activation Theory, we developed an 8-week manualized behavioral intervention to teach individuals energy conservation strategies. In the Maximizing Energy (MAX) intervention, OT-delivered energy conservation strategy education is activated using the Problem-Solving Therapy (PST) framework to enhance the probability of successful implementation in everyday life situations. Problem-Solving Therapy is a framework that teaches individuals to initiate and maintain a systematic process of problem identification, goal setting, solution identification and evaluation, solution implementation, and outcome evaluation through 7 manualized steps.28–30 The PST framework provides a personalized education approach, using specific client problems to learn energy conservation strategies. Several aspects of PST make it a particularly good approach to combine with energy conservation strategy education. First, PST uses a behavioral approach to defining and solving problems, focuses on specific problems that are bothering the individual, and is skills oriented. Second, PST readily includes educational materials and information gathering to help clients identify potential solutions. Third, both approaches highlight generalization of the skills learned by encouraging individuals to think about how the solutions that work might be applied to other fatigue-related problems, thereby increasing the potential benefit of the MAX intervention. The MAX intervention combines the “doing” strategies of occupational therapy with the “thinking” strategies of PST. Before testing the efficacy of a novel intervention, it is necessary both to demonstrate the feasibility of delivering the intervention and to test the study methods with the population of interest.31 This step is particularly important when the intervention is to be delivered via the Internet in a sample of individuals known to have cognitive deficits. The primary aims of this study were to evaluate (1) the feasibility of recruiting
and retaining the study sample in the experimental and control interventions, (2) the ability of individuals in the experimental group to learn and apply self-management intervention during the length of the study, and (3) the usability and acceptability of the experimental and control interventions. The secondary aim was an exploratory evaluation of possible intervention effects on measures of fatigue impact on everyday life and fatigue severity. METHODS Design The study was a single-blind, randomized controlled trial in which individuals who had experienced a TBI were randomized to the experimental (MAX) intervention group or the attention control (Health Education) group. This research was approved by the institutional review board of University of Pittsburgh and the Human Research Protection Office of the Department of Defense. Participants Individuals were recruited through a universityaffiliated medical center, local TBI support groups, and a TBI research registry. Inclusion criteria were (1) adults with a history of mild to severe TBI, (2) at least 6 months postinjury, (3) fatigue severe enough to limit activities of daily living (score ≥4 on the Fatigue Severity Scale [FSS]),32 (4) living in the community within a 50-mile radius of the university, (5) adequate vision to operate a computer, (6) able to provide informed consent, and (7) have sufficient language functioning to participate in a treatment conducted in English. Mild to severe TBI was defined as any injury sustained from an outside force to the head resulting in an initial Glasgow Coma Scale score of 3 to 15 with positive neuroradiologic findings.33 Exclusion criteria were (1) dependence in basic activities of daily living (score
Feasibility of a Cognitive Behavioral Intervention to Manage Fatigue in Individuals With Traumatic Brain Injury: A Pilot Study Ketki D. Raina, PhD, OTR/L; Jennifer Q. Morse, PhD; Denise Chisholm, PhD, OTR/L; Mary Lou Leibold, PhD, OTR/L; Jennifer Shen, MD; Ellen Whyte, MD Objective: To evaluate the feasibility of conducting a randomized clinical trial of an Internet-based manualized intervention to teach individuals with traumatic brain injury to manage their fatigue. Setting: Community dwelling. Participants: Forty-one participants randomized to Maximizing Energy (MAX) intervention group (n = 20) and Health Education group (n = 21). Intervention: The experimental group (MAX intervention) received an 8-week program that combined education and Problem-Solving Therapy to teach individuals to manage fatigue-related problems. The attention control group received health education. Measures: Primary outcome measures pertained to the feasibility of conducting the trial. Secondary outcomes were fatigue impact and fatigue severity assessed at baseline and postintervention. Results: Of the 65 participants referred, 41 were enrolled (63% recruitment rate), of which 3 withdrew (92% retention rate). Participants in the experimental and control groups completed their homework 75% and 85% of the time, respectively, and were equally engaged in the sessions. Participants in the experimental group were able to learn and implement the MAX intervention steps. Effect sizes for all measures ranged from small (−0.17) to medium (−0.58) in favor of the intervention group. Conclusion: Findings from the study suggest that the MAX intervention is feasible to administer to individuals with post–traumatic brain injury fatigue. Key words: behavioral, energy conservation, fatigue, problem solving, traumatic brain injury
A
SIGNIFICANT PROPORTION (50%-80%) of individuals with traumatic brain injury (TBI) experience persistent and significant fatigue that affects their daily life.1–7 The chronic pathologic fatigue experienced by individuals with TBI is different from normal “everyday” fatigue experienced occasionally by most people. Chronic pathologic fatigue is defined as “the self-recognized state in which the person experiences an overwhelming sustained sense of exhaustion and deAuthor Affiliations: Department of Occupational Therapy, School of Health and Rehabilitation Sciences (Drs Raina, Chisholm, and Leibold), Department of Physical Medicine and Rehabilitation, School of Medicine (Dr Shen), and Department of Psychiatry, School of Medicine (Dr Whyte), University of Pittsburgh, Pittsburgh, Pennsylvania; and Department of Counseling Psychology, School of Health Sciences, Chatham University, Pittsburgh, Pennsylvania (Dr Morse). The study was funded by the US Army Medical Research and Material Command (award no. W81XWH-10-1-0920). The authors declare no conflicts of interest. Corresponding Author: Ketki D. Raina, PhD, OTR/L, Department of Occupational Therapy, School of Health and Rehabilitation Sciences, University of Pittsburgh, 5012 Forbes Tower, Pittsburgh, PA 15260 ([email protected]). DOI: 10.1097/HTR.0000000000000196
creased capacity for physical and mental work that is not relieved by rest.”8(p309) Chronic pathologic fatigue often accompanies medical illness, has multiple or unknown causes, and is disproportionate to the individual’s level of actual physical or mental exertion. While fatigue frequently co-occurs with other post-TBI conditions, such as depression, pain, and disturbed sleep, evidence suggests that fatigue is a disabling syndrome distinct from these comorbid conditions and that these conditions do not account for the fatigue.9 It is critical for clinician to reduce post-TBI fatigue because it has a devastating impact on the individual. Numerous studies report an inverse relationship between fatigue and participation in everyday life.10–14 Post-TBI fatigue is a barrier to return to work.15 Even for patients who return to work, fatigue is a common complaint.16,17 Pharmacologic and exercise-based interventions have not been successful in reducing fatigue severity.18,19 However, several studies suggested that rehabilitation after TBI should include patient education to (a) stress the awareness of fatigue as a natural consequence of TBI20 ; (b) identify triggers leading to fatigue and learn strategies to manage these triggers to optimize 1
Copyright © 2015 Wolters Kluwer Health, Inc. Unauthorized reproduction of this article is prohibited.
2
JOURNAL OF HEAD TRAUMA REHABILITATION
participation in everyday life21 ; and (c) teach compensatory methods that include the monitoring of fatigue, pacing activities by alternating work and rest, and establishing regular sleep patterns.22,23 These recommendations for managing fatigue have yet to be empirically tested in individuals with post-TBI fatigue. Occupational therapists (OTs) have expertise in providing education to facilitate successful management of chronic fatigue with various clinical populations.24 Through energy conservation strategy education, individuals learn to modify their daily activities by (a) evaluating and monitoring their energy expenditure for daily activities, (b) breaking activities down into their subcomponents and performing each subcomponent separately, (c) evaluating rest-activity ratios, (d) using their bodies efficiently to perform activities, (e) pacing their daily routine, and (f) using equipment and community resources.24–27 Using the principles of Behavior Activation Theory, we developed an 8-week manualized behavioral intervention to teach individuals energy conservation strategies. In the Maximizing Energy (MAX) intervention, OT-delivered energy conservation strategy education is activated using the Problem-Solving Therapy (PST) framework to enhance the probability of successful implementation in everyday life situations. Problem-Solving Therapy is a framework that teaches individuals to initiate and maintain a systematic process of problem identification, goal setting, solution identification and evaluation, solution implementation, and outcome evaluation through 7 manualized steps.28–30 The PST framework provides a personalized education approach, using specific client problems to learn energy conservation strategies. Several aspects of PST make it a particularly good approach to combine with energy conservation strategy education. First, PST uses a behavioral approach to defining and solving problems, focuses on specific problems that are bothering the individual, and is skills oriented. Second, PST readily includes educational materials and information gathering to help clients identify potential solutions. Third, both approaches highlight generalization of the skills learned by encouraging individuals to think about how the solutions that work might be applied to other fatigue-related problems, thereby increasing the potential benefit of the MAX intervention. The MAX intervention combines the “doing” strategies of occupational therapy with the “thinking” strategies of PST. Before testing the efficacy of a novel intervention, it is necessary both to demonstrate the feasibility of delivering the intervention and to test the study methods with the population of interest.31 This step is particularly important when the intervention is to be delivered via the Internet in a sample of individuals known to have cognitive deficits. The primary aims of this study were to evaluate (1) the feasibility of recruiting
and retaining the study sample in the experimental and control interventions, (2) the ability of individuals in the experimental group to learn and apply self-management intervention during the length of the study, and (3) the usability and acceptability of the experimental and control interventions. The secondary aim was an exploratory evaluation of possible intervention effects on measures of fatigue impact on everyday life and fatigue severity. METHODS Design The study was a single-blind, randomized controlled trial in which individuals who had experienced a TBI were randomized to the experimental (MAX) intervention group or the attention control (Health Education) group. This research was approved by the institutional review board of University of Pittsburgh and the Human Research Protection Office of the Department of Defense. Participants Individuals were recruited through a universityaffiliated medical center, local TBI support groups, and a TBI research registry. Inclusion criteria were (1) adults with a history of mild to severe TBI, (2) at least 6 months postinjury, (3) fatigue severe enough to limit activities of daily living (score ≥4 on the Fatigue Severity Scale [FSS]),32 (4) living in the community within a 50-mile radius of the university, (5) adequate vision to operate a computer, (6) able to provide informed consent, and (7) have sufficient language functioning to participate in a treatment conducted in English. Mild to severe TBI was defined as any injury sustained from an outside force to the head resulting in an initial Glasgow Coma Scale score of 3 to 15 with positive neuroradiologic findings.33 Exclusion criteria were (1) dependence in basic activities of daily living (score
