Applied Nursing Research 30 (2016) 90–93
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Applied Nursing Research journal homepage: www.elsevier.com/locate/apnr
Development and testing of two lifestyle interventions for persons with chronic mild-to-moderate traumatic brain injury: Acceptability and feasibility Esther Bay, PhD, ACNS-BC b,⁎, Christine Ribbens-Grimm, BSN a, Roxane R. Chan, PhD, RN c a b c
University of Michigan Department of Psychiatry, Ann Arbor, MI University of Michigan School of Nursing, Ann Arbor, MI Michigan State University, E. Lansing MI
a r t i c l e
i n f o
Article history: Received 3 May 2015 Revised 4 November 2015 Accepted 8 November 2015 Keywords: Traumatic brain injury Mindfulness Methods Wellness Intervention
a b s t r a c t This clinical methods discursive highlights the development, piloting, and evaluation of two group interventions designed for persons who experienced chronic traumatic brain injury (TBI). Intervention science for this population is limited and lacking in rigor. Our innovative approach to customize existing interventions and develop parallel delivery methods guided by Allostatic Load theory is presented and preliminary results described. Overall, parallel group interventions delivered by trained leaders with mental health expertise were acceptable and feasible for persons who reported being depressed, stressed, and symptomatic. They reported being satisfied with the overall programs and mostly satisfied with the individual classes. Attendance was over the anticipated 70% expected rate and changes in daily living habits were reported by participants. These two group interventions show promise in helping persons to self manage their chronic stress and symptomatology. © 2015 Elsevier Inc. All rights reserved.
1. Introduction Worldwide, an estimated 10 million people (Institute of Medicine, 2011) experience traumatic brain injury (TBI). It results from a force impacting the brain and is an “alteration in brain function or other evidence of brain pathology, caused by an external force”(Menon, Schwab, Wright, & Maas, 2010). Motor vehicle crashes (17.3%), blunt impact (16.5%), falls (35.2%), assaults (10%) or blasts (Centers for Disease Control [CDC], 2015) are major causes. TBI is costly and affects those of all ages. The majority are aged 18–25 or over 75 years. Every year, nearly 1.7 million emergency department visits occur and about 25% of these visits require hospitalization for TBI (CDC, 2015). Furthermore, the annual sum of direct and indirect costs associated with TBI hospitalizations and rehabilitation are estimated to exceed $76 billion (CDC, 2015). These costs are incurred within various healthcare transitions involving acute hospitalization, rehabilitation, and outpatient therapies. Not everyone experiences complete recovery after TBI. Currently, TBI is considered a disease with lifelong consequences and reduced mortality (Bay & Chartier, 2014; Bazarian, Cernak, Noble-Haeusslein, Potolicchio, & Temkin, 2009). Thus, interventions are likely needed to
Conflicts of interest: None. ⁎ Corresponding author at: University of Michigan, School of Nursing, 400 N. Ingalls Division I, Ann Arbor MI 48108. Tel.: +1 734 764 1391. E-mail address:
[email protected] (E. Bay). http://dx.doi.org/10.1016/j.apnr.2015.11.003 0897-1897/© 2015 Elsevier Inc. All rights reserved.
disrupt the intricate pathogenesis and chronic difficulties that result in a myriad of healthcare encounters. Currently, the CDC recommends comprehensive rehabilitation linked to public health interventions (CDC, 2015). We believe such interventions should focus on lifestyle interventions aimed at stress reduction and symptom management. Efforts to deliver interventions linked to lifestyle interventions after TBI have been limited. Mindfulness-based group interventions for persons with TBI have focused on outcomes of attention (McMillan, Robertson, Brock, & Chorlton, 2002), quality of life (Bedard et al., 2003), self-efficacy (Azulay, Smart, Mott, & Cicerone, 2012) and depression (Bedard et al., 2013). To our knowledge, these studies are without active comparison groups or focus on stress or symptom management outcomes, both foci in the mindfulness research literature. However, this research did suggest that mindfulness could improve self-efficacy and depression, rather than cognition. Wellness interventions have been suggested to be important, but are without specific trials. Here, we intend to describe the two tailored lifestyle interventions, their methods of delivery, and participants’ levels of satisfaction for persons with chronic TBI. 2. Description of two lifestyle interventions and their theoretical bases Two group therapy interventions were developed and included: Positive focused mindfulness group therapy (PFM-GT) and healthyliving after TBI group therapy (HLA-GT). Both interventions fall within
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the definition of complex interventions as defined by the Medical Research Council (Moore et al., 2015). They include multiple components that must be mastered in combination and are impacted by the expertise of the interventionist and the culture of the setting in which they are delivered (Mohler, Bartoszek, & Meyer, 2013). Researcher organizations such as Consort and the British Medical Research Council have recognized that non-pharmaceutical bio-behavioral interventions require a specific process of evaluation in order to promote reproducibility and successful phase III long term interventional study (Mohler, Kopke, & Meyer, 2015). In keeping with the steps outlined in their framework, we will describe the underlying theoretical basis of the interventions, their pre-clinical phase development leading to the pilot study, and satisfaction findings and comments from our participants. Both interventions were tailored for persons who were within 3– 24 months from the injury event or in the chronic phase of recovery. In this phase, residual symptoms may be present and include challenges in mood (depression), cognition (deficits in planning, memory or attention), sleep, or behavior (irritable, isolative or critical of others). (Bay & Chartier, 2014) Chronic stress, present before, during, and after the event of TBI (Bay, Kirsch, & Gillespie, 2004; Griesbach, Hovda, Tio, & Taylor, 2011) is reported to mediate the relationship between TBI symptoms and psychological functioning (Bay, Sikorskii, & Gao, 2009). Additionally, hormones and chemicals involved in stress regulation are noted to be dysregulated after TBI. These findings are aligned with Allostatic Load (AL) Stress theory. This multivariate biological model of stress is based on the assumption that the brain regulates reciprocal and flexible stress systems (cardiovascular, immune, endocrine and metabolic systems) to achieve a state of allostasis (Juster, McEwen, & Lupien, 2010). Allostasis, the ability to maintain stability through change, can be threatened by chronic stress. Chronic stress contributes to inefficiencies or over activity of these flexible stress systems, termed allostatic load. Then, symptomatology or behavioral change can occur over time that is aligned with chronic disease development. Allostatic load has been hypothesized to contribute to the development of chronic diseases associated with TBI, including dementia, depression, vascular disease, and post-traumatic stress disorder (PTSD)(Bay & Chartier, 2014; McEwen, 2002). For purposes of this study, we suggest that allostatic load, operationalized as chronic stress, can be moderated by lifestyle interventions focused on stress management and lead to reductions in depressive and TBI symptoms and improvements in psychological functioning. 3. PFM-GT: the pre-clinical stage of development Aligned with current findings on mindfulness therapies after TBI, our PFM-GT intervention was developed. This focused not only on controlling attention, but also developing or regaining a positive self-image while experiencing feelings of self-criticism and challenges in relationships and social situations. Therefore, the primary intervention focused on meditation and was based on components of the Mindfulness-based Stress Reduction program (MBSR) (Kabat-Zinn, 1982). It included positive mantra/affirmation development, compassionate meditation and developing positive body awareness. The Positive Focused Mindfulness Group Therapy (PFM-GT) class sessions were: 1) Introduction to bodily sensations and the concept of mindfulness, 2) Positive body awareness and gentle movement, 3) Single focused meditation using a self-created positive mantra, and 4) Self- compassionate meditation and focus on positive affirmations. The PFM-GT provided the opportunity to practice and develop attentional focus through learning both exclusive and inclusive focused meditation while tailoring these skills to the needs of persons with TBI. Specifically, the PFM-GT avoided the more challenging aspects of MBSR by replacing the mindful experience of negative emotions with a focus on ambient sounds and providing body movement classes using three gentle QiGong movements that did not exacerbate problems with balance or vertigo. Further, positive self-created mantras, self-compassion
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meditation skills and the use of positive affirmations provided several opportunities to address negative self-concepts and teach self-soothing skills (Kabat-Zinn, 1982). 4. HLA-GT: pre-clinical stage of development The HLA-GT, our control intervention, was a tailored self-care intervention for persons with TBI and adapted from the Health Enhancement Program (HEP) (Maccoon et al., 2011). The HEP program is a control intervention developed for those receiving MBSR therapies and emphasizes self-care and wellness. Classes were developed in nutrition, physical activity, functional movement and music therapy that paralleled classes in mindfulness. For our population, we tailored this control intervention according to AL Stress theory, general cognitive and functional abilities of the population, and the group format. While the core elements of the HEP were upheld (structural equivalence, social support, common facilitators, trained teachers/trainers, flexibility in content delivery), we developed interactive content that emphasized brain health through stress management and lifestyle change. Our content focused on mood and stress management, armchair exercises and nutrition for everyday living, and sleep hygiene. Our group activities were based on principles of health education and included establishing weekly personal goals, healthy choices, and strategies to maintain the behavior changes. Our content was derived from government-sponsored websites. 5. Design and methods This 8-week randomized control trial was designed to determine whether these newly developed interventions were feasible and acceptable for persons with chronic TBI who were participating in an out-patient rehabilitation program. Both complemented the physical, speech, vocational, and occupational therapies prescribed by the treating team. The sample consisted of consenting adults aged 18–80 who were enrolled in two programs affiliated with large trauma health systems. Because it was anticipated that most participants would have some cognitive challenges, other trauma-related injuries, and depression, our interventionists possessed content expertise and experience in mental health. All interventionists were oriented to common problems and symptoms associated with TBI and trained to deliver consistent interpersonal messages while minimizing unnecessary social support and discussion about the TBI event and medical interventions. The same interventionist delivered the in-person and subsequent telephone class. We asked all participants to record their minutes of daily practice for 84 days along with their daily ratings of depression and stress on a log sheet. Program evaluation of persons’ satisfaction with the program, individual classes, and overall barriers to practice were collected at the 12-week assessment. Staff from two TBI outpatient rehabilitation programs affiliated with large trauma systems assisted with recruiting participants for this pilot study. Neuropsychologists affiliated with both programs provided the initial list of potential participants to ensure that participants met standard criteria for mild or moderate TBI. Providers at each site facilitated enrollment. Recruitment occurred during 2012–2013. Institutional Review Board approval was obtained at both Midwest urban settings. Fidelity of intervention was insured with the use of an established manual for all classes as well as a non-biased observer for 50% of the classes, attendance logs, and recordings of the telephone classes. Classes occurred during the winter. Data on main study variables were collected at baseline, immediately post intervention, and 12 weeks following the start of the program. These main outcomes included continuous data on depressive and TBI symptoms as measured with the Center for Epidemiological Studies-Depression (CES-D) scale, and the Rivermead Post-Concussion
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Questionnaire (RPQ) respectively. The CES-D is a 20-item epidemiological tool designed for a community sample to determine their severity of depressive symptoms. In the case of TBI, good validity and reliability have been reported (Bay, Kalpakjian, & Giordani, 2012). The RPQ is a 16-item self-report checklist used to determine the severity of TBI symptoms compared to pre-injury, if present. It contains 3 subscales: cognitive, emotional and somatic with higher scores suggesting more problematic symptoms. Good validity and reliability for this symptom inventory have been reported in large community samples (Lannsjo, Geijerstam, Johansson, Bring, & Borg, 2009). We determined the baseline severity of chronic stress for the month prior to beginning the study with the Perceived Stress Scale, a scale focused on retrospective review of situations that were viewed as unpredictable, uncontrollable, and unmanageable. This has been used reliably with persons with chronic disabilities, including those with brain and spinal cord injury (Cohen, Kessler, & Gordon, 1995). Two subscales (the sum of interpersonal and emotional functioning) of the Patient Competency Rating Scale were used to determine psychological functioning. This determined the perceived level of difficulty in carrying out interpersonal relationships in order to achieve a stable emotional state. Its reliability and validity as a self-reported functional measure have been established (Bay et al., 2009). Both interventions were delivered in a face-to-face group setting (90 min for the first 4 weeks) and telephone group conference call (60 min for the second 4 weeks). We designed teaching methods and learning activities that appealed to multiple senses, allowed for some repetition of content, as well as opportunities for group sharing and goal setting. Content was reinforced with printed instructions, handouts and take-home materials for home practice, including a home practice log sheet. The PFM-GT also included an audio-CD. Additionally we prepared focus questions for each of the telephone classes; this focused on applying the “class” content, group applications, and problem solving. 6. Results The treating neuropsychologists from both sites were responsible for verifying that all participants met the CDC criteria for mild to moderate TBI and were hospitalized. Nearly 50% of all eligible participants participated in this program. Reasons for lack of participation included:“too busy”, “there’s nothing wrong with me”, or “I’ve returned to work”. Within the two sites, 78 persons were approached and 65 agreed to be contacted by the PI. Nearly 50% declined to participate for the following reasons: “not interested”, “too busy”, “don’t like group activities”, “I’m fine and don’t need anything else”, or “social and work commitments prevent regular attendance.” Thirty three persons signed written consent and were randomized to one of two groups. All persons were unaware of their group assignment until attendance at the first class. Three persons required group reassignment due to therapy scheduling conflicts, but were not informed of their group assignment until the first class. Over 8 weeks, 14 persons received PFM-GT and 11 persons received the HLA-GT training. Drop outs (N = 8) were associated with life events (childbirth, surgery, relatives’ deaths) or time conflicts. One individual attended all classes but failed to complete the 12-week assessments. Attendance for “live classes” averaged 89% and 73%–75% for “telephone classes”. There were no group differences in demographic variables, outcome variables, or factors associated with ‘risk for poor recovery’ ((CDC), 2015), such as sex, age, or comorbidities. In brief, this sample reflected those who experienced chronic difficulties after mild to moderate TBI. On average, they were female (68%), Caucasian (80%), and despite their time-since-injury averaging 9.45 months, they were still symptomatic. Most had received their TBI in a crash or fall. Nearly 80% of the sample had a normal imaging scan. Both live interventions were conducted at participants’ respective rehabilitation sites and incorporated into their weekly treatment schedules planned by their treatment team. Each group completed a 4-week face-to-face intervention followed by a 4-week telephone
group intervention. During the phone sessions, content from the live classes was reviewed and participants had an opportunity to discuss how they were using the skills in their everyday lives. At the completion of each class, participants were instructed on how to complete their daily log of practice and reminded to bring this record to the next class. This log provided a simple accounting of daily stress and depression level ratings and daily minutes of practice. Participation in the daily log was sporadic and difficult to interpret; some used more of a journaling technique, others neglected doing this at all, while others provided intermittent feedback. All participants were issued a $25 gift card and formal thank you. Each intervention group rated their level of satisfaction with each class as well as the overall intervention and methods of delivery using a Likert scale. Chi-square analyses for each class to determine group satisfaction levels revealed very little dissatisfaction with the specific class content or activities. Those in the PFM-GT intervention compared to the HLA-GT intervention had statistically higher ratings of overall program satisfaction (X 2 = 6.018, p b .05). Participants claimed to prefer faceto-face classes over telephone, but generally both groups were equally satisfied with this method of delivery. Not surprisingly, participants who received the mantra class compared to those in the “armchair exercises” class (designed to circumvent any issues with dizziness or balance) were significantly more satisfied with mantra. Importantly, members in the compassion meditation class were significantly more satisfied compared to those in the healthy-living class on sleep hygiene. 7. Evaluation of our group interventions To our knowledge, this is the first report of two complex interventions with a wellness focus that have been piloted with persons who experienced the chronic effects of mild-to-moderate TBI. Based on our acceptability and feasibility results, it seems that both parallel interventions show promise in delivering health information that can be understood, practiced, and applied in the daily lives of persons with TBI. In the companion paper to this report, we note that TBI symptoms and depression were lowered following the 8-week intervention, chronic stress levels were reduced, and psychological functioning did not worsen. While we did not receive daily log entries from all study participants, our 12-week program survey on satisfaction revealed that the participants did bring these new approaches into their daily lives. Open ended questions about our interventions revealed that the information was applied in daily living. For example, participants in the PFM-GT reported being able to forgive “nagging spouses” or demanding drivers or caregivers after taking the compassion class. One participant in the PFM-GT taught his entire construction crew to practice mindfulness after they queried him about his personal practice habits and improvements. Several members experienced the deaths of loved ones while enrolled and continued with the practice and classes because they helped them to cope with grief, childcare demands, and spousal conflicts. Those in the HLA-GT noted that headache reduction was achieved by improved diet, exercise and sleep. Others reported being more socially engaged as a way to combat the chronic stress associated with social isolation during the winter months. Because of the emphasis on exercise and its connection to neuroplasticity after TBI, participants reported “taking action”: purchasing walking shoes or health fitness memberships, and changing their daily eating habits. These suggest that group interventions, support and practice tailored to the needs, wants, and experiences of persons with TBI may be beneficial. 8. Conclusions This study developed content and standardization for two interventions based on previous research and conducted a successful phase II trial which identified the feasibility and acceptability of these interventions along with testing the intervention format and ability to randomize persons with chronic TBI. Both interventions were well received as
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demonstrated by high attendance and satisfaction ratings for the inperson classes. The interventionists reported good class participation and in fact, all groups made efforts to remain connected. Further, only a few reported some sensitivity to comments made by group members that were personalized, meaning that interventionists were well selected and prepared to deliver the interventions. Thus, few changes in the manuals and interventionists are required; some lessons were learned regarding randomization, scheduling, and using the log to record practice times. Future studies are needed that will focus on assessing effectiveness in a broad sample reflective of the TBI population. References Azulay, J., Smart, C., Mott, T., & Cicerone, K. (2012). A pilot study examining the effect of mindfulness-based stress reduction on symptoms of chronic mild TBI/postconcussive syndrome. Journal of Head Trauma Rehabilitation, 28(4), 323–331. Bay, E., & Chartier, K. (2014). Chronic morbidities after TBI: An update for the advanced practice nurse. Journal of Neuroscience Nursing, 46(3), 142–152. Bay, E., Kalpakjian, C., & Giordani, B. (2012). Determinants of subjective cognitive complaints in community-dwelling adults with mild-to-moderate TBI. Brain Injury, 26(7), 941–949. Bay, E., Kirsch, N., & Gillespie, B. (2004). Chronic stress conditions do explain post-TBI depression. Research and Theory for Nursing Practice: An International Journal, 18(2/3), 213–228. Bay, E., Sikorskii, A., & Gao, F. (2009). Functional status, chronic stress, and cortisol response after mild-to-moderate TBI. Biological Research in Nursing, 10(3), 213–225. Bazarian, J., Cernak, I., Noble-Haeusslein, L., Potolicchio, S., & Temkin, N. (2009). Long-term neurologic outcomes after TBI. Journal of Head Trauma Rehabilitation, 24(6), 439–451. Bedard, M., Felteau, M., Marshall, S., Cullen, N., Gibbons, C., Dubois, S., ... Moustgaard, A. (2013). Mindfulness-based cognitive therapy reduces depression in people with a TBI: Results from an RCT. Journal of Head Trauma Rehabilitation, 29(4), E13–E22. Bedard, M., Felteau, M., Mazmanian, D., Fedyk, K., Klein, R., Richardson, J., ... Minthorn-Biggs, M. (2003). Pilot evaluation of a mindfulness-based intervention to improve quality of life among individuals who sustained TBI. Disability Rehabilitation, 8(25), 722–731.
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