Recently, there has been emphasis on the long-term consequences of injuries to the brain associated with sports-related concussion (Mez et al., 2017; Papa, Ramia, Edwards, Johnson, & Slobounov, 2015). However, there remains a lack of nonpharmacological interventions for individuals who experience traumatic brain injury (TBI) (Eliyahu, Kirkland, Campbell, & Rowe, 2016; Nygren-de Boussard et al., 2014; Sayegh, Sandford, & Carson, 2011). This seemingly invisible injury contributes to rising chronic morbidities and negative outcomes in the global population. These chronic morbidities and negative outcomes in turn affect the injured individuals' families (Masel, 2015; Wilson et al., 2017). Heightened symptoms and stress worsen soon after injury (Auvergne et al., 2016) and co-occur with mental health and cognitive challenges (Bay & Donders, 2008; Bay, Kalpakjian, & Giordani, 2012; Waljas et al., 2015). Thus, health treatment challenges persist for injured individuals.
Various factors illustrate the acceleration of health treatment challenges: rising numbers of emergency department visits (Taylor, Bell, Breiding, & Xu, 2017), increasing prevalence of TBI among younger and older adults (Taylor et al., 2017), and worse chronic symptom outcomes for women (Bay, Sikorskii, & Saint-Arnault, 2009; Bazarian, Blyth, Mookerjee, He, & McDermott, 2010; Savola & Hillbom, 2003). Systematic reviews report that broad-based interventions are urgently needed (Carroll et al., 2014; Nygren-de Boussard et al., 2014), whereas results from randomized trials to date lack definitive behavioral or nonpharmacological therapies for individuals who experience heightened symptoms and stress following TBI.
In addition to this evidence, basic and human scientists' research shows that psychological stress after TBI is problematic and contributes to chronicity (Bay & de-Leon, 2011; Bay, Sikorskii, & Gao, 2009; Bell et al., 2008; Griesbach, Tio, Nair, & Hovda, 2014; Griesbach, Vincelli, Tio, & Hovda, 2012). TBI, an “alteration in brain function or other evidence of brain pathology, is caused by an external force” (Menon, Schwab, Wright, & Maas, 2010, p. 1637), and annually affects approximately 1.7 million individuals in the United States. Approximately 5.3 million American individuals are living with the effects of their brain injury (Centers for Disease Control and Prevention [CDC], 2015). In the case of individuals with mild TBI, psychological stress and symptoms (i.e., physical, emotional, sleep disturbances, and cognitive changes) are expected to escalate for weeks to months following injury (Auvergne et al., 2016). Basic science and neurodiagnostic studies indicate that repeated and chronic stress contributes to long-term chronic outcomes, including depression and cognitive challenges (McInnes, Friesen, MacKenzie, Westwood, & Boe, 2017; Mez et al., 2017; Montenigro et al., 2017; Ogier et al., 2017; Rajesh et al., 2017; Wilson et al., 2017). To date, telephone-based symptom management programs have not improved behavioral functioning, simply reducing symptoms over time (Bell et al., 2011; Bell et al., 2008). Various emerging studies about mindfulness-based interventions (MBIs) claim effectiveness with cognitive and depression outcomes and acceptability for individuals with chronic and mild TBI (Azulay, Smart, Mott, & Cicerone, 2013; Bedard et al., 2014; Bedard et al., 2003). However, these studies include small samples without a rigorous control intervention.
The current contemplative intervention report highlights the researchers' MBI, tailored for individuals who experienced mild-to-moderate TBI. The report improves scientific rigor by comparing this MBI to an active-control health promotion intervention. The report differs from earlier emerging studies by including live group classes and reinforcement of class material performed via telephone for groups, as well as by focusing on reducing symptom burden and psychological stress. In the current report, researchers investigate whether there are group differences in chronic stress and/or symptoms following 8-week group interventions: mindfulness-based group therapy (defined as positive focused mindfulness group therapy [PFM-GT]) versus group health promotion (active control group therapy [AC-GT]). PFM-GT includes stress-based interventions of mindfulness with emphasis on positive emotions and engagement after the TBI event, whereas AC-GT includes practical content and activities about living with stress, balancing sleep with physical activity and stretching, and healthy nutrition and caring for the brain.
TBI begins with a biomechanical force against a soft, wrinkled organ (i.e., the brain) that consumes 20% of the body's energy. The biomechanical force unleashes a cascade of cellular changes, including inflammation, synaptic retraction, and disconnection of axons. This cascade is believed to contribute to cognitive, emotional, physical, and sleep disturbances that are noted shortly after and long after the event (Barkhoudarian, Hovda, & Giza, 2016).
Complicating this cascade is individual variability in the brain, including its age as well as pre-injury comorbidities, stressors, and genetics (Auvergne et al., 2016). A prospective study indicates that symptoms and stress increase after injury (Auvergne et al., 2016), establishing a foundation for evolving chronic changes that could include post-concussion syndrome, depression, posttraumatic stress disorder, endocrine dysfunction, and chronic cognitive impairment (Bay & Chartier, 2014).
Lack of specific and sensitive markers for detection, individual brain variation, and reliance on self-reported outcome measures limit the growth and sustainability of nonpharmacological therapies after TBI. To date, interventions include: psychoeducation, rest (de Kruijk, Leffers, Meerhoff, Rutten, & Twijnstra, 2002), cognitive and rehabilitation therapies, and telephone counseling (Bell et al., 2008; Eliyahu et al., 2016; Nygren-de Boussard et al., 2014). Although psychoeducation has yielded improved outcomes, these studies lack a sufficient control intervention, and immediate rest was not beneficial. Telephone counseling improved symptom burden, but without effects on behavioral changes. A theoretically sound and broad-based psychosocial intervention with improved rigor is needed to guide and advance intervention science after TBI.
The current study blends self-management theory and contemplative science. Self-management refers to having the skills and confidence to manage daily tasks and live well with a chronic condition (Kessler & Liddy, 2017). Self-management programs are well-supported treatment methods for individuals with cancer, diabetes, and pulmonary and heart disease (Kessler & Liddy, 2017; Ory et al., 2014; Ritter, Ory, Laurent, & Lorig, 2014; Smith et al., 2017). For example, self-management programs show improvement in quality of life and reduction in depressive symptoms (Ludman et al., 2016; Musekamp et al., 2017). Such programs involve processes of goal setting, problem solving, support, and education.
In general, self-management programs that focus on chronic disease management and/or symptom reduction include self-management tasks aimed toward programmatic outcomes. Gaps identified in this theoretic approach include clarity of the processes across the life span, reciprocity of relationships between the individual and family, and knowledge of health behavior changes (Ryan & Sawin, 2009). According to Ryan and Sawin's (2009) middle-range theory of self-management, contextual dimensions influence the processes of self-management and outcomes. For the current study, researchers examined whether self-management behaviors of meditation versus health-promotion through goal-directed processes of self-regulation, goal setting, and self-reflection resulted in reductions in symptoms and/or psychological stress (Figure 1).
Stress and symptom self-management after traumatic brain injury.
MBIs are guided by contemplative science. In contemplative science, one proposed mechanism, termed top-down and bottom-up processing, involves neurological connectivity driven by a feedback loop between interoceptive signals and processing of social emotional interactions (Cole et al., 2015; Taylor, Goehler, Galper, Innes, & Bourguignon, 2010) or mind/body science (Grossman, 2003). Benefits of mindfulness meditation include: (a) improved control over varying rates of distraction and worry; (b) maintenance of an open-minded, nonjudgmental, and curious orientation; and (c) an overall ability to respond well physically and emotionally to day-to-day life events, including self-management of chronic conditions (Kabat-Zinn & Hanh, 1990).
MBIs have evolved over the past 3 decades. The first contemplative intervention to address a chronic condition was mindfulness-based stress reduction (MBSR). This 8-week contemplative intervention, developed by Kabat-Zinn (1982), demonstrated ability to reduce pain in individuals with chronic pain. Variations of this 8-week framework now exist and include cognitive therapy for individuals with depression (Lau & McMain, 2005) and acceptance-based therapy for individuals with addictive disorders (Witkiewitz, Lustyk, & Bowen, 2013). Another adaptation of contemplative interventions includes the addition of self-compassion or loving-kindness. Adapting contemplative interventions to foster a loving and kind view of self for individuals with chronic disease increases self-improvement motivation and positive self-appraisal during difficult times (Azulay et al., 2013; Breines & Chen, 2012; Leary, Tate, Adams, Allen, & Hancock, 2007). Further evolution of mindfulness interventions include abbreviations in the 8-week format. Research now exists identifying positive changes in response to brief and intense training programs reflecting variations in dose (i.e., time duration devoted to training and practice) (Ditto, Eclache, & Goldman, 2006; Fan, Tang, & Posner, 2014; Taren et al., 2017).
Traditional comparison groups in contemplative science research include treatment as usual or waitlist control groups. More recently, active control groups are included. These active control groups focus on relaxation or sham relaxation (Hughes et al., 2013), or targeted health education programs (Rosenkranz et al., 2013). The current study used a tailored approach for the sample and included revisions in the traditional delivery methods and dose duration of MBSR by excluding an allday retreat, restricting the group classes to 90 minutes, and including live and telephone-based group classes. These changes accommodate individuals with challenges in travel during unfavorable weather conditions as well as those with prolonged sitting and attentional demands.
The current intervention is aimed at a sample with chronic TBI that is cognitively impaired and stressed and is based on work by Taren et al. (2017). In a psychologically distressed sample, the study by Taren et al. (2017) showed that broad neurological benefits in brain connectivity and emotional self-regulation, along with improvements in executive function, occur with brief but intense MBI. Taren et al.'s (2017) sample was psychologically stressed and healthy, and the study involved three all-day retreats or 24 hours of mindfulness training. Mind–body research shows that MBI returns flexibility to physiological systems, such as the cardiovascular (Nijjar et al., 2014), immune (Fan et al., 2014), and neurological systems (Tang, Rothbart, & Posner, 2012). This finding suggests that mindfulness therapies might benefit individuals with mild cognitive impairment who experience difficulty managing psychological stress.
In general, meditation involves focus on the breath and intentional redirection of the attention to the present moment, and moderately affects emotional regulation, not symptoms (Bormann et al., 2006; Crawford et al., 2013; Doll et al., 2016; Maki-Marttunen et al., 2015; van der Horn, Liemburg, Aleman, Spikman, & van der Naalt, 2015). However, studies with these findings failed to adjust for the degree of symptoms prior to the intervention (Goyal et al., 2014). For the current study, all individuals reported TBI symptoms.
In addition, evidence exists that mindfulness interventions may affect depression after TBI. Two initial studies with a sample with chronic TBI showed that cognitive-based mindfulness interventions improved attentional and executive functioning, self-efficacy, and quality of life (Azulay et al., 2013; Bedard et al., 2014; Bedard et al., 2003), and were effective in reducing depression. However, both lacked an active control group, which is recommended by the National Institutes of Health for improving mindfulness science (MacCoon et al., 2012; Rosenkranz et al., 2013). The foundation for the current active control intervention is MacCoon's Health Enhancement Program (MacCoon et al., 2012).
Design, Setting, and Sample
The current 8-week repeated measures intervention study compares PFM-GT with AC-GT and includes pre-intervention assessments, 8-week post-intervention assessments, and a 12-week follow up for sustainability and acceptability (Figure 2). The university Institutional Review Board approved the current study at two large health systems offering outpatient TBI therapies. Researchers randomized participants to one of two 8-week group interventions (PFM-GT versus AC-GT). Over a 1-year period, six groups met, with four to six individuals per group. In all groups, in-person and telephone interaction occurred. Trained facilitators with mental health and/or mindfulness backgrounds (R.R.C. and others) led each group intervention. Trained research aides, blinded to group, completed all assessments by phone immediately before and after the interventions. For the 12-week assessment that included program evaluation, research aides were not blinded (Bay, Ribbens-Grimm, & Chan, 2016).
Timelines for comparison interventions.
Eligibility conditions for study inclusion were individuals who were community-dwelling, ages 18 to 85, were hospitalized for TBI, did not have other neurological diseases or severe TBI, and were not psychotic. The World Health Organizations' definition for mild TBI was used to determine individuals' eligibility and classification for mild TBI (Kristman et al., 2014). Williams, Levin, and Eisenberg's (1990) criteria for moderate TBI was used to determine eligibility and classification for moderate TBI. After treating neuropsychologists determined individuals' eligibility, the site facilitators approached 78 individuals to seek permission for additional explanation. Sixty-five individuals agreed to additional contact for more information and/or consent. A total of 33 individuals agreed to participate and were randomized to one of two groups.
The main study variables included continuous data on (a) depressive symptoms, (b) TBI symptoms, and (c) chronic stress. The Center for Epidemiologic Studies-Depression (CES-D) scale is a 20-item tool designed for a community sample. Higher scores indicate more depressive symptomatology. In the case of TBI, good validity and reliability of the CES-D has been reported (Bay et al., 2011). The Rivermead Post-Concussion Questionnaire (RPQ) is a 16-item self-report checklist used to determine the severity of TBI symptoms, if present, compared to pre-injury. The RPQ contains three subscales: cognitive, emotional, and somatic subscales, with higher scores representing greater symptom burden. Good validity and reliability for this symptom inventory have been reported in large community samples (Lannsjo, af Geijerstam, Johansson, Bring, & Borg, 2009). Chronic stress severity was assessed with the Perceived Stress Scale-10, a scale focused on a 30-day retrospective review of situations that were unpredictable, uncontrollable, and unmanageable. This scale has been used reliably with individuals with chronic disabilities, including those with brain and spinal cord injury; higher scores denote greater chronic stress (Cohen, Kessler, & Gordon, 1995)
The researchers' tailored PFM-GT curriculum focuses on aspects of mindfulness that promote positive self-awareness with capacity for practice in multiple settings. Four 90-minute classes include: positive body awareness, mindful movement (as well as mantra), and mindful and compassionate meditation. The AC-GT curriculum focused on tailored health promotion practices to promote knowledge and skill on preserving brain health and reducing stress, and evidence-based practices with exercise, nutrition, and sleep hygiene and was guided by the program by MacCoon et al. (2012). Both interventions comprised four in-person classes followed by four group telephone-based booster classes focused on personal application. All classes included opportunities for establishing personal practice goals and reflections. For these booster classes, individuals were provided with specific discussion questions in advance. Class attendance was expected. Personal goals guided participants in the application of knowledge and skills gained in the classes to their daily lives. Participants logged their practice time and offered written reflections following home practice.
Data were analyzed using SPSS version 21. Researchers performed descriptive results, paired t tests, and regression analyses. Because the current study was small, researchers performed no a priori sample size calculations. The proposed sample of 30 was based on feasibility for two sites in 1 year.
Randomization, as planned, did not occur. Following randomization and in efforts to maintain five to eight members per intervention group, three individuals required group reassignment due to personal or therapy scheduling conflicts. Group assignment was revealed at the first class. Over 8 weeks, 14 individuals received PFM-GT and 11 individuals received AC-GT training. Individuals who failed to attend the second class and beyond (n = 8) reported life events (e.g., childbirth, surgery, relatives' deaths) or time conflicts and were not included in the analysis. There was one dropout who attended all classes but failed to complete the 12-week assessment, despite eight scheduled attempts. Attendance for live classes averaged 89%, and 73% to 75% for telephone classes. There were no group differences in demographic or outcome variables, or factors associated with risk for poor recovery (CDC, 2015).
The current sample comprised individuals who experienced chronic difficulties after mild-to-moderate TBI. One third (n = 8) were classified with moderate TBI based on imaging results or initial Glasgow Coma Scale results as specified by Williams et al. (1990). On average, the sample was mainly female (68%), Caucasian (80%), and symptomatic, despite their time-since-injury average of 9.45 months. All met CDC criteria for “poor recovery” (i.e., female, prior TBI or learning disability, or mental health or migraine history). Most had received their TBI in a crash or fall. Two thirds of the sample had a normal imaging scan. The Table provides descriptive data on baseline and post-intervention outcome scores, paired t test results, and effect sizes (calculated as: Mean 1 − Mean 2 / pooled standard deviation) (Berben, Sereika, & Engberg, 2012).
Change in Outcome Measures Over Time by Group
Researchers performed a series of regression analyses to examine associations between pre-/posttest 8-week change scores (for each outcome) and their group membership while controlling for their baseline scores of each outcome: (a) chronic stress, (b) depressive symptoms, or (c) TBI symptoms. PFM-GT was significantly associated with larger change scores for all outcome variables of interest (p < 0.05).
Results of the current study support the potential effectiveness of PFM-GT over AC-GT for individuals in the community with mild-to-moderate TBI who are receiving outpatient rehabilitation therapies. Despite the small sample size, effect sizes for most outcome variables of interest were small to moderate. Individuals in PFM-GT experienced significantly greater change between their pre- and postintervention scores than individuals in AC-GT. Depression symptoms and chronic stress scores declined in PFM-GT more than in AC-GT. This finding is aligned with prior work on depression reduction after mindfulness cognitive therapies and adds additional support for interventions directed at the chronic stress mediator to lower depressive symptoms (Bedard et al., 2012). Further, results suggest that a goal-directed self-management approach may be a useful process to achieve self-management for stress and TBI symptoms.
Mindfulness interventions often classify dose according to class attendance or minutes of training or practice (Fan et al., 2014). The current intervention challenged the in-person traditional format by allocating less time (360 minutes) to in-person class time than traditional mindfulness interventions and providing booster telephone classes (240 minutes) to develop use of mindfulness skills in daily life while reducing the burden of travel to attend class. This novel approach appears to be effective, acceptable, and feasible in the TBI population. Further, mindfulness in daily living or dispositional mindfulness has been associated with increased wellness (Branstrom, Duncan, & Moskowitz, 2011).
The current study has many strengths. Self-management theory and mindfulness science guided the tailored interventions. This design is important as researchers begin to plan longitudinal intervention trials to limit development of chronic conditions, including depression, dementia, cardiovascular disease, and stroke (Bay & Chartier, 2014). The current study adds to TBI intervention science, as it is the first study to report an active control group with mindfulness therapy and note improvements in stress and symptom management. Researchers offered interventions in a group setting that allowed for convenient travel to their rehabilitation setting and prevented group contamination at each site. Facilitators of the current study are trained in mental health conditions and TBI, and the study's mindfulness trainer (R.R.C.) had prior experience conducting intervention trials.
Nursing as a practice profession can benefit by offering this emerging mindfulness intervention to families and the injured individual. Researchers offered digital media for the practice component of this therapy and participants reported acceptance of this mode. Researchers did not explore telephone applications as reminders. Community classes may be an option that could be explored while nurses continue to teach principles of mindfulness: focus on the breath while remaining nonjudgmental and present-minded in focus.
There were several limitations in the current study. The sample was located mostly in a suburban setting affiliated with a university setting. This small sample may not generalize to other communities. Data were obtained by self-report and are subject to recall bias. Home practice could not be determined with the daily log, as only eight individuals returned their final log. Researchers are unclear about the extent to which the current sample practiced in their home setting, and whether attention to breath and redirecting attention were reliably performed. Randomization was not possible for all due to life circumstances, including competing medical appointments, childcare responsibilities, and family commitments. Absences occurred due to hospitalizations, illnesses, and inclement weather. Although researchers provided a recording and paper copies of the class activities to absent individuals, the strength of these substitutions to the outcomes is unknown.
Overall, the high attendance rates for in-person and telephone-based sessions indicates that individuals with chronic TBI can successfully participate in group-style interventions that facilitate the intimacies of group practice. The high attendance rates also identified PFM-GT as a feasible and acceptable active control for future study of mindfulness interventions. A longitudinal study is needed to assess sustainability. Future research will benefit by redesign of randomization procedures. PFM-GT is an acceptable and potentially effective addition to a comprehensive program of rehabilitation for individuals with chronic TBI.
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Change in Outcome Measures Over Time by Group
|Outcome Variable||Pre-Intervention Mean (SD)||8-Week Post-Intervention Mean (SD)||t Statistic (df)||Significance Level||Effect Size|
|CES-Da (mean [range])||28.29 (2 to 57)||22.20 (2 to 56)||0.37|
| PFM-GT b||27.29 (14.9)||17.64 (9.28)||3.27 (13)||0.006|
| AC-GTc||29.45 (17.8)||28.00 (15.57)||0.53 (10)||NS|
|PSS-10d (mean [range])||21.32 (9 to 35)||23.64 (10 to 42)||0.35|
| PFM-GTb||21.64 (7.9)||14.21 (6.87)||3.01 (13)||0.01|
| AC-GTc||20.90 (6.32)||19.27 (6.48)||0.96 (10)||NS|
|RPQe (mean [range])||33.4 (6 to 53)||29.2 (6 to 48)||0.16|
| PFM-GTb||35.36 (13.72)||27.57 (12.9)||4.20 (13)||0.001|
| AC-GTc||30.97 (9.8)||31.27 (9.22)||0.23 (10)||NS|