Lifestyle Interventions in Patients With Serious Mental Illness

Chapter 20

Lifestyle Interventions in Patients With Serious Mental Illness Aaron Gluth*, DeJuan White†,‡, Martha Ward†,‡ *

Division of Hospital Medicine, Department of Psychiatry and Behavioral Sciences, Emory University, Atlanta, GA, United States, Department of Psychiatry and Behavioral Sciences, Emory University, Atlanta, GA, United States, ‡Department of General Medicine, Emory University, Atlanta, GA, United States †

BACKGROUND The burden of morbidity and mortality due to cardiovascular disease (CVD) within the general population is well established [1]. Mounting evidence suggests that people with serious mental illness (SMI) suffer from disproportionately high rates of CVD and conditions known to be risk factors for CVD [2]. Studies have also consistently found that patients with SMI have significantly shorter life spans than the general population. A large 16-state study from 2003 found that people with SMI treated in the public sector were dying an average of 25 years earlier than people without SMI [3]. A recent metaanalysis by Walker et al. found a median of 10.1 years of potential life lost and a pooled relative mortality risk of 2.22 (95% CI, 2.12–2.33) in patients with mental illness [4]. The factors contributing to the mortality gap are numerous, complex, and often interconnected. Commonly cited examples of such factors include suicide, violence, accidents, medication side effects, poverty, access to care, health-related behaviors, and general medical comorbidity. It is important to recognize, however, that medical illnesses contribute more to the mortality gap than suicides or accidents [2,5,6]. Cardiovascular disease (CVD) and the associated risk factors are particularly important contributors to the mortality gap, and CVD is the leading cause of death in those with SMI [6–8]. There are elevated rates of obesity, metabolic syndrome, diabetes, and tobacco use in people with SMI. Those with SMI are also more likely to be sedentary and tend to consume less fruit, vegetables, and fiber compared with the general population [2,6,9,10]. Many psychotropic medications, particularly the atypical antipsychotics, are known to cause or exacerbate weight gain, dyslipidemia, and glucose dysregulation [11]. Nonpharmacological interventions (diet, exercise, and behavior modifications) are crucial tools in managing metabolic syndrome, obesity, and related conditions in the general population. Five percent or greater weight loss has been shown to significantly decrease risk of cardiovascular disease. Additionally, improved fitness (regardless of weight change) decreases mortality related to CVD [12]. Decades of accumulated evidence suggests that lifestyle interventions can be effective in preventing CVD and in managing metabolic risk factors in the general population. In fact, many physicians consider lifestyle interventions to be the cornerstone of treatment for CVD risk factors. A smaller but rapidly growing body of research has explored the benefits of lifestyle interventions in the SMI population.

EFFICACY OF LIFESTYLE INTERVENTIONS IN THE SMI POPULATION Key Reviews—Trials and publications examining lifestyle interventions in the SMI population have generally been small and heterogeneous, so reviews and meta-analyses are indispensable in interpreting the evidence. Disappointingly, reviews suggest that lifestyle interventions are only modestly effective in the SMI population. A 2010 review by Cabassa et al. examined seven randomized controlled trials that demonstrated that nonpharmacological interventions resulted in a mean weight loss of 1.6 kg in subjects with SMI. This is significantly less than the 3.6–5 kg weight loss seen in meta-analyses of lifestyle interventions in the general population [13]. A number of reviews demonstrate study interventions that produce varying amounts of statistically significant weight loss but fail to show the clinically significant (5%–10%) weight loss deemed necessary to reduce cardiovascular risk. A systematic Lifestyle in Heart Health and Disease. https://doi.org/10.1016/B978-0-12-811279-3.00020-3 © 2018 Elsevier Inc. All rights reserved.

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review of 14 studies by Verhaeghe et al. revealed a mean weight loss of only 1.96 kg (95% CI, 0.12 to −3.80 kg). Weight loss was statistically significant in 9 of the 14 reviewed studies, but none reached 5% weight loss. The authors were also unable to find studies that examined cost-effectiveness of the interventions in question [14]. A 2008 systematic review and meta-analysis of 10 RCTs reported a 2.56 kg (95% CI, −3.20–1.92 kg, P < 0.001) decrease, which corresponded to a 3.2% mean weight loss. The studies included were limited by short follow-up (18.2 week mean follow-up) and inconsistently reported methods [15]. Bartels and Desilets included a larger number of trials in their review, which showed statistically significant weight loss in 22 of 24 studies, yet the median total body weight loss was only 2.6% [16]. A 2012 systematic review and meta-analysis by Bonfioli et al. included 13 RCTs that studied weight loss interventions in patients with psychotic illnesses. They noted a statistically significant mean of 3.12% weight loss but observed that this falls short of the 5% goal. The authors pointed out that the mean follow-up of 18 weeks was relatively short; they also raised the possibility that “in individuals taking atypical antipsychotics, outcomes associated with metabolic risk factors may have greater health implications than weight changes alone,” suggesting that we may be underestimating the potential benefits of interventions in this particular population [17]. Reviews on lifestyle interventions in SMI are not universally underwhelming. Gabriele et al. reviewed 16 studies that addressed behavioral interventions in patients taking antipsychotics and found a bell curve-like relationship between study duration and amount of weight lost. The mean weight lost was 2.63 kg for 12th–16th-week interventions, 4.24 kg for 6thmonth interventions, and 3.05 kg for 12th–18th-month interventions. Importantly, the 12th–18th-month intervention category only consisted of two studies. The authors also noted evidence of improved hemoglobin A1c and insulin regulation in the studies examined. This review raises interesting questions about the relationship between intervention duration and effectiveness. It may be helpful to have future studies that test long-term (greater than 12 months) lifestyle modifications [18]. Key Positive Studies—The systematic reviews and meta-analyses of nonpharmacological interventions on weight and cardiovascular risk factors in SMI have largely yielded negative to modest results. This may be due to small sample sizes, short study/follow-up duration, and considerable study heterogeneity. Also, despite growing interest and an expanding body of literature pertaining to lifestyle interventions in SMI, the quantity of publications on the subject is still small compared with that of lifestyle interventions in the general population. Nonetheless, given the modest results generally seen in these reviews and the unclear clinical significance, some authors assert that there is currently insignificant (or very limited) evidence to recommend lifestyle modifications to manage obesity and cardiovascular risk in patients with SMI, particularly given the lack of data on cost-effectiveness [14,19,20]. Despite this somewhat nihilistic conclusion, there are a few randomized controlled trials yielding clinically significant results. It may prove useful to examine these studies closer to try to understand how particular elements of study design contribute to more robust results. A small (n = 14) crossover style randomized controlled trial (RCT) by Jean-Baptiste et al. examined intensive lifestyle interventions versus no intervention in obese (BMI > 30) patients with psychotic disorders who were on antipsychotics. During the active treatment phase, the mean weight difference between the experimental group and the control group was 5.6 kg. It was also noted that weight loss continued beyond the duration of the intervention, to as far as 6 months out, without any booster treatments. The small size of the trial is an obvious limitation. The intensity of the intervention is also noteworthy and calls into question the feasibility of the intervention in relatively resource-poor settings. Subjects received lifestyle counseling, dietary education, physical activity enhancement, pedometers, tailored nutrition support, a grocery store tour, and healthy cooking classes [21]. A 2006 RCT by McKibbin et al. randomized 57 subjects with schizophrenia and diabetes to a diet and exercise intervention or usual care plus information. The intervention was 24 weeks of Diabetes Awareness and Rehabilitation Training (DART), which consisted of teaching sessions pertaining to physical activity and nutrition. The subjects were all 40 years or older and were recruited from day treatment programs, board-and-care facilities, and community clubrooms. The intervention arm showed a mean weight change of −5.4 kg compared with the usual treatment group [22]. Wu et al. included 53 schizophrenic patients in an RCT comparing lifestyle changes with usual treatment in an inpatient setting in Taiwan. All of the subjects were on clozapine and had BMIs > 27 (the threshold for obesity in Taiwan). The intervention consisted of a balanced and calorically restricted diet and a supervised exercise program. The study lasted 6 months and resulted in a mean weight difference of −5.2 kg in the intervention arm compared with the control arm. This translated to a 5.4% reduction in BMI. The intervention arm also enjoyed significantly decreased waist circumference, triglycerides, insulin, and IGFBP-3 levels. These results suggest that intensive supervised interventions may be beneficial for inpatients with significant risk factors for metabolic disease (clozapine use and preexisting obesity) [23]. A 2016 intent-to-treat randomized, controlled, parallel superiority study completed in an outpatient VA setting randomized 122 veterans to a lifestyle balance (LB) intervention or to a usual care intervention. The subjects were adults who had experienced either a 7% gain in body weight or had a BMI > 25 while on a second-generation antipsychotic. The LB

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group received education about diet and exercise, dietary monitoring, individual counseling regarding lifestyle choices, and recommended (not mandatory) exercise routine. The LB group also took quizzes pertaining to lifestyle changes, and they received modest rewards (e.g., gift certificates) for completing goals. The usual care group received recommendations from clinicians to improve their nutrition and physical activity, and they had access to publically available educational materials about lifestyle modifications. The average weight difference at a year was 5.2 kg, favoring the intervention group. Despite the difference in weight-based outcomes, both groups completed the study with similar knowledge about lifestyle interventions, suggesting that education alone is probably not sufficient to achieve favorable outcomes [24].

OTHER IMPORTANT STUDIES Although not all studies demonstrated robust clinically significant weight loss, a number of studies yield other notable findings. The In SHAPE RCT randomized 133 overweight or obese patients with SMI to receive either a supervised fitness and nutrition program (the In SHAPE program) or free fitness club membership and education. The intervention program consisted of weekly exercise and education sessions with a personal trainer who had received additional training in nutrition. The trial lasted 12 months and revealed a significant increase in the fitness of the experimental group, as measured by serial 6 min walk tests. The intervention group enjoyed a 97.3 ft increase in their 6 min walk distance, while the control group had a 20 ft decrease in their distance (a 117.3 ft between-group difference). No significant changes were seen in the BMI or mean weight changes between the intervention and control groups, but the authors reference an observation study by Lee et al., which suggests that level of fitness may be a more important marker of all-cause and CVD-related mortality than BMI and weight changes [25,26]. Bartels et al. published a slightly larger pragmatic replication of the In SHAPE study. The replication included a more heterogeneous population spread out across multiple outpatient community clinics. Once again, the control group had an improvement in the 6 min walk test, but they also had a statistically significant improvement in weight and BMI. The authors conclude that at 12 months, about half of the In SHAPE group (51%) achieved clinically significant cardiovascular risk reduction, which they defined as a weight loss of 5% or an increase of >50 m (164 ft) on the 6 min walk test [27]. The STRIDE trial was an intent-to-treat RCT that randomized 200 obese adults on antipsychotic medication to a nonpharmacological lifestyle intervention or to usual care. The experimental condition was based on the PREMIER multicomponent lifestyle intervention. The sixth-month intervention included moderate physical activity, calorie restriction, and dietary changes based on the DASH diet [28]. The treatment arm had a 4.4 kg weight decrease compared with the control arm at 6 months, but at 12th-month follow-up, the difference had attenuated to 2.6 kg. There were some remarkable findings noted in this trial, aside from the quantitative weight differences. The authors note that the 4.4 kg weight difference seen in the STRIDE trial was similar to the 4.7 kg weight difference seen in the PREMIER trial [28], which was a study conducted in the general population. It is noteworthy that similar results were achieved by a group that was heavier at baseline, on antipsychotics, and faced with the constellation of challenges that are specific to the SMI population. The intervention group also had a significant improvement in fasting glucose levels and a significant decrease in medical hospitalizations (6.7 vs 18.8%) compared with the control group [29]. The Randomized Trial of Achieving Healthy Lifestyles in Psychiatric Rehabilitation (ACHIEVE) examined 291 overweight or obese patients in outpatient community psychiatric rehabilitation centers. The subjects recruited included patients with schizophrenia, schizoaffective disorder, major depression, and bipolar disorder. The intervention group received group weight management sessions, individual weight management sessions, and group exercise sessions. The sessions were also tailored to be easily digestible for patients with potential deficits in memory and executive function. The control group received standard nutrition and exercise information along with the option to attend quarterly nonweight-related health classes (e.g., cancer screening). Throughout the duration of the study (18 months), the experimental group had a progressive decrease in weight compared with controls. At the 18th-month conclusion, mean weight change was −3.2 kg, and 37.8% of the intervention group achieved 5% or more of their initial weight compared with 22.7% of controls. ACHIEVE is noteworthy due to the diversity of psychiatric diagnoses included and also due to the progressive and sustained nature of weight lost. [30]

KEYS TO SUCCESS There is significant heterogeneity in the design and the results of the studies examining lifestyle modifications in SMI. While this can present challenges in reviewing and synthesizing the available data, the heterogeneity can also provide useful hints about which factors are associated with favorable outcomes. In their 2012 systematic review, Bartels and Desilets attempted to identify the useful and successful aspects of health promotion programs for SMI populations. They reviewed

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30 publications (6 reviews and 24 trials) pertinent to nonpharmacological weight management in patients with SMI and found that interventions with longer duration (3 months or more) were more likely to be successful. Programs that addressed both nutrition and physical activity were more likely to produce positive results. Treatments that were structured, manualized, and monitored were also more effective [16]. As previously discussed, interventions that utilize active engagement, supervision, and incentives are probably more effective than education alone [24]. In the general population, multiple studies suggest that tailoring and personalization of lifestyle interventions yield greater results compared with generic interventions; the same principle may apply to the SMI population [31].

UNIQUE BARRIERS Addressing lifestyle choices to modify cardiovascular risk is challenging in any demographic, but those with SMI must contend with a unique set of barriers above and beyond those of the general population. Ward et al. suggest that in order to maximize effectiveness, interventions should be tailored to address the barriers commonly encountered by the SMI population such as poverty, medication side effects, and psychiatric symptoms. [32] SMI is associated with disproportionate rates of poverty [33]. People of lower socioeconomic status (SES) may have difficulty affording athletic clothing, appropriate footwear, gym memberships, and exercise equipment. Low-SES communities may be less conducive to safe outdoor activities and exercise. Utilizing the resources available in the immediate environment can help to circumvent socioeconomic challenges. Walking on level ground and climbing up- and downstairs can be meaningful components of a weight management program [20]. Providing instructional exercise handouts, books, and videos could be a relatively cost-effective intervention (although, as noted above, probably not sufficient as a lone intervention). Providing free or subsidized gym memberships is another way to help mitigate socioeconomic disparities [34]. Other free or public resources such as schools, senior centers, and parks can also be potential sites for fitness-related activities [32]. Exercise sessions and equipment made available within the clinic may help to overcome perceived cost-related and time-related barriers [35,36]. Some of our psychotherapist colleagues conduct “walk and talk” sessions, which combine therapy encounters with brisk walks. Wu et al. instituted a successful supervised exercise program within a Taiwanese long-term inpatient psychiatric unit [23], though these results may not be generalizable to countries and locales where long-term hospitalization is less common. Minority ethnic groups, people of low SES, and people with SMI often perceive that their access to health-care services is poor, largely due to transportation issues. Troubleshooting transportation issues with shuttles, public transportation vouchers, and bus or train fare could improve patient participation [36–38]. Low SES is also associated with unhealthy eating habits. Persons receiving food stamps have been shown to consume fewer whole grains, more sugar-containing drinks, more potatoes, and more red meat compared with the rest of the population [39]. Those living in poverty often suffer from limited access to fresh fruits and vegetables, in part due to the presence of food desserts [40]. Providing patients with healthier groceries and meals is a simple intervention in the setting of wellfunded and short-lived trials but may not be fiscally and logistically sustainable on a large scale. Other potential solutions include escorting patients to restaurants and grocery stores in order to educate them about healthier choices, helping patients to identify food banks with fruit and vegetable options, and providing instruction on nutritional cooking techniques. [13,35] An increasing number of farmer's markets accept food stamps and could be valuable sources of fresh food for patients. Some studies yielded favorable results by focusing on total caloric intake or portion control, as opposed to complex diets and detailed nutritional education [23,35]. Psychiatric symptoms present a common barrier to effective health-care delivery. Amotivation is common in psychotic and depressive disorders and can contribute to poor adherence with health promotion programs and a lack of engagement with lifestyle interventions. Interventions done in group settings may improve engagement, bolster social connections, and reduce attrition and can make the program more enjoyable [36]. Incentivizing participants with modest rewards (e.g., gift certificates and token systems) can improve outcomes [24,34]. Provider/facilitator factors can also have a positive effect on patient motivation, and staff can effectively model healthy behaviors alongside patients in order to improve adherence and solidify therapeutic alliance [41]. Positive symptoms of psychosis, including paranoia and hallucinations, can pose barriers to adherence and to therapeutic alliance [32,42]. This underscores the importance of optimized management of the underlying psychiatric illness. Incorporating nonpharmacological lifestyle interventions into visits with established mental health providers may promote engagement and therapeutic alliance [43,44]. Patients with SMI frequently suffer from cognitive impairment. Neuropsychiatric studies in the SMI population reveal deficits in memory, attention, processing speed, and executive functions [45]. Some studies included interventions that were structured deliberately to mitigate cognitive deficits. Authors provided simplified handout materials, they printed materials

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in large font sizes, and they gave frequent quizzes to reinforce lessons. They also took advantage of mnemonic aides and visual learning materials [13]. The ACHIEVE group tailored their intervention specifically to address cognitive issues by dividing information into smaller sections and by utilizing repetition to solidify important concepts [30]. Additionally, certain side effects of psychotropic medications can present substantial barriers to lifestyle interventions. Psychotropic medications (particularly antipsychotics and mood stabilizers) can be sedating. Sedation can reduce motivation to exercise and can impair attention during health education sessions. In order to address sedation, exercise and education sessions can be timed in the early morning before medications are administered or later in the day when the side effects have had time to wear off. Dry mouth is a common side effect, which can sometimes prompt patients to increase consumption of sugary drinks. Providers can encourage patients to use sugar-free hard candies or water to replace sugar-containing beverages. Extrapyramidal side effects (EPS) such as tremor, bradykinesia, and rigidity can make exercise challenging and uncomfortable. EPS can often be managed effectively by adding anticholinergic medications, adjusting the dose of the offending medication, or switching medications. Finally, weight gain is a common side effect, particularly with use of second-generation antipsychotics (SGAs). This underscores the importance of utilizing lifestyle interventions when these medications are prescribed [32]. There is also evidence to support switching to a less metabolically active medication in order to manage SGA-induced weight gain [46].

FUTURE DIRECTIONS The body of data on lifestyle interventions in serious mental illness (SMI) reveals the difficulty of achieving substantial weight loss in this population. Improving metabolic outcomes in this complex population may require novel approaches and techniques. A number of studies have recruited subjects with chronic mental illness, established obesity, and longstanding use of antipsychotics. Relatively, fewer studies have looked at primary prevention measures in patients with recently diagnosed SMI (before weight gain begins), but the available evidence suggests that such early interventions may attenuate weight gain and improve dietary measures in adolescents and young adults with first-episode psychosis [47,48]. Technology has changed the landscape of health and medicine tremendously. Mobile health technologies have become increasingly popular within the general population. Small pilot studies suggest that mobile health technologies such as smartphone applications and wearable activity trackers (e.g., Fitbits) could be useful additions to lifestyle intervention programs within the SMI population [49,50].

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