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Tuesday, 18.05.2021

Jacob Daniel Kanofsky and Judith Wylie-Rosett: Does assertive community lifestyle coaching have a role in the treatment of severe mental disorders?


        The World Health Organization (WHO) reports of mortality rates for individuals with severe mental disorders (SMD), namely major depression, bipolar disorders, schizophrenia and related spectrum disorders, are 2-3 times higher than for the general population, which translates to a 10-20 year reduction in life expectancy (World Health Organization 2018).  The WHO also notes many of the medications used to treat SMD can increase appetite, body weight, insulin resistance and cardiometabolic risk. These co-morbidities, particularly obesity and cardiovascular disease, account for the vast majority of these premature deaths (Fiorillo, Luciano, Pompii and Sartorius 2019). Modifiable risk behaviors (tobacco smoking, obesity, physical inactivity, unhealthy diet) account for much of the mortality gap associated  with SMD and there is recognition of  "an urgent need for tailored effective interventions to promote cardiovascular health" (Dalcin, Jerome, Appel et al. 2019). To address this urgent need, we feel more consideration needs to be given to an assertive community lifestyle coaching (ACLC) intervention approach. ACLC is based on a theoretical framework adapted from assertive community treatment, which focuses on utilizing home visits to address the many treatment needs of patients with SMD (Stein and Test 1980). Ironically, the evidence of a promising ACLC intervention may have been undeservedly dismissed by its investigators (Speyer, Norgaard, Birk et al. 2016).

        We wish to comment on the Danish CHANGE trial which tested the value of assertive lifestyle coaching to reduce the 10-year risk of cardiovascular disease in a group of obese subjects with schizophrenia. A total of 428 patients was randomized 1:1:1 to one of the following three treatment groups for 12 months: the CHANGE group received assertive community lifestyle coaching plus care coordination with weekly nurse contacts plus treatment as usual; the CARE group received care coordination with weekly nurse contacts plus treatment as usual; the TAU group received only treatment as usual. At the end of the study no intervention effects could be found in the 10-year risk of cardiovascular disease, cardiorespiratory fitness, weight and self-reported behaviors such as smoking, physical activity and diet. On the basis of these findings the investigators "suggest that future research should focus on environmental/structural changes rather than individually anchored interventions” (Speyer, Norgaard, Birk et al. 2016). This conclusion strongly discourages the development of concerted efforts to improve lifestyle habits in clinic-anchored patients and is in stark contrast to many other recent studies demonstrating outpatient lifestyle habits can be altered and can produce better health outcomes (Green, Yarborough, Leo et al. 2015; Green, Yarborough, Leo et al. 2015; Daumit, Dickerson, Wang et al. 2013). A recently published two-year follow-up of the CHANGE trial compares it to the landmark Look AHEAD (Action for Health in Diabetes) study and implies both studies demonstrate lifestyle health coaching is of little clinical or economic value (Jakobson, Speyer, Norgaard et al. 2017). This does a disservice to the findings of both studies.

        The Look AHEAD trial was a randomized controlled study comparing Intensive Lifestyle Intervention (ILI) to Diabetes Support and Education (DSE) in overweight and obese type 2 diabetics, to track the development of cardiovascular disease over time. The trial intervention was stopped for futility after a median follow-up of 9.6 years. Similar to the CHANGE trial the ILI intervention did not decrease cardiovascular events (Look AHEAD Research Group 2013). Indeed, both groups had half the projected cardiovascular events, perhaps because both groups had become more cognizant of the value of lifestyle changes. However, there were many differences between the two groups. These included the ILI group having improved insulin sensitivity, reduced need of diabetes medication, less depression and maintenance of physical mobility (Pi-Sunyer 2014). It is of particular interest to note that the ILI group had lower hospitalization rates. "Compared with DSE over 10 years, ILI had fewer hospitalizations, fewer medications and lower health care costs” (Pi-Sunyer 2014; Espeland, Glick, Bertoni et al. 2014).  "ILI led to a reduction in annual hospitalizations (11%, p=0.004), hospital days (15%, p=0.01) and number of medications (6%, p<0.0001) resulting in cost savings for hospitalization (10%, p=0.04)” (Espeland, Glick, Bertoni et al. 2014). No extensive analysis of hospitalization rate or cost was done for the CHANGE trial.

        The medical hospitalization rates in the CHANGE trial were 16.2% for treatment as usual (TAU), 17.6% for the CARE group and a substantially lower 12.3% for the CHANGE group. Our hand calculated relative risks of medical hospitalization (CHANGE vs. CARE = 1.43; CHANGE vs. TAU = 1.32) were not statistically significant. However, the almost two-fold higher prevalence of diabetes and high alcohol intake in the CHANGE and CARE groups was not taken into account (diabetes prevalence: CHANGE = 18.6%, CARE = 17.0%, TAU = 9.5%; high alcohol consumption prevalence: CHANGE = 8.0%, CARE = 8.5%, TAU = 4.1%). Both diabetes and high alcohol consumption are associated with an increased risk of a medical hospitalization (Tomlin, Tilyard, Dovey and Dawson 2006; Trevejo-Nunez, Kolls and de Wit 2015). Therefore, it would be reasonable to expect that the CHANGE and CARE groups would have higher medical hospitalization rates than the TAU group. However, the medical hospitalization rates were similar for the CARE and TAU groups (17.6% versus 16.2%) while the CHANGE group had an unexpectedly lower rate of 12.3%. These findings were reported in the text but were not included in the tables that were statistically adjusted for baseline differences. It would have been desirable to have the medical hospitalization rates adjusted for diabetes and high alcohol consumption, as well as other variables. For example, substance dependence prevalence was greater in the CHANGE group (5.8%) than the TAU group (3.4%) and the CARE group (2.8%).

        The effects of therapeutic lifestyle coaching in seriously mentally ill patients has been examined in the STRIDE study. Green, Yarborough, Leo et al. (2015) noted a lower medical hospitalization rate not only in the 12-month intervention period but also in the 12-month follow-up period. The intervention was weekly or monthly group sessions. During the 12-month follow-up period, the medical hospitalization rate was 5.7% for the treatment group versus 21.0% for the control group, p = 0.004. This occurred even though the patients in the intervention group gained weight and had rising fasting glucose levels during the follow-up period. The one blood parameter that did improve during the follow-up period was the average fasting insulin level, which went from 9.343 to 7.912 micromoles per ml.

        Green, Yarborough, Leo et al. (2015) state, "The steady decreases in fasting insulin levels found in this trial suggest that improved insulin sensitivity may help explain the long-term benefits of such lifestyle modification." As mentioned earlier, the ILI group in the Look AHEAD study also had improved insulin sensitivity. Fasting insulin levels were not reported in the CHANGE trial.

        The recent update of the CHANGE trial (Jakobson, Speyer, Norgaard et al. 2017) gives further evidence that the assertive lifestyle interventions of this trial may have been beneficial. Although the evidence is scanty, the 2 year follow-up data show notably fewer deaths in the CHANGE group (CHANGE = 2; CARE = 7; TAU = 4) even though the CHANGE group seems to be the sickest group. Declining hospitalization and mortality rates are a more authentic bottom line measure of improving health than declining weight or cholesterol levels. The investigators of the CHANGE trial have an opportunity to apply more depth to the analysis of hospitalization rates. This could include psychiatric hospitalization rates, which also received minimal analysis. These unadjusted hospitalization rates already demonstrate at least one statistically significant difference in favor of the CHANGE treatment: "Psychiatric hospitalization amounted to 18.8% in the CHANGE group, 33.8% in the care coordination group and 24.3% in the treatment as usual group; the difference between the care coordination group and the CHANGE group was statistically significant, p = 0.004" (Speyer, Norgaard, Birk et al. 2016).

        We think an ANCOVA statistical adjustment using hospitalization rates as outcome variables is of clinical and scientific interest. If the CHANGE group, after adjustments, had a significant reduction in hospitalization rates, consideration should be given to estimating the potential cost savings of this benefit. If there are savings, this would be compatible with the contention that an assertive community treatment (ACT) model intervention - which was an intervention used in the CHANGE group - is underutilized and may be clinically and fiscally valuable for some medical-psychiatric cohorts (Kanofsky, Bronovitski and Woesner 2017).



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November 26, 2020