Abstract
This multicentric randomized controlled trial (RCT), carried out in six Italian University mental health sites, aims to test the efficacy of a six-month psychosocial intervention (LYFESTYLE) on Body Mass Index (BMI), body weight, waist circumference, fasting glucose, triglycerides, cholesterol, Framingham and HOmeostasis Model Assessment of insulin resistance (HOMA-IR) indexes in patients with schizophrenia, bipolar disorder, and major depression. Moreover, the efficacy of the intervention has also been tested on several other physical and mental health domains. Patients were randomly allocated to receive the six-month experimental intervention (LIFESTYLE) or a behavioural control intervention. All enrolled patients were assessed at baseline and after one year. We recruited 401 patients (206 in the experimental and 195 in the control group) with a diagnosis of schizophrenia or other psychotic disorder (29.9%), bipolar disorder (43.3%), or major depression (26.9%). At one year, patients receiving the experimental intervention reported an improvement in body mass index, body weight, waist circumference, HOMA-IR index, anxiety and depressive symptoms and in quality of life. Our findings confirm the efficacy of the LIFESTYLE intervention in improving physical and mental health-related outcomes in patients with severe mental illnesses after one year.
Similar content being viewed by others
Avoid common mistakes on your manuscript.
Introduction
Patients with severe mental disorders (SMI; namely schizophrenia and other psychotic disorders; bipolar disorders; and major depression) have a significantly lower life expectancy compared to the general population, largely as a consequence of the increased prevalence of cardiovascular and metabolic diseases, including obesity, dyslipidaemia, diabetes mellitus, and metabolic syndrome [1]. The high rates of comorbidity between mental and physical illnesses is mainly due to the adoption of unhealthy lifestyle behaviours (i.e., poor dietary habits and physical activity, heavy smoking, alcohol or drug abuse) and reduced access to screening programmes and check-up visits for physical disorders. Other factors include the erroneous attribution by physicians of patients’ somatic complaints to mental rather than to physical diseases [2, 3] and the adverse events of several psychotropic medications, including antipsychotic medications, mood stabilizers and antidepressants [4].
Because of the high rates of physical comorbidities and premature mortality in patients with severe mental disorders [5], several lifestyle interventions have been recently developed, with the aim to improve their cardiovascular and metabolic parameters [6]. These interventions can be defined as structured approaches that help individuals to perform physical activities, stop smoking, manage body weight, have a balanced and healthy diet and engage in healthy programmes [7]. Some of these lifestyle interventions effectively reduce Body Mass Index (BMI), body weight [8, 9], triglyceride levels and fasting glucose [10]. BMI reductions seem greater and more persistent after three, six and 12 months [11]. Some of these approaches also reduce waist circumference, which is considered a more reliable cardiovascular risk factor than BMI [12], although its assessment is hampered by the lack of reliable standardized assessment tools [11].
The efficacy of lifestyle interventions has also been tested in terms of analytical blood parameters (i.e., blood levels of total cholesterol, triglycerides, insulin and fasting glucose), despite heterogeneous results do not allow to draw firm conclusions. According to systematic reviews [10,11,12,13], analytical blood parameters significantly decrease after the provision of lifestyle behavioural interventions focusing on diet and physical activity. However, most of these studies have included short follow-ups (i.e., up to three months), while longer follow-ups are rarely available. Of note, no study has specifically investigated the impact of lifestyle interventions on complex cardiovascular indexes, such as the HOmeostasis Model Assessment of insulin resistance (HOMA- IR) and the Framingham indexes, which are more reliable predictors of cardiometabolic disorders [14].
Lifestyle interventions also have a positive impact on patients’ psychosocial well-being [15,16,17], quality of life and severity of symptoms [18, 19], such as psychotic [20,21,22], depressive [22, 23] and anxiety [24] symptoms.
However, most randomized controlled trials (RCTs) carried out so far present several methodological weaknesses, with up to 64% of studies rated as at high risk of bias [8]. The most frequently reported biases include the process of randomization, lack of blinding assessments, missing outcome data, imprecise outcome reporting [8], small sample sizes, statistical heterogeneity and lack of active control groups [3].
The LIFESTYLE trial has been designed to assess the efficacy of a psychosocial group intervention promoting healthy lifestyle behaviours on patients’ physical health, compared to a brief psychoeducational group intervention. In particular, the efficacy of the experimental intervention has been tested on the reduction of Body Mass Index (BMI), the improvement of anthropometric and haematological parameters, and reduction of cardiovascular risk and insulin resistance. Other secondary outcomes include the improvement of patients’ eating habits (e.g., reduction in fat food and increase in fruits and vegetables), smoking habits (i.e., number of cigarettes smoked per day), sleeping habits (i.e., number of hours slept per night), physical activity (i.e., increase in walking time every day), personal and social functioning, presence of physical illnesses, and adherence to medications. The overall study aims, with the relevant assessment instruments, are reported in Table 1.
In this paper, we report data on the efficacy at one year of the LIFESTYLE intervention on BMI, fasting glucose, blood levels of triglycerides, cholesterol, Framingham and HOMA-IR indexes, weight, waist circumference, and subscales of the Cumulative Illness Rating Scale (CIRS). Moreover, we also report data on the impact of the experimental intervention on mental health domains, such as severity of psychiatric symptoms and quality of life.
Methods
The study was carried out at the outpatient units of six Italian sites (University of Campania “L. Vanvitelli in Naples, University of Bari, L’Aquila Genova, Pisa and Rome Tor Vergata). Eligible patients were randomized by the Naples coordinating centre taking into account center, age, gender, and educational level, with a 1:1 ratio.
The following inclusion criteria were considered: (1) age between 18 and 65 years; (2) a diagnosis of schizophrenia and other primary psychosis, unipolar depression, or bipolar disorder according to the DSM-5 and confirmed by the Structured Clinical Interview for DSM-5 (SCID-5) [25]; (3) a BMI ≥ 25; (4) at least one monthly contact with the referring psychiatric unit for the three months before enrollment. Patients who were not able to perform moderate physical activity as well as pregnant or breastfeeding women were excluded. Patients with intellectual disability or severe cognitive impairment were considered not eligible, as well as patients who were experiencing a clinically relevant worsening of psychiatric symptoms (i.e., requiring a substantial change in the therapeutic dosage of psychiatric medications or an access to emergency care or hospitalization) in the previous three months.
For each participating center, three mental health professionals (at least one of them being a psychiatrist) participated in a five-day training course on the main characteristics of the two interventions. Supervision meetings have been regularly provided to mental health professionals by phone, by e-mail or in presence during the whole duration of the intervention. Researchers involved in patients’ assessments were blinded with respect to patient’s allocation. The study was carried out in accordance with the Declaration of Helsinki and with local regulations. A formal ethical approval for conducting the trial was obtained by the Coordinating Center’s Ethics Committee, which approved the study protocol in January 2017 (approval number: prot. 64), and by the Ethics Committee of each participating centre.
Interventions
The LIFESTYLE intervention
The LIFESTYLE intervention is a five-month, multicomponent psychosocial intervention provided to groups of five to ten patients every 7–10 days, covering the following lifestyle topics: (1) healthy diet; (2) physical activity; (3) smoking habits; (4) adherence to medications; (5) adoption of risky behaviors; (6) promotion of circadian rhythms. Each topic is divided in the following components: (a) information on the risks of unhealthy lifestyle behaviours and on benefits of healthy lifestyle; (b) motivational interview and problem-solving session on changing the unhealthy lifestyle behaviors; (c) identification of personal healthy lifestyle goals for each participant. All sessions are organized in order to stimulate discussion, small workgroups and active interaction among participants. At the end of each meeting, a 20-min group session of moderate physical activity is scheduled. The intervention has been developed according to the guidelines on the management of physical health in people with mental disorders of the World Health Organization [26, 27], the European Association for the Study of Diabetes [28], the European Society of Cardiology [29], and the European Psychiatric Association [30].
The educational material has been developed according to the following phases: (1) analysis of the scientific literature; (2) evaluation of handbooks and manuals on other psychosocial lifestyle behavioural interventions; (3) focus groups with expert researchers and clinicians, and with users and carers, in order to identify the most relevant needs to be addressed; (4) development of an ad-hoc manual for mental health professionals with a detailed description of the whole intervention. Leaflets and other written materials are given to patients, whenever relevant.
Key features of the intervention are the inclusion of the motivational interview and the identification of one or two personal healthy lifestyle goals. After the identification of personal goals, professionals motivate patients to change their lifestyle and teach them problem-solving strategies for sustaining the behavioral change [31].
Control intervention
The control intervention consists of 5 psychoeducational sessions, provided every 7 days to groups of 5–10 patients, on: (1) promotion of healthy diet and physical activity; (2) detection of early warning signs; (3) pharmacological treatments for severe mental disorders and their side effects; (4) stress management; (5) problem-solving skills. Moreover, the intervention includes an introductory session, in which professionals explain aims, format, duration and timing of the intervention. Educational materials and leaflets are provided to participants during and at the end of each session.
Assessment procedures
Patients were assessed at baseline and after six, 12 and 24 months. Twelve months’ follow-up data (T2) were analysed for the purposes of this paper. Results at six months’ evaluation (T1) can be found in Luciano et al. [4, 32].
Patients’ mental health status and psychosocial functioning were assessed through: (a) the Brief Psychiatric Rating Scale (BPRS) [34]; (b) the Personal and Social Performance Scale (PSP) [35]; (c) the 17-item Manchester Short Assessment of Quality of Life (MANSA) questionnaire [36]; (d) the MATRICS Consensus Trail Making Test – part A, Brief Assessment of Cognition in Schizophrenia: Symbol Coding, and the Category Fluency-Animal Naming [37, 38]; e) the Pattern of Care Schedule (PCS), modified version [33]. The BPRS subscales were calculated according to Shafer et al. [39] in “Positive Symptoms”, “Negative Symptoms”, “Affectivity”, “Resistance”, and “Activation”.
Patients’ physical health was assessed through: (a) the Cumulative Illness Rating Scale (CIRS) [40]; (b) weight, height, Body Mass Index (BMI), waist circumference, blood pressure, resting heart rate, overall blood levels of cholesterolemia, low-density lipoprotein (LDL) cholesterolemia, high-density lipoprotein (LDL) cholesterolemia, blood glucose, serum triglycerides; (c) the homeostasis model assessment of insulin resistance (HOMA-IR) [41].
Cohen’s Kappa coefficient was satisfactory for PSP total score (K value = 0.918) and BPRS (K value ranging from 0.835 to 0.972). A 100% agreement rate was found for the SCID-5 diagnoses.
Statistical analyses
Statistical analyses were conducted according to the “Intention to Treat” principle. Missing data were handled using the Last Observation Carried Forward (LOCF). Descriptive statistics (frequency table, means and SD) were calculated for the experimental and control groups at baseline and at the end of the intervention. In each group (experimental vs. control), Student t-test for paired sample was used to test differences between baseline and 12-month follow-up with respect to outcome variables in the total sample and within diagnostic subgroups. Differences in socio-demographic and clinical characteristics among completers and drop-outs were analyzed with Student t-test for paired sample or χ2, as appropriate. Corrections for multiple comparisons were performed and Bonferroni-corrected p values were provided.
Generalized estimating equation models (GEE) were performed in order to assess the efficacy of the LIFESTYLE intervention on primary and secondary outcomes. Those mental and physical-related domains which were significantly improved in the experimental intervention were included as dependent variables. Covariates included cognitive functioning, age, gender, years of education, duration of illness and psychosocial functioning. Covariates were selected among those identified by the literature as at higher impact on the efficacy of behavioral interventions. GEE models were adjusted according to pharmacological treatment and diagnosis, which were included in the models as dummy variables.
Results
401 patients were recruited; 206 of them were allocated in the experimental intervention and 195 in the control group. 173 participants completed the intervention, 87 from the experimental group and 86 from the control group. Main reasons for drop-out were: logistic difficulties to reach the unit to attend the sessions (27%); not being anymore in charge to the mental health unit (30%); worsening of psychiatric symptoms (20%); lack of interest (18%); refusal to complete the twelve-month follow-up assessments (5%). Baseline socio-demographic and clinical characteristics did not differ between completers and drop-outs in both groups.
Of the 401 recruited patients, 57% were female, with a main age of 45.8 ± 11.8 and with a main diagnosis of bipolar disorder (43.3%), psychotic disorder (29.6%) and major depression (27.1%). They were in charge to the local mental health service since 5.9 ± 6.9 years; all of them were receiving at least one psychotropic drug: 35% were given one pharmacological agent, 39% two psychotropic medications, 21% three, and 5% of them were treated with four or more pychotropics.
Mean body weight was 91.4 ± 17.4 kg; BMI was 32.5 ± 5.5, and waist circumference was 109.3 ± 14.2 cm. Patients’ socio-demographic, clinical and metabolic characteristics did not differ between the two groups (Table 2).
Efficacy of the LIFESTYLE intervention at 1 one-year follow-up.
At one year, we observed a reduction in BMI (from 32.2 ± 5.2 at T0 to 30.9 ± 5.2 at T2, p < 0.01), body weight (from 91.8 ± 17.2 to 87.6 ± 16.9, p < 0.01), waist circumference (from 108.6 ± 14.4 to 104.2 ± 13.7, p < 0.01), CIRS comorbidity index (from 0.3 ± 1.6 to 0.04 ± 0.2, p < 0.01) and HOMA-IR index (from 4.3 ± 5.5 to 3.1 ± 2.9, p < 0.01) in patients receiving the LIFESTYLE intervention. Moreover, a reduction in the levels of serum triglycerides (from 162.5 ± 78.1 mg/dL at T0 to 131.4 ± 76.0 mg/dL; p < 0.001 at T2), and an improvement of high-density lipoprotein cholesterolemia (from 46.2 ± 14.6 mg/dL to 50.9 ± 26.7 mg/dL; p < 0.05) were found in treated patients at T2 follow-up (Table 3).
A reduction in the “Affectivity” (from 8.7 ± 3.0 to 7.2 ± 2.5, p < 0.001), “Activity” (from 4.7 ± 1.9 to 4.2 ± 1.3, p < 0.01) and “Negative Symptoms” (from 7.7 ± 3.1 to 7.0 ± 2.7, p < 0.05) subscales of BPRS were reported, as well as a significant improvement in perceived quality of life (MANSA total score from 4.0 ± 1.0 to 5.3 ± 0.8, p < 0.01) were found in the group receiving the LIFESTYLE intervention (Table 4). There were no statistical changes in the control group with respect to physical and mental health-related outcomes.
Differences in the efficacy of the intervention at one year in the different diagnostic groups are reported in Table 5.
GEE models
Findings of the univariate analyses were confirmed at the GEE models. In fact, the LIFESTYLE intervention was associated with a reduction in BMI (B = – 0.66, 95% CI – 0.99 to – 0.30, p < 0.001), body weight (B = – 1.68, 95% CI – 3.37 to 0.01, p < 0.05), waist circumference (B = – 1.43, 95% CI – 2.60 to – 0.27, p < 0.05) and HOMA-IR-IR index (B = – 1.54, 95% CI = – 3.71 to 0.63, p < 0.05) (Table 6). Moreover, the GEE model confirmed that the LIFESTYLE intervention improves “Affectivity” at BPRS (B = – 0.19; 95% CI – 0.40 to 0.02, p < 0.05) and of quality of life (B = 1.6, 95% CI 0.00 to 2.31, p < 0.05) (Table 7).
Participants’ years of education and social functioning significantly influenced the efficacy of the intervention on BMI (B = – 0.20, 95% CI = – 0.34 to -0.06, p < 0.01) waist circumference (B = -0.24, 95%CI – 0.75 to 0.27, p < 0.01) and BPRS “Affectivity” subscale (B = – 0.12; 95% CI = – 0.02 to 0.03, p < 0.05); in fact, higher scores at PSP were associated with reduced BMI (B = – 0.91, 95% CI – 1.05 to – 0.01, p < 0.05), body weight (B = – 0.02, 95% CI – 0.02 to – 0.01, p < 0.001), waist circumference (B = – 0.01, 95% CI – 0.02 to 0.00, p < 0.001) and improved quality of life (B = 1.02, 95% CI 0.00 to 1.30, p < 0.01). We also found that being male was associated with a smaller effect of the intervention on BMI (B = 0.96; 95% CI = – 0.70 to – 0.22, p < 0.05), body weight (B = 10.29; 95% CI 8.36 to 12.22, p < 0.001) and on waist circumference (B = 6.40; 95% CI 4.29 to 8.52).
Discussion
Our findings confirm the main study hypothesis that the lifestyle behavioural intervention improves mental and physical health of patients with severe mental illness after one year. In fact, although the LIFESTYLE intervention was already effective at six months in reducing BMI, body weight and waist circumference [4], data on its long-term efficacy were missing. Moreover, at six-month the experimental intervention also contributed to promote healthy lifestyle behaviours, by increasing patients’ physical activity and healthy diet (i.e., reduced consumption of junk food and increased eating of fruit and vegetables) [32]. The 12-month findings presented in this paper confirm that the LIFESTYLE intervention is still effective at one year (B = – 0.66, – 1.68, and – 1.43 for BMI, weight and waist circumference, respectively), also after controlling for several confounding factors. Moreover, at 12 months, the intervention significantly improved also the HOMA-IR index, which was not significant at six months. This finding is particularly interesting, since the importance of assessing cardiovascular risk scores (CVD) (i.e., HOMA-IR-IR or Framingham indexes) in patients with SMI has been recently highlighted [11, 15, 42, 43]. However, only in a few studies [44,45,46] considered CVD risk indexes among outcomes of behavioral interventions. Moreover, since changes in blood parameters are not easily detectable over a short period, the efficacy of psychosocial interventions on physical health should be evaluated in a longer period, such as the one used in our study.
Additionally, in the majority of available RCTs only one physical health parameter (i.e., body weight or BMI) was considered, while a complete assessment of anthropometric and haematological parameters was missing. We assessed both BMI and waist circumference as they are strongly correlated with cardiovascular [47] and metabolic syndromes [12] and considered more reliable parameters compared to body weight.
The magnitude of changes found in our study is substantially higher compared to changes reported by Bradley et al. in a recent metanalysis [8], in which the pooled positive effect of studies was in the range of 1.42 kg for weight loss (compared to 4.18 kg reported in our study), of 0.48 units for BMI (compared to 1.25 in our study), and of 0.87 cm for waist circumference (compared to 4.48 cm reported in our study). These differences can be due to several factors, one being the motivational approach included in each session of our experimental intervention. In fact, the motivational approach is one of the most effective strategies to promote behavioural changes and weight loss [48, 49]. Behavioural interventions including a motivational component are consistently associated with more evident benefits on patients’ physical health. Second, the development of a comprehensive approach to healthy living, which includes aspects related to the promotion of physical activity, the promotion of the Mediterranean diet principles, the provision of suggestions on how to quit smoking and to reduce risky behaviours, the focus on the regularization of circadian rhythms and on the improvement of adherence to medical advice (including medications). A third aspect that may have contributed to foster the effects of the LIFESTYLE intervention is the group format, in which patients with different diagnoses discussed together aspects not directly related to their mental illness, but rather to their common daily life difficulties, which is in line with the transdiagnostic paradigm of mental health care [50].
Patients’ socio-demographic and clinical characteristics, such as gender, educational level, and psychosocial functioning significantly influenced the impact of the LIFESTYLE intervention on physical health-related domains. In particular, gender differences in BMI, body weight and waist circumference indicate that the LIFESTYLE intervention was less effective in men compared to women, suggesting the need for a personalized approach to patients with severe mental illnesses and for different approaches to men and women. It may be that male patients, being less motivated to body weight changes than females, tend to perform less frequently physical activity or to follow healthy eating suggestions, with a consequent reduced efficacy of the intervention [51]. In clinical practice, the presence of a gender difference should be considered while planning supportive interventions, with the need to find alternative strategies for BMI reduction when male patients are involved. However, the gender effect on the efficacy of psychosocial interventions on physical health domains is still yet to be fully elucidated and further analyses will be performed from our dataset.
We also found that the level of education has a significant impact on the efficacy of the LIFESTYLE approach, especially on BMI and waist circumference. It may be that less educated patients experience more difficulties in understanding content of sessions and the importance of implementing healthier habits. Thus, information should be adapted in content and language to the level of patients’ education in order to increase intervention effectiveness. Also patient’s psychosocial functioning significantly influenced the efficacy of the intervention. In fact, patients with a poor psychosocial functioning reported less benefits from the intervention on BMI, body weight and waist circumference. It may be that these patients are less motivated to participate in social and group activities, suggesting the need for a multilevel intervention, aimed at improving patients’ psychosocial functioning first and focusing on physical health only later [52,53,54,55,56,57].
The LIFESTYLE intervention was also significantly effective on several mental health domains. In fact, according to the GEE models, the experimental intervention reduced patients’ anxiety and depressive symptoms and improved their quality of life (QoL). The improvement of patients’ QoL is crucial to strengthen their motivation toward healthy lifestyle behaviours and thus it should always be the target of behavioural interventions focusing on patients’ physical health [58]. This result is in line with those reported by Sampasa-Kanyinga et al. [59] and Kleppang et al. [60], which reported that the improvement of healthy lifestyle is associated with reduced anxiety and depressive symptoms as well as suicide ideation and attempts. This result might be explained by the inclusion in the experimental intervention of a structured programme to promote physical exercise, which is associated with brain plasticity and neurogenesis that, in turn, increase patients’ cognitive performance, problem-solving ability and skills to cope with environmental stressors [61]. The reduction of anxiety symptoms is also particularly relevant, since these symptoms in patients with severe mental disorders are frequently associated with the adoption of unhealthy lifestyle behaviours, in particular heavy smoking, sedentary habits, emotional eating and substance abuse [62]. Moreover, the presence of depressive symptoms may reduce patients’ motivation to attend physical health consultations [63], adherence to pharmacological treatments and to behavioural changes [61, 64]. Thus, the improvement of depressive symptoms further strengths the importance to provide behavioural interventions, such as ours, to patients with severe mental disorders in routine care.
The following limitations shall be mentioned. First, the high drop-out rate which is, however, in line with other trials carried out on other psychosocial interventions for people with severe mental illnesses [33, 65], where drop-out rates of 40% were reported. Despite this, the final sample size at one year can be still considered satisfactory compared with previous studies. Several strategies could be implemented in order to increase the rate of participants who complete psychoeducational or behavioural interventions, such as the use of electronic reminders (e.g., phone calls, emails, instant messages), the availability of dedicated staff members and of rooms/spaces to run the intervention [33, 66]. Future implementation strategies could include the use of web-based components, such as smartphone apps and wearable devices, for increasing real-time interaction with participants [67]. Another limitation is the fact that the role of psychiatric medications on patients’ physical parameters was not assessed. However, we tried to overcome this bias by controlling the GEE for pharmacological treatments, and by including in the study only patients in a stable phase of the illness. Another possible limitation is the shorter duration of the intervention provided to the control group. However, most RCTs on psychosocial interventions explore the efficacy of the experimental interventions against treatment as usual, or against a waiting list (meaning no active comparator) or against no intervention. Thus, we considered the comparison between two active interventions an added value of our protocol.
In conclusion, the LIFESTYLE experimental intervention improved both physical and mental health domains at a 12-month follow-up in a sample of overweight patients with severe mental disorders. This supports the notion that appropriate support can help patients to improve their lifestyle behaviours and to achieve a healthy living. If we really want to reduce the mortality gap in patients with severe mental disorders, more efforts need to be done in order to increase the availability of these interventions in routine clinical settings [68], eventually also through the use of digital means [69, 70].
Data availability
Data published in this paper are available at the corresponding author upon request.
References
Kim H, Turiano NA, Forbes MK, Kotov R, Krueger RF, Eaton NR, Workgroup HU (2021) Internalizing psychopathology and all-cause mortality: a comparison of transdiagnostic vs. diagnosis-based risk prediction. World Psychiatry 20:276–282. https://doi.org/10.1002/wps.20859
Correll CU, Solmi M, Croatto G, Schneider LK, Rohani-Montez SC, Fairley L, Smith N, Bitter I, Gorwood P, Taipale H, Tiihonen J (2022) Mortality in people with schizophrenia: a systematic review and meta-analysis of relative risk and aggravating or attenuating factors. World Psychiatry 21:248–271. https://doi.org/10.1002/wps.20994
Sampogna G, Di Vincenzo M, Della Rocca B, Mancuso E, Volpicelli A, Perris F, Del Vecchio V, Giallonardo V, Luciano M, Fiorillo A (2022) Physical comorbidities in patients with severe mental disorders: a brief narrative review on current challenges and practical implications for professionals. Riv Psichiatr 57:251–257. https://doi.org/10.1708/3922.39071
Luciano M, Sampogna G, Amore M, Andriola I, Calcagno P, Carmassi C, Del Vecchio V, Dell’Osso L, Di Lorenzo G, Gelao B, Giallonardo V, Rossi A, Rossi R, Siracusano A, Fiorillo A, LIFESTYLE Working Group (2021) How to improve the physical health of people with severe mental illness? A multicentric randomized controlled trial on the efficacy of a lifestyle group intervention. Eur Psychiatry 64:e72. https://doi.org/10.1192/j.eurpsy.2021.2253
Suokas K, Hakulinen C, Sund R, Kampman O, Pirkola S (2022) Mortality in persons with recent primary or secondary care contacts for mental disorders in Finland. World Psychiatry 21:470–471. https://doi.org/10.1002/wps.21027
De Rosa C, Sampogna G, Luciano M, Del Vecchio V, Pocai B, Borriello G, Giallonardo V, Savorani M, Pinna F, Pompili M, Fiorillo A (2017) Improving physical health of patients with severe mental disorders: a critical review of lifestyle psychosocial interventions. Expert Rev Neurother 17:667–681. https://doi.org/10.1080/14737175.2017
Cabassa LJ, Ezell JM, Lewis-Fernández R (2010) Lifestyle interventions for adults with serious mental illness: a systematic literature review. Psychiatr Serv 61:774–782. https://doi.org/10.1176/ps.2010.61.8.774
Bradley T, Campbell E, Dray J, Bartlem K, Wye P, Hanly G, Gibson L, Fehily C, Bailey J, Wynne O, Colyvas K, Bowman J (2022) Systematic review of lifestyle interventions to improve weight, physical activity and diet among people with a mental health condition. Syst Rev 11:198. https://doi.org/10.1186/s13643-022-02067-3
Mucheru D, Hanlon MC, McEvoy M, Thakkinstian A, MacDonald-Wicks L (2019) Comparative efficacy of lifestyle intervention strategies targeting weight outcomes in people with psychosis: a systematic review and network meta-analysis. JBI Database Syst Rev Implement Rep 17:1770–1825. https://doi.org/10.11124/JBISRIR-2017-003943
Bruins J, Jörg F, Bruggeman R, Slooff C, Corpeleijn E, Pijnenborg M (2014) The effects of lifestyle interventions on (long-term) weight management, cardiometabolic risk and depressive symptoms in people with psychotic disorders: a meta-analysis. PLoS One 9:e112276. https://doi.org/10.1371/journal.pone.0112276
Fernández-San-Martín MI, Martín-López LM, Masa-Font R, Olona-Tabueña N, Roman Y, Martin-Royo J, Oller-Canet S, González-Tejón S, San-Emeterio L, Barroso-Garcia A, Viñas-Cabrera L, Flores-Mateo G (2014) The effectiveness of lifestyle interventions to reduce cardiovascular risk in patients with severe mental disorders: meta-analysis of intervention studies. Commun Ment Health J 50:81–95. https://doi.org/10.1007/s10597-013-9614-6
Grundy SM (2005) Metabolic syndrome: therapeutic considerations. Handb Exp Pharmacol 170:107–133. https://doi.org/10.1007/3-540-27661-0_3
Bonfioli E, Berti L, Goss C, Muraro F, Burti L (2012) 2012 Health promotion lifestyle interventions for weight management in psychosis: a systematic review and meta-analysis of randomised controlled trials. BMC Psychiatry 12:78. https://doi.org/10.1186/1471-244X-12-78
Foguet-Boreu Q, Fernandez San Martin MI, Flores Mateo G, Zabaleta Del Olmo E, Ayerbe García-Morzon L, Perez-Piñar López M, Martin-López LM, Montes Hidalgo J, Violán C (2016) Cardiovascular risk assessment in patients with a severe mental illness: a systematic review and meta-analysis. BMC Psychiatry 16:141. https://doi.org/10.1186/s12888-016-0833-6
Lang JJ, McNeil J, Tremblay MS, Saunders TJ (2015) Sit less, stand more: A randomized point-of-decision prompt intervention to reduce sedentary time. Prev Med 73:67–69. https://doi.org/10.1016/j.ypmed.2015.01.026
Penedo FJ, Dahn JR (2005) Exercise and well-being: a review of mental and physical health benefits associated with physical activity. Curr Opin Psychiatry 18:189–193. https://doi.org/10.1097/00001504-200503000-00013
Ross CE, Hayes D (1988) Exercise and psychologic well-being in the community. Am J Epidemiol 127:762–771. https://doi.org/10.1093/oxfordjournals.aje.a114857
Rosenbaum S, Tiedemann A, Ward PB, Curtis J, Sherrington C (2015) Physical activity interventions: an essential component in recovery from mental illness. Br J Sports Med 49:1544–1545. https://doi.org/10.1136/bjsports-2014-094314
Højlund M, Andersen K, Ernst MT, Correll CU, Hallas J (2022) Use of low-dose quetiapine increases the risk of major adverse cardiovascular events: results from a nationwide active comparator-controlled cohort study. World Psychiatry 21:444–451. https://doi.org/10.1002/wps.21010
Beebe LH, Tian L, Morris N, Goodwin A, Allen SS, Kuldau J (2005) Effects of exercise on mental and physical health parameters of persons with schizophrenia. Issues Ment Health Nurs 26:661–676. https://doi.org/10.1080/01612840590959551
Rimes RR, de Souza Moura AM, Lamego MK, de Sá Filho AS, Manochio J, Paes F, Carta MG, Mura G, Wegner M, Budde H, Ferreira Rocha NB, Rocha J, Tavares JM, Arias-Carrión O, Nardi AE, Yuan TF, Machado S (2015) Effects of exercise on physical and mental health, and cognitive and brain functions in schizophrenia: clinical and experimental evidence. CNS Neurol Disord Drug Targets 14:1244–1254. https://doi.org/10.2174/1871527315666151111130659
Scheewe TW, Backx FJ, Takken T, Jörg F, van Strater AC, Kroes AG, Kahn RS, Cahn W (2013) Exercise therapy improves mental and physical health in schizophrenia: a randomised controlled trial. Acta Psychiatr Scand 127:464–473. https://doi.org/10.1111/acps.12029
Acil AA, Dogan S, Dogan O (2002) The effects of physical exercises to mental state and quality of life in patients with schizophrenia. J Psychiatr Ment Health Nurs 15:808–815. https://doi.org/10.1111/j.1365-2850.2008.01317.x
Wipfli BM, Rethorst CD, Landers DM (2008) The anxiolytic effects of exercise: a meta-analysis of randomized trials and dose-response analysis. J Sport Exerc Psychol 30:392–410. https://doi.org/10.1123/jsep.30.4.392
American Psychiatric Association (2013) Structured Clinical Interview for DSM-5 (SCID-5). American Psychiatric Association publishing
World Health Organization (2010) Global Recommendations on Physical Activity for Health
World Health Organization (2013)Global Action Plan for the Prevention and Control of NCDs 2013–2020
Rydén L, Grant PJ, Anker SD, Berne C, Cosentino F, Danchin N et al (2013) ESC Guidelines on diabetes, pre-diabetes, and cardiovascular diseases developed in collaboration with the EASD: the Task Force on diabetes, prediabetes, and cardiovascular diseases of the European Society of Cardiology (ESC) and developed in collaboration with the European Association for the Study of Diabetes (EASD). Eur Heart J 34:3035–3087. https://doi.org/10.1093/eurheartj/eht108
Piepoli MF, Hoes AW, Agewall S, Albus C, Brotons C, Catapano AL et al (2016) European Guidelines on cardiovascular disease prevention in clinical practice: The sixth joint task force of the European Society of Cardiology and other societies on cardiovascular disease prevention in clinical practice (constituted by representatives of 10 societies and by invited experts) developed with the special contribution of the European Association for Cardiovascular Prevention & Rehabilitation (EACPR). Atherosclerosis 252:207–274. https://doi.org/10.1093/eurheartj/ehw106
De Hert M, Dekker JM, Wood D, Kahl KG, Holt RI, Möller HJ (2009) Cardiovascular disease and diabetes in people with severe mental illness position statement from the European Psychiatric Association (EPA), supported by the European Association for the Study of Diabetes (EASD) and the European Society of Cardiology (ESC). Eur Psychiatry 24:412–424. https://doi.org/10.1016/j.eurpsy.2009.01.005
Sampogna G, Fiorillo A, Luciano M, Del Vecchio V, Steardo L Jr, Pocai B, Barone M, Amore M, Pacitti F, Dell’Osso L, Di Lorenzo G, Maj M, LIFESTYLE Working Group (2018) A Randomized controlled trial on the efficacy of a psychosocial behavioral intervention to improve the lifestyle of patients with severe mental disorders: study protocol. Front Psychiatry 9:235. https://doi.org/10.3389/fpsyt.2018.00235
Luciano M, Sampogna G, Amore M, Bertolino A, Dell’Osso L, Rossi A, Siracusano A, Calcagno P, Carmassi C, Di Lorenzo G, Di Vincenzo M, Giallonardo V, Rampino A, Rossi R, LIFESTYLE Working Group, Fiorillo A (2022) Improving physical activity and diet in patients with severe mental disorders: Results from the LIFESTYLE multicentric, real-world randomized controlled trial. Psychiatry Res 317:114818. https://doi.org/10.1016/j.psychres.2022.114818
Fiorillo A, Del Vecchio V, Luciano M, Sampogna G, De Rosa C, Malangone C, Volpe U, Bardicchia F, Ciampini G, Crocamo C, Iapichino S, Lampis D, Moroni A, Orlandi E, Piselli M, Pompili E, Veltro F, Carrà G, Maj M (2015) Efficacy of psychoeducational family intervention for bipolar I disorder: a controlled, multicentric, real-world study. J Affect Disord 172:291–299
Lukoff D, Nuechterlein KH, Ventura J (1986) Appendix A: manual for expanded Brief Psychiatric Rating Scale (BPRS). Schizophr Bull 12:594–602
Morosini PL, Magliano L, Brambilla L, Ugolini S, Pioli R (2000) Development, reliability and acceptability of a new version of the DSM-IV Social and Occupational Functioning Assessment Scale (SOFAS) to assess routine social functioning. Acta Psychiatr Scand 101:323–329
Priebe S, Huxley P, Knight S, Evans S (1999) Application and results of the Manchester Short Assessment of Quality of Life (MANSA). Int J Soc Psychiatry 45:7–12
Kern RS, Nuechterlein KH, Green MF, Baade LE, Fenton WS, Gold JM et al (2008) The MATRICS consensus cognitive battery, part 2: co-norming and standardization. Am J Psychiatry 165:214–220
Nuechterlein KH, Green MF, Kern RS, Baade LE, Barch DM, Cohen JD et al (2008) The MATRICS consensus cognitive battery, part 1: test selection, reliability, and validity. Am J Psychiatry 165:203–213
Shafer A (2005) Meta-analysis of the brief psychiatric rating scale factor structure. Psychol Assess 2005(17):324–335. https://doi.org/10.1037/1040-3590.17.3.324
Linn BS, Linn MW, Gurel L (1968) Cumulative illness rating scale. J Am Geriatr Soc 8(16):622–626
Freeman AM, Pennings N (2021) Insulin Resistance. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing
Foguet-Boreu Q, Ayerbe G-M (2021) Psychosocial stress, high blood pressure and cardiovascular risk. Hipertens Riesgo Vasc 38:83–90. https://doi.org/10.1016/j.hipert.2020.09.001
Ayerbe L, Forgnone I, Foguet-Boreu Q, González E, Addo J, Ayis S (2018) Disparities in the management of cardiovascular risk factors in patients with psychiatric disorders: a systematic review and meta-analysis. Psychol Med 48:2693–2701. https://doi.org/10.1017/S0033291718000302
Daumit GL, Dalcin AT, Dickerson FB, Miller ER, Evins AE, Cather C, Jerome GJ, Young DR, Charleston JB, Gennusa JV 3rd, Goldsholl S, Cook C, Heller A, McGinty EE, Crum RM, Appel LJ, Wang NY (2020) Effect of a comprehensive cardiovascular risk reduction intervention in persons with serious mental illness: a randomized clinical trial. JAMA Netw Open 2020(3):e207247. https://doi.org/10.1001/jamanetworkopen.2020.7247
Ma J, Berra K, Haskell WL, Klieman L, Hyde S, Smith MW, Xiao L, Stafford RS (2009) Case management to reduce risk of cardiovascular disease in a county health care system. Arch Intern Med 169:1988–1995. https://doi.org/10.1001/archinternmed.2009.381
Lönnberg L, Ekblom-Bak E, Damberg M (2020) Reduced 10-year risk of developing cardiovascular disease after participating in a lifestyle programme in primary care. Ups J Med Sci 125:250–256. https://doi.org/10.1080/03009734.2020.1726533
Ross R, Neeland IJ, Yamashita S, Shai I, Seidell J, Magni P, Santos RD, Arsenault B, Cuevas A, Hu FB, Griffin BA, Zambon A, Barter P, Fruchart JC, Eckel RH, Matsuzawa Y, Després JP (2020) Waist circumference as a vital sign in clinical practice: a consensus statement from the IAS and ICCR working group on visceral obesity. Nat Rev Endocrinol 16:177–189
Ritunnano R, Stanghellini G, Broome MR (2021) Self-interpretation and meaning-making processes: re-humanizing research on early psychosis. World Psychiatry 20:304–306. https://doi.org/10.1002/wps.20878
Swift JK, Mullins RH, Penix EA, Roth KL, Trusty WT (2021) The importance of listening to patient preferences when making mental health care decisions. World Psychiatry 20:316–317. https://doi.org/10.1002/wps.20912
Wakefield JC (2022) Klerman’s “credo” reconsidered: neo-Kraepelinianism, Spitzer’s views, and what we can learn from the past. World Psychiatry 21:4–25. https://doi.org/10.1002/wps.20942
Schuch HS, Peres KG, Haag DG, Boing AF, Peres MA (2022) The independent and joint contribution of objective and subjective socioeconomic status on oral health indicators. Commun Dent Oral Epidemiol 50:570–578. https://doi.org/10.1111/cdoe.12715
Penninx BWJH (2021) Psychiatric symptoms and cognitive impairment in “Long COVID”: the relevance of immunopsychiatry. World Psychiatry 20:357–358. https://doi.org/10.1002/wps.20913
Thornicroft G (2022) Psychiatric diagnosis and treatment in the 21st century: paradigm shifts or power shifts? World Psychiatry 2022(21):334–335. https://doi.org/10.1002/wps.21000
Valtorta NK, Kanaan M, Gilbody S, Hanratty B (2018) Loneliness, social isolation and risk of cardiovascular disease in the English Longitudinal Study of Ageing. Eur J Prev Cardiol 25:1387–1396
Maj M, van Os J, De Hert M, Gaebel W, Galderisi S, Green MF, Guloksuz S, Harvey PD, Jones PB, Malaspina D, McGorry P, Miettunen J, Murray RM, Nuechterlein KH, Peralta V, Thornicroft G, van Winkel R, Ventura J (2021) The clinical characterization of the patient with primary psychosis aimed at personalization of management. World Psychiatry 20:4–33. https://doi.org/10.1002/wps.20809
Stein DJ, Craske MG, Rothbaum BO, Chamberlain SR, Fineberg NA, Choi KW, de Jonge P, Baldwin DS, Maj M (2021) The clinical characterization of the adult patient with an anxiety or related disorder aimed at personalization of management. World Psychiatry 20:336–356. https://doi.org/10.1002/wps.20919
McIntyre RS, Alda M, Baldessarini RJ, Bauer M, Berk M, Correll CU, Fagiolini A, Fountoulakis K, Frye MA, Grunze H, Kessing LV, Miklowitz DJ, Parker G, Post RM, Swann AC, Suppes T, Vieta E, Young A, Maj M (2022) The clinical characterization of the adult patient with bipolar disorder aimed at personalization of management. World Psychiatry 21:364–387. https://doi.org/10.1002/wps.20997
Fabiano N, Gupta A, Fiedorowicz JG, Firth J, Stubbs B, Vancampfort D, Schuch FB, Carr LJ, Solmi M (2023) The effect of exercise on suicidal ideation and behaviors: A systematic review and meta-analysis of randomized controlled trials. J Affect Disord 330:355–366. https://doi.org/10.1016/j.jad.2023.02.071
Sampasa-Kanyinga H, Hamilton HA (2016) Does socioeconomic status moderate the relationships between school connectedness with psychological distress, suicidal ideation and attempts in adolescents? Prev Med 87:11–17. https://doi.org/10.1016/j.ypmed.2016.02.010
Kleppang AL, Haugland SH, Bakken A, Stea TH (2021) Lifestyle habits and depressive symptoms in Norwegian adolescents: a national cross-sectional study. BMC Public Health 21:816. https://doi.org/10.1186/s12889-021-10846-1
Wang R, Zhang H, Li H, Ren H, Sun T, Xu L, Liu Y, Hou X (2022) The influence of exercise interventions on cognitive functions in patients with amnestic mild cognitive impairment: A systematic review and meta-analysis. Front Public Health 10:1046841. https://doi.org/10.3389/fpubh.2022.1046841
Allgulander C (2016) Anxiety as a risk factor in cardiovascular disease. Curr Opin Psychiatry 29:13–17. https://doi.org/10.1097/YCO.0000000000000217
Jacobs S, Hann M, Bradley F, Elvey R, Fegan T, Halsall D, Hassell K, Wagner A, Schafheutle EI (2020) Organisational factors associated with safety climate, patient satisfaction and self-reported medicines adherence in community pharmacies. Res Social Adm Pharm 16:895–903. https://doi.org/10.1016/j.sapharm.2019.09.058
Fiorillo A, Carpiniello B, De Giorgi S, La Pia S, Maina G, Sampogna G, Spina E, Tortorella A, Vita A (2018) Assessment and management of cognitive and psychosocial dysfunctions in patients with major depressive disorder: a clinical review. Front Psychiatry 2018(9):493. https://doi.org/10.3389/fpsyt.2018.00493
Speyer H, Nørgaard HC, Hjorthøj C, Madsen TA, Drivsholm S, Pisinger C, Gluud C, Mors O, Krogh J, Nordentoft M (2015) Protocol for CHANGE: a randomized clinical trial assessing lifestyle coaching plus care coordination versus care coordination alone versus treatment as usual to reduce risks of cardiovascular disease in adults with schizophrenia and abdominal obesity. BMC Psychiatry 23(15):119. https://doi.org/10.1186/s12888-015-0465-2
Fiorillo A, Del Vecchio V, Luciano M, Sampogna G, Sbordone D, Catapano F, De Rosa C, Malangone C, Tortorella A, Veltro F, Nicolò G, Piselli M, Bardicchia F, Ciampini G, Lampis D, Moroni A, Bassi M, Iapichino S, Biondi S, Graziani A, Orlandi E, Starace F, Baronessa C, Carrà G, Maj M (2016) Feasibility of a psychoeducational family intervention for people with bipolar I disorder and their relatives: results from an Italian real-world multicentre study. J Affect Disord 15(190):657–662
Torous J, Bucci S, Bell IH, Kessing LV, Faurholt-Jepsen M, Whelan P, Carvalho AF, Keshavan M, Linardon J, Firth J (2021) The growing field of digital psychiatry: current evidence and the future of apps, social media, chatbots, and virtual reality. World Psychiatry 20:318–335. https://doi.org/10.1002/wps.20883
Stein DJ, Shoptaw SJ, Vigo DV, Lund C, Cuijpers P, Bantjes J, Sartorius N, Maj M (2022) Psychiatric diagnosis and treatment in the 21st century: paradigm shifts versus incremental integration. World Psychiatry 21:393–414. https://doi.org/10.1002/wps.20998
Espie CA, Firth J, Torous J (2022) Evidence-informed is not enough: digital therapeutics also need to be evidence-based. World Psychiatry 21:320–321. https://doi.org/10.1002/wps.20993
Wasil AR, Gillespie S, Schell T, Lorenzo-Luaces L, DeRubeis RJ (2021) Estimating the real-world usage of mobile apps for mental health: development and application of two novel metrics. World Psychiatry 20:137–138. https://doi.org/10.1002/wps.20827
Acknowledgements
LIFESTYLE Working Group: Valeria Del Vecchio, Claudio Malangone, Emiliana Mancuso, Claudia Toni, Antonio Volpicelli: Department of Psychiatry, University of Campania “L. Vanvitelli”, Naples; Ileana Andriola, Pierluigi Selvaggi: Department of Basic Medical Science, Neuroscience and Sense Organs, University of Bari “Aldo Moro”; Martino Belvederi Murri: Section of Psychiatry, Department of Neuroscience, Ophthalmology, Genetics and Infant-Maternal Science, University of Genoa; Ramona Di Stefano, Francesca Pacitti: Section of Psychiatry, Department of Biotechnological and Applied Clinical Sciences, University of L’Aquila; Valerio Dell’Oste, Sara Fantasia, Virginia Pedrinelli: Department of Clinical and Experimental Medicine, University of Pisa; Giorgio Di Lorenzo, Cinzia Niolu: Department of System Medicine, University of Rome Tor Vergata.
Funding
Open access funding provided by Università degli Studi della Campania Luigi Vanvitelli within the CRUI-CARE Agreement. This work was supported by a grant from the Italian Ministry of Education, Universities and Research within the framework of the “Progetti di Rilevante Interesse Nazionale (PRIN) – year 2015”. This study was funded by the Ministero dell’Università e della Ricerca, grant number 2015C7374S.
Author information
Authors and Affiliations
Consortia
Corresponding author
Ethics declarations
Conflict of interest
None.
Ethical standards
The authors report that all procedures contributing to this work comply with the ethical standards of the relevant national and institutional committees on human experimentation and with the Helsinki Declaration of 1975, revised in 2008.
Rights and permissions
Open Access This article is licensed under a Creative Commons Attribution 4.0 International License, which permits use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if changes were made. The images or other third party material in this article are included in the article's Creative Commons licence, unless indicated otherwise in a credit line to the material. If material is not included in the article's Creative Commons licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. To view a copy of this licence, visit http://creativecommons.org/licenses/by/4.0/.
About this article
Cite this article
Luciano, M., Sampogna, G., D’Ambrosio, E. et al. One-year efficacy of a lifestyle behavioural intervention on physical and mental health in people with severe mental disorders: results from a randomized controlled trial. Eur Arch Psychiatry Clin Neurosci 274, 903–915 (2024). https://doi.org/10.1007/s00406-023-01684-w
Received:
Accepted:
Published:
Issue Date:
DOI: https://doi.org/10.1007/s00406-023-01684-w