A Randomized Controlled Trial on the Efficacy of a Psychosocial Behavioral Intervention to Improve the Lifestyle of Patients With Severe Mental Disorders: Study Protocol

Abstract

Patients with severe mental disorders die on average 20 years prior to the general population. This mortality gap is mainly due to the higher prevalence of physical diseases and the adoption of unhealthy lifestyle behaviors.The LIFESTYLE trial aims to evaluate the efficacy of a new psychosocial group intervention (including psychoeducational, motivational, and problem-solving techniques) focused on healthy lifestyle behavior compared to a brief educational group intervention in a community sample of patients with severe mental disorders. The trial is a national-funded, multicentric, randomized controlled trial with blinded outcome assessments, which is carried out in six outpatient units of the Universities of Campania “Luigi Vanvitelli” in Naples, Bari, Genova, L'Aquila, Pisa, and Rome—Tor Vergata. All patients are assessed at the following time points: baseline (T0); 2 months post-randomization (T1); 4 months post-randomization (T2); 6 months post-randomization (T3); 12 months post-randomization (T4); and 24 months post-randomization (T5). T1 and T2 assessments include only anthropometric tests. The BMI, a reliable and feasible anthropometric parameter, has been selected as primary outcome. In particular, the mean value of BMI at 6 months from baseline (T3) will be evaluated through a Generalized Estimated Equation model. The work hypothesis is that the LIFESTYLE psychosocial group intervention will be more effective than the brief educational group intervention in reducing the BMI. We expect a mean difference between the two groups of at least one point (and standard deviation of two points) at BMI. Secondary outcomes are: the improvement in dietary patterns, in smoking habits, in sleeping habits, physical activity, personal and social functioning, severity of physical comorbidities, and adherence to medications. The expected sample size consists of 420 patients (70 patients for each of the six participating centers), and they are allocated with a 1:1 ratio randomization, stratified according to center, age, gender, and educational level. Heavy smoking, sedentary behavior, and unhealthy diet pattern are very frequent and are associated with a reduced life expectancy and higher levels of physical comorbidities in people with severe mental disorders. New interventions are needed and we hope that the LIFESTYLE protocol will help to fill this gap.Trial registration number: 2015C7374S.

Cardiovascular risk in patients with severe mental illness in Italy

“…Cardiovascular risk is the main driver of the observed reduction in life expectancy in people with SMI [1]. Preventive strategies should include frequent monitoring, lifestyle interventions such as encouraging healthy eating and physical activity [35], and modifying psychopharmacological treatment by switching to medications with negligible effects on weight and metabolism. Being these strategies not easily accomplished by SMI patients, some ways to overcome difficulties may be the enforcement of mental health services with integrated care managers or allocating funds to implement lifestyle modification programs in community mental health centers.…”

Physical Exercise in Major Depression: Reducing the Mortality Gap While Improving Clinical Outcomes

“…There is wide agreement that current research and clinical efforts to address these issues are arguably not proportional to their gravity. There is an urgent need to develop and implement novel treatments that are effective to treat symptoms of depression and, at the same time, are beneficial for physical health (13). One such intervention is physical exercise, which is increasingly recognized as both an antidepressant agent (14) and a potent tool to delay mortality (15).…”

Stop Turning a Blind Eye: Tobacco Smoking Among Egyptian Patients With Schizophrenia

“…Mortality gap in schizophrenia is a significant issue (1). Physical illness is associated with the problem, which may be related to the adoption of unhealthy lifestyle behaviors (2).…”

“…Moreover, only modest results are achieved with the available regular approaches for smoking cessation (23). However, specific programs that promote healthy living, e.g., LIFESTYLE trial (2) are emerging recently. Those programs might play a key role in helping patients with Schizophrenia getting rid of harmful habits like smoking which might decrease mortality rates.…”