Fulfilling the glass: association between an integrated psychosocial intervention and pharmacological treatment in patients with schizophrenia

Abstract

Background: Schizophrenia is one of the most prevalent and disabling psychiatric diseases. Several intervention programs have been implemented in order to assess schizophrenia from a community and integrated view. Despite the well-known effectiveness of psychosocial interventions, little is known about the effect they have in the pharmacological treatment with antipsychotics indicated in this group of patients. Despite their effectiveness, antipsychotics are known to have important secondary effects, highlighting cardiovascular side effects for being highly prevalent, and for being the most important cause of natural death among those patients. Moreover, antipsychotics account for a non - despicable proportion of the global cost of the disease, contributing to make schizophrenia the most expensive psychiatric disorder. Aim: To analyze the effect an integrated psychosocial intervention has on the dose of antipsychotic used in the maintenance phase treatment (defined as a Global Assessment of Functioning scale (GAF) ≥ 70) in patients with a diagnosis of severe schizophrenia. Secondary, it would be interesting to determine its effect on the cardiovascular disease risk and metabolic syndrome, as well as on the global cost of the disease. Methods: A prospective cohort study will be performed following 148 patients diagnosed with severe schizophrenia consulting to any service of the Xarxa de Salut Mental de la provincia de Girona due to an exacerbation of the disease. Patients will be collected in a non – probabilistic consecutive method and will be classified in two groups, both following interventions used in the routine clinical practice: an integrated psychosocial intervention program plus pharmacological treatment or only pharmacological treatment plus standardized visits. Patients will be categorized using a propensity score matching method regarding sex, age, family support and initial GAF score, in order to diminish selection bias. Patients will be followed during a 2 – year period, and the dose of antipsychotic needed in the maintenance phase at the end of the study will be compared in both groups, using bioequivalence transformations into olanzapine and categorizing patients according to the dose required. Maintenance will be defined using the GAF scale. The cardiovascular disease risk will be compared at the beginning and the end of the study in both groups, using the REGICOR scale, as well as the Metabolic Syndrome prevalence. Finally, an estimation of the global cost of the disease will be analyzed in both groups. Several co – variates will be taken into account in the statistical analysis in order to determine possible confounding factors, using a Multiple Logistic Lineal Regression Model for qualitative variables, and a Multiple General Lineal Model for quantitative variables