The Implementation of Evidence Based Psychosocial/Rehabilitative Interventions in Patients With Early Schizophrenia Treated Continuously With Antipsychotics: a Prospective Observational Study in Italy

Background:

The Italian document Stato Regioni (an agreement between Italian Government and local regions) analyses objectives indicated by the PANSM (Piano Nazionale di Azioni per la Salute mentale - National Plan of Actions for Mental Health) to identify pathways of care for severe mental illnesses (schizophrenia, affective disorders and severe personality disorders) which should be offered by Italian Departments of Mental Health in order to reduce the variability of treatments and to increase the quality of the service offered and the efficiency of resource use. As for schizophrenia, it is underlined the importance that the patient is offered an integrated treatment which involves a multiprofessional team and the application of several clinical and psychosocial and rehabilitative interventions based on the scientific evidence and guidelines recommendations. The proposal of activities should be linked to the patient degree of functional impairment or disability in order to improve patient's functioning and level of personal and social autonomy. This consideration is consistent with the evidence that antipsychotic therapy alone, even if effective on some clinical parameters, should be integrated with psychosocial and rehabilitative interventions to achieve better outcomes in terms of personal and social functioning and quality of life and that "evidence-based" (EB) psychosocial treatments (such as cognitive behaviour therapy for psychosis, cognitive remediation, family psychoeducation, social skills training and supported employment) are considered more effective than nonspecific and unstructured interventions, which, however, are more often implemented in the psychiatric services. In a Survey recently performed in Lombardia Region the frequency with which community health centers offer their patients any evidence based rehabilitative intervention has been found to be less than 10%, while a percentage of about 18% of subjects undergoing EB treatments (including supported employment) emerged in a wider national Survey promoted by the Italian Society of Psychosocial Rehabilitation (SIRP National Congress, Salerno, 2014; Italian Society of Psychiatry (SIP) National Congress, Taormina, 2015). Unfortunately, transversal or retrospective study designs do not allow to assess accurately the frequency of implementation of specific interventions, which are differently defined and applied in different contexts, and to characterize the clinical-functional features of patients assigned to any specific intervention. The Stato- Regioni document underlines also the importance of proposing an integrated multidisciplinary approach as soon as possible after the diagnosis of schizophrenia and the crucial importance of the continuity of treatment with antipsychotics from the onset of psychosis onward. Unfortunately, no data are available on the implementation of EB treatments in patients treated continuously with antipsychotics in the early phases of the disease.

In front of the importance of offering a wide range of activities to the patient, a high variability of treatments is offered in the different Italian psychiatric departments, with no data available for most Italian regions and, even in the case of the more advanced regions, with a low delivery rate of evidence-based psychosocial activities as compared with other non-evidence-based psychosocial activities.

The pharmacological continuity is a challenge as well. Literature data confirm the importance of poor adherence which may cause not only the occurrence of relapses and re-hospitalizations but also other negative outcomes for the patient, such as the inability to access and maintain rehabilitative interventions and reintegration. Treatment with antipsychotics of patients suffering from schizophrenia should provide a good balance between efficacy, safety, tolerability and acceptability for the patient to determine the continuity and the use of long-acting injection (LAI) antipsychotics is an effective response to these problems, ensuring better outcomes than oral treatment. In addition, drug treatment applied promptly and continuously is particularly important in order to prevent relapses in the early stages of schizophrenia thus limiting the functional deterioration which generally occurs within the first 5-10 years after the first episode and the clinical and psychosocial deterioration which occurs mostly within the first 5 years from the onset of the illness. Moreover, there is evidence in the literature that treatment of first episode patients with a LAI atypical antipsychotic increases treatment acceptability, adherence and the rate of sustained remission.

Given all these premises the investigators are interested in observing how often Evidence Based (EB) psychosocial and rehabilitative interventions are actually offered to patients in the real world clinical practice of psychiatric Italian services able to deliver this kind of treatments, focusing on a cohort of patients with recent onset schizophrenia, for whom delivery of integrated treatments is especially recommended, treated continuously with LAI antipsychotics.