A Study in Italy About Evidence Based Psychosocial/Rehabilitative Interventions in Patients With Early Schizophrenia Treated Continuously With Antipsychotics

NCT03693794 | Unknown

• 1 other identifier: ESCHILO
• Study Type: observational
• Target: 270
• Locations: 1 country
• Sites: 1

Brief Summary

This is a prospective, observational, naturalistic study conducted according to Italian law. 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 Long Acting Injection (LAI) antipsychotics. The primary objective of this study is to explore the level of implementation of EB psychosocial/rehabilitative treatments during a prospective 12-month period in patients with recent onset schizophrenia (≤ 5 years) being treated with a LAI Antipsychotic in Psychiatric Departments with expertise in the application of such interventions and to describe the reasons of implementing the particular EB psychosocial intervention and the clinical-functional characteristics of patients assigned to them. The prospective design is strictly required both for allowing consistent definition and application of such interventions and for describing reliably the characteristics of patients assigned to them. Secondary objectives are to describe the reasons for the choice of the specific assigned psychosocial intervention (if any) and the clinical and functional treatment outcomes of patients assigned or not-assigned to EB psychosocial therapies.The assignment of a patient to any particular treatment is not decided in advance by the study protocol, but falls within current clinical practice. Inclusion criteria are:

• Patients with schizophrenia (F20 according to ICD-10 version 2013)
• Onset of schizophrenia, defined as the first onset of symptoms that required specific antipsychotic treatment or hospitalization, as derived from anamnesis or available clinical documentation, not more than 5 years before study entry
• Age between 18 and 40 years
• Patients under treatment with a LAI on the basis of physician's decision (LAI started no longer than 6 months before study entry) and clinically stable (no relapse requiring hospitalization or change of treatment due to clinical worsening) during the last 1 month. Primary outcome of interest ("endpoint") is percentage of patients within the total study population who have been assigned to any EB psychosocial/rehabilitative treatment (listed below) for at least 1 month consecutively during the 12-month observation period (given the heterogeneity of interventions, this is an arbitrary duration which may reliably indicate a significant exposure to a given intervention). The percentage of each type of psychosocial intervention delivered together with frequency of sessions and length of treatment, and the reasons (categorized) given by the clinicians to justify the selected psychosocial intervention as well as the clinical-functional characteristics of patients assigned to them will be described. Patient assignment to the different interventions and their delivery will be traced in the patients' clinical charts. A list of key-words to describe each intervention will be provided in order to identify reliably and univocally the activities delivered. Secondary endpoints:
• Sociodemographic information
• Percentage of patients assigned during the 12-months period to at least one non EB intervention for at least 1 month consecutively (given the heterogeneity of interventions, this is an arbitrary duration which may reliably indicate a significant exposure to a given intervention) but not to any of the EB interventions.
• Percentage of relapses
• % of patients who discontinue drug treatment (for ineffectiveness, side effects or other reasons and patient/physician decision) and/or psychosocial interventions (for team or patient decision)
• Changes in clinical, cognitive, functional and quality of life measures Additional endpoints: \- Health economic information collected through 3 specific questionnaires: detection of i) health resources consumption for the care of the disorder (direct costs, eg. drug cost, hospitalization, emergency visits, Day hospitals, General Physician visits…) and assessment of indirect costs through evaluation of : ii) patient's potential income loss, absenteeism and presenteeism to estimate work productivity, daily activity impairment due to the mental illness and of iii) caregiver's potential income loss, commitment of time for the patient's care, absenteeism and presenteeism to estimate work productivity, daily activity impairment because of the patient's mental illness

Conditions

Schizophrenia

Keywords

psychosocial/rehabilitative interventions; Schizophrenia; evidence based interventions; long acting injection antipsychotic; functional outcome

Outcome Measures

Primary Outcomes (1)

• percentage of patients within the total study population who have been assigned to any EB psychosocial/rehabilitative treatment for at least 1 month consecutively during the 12-month observation period

  Patient assignment to the different interventions and their delivery will be traced in the patients' clinical charts

  12 months

Secondary Outcomes (6)

• Percentage of patients assigned during the 12-months period to at least one non EB intervention for at least 1 month consecutively but not to any of the EB interventions.

  12 months

• clinical variation of psychotic symptoms

  12 months

• variation of psychosocial functioning

  12 months

• wellbeing

  12 months

• variation of cognitive symptoms

  12 months

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Partecipants will be recruited from patients already being followed in psychiatric rehabilitation communities and psychiatric public ambulatories. Will be recruited young patients with onset of schizophrenia not more than 5 years before study entry, under treatment with a LAI on the basis of physician's decision (LAI started no longer than 6 months before study entry) and clinically stable (no relapse requiring hospitalization or change of treatment due to clinical worsening) during the last month.

You may qualify if:

• Patients with schizophrenia (F20 according to ICD-10 version 2013)
• Onset of schizophrenia, defined as the first onset of symptoms that required specific antipsychotic treatment or hospitalization, as derived from anamnesis or available clinical documentation, not more than 5 years before study entry
• Age between 18 and 40 years
• Patients under treatment with a LAI on the basis of physician's decision (LAI started no longer than 6 months before study entry) and clinically stable (no relapse requiring hospitalization or change of treatment due to clinical worsening) during the last 1 month.

You may not qualify if:

• drug abuse
• mental retardation

Sponsors & Collaborators

• Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia: lead

Study Sites (1)

Department of Mental Health and Addiction

Brescia, BS, 25123, Italy

RECRUITING

MeSH Terms

Conditions

Schizophrenia

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders

Central Study Contacts

Antonio Vita, Professor

CONTACT

+390303995233; antonio.vita@unibs.it

Stefano Barlati, Doctor

CONTACT

+39 3382027373; stefano.barlati@libero.it

Study Design

• Study Type: observational
• Observational Model: ECOLOGIC OR COMMUNITY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Full Professor

Study Record Dates

• First Submitted: July 18, 2018
• First Posted: October 3, 2018
• Study Start: December 15, 2017
• Primary Completion: July 1, 2020
• Study Completion: December 1, 2020
• Last Updated: July 10, 2020

Record last verified: 2020-07

Locations

IT (1)