Study on Psychoeducation Enhancing Results of Adherence in Schizophrenia (SPERA-S)

This study is not yet open for participant recruitment.
Verified August 2012 by University of Cagliari
Sponsor:
Information provided by (Responsible Party):
donatella rita petretto, University of Cagliari
ClinicalTrials.gov Identifier:
NCT01433094
First received: August 20, 2011
Last updated: August 6, 2012
Last verified: August 2012
  Purpose

Background: Psychosis in the spectrum of schizophrenia (PSS) are severe mental disorders, with a high impact on disability and participation. Poor adherence to pharmacotherapy negatively impacts on the course and outcome of PSS.

Non-adherence in these patients is 41 to 50%, and it is predictive of a higher risk of relapse and readmission up to 5-time higher than in adherent patients. Falloon et al. developed a Psychoeducation Program (FPP) aimed at improving communication and problem-solving abilities in patients and their families. Past studies reported a statistically significant reduction of the risk of relapse in patients receiving the FPP, but did not take into account effects on adherence.

Objectives: To evaluate changes in adherence to pharmacotherapy in a sample of patients diagnosed with PSS (ICD-10: F20 to F29), by comparing a group exposed to the FPP with another group exposed to a treatment with generic informative prospects on the disorders provided with same attendance frequency as the FPP (Generic Treatment - GT).

Methods: 340 patients with PSS, from 10 participating units distributed in the territory of the Italian National Health System, will be enrolled, with allocation 1:1. The sample will be randomized into an exposed group (to FPP) and an unexposed group. Adherence will be assessed on a three-monthly basis with blood levels of the primary prescribed drug by High Pressure Liquid Chromatography, with a self-report, the Medication Adherence Questionnaire, and concurrently with the administration of a 4-item interview, based on a modified version of the Adherence Interview. Survival analyses will be performed using Kaplan-Meier method, followed by Log-rank test, defining as terminal events both the start of non-adherence and/or the first relapse or readmission episode. Intention-to-treat will be applied in considering the primary and secondary outcomes. Multiple imputations will be applied to integrate missing data.

Expected results: Median prevalence of non-adherence to pharmacotherapy in patients already in contact with a psychiatric service is 47%; effect size of psychosocial treatment on various outcomes, including relapse, readmission and adherence to drug is 0.48 of the standard deviation (SD), with 95% C.I.=0.10 to 0.85. The intervention is expected to produce a change in the prevalence of non-adherence to drug in the exposed group with an effect size of 0.45 SD.


Condition Intervention
Patient Non-Compliance
Schizophrenia and Related Disorders
Behavioral: Falloon et al. Psychoeducation Program
Behavioral: Generic Treatment

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Study on Psychoeducation Enhancing Results of Adherence in Schizophrenia

Resource links provided by NLM:


Further study details as provided by University of Cagliari:

Primary Outcome Measures:
  • Adherence [ Time Frame: Change from baseline in adherence to treatment at 6 months ] [ Designated as safety issue: No ]
    Adherence will be checked with a triple method of assessment: patient's self-report, patient's replies to a four-query interview, and assessment of blood levels of the prescribed drug.


Secondary Outcome Measures:
  • Psychotic symptoms [ Time Frame: Changes from baseline in levels of psychotic symptoms at 6 months, with effects maintained at12 months and 18 months ] [ Designated as safety issue: No ]
    The occurrence of psychotic symptoms, according to the Brief psychiatric Rating Scale (BPRS) and the Positive and Negative Syndrome Scale (PANSS)

  • General level of psychopathology [ Time Frame: Changes from baseline in levels of general psychopathology at 6 months, with effects maintained at 12 and 18 months ] [ Designated as safety issue: No ]
    The general level of psychopathology will be measured according to the Health of the Nation rating scale (HoNOS)

  • Changes in the social functioning [ Time Frame: Changes from baseline in social functioning at 6 months, maintained at 12 and 18 months ] [ Designated as safety issue: No ]
    Social functioning will be measured according to Personal and Social Performance scale (PSP). Quality of life will be measured as well, using the WHO-Quality of Life-Short version (WHOQOL-Bref).

  • Readmission [ Time Frame: Occurrence of episodes of readmission over 27 months ] [ Designated as safety issue: No ]
    An episode of readmission is any admission to a psychiatric service for the necessity of controlling symptoms, behavior or therapy. Admission to the hospital for reason of somatic illness will be not considered an episode of readmission.


Estimated Enrollment: 280
Study Start Date: September 2012
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: March 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Falloon et al.'s Psychoeducation Program Behavioral: Falloon et al. Psychoeducation Program
The intervention aims to improve communication and problem-solving abilities in patients and their families by sessions focused on: assessment of the individual's and the family's strengths, weaknesses, and goals; education about schizophrenia and treatment; communication skills training; problem-solving training; and special problems (Falloon et al. 1985). Treatment sessions are provided on a weekly basis for months (1 hour for each session) (groups of about 8-9 persons - patients and caregivers).
Other Name: Family psychoeducation
Active Comparator: Generic Treatment
The comparator is a treatment with generic informative prospect on the disorders and with the same frequencies as the Intervention. Treatment sessions are provided on a weekly basis for 6 months (1 hour for each session) (groups of about 8-9 persons - patients and caregivers).
Behavioral: Generic Treatment
The comparator is a treatment with generic informative prospect on the disorders and with the same frequencies as the Intervention. Treatment sessions are provided on a weekly basis for 6 months (1 hour for each session) (groups of about 8-9 persons - patients and caregivers).

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • diagnosis of psychosis in the spectrum of schizophrenia (ICD-10: F20 to F29); -age from 18 to 55;
  • being in care for 2 years or more.

Exclusion Criteria:

  • mental retardation, or any severe cognitive impairment;
  • psychosis due to substance abuse or to a medical condition;
  • affective psychosis;
  • comorbid substance dependence;
  • patient does not understand Italian language;
  • pharmacotherapy with depot.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01433094

Contacts
Contact: donatella rita petretto, PhD eq 00393286942727 drpetretto@unica.it

Locations
Italy
Università Degli Studi Di Urbino "Carlo Bo" Not yet recruiting
Urbino, Urbino/Pesaro, Italy
Contact: Marco BL Rocchi, M.Sc. PhD       MARCO.ROCCHI@UNIURB.IT   
Sub-Investigator: Davide Sisti, M.Sc.         
Università Degli Studi Di Bari Not yet recruiting
Bari, Italy
Contact: Marcello Nardini, M.D.       NARDINI.M@PSICHIAT.UNIBA.IT   
Sub-Investigator: Marcello Nardini, M.D.         
Fatebenefratelli Irccs Not yet recruiting
Brescia, Italy
Contact: Rosaria Pioli, M.D.    0039 030 3543838      
Sub-Investigator: Rosaria Pioli, M.D.         
Università Degli Studi Di Cagliari Not yet recruiting
Cagliari, Italy
Contact: Mauro G Carta, M.D.       MGCARTA@TISCALI.IT   
Sub-Investigator: Mauro G Carta, M.D.         
Azienda Universitaria Ospedaliera Cagliari Not yet recruiting
Cagliari, Italy
Contact: Valentina Martinelli, M.Sc.    0039 070 6092322      
Sub-Investigator: Valentina Martinelli, M.Sc.         
AUSL-8 Cagliari Not yet recruiting
Cagliari, Italy
Contact: Alessandro Montixi, M.D.         
Sub-Investigator: Mariangela Marras, M.D.         
Ausl 3 Centro Molise Di Campobasso Not yet recruiting
Campobasso, Italy
Contact: Franco Veltro, M.D.    0039 0874 409351      
Sub-Investigator: Franco Veltro, M.D.         
Università Degli Studi Di Catania Not yet recruiting
Catania, Italy
Contact: Eugenio Aguglia, M.D.    0039 040 571077      
Sub-Investigator: Eugenio Aguglia, M.D.         
Università Degli Studi Di Firenze Not yet recruiting
Firenze, Italy
Contact: Carlo Faravelli, M.D.       CARLO.FARAVELLI@UNIFI.IT   
Sub-Investigator: Carlo Faravelli, M.D.         
Azienda Ospedaliera Universitaria Policlinico Martino Di Messina Not yet recruiting
Messina, Italy
Contact: Antonio Di Rosa, M.D.    0039 090 22203751      
Sub-Investigator: Antonio Di Rosa, M.D.         
Università La Sapienza Not yet recruiting
Roma, Italy
Contact: Paolo Fiori-Nastro, M.D.       paolo.fiorinastro@uniroma1.it   
Sub-Investigator: Paolo Fiori-Nastro, M.D.         
Sponsors and Collaborators
University of Cagliari
Investigators
Principal Investigator: donatella rita petretto, PhD eq Department of Psychology, State University of Cagliari
  More Information

Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: donatella rita petretto, Assistant Professor, University of Cagliari
ClinicalTrials.gov Identifier: NCT01433094     History of Changes
Other Study ID Numbers: AIFA FARM892ZXE
Study First Received: August 20, 2011
Last Updated: August 6, 2012
Health Authority: Italy: The Italian Medicines Agency

Keywords provided by University of Cagliari:
Adherence
Psychoeducation
Pharmacotherapy
Schizophrenia
Family support

Additional relevant MeSH terms:
Schizophrenia
Schizophrenia and Disorders with Psychotic Features
Mental Disorders

ClinicalTrials.gov processed this record on April 15, 2014