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

This study is not yet open for participant recruitment. (see Contacts and Locations)
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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.         
Azienda Universitaria Ospedaliera Cagliari Not yet recruiting
Cagliari, Italy
Contact: Valentina Martinelli, M.Sc.    0039 070 6092322      
Sub-Investigator: Valentina Martinelli, M.Sc.         
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.         
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
Mental Disorders
Schizophrenia and Disorders with Psychotic Features

ClinicalTrials.gov processed this record on October 20, 2014