Study on psychoeducation enhancing results of adherence in patients with schizophrenia (SPERA-S): Study protocol for a randomized controlled trial

Donatella Rita Petretto, Antonio Preti, Carlo Zuddas, Franco Veltro, Marco Bruno Luigi Rocchi, Davide Sisti, Valentina Martinelli, Mauro Giovanni Carta, Carmelo Masala, Rossella Alfa, Eleonora Arcidiacono, Eugenio Aguglia, Emiliana Bonanni, Marta Borea, Michol Consolazione, Patrizia De Giglio, Antonio Di Rosa, Carlo Faravelli, Giulia Fioravanti, Paolo Fiori NastroAlessandro Floris, Francesca Floris, Claudia Iannone, Salvatore Iuso, Melania La Verde, Laura Laffranchini, Maria Efisia Lecca, Carolina Lo Sauro, Laura Rosa Magni, Francesco Margari, Mariangela Marras, Lorenzo Marzano, Elena Masotti, Carla Matta, Giuseppe Minutolo, Maria Francesca Moro, Gioia Mura, Marcello Nardini, Ilenia Nicchiniello, Flavia Padalino, Maria Novella Papini, Adriana Pastore, Annamaria Petito, Rosaria Pioli, Giulio Maria Porfiri, Alessia Pullara, Federica Sancassiani, Maria Ignazia Seu, Valentina Stallone, Silvia Vinci, Lilia Zappone

Research output: Contribution to journalArticlepeer-review

Abstract

Background: Poor adherence to pharmacotherapy negatively affects the course and the outcome of schizophreniaspectrum psychoses, enhancing the risk of relapse. Falloon and coworkers developed a Psychoeducation Program aimed at improving communication and problem-solving abilities in patients and their families. This study set out to evaluate changes in adherence to pharmacotherapy in patients diagnosed with schizophrenia-spectrum psychoses, by comparing one group exposed to the Falloon Psychoeducation Program (FPP) with another group exposed to family supportive therapy with generic information on the disorders.Methods: 340 patients diagnosed with schizophrenia and related disorders according to standardized criteria from 10 participating units distributed throughout the Italian National Health System (NHS), will be enrolled with 1:1 allocation by the method of blocks of randomized permutations. Patients will be reassessed at 6, 12 and 18 months after start of treatment (duration: 6 months). The primary objective is to evaluate changes in adherence to pharmacotherapy after psychoeducation. Adherence will be assessed at three-month intervals by measuring blood levels of the primary prescribed drug using high pressure liquid chromatography, and via the Medication Adherence Questionnaire and a modified version of the Adherence Interview. Secondary objectives are changes in the frequency of relapse and readmission, as the main indicator of the course of the disorder. Enrolled patients will be allocated to the FPP (yes/no) randomly, 1:1, in a procedure controlled by the coordinating unit; codes will be masked until the conclusion of the protocol (or the occurrence of a severe negative event). The raters will be blind to treatment allocation and will be tested for blinding after treatment completion. Intention-to-treat will be applied in considering the primary and secondary outcomes. Multiple imputations will be applied to integrate the missing data. The study started recruitment in February 2013; the total duration of the study is 27 months.Discussion: If the psychoeducation program proves effective in improving adherence to pharmacotherapy and in reducing relapse and readmissions, its application could be proposed as a standard adjunctive psychosocial treatment within the Italian NHS. Trial registration: Protocol Registration System of ClinicalTrials.gov NCT01433094; registered on 20 August 2011; first patient was randomized on 12 February 2013.

Original languageEnglish
Article number323
JournalTrials
Volume14
Issue number1
DOIs
Publication statusPublished - Oct 7 2013

Keywords

  • Adherence to pharmacotherapy
  • Caregiver
  • Falloon's method
  • Family
  • Psychoeducation
  • Randomized controlled trial
  • Schizophrenia

ASJC Scopus subject areas

  • Medicine (miscellaneous)
  • Pharmacology (medical)

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