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

Trials

Carmelo Masala¹  Mauro Giovanni Carta⁴  Valentina Martinelli⁵  Davide Sisti³  Marco Bruno Luigi Rocchi³  Franco Veltro²  Carlo Zuddas¹  Antonio Preti¹  Donatella Rita Petretto¹ 

[1] Department of Education, Psychology, Philosophy - University of Cagliari, Cagliari, Italy;ASL 3, Campobasso, Italy;Department Of Biomolecular Sciences, University of Urbino ‘Carlo Bo’, Urbino, Italy;Consultation-Liaison Psychiatric Unit at the University Hospital of Cagliari, University of Cagliari and AOU Cagliari, Cagliari, Italy;Pharmacology Unit at the University Hospital of Cagliari, University of Cagliari and AOU Cagliari, Cagliari, Italy

关键词: Caregiver;    Family;    Adherence to pharmacotherapy;    Falloon’s method;    Psychoeducation;    Schizophrenia;    Randomized controlled trial;   

Others  :  1092941
DOI  :  10.1186/1745-6215-14-323

 received in 2012-09-02, accepted in 2013-09-10,  发布年份 2013

【 摘 要 】

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.

【 授权许可】

   
2013 Petretto et al.; licensee BioMed Central Ltd.

【 图 表 】

Figure 1.

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