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

Abstract

BackgroundPoor 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.Methods340 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.DiscussionIf 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 registrationProtocol Registration System of ClinicalTrials.gov NCT01433094; registered on 20 August 2011; first patient was randomized on 12 February 2013.

Non‐adherence to psychotropic medication assessed by plasma level in newly admitted psychiatric patients: Prevalence before acute admission

“…Psychoeducation may be one of the best intervention strategies for improving adherence . Individual cognitive‐behavioral interventions also improved adherence .…”

Educação Em Saúde Com Pessoas Usuárias De Álcool E Outras Drogas

“…Os estudos mostram que a intervenção educativa mobiliza melhoria dos comportamentos de saúde da população que recebe o cuidado (27) , ou seja, o processo educativo promove a saúde das pessoas, e o uso da psicoeducação visa à adesão ao tratamento e à redução de recaídas, até mesmo nas situações de comorbidade com transtornos mentais graves (10)(11) .…”

“…Neste estudo, o interesse foi pela efetivação de educação em saúde para dependentes químicos, com inspiração nos pressupostos da psicoeducação. Que, sumariamente, acompanha clinicamente o indivíduo quanto ao processo saúde-doença, e promove a construção do autoconhecimento, com intuito de melhorar o enfrentamento de situação vivida e estimular a participação ativa em seu tratamento/reabilitação (10)(11) . O objetivo do estudo foi analisar a constituição de conhecimento entre pessoas em reabilitação do uso e abuso de álcool e outras drogas, a partir de grupos de educação em saúde inspirados na psicoeducação, como contribuição à estruturação de modelos de intervenção no processo de cuidados em enfermagem.…”

The Pharmacological Treatment of Migraine in Brazil

“…However, the simple prescription of a drug, without explaining why the headache attack occurs, the biological and chronic nature of migraine as a disease, and the problems involved in using one or more medications on a daily basis may result in treatment failure, lack of adherence, and excessive use of different health resources. This psycho‐education of the patients is crucial for adherence, has been widely suggested in other areas of medicine, and has been routinely practiced in some headache specialty centers …”

“…This psycho-education of the patients is crucial for adherence, has been widely suggested in other areas of medicine, and has been routinely practiced in some headache specialty centers. [5][6][7][8][9][10] In countries like Brazil, there are no reliable studies mapping the patterns of medication use, with the exception of a few studies conducted in tertiary centers. In these centers, 11 patients having undergone numerous treatment attempts with different health professionals, are usually seen and often reveal previously mistaken treatment approaches.…”