Petretto Donatella Rita, Preti Antonio, Zuddas Carlo, Veltro Franco, Rocchi Marco Bruno Luigi, Sisti Davide, Martinelli Valentina, Carta Mauro Giovanni, Masala Carmelo
Department of Education, Psychology, Philosophy - University of Cagliari, Cagliari, Italy.
Trials. 2013 Oct 7;14:323. doi: 10.1186/1745-6215-14-323.
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.
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.
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.
Protocol Registration System of ClinicalTrials.gov NCT01433094; registered on 20 August 2011; first patient was randomized on 12 February 2013.
药物治疗依从性差会对精神分裂症谱系精神病的病程和结局产生负面影响，增加复发风险。法隆及其同事制定了一项心理教育计划，旨在提高患者及其家属的沟通和解决问题的能力。本研究旨在通过比较一组接受法隆心理教育计划（FPP）的患者和另一组接受关于疾病的一般信息的家庭支持治疗的患者，评估被诊断为精神分裂症谱系精神病患者的药物治疗依从性变化。
根据来自意大利国家卫生系统（NHS）的10个参与单位的标准化标准，将340例被诊断为精神分裂症及相关疾病的患者，采用随机排列分组法按1:1分配入组。患者将在治疗开始后6个月、12个月和18个月（疗程：6个月）进行重新评估。主要目的是评估心理教育后药物治疗依从性的变化。将通过使用高压液相色谱法测量主要处方药物的血药浓度，以及通过药物治疗依从性问卷和依从性访谈的修改版，每隔三个月评估一次依从性。次要目的是复发和再入院频率的变化，作为疾病病程的主要指标。入组患者将由协调单位控制的程序以1:1的比例随机分配到FPP（是/否）；在方案结束（或发生严重不良事件）之前，编码将被屏蔽。评估者对治疗分配情况不知情，并将在治疗完成后进行盲法测试。在考虑主要和次要结局时将采用意向性分析。将应用多重填补法整合缺失数据。该研究于2013年2月开始招募；研究总时长为27个月。
如果心理教育计划被证明在提高药物治疗依从性以及减少复发和再入院方面有效，那么可以提议将其应用作为意大利NHS内的标准辅助心理社会治疗方法。
ClinicalTrials.gov的方案注册系统NCT01433094；于2011年8月20日注册；首例患者于2013年2月12日随机分组。
