Pozza A, Coluccia A, Gualtieri G, Ferretti F
Department of Medical Sciences, Surgery and Neurosciences, University of Siena, Siena.
Legal Medicine Unit, Santa Maria alle Scotte University Hospital of Siena, Siena, Italy.
Clin Ter. 2020 Mar-Apr;171(2):e7-e93. doi: 10.7417/CT.2020.2194.
Group Psychoeducation (PE) is an effective strategy to enhance adherence to antipsychotic treatment in Bipolar Disorders (BD). However, it requires attendance to weekly sessions during a period of about 6 months. This may impede its application for those patients living far from mental health centres, resulting inequality in access to evidence-based care. Therefore, there is an increasing need to find new efficient strategies to deliver and extend PE programs to a wider population of BD patients. Mobile apps are a cost-effective way to deliver PE. In the Italian healthcare context, no evidence about the use of apps is available. The current paper presents the protocol about the development of a smartphone app to deliver PE for BD and the protocol for a trial assessing its effectiveness. In euthymic BD patients, the study will compare the adherence rates to antipsychotics between PE delivered through Bipolar mobile Application (Bip.App), group PE and a combination of both, will investigate demographic, socio-cultural and clinical predictors of lower adherence in the arms, and will investigate whether PE combined with Bip.App is associated with lower risk of recurrence of (hypo)manic and depressive episodes than group PE alone, and assess the feasibility and satisfaction for Bip.App. Participants will be recruited from mental health centres and included if they are 18-65 year-old, have primary BD in the euthymic phase, they have been prescribed a second-generation oral antipsychotic as a maintenance/prophylactic therapy for at least 1 year, they have not undergone a structured protocol of PE for BD, they have access to a smartphone and sufficient competence in using it. Participants will be excluded if they have neurological disease, mental retardation or learning disability, psychosis, limited fluency in Italian. Adherence will be assessed through count pills, blood levels, and self-reported adherence. A single-blinded parallel-group superiority multi-centre randomised controlled trial design will be used.
团体心理教育（PE）是增强双相情感障碍（BD）患者抗精神病药物治疗依从性的有效策略。然而，这需要在大约6个月的时间内每周参加课程。这可能会阻碍其应用于那些居住在远离心理健康中心的患者，导致获得循证护理方面的不平等。因此，越来越需要找到新的有效策略，以将PE项目提供给更广泛的BD患者群体并加以推广。移动应用程序是提供PE的一种具有成本效益的方式。在意大利的医疗环境中，尚无关于应用程序使用的证据。本文介绍了一款用于为BD患者提供PE的智能手机应用程序的开发方案以及一项评估其有效性的试验方案。在心境正常的BD患者中，该研究将比较通过双相情感障碍移动应用程序（Bip.App）提供的PE、团体PE以及两者结合方式下的抗精神病药物依从率，将调查各组中依从性较低的人口统计学、社会文化和临床预测因素，并将调查与单独的团体PE相比，PE与Bip.App结合是否与（轻）躁狂和抑郁发作复发风险较低相关，并评估Bip.App的可行性和满意度。参与者将从心理健康中心招募，如果他们年龄在18 - 65岁之间、处于心境正常阶段的原发性BD、已被处方第二代口服抗精神病药物作为维持/预防性治疗至少1年、未接受过针对BD的结构化PE方案、能够使用智能手机且具备足够的使用能力，则将被纳入。如果参与者患有神经系统疾病、智力发育迟缓或学习障碍、精神病、意大利语流利程度有限，则将被排除。依从性将通过清点药片、血液水平和自我报告的依从性来评估。将采用单盲平行组优效性多中心随机对照试验设计。
