Supervised Treatment in Out-Patients for Schizophrenia (STOPS+)

精神分裂症是一种严重的长期精神健康问题。它会导致一系列不同的心理症状，包括幻觉(听到或看到不存在的东西)、妄想(不寻常的信念不是基于现实)、基于幻觉或错觉的混乱思想以及行为变化。精神分裂症是15-49岁人群长期残疾的常见原因，虽然有有效的治疗方法，但在发展中国家，约三分之二的患者没有得到治疗。这种缺乏治疗，即通常所说的“治疗差距”，是由于治疗依从性差、缺乏初级保健参与和难以获得治疗等因素造成的。我们之前曾报道过一种新的方法(精神分裂症门诊患者的监督治疗(停止))，在巴基斯坦开伯尔-普赫图赫瓦(KP)资源贫乏的情况下，这种方法改善了治疗依从性和功能。在这项研究中，我们在结核病患者类似方法的成功基础上，培训和支持亲属和家人监督药物服用。我们现在的目标是实施和评估基于世界卫生组织精神健康指南的扩大版的STOPS(STOKS)，并在家人和短信提醒的帮助下保持治疗依从性。我们将与初级保健医生和多功能初级保健技术人员合作，在心理健康专家的监督下执行任务转移保健。该研究分为三个阶段：第一阶段：实施前阶段，涉及社区参与，修改Stop to Stop(涉及患者、医疗保健和更广泛的社区合作伙伴)，以及确定潜在的研究参与者。阶段2：使用集群试验设计在初级保健环境中实施Stop，以确定临床和成本效益。KP白沙瓦地区的24个初级保健中心将随机提供服务或照常加强治疗(Etau)。我们将根据国际疾病分类(ICD)-10标准招募526名精神分裂症或分裂情感障碍患者(每支手臂263名)。感兴趣的结果将包括全球功能评估和对治疗方案的坚持。阶段3：将使用标准化的世界卫生组织精神卫生系统评估工具(WHO-AIMS)、经济评估、初级卫生保健试验和利用的二级数据以及涉及所有参与者的深入访谈研究来衡量在现实世界环境中对实施情况的评价。如果试验成功，这项试验将改善精神分裂症的护理，改善患者及其家人的生活。这项工作将为政策制定者提供重要信息，并为减少残疾和改善长期患者结果奠定基础。

Schizophrenia is a severe long-term mental health condition. It causes a range of different psychological symptoms including hallucinations (hearing or seeing things that don't exist), delusions (unusual beliefs not based on reality), muddled thoughts based on hallucinations or delusions and changes in behaviour. Schizophrenia is a common cause of long-term disability in the 15-49-year-old group and whilst effective treatments are available, in developing countries around two thirds of patients receive no treatment.This lack of treatment, commonly known as the 'treatment gap' arises due to factors including poor treatment adherence, a lack of primary care involvement and poor access treatments. We have previously reported a new approach (Supervised Treatment in Out-Patients for Schizophrenia (STOPS)) that resulted in improved treatment adherence and functioning in a resource poor setting in Khyber Pakhtunkhwa (KP), Pakistan. In this study we trained and supported relatives and family members to monitor medication taking, building on the success of a similar approach used for patients with tuberculosis.We now aim to implement and evaluate a 'scaled-up' version of STOPS (STOPS+) which is based on the World Health Organisation mental health guidelines and maintain treatment adherence with the help of family members and text message reminders. We will work with primary care physicians and multipurpose primary are technicians to task shift care, under the supervision of mental health experts.The study has 3 phases:PHASE 1: PRE-IMPLEMENTATION PHASE involving community engagement, modification of STOP to STOPS+ (involving patient, healthcare and wider community partners) and the identification of potential study participants.PHASE 2: IMPLEMENTATION OF STOPS+ IN PRIMARY CARE SETTINGS USING A CLUSTER TRIAL DESIGN to determine the clinical and cost-effectiveness. 24 primary care centres in district Peshawar, KP will be randomised to deliver either STOPS+ or Enhanced Treatment As Usual (ETAU). We will recruit 526 patients (263 in each arm) suffering from Schizophrenia or schizoaffective disorder based on the International Classification of Diseases (ICD)-10 criteria. The outcomes of interest will include Global Assessment of Functioning and adherence to treatment regimen.PHASE 3: EVALUATION OF THE IMPLEMENTATION IN REAL WORLD SETTING will be measured using the standardised World Health Organization's Assessment Instrument for Mental Health Systems (WHO-AIMS), economic evaluation, secondary data from the trial and utilisation of primary health care, and in depth interview study involving all participants.If successful this trial will improve schizophrenia care, improving lives for patients and their families. This work will provide important information for policy makers and set the foundations for reducing disability and improving long term patient outcomes.