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

精神分裂症是一种严重的长期心理健康状况。它会引起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（不基于现实的不寻常信念），基于幻觉或妄想的混乱思想以及行为变化。精神分裂症是导致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，约有三分之二的患者得不到治疗。这种缺乏治疗的现象，通常被称为“治疗差距”，其原因包括治疗依从性差、缺乏初级保健参与和难以获得治疗。我们以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（STOPS）），导致在开伯尔-普赫图赫瓦省（KP），巴基斯坦的资源贫乏的环境中改善治疗依从性和功能。在这项研究中，我们培训和支持亲属和家庭成员监测药物服用，建立在用于结核病患者的类似方法的成功基础上。我们现在的目标是实施和评估基于世界卫生组织精神卫生指南的“扩大”版本的STOPS（STOPS+），并在家庭成员的帮助下和短信提醒下保持治疗依从性。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进行任务转移护理。该研究分为3个阶段：第1阶段：实施前阶段，涉及社区参与，将STOP修改为STOP +（涉及患者、医疗保健和更广泛的社区合作伙伴）和潜在研究参与者的识别。采用聚类试验设计在初级保健机构中实施Stops+，以确定临床和成本效益。KP白沙瓦地区的24个初级保健中心将被随机分配，以提供STOPS+或强化治疗作为基础（ETAU）。我们将招募526名患有精神分裂症或情感性精神障碍的患者（每组263名），这些患者基于国际疾病分类（ICD）-10标准。关注的结果将包括功能和治疗方案依从性的总体评估。将使用标准化的世界卫生组织精神卫生系统评估工具来衡量在真实的世界中的执行情况（WHO-AIMS）、经济评价、试验的二级数据和初级卫生保健的利用，如果这项试验成功，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.