Renwick Laoise, Susanti Herni, Brooks Helen, Keliat Budi-Anna, Bradshaw Tim, Bee Penny, Lovell Karina
Division of Nursing, Midwifery and Social Work, Faculty of Medicine, Biology and Health, School of Health Sciences, University of Manchester, Manchester, M13 9PL, UK.
Faculty of Nursing, Universitas Indonesia, Depok, Indonesia.
Pilot Feasibility Stud. 2023 Mar 30;9(1):53. doi: 10.1186/s40814-023-01280-8.
Mental illnesses comprise the single largest source of health-related economic burden globally, and low- and middle-income countries are disproportionately affected. The majority of people with schizophrenia who need treatment do not receive it and are often wholly reliant on family caregivers for daily care and support. Family interventions have an exceptionally robust evidence base for their efficacy in high-resource settings, but it is unknown whether they can produce equivalent effects in some low-resource settings where cultural beliefs, explanatory models of illness and contextual socio-economic issues differ.
This protocol describes the methods for a randomised controlled trial to determine the feasibility of testing culturally adapt and refine an evidence-based, family intervention for relatives and caregivers of people with schizophrenia in Indonesia. The feasibility and acceptability of implementing our adapted, co-produced intervention via task shifting in primary care settings will be evaluated using the Medical Research Council framework for complex interventions. We will recruit 60 carer-service-user dyads and randomise them in a 1:1 ratio either to receive our manualised intervention or continue to receive treatment as usual. Healthcare workers in primary care settings will be trained to deliver family interventions using our manualised intervention by a family intervention specialist. Participants will complete the ECI, IEQ, KAST and GHQ. Service-user symptom level and relapse status will be measured using the PANSS at baseline, post-intervention and 3 months later by trained researchers. Fidelity to the intervention model will be measured using the FIPAS. Qualitative evaluation will further assist with refining the intervention, evaluating trial processes and evaluating acceptability.
National healthcare policy in Indonesia supports the delivery of mental health services in a complex network of primary care centres. This study will provide important information on the feasibility of delivering family interventions for people with schizophrenia via task shifting in primary care settings in Indonesia and allow further refinement of the intervention and trial processes.
精神疾病是全球与健康相关的经济负担的最大单一来源,低收入和中等收入国家受到的影响尤为严重。大多数需要治疗的精神分裂症患者未得到治疗,且在日常生活照料和支持方面往往完全依赖家庭照料者。在资源丰富的环境中,家庭干预在疗效方面有着极为坚实的证据基础,但在一些文化信仰、疾病解释模型和背景社会经济问题不同的低资源环境中,家庭干预是否能产生同等效果尚不清楚。
本方案描述了一项随机对照试验的方法,以确定在印度尼西亚对精神分裂症患者的亲属和照料者进行文化适应性调整并完善基于证据的家庭干预措施进行测试的可行性。我们将使用医学研究理事会针对复杂干预措施的框架,评估通过在初级保健机构中进行任务转移来实施我们经过调整的、共同制定的干预措施的可行性和可接受性。我们将招募60对照料者 - 服务使用者二元组,并以1:1的比例将他们随机分组,一组接受我们的手册化干预措施,另一组继续照常接受治疗。初级保健机构的医护人员将由一名家庭干预专家培训,以便使用我们的手册化干预措施来提供家庭干预。参与者将完成ECI、IEQ、KAST和GHQ。经过培训的研究人员将在基线、干预后和3个月后使用PANSS来测量服务使用者的症状水平和复发状态。将使用FIPAS来衡量对干预模型的依从性。定性评估将进一步协助完善干预措施、评估试验过程和评估可接受性。
印度尼西亚的国家医疗政策支持在复杂的初级保健中心网络中提供精神卫生服务。本研究将提供关于在印度尼西亚通过初级保健机构中的任务转移为精神分裂症患者提供家庭干预措施的可行性的重要信息,并允许进一步完善干预措施和试验过程。