Relapse Prevention Trial in Top End Aboriginal People With Chronic Mental Illness
试验速览
- 阶段
- 不适用
- 入组人数
- 90
- 试验地点
- 2
- 主要终点
- Health of Nations Outcome Scale (HONOS)
研究概览
简要总结
A new treatment for indigenous people with mental illness in remote communities has been developed. The study hypothesis is that this new treatment will result in better outcomes for clients and carers than the outcomes of clients and carers who do not receive the treatment. The treatment is a combination of a talking treatment and sharing of stories about mental health. The treatment will be delivered to the client with their chosen carer and with the local Aboriginal Mental Health Worker or Health Worker. The treatment will be given by the research team - a psychiatrist and an indigenous research officer. The trial will compare two groups of clients - a control group which is receiving 'treatment as usual', and the group which receives the new treatment. Measures of social functioning and symptoms of mental illness will be administered at base line and every six months for two years.
详细描述
A combined education and counselling treatment has been developed using a care plan and stories delivered via computer based animated software, with associated flip charts and information sheets. The new treatment will take about 60 minutes to administer and will be delivered on two occasions. It will include a discussion and assessment phase, setting of goals, and completion of a care plan. Three 5-minute stories will be shown during the session. Each story will have been adapted for use by the community Aboriginal Mental Health Workers prior to base line. The process for development of the stories in each community will involve showing the generic resources and any completed community specific resources - and allowing time for the stories to be adjusted by the community. The new community - specific resources will then be used in the treatment sessions - conducted by the chief investigator- a consultant psychiatrist with 15 years experience working with indigenous mental health clients and an indigenous research officer and Aboriginal Mental Health Worker (or Health Worker). The Aboriginal Mental Health Workers will receive training in the stories at two stages - through the consultation and workshop phase of the story development, and through the delivery phase with clients and carers. The stories and care planning intervention aim to promote change through encouraging clients in their own choices and their own control of their lives, and through setting goals to make changes if they choose. The intervention involves culturally appropriate sharing of information with clients and carers about illness and treatment. The information sharing is two way - as clients are invited to share their own stories during the process.
Overview
The project design is 2 years from base line to end. Base line measures of psychosocial functioning will be completed for clients and carers at commencement of the project. The measures will include self-completion and clinician completed scales. There will also be an interview - focusing on protective factors, precipitants of illness, symptoms, goals for change, and strategies for change. The new treatment will be delivered between base line and 6 weeks for group one, and in the six weeks following the six-month measures for group two. Follow up measures will be completed six months post new treatment, and every six months for 2 years post new treatment for group one. Follow up measures will be completed six months post new treatment for group two with 18 months follow up. Aboriginal Mental Health Workers will also have base line and follow up measures of knowledge and confidence in treatment - and qualitative information will be gathered about the client's progress and about the Aboriginal Mental Health Worker's experience of the new treatment.
Informed Consent
Patients, carers and Aboriginal Mental Health Workers will be given information about the project in written and spoken form, with the Aboriginal research officer, prior to obtaining their consent to participate.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participants will be recruited by Aboriginal Mental Health Workers - or nominated by mental health staff or the General Practitioner. The treating doctors or local mental health team will be notified of the nomination in each case and, if they have no concerns, the Aboriginal Mental Health Worker will arrange the information and consent session with the research team. The participants will be clients who have a primary chronic mental illness, are aged over 18 years, are able to give informed consent, and are current clients. The diagnoses for inclusion are Schizophrenia, Delusional disorder, Schizoaffective disorder, Drug-induced psychosis, Non-specific psychoses, and Affective disorders. The criteria for chronicity for the purposes of the project are defined by two or more episodes of illness severe enough to require medical intervention and treatment. The carer will be identified by discussion between the client and the Aboriginal Mental Health Worker or Health Worker.
排除标准
- •People aged less than 18 years, and people with known Intellectual disability or organic brain disorders will be excluded. People with illnesses which have not recurred, or which are not likely to recur will be excluded.
结局指标
主要结局
Health of Nations Outcome Scale (HONOS)
时间窗: Baseline, 6 months, 12 months, 18 months,
次要结局
- Life Skills Profile 16 (LSP)(Baseline, 6 months, 12 months, 18 months,)
- Severity of Dependence Scale (SDS)(Baseline, 6 months, 12 months, 18 months,)
- Kessler 10 - client and carer(Baseline, 6 months, 12 months, 18 months,)
- Partners in Health Scale (PIH) - modified(Baseline, 6 months, 12 months, 18 months,)
- Semi structured interview with carer and client and Aboriginal Mental Health Worker(Baseline, 6 months, 12 months, 18 months,)