Randomised Control Trial of the Clinical and Cost Effectiveness of a Specialist Expert Mood Disorder Team for Refractory Unipolar Depressive Disorder
试验速览
- 阶段
- 不适用
- 入组人数
- 219
- 试验地点
- 3
- 主要终点
- Hamilton Depression Rating Scale - Grid version
研究概览
简要总结
The purpose of this study is determine whether a specialised mood disorder service, which offers tailored psychological and pharmacological treatment, is more effective in the treatment of chronic unipolar depressive disorder then treatment as usual.
详细描述
A pragmatic randomised controlled trial of a specialist mood disorder intervention versus treatment as usual will be conducted. Patients will be individually randomised with stratification by mental health trust to either treatment by a specialist team offering tailored psychological and pharmacological treatment or treatment as usual.
The specialist mood disorders team will include a psychiatrist and health professionals providing cognitive behaviour therapy. Together the team will assess participants and then provide a co-ordinated and supervised combination of pharmacological and psychological treatment according to guidelines developed by NICE and the British Association of Psychopharmacology. Each participant will receive a treatment plan that is tailored to his/her specific needs. The participants in the treatment as usual team will have their usual access to the same treatments. The outcome in terms of improvement in depressive symptoms, function and costs will be examined after one year in service users with chronic depression.
Eligible patients will be followed for 12 months and the primary outcomes will be observer rated depressive symptoms and cost effectiveness from a health and social care perspective. Along side the RCT, implementation analysis and audit of the standard care and specialised care for depression will be carried out.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
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
- •The responsible medical officer or care coordinator leading care considers the patient to be suffering from a primary unipolar depressive disorder which is not a consequence of having another axis 1 or 2 psychiatric disorder.
- •Age over 18 years.
- •Able and willing to give oral and written informed consent to participation in the study.
- •From the date of first assessment by a health professional working for the index mental health trust, they have been offered or received direct care from one or more health professionals from the Trust three or more occasions for 6 months.
- •Meet NICE criteria for moderate depression, namely the presence of five out of nine symptoms of (NICE, 2004), have a Hamilton Depression Rating Scale of at least 20, and score 60 or less on the Global Assessment of Functioning Scale (American Psychiatric Association, 1994).
排除标准
- •Is receiving emergency care for suicide risk, risk of severe neglect or homicide risk and requires it; however, patients will not be excluded because of such risk provided the risk is adequately contained with their current care setting and the primary medical responsibility for care remains with the referring team.
- •Does not speak fluent English.
- •Is pregnant
结局指标
主要结局
Hamilton Depression Rating Scale - Grid version
时间窗: 6 months
次要结局
- Change in self rated depression measures: Beck Depression Inventory version 1; Personal Health Questionnaire; Quick Inventory of Depressive Symptomology(3 months)
- Cost utility or cost effectiveness using the Euroqol 5D as a measure of quality of life and costs from health and social care and society perspectives.(6 months)
- Change in social adjustment (Cooper, Osborn, Gath & Feggetter, 1982), an assessment of social and occupational functioning.(6 months)
- Patient satisfaction and patient/doctor relationship(6 months)