Projekt Collabri Flex - The Effect of a Danish Model for Collaborative Care for People With Depression in General Practice
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 389
- 试验地点
- 1
- 主要终点
- Self-reported degree of depression
研究概览
简要总结
The aim of the study Collabri Flex is to:
- Develop a Danish model for collaborative care for patients with depression in general practice, based on past experience gained in the Collabri Project.
- Examine the impact of this model compared with liaison-consultation for people with depression in a randomized controlled design from selected endpoints.
详细描述
The Collabri Flex model for Collaborative Care takes point of departure in the earlier study Collabri. It is changed according to gathered information under the first study of the Collabri model in order to achieve a Danish Collaborative Care model easier to implement.
The aims of Project Collabri Flex are to:
- Develop a flexible model for collaborative care (the Collabri Flex model) for patients with depression.
- Study the effects of this Collabri Flex model against consultation liaison in a randomized design on selected outcomes.
In Collabri the treatment is in line with a set of general treatment principles relevant for collaborative care interventions. The patients in the intervention group are offered cognitive behavioral therapy (CBT), psychoeducation and medication according to a stepped care model by a care manager refering to the general practitioner.
The Collabri Flex study is set up as a researcher-blinded individually randomized controlled trial with participation of an intervention group (treatment according to the Collabri Flex model) and a consultation liaison group.
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 (Investigator)
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
- •Danish speaking
- •Diagnosis of current depression based on the Mini International Neuropsychiatric Interview (MINI) by care managers that have been trained in using MINI in close collaboration with the psychiatrist/psychologist.
- •The patient has given her/his written informed consent to participate in the trial at the described terms
排除标准
- •High risk of suicide assessed in the Mini International Neuropsychiatric Interview (MINI) and/or by the GP
- •Psychotic condition detected in the MINI and/or by the GP
- •Patients with a diagnosis of dementia
- •Alcohol or substance misuse that hinders the person participating in Collabri treat-ment as assessed by the practitioner or care manager at inclusion interview
- •If the patient has been referred or is recommended referral to secondary care treatment (mental health center) or psychiatrist in private practice
- •Patients who are assessed by the GP as medically unstable making it impossible for the patient to adhere to treatment
- •Bipolar affective disorder as assessed in the MINI and/or by the GP
- •Pregnancy
- •For patients in the Collabri Flex group:
- •Patients with depression who wants treatment cf. the psychologist scheme (Psykologordningen) or similar treatment and do not want the refferal to the psychologist preceded by other treatment, cf. the Collabri Flex model assessed by the GP
- •Patients that wish to continue current psychological or psychiatric treatment due to anxiety or depression
研究组 & 干预措施
Collabri Flex
Collaborative care
干预措施: Collaborative care (Behavioral)
Consultation-Liaison
Consultations with general practitioner
干预措施: Consultations-Liaison (Behavioral)
结局指标
主要结局
Self-reported degree of depression
时间窗: 6 months
Measured by Beck Depression Inventory (BDI-II)
次要结局
- Self-reported degree of anxiety(6 months)
- Self-reported quality of life/well-being(6 months)
- Self-reported psychological stress(6 months)
- Self-reported functional impairment(6 months)
研究者
Lene Falgaard Eplov
Head of Research, Associate professor
Amager Hospital