Project Collabri. The Effect of a Collaborative Care Model for Treatment of Depression in Primary Care in Denmark - A Cluster Randomized Clinical Superiority Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 325
- 试验地点
- 1
- 主要终点
- Degree of depression measured by the Beck Depression Inventory (BDI)
研究概览
简要总结
The purpose of this study is to determine whether treatment of patients with depression according to the Collabri Model is more effective in reducing symptoms compared to treatment as usual (TAU)
详细描述
Background:
Depression is a common disease mostly treated in general practice. Diagnose and evidence based treatment in general practice today is not optimal (e.g. lack of continuity in disease management and lack of treatment opportunities).
International studies show effect of collaborative care on depression, but is not directly applicable into a Danish context.
A Danish model for collaborative care treatment of people with depression, generalized anxiety disorder, social phobia and panic disorder (the Collabri Model) is developed. The Collabri model consists of a multi-professional approach to treatment, scheduled monitoring and review, enhanced inter-professional communication and a structured treatment plan.
Objectives:
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
- •Age: 18+ years
- •Danish speaking
- •Diagnosis of current depression using the Mini International Neuropsychiatric Interview (MINI) (DSM IV) by researchers that have been trained in using MINI and according to the ICD-10 criteria or when diagnosed by GP after conference with a psychiatrist in Project Collabri
- •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 general practitioner
- •Psychotic condition detected in the MINI and/or by general practitioner
- •Patients with a diagnosis of dementia
- •Pregnancy
- •Alcohol or substance misuse that hinders the person participating in Collabri treatment as assessed by the practitioner or researcher at inclusion interview
- •Patients that are in current psychological or psychiatric treatment due to anxiety or depression
- •Patients with a pending disability pension case
- •Patients who have been treated for anxiety or depression within the last 6 months
- •For patients in the intervention group: Patients with depression who wants treatment cf. the Danish psychologist scheme and do not want the reference to the psychologist preceded by other treatment, cf. the Collabri model
- •For patients in the intervention group: If the patient at the first point of contact with the general practitioner after inclusion by a research assistant is referred to treatment as a part of the secondary psychiatric care system.
- •Patients who are assessed by the general practitioner as medically unstable making it impossible for the patient to adhere to treatment
- •OCD, PTSD, bipolar affective disorder as assessed in the MINI and/or by the general practitioner
研究组 & 干预措施
Treatment according to the Collabri model
Participants in this group will recive treatment according to the Collabri model which is a Danish model for collaborative care between primary and secondary care for depression, social phobia, generalized anxiety and panic disorder
干预措施: Treatment according to the Collabri model (Other)
Treatment as usual
Control group. Participants in this group will recive treatment as usual. This means that participants will recive treatment corresponding to what their GP normally would offer as treatment. E.g. this could be refferal to a psychologist or psychiatrist and/or medicine.
结局指标
主要结局
Degree of depression measured by the Beck Depression Inventory (BDI)
时间窗: At 6 months follow up after baseline
The measure is self-reported
次要结局
- Degree of anxiety measured by the Beck Anxiety Inventory (BAI)(At 6 months follow up after baseline)
- Psychological stress measured with the Symptom Checklist (SCL-92)(At 6 months follow up after baseline)
- Functional impairment measured with the Global Assessment of Functioning (GAF-F split version)(At 6 months follow up after baseline)
研究者
Lene Falgaard Eplov
Head of Research, Associate professor
Amager Hospital