Integrated Mental Health Care and Vocational Rehabilitation to Individuals on Sick Leave Due to Anxiety and Depression in Denmark (the Danish IBBIS Study): A Multi-center Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 631
- 试验地点
- 1
- 主要终点
- Time to return to work
研究概览
简要总结
The purpose of this study is to investigate the efficacy of 1) a stepped mental health care intervention and 2) an integrated mental health care and vocational rehabilitation intervention for people on sick leave because of depression and anxiety in Denmark
详细描述
Background:
Depression and anxiety are important contributors to the global burden of disease and causes negative effects on both the individual and society. Depression and anxiety are very likely to influence the individual's workability and up to 40 % of the people on sick leave in Denmark have common mental disorders like depression and anxiety. There is no clear evidence that mental health care alone will provide sufficient support for vocational recovery for this target group. Integrated vocational and health care services have shown good effects on return to work in other Scandinavian countries.
Objective:
The purpose of the Danish IBBIS study is to examine the efficacy of 1) a stepped mental health care intervention and 2) an integrated mental health care and vocational rehabilitation intervention for people on sick leave because of depression and anxiety in Denmark.
Method:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Double (Investigator, 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
- •Depression, Generalized Anxiety, Social Phobia or Panic Disorder according to Mini International Neuropsychiatric Interview (MINI)
- •On sick leave from work or unemployment and have received sick leave benefit for minimum four weeks OR have started a sick leave benefit case which is estimated to last for minimum eight weeks
- •Citizen in one of the following municipalities: Copenhagen City, Gladsaxe Municipality, Lyngby-Taarbæk Municipality or Gentofte Municipality
- •Danish-speaking
- •Given informed consent
排除标准
- •High degree of suicidal ideation
- •Alcohol or substance misuse that hinders the person participating in treatment
- •Wish to start or continue psychological therapy
- •Need for psychiatric treatment in the secondary psychiatric care system
- •Medically unstable to a degree that the patient cannot adhere to treatment
- •Participant in the research project Collabri
- •Attending stress courses in the stress clinics of Copenhagen City
- •Assessed by job center case managers to be dangerous
研究组 & 干预措施
Control
Standard treatment and standard vocational rehabilitation
IBBIS MHC
IBBIS mental health care and standard vocational rehabilitation
干预措施: IBBIS mental health care and standard vocational rehabilitation (Behavioral)
IBBIS integrated MCH and VR
Integrated mental health care and vocational rehabilitation
干预措施: Integrated mental health care and vocational rehabilitation (Other)
结局指标
主要结局
Time to return to work
时间窗: 12 months
Time from baseline to first return to work for more than four consecutive weeks
次要结局
- Work(12 months)
- Time to return to work(24 months)
- Recurrent Sickness Absence(24 months)
- Degree of depressive symptoms(6 months)
- Degree of anxiety symptoms(6 months)
- Degree of psychological stress symptoms(6 months)
- Work and social functioning(6 months)