Integrated Mental Health Care and Vocational Rehabilitation to Individuals on Sick Leave Due to Burnout, Adjustment Disorder or Psychological Stress 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 (MHC) intervention and 2) an integrated mental health care and vocational rehabilitation (VR) intervention for people on sick leave because of burnout, adjustment disorder and psychological stress in Denmark
详细描述
Background:
Stress disorders have negative effects on workability and have negative effects on both the individual and society. Psychological stress and burnout is not recognized as psychiatric diagnoses, and thus, the estimated prevalence in healthy and sick-listed people is somewhat insecure in Denmark. Together with other common mental disorders, burnout, adjustment disorder and psychological stress are causes of up 40 % of the sick leave claims in Denmark. 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 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 burnout, adjustment disorder and psychological stress 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
- •Burnout OR adjustment disorder OR psychological stress according to 4DSQ
- •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 Jobcentre 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 (Behavioral)
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
- Degree of depressive symptoms(6 months)
- Work(12 months)
- Time to return to work(24 months)
- Recurrent Sickness Absence(24 months)
- Degree of anxiety symptoms(6 months)
- Degree of psychological stress symptoms(6 months)
- Work and social functioning(6 months)
研究者
Lene Falgaard Eplov
Head of Research, Associate professor
Amager Hospital