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
Overview
- Phase
- N/A
- Intervention
- Control
- Conditions
- Generalized Anxiety
- Sponsor
- Amager Hospital
- Enrollment
- 631
- Locations
- 1
- Primary Endpoint
- Time to return to work
- Status
- Completed
- Last Updated
- 2 months ago
Overview
Brief Summary
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
Detailed Description
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: This three-arm, randomized, controlled trial is set up to investigate the effectiveness of the stepped mental health care model and the integrated mental health care and vocational rehabilitation intervention for people on sick leave because of depression and anxiety in Denmark. 603 patients are recruited from Danish job centers in four municipalities. The primary outcome is return to work at 12 months. Results/discussion: This study will contribute with new knowledge on vocational recovery and integrated vocational and health care interventions in a Scandinavian context.
Investigators
Lene Falgaard Eplov
MD, PhD
Amager Hospital
Eligibility Criteria
Inclusion Criteria
- •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
Exclusion Criteria
- •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
Arms & Interventions
Control
Standard treatment and standard vocational rehabilitation
IBBIS MHC
IBBIS mental health care and standard vocational rehabilitation
Intervention: IBBIS mental health care and standard vocational rehabilitation
IBBIS integrated MCH and VR
Integrated mental health care and vocational rehabilitation
Intervention: Integrated mental health care and vocational rehabilitation
Outcomes
Primary Outcomes
Time to return to work
Time Frame: 12 months
Time from baseline to first return to work for more than four consecutive weeks
Secondary Outcomes
- 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)