Depression Clinical Trial
— IBBISOfficial title:
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
Verified date | February 2024 |
Source | Mental Health Services in the Capital Region, Denmark |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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
Status | Completed |
Enrollment | 631 |
Est. completion date | June 2020 |
Est. primary completion date | June 2019 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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: - Pregnant - High degree of suicidal ideation - Dementia - 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 |
Country | Name | City | State |
---|---|---|---|
Denmark | Mental Health Services of the Capital Region of Denmark | Copenhagen | Capital Region Of Denmark |
Lead Sponsor | Collaborator |
---|---|
Mental Health Services in the Capital Region, Denmark | Copenhagen Municipality, Denmark, Gentofte Municipality, Denmark, Gladsaxe Municipality, Denmark, Municipality of Lyngby-Taarbæk, Denmark, The Danish Agency for Labour Market and Recruitment |
Denmark,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Symptom level | Symptom level on de four dimensions: Distress, Depression, Anxiety and Somatization by 4-dimensional symptom questionnaire (4DSQ) | 6, 12 and 24 months | |
Other | Death | Death and cause of death by register data | 6, 12 and 24 months | |
Other | Suicidal ideation | Suicidal ideation by BDI | 6, 12 and 24 months | |
Other | Life-threatening conditions | Life-threatening conditions by register data | 6, 12 and 24 months | |
Primary | Time to return to work | Time from baseline to first return to work for more than four consecutive weeks | 12 months | |
Secondary | Work | Competitive work 12 months after baseline (yes/no) | 12 months | |
Secondary | Time to return to work | Time from baseline to first return to work for more than four consecutive weeks | 24 months | |
Secondary | Recurrent Sickness Absence | Time from baseline to recurrent sickness absence for more than 8 weeks | 24 months | |
Secondary | Degree of depressive symptoms | Self-assessed depressive symptoms by the Beck Depression Inventory (BDI) | 6 months | |
Secondary | Degree of anxiety symptoms | Self-assessed anxiety symptoms by the Beck Anxiety Inventory (BAI) | 6 months | |
Secondary | Degree of psychological stress symptoms | Self-assessed psychological stress by the Cohen perceived stress scale (PSS) | 6 months | |
Secondary | Work and social functioning | Work and social functioning by the Work and Social Adjustment Scale (WSAS) | 6 months |
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