|
Main
|
|
Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
|
Register:
|
ClinicalTrials.gov |
|
Last refreshed on:
|
19 February 2024 |
|
Main ID: |
NCT02872051 |
|
Date of registration:
|
15/08/2016 |
|
Prospective Registration:
|
No |
|
Primary sponsor: |
|
|
Public title:
|
Integrated Mental Health Care and Vocational Rehabilitation to Individuals on Sick Leave Due to Anxiety and Depression
IBBIS |
|
Scientific 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 |
|
Date of first enrolment:
|
April 2016 |
|
Target sample size:
|
631 |
|
Recruitment status: |
Completed |
|
URL:
|
https://clinicaltrials.gov/ct2/show/NCT02872051 |
|
Study type:
|
Interventional |
|
Study design:
|
Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Other. Masking: Double (Investigator, Outcomes Assessor).
|
|
Phase:
|
N/A
|
|
|
Countries of recruitment
|
|
Denmark
| | | | | | | |
|
Key inclusion & exclusion 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:
- 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
Age minimum:
18 Years
Age maximum:
N/A
Gender:
All
|
|
Health Condition(s) or Problem(s) studied
|
|
Generalized Anxiety
|
|
Depression
|
|
Social Phobia
|
|
Panic Disorder
|
|
Intervention(s)
|
|
Behavioral: IBBIS mental health care and standard vocational rehabilitation
|
|
Other: Integrated mental health care and vocational rehabilitation
|
|
Primary Outcome(s)
|
|
Time to return to work
[Time Frame: 12 months]
|
|
Secondary Outcome(s)
|
|
Recurrent Sickness Absence
[Time Frame: 24 months]
|
|
Work and social functioning
[Time Frame: 6 months]
|
|
Degree of anxiety symptoms
[Time Frame: 6 months]
|
|
Degree of psychological stress symptoms
[Time Frame: 6 months]
|
|
Degree of depressive symptoms
[Time Frame: 6 months]
|
|
Time to return to work
[Time Frame: 24 months]
|
|
Work
[Time Frame: 12 months]
|
|
Secondary ID(s)
|
|
IBBIS Anxiety Depression
|
|
Source(s) of Monetary Support
|
|
Please refer to primary and secondary sponsors
|
|
Results
|
|
Results available:
|
|
|
Date Posted:
|
|
|
Date Completed:
|
|
|
URL:
|
|
|
|