Copenhagen Research Center for Mental Health - CORE
Copenhagen, 2900, Denmark
NCT Number: NCT04432129
The purpose of this study is to investigate the efficacy of an integrated mental health care and vocational rehabilitation intervention for people on sick leave because of depression, stress, anxiety, personality- and functional disorders in Denmark
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Notify Me18 year and older
All sexes
Interventional
Not applicable
Copenhagen, 2900, Denmark
Background:
Mental illness has an estimated financial burden on the Danish economy of 3.4 % of Gross National Product every year due to lost productivity, social benefits and healthcare costs and approximately 50 % of people receiving long-term sickness benefits have a common mental illness. Furthermore, a significant treatment gap exists where less than 30% were treated for their mental illness.
Objective:
The primary objective of the randomized trial is to examine whether people on sick leave with a diagnosis of anxiety, depression, stress, personality disorders or functional disorders, return to work faster and have a higher job retention if they receive an integrated and optimized vocational rehabilitation and mental health care intervention, compared to people who receive the standard mental health care and vocational rehabilitation service.
Method:
The trial is designed as an randomized, two-group parallel, assessor-blinded, multisite trial. A total of 800 participants with a common mental illness will randomly be assigned into two groups 1) IBBIS II, consisting of an integrated mental health care and vocational rehabilitation; or 2) Service as usual, at two sites in Denmark. The primary outcome is difference between the two groups in time to 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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
The IBBIS-II service consists of:
Service as usual consists of standard mental health care and vocational rehabilitation
Time frame: 12 months
Difference between the two groups in time to return to work from baseline until 12 months after baseline measured whit register based data. Time to return to work is defined as a minimum of four weeks of continuous work without receiving sickness benefit.
Time frame: 12 months
Proportion in unsupported competitive work at 6 and 12-months follow up
Time frame: 6 months
Time to return to work from baseline until 6 months after baseline measured whit register based data
Time frame: 12 months
Proportion in supported work at 6 and 12-months follow up
Time frame: 12 months
Number of weeks in competitive employment from baseline to 6 and 12 months
Time frame: 12 months
The duration from return to work to potential new sick leave of more than 4 weeks within the 12-month follow-up period
Time frame: 12 months
Salary income from competitive employment at 6 and 12 months after baseline
Time frame: 12 months
Number of admissions, inpatient days and outpatient contacts at the psychiatric hospitals at 6- and 12-months follow-up
Time frame: 12 months
Number of admissions, inpatient days and outpatient contacts at the somatic hospitals at 6- and 12-months follow-up
Time frame: 12 months
Number of contacts with private health care professionals under the Health Insurance
Amager Hospital
Other
Integrated Mental Health Care and Vocational Rehabilitation Intervention to Individuals on Sick Leave Due to Anxiety, Depression, Personality Disorders, Stress and Functional Disorders
Acronym: IBBIS II
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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