An interventional study of IBBIS II and Service as Usual in Common Mental Disorders, Depression and Anxiety, sponsored by Amager Hospital. Completed at 1 site in Denmark. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-02-04.
Sponsored by Amager Hospital · Not applicable, Interventional, and Other
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
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.
- Inclusion criteria
Exclusion Criteria:
Integrated Mental Health Care and Vocational Rehabilitation
Behavioral: IBBIS II
Standard vocational rehabilitation and treatment
Behavioral: Service as Usual
The IBBIS-II service consists of: 1. Mental health assessment. 2. Planned integrated service. The participant has the same employment specialists and care manager throughout the intervention. A joint plan is made with shared decisions between the participant, the employment specialist and the care manager. There is a focus on disclosure (openness about illness) and involvement of relatives and significant others. 3. Vocational rehabilitation. Focus on return to work with ongoing assessment of job goals, competencies and need of support. Participants receive help in contacting existing employers (employed) and potential employers (unemployed). Unemployed participants are offered an individualized job search effort. The focus is on competitive jobs within the community. 4. Treatment consists of stepped care with structured treatment guidelines. 5. When the participant has obtained work the team continues to offer support.
Service as usual consists of standard mental health care and vocational rehabilitation
Return to work
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
Work at one point during follow-up
Proportion in unsupported competitive work at 6 and 12-months follow up
Time frame: 12 months
Return to work
Time to return to work from baseline until 6 months after baseline measured whit register based data
Time frame: 6 months
Supported work at one point during follow-up
Proportion in supported work at 6 and 12-months follow up
Time frame: 12 months
Weeks of work
Number of weeks in competitive employment from baseline to 6 and 12 months
Time frame: 12 months
Time to new sick leave
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
Income
Salary income from competitive employment at 6 and 12 months after baseline
Time frame: 12 months
Use of psychiatric services
Number of admissions, inpatient days and outpatient contacts at the psychiatric hospitals at 6- and 12-months follow-up
Time frame: 12 months
Use of somatic services
Number of admissions, inpatient days and outpatient contacts at the somatic hospitals at 6- and 12-months follow-up
Time frame: 12 months
Use of private health care
Number of contacts with private health care professionals under the Health Insurance
Time frame: 12 months
Plan to share: No — Individual participant data will not be publicly available due to legal restrictions from the Danish data protection agency and the European data protection regulation
This study is completed, as verified in Feb 2026. You cannot join it, but the record below documents what was studied.
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Amager Hospital