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Integrated Mental Health Care and Vocational Rehabilitation to People With to Common Mental Disorders

Integrated Mental Health Care and Vocational Rehabilitation Intervention to Individuals on Sick Leave Due to Anxiety, Depression, Personality Disorders, Stress and Functional Disorders

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04432129
Acronym
IBBIS II
Enrollment
900
Registered
2020-06-16
Start date
2020-06-09
Completion date
2022-10-01
Last updated
2026-02-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anxiety, Common Mental Disorders, Depression, Functional Disease Present, Personality Disorders, Stress

Keywords

Vocational rehabilitation, Mental health services, Return to Work

Brief summary

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

Detailed description

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.

Interventions

BEHAVIORALIBBIS II

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

Sponsors

Amager Hospital
Lead SponsorOTHER
The Danish Agency for Labour Market and Recruitment
CollaboratorOTHER
Central Denmark Region
CollaboratorOTHER
Aarhus Kommune
CollaboratorOTHER
Københavns Kommune
CollaboratorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
DOUBLE (Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

Inclusion criteria

\- Inclusion criteria * Anxiety, depression, stress, personality disorder or functional disorder diagnosed at a structured diagnostic interview based on the Mini International Neuropsychiatric Interview conducted by the IBBIS team * Sickness benefit recipient at baseline; on sick leave from job or unemployed for a minimum of four weeks * Resident in Copenhagen or Aarhus municipalities * Speak sufficient Danish to participate in interviews and complete questionnaires without an interpreter * Aged 18 or older * Has given informed written consent

Exclusion criteria

* Pregnant * High degree of suicidal ideation * Dementia * Abuse of alcohol or other drugs to the degree that participation in therapy is not possible * A need for mental health treatment in secondary sector care * Unstable somatic condition that is too severe for participation in the project * The participant will not refrain from participating in other psychotherapeutic treatment outside the IBBIS project if the participant will be allocated to the experimental group

Design outcomes

Primary

MeasureTime frameDescription
Return to work12 monthsDifference 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.

Secondary

MeasureTime frameDescription
Work at one point during follow-up12 monthsProportion in unsupported competitive work at 6 and 12-months follow up
Return to work6 monthsTime to return to work from baseline until 6 months after baseline measured whit register based data
Supported work at one point during follow-up12 monthsProportion in supported work at 6 and 12-months follow up
Weeks of work12 monthsNumber of weeks in competitive employment from baseline to 6 and 12 months
Time to new sick leave12 monthsThe duration from return to work to potential new sick leave of more than 4 weeks within the 12-month follow-up period
Income12 monthsSalary income from competitive employment at 6 and 12 months after baseline
Use of psychiatric services12 monthsNumber of admissions, inpatient days and outpatient contacts at the psychiatric hospitals at 6- and 12-months follow-up
Use of somatic services12 monthsNumber of admissions, inpatient days and outpatient contacts at the somatic hospitals at 6- and 12-months follow-up
Use of private health care12 monthsNumber of contacts with private health care professionals under the Health Insurance

Countries

Denmark

Contacts

PRINCIPAL_INVESTIGATORLene F Eplov, PhD

Mental Health Center Copenhagen

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 13, 2026