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Integrated Mental Health Care and Vocational Rehabilitation to Individuals on Sick Leave Due to Anxiety and Depression

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

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02872051
Acronym
IBBIS
Enrollment
631
Registered
2016-08-18
Start date
2016-04-01
Completion date
2020-06-01
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

Depression, Generalized Anxiety, Panic Disorder, Social Phobia

Keywords

Vocational Rehabilitation, Anxiety, Depression, Common Mental Disorders, Cognitive Behavior Therapy, Return to Work, Mental Health Services, Integration

Brief summary

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

Detailed description

Background: Depression and anxiety are important contributors to the global burden of disease and causes negative effects on both the individual and society. Depression and anxiety are very likely to influence the individual's workability and up to 40 % of the people on sick leave in Denmark have common mental disorders like depression and anxiety. There is no clear evidence that mental health care alone will provide sufficient support for vocational recovery for this target group. Integrated vocational and health care services have shown good effects on return to work in other Scandinavian countries. Objective: The purpose of the Danish IBBIS study is to examine 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. Method: This three-arm, randomized, controlled trial is set up to investigate the effectiveness of the stepped mental health care model and the integrated mental health care and vocational rehabilitation intervention for people on sick leave because of depression and anxiety in Denmark. 603 patients are recruited from Danish job centers in four municipalities. The primary outcome is 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

Standard vocational rehabilitation. Stepped mental health care provided by the IBBIS mental health care team (e.g. nurses, psychologists, and medical doctors) with the treatment modalities: Psychoeducation Bibliotherapy Cognitive-behavior Therapy Monitoring and reassessment

Integrated mental health care and vocational rehabilitation provided by the IBBIS team. The IBBIS team is composed by employment specialists from the municipal job centers and health care professionals from the mental health services (e.g. nurses, psychologists, and medical doctors). Mental health care is provided according to a stepped care model with the following treatment modalities: Psychoeducation Bibliotherapy Cognitive-behavior Therapy Monitoring and reassessment Vocational rehabilitation is inspired by Individual Placement and Support and is a workplace-oriented intervention with problem-solving conversations as a core element

Sponsors

Amager Hospital
Lead SponsorOTHER
The Danish Agency for Labour Market and Recruitment
CollaboratorOTHER
Copenhagen Municipality, Denmark
CollaboratorOTHER_GOV
Gentofte Municipality, Denmark
CollaboratorUNKNOWN
Municipality of Lyngby-Taarbæk, Denmark
CollaboratorUNKNOWN
Gladsaxe Municipality, Denmark
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
No

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

Design outcomes

Primary

MeasureTime frameDescription
Time to return to work12 monthsTime from baseline to first return to work for more than four consecutive weeks

Secondary

MeasureTime frameDescription
Work12 monthsCompetitive work 12 months after baseline (yes/no)
Time to return to work24 monthsTime from baseline to first return to work for more than four consecutive weeks
Recurrent Sickness Absence24 monthsTime from baseline to recurrent sickness absence for more than 8 weeks
Degree of depressive symptoms6 monthsSelf-assessed depressive symptoms by the Beck Depression Inventory (BDI)
Degree of anxiety symptoms6 monthsSelf-assessed anxiety symptoms by the Beck Anxiety Inventory (BAI)
Degree of psychological stress symptoms6 monthsSelf-assessed psychological stress by the Cohen perceived stress scale (PSS)
Work and social functioning6 monthsWork and social functioning by the Work and Social Adjustment Scale (WSAS)

Countries

Denmark

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 8, 2026