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Integrated Mental Health Care and Vocational Rehabilitation to Individuals on Sick Leave Due to Stress Disorders

Integrated Mental Health Care and Vocational Rehabilitation to Individuals on Sick Leave Due to Burnout, Adjustment Disorder or Psychological Stress in Denmark (the Danish IBBIS Study): A Multi-center Randomized Controlled Trial

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02885519
Acronym
IBBIS
Enrollment
631
Registered
2016-08-31
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

Adjustment Disorder, Burnout, Psychological Stress

Keywords

Vocational Rehabilitation, Common Mental Disorders, Return to Work, Mental Health Services, Psychological Stress, Adjustment Disorder, Burnout, Integration, Cognitive Behavior Therapy

Brief summary

The purpose of this study is to investigate the efficacy of 1) a stepped mental health care (MHC) intervention and 2) an integrated mental health care and vocational rehabilitation (VR) intervention for people on sick leave because of burnout, adjustment disorder and psychological stress in Denmark

Detailed description

Background: Stress disorders have negative effects on workability and have negative effects on both the individual and society. Psychological stress and burnout is not recognized as psychiatric diagnoses, and thus, the estimated prevalence in healthy and sick-listed people is somewhat insecure in Denmark. Together with other common mental disorders, burnout, adjustment disorder and psychological stress are causes of up 40 % of the sick leave claims in Denmark. 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 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 burnout, adjustment disorder and psychological stress 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 burnout, adjustment disorder and psychological stress 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 Stress-coaching Mindfulness-based stress reduction Monitoring and re-assessment

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 Stress-coaching Mindfulness-based stress reduction Monitoring and re-assessment 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

* Burnout OR adjustment disorder OR psychological stress according to 4DSQ * 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 Jobcentre 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 anxiety symptoms by the Beck Anxiety 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