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

February 2, 2026 updated by: Lene Falgaard Eplov, Amager Hospital

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

631

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
    • Capital Region of Denmark
      • Copenhagen, Capital Region of Denmark, Denmark, 2100
        • Mental Health Services of the Capital Region of Denmark

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Control
Standard treatment and standard vocational rehabilitation
Experimental: IBBIS MHC
IBBIS mental health care and standard vocational rehabilitation
Behavioral: IBBIS mental health care and standard vocational rehabilitation

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
Experimental: IBBIS integrated MCH and VR
Integrated mental health care and vocational rehabilitation
Behavioral: Integrated mental health care and vocational rehabilitation

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time to return to work
Time Frame: 12 months
Time from baseline to first return to work for more than four consecutive weeks
12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Work
Time Frame: 12 months
Competitive work 12 months after baseline (yes/no)
12 months
Time to return to work
Time Frame: 24 months
Time from baseline to first return to work for more than four consecutive weeks
24 months
Recurrent Sickness Absence
Time Frame: 24 months
Time from baseline to recurrent sickness absence for more than 8 weeks
24 months
Degree of anxiety symptoms
Time Frame: 6 months
Self-assessed anxiety symptoms by the Beck Anxiety Inventory (BAI)
6 months
Degree of psychological stress symptoms
Time Frame: 6 months
Self-assessed psychological stress by the Cohen perceived stress scale (PSS)
6 months
Work and social functioning
Time Frame: 6 months
Work and social functioning by the Work and Social Adjustment Scale (WSAS)
6 months
Degree of depressive symptoms
Time Frame: 6 months
Self-assessed anxiety symptoms by the Beck Anxiety Inventory (BDI)
6 months

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Symptom level
Time Frame: 6, 12 and 24 months
Symptom level on de four dimensions: Distress, Depression, Anxiety and Somatization by 4-dimensional symptom questionnaire (4DSQ)
6, 12 and 24 months
Death
Time Frame: 6, 12 and 24 months
Death and cause of death by register data
6, 12 and 24 months
Suicidal ideation
Time Frame: 6, 12 and 24 months
Suicidal ideation by BDI
6, 12 and 24 months
Life-threatening conditions
Time Frame: 6, 12 and 24 months
Life-threatening conditions by register data
6, 12 and 24 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Amager Hospital

Collaborators

Copenhagen Municipality, Denmark
Municipality of Lyngby-Taarbæk, Denmark
Gladsaxe Municipality, Denmark
The Danish Agency for Labour Market and Recruitment
Gentofte Municipality, Denmark

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 1, 2016

Primary Completion (Actual)

June 1, 2019

Study Completion (Actual)

June 1, 2020

Study Registration Dates

First Submitted

August 15, 2016

First Submitted That Met QC Criteria

August 30, 2016

First Posted (Estimated)

August 31, 2016

Study Record Updates

Last Update Posted (Actual)

February 4, 2026

Last Update Submitted That Met QC Criteria

February 2, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IBBIS Stress

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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