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

NCT ID: NCT02885519

Last Updated: 2026-02-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 631 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-04-30
• Study Completion Date: 2020-06-30

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.

Conditions

Adjustment Disorder; Burnout; Psychological Stress

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: DOUBLE

Study Groups

Control

Standard treatment and standard vocational rehabilitation

Group Type: NO_INTERVENTION

No interventions assigned to this group

IBBIS MHC

IBBIS mental health care and standard vocational rehabilitation

Group Type: EXPERIMENTAL

IBBIS mental health care and standard vocational rehabilitation

Intervention Type: BEHAVIORAL

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

IBBIS integrated MCH and VR

Integrated mental health care and vocational rehabilitation

Group Type: EXPERIMENTAL

Integrated mental health care and vocational rehabilitation

Intervention Type: BEHAVIORAL

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

Interventions

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

Intervention Type: 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

Intervention Type: BEHAVIORAL

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

The Danish Agency for Labour Market and Recruitment

OTHER

Sponsor Role: collaborator

Copenhagen Municipality, Denmark

OTHER_GOV

Sponsor Role: collaborator

Gentofte Municipality, Denmark

UNKNOWN

Sponsor Role: collaborator

Municipality of Lyngby-Taarbæk, Denmark

UNKNOWN

Sponsor Role: collaborator

Gladsaxe Municipality, Denmark

OTHER

Sponsor Role: collaborator

Amager Hospital

OTHER

Sponsor Role: lead

Responsible Party

Lene Falgaard Eplov

Head of Research, Associate professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Mental Health Services of the Capital Region of Denmark

Copenhagen, Capital Region of Denmark, Denmark

Countries

Denmark

References

Hoff A, Poulsen RM, Fisker JP, Hjorthoj C, Nordentoft M, Bojesen AB, Eplov LF. Integrated mental healthcare and vocational rehabilitation for people on sick leave with stress-related disorders: 24-month follow-up of the randomized IBBIS trial. Scand J Work Environ Health. 2023 May 1;49(4):303-308. doi: 10.5271/sjweh.4084. Epub 2023 Mar 5.

Reference Type: DERIVED

PMID: 36871310 (View on PubMed)

Poulsen R, Fisker J, Hoff A, Hjorthoj C, Eplov LF. Integrated mental health care and vocational rehabilitation to improve return to work rates for people on sick leave because of exhaustion disorder, adjustment disorder, and distress (the Danish IBBIS trial): study protocol for a randomized controlled trial. Trials. 2017 Dec 2;18(1):579. doi: 10.1186/s13063-017-2273-0.

Reference Type: DERIVED

PMID: 29197404 (View on PubMed)

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

IBBIS Stress

Identifier Type: -

Identifier Source: org_study_id