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Completed

NCT Number: NCT02885519

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

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

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Mental Health Services of the Capital Region of Denmark

Copenhagen, Capital Region of Denmark, 2100, Denmark

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

IBBIS mental health care and standard vocational rehabilitation

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

Integrated mental health care and vocational rehabilitation

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

Primary outcomes

  1. Time to return to work

    Time frame: 12 months

    Time from baseline to first return to work for more than four consecutive weeks

Secondary outcomes

  1. Work

    Time frame: 12 months

    Competitive work 12 months after baseline (yes/no)

  2. Time to return to work

    Time frame: 24 months

    Time from baseline to first return to work for more than four consecutive weeks

  3. Recurrent Sickness Absence

    Time frame: 24 months

    Time from baseline to recurrent sickness absence for more than 8 weeks

  4. Degree of depressive symptoms

    Time frame: 6 months

    Self-assessed anxiety symptoms by the Beck Anxiety Inventory (BDI)

  5. Degree of anxiety symptoms

    Time frame: 6 months

    Self-assessed anxiety symptoms by the Beck Anxiety Inventory (BAI)

  6. Degree of psychological stress symptoms

    Time frame: 6 months

    Self-assessed psychological stress by the Cohen perceived stress scale (PSS)

  7. Work and social functioning

    Time frame: 6 months

    Work and social functioning by the Work and Social Adjustment Scale (WSAS)

Other outcomes

  1. 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)

  2. Death

    Time frame: 6, 12 and 24 months

    Death and cause of death by register data

  3. Suicidal ideation

    Time frame: 6, 12 and 24 months

    Suicidal ideation by BDI

  4. Life-threatening conditions

    Time frame: 6, 12 and 24 months

    Life-threatening conditions by register data

Sponsors and collaborators

Lead sponsor

Amager Hospital

Other

Collaborators

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

Registry information

Official study title

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

Acronym: IBBIS

Important dates

Study start
2016
Primary completion
2019
Study completion
2020
First posted
Aug 31, 2016
Registry last updated
Feb 4, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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