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Completed

NCT Number: NCT04432129

Integrated Mental Health Care and Vocational Rehabilitation to People With to Common Mental Disorders

The purpose of this study is to investigate the efficacy of an integrated mental health care and vocational rehabilitation intervention for people on sick leave because of depression, stress, anxiety, personality- and functional disorders 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

Copenhagen Research Center for Mental Health - CORE

Copenhagen, 2900, Denmark

About this study

Background:

Mental illness has an estimated financial burden on the Danish economy of 3.4 % of Gross National Product every year due to lost productivity, social benefits and healthcare costs and approximately 50 % of people receiving long-term sickness benefits have a common mental illness. Furthermore, a significant treatment gap exists where less than 30% were treated for their mental illness.

Objective:

The primary objective of the randomized trial is to examine whether people on sick leave with a diagnosis of anxiety, depression, stress, personality disorders or functional disorders, return to work faster and have a higher job retention if they receive an integrated and optimized vocational rehabilitation and mental health care intervention, compared to people who receive the standard mental health care and vocational rehabilitation service.

Method:

The trial is designed as an randomized, two-group parallel, assessor-blinded, multisite trial. A total of 800 participants with a common mental illness will randomly be assigned into two groups 1) IBBIS II, consisting of an integrated mental health care and vocational rehabilitation; or 2) Service as usual, at two sites in Denmark. The primary outcome is difference between the two groups in time to 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: Yes

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

Inclusion criteria

  • Inclusion criteria
  • Anxiety, depression, stress, personality disorder or functional disorder diagnosed at a structured diagnostic interview based on the Mini International Neuropsychiatric Interview conducted by the IBBIS team
  • Sickness benefit recipient at baseline; on sick leave from job or unemployed for a minimum of four weeks
  • Resident in Copenhagen or Aarhus municipalities
  • Speak sufficient Danish to participate in interviews and complete questionnaires without an interpreter
  • Aged 18 or older
  • Has given informed written consent

Exclusion criteria

  • Pregnant
  • High degree of suicidal ideation
  • Dementia
  • Abuse of alcohol or other drugs to the degree that participation in therapy is not possible
  • A need for mental health treatment in secondary sector care
  • Unstable somatic condition that is too severe for participation in the project
  • The participant will not refrain from participating in other psychotherapeutic treatment outside the IBBIS project if the participant will be allocated to the experimental group

Treatment and study plan

IBBIS II

Behavioral

The IBBIS-II service consists of:

  • Mental health assessment.
  • Planned integrated service. The participant has the same employment specialists and care manager throughout the intervention. A joint plan is made with shared decisions between the participant, the employment specialist and the care manager. There is a focus on disclosure (openness about illness) and involvement of relatives and significant others.
  • Vocational rehabilitation. Focus on return to work with ongoing assessment of job goals, competencies and need of support. Participants receive help in contacting existing employers (employed) and potential employers (unemployed). Unemployed participants are offered an individualized job search effort. The focus is on competitive jobs within the community.
  • Treatment consists of stepped care with structured treatment guidelines.
  • When the participant has obtained work the team continues to offer support.

Service as usual

Behavioral

Service as usual consists of standard mental health care and vocational rehabilitation

Primary outcomes

  1. Return to work

    Time frame: 12 months

    Difference between the two groups in time to return to work from baseline until 12 months after baseline measured whit register based data. Time to return to work is defined as a minimum of four weeks of continuous work without receiving sickness benefit.

Secondary outcomes

  1. Work at one point during follow-up

    Time frame: 12 months

    Proportion in unsupported competitive work at 6 and 12-months follow up

  2. Return to work

    Time frame: 6 months

    Time to return to work from baseline until 6 months after baseline measured whit register based data

  3. Supported work at one point during follow-up

    Time frame: 12 months

    Proportion in supported work at 6 and 12-months follow up

  4. Weeks of work

    Time frame: 12 months

    Number of weeks in competitive employment from baseline to 6 and 12 months

  5. Time to new sick leave

    Time frame: 12 months

    The duration from return to work to potential new sick leave of more than 4 weeks within the 12-month follow-up period

  6. Income

    Time frame: 12 months

    Salary income from competitive employment at 6 and 12 months after baseline

  7. Use of psychiatric services

    Time frame: 12 months

    Number of admissions, inpatient days and outpatient contacts at the psychiatric hospitals at 6- and 12-months follow-up

  8. Use of somatic services

    Time frame: 12 months

    Number of admissions, inpatient days and outpatient contacts at the somatic hospitals at 6- and 12-months follow-up

  9. Use of private health care

    Time frame: 12 months

    Number of contacts with private health care professionals under the Health Insurance

Sponsors and collaborators

Lead sponsor

Amager Hospital

Other

Collaborators

  • Aarhus Kommune
  • Central Denmark Region
  • Københavns Kommune
  • The Danish Agency for Labour Market and Recruitment

Registry information

Official study title

Integrated Mental Health Care and Vocational Rehabilitation Intervention to Individuals on Sick Leave Due to Anxiety, Depression, Personality Disorders, Stress and Functional Disorders

Acronym: IBBIS II

Important dates

Study start
2020
Primary completion
2022
Study completion
2022
First posted
Jun 16, 2020
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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