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Common Mental DisordersIBBIS IINCT04432129

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

A study testing IBBIS II and Service as Usual in people with Common Mental Disorders and Depression, run by Amager Hospital at 1 site in Denmark.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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 Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
Common Mental Disorders, Depression, Anxiety
What is being tested?
IBBIS II and Service as Usual
Could I receive a placebo?
No, everyone receives an active treatment
How many people
900 participants
Where
1 siteDenmark
Study dates
9 Jun 2020to 1 Oct 2022
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

Denmark1 site

  • Copenhagen Research Center for Mental Health - CORE

    Copenhagen, 2900

Other trials in Denmark

About this study

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

Read the detailed description

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.

Being tested
IBBIS II, Service as Usual
Keywords
Vocational rehabilitation, Mental health services, Return to Work
Medical subject headings
Depression, Anxiety Disorders, Personality Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • IBBIS IIBehavioural

    The IBBIS-II service consists of:

    1. Mental health assessment.
    2. 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.
    3. 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.
    4. Treatment consists of stepped care with structured treatment guidelines.
    5. When the participant has obtained work the team continues to offer support.

  • Service as UsualBehavioural

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

Study groups in NCT04432129
Study groupRoleWhat they receive
IBBIS IIExperimentalIntegrated Mental Health Care and Vocational Rehabilitation
Receives: Behavioral: IBBIS II
Service As UsualActive comparatorStandard vocational rehabilitation and treatment
Receives: Behavioral: Service as Usual

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Return to work

    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.

    Measured: 12 months

Secondary outcomes (9)

  1. Work at one point during follow-up

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

    Measured: 12 months

  2. Return to work

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

    Measured: 6 months

  3. Supported work at one point during follow-up

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

    Measured: 12 months

  4. Weeks of work

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

    Measured: 12 months

  5. Time to new sick leave

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

    Measured: 12 months

  6. Income

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

    Measured: 12 months

  7. Use of psychiatric services

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

    Measured: 12 months

  8. Use of somatic services

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

    Measured: 12 months

  9. Use of private health care

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

    Measured: 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 Jun 2020
  2. Study start9 Jun 2020
  3. Primary completion1 Oct 2022
  4. Study completion1 Oct 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Other
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Investigator, Outcomes assessor
Enrolment
900 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04432129
Sponsor's protocol ID
Version 3.1. 27.5.2020
Acronym
IBBIS II
Status last verified
Feb 2026
First submitted
9 Jun 2020
Last updated
4 Feb 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: Individual participant data will not be publicly available due to legal restrictions from the Danish data protection agency and the European data protection regulation

Publications

  • Christensen TN, Poulsen CH, Ebersbach BK, Eplov LF. Integrated mental health care and vocational rehabilitation intervention to improve return to work rates for people on sick leave due to common mental and functional disorders (IBBIS-II)-a study protocol for a randomized clinical trial. Trials. 2022 Sep 30;23(1):820. doi: 10.1186/s13063-022-06718-7.

    PubMed 36175977

  • Christensen TN, Hjorthoj C, Poulsen CH, Ebersbach B, Eplov LF. Integrated mental health care and vocational rehabilitation intervention to improve return to work rates for people on sick leave due to common mental and functional disorders (IBBIS-II) - results from a randomized clinical trial. Nord J Psychiatry. 2025 Jan;79(1):86-95. doi: 10.1080/08039488.2024.2446362. Epub 2025 Jan 6.

    PubMed 39760219

Questions about this trial

What is this clinical trial studying?

A study testing IBBIS II and Service as Usual in people with Common Mental Disorders and Depression, run by Amager Hospital at 1 site in Denmark.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 4 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Return to work (time frame: 12 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04432129, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Feb 2026.

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