Adjustment DisorderIBBISNCT02885519
Integrated Mental Health Care and Vocational Rehabilitation to Individuals on Sick Leave Due to Stress Disorders
A study testing IBBIS mental health care and standard vocational rehabilitation and Integrated mental health care and vocational rehabilitation in people with Adjustment Disorder and Burnout, run by Amager Hospital at 1 site in Denmark.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Adjustment Disorder, Burnout, Psychological Stress
- What is being tested?
- IBBIS mental health care and standard vocational rehabilitation and Integrated mental health care and vocational rehabilitation
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 631 participants
- Where
- 1 siteDenmark
- Study dates
- Apr 2016to Jun 2020
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 10Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Mental Health Services of the Capital Region of Denmark
Copenhagen, Capital Region of Denmark, 2100
About this study
Official 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
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
Read the 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
- Being tested
- IBBIS mental health care and standard vocational rehabilitation, Integrated mental health care and vocational rehabilitation
- Keywords
- Vocational Rehabilitation, Common Mental Disorders, Return to Work, Mental Health Services, Psychological Stress, Adjustment Disorder, Burnout, Integration, Cognitive Behavior Therapy
- Medical subject headings
- Adjustment Disorders, Burnout, Psychological, Stress, Psychological
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IBBIS mental health care and standard vocational rehabilitationBehavioural
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 rehabilitationBehavioural
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
| Study group | Role | What they receive |
|---|---|---|
| Control | No intervention | Standard treatment and standard vocational rehabilitation |
| IBBIS MHC | Experimental | IBBIS mental health care and standard vocational rehabilitation Receives: Behavioral: IBBIS mental health care and standard vocational rehabilitation |
| IBBIS integrated MCH and VR | Experimental | Integrated mental health care and vocational rehabilitation Receives: Behavioral: Integrated mental health care and vocational rehabilitation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to return to work
Time from baseline to first return to work for more than four consecutive weeks
Measured: 12 months
Secondary outcomes (7)
Work
Competitive work 12 months after baseline (yes/no)
Measured: 12 months
Time to return to work
Time from baseline to first return to work for more than four consecutive weeks
Measured: 24 months
Recurrent Sickness Absence
Time from baseline to recurrent sickness absence for more than 8 weeks
Measured: 24 months
Degree of depressive symptoms
Self-assessed anxiety symptoms by the Beck Anxiety Inventory (BDI)
Measured: 6 months
Degree of anxiety symptoms
Self-assessed anxiety symptoms by the Beck Anxiety Inventory (BAI)
Measured: 6 months
Degree of psychological stress symptoms
Self-assessed psychological stress by the Cohen perceived stress scale (PSS)
Measured: 6 months
Work and social functioning
Work and social functioning by the Work and Social Adjustment Scale (WSAS)
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Aug 2016 (estimated)
- Study startApr 2016
- Primary completionJun 2019
- Study completionJun 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Adjustment DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- 631 participants (actual)
Sponsor and investigators
- Lead sponsor
- Amager Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- The Danish Agency for Labour Market and Recruitment, Copenhagen Municipality, Denmark, Gentofte Municipality, Denmark, Municipality of Lyngby-Taarbæk, Denmark, Gladsaxe Municipality, Denmark
- Responsible party
- Principal investigator, Lene Falgaard Eplov, Amager Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02885519
- Sponsor's protocol ID
- IBBIS Stress
- Acronym
- IBBIS
- Status last verified
- Feb 2026
- First submitted
- 15 Aug 2016
- Last updated
- 4 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 36871310Poulsen 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.
PubMed 29197404
Study at a glance
From the registry record, last updated by the sponsor on 4 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT02885519
- Acronym / sponsor ID
- IBBIS / IBBIS Stress
- Conditions
- Adjustment Disorder, Burnout, Psychological Stress
- Keywords
- Vocational Rehabilitation, Common Mental Disorders, Return to Work, Mental Health Services, Psychological Stress, Adjustment Disorder, Burnout, Integration
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 631 participants (actual)
- Lead sponsor
- Amager HospitalUniversity, hospital or other
- Collaborators
- The Danish Agency for Labour Market and Recruitment, Copenhagen Municipality, Denmark, Gentofte Municipality, Denmark, Municipality of Lyngby-Taarbæk, Denmark, Gladsaxe Municipality, Denmark
- Study start
- Apr 2016 (actual)
- Primary completion
- Jun 2019 (actual)
- Study completion
- Jun 2020 (actual)
- First posted
- 31 Aug 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | –Standard treatment and standard vocational rehabilitation |
| IBBIS MHC | Experimental | Behavioral: IBBIS mental health care and standard vocational rehabilitationIBBIS mental health care and standard vocational rehabilitation |
| IBBIS integrated MCH and VR | Experimental | Behavioral: Integrated mental health care and vocational rehabilitationIntegrated mental health care and vocational rehabilitation |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| IBBIS mental health care and standard vocational rehabilitationStandard 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 | Behavioural | IBBIS MHC |
| Integrated mental health care and vocational rehabilitationIntegrated 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 | Behavioural | IBBIS integrated MCH and VR |
Primary outcome
Time to return to work
Time frame: 12 months
Time from baseline to first return to work for more than four consecutive weeks
7 secondary outcomes
Work
Time frame: 12 months
Time to return to work
Time frame: 24 months
Recurrent Sickness Absence
Time frame: 24 months
Degree of depressive symptoms
Time frame: 6 months
Degree of anxiety symptoms
Time frame: 6 months
Degree of psychological stress symptoms
Time frame: 6 months
Work and social functioning
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Feb 2026.
- Derived from this study: PubMed 36871310Hoff 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.
- Derived from this study: PubMed 29197404Poulsen 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing IBBIS mental health care and standard vocational rehabilitation and Integrated mental health care and vocational rehabilitation in people with Adjustment Disorder and Burnout, 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 5 inclusion and 10 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?
Time to 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 NCT02885519, 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.