Generalized AnxietyIBBISNCT02872051

Integrated Mental Health Care and Vocational Rehabilitation to Individuals on Sick Leave Due to Anxiety and Depression

A study testing IBBIS mental health care and standard vocational rehabilitation and Integrated mental health care and vocational rehabilitation in people with Generalized Anxiety and Social Phobia, 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 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 depression and anxiety in Denmark Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Generalized Anxiety, Social Phobia, Panic Disorder
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

Depression, Generalized Anxiety, Social Phobia or Panic Disorder according to Mini International Neuropsychiatric Interview (MINI)
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 job center 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

Other trials in Denmark

About this study

Official title: Integrated Mental Health Care and Vocational Rehabilitation to Individuals on Sick Leave Due to Anxiety and Depression in Denmark (the Danish IBBIS Study): A Multi-center Randomized Controlled Trial

Read the detailed description

Background:

Depression and anxiety are important contributors to the global burden of disease and causes negative effects on both the individual and society. Depression and anxiety are very likely to influence the individual's workability and up to 40 % of the people on sick leave in Denmark have common mental disorders like depression and anxiety. 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 examine 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 depression and anxiety 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 depression and anxiety 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: Generalized Anxiety, Social Phobia, Panic Disorder, Depression
Being tested: IBBIS mental health care and standard vocational rehabilitation, Integrated mental health care and vocational rehabilitation
Keywords: Vocational Rehabilitation, Anxiety, Depression, Common Mental Disorders, Cognitive Behavior Therapy, Return to Work, Mental Health Services, Integration
Medical subject headings: Generalized Anxiety Disorder, Phobia, Social, Panic Disorder, Depression, Anxiety Disorders

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 Cognitive-behavior Therapy Monitoring and reassessment
Integrated mental health care and vocational rehabilitationOther
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 Cognitive-behavior Therapy Monitoring and reassessment
Vocational rehabilitation is inspired by Individual Placement and Support and is a workplace-oriented intervention with problem-solving conversations as a core element

Study groups in NCT02872051
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: Other: 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 depressive symptoms by the Beck Depression 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.

Apr 2016Jun 2020

First posted18 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 (3)Papers the sponsor has linked to this study.
Other trials for Generalized AnxietyStudies 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)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02872051
Sponsor's protocol ID: IBBIS Anxiety Depression
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, Christensen U, Bojesen AB, Eplov LF. Integrated Mental Healthcare and Vocational Rehabilitation for People on Sick Leave with Anxiety or Depression: 24-Month Follow-up of the Randomized IBBIS Trial. J Occup Rehabil. 2023 Sep;33(3):570-580. doi: 10.1007/s10926-023-10094-7. Epub 2023 Feb 27.
PubMed 36849841
Hoff A, Poulsen RM, Fisker J, Hjorthoj C, Rosenberg N, Nordentoft M, Bojesen AB, Eplov LF. Integrating vocational rehabilitation and mental healthcare to improve the return-to-work process for people on sick leave with depression or anxiety: results from a three-arm, parallel randomised trial. Occup Environ Med. 2022 Feb;79(2):134-142. doi: 10.1136/oemed-2021-107894. Epub 2021 Dec 16.
PubMed 34916330
Poulsen R, Hoff A, Fisker J, Hjorthoj C, Eplov LF. Integrated mental health care and vocational rehabilitation to improve return to work rates for people on sick leave because of depression and anxiety (the Danish IBBIS trial): study protocol for a randomized controlled trial. Trials. 2017 Dec 2;18(1):578. doi: 10.1186/s13063-017-2272-1.
PubMed 29197414

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Generalized Anxiety trials

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 Anxiety and Depression in Denmark (the Danish IBBIS Study): A Multi-center Randomized Controlled Trial
ClinicalTrials.gov ID: NCT02872051
Acronym / sponsor ID: IBBIS / IBBIS Anxiety Depression
Conditions: Generalized Anxiety, Social Phobia, Panic Disorder, Depression
Keywords: Vocational Rehabilitation, Anxiety, Depression, Common Mental Disorders, Cognitive Behavior Therapy, Return to Work, Mental Health Services, 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: 18 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.

Detailed description

Background:

Objective:

Method:

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	Other: 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)

Depression, Generalized Anxiety, Social Phobia or Panic Disorder according to Mini International Neuropsychiatric Interview (MINI)
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 Cognitive-behavior Therapy Monitoring and reassessment	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 Cognitive-behavior Therapy Monitoring and reassessment Vocational rehabilitation is inspired by Individual Placement and Support and is a workplace-oriented intervention with problem-solving conversations as a core element	Other	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 36849841Hoff A, Poulsen RM, Fisker JP, Hjorthoj C, Nordentoft M, Christensen U, Bojesen AB, Eplov LF. Integrated Mental Healthcare and Vocational Rehabilitation for People on Sick Leave with Anxiety or Depression: 24-Month Follow-up of the Randomized IBBIS Trial. J Occup Rehabil. 2023 Sep;33(3):570-580. doi: 10.1007/s10926-023-10094-7. Epub 2023 Feb 27.
Derived from this study: PubMed 34916330Hoff A, Poulsen RM, Fisker J, Hjorthoj C, Rosenberg N, Nordentoft M, Bojesen AB, Eplov LF. Integrating vocational rehabilitation and mental healthcare to improve the return-to-work process for people on sick leave with depression or anxiety: results from a three-arm, parallel randomised trial. Occup Environ Med. 2022 Feb;79(2):134-142. doi: 10.1136/oemed-2021-107894. Epub 2021 Dec 16.
Derived from this study: PubMed 29197414Poulsen R, Hoff A, Fisker J, Hjorthoj C, Eplov LF. Integrated mental health care and vocational rehabilitation to improve return to work rates for people on sick leave because of depression and anxiety (the Danish IBBIS trial): study protocol for a randomized controlled trial. Trials. 2017 Dec 2;18(1):578. doi: 10.1186/s13063-017-2272-1.
Individual participant dataSharing planned: Undecided

Related trials for Generalized Anxiety

Recruiting
Effect of a Brief Daily Digital Meditation on Well-Being in US Young Adults (BEGIN II)
Mental Health and General Well-being
RecruitingObservational study
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Depressive Disorder, Major, Generalized Anxiety Disorder
Active, not recruitingObservational study
BreathinG-induced Myocardial and Cerebral Perfusion in Anxiety Disorders
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RecruitingPhase 3
A Study to Asses Safety and Tolerability of ITI-1284 Given Alone or as an Additional Treatment in Participants With Generalized Anxiety Disorder (GAD)
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RecruitingPhase 3
A Study of JNJ-99245354 (ITI-1284) as an Adjunctive Treatment in Participants With Generalized Anxiety Disorder (GAD) Who Have an Inadequate Response to GAD Treatment
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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?

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 NCT02872051, which also lists 3 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.