- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02872051
Integrated Mental Health Care and Vocational Rehabilitation to Individuals on Sick Leave Due to Anxiety and Depression (IBBIS)
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
Study Overview
Status
Conditions
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Capital Region Of Denmark
-
Copenhagen, Capital Region Of Denmark, Denmark, 2100
- Mental Health Services of the Capital Region of Denmark
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 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
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 job center case managers to be dangerous
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
No Intervention: Control
Standard treatment and standard vocational rehabilitation
|
|
Experimental: IBBIS MHC
IBBIS mental health care and standard vocational rehabilitation
|
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 |
Experimental: IBBIS integrated MCH and VR
Integrated mental health care and vocational rehabilitation
|
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 |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Time to return to work
Time Frame: 12 months
|
Time from baseline to first return to work for more than four consecutive weeks
|
12 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Work
Time Frame: 12 months
|
Competitive work 12 months after baseline (yes/no)
|
12 months
|
Time to return to work
Time Frame: 24 months
|
Time from baseline to first return to work for more than four consecutive weeks
|
24 months
|
Recurrent Sickness Absence
Time Frame: 24 months
|
Time from baseline to recurrent sickness absence for more than 8 weeks
|
24 months
|
Degree of depressive symptoms
Time Frame: 6 months
|
Self-assessed depressive symptoms by the Beck Depression Inventory (BDI)
|
6 months
|
Degree of anxiety symptoms
Time Frame: 6 months
|
Self-assessed anxiety symptoms by the Beck Anxiety Inventory (BAI)
|
6 months
|
Degree of psychological stress symptoms
Time Frame: 6 months
|
Self-assessed psychological stress by the Cohen perceived stress scale (PSS)
|
6 months
|
Work and social functioning
Time Frame: 6 months
|
Work and social functioning by the Work and Social Adjustment Scale (WSAS)
|
6 months
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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)
|
6, 12 and 24 months
|
Death
Time Frame: 6, 12 and 24 months
|
Death and cause of death by register data
|
6, 12 and 24 months
|
Suicidal ideation
Time Frame: 6, 12 and 24 months
|
Suicidal ideation by BDI
|
6, 12 and 24 months
|
Life-threatening conditions
Time Frame: 6, 12 and 24 months
|
Life-threatening conditions by register data
|
6, 12 and 24 months
|
Collaborators and Investigators
Publications and helpful links
General Publications
- 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. Erratum In: Occup Environ Med. 2022 Aug;79(8):e5.
- 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.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimated)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- IBBIS Anxiety Depression
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Depression
-
ProgenaBiomeRecruitingDepression | Depression, Postpartum | Depression, Anxiety | Depression Moderate | Depression Severe | Clinical Depression | Depression in Remission | Depression, Endogenous | Depression ChronicUnited States
-
Washington University School of MedicineCompletedTreatment Resistant Depression | Late Life Depression | Geriatric Depression | Refractory Depression | Therapy-Resistant DepressionUnited States, Canada
-
Kintsugi Mindful Wellness, Inc.Sonar Strategies; Vituity PsychiatryRecruitingDepression | Depression Moderate | Depression Severe | Depression MildUnited States
-
University of California, San FranciscoRecruitingDepression Moderate | Depression Mild | Depression, TeenUnited States
-
University GhentUniversiteit Antwerpen; Janssen-Cilag Ltd.RecruitingDepression Moderate | Depression Severe | Depression MildBelgium
-
Baylor College of MedicineUniversity of TexasRecruitingDepression | Depression Moderate | Depression Severe | Suicide and Self-harm | Depression in Adolescence | Depression MildUnited States
-
University of Cape TownNational Institute of Mental Health (NIMH)CompletedPostpartum Depression | Clinical Depression | Moderate DepressionSouth Africa
-
Washington University School of MedicinePatient-Centered Outcomes Research Institute; National Institute of Mental...CompletedMajor Depressive Disorder | Treatment Resistant Depression | Treatment-Refractory Depression | Late Life Depression | Geriatric DepressionUnited States, Canada
-
Northern Illinois UniversityUniversity Autonoma de Santo DomingoTerminatedDepression Moderate | Depression MildUnited States, Dominican Republic
-
Gerbera Therapeutics, Inc.Not yet recruitingPostpartum Depression | Depression, Postpartum | Postnatal Depression | Post-partum Depression | Post-Natal DepressionUnited States
Clinical Trials on IBBIS mental health care and standard vocational rehabilitation
-
Mental Health Services in the Capital Region, DenmarkCopenhagen Municipality, Denmark; Municipality of Lyngby-Taarbæk, Denmark; Gladsaxe... and other collaboratorsCompletedBurnout | Adjustment Disorder | Psychological StressDenmark
-
White River Junction Veterans Affairs Medical CenterVHA Office of Rural HealthRecruitingSuicide PreventionUnited States
-
Duke UniversityKilimanjaro Christian Medical Centre, TanzaniaCompletedHIV | Mental Health | Health BehaviorTanzania
-
University of California, San FranciscoNational Institute of Mental Health (NIMH)Recruiting
-
University of TromsoThe Royal Norwegian Ministry of HealthActive, not recruiting
-
University of Cape TownKing's College London; University of KwaZuluCompletedDepression | HIV/AIDS | Chronic Diseases of LifestyleSouth Africa
-
The University of Texas Health Science Center,...US Department of Health and Human Services, Administration on Community LivingRecruitingDepression in Old AgeUnited States
-
University of KonstanzVivo international e.V.RecruitingPsychiatric Disorders From Chapters 3 and 4 of ICD10Germany
-
Dartmouth-Hitchcock Medical CenterNational Institute of Mental Health (NIMH)CompletedSchizophrenia | Schizoaffective Disorder | Bipolar Disorder | Major DepressionUnited States
-
Mental Health Services in the Capital Region, DenmarkEnrolling by invitationSchizophrenia Spectrum and Other Psychotic DisordersDenmark