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

Study Overview
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Brief Summary
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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

Detailed Description
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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.

Official Title
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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

Conditions
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Generalized Anxiety, Social Phobia, Panic Disorder, Depression

Intervention / Treatment
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* Behavioral: IBBIS mental health care and standard vocational rehabilitation
* Other: Integrated mental health care and vocational rehabilitation


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Control<br>Standard treatment and standard vocational rehabilitation | |
| Experimental: IBBIS MHC<br>IBBIS mental health care and standard vocational rehabilitation | Behavioral: IBBIS mental health care and standard vocational rehabilitation<br>* 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<br>|
| Experimental: IBBIS integrated MCH and VR<br>Integrated mental health care and vocational rehabilitation | Other: Integrated mental health care and vocational rehabilitation<br>* 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<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to return to work | 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 | Competitive work 12 months after baseline (yes/no) | 12 months | 
| Time to return to work | Time from baseline to first return to work for more than four consecutive weeks | 24 months | 
| Recurrent Sickness Absence | Time from baseline to recurrent sickness absence for more than 8 weeks | 24 months | 
| Degree of depressive symptoms | Self-assessed depressive symptoms by the Beck Depression Inventory (BDI) | 6 months | 
| Degree of anxiety symptoms | Self-assessed anxiety symptoms by the Beck Anxiety Inventory (BAI) | 6 months | 
| Degree of psychological stress symptoms | Self-assessed psychological stress by the Cohen perceived stress scale (PSS) | 6 months | 
| Work and social functioning | Work and social functioning by the Work and Social Adjustment Scale (WSAS) | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Vocational Rehabilitation, Anxiety, Depression, Common Mental Disorders, Cognitive Behavior Therapy, Return to Work, Mental Health Services, Integration