Integrated Mental Health Care and Vocational Rehabilitation to Individuals on Sick Leave Due to Stress Disorders

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 (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
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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.

Official Title
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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

Conditions
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Adjustment Disorder, Burnout, Psychological Stress

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


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 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 Jobcentre 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 Stress-coaching Mindfulness-based stress reduction Monitoring and re-assessment<br>|
| Experimental: IBBIS integrated MCH and VR<br>Integrated mental health care and vocational rehabilitation | Behavioral: 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 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<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 anxiety symptoms by the Beck Anxiety 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, Common Mental Disorders, Return to Work, Mental Health Services, Psychological Stress, Adjustment Disorder, Burnout, Integration, Cognitive Behavior Therapy