Integrated Mental Health Care and Vocational Rehabilitation to People With to Common Mental Disorders

Study Overview
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Brief Summary
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The purpose of this study is to investigate the efficacy of an integrated mental health care and vocational rehabilitation intervention for people on sick leave because of depression, stress, anxiety, personality- and functional disorders in Denmark

Detailed Description
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Background: Mental illness has an estimated financial burden on the Danish economy of 3.4 % of Gross National Product every year due to lost productivity, social benefits and healthcare costs and approximately 50 % of people receiving long-term sickness benefits have a common mental illness. Furthermore, a significant treatment gap exists where less than 30% were treated for their mental illness. Objective: The primary objective of the randomized trial is to examine whether people on sick leave with a diagnosis of anxiety, depression, stress, personality disorders or functional disorders, return to work faster and have a higher job retention if they receive an integrated and optimized vocational rehabilitation and mental health care intervention, compared to people who receive the standard mental health care and vocational rehabilitation service. Method: The trial is designed as an randomized, two-group parallel, assessor-blinded, multisite trial. A total of 800 participants with a common mental illness will randomly be assigned into two groups 1) IBBIS II, consisting of an integrated mental health care and vocational rehabilitation; or 2) Service as usual, at two sites in Denmark. The primary outcome is difference between the two groups in time to 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 Intervention to Individuals on Sick Leave Due to Anxiety, Depression, Personality Disorders, Stress and Functional Disorders

Conditions
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Anxiety, Common Mental Disorders, Depression, Personality Disorders, Functional Disease Present, Stress

Intervention / Treatment
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* Behavioral: IBBIS II
* Behavioral: Service as Usual


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: - Inclusion criteria Anxiety, depression, stress, personality disorder or functional disorder diagnosed at a structured diagnostic interview based on the Mini International Neuropsychiatric Interview conducted by the IBBIS team Sickness benefit recipient at baseline; on sick leave from job or unemployed for a minimum of four weeks Resident in Copenhagen or Aarhus municipalities Speak sufficient Danish to participate in interviews and complete questionnaires without an interpreter Aged 18 or older Has given informed written consent Exclusion Criteria: Pregnant High degree of suicidal ideation Dementia Abuse of alcohol or other drugs to the degree that participation in therapy is not possible A need for mental health treatment in secondary sector care Unstable somatic condition that is too severe for participation in the project The participant will not refrain from participating in other psychotherapeutic treatment outside the IBBIS project if the participant will be allocated to the experimental group

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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Accepts Healthy Volunteers

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 |
| --- | --- |
| Experimental: IBBIS II<br>Integrated Mental Health Care and Vocational Rehabilitation | Behavioral: IBBIS II<br>* The IBBIS-II service consists of: Mental health assessment. Planned integrated service. The participant has the same employment specialists and care manager throughout the intervention. A joint plan is made with shared decisions between the participant, the employment specialist and the care manager. There is a focus on disclosure (openness about illness) and involvement of relatives and significant others. Vocational rehabilitation. Focus on return to work with ongoing assessment of job goals, competencies and need of support. Participants receive help in contacting existing employers (employed) and potential employers (unemployed). Unemployed participants are offered an individualized job search effort. The focus is on competitive jobs within the community. Treatment consists of stepped care with structured treatment guidelines. When the participant has obtained work the team continues to offer support.<br>|
| Active Comparator: Service As Usual<br>Standard vocational rehabilitation and treatment | Behavioral: Service as Usual<br>* Service as usual consists of standard mental health care and vocational rehabilitation<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Return to work | Difference between the two groups in time to return to work from baseline until 12 months after baseline measured whit register based data. Time to return to work is defined as a minimum of four weeks of continuous work without receiving sickness benefit. | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Work at one point during follow-up | Proportion in unsupported competitive work at 6 and 12-months follow up | 12 months | 
| Return to work | Time to return to work from baseline until 6 months after baseline measured whit register based data | 6 months | 
| Supported work at one point during follow-up | Proportion in supported work at 6 and 12-months follow up | 12 months | 
| Weeks of work | Number of weeks in competitive employment from baseline to 6 and 12 months | 12 months | 
| Time to new sick leave | The duration from return to work to potential new sick leave of more than 4 weeks within the 12-month follow-up period | 12 months | 
| Income | Salary income from competitive employment at 6 and 12 months after baseline | 12 months | 
| Use of psychiatric services | Number of admissions, inpatient days and outpatient contacts at the psychiatric hospitals at 6- and 12-months follow-up | 12 months | 
| Use of somatic services | Number of admissions, inpatient days and outpatient contacts at the somatic hospitals at 6- and 12-months follow-up | 12 months | 
| Use of private health care | Number of contacts with private health care professionals under the Health Insurance | 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Vocational rehabilitation, Mental health services, Return to Work