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

Depression Clinical Trial

— IBBIS II  

Official title:

Integrated Mental Health Care and Vocational Rehabilitation Intervention to Individuals on Sick Leave Due to Anxiety, Depression, Personality Disorders, Stress and Functional Disorders

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04432129
• Other study ID #: Version 3.1. 27.5.2020
• Status: Completed
• Phase: N/A
• Start date: June 9, 2020
• Est. completion date: October 1, 2022

Study information

• Verified date: February 2024
• Source: Mental Health Services in the Capital Region, Denmark
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 900
• Est. completion date: October 1, 2022
• Est. primary completion date: October 1, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Anxiety
• Common Mental Disorders
• Depression
• Functional Disease Present
• Mental Disorders
• Personality Disorders
• Psychotic Disorders
• Stress

Intervention

Behavioral:
• IBBIS II
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.
• Service as Usual
Service as usual consists of standard mental health care and vocational rehabilitation

Locations

Country	Name	City	State
Denmark	Copenhagen Research Center for Mental Health - CORE	Copenhagen

Sponsors (5)

Lead Sponsor	Collaborator
Mental Health Services in the Capital Region, Denmark	Aarhus Kommune, Central Denmark Region, Københavns Kommune, The Danish Agency for Labour Market and Recruitment

Country where clinical trial is conducted

Denmark, 

References & Publications (1)

Christensen TN, Poulsen CH, Ebersbach BK, Eplov LF. Integrated mental health care and vocational rehabilitation intervention to improve return to work rates for people on sick leave due to common mental and functional disorders (IBBIS-II)-a study protocol for a randomized clinical trial. Trials. 2022 Sep 30;23(1):820. doi: 10.1186/s13063-022-06718-7. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Work at one point during follow-up	Proportion in unsupported competitive work at 6 and 12-months follow up	12 months
Secondary	Return to work	Time to return to work from baseline until 6 months after baseline measured whit register based data	6 months
Secondary	Supported work at one point during follow-up	Proportion in supported work at 6 and 12-months follow up	12 months
Secondary	Weeks of work	Number of weeks in competitive employment from baseline to 6 and 12 months	12 months
Secondary	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
Secondary	Income	Salary income from competitive employment at 6 and 12 months after baseline	12 months
Secondary	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
Secondary	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
Secondary	Use of private health care	Number of contacts with private health care professionals under the Health Insurance	12 months

External Links

•   study protocol article