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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04432129
Other study ID # Version 3.1. 27.5.2020
Secondary ID
Status Completed
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


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
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