Integrated Mental Health Care and Vocational Rehabilitation to People With to Common Mental Disorders (IBBIS II)

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

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

Study Overview

• Status: Completed
• Conditions: Personality Disorders; Depression; Stress; Anxiety; Common Mental Disorders; Functional Disease Present
• Intervention / Treatment: Behavioral: IBBIS II; Behavioral: Service as Usual

Detailed 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.

• Study Type: Interventional
• Enrollment (Actual): 900
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Denmark
  • Copenhagen, Denmark, 2900
    • Copenhagen Research Center for Mental Health - CORE

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: IBBIS II; Integrated Mental Health Care and Vocational Rehabilitation	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.
Active Comparator: Service As Usual; Standard vocational rehabilitation and treatment	Behavioral: Service as Usual; Service as usual consists of standard mental health care and vocational rehabilitation

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Mental Health Services in the Capital Region, Denmark
• Collaborators: Central Denmark Region; Københavns Kommune; The Danish Agency for Labour Market and Recruitment; Aarhus Kommune
• Investigators: Principal Investigator: Lene F Eplov, PhD, Mental Health Center Copenhagen

Publications and helpful links

General Publications

• 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.

Helpful Links

• study protocol article

Study record dates

Study Major Dates

• Study Start (Actual): June 9, 2020
• Primary Completion (Actual): October 1, 2022
• Study Completion (Actual): October 1, 2022

Study Registration Dates

• First Submitted: June 9, 2020
• First Submitted That Met QC Criteria: June 11, 2020
• First Posted (Actual): June 16, 2020

Study Record Updates

• Last Update Posted (Actual): February 7, 2024
• Last Update Submitted That Met QC Criteria: February 6, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Keywords: Vocational rehabilitation; Mental health services; Return to Work
• Additional Relevant MeSH Terms: Behavioral Symptoms; Schizophrenia Spectrum and Other Psychotic Disorders; Personality Disorders; Depression; Psychotic Disorders; Mental Disorders
• Other Study ID Numbers: Version 3.1. 27.5.2020

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Individual participant data will not be publicly available due to legal restrictions from the Danish data protection agency and the European data protection regulation

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No