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

Not Applicable

Completed

• Conditions: Personality Disorders; Depression; Anxiety; Stress; Common Mental Disorders; Functional Disease Present
• Interventions: Behavioral: Service as Usual; Behavioral: IBBIS II

• Registration Number: NCT04432129
• Lead Sponsor: Mental Health Services in the Capital Region, Denmark

Brief 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

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 Timeline

• Study Start: 2020-06-09
• Study First Submitted: 2020-06-09
• Study First Submitted QC: 2020-06-11
• Study First Posted: 2020-06-16
• Primary Completion: 2022-10-01
• Study Completion: 2022-10-01
• Status Verified: 2024-02
• Last Update Submitted: 2024-11-20
• Last Update Posted: 2024-11-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 900

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Service As Usual	Service as Usual	Standard vocational rehabilitation and treatment
IBBIS II	IBBIS II	Integrated Mental Health Care and Vocational Rehabilitation

Primary Outcome Measures

Name	Time	Method
Return to work	12 months	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.

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Copenhagen Research Center for Mental Health - CORE; 🇩🇰 Copenhagen, Denmark