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

Primary Purpose

Common Mental Disorders, Depression, Anxiety

Status
Completed
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
IBBIS II
Service as Usual
Sponsored by
Mental Health Centre Copenhagen
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Common Mental Disorders focused on measuring Vocational rehabilitation, Mental health services, Return to Work

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Copenhagen Research Center for Mental Health - CORE

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

IBBIS II

Service As Usual

Arm Description

Integrated Mental Health Care and Vocational Rehabilitation

Standard vocational rehabilitation and treatment

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Work at one point during follow-up
Proportion in unsupported competitive work at 6 and 12-months follow up
Return to work
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
Proportion in supported work at 6 and 12-months follow up
Weeks of work
Number of weeks in competitive employment from baseline to 6 and 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
Income
Salary income from competitive employment at 6 and 12 months after baseline
Use of psychiatric services
Number of admissions, inpatient days and outpatient contacts at the psychiatric hospitals at 6- and 12-months follow-up
Use of somatic services
Number of admissions, inpatient days and outpatient contacts at the somatic hospitals at 6- and 12-months follow-up
Use of private health care
Number of contacts with private health care professionals under the Health Insurance

Full Information

First Posted
June 9, 2020
Last Updated
October 5, 2022
Sponsor
Mental Health Centre Copenhagen
Collaborators
The Danish Agency for Labour Market and Recruitment, Central Denmark Region, Aarhus Kommune, Københavns Kommune
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1. Study Identification

Unique Protocol Identification Number
NCT04432129
Brief Title
Integrated Mental Health Care and Vocational Rehabilitation to People With to Common Mental Disorders
Acronym
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
Study Type
Interventional

2. Study Status

Record Verification Date
October 2022
Overall Recruitment Status
Completed
Study Start Date
June 9, 2020 (Actual)
Primary Completion Date
October 1, 2022 (Actual)
Study Completion Date
October 1, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Mental Health Centre Copenhagen
Collaborators
The Danish Agency for Labour Market and Recruitment, Central Denmark Region, Aarhus Kommune, Københavns Kommune

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Common Mental Disorders, Depression, Anxiety, Personality Disorders, Functional Disease Present, Stress
Keywords
Vocational rehabilitation, Mental health services, Return to Work

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
900 (Actual)

8. Arms, Groups, and Interventions

Arm Title
IBBIS II
Arm Type
Experimental
Arm Description
Integrated Mental Health Care and Vocational Rehabilitation
Arm Title
Service As Usual
Arm Type
Active Comparator
Arm Description
Standard vocational rehabilitation and treatment
Intervention Type
Behavioral
Intervention Name(s)
IBBIS II
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Service as Usual
Intervention Description
Service as usual consists of standard mental health care and vocational rehabilitation
Primary Outcome Measure Information:
Title
Return to work
Description
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.
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Work at one point during follow-up
Description
Proportion in unsupported competitive work at 6 and 12-months follow up
Time Frame
12 months
Title
Return to work
Description
Time to return to work from baseline until 6 months after baseline measured whit register based data
Time Frame
6 months
Title
Supported work at one point during follow-up
Description
Proportion in supported work at 6 and 12-months follow up
Time Frame
12 months
Title
Weeks of work
Description
Number of weeks in competitive employment from baseline to 6 and 12 months
Time Frame
12 months
Title
Time to new sick leave
Description
The duration from return to work to potential new sick leave of more than 4 weeks within the 12-month follow-up period
Time Frame
12 months
Title
Income
Description
Salary income from competitive employment at 6 and 12 months after baseline
Time Frame
12 months
Title
Use of psychiatric services
Description
Number of admissions, inpatient days and outpatient contacts at the psychiatric hospitals at 6- and 12-months follow-up
Time Frame
12 months
Title
Use of somatic services
Description
Number of admissions, inpatient days and outpatient contacts at the somatic hospitals at 6- and 12-months follow-up
Time Frame
12 months
Title
Use of private health care
Description
Number of contacts with private health care professionals under the Health Insurance
Time Frame
12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lene f Eplov, PhD
Organizational Affiliation
Mental Health Center Copenhagen
Official's Role
Principal Investigator
Facility Information:
Facility Name
Copenhagen Research Center for Mental Health - CORE
City
Copenhagen
ZIP/Postal Code
2900
Country
Denmark

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing 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
Citations:
PubMed Identifier
36175977
Citation
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.
Results Reference
background
Links:
URL
https://trialsjournal.biomedcentral.com/articles/10.1186/s13063-022-06718-7
Description
study protocol article

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

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