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

Sponsor
Mental Health Centre Copenhagen (Other)
Overall Status
Recruiting
CT.gov ID
NCT04432129
Collaborator
The Danish Agency for Labour Market and Recruitment (Other), Central Denmark Region (Other), Aarhus Kommune (Other), Københavns Kommune (Other)
800
1
2
29.2
27.4

Study Details

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

Condition or Disease Intervention/Treatment Phase
  • Behavioral: IBBIS II
  • Behavioral: Service as Usual
N/A

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 Design

Study Type:
Interventional
Anticipated Enrollment :
800 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Investigator, Outcomes Assessor)
Primary Purpose:
Other
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
Actual Study Start Date :
Jun 9, 2020
Anticipated Primary Completion Date :
Nov 15, 2022
Anticipated Study Completion Date :
Nov 15, 2022

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. 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

  1. Work at one point during follow-up [12 months]

    Proportion in unsupported competitive work at 6 and 12-months follow up

  2. Return to work [6 months]

    Time to return to work from baseline until 6 months after baseline measured whit register based data

  3. Supported work at one point during follow-up [12 months]

    Proportion in supported work at 6 and 12-months follow up

  4. Weeks of work [12 months]

    Number of weeks in competitive employment from baseline to 6 and 12 months

  5. 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

  6. Income [12 months]

    Salary income from competitive employment at 6 and 12 months after baseline

  7. 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

  8. 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

  9. Use of private health care [12 months]

    Number of contacts with private health care professionals under the Health Insurance

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Copenhagen Research Center for Mental Health - CORE Copenhagen Denmark 2900

Sponsors and Collaborators

  • Mental Health Centre Copenhagen
  • The Danish Agency for Labour Market and Recruitment
  • Central Denmark Region
  • Aarhus Kommune
  • Københavns Kommune

Investigators

  • Principal Investigator: Lene f Eplov, PhD, Mental Health Center Copenhagen

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Mental Health Centre Copenhagen
ClinicalTrials.gov Identifier:
NCT04432129
Other Study ID Numbers:
  • Version 3.1. 27.5.2020
First Posted:
Jun 16, 2020
Last Update Posted:
Sep 8, 2021
Last Verified:
Sep 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Mental Health Centre Copenhagen
Additional relevant MeSH terms:

Study Results

No Results Posted as of Sep 8, 2021