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

NCT ID: NCT04432129

Last Updated: 2024-11-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

900 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-06-09

Study Completion Date

2022-10-01

Brief Summary

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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

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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.

Conditions

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Common Mental Disorders Depression Anxiety Personality Disorders Functional Disease Present Stress

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

DOUBLE

Investigators Outcome Assessors

Study Groups

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IBBIS II

Integrated Mental Health Care and Vocational Rehabilitation

Group Type EXPERIMENTAL

IBBIS II

Intervention Type BEHAVIORAL

The IBBIS-II service consists of:

1. Mental health assessment.
2. 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.
3. 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.
4. Treatment consists of stepped care with structured treatment guidelines.
5. When the participant has obtained work the team continues to offer support.

Service As Usual

Standard vocational rehabilitation and treatment

Group Type ACTIVE_COMPARATOR

Service as Usual

Intervention Type BEHAVIORAL

Service as usual consists of standard mental health care and vocational rehabilitation

Interventions

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IBBIS II

The IBBIS-II service consists of:

1. Mental health assessment.
2. 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.
3. 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.
4. Treatment consists of stepped care with structured treatment guidelines.
5. When the participant has obtained work the team continues to offer support.

Intervention Type BEHAVIORAL

Service as Usual

Service as usual consists of standard mental health care and vocational rehabilitation

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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The Danish Agency for Labour Market and Recruitment

OTHER

Sponsor Role collaborator

Central Denmark Region

OTHER

Sponsor Role collaborator

Aarhus Kommune

OTHER

Sponsor Role collaborator

Københavns Kommune

OTHER

Sponsor Role collaborator

Mental Health Services in the Capital Region, Denmark

OTHER

Sponsor Role lead

Responsible Party

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Lene Falgaard Eplov

Senior consultant, ph.d.

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Lene F Eplov, PhD

Role: PRINCIPAL_INVESTIGATOR

Mental Health Center Copenhagen

Locations

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Copenhagen Research Center for Mental Health - CORE

Copenhagen, , Denmark

Site Status

Countries

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Denmark

References

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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.

Reference Type BACKGROUND
PMID: 36175977 (View on PubMed)

Christensen TN, Hjorthoj C, Poulsen CH, Ebersbach B, 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) - results from a randomized clinical trial. Nord J Psychiatry. 2025 Jan;79(1):86-95. doi: 10.1080/08039488.2024.2446362. Epub 2025 Jan 6.

Reference Type DERIVED
PMID: 39760219 (View on PubMed)

Related Links

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Other Identifiers

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Version 3.1. 27.5.2020

Identifier Type: -

Identifier Source: org_study_id

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