Integrated Mental Health Care and Vocational Rehabilitation to Individuals on Sick Leave Due to Anxiety and Depression

NCT ID: NCT02872051

Last Updated: 2024-02-08

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

631 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-04-30

Study Completion Date

2020-06-30

Brief Summary

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The purpose of this study is to investigate the efficacy of 1) a stepped mental health care intervention and 2) an integrated mental health care and vocational rehabilitation intervention for people on sick leave because of depression and anxiety in Denmark

Detailed Description

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Background:

Depression and anxiety are important contributors to the global burden of disease and causes negative effects on both the individual and society. Depression and anxiety are very likely to influence the individual's workability and up to 40 % of the people on sick leave in Denmark have common mental disorders like depression and anxiety. There is no clear evidence that mental health care alone will provide sufficient support for vocational recovery for this target group. Integrated vocational and health care services have shown good effects on return to work in other Scandinavian countries.

Objective:

The purpose of the Danish IBBIS study is to examine the efficacy of 1) a stepped mental health care intervention and 2) an integrated mental health care and vocational rehabilitation intervention for people on sick leave because of depression and anxiety in Denmark.

Method:

This three-arm, randomized, controlled trial is set up to investigate the effectiveness of the stepped mental health care model and the integrated mental health care and vocational rehabilitation intervention for people on sick leave because of depression and anxiety in Denmark. 603 patients are recruited from Danish job centers in four municipalities. The primary outcome is 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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Generalized Anxiety Social Phobia Panic Disorder Depression

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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Control

Standard treatment and standard vocational rehabilitation

Group Type NO_INTERVENTION

No interventions assigned to this group

IBBIS MHC

IBBIS mental health care and standard vocational rehabilitation

Group Type EXPERIMENTAL

IBBIS mental health care and standard vocational rehabilitation

Intervention Type BEHAVIORAL

Standard vocational rehabilitation.

Stepped mental health care provided by the IBBIS mental health care team (e.g. nurses, psychologists, and medical doctors) with the treatment modalities:

Psychoeducation Bibliotherapy Cognitive-behavior Therapy Monitoring and reassessment

IBBIS integrated MCH and VR

Integrated mental health care and vocational rehabilitation

Group Type EXPERIMENTAL

Integrated mental health care and vocational rehabilitation

Intervention Type OTHER

Integrated mental health care and vocational rehabilitation provided by the IBBIS team. The IBBIS team is composed by employment specialists from the municipal job centers and health care professionals from the mental health services (e.g. nurses, psychologists, and medical doctors).

Mental health care is provided according to a stepped care model with the following treatment modalities:

Psychoeducation Bibliotherapy Cognitive-behavior Therapy Monitoring and reassessment

Vocational rehabilitation is inspired by Individual Placement and Support and is a workplace-oriented intervention with problem-solving conversations as a core element

Interventions

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IBBIS mental health care and standard vocational rehabilitation

Standard vocational rehabilitation.

Stepped mental health care provided by the IBBIS mental health care team (e.g. nurses, psychologists, and medical doctors) with the treatment modalities:

Psychoeducation Bibliotherapy Cognitive-behavior Therapy Monitoring and reassessment

Intervention Type BEHAVIORAL

Integrated mental health care and vocational rehabilitation

Integrated mental health care and vocational rehabilitation provided by the IBBIS team. The IBBIS team is composed by employment specialists from the municipal job centers and health care professionals from the mental health services (e.g. nurses, psychologists, and medical doctors).

Mental health care is provided according to a stepped care model with the following treatment modalities:

Psychoeducation Bibliotherapy Cognitive-behavior Therapy Monitoring and reassessment

Vocational rehabilitation is inspired by Individual Placement and Support and is a workplace-oriented intervention with problem-solving conversations as a core element

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Depression, Generalized Anxiety, Social Phobia or Panic Disorder according to Mini International Neuropsychiatric Interview (MINI)
* On sick leave from work or unemployment and have received sick leave benefit for minimum four weeks OR have started a sick leave benefit case which is estimated to last for minimum eight weeks
* Citizen in one of the following municipalities: Copenhagen City, Gladsaxe Municipality, Lyngby-Taarbæk Municipality or Gentofte Municipality
* Danish-speaking
* Given informed consent

Exclusion Criteria

* Pregnant
* High degree of suicidal ideation
* Dementia
* Alcohol or substance misuse that hinders the person participating in treatment
* Wish to start or continue psychological therapy
* Need for psychiatric treatment in the secondary psychiatric care system
* Medically unstable to a degree that the patient cannot adhere to treatment
* Participant in the research project Collabri
* Attending stress courses in the stress clinics of Copenhagen City
* Assessed by job center case managers to be dangerous
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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The Danish Agency for Labour Market and Recruitment

OTHER

Sponsor Role collaborator

Copenhagen Municipality, Denmark

OTHER_GOV

Sponsor Role collaborator

Gentofte Municipality, Denmark

UNKNOWN

Sponsor Role collaborator

Municipality of Lyngby-Taarbæk, Denmark

UNKNOWN

Sponsor Role collaborator

Gladsaxe Municipality, Denmark

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

MD, PhD

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Mental Health Services of the Capital Region of Denmark

Copenhagen, Capital Region of Denmark, Denmark

Site Status

Countries

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Denmark

References

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Hoff A, Poulsen RM, Fisker JP, Hjorthoj C, Nordentoft M, Christensen U, Bojesen AB, Eplov LF. Integrated Mental Healthcare and Vocational Rehabilitation for People on Sick Leave with Anxiety or Depression: 24-Month Follow-up of the Randomized IBBIS Trial. J Occup Rehabil. 2023 Sep;33(3):570-580. doi: 10.1007/s10926-023-10094-7. Epub 2023 Feb 27.

Reference Type DERIVED
PMID: 36849841 (View on PubMed)

Hoff A, Poulsen RM, Fisker J, Hjorthoj C, Rosenberg N, Nordentoft M, Bojesen AB, Eplov LF. Integrating vocational rehabilitation and mental healthcare to improve the return-to-work process for people on sick leave with depression or anxiety: results from a three-arm, parallel randomised trial. Occup Environ Med. 2022 Feb;79(2):134-142. doi: 10.1136/oemed-2021-107894. Epub 2021 Dec 16.

Reference Type DERIVED
PMID: 34916330 (View on PubMed)

Poulsen R, Hoff A, Fisker J, Hjorthoj C, Eplov LF. Integrated mental health care and vocational rehabilitation to improve return to work rates for people on sick leave because of depression and anxiety (the Danish IBBIS trial): study protocol for a randomized controlled trial. Trials. 2017 Dec 2;18(1):578. doi: 10.1186/s13063-017-2272-1.

Reference Type DERIVED
PMID: 29197414 (View on PubMed)

Provided Documents

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Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

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IBBIS Anxiety Depression

Identifier Type: -

Identifier Source: org_study_id

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