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Clinical Trials/NCT04432129
NCT04432129
Completed
N/A

Integrated Mental Health Care and Vocational Rehabilitation Intervention to Individuals on Sick Leave Due to Anxiety, Depression, Personality Disorders, Stress and Functional Disorders

Amager Hospital1 site in 1 country900 target enrollmentJune 9, 2020

Overview

Phase
N/A
Intervention
IBBIS II
Conditions
Common Mental Disorders
Sponsor
Amager Hospital
Enrollment
900
Locations
1
Primary Endpoint
Return to work
Status
Completed
Last Updated
2 months ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
June 9, 2020
End Date
October 1, 2022
Last Updated
2 months ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Lene Falgaard Eplov

Head of Research, Associate professor

Amager Hospital

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

  • High degree of suicidal ideation
  • 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

Arms & Interventions

IBBIS II

Integrated Mental Health Care and Vocational Rehabilitation

Intervention: IBBIS II

Service As Usual

Standard vocational rehabilitation and treatment

Intervention: Service as Usual

Outcomes

Primary Outcomes

Return to work

Time Frame: 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 Outcomes

  • Work at one point during follow-up(12 months)
  • Return to work(6 months)
  • Supported work at one point during follow-up(12 months)
  • Weeks of work(12 months)
  • Time to new sick leave(12 months)
  • Income(12 months)
  • Use of psychiatric services(12 months)
  • Use of private health care(12 months)
  • Use of somatic services(12 months)

Study Sites (1)

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DRKS00022338niversität Potsdam; Professur für Sozial- und Präventivmedizin240