Clinical trial NCT04432129: Integrated Mental Health Care and Vocational Rehabilitation to People with to Common Mental Disorders
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
Overall status: COMPLETED
Phase: NA
Conditions: Common Mental Disorders
Depression
Anxiety
Personality Disorders
Functional Disease Present
Stress
Keywords: Vocational rehabilitation
Mental health services
Return to Work
Lead sponsor: Mental Health Services in the Capital Region, Denmark
Sponsor class: OTHER
Collaborators: name: The Danish Agency for Labour Market and Recruitment
name: Central Denmark Region
name: Aarhus Kommune
name: Københavns Kommune
First posted: 2020-06-16
Enrollment: 900
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.

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

Primary outcomes:
measure: Return to work
timeFrame: 12 months
Secondary outcomes:
measure: Work at one point during follow-up
timeFrame: 12 months
measure: Return to work
timeFrame: 6 months
measure: Supported work at one point during follow-up
timeFrame: 12 months
measure: Weeks of work
timeFrame: 12 months
measure: Time to new sick leave
timeFrame: 12 months
measure: Income
timeFrame: 12 months
measure: Use of psychiatric services
timeFrame: 12 months
measure: Use of somatic services
timeFrame: 12 months
measure: Use of private health care
timeFrame: 12 months
Other outcomes:
Locations:
city: Copenhagen
country: Denmark
facility: Copenhagen Research Center for Mental Health - CORE
Study officials:
affiliation: Mental Health Center Copenhagen
name: Lene F Eplov, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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.