Clinical trial NCT02872051: Integrated Mental Health Care and Vocational Rehabilitation to Individuals on Sick Leave Due to Anxiety and Depression
Official title: Integrated Mental Health Care and Vocational Rehabilitation to Individuals on Sick Leave Due to Anxiety and Depression in Denmark (the Danish IBBIS Study): A Multi-center Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Generalized Anxiety
Social Phobia
Panic Disorder
Depression
Keywords: Vocational Rehabilitation
Anxiety
Depression
Common Mental Disorders
Cognitive Behavior Therapy
Return to Work
Mental Health Services
Integration
Lead sponsor: Mental Health Services in the Capital Region, Denmark
Sponsor class: OTHER
Collaborators: name: The Danish Agency for Labour Market and Recruitment
name: Copenhagen Municipality, Denmark
name: Gentofte Municipality, Denmark
name: Municipality of Lyngby-Taarbæk, Denmark
name: Gladsaxe Municipality, Denmark
First posted: 2016-08-18
Enrollment: 631
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: 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: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Time to return to work
timeFrame: 12 months
Secondary outcomes:
measure: Work
timeFrame: 12 months
measure: Time to return to work
timeFrame: 24 months
measure: Recurrent Sickness Absence
timeFrame: 24 months
measure: Degree of depressive symptoms
timeFrame: 6 months
measure: Degree of anxiety symptoms
timeFrame: 6 months
measure: Degree of psychological stress symptoms
timeFrame: 6 months
measure: Work and social functioning
timeFrame: 6 months
Other outcomes:
measure: Symptom level
timeFrame: 6, 12 and 24 months
measure: Death
timeFrame: 6, 12 and 24 months
measure: Suicidal ideation
timeFrame: 6, 12 and 24 months
measure: Life-threatening conditions
timeFrame: 6, 12 and 24 months
Locations:
city: Copenhagen
country: Denmark
facility: Mental Health Services of the Capital Region of Denmark
state: Capital Region Of Denmark
Study officials:
References:
citation: 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.
citation: 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.