Clinical trial NCT02885519: Integrated Mental Health Care and Vocational Rehabilitation to Individuals on Sick Leave Due to Stress Disorders
Official title: Integrated Mental Health Care and Vocational Rehabilitation to Individuals on Sick Leave Due to Burnout, Adjustment Disorder or Psychological Stress in Denmark (the Danish IBBIS Study): A Multi-center Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Adjustment Disorder
Burnout
Psychological Stress
Keywords: Vocational Rehabilitation
Common Mental Disorders
Return to Work
Mental Health Services
Psychological Stress
Adjustment Disorder
Burnout
Integration
Cognitive Behavior Therapy
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: 2016-08-31
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 (MHC) intervention and 2) an integrated mental health care and vocational rehabilitation (VR) intervention for people on sick leave because of burnout, adjustment disorder and psychological stress in Denmark

Detailed description: Background:

Stress disorders have negative effects on workability and have negative effects on both the individual and society. Psychological stress and burnout is not recognized as psychiatric diagnoses, and thus, the estimated prevalence in healthy and sick-listed people is somewhat insecure in Denmark. Together with other common mental disorders, burnout, adjustment disorder and psychological stress are causes of up 40 % of the sick leave claims in Denmark. 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 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 burnout, adjustment disorder and psychological stress 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 burnout, adjustment disorder and psychological stress 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:

* Burnout OR adjustment disorder OR psychological stress according to 4DSQ
* 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 Jobcentre 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: Poulsen R, Fisker J, Hoff A, Hjorthoj C, Eplov LF. Integrated mental health care and vocational rehabilitation to improve return to work rates for people on sick leave because of exhaustion disorder, adjustment disorder, and distress (the Danish IBBIS trial): study protocol for a randomized controlled trial. Trials. 2017 Dec 2;18(1):579. doi: 10.1186/s13063-017-2273-0.