Integrated Mental Health Care and Vocational Rehabilitation to Individuals on Sick Leave Due to Stress Disorders (IBBIS)

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

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

Study Overview

• Status: Completed
• Conditions: Burnout; Adjustment Disorder; Psychological Stress
• Intervention / Treatment: Behavioral: IBBIS mental health care and standard vocational rehabilitation; Behavioral: Integrated mental health care and vocational rehabilitation

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.

• Study Type: Interventional
• Enrollment (Actual): 631
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Denmark
  • Capital Region Of Denmark
    • Copenhagen, Capital Region Of Denmark, Denmark, 2100
      • Mental Health Services of the Capital Region of Denmark

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Control; Standard treatment and standard vocational rehabilitation
Experimental: IBBIS MHC; IBBIS mental health care and standard vocational rehabilitation	Behavioral: 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 Stress-coaching Mindfulness-based stress reduction Monitoring and re-assessment
Experimental: IBBIS integrated MCH and VR; Integrated mental health care and vocational rehabilitation	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 Stress-coaching Mindfulness-based stress reduction Monitoring and re-assessment Vocational rehabilitation is inspired by Individual Placement and Support and is a workplace-oriented intervention with problem-solving conversations as a core element

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time to return to work	Time from baseline to first return to work for more than four consecutive weeks	12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Work	Competitive work 12 months after baseline (yes/no)	12 months
Time to return to work	Time from baseline to first return to work for more than four consecutive weeks	24 months
Recurrent Sickness Absence	Time from baseline to recurrent sickness absence for more than 8 weeks	24 months
Degree of anxiety symptoms	Self-assessed anxiety symptoms by the Beck Anxiety Inventory (BAI)	6 months
Degree of psychological stress symptoms	Self-assessed psychological stress by the Cohen perceived stress scale (PSS)	6 months
Work and social functioning	Work and social functioning by the Work and Social Adjustment Scale (WSAS)	6 months
Degree of depressive symptoms	Self-assessed anxiety symptoms by the Beck Anxiety Inventory (BDI)	6 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Symptom level	Symptom level on de four dimensions: Distress, Depression, Anxiety and Somatization by 4-dimensional symptom questionnaire (4DSQ)	6, 12 and 24 months
Death	Death and cause of death by register data	6, 12 and 24 months
Suicidal ideation	Suicidal ideation by BDI	6, 12 and 24 months
Life-threatening conditions	Life-threatening conditions by register data	6, 12 and 24 months

Collaborators and Investigators

• Sponsor: Mental Health Services in the Capital Region, Denmark
• Collaborators: Copenhagen Municipality, Denmark; Municipality of Lyngby-Taarbæk, Denmark; Gladsaxe Municipality, Denmark; The Danish Agency for Labour Market and Recruitment; Gentofte Municipality, Denmark

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2016
• Primary Completion (Actual): June 1, 2019
• Study Completion (Actual): June 1, 2020

Study Registration Dates

• First Submitted: August 15, 2016
• First Submitted That Met QC Criteria: August 30, 2016
• First Posted (Estimated): August 31, 2016

Study Record Updates

• Last Update Posted (Actual): February 8, 2024
• Last Update Submitted That Met QC Criteria: February 6, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Keywords: Burnout; Mental Health Services; Cognitive Behavior Therapy; Return to Work; Integration; Psychological Stress; Vocational Rehabilitation; Common Mental Disorders; Adjustment Disorder
• Additional Relevant MeSH Terms: Behavioral Symptoms; Mental Disorders; Trauma and Stressor Related Disorders; Burnout, Psychological; Stress, Psychological; Adjustment Disorders
• Other Study ID Numbers: IBBIS Stress

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED