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

Primary Purpose

Adjustment Disorder, Burnout, Psychological Stress

Status
Completed
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
IBBIS mental health care and standard vocational rehabilitation
Integrated mental health care and vocational rehabilitation
Sponsored by
Mental Health Centre Copenhagen
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Adjustment Disorder focused on measuring Vocational Rehabilitation, Common Mental Disorders, Return to Work, Mental Health Services, Psychological Stress, Adjustment Disorder, Burnout, Integration, Cognitive Behavior Therapy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Mental Health Services of the Capital Region of Denmark

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

No Intervention

Experimental

Experimental

Arm Label

Control

IBBIS MHC

IBBIS integrated MCH and VR

Arm Description

Standard treatment and standard vocational rehabilitation

IBBIS mental health care and standard vocational rehabilitation

Integrated mental health care and vocational rehabilitation

Outcomes

Primary Outcome Measures

Time to return to work
Time from baseline to first return to work for more than four consecutive weeks

Secondary Outcome Measures

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

Full Information

First Posted
August 15, 2016
Last Updated
January 25, 2021
Sponsor
Mental Health Centre Copenhagen
Collaborators
The Danish Agency for Labour Market and Recruitment, Copenhagen Municipality, Denmark, Gentofte Municipality, Denmark, Municipality of Lyngby-Taarbæk, Denmark, Gladsaxe Municipality, Denmark
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1. Study Identification

Unique Protocol Identification Number
NCT02885519
Brief Title
Integrated Mental Health Care and Vocational Rehabilitation to Individuals on Sick Leave Due to Stress Disorders
Acronym
IBBIS
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

2. Study Status

Record Verification Date
January 2021
Overall Recruitment Status
Completed
Study Start Date
April 2016 (Actual)
Primary Completion Date
June 2019 (Actual)
Study Completion Date
June 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Mental Health Centre Copenhagen
Collaborators
The Danish Agency for Labour Market and Recruitment, Copenhagen Municipality, Denmark, Gentofte Municipality, Denmark, Municipality of Lyngby-Taarbæk, Denmark, Gladsaxe Municipality, Denmark

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
631 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Control
Arm Type
No Intervention
Arm Description
Standard treatment and standard vocational rehabilitation
Arm Title
IBBIS MHC
Arm Type
Experimental
Arm Description
IBBIS mental health care and standard vocational rehabilitation
Arm Title
IBBIS integrated MCH and VR
Arm Type
Experimental
Arm Description
Integrated mental health care and vocational rehabilitation
Intervention Type
Behavioral
Intervention Name(s)
IBBIS mental health care and standard vocational rehabilitation
Intervention Description
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
Intervention Type
Behavioral
Intervention Name(s)
Integrated mental health care and vocational rehabilitation
Intervention Description
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
Primary Outcome Measure Information:
Title
Time to return to work
Description
Time from baseline to first return to work for more than four consecutive weeks
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Work
Description
Competitive work 12 months after baseline (yes/no)
Time Frame
12 months
Title
Time to return to work
Description
Time from baseline to first return to work for more than four consecutive weeks
Time Frame
24 months
Title
Recurrent Sickness Absence
Description
Time from baseline to recurrent sickness absence for more than 8 weeks
Time Frame
24 months
Title
Degree of depressive symptoms
Description
Self-assessed anxiety symptoms by the Beck Anxiety Inventory (BDI)
Time Frame
6 months
Title
Degree of anxiety symptoms
Description
Self-assessed anxiety symptoms by the Beck Anxiety Inventory (BAI)
Time Frame
6 months
Title
Degree of psychological stress symptoms
Description
Self-assessed psychological stress by the Cohen perceived stress scale (PSS)
Time Frame
6 months
Title
Work and social functioning
Description
Work and social functioning by the Work and Social Adjustment Scale (WSAS)
Time Frame
6 months
Other Pre-specified Outcome Measures:
Title
Symptom level
Description
Symptom level on de four dimensions: Distress, Depression, Anxiety and Somatization by 4-dimensional symptom questionnaire (4DSQ)
Time Frame
6, 12 and 24 months
Title
Death
Description
Death and cause of death by register data
Time Frame
6, 12 and 24 months
Title
Suicidal ideation
Description
Suicidal ideation by BDI
Time Frame
6, 12 and 24 months
Title
Life-threatening conditions
Description
Life-threatening conditions by register data
Time Frame
6, 12 and 24 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
Mental Health Services of the Capital Region of Denmark
City
Copenhagen
State/Province
Capital Region Of Denmark
ZIP/Postal Code
2100
Country
Denmark

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
29197404
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.
Results Reference
derived

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

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