IBBIS: Integrated Mental Health Care and Vocational Rehabilitation to Individuals on Sick Leave Due to Anxiety and Depression

Sponsor
Mental Health Centre Copenhagen (Other)
Overall Status
Completed
CT.gov ID
NCT02872051
Collaborator
The Danish Agency for Labour Market and Recruitment (Other), Copenhagen Municipality, Denmark (Other), Gentofte Municipality, Denmark (Other), Municipality of Lyngby-Taarbæk, Denmark (Other), Gladsaxe Municipality, Denmark (Other)
631
1
3
50
12.6

Study Details

Study Description

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

Condition or Disease Intervention/Treatment Phase
  • Behavioral: IBBIS mental health care and standard vocational rehabilitation
  • Other: Integrated mental health care and vocational rehabilitation
N/A

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.

Study Design

Study Type:
Interventional
Actual Enrollment :
631 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Investigator, Outcomes Assessor)
Primary Purpose:
Other
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
Actual Study Start Date :
Apr 1, 2016
Actual Primary Completion Date :
Jun 1, 2019
Actual Study Completion Date :
Jun 1, 2020

Arms and Interventions

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 Cognitive-behavior Therapy Monitoring and reassessment

Experimental: IBBIS integrated MCH and VR

Integrated mental health care and vocational rehabilitation

Other: 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 Cognitive-behavior Therapy Monitoring and reassessment Vocational rehabilitation is inspired by Individual Placement and Support and is a workplace-oriented intervention with problem-solving conversations as a core element

Outcome Measures

Primary Outcome Measures

  1. Time to return to work [12 months]

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

Secondary Outcome Measures

  1. Work [12 months]

    Competitive work 12 months after baseline (yes/no)

  2. Time to return to work [24 months]

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

  3. Recurrent Sickness Absence [24 months]

    Time from baseline to recurrent sickness absence for more than 8 weeks

  4. Degree of depressive symptoms [6 months]

    Self-assessed depressive symptoms by the Beck Depression Inventory (BDI)

  5. Degree of anxiety symptoms [6 months]

    Self-assessed anxiety symptoms by the Beck Anxiety Inventory (BAI)

  6. Degree of psychological stress symptoms [6 months]

    Self-assessed psychological stress by the Cohen perceived stress scale (PSS)

  7. Work and social functioning [6 months]

    Work and social functioning by the Work and Social Adjustment Scale (WSAS)

Other Outcome Measures

  1. Symptom level [6, 12 and 24 months]

    Symptom level on de four dimensions: Distress, Depression, Anxiety and Somatization by 4-dimensional symptom questionnaire (4DSQ)

  2. Death [6, 12 and 24 months]

    Death and cause of death by register data

  3. Suicidal ideation [6, 12 and 24 months]

    Suicidal ideation by BDI

  4. Life-threatening conditions [6, 12 and 24 months]

    Life-threatening conditions by register data

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Mental Health Services of the Capital Region of Denmark Copenhagen Capital Region Of Denmark Denmark 2100

Sponsors and Collaborators

  • Mental Health Centre Copenhagen
  • The Danish Agency for Labour Market and Recruitment
  • Copenhagen Municipality, Denmark
  • Gentofte Municipality, Denmark
  • Municipality of Lyngby-Taarbæk, Denmark
  • Gladsaxe Municipality, Denmark

Investigators

None specified.

Study Documents (Full-Text)

More Information

Publications

None provided.
Responsible Party:
Lene Falgaard Eplov, MD, PhD, Mental Health Centre Copenhagen
ClinicalTrials.gov Identifier:
NCT02872051
Other Study ID Numbers:
  • IBBIS Anxiety Depression
First Posted:
Aug 18, 2016
Last Update Posted:
Jan 28, 2021
Last Verified:
Jan 1, 2021
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Keywords provided by Lene Falgaard Eplov, MD, PhD, Mental Health Centre Copenhagen
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jan 28, 2021