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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02872051
Recruitment Status : Completed
First Posted : August 18, 2016
Last Update Posted : January 28, 2021
Sponsor:
Collaborators:
The Danish Agency for Labour Market and Recruitment
Copenhagen Municipality, Denmark
Gentofte Municipality, Denmark
Municipality of Lyngby-Taarbæk, Denmark
Gladsaxe Municipality, Denmark
Information provided by (Responsible Party):
Lene Falgaard Eplov, Mental Health Centre Copenhagen

Study Description
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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
Generalized Anxiety Social Phobia Panic Disorder Depression Behavioral: IBBIS mental health care and standard vocational rehabilitation Other: Integrated mental health care and vocational rehabilitation Not Applicable

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
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Study Type : Interventional  (Clinical Trial)
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 : April 2016
Actual Primary Completion Date : June 2019
Actual Study Completion Date : June 2020

Resource links provided by the National Library of Medicine


Arms and Interventions
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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
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Primary Outcome Measures :
  1. Time to return to work [ Time Frame: 12 months ]
    Time from baseline to first return to work for more than four consecutive weeks


Secondary Outcome Measures :
  1. Work [ Time Frame: 12 months ]
    Competitive work 12 months after baseline (yes/no)

  2. Time to return to work [ Time Frame: 24 months ]
    Time from baseline to first return to work for more than four consecutive weeks

  3. Recurrent Sickness Absence [ Time Frame: 24 months ]
    Time from baseline to recurrent sickness absence for more than 8 weeks

  4. Degree of depressive symptoms [ Time Frame: 6 months ]
    Self-assessed depressive symptoms by the Beck Depression Inventory (BDI)

  5. Degree of anxiety symptoms [ Time Frame: 6 months ]
    Self-assessed anxiety symptoms by the Beck Anxiety Inventory (BAI)

  6. Degree of psychological stress symptoms [ Time Frame: 6 months ]
    Self-assessed psychological stress by the Cohen perceived stress scale (PSS)

  7. Work and social functioning [ Time Frame: 6 months ]
    Work and social functioning by the Work and Social Adjustment Scale (WSAS)


Other Outcome Measures:
  1. Symptom level [ Time Frame: 6, 12 and 24 months ]
    Symptom level on de four dimensions: Distress, Depression, Anxiety and Somatization by 4-dimensional symptom questionnaire (4DSQ)

  2. Death [ Time Frame: 6, 12 and 24 months ]
    Death and cause of death by register data

  3. Suicidal ideation [ Time Frame: 6, 12 and 24 months ]
    Suicidal ideation by BDI

  4. Life-threatening conditions [ Time Frame: 6, 12 and 24 months ]
    Life-threatening conditions by register data


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02872051


Locations
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Denmark
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
  Study Documents (Full-Text)

Documents provided by Lene Falgaard Eplov, Mental Health Centre Copenhagen:
Study Protocol  [PDF] July 5, 2019
Statistical Analysis Plan  [PDF] November 30, 2020

More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Lene Falgaard Eplov, MD, PhD, Mental Health Centre Copenhagen
ClinicalTrials.gov Identifier: NCT02872051    
Other Study ID Numbers: IBBIS Anxiety Depression
First Posted: August 18, 2016    Key Record Dates
Last Update Posted: January 28, 2021
Last Verified: January 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Keywords provided by Lene Falgaard Eplov, Mental Health Centre Copenhagen:
Vocational Rehabilitation
Anxiety
Depression
Common Mental Disorders
 Cognitive Behavior Therapy
Return to Work
Mental Health Services
Integration
Additional relevant MeSH terms:
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Depression
Depressive Disorder
Anxiety Disorders
Panic Disorder
Phobia, Social
 Behavioral Symptoms
Mood Disorders
Mental Disorders
Phobic Disorders