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

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ClinicalTrials.gov Identifier: NCT02872051
Recruitment Status : Recruiting
First Posted : August 18, 2016
Last Update Posted : April 10, 2017
Sponsor:
Collaborators:
Danish Agency for Labour Market and Recruitment, Denmark
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

August 15, 2016
August 18, 2016
April 10, 2017
April 2016
June 2018   (Final data collection date for primary outcome measure)
Time to return to work [ Time Frame: 12 months ]
Time from baseline to first return to work for more than four consecutive weeks
Same as current
Complete list of historical versions of study NCT02872051 on ClinicalTrials.gov Archive Site
  • Work [ Time Frame: 12 months ]
    Competitive work 12 months after baseline (yes/no)
  • Time to return to work [ Time Frame: 24 months ]
    Time from baseline to first return to work for more than four consecutive weeks
  • Recurrent Sickness Absence [ Time Frame: 24 months ]
    Time from baseline to recurrent sickness absence for more than 8 weeks
  • Degree of depressive symptoms [ Time Frame: 6 months ]
    Self-assessed depressive symptoms by the Beck Depression Inventory (BDI)
  • Degree of anxiety symptoms [ Time Frame: 6 months ]
    Self-assessed anxiety symptoms by the Beck Anxiety Inventory (BAI)
  • Degree of psychological stress symptoms [ Time Frame: 6 months ]
    Self-assessed psychological stress by the Cohen perceived stress scale (PSS)
  • Work and social functioning [ Time Frame: 6 months ]
    Work and social functioning by the Work and Social Adjustment Scale (WSAS)
Same as current
  • 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)
  • Death [ Time Frame: 6, 12 and 24 months ]
    Death and cause of death by register data
  • Suicidal ideation [ Time Frame: 6, 12 and 24 months ]
    Suicidal ideation by BDI
  • Life-threatening conditions [ Time Frame: 6, 12 and 24 months ]
    Life-threatening conditions by register data
  • Symptom level [ Time Frame: 6, 12 and 24 months ]
    Symptom level on de four dimentions: Distress, Depression, Anxiety and Somatization by 4-dimentional symptom questionnaire (4DSQ)
  • Death [ Time Frame: 6, 12 and 24 months ]
    Death and cause of death by register data
  • Suicidal ideation [ Time Frame: 6, 12 and 24 months ]
    Suicidal ideation by BDI
  • Life-threatening conditions [ Time Frame: 6, 12 and 24 months ]
    Life-threatening conditions by register data
 
Integrated Mental Health Care and Vocational Rehabilitation to Individuals on Sick Leave Due to Anxiety and Depression
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
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

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.

Interventional
Not Applicable
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Other
  • Generalized Anxiety
  • Social Phobia
  • Panic Disorder
  • Depression
  • 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

  • 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

  • No Intervention: Control
    Standard treatment and standard vocational rehabilitation
  • Experimental: IBBIS MHC
    IBBIS mental health care and standard vocational rehabilitation
    Intervention: Behavioral: IBBIS mental health care and standard vocational rehabilitation
  • Experimental: IBBIS integrated MCH and VR
    Integrated mental health care and vocational rehabilitation
    Intervention: Other: Integrated mental health care and vocational rehabilitation
Poulsen R, Hoff A, Fisker J, Hjorthøj C, Eplov LF. Integrated mental health care and vocational rehabilitation to improve return to work rates for people on sick leave because of depression and anxiety (the Danish IBBIS trial): study protocol for a randomized controlled trial. Trials. 2017 Dec 2;18(1):578. doi: 10.1186/s13063-017-2272-1.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
603
768
August 2020
June 2018   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact: Lene F Eplov, MD PhD +45 38647461 lene.falgaard.eplov@regionh.dk
Contact: Rie Poulsen, MScPH +45 23258879 rie.poulsen@regionh.dk
Denmark
 
 
NCT02872051
IBBIS Anxiety Depression
No
Not Provided
Plan to Share IPD: Undecided
Lene Falgaard Eplov, Mental Health Centre Copenhagen
Mental Health Centre Copenhagen
  • Danish Agency for Labour Market and Recruitment, Denmark
  • Copenhagen Municipality, Denmark
  • Gentofte Municipality, Denmark
  • Municipality of Lyngby-Taarbæk, Denmark
  • Gladsaxe Municipality, Denmark
Not Provided
Mental Health Centre Copenhagen
April 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP