We updated the design of this site on December 18, 2017. Learn more.
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 38 of 200 for:    Recruiting, Not yet recruiting, Available Studies | "Mental Health"

Integrated Mental Health Care and Vocational Rehabilitation to Individuals on Sick Leave Due to Stress Disorders (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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02885519
Recruitment Status : Recruiting
First Posted : August 31, 2016
Last Update Posted : April 10, 2017
Sponsor:
Collaborators:
Information provided by (Responsible Party):

August 15, 2016
August 31, 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 NCT02885519 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 anxiety symptoms by the Beck Anxiety 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
Same as current
 
Integrated Mental Health Care and Vocational Rehabilitation to Individuals on Sick Leave Due to Stress Disorders
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

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.

Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Other
  • Adjustment Disorder
  • Burnout
  • Psychological Stress
  • 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

  • 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

  • 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: Behavioral: Integrated mental health care and vocational rehabilitation
Not Provided

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

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
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
 
 
NCT02885519
IBBIS Stress
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