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

ID: NCT02872051
Status: Recruiting
Phase: N/A
Start Date: April 01, 2016
First Submitted: August 15, 2016
Last Updated: April 06, 2017
Results: N/A
Sponsors & Collaborators: Mental Health Centre Copenhagen, Danish Agency for Labour Market and Recruitment, Denmark, Copenhagen Municipality, Denmark, Gentofte Municipality and 5 more..
Location: Denmark
Conditions: Generalized Anxiety, Social Phobia, Panic Disorder, Depression
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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

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.
Condition or disease Intervention/treatment Phase

Depression

Generalized Anxiety

Panic Disorder

Social Phobia
Behavioral: IBBIS mental health care and standard vocational rehabilitation
Other Names
Other: Integrated mental health care and vocational rehabilitation
Other Names
N/A

Tracking Information

First Submitted DateAugust 15, 2016
Last Update Posted DateApril 06, 2017
Start DateApril 01, 2016
Anticipated Completion DateAugust 01, 2020
Primary Completion DateJune 01, 2018
Results First Submitted DateN/A
Received Results Disposit DateN/A

Current Primary Outcome Measures

  • Time to return to work [Time Frame: 12 months]

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

Original Primary Outcome Measures

Not Available

Current Secondary Outcome Measures

  • 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)

Original Secondary Outcome Measures

Not Available

Study Design

Brief TitleIntegrated Mental Health Care and Vocational Rehabilitation to Individuals on Sick Leave Due to Anxiety and Depression
Official TitleIntegrated 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
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

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 TypeInterventional
Study PhaseN/A
Estimated Enrollment
603
Allocation
Randomized
Interventional Model
Parallel Assignment
Masking
Double
Primary Purpose
Other
Conditions
Depression
Generalized Anxiety
Panic Disorder
Social Phobia
Target Follow-Up Duration N/A
Biospecimen:
N/A
Sampling MethodN/A
Study PopulationN/A
Intervention
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 Names
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

Other Names
Study Groups/Cohorts
Control
Standard treatment and standard vocational rehabilitation

IBBIS MHC
IBBIS mental health care and standard vocational rehabilitation

IBBIS integrated MCH and VR
Integrated mental health care and vocational rehabilitation

Study Arms
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

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

Arm Intervention/Treatment
Experimental IBBIS integrated MCH and VR
Integrated mental health care and vocational rehabilitation
 Other : Integrated mental health care and vocational rehabilitation
Experimental IBBIS MHC
IBBIS mental health care and standard vocational rehabilitation
 Behavioral : IBBIS mental health care and standard vocational rehabilitation

Recruitment Information

Recruitment Status:Recruiting
Enrollment603
Completion DateAugust 01, 2020
Eligibility 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
GenderAll
Age18 Years to N/A
Accepts Healthy VolunteersNo
Contacts
Listed Location Countries
Denmark

Administrative Information

NCT Number:NCT02872051
Other Study ID Numbers
IBBIS Anxiety Depression
Has Data Monitoring CommitteeNo
U.S. FDA-regulated Product Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Device Product Not Approved or Cleared by U.S. FDA: No
IPD Sharing Statement
Plan to Share IPD: Undecided
Responsible PartyLene Falgaard Eplov, Mental Health Centre Copenhagen
Study Sponsor
Mental Health Centre Copenhagen
Collaborators
Danish Agency for Labour Market and Recruitment, Denmark
Copenhagen Municipality, Denmark
Gentofte Municipality, Denmark
Municipality of Lyngby-Taarbæk, Denmark
Gladsaxe Municipality, Denmark
Investigators
Not Available