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 : Completed

First Posted : August 18, 2016

Last Update Posted : January 28, 2021

View this study on Beta.ClinicalTrials.gov

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

Tracking Information

First Submitted Date ^ICMJE

August 15, 2016

First Posted Date ^ICMJE

August 18, 2016

Last Update Posted Date

January 28, 2021

Actual Study Start Date ^ICMJE

April 2016

Actual Primary Completion Date

June 2019 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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 ^ICMJE

Same as current

Change History

Current Secondary Outcome Measures ^ICMJE

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 ^ICMJE

Same as current

Current Other Pre-specified Outcome Measures

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

Original Other Pre-specified Outcome Measures

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

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

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 Type ^ICMJE

Interventional

Study Phase ^ICMJE

Not Applicable

Study Design ^ICMJE

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Other

Condition ^ICMJE

Generalized Anxiety
Social Phobia
Panic Disorder
Depression

Intervention ^ICMJE

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

Study Arms ^ICMJE

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

Publications *

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Actual Enrollment ^ICMJE

631

Original Estimated Enrollment ^ICMJE

768

Actual Study Completion Date ^ICMJE

June 2020

Actual Primary Completion Date

June 2019 (Final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Sex/Gender ^ICMJE

Sexes Eligible for Study:

All

Ages ^ICMJE

18 Years and older (Adult, Older Adult)

Accepts Healthy Volunteers ^ICMJE

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Listed Location Countries ^ICMJE

Denmark

Removed Location Countries

Administrative Information

NCT Number ^ICMJE

NCT02872051

Other Study ID Numbers ^ICMJE

IBBIS Anxiety Depression

Has Data Monitoring Committee

U.S. FDA-regulated Product

Not Provided

IPD Sharing Statement ^ICMJE

Plan to Share IPD:

Undecided

Current Responsible Party

Lene Falgaard Eplov, Mental Health Centre Copenhagen

Original Responsible Party

Same as current

Current Study Sponsor ^ICMJE

Mental Health Centre Copenhagen

Original Study Sponsor ^ICMJE

Same as current

Collaborators ^ICMJE

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

Investigators ^ICMJE

Not Provided

PRS Account

Mental Health Centre Copenhagen

Verification Date

January 2021

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

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