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

Depression Clinical Trial

— IBBIS  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02872051
• Other study ID #: IBBIS Anxiety Depression
• Status: Completed
• Phase: N/A
• Start date: April 2016
• Est. completion date: June 2020

Study information

• Verified date: February 2024
• Source: Mental Health Services in the Capital Region, Denmark
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 631
• Est. completion date: June 2020
• Est. primary completion date: June 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Anxiety Disorders
• Depression
• Depressive Disorder
• Generalized Anxiety
• Panic Disorder
• Phobia, Social
• Social Phobia

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:
• 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

Locations

Country	Name	City	State
Denmark	Mental Health Services of the Capital Region of Denmark	Copenhagen	Capital Region Of Denmark

Sponsors (6)

Lead Sponsor	Collaborator
Mental Health Services in the Capital Region, Denmark	Copenhagen Municipality, Denmark, Gentofte Municipality, Denmark, Gladsaxe Municipality, Denmark, Municipality of Lyngby-Taarbæk, Denmark, The Danish Agency for Labour Market and Recruitment

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Symptom level	Symptom level on de four dimensions: Distress, Depression, Anxiety and Somatization by 4-dimensional symptom questionnaire (4DSQ)	6, 12 and 24 months
Other	Death	Death and cause of death by register data	6, 12 and 24 months
Other	Suicidal ideation	Suicidal ideation by BDI	6, 12 and 24 months
Other	Life-threatening conditions	Life-threatening conditions by register data	6, 12 and 24 months
Primary	Time to return to work	Time from baseline to first return to work for more than four consecutive weeks	12 months
Secondary	Work	Competitive work 12 months after baseline (yes/no)	12 months
Secondary	Time to return to work	Time from baseline to first return to work for more than four consecutive weeks	24 months
Secondary	Recurrent Sickness Absence	Time from baseline to recurrent sickness absence for more than 8 weeks	24 months
Secondary	Degree of depressive symptoms	Self-assessed depressive symptoms by the Beck Depression Inventory (BDI)	6 months
Secondary	Degree of anxiety symptoms	Self-assessed anxiety symptoms by the Beck Anxiety Inventory (BAI)	6 months
Secondary	Degree of psychological stress symptoms	Self-assessed psychological stress by the Cohen perceived stress scale (PSS)	6 months
Secondary	Work and social functioning	Work and social functioning by the Work and Social Adjustment Scale (WSAS)	6 months