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

Not Applicable

Completed

• Conditions: Generalized Anxiety; Social Phobia; Panic Disorder; Depression
• Interventions: Behavioral: IBBIS mental health care and standard vocational rehabilitation; Other: Integrated mental health care and vocational rehabilitation

• Registration Number: NCT02872051
• Lead Sponsor: Mental Health Services in the Capital Region, Denmark

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 Timeline

• Study Start: 2016-04
• Study First Submitted: 2016-08-15
• Study First Submitted QC: 2016-08-17
• Study First Posted: 2016-08-18
• Primary Completion: 2019-06
• Study Completion: 2020-06
• Status Verified: 2024-02
• Last Update Submitted: 2024-02-06
• Last Update Posted: 2024-02-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 631

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
IBBIS MHC	IBBIS mental health care and standard vocational rehabilitation	IBBIS mental health care and standard vocational rehabilitation
IBBIS integrated MCH and VR	Integrated mental health care and vocational rehabilitation	Integrated mental health care and vocational rehabilitation

Primary Outcome Measures

Name	Time	Method
Time to return to work	12 months	Time from baseline to first return to work for more than four consecutive weeks

Secondary Outcome Measures

Name	Time	Method
Time to return to work	24 months	Time from baseline to first return to work for more than four consecutive weeks
Work	12 months	Competitive work 12 months after baseline (yes/no)
Recurrent Sickness Absence	24 months	Time from baseline to recurrent sickness absence for more than 8 weeks
Degree of depressive symptoms	6 months	Self-assessed depressive symptoms by the Beck Depression Inventory (BDI)
Degree of anxiety symptoms	6 months	Self-assessed anxiety symptoms by the Beck Anxiety Inventory (BAI)
Degree of psychological stress symptoms	6 months	Self-assessed psychological stress by the Cohen perceived stress scale (PSS)
Work and social functioning	6 months	Work and social functioning by the Work and Social Adjustment Scale (WSAS)

Trial Locations

Locations (1)

Mental Health Services of the Capital Region of Denmark; 🇩🇰 Copenhagen, Capital Region Of Denmark, Denmark