Integrated Mental Health Care and Vocational Rehabilitation to People With to Common Mental Disorders (IBBIS II)

Amager Hospital

Status: Completed

Conditions: Common Mental Disorders; Depression; Functional Disease Present; Anxiety; Personality Disorders; Stress

Treatments: Behavioral: Service as Usual; Behavioral: IBBIS II

Study type: Interventional

Funder types: Other

Identifiers

NCT04432129

Version 3.1. 27.5.2020

Details and patient eligibility

About

The purpose of this study is to investigate the efficacy of an integrated mental health care and vocational rehabilitation intervention for people on sick leave because of depression, stress, anxiety, personality- and functional disorders in Denmark

Full description

Background:

Mental illness has an estimated financial burden on the Danish economy of 3.4 % of Gross National Product every year due to lost productivity, social benefits and healthcare costs and approximately 50 % of people receiving long-term sickness benefits have a common mental illness. Furthermore, a significant treatment gap exists where less than 30% were treated for their mental illness.

Objective:

The primary objective of the randomized trial is to examine whether people on sick leave with a diagnosis of anxiety, depression, stress, personality disorders or functional disorders, return to work faster and have a higher job retention if they receive an integrated and optimized vocational rehabilitation and mental health care intervention, compared to people who receive the standard mental health care and vocational rehabilitation service.

Method:

The trial is designed as an randomized, two-group parallel, assessor-blinded, multisite trial. A total of 800 participants with a common mental illness will randomly be assigned into two groups 1) IBBIS II, consisting of an integrated mental health care and vocational rehabilitation; or 2) Service as usual, at two sites in Denmark. The primary outcome is difference between the two groups in time to 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.

Enrollment: 900 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

- Inclusion criteria

• Anxiety, depression, stress, personality disorder or functional disorder diagnosed at a structured diagnostic interview based on the Mini International Neuropsychiatric Interview conducted by the IBBIS team
• Sickness benefit recipient at baseline; on sick leave from job or unemployed for a minimum of four weeks
• Resident in Copenhagen or Aarhus municipalities
• Speak sufficient Danish to participate in interviews and complete questionnaires without an interpreter
• Aged 18 or older
• Has given informed written consent

Exclusion criteria

• Pregnant
• High degree of suicidal ideation
• Dementia
• Abuse of alcohol or other drugs to the degree that participation in therapy is not possible
• A need for mental health treatment in secondary sector care
• Unstable somatic condition that is too severe for participation in the project
• The participant will not refrain from participating in other psychotherapeutic treatment outside the IBBIS project if the participant will be allocated to the experimental group

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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900 participants in 2 patient groups

IBBIS II

Experimental group

Description:

Integrated Mental Health Care and Vocational Rehabilitation

Treatment:

Behavioral: IBBIS II

Service As Usual

Active Comparator group

Description:

Standard vocational rehabilitation and treatment

Treatment:

Behavioral: Service as Usual