Integrated Mental Health Care and Vocational Rehabilitation to People With to Common Mental Disorders

NCT04432129 | Completed

• 1 other identifier: Version 3.1. 27.5.2020
• Study Type: interventional
• Target: 900
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

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

Keywords

Vocational rehabilitation; Mental health services; Return to Work

Outcome Measures

Primary Outcomes (1)

• Return to work

  Difference between the two groups in time to return to work from baseline until 12 months after baseline measured whit register based data. Time to return to work is defined as a minimum of four weeks of continuous work without receiving sickness benefit.

  12 months

Secondary Outcomes (9)

• Work at one point during follow-up

  12 months

• Return to work

  6 months

• Supported work at one point during follow-up

  12 months

• Weeks of work

  12 months

• Time to new sick leave

  12 months

Study Arms (2)

IBBIS II

EXPERIMENTAL

Integrated Mental Health Care and Vocational Rehabilitation

Behavioral: IBBIS II

Service As Usual

ACTIVE COMPARATOR

Standard vocational rehabilitation and treatment

Behavioral: Service as Usual

Interventions

IBBIS II BEHAVIORAL

The IBBIS-II service consists of: 1. Mental health assessment. 2. Planned integrated service. The participant has the same employment specialists and care manager throughout the intervention. A joint plan is made with shared decisions between the participant, the employment specialist and the care manager. There is a focus on disclosure (openness about illness) and involvement of relatives and significant others. 3. Vocational rehabilitation. Focus on return to work with ongoing assessment of job goals, competencies and need of support. Participants receive help in contacting existing employers (employed) and potential employers (unemployed). Unemployed participants are offered an individualized job search effort. The focus is on competitive jobs within the community. 4. Treatment consists of stepped care with structured treatment guidelines. 5. When the participant has obtained work the team continues to offer support.

IBBIS II

Service as Usual BEHAVIORAL

Service as usual consists of standard mental health care and vocational rehabilitation

Service As Usual

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Amager Hospital: lead
• The Danish Agency for Labour Market and Recruitment: collaborator
• Central Denmark Region: collaborator
• Aarhus Kommune: collaborator
• Københavns Kommune: collaborator

Study Sites (1)

Copenhagen Research Center for Mental Health - CORE

Copenhagen, 2900, Denmark

Location

Related Publications (2)

• Christensen TN, Poulsen CH, Ebersbach BK, Eplov LF. Integrated mental health care and vocational rehabilitation intervention to improve return to work rates for people on sick leave due to common mental and functional disorders (IBBIS-II)-a study protocol for a randomized clinical trial. Trials. 2022 Sep 30;23(1):820. doi: 10.1186/s13063-022-06718-7.

  PMID: 36175977 BACKGROUND

• Christensen TN, Hjorthoj C, Poulsen CH, Ebersbach B, Eplov LF. Integrated mental health care and vocational rehabilitation intervention to improve return to work rates for people on sick leave due to common mental and functional disorders (IBBIS-II) - results from a randomized clinical trial. Nord J Psychiatry. 2025 Jan;79(1):86-95. doi: 10.1080/08039488.2024.2446362. Epub 2025 Jan 6.

  PMID: 39760219 DERIVED

Related Links

• study protocol article

MeSH Terms

Conditions

Depression; Anxiety Disorders; Personality Disorders

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Mental Disorders

Study Officials

• Lene F Eplov, PhD

  Mental Health Center Copenhagen

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of Research, Associate professor

Study Record Dates

• First Submitted: June 9, 2020
• First Posted: June 16, 2020
• Study Start: June 9, 2020
• Primary Completion: October 1, 2022
• Study Completion: October 1, 2022
• Last Updated: February 4, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)