NCT02872051

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
631

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Apr 2016

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2016

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

August 15, 2016

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 18, 2016

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2019

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2020

Completed
Last Updated

February 4, 2026

Status Verified

February 1, 2026

Enrollment Period

3.2 years

First QC Date

August 15, 2016

Last Update Submit

February 2, 2026

Conditions

Generalized AnxietySocial PhobiaPanic DisorderDepression

Keywords

Vocational RehabilitationAnxietyDepressionCommon Mental DisordersCognitive Behavior TherapyReturn to WorkMental Health ServicesIntegration

Outcome Measures

Primary Outcomes (1)

  • Time to return to work

    Time from baseline to first return to work for more than four consecutive weeks

    12 months

Secondary Outcomes (7)

  • Work

    12 months

  • Time to return to work

    24 months

  • Recurrent Sickness Absence

    24 months

  • Degree of depressive symptoms

    6 months

  • Degree of anxiety symptoms

    6 months

  • +2 more secondary outcomes

Other Outcomes (4)

  • Symptom level

    6, 12 and 24 months

  • Death

    6, 12 and 24 months

  • Suicidal ideation

    6, 12 and 24 months

  • +1 more other outcomes

Study Arms (3)

Control

NO INTERVENTION

Standard treatment and standard vocational rehabilitation

IBBIS MHC

EXPERIMENTAL

IBBIS mental health care and standard vocational rehabilitation

Behavioral: IBBIS mental health care and standard vocational rehabilitation

IBBIS integrated MCH and VR

EXPERIMENTAL

Integrated mental health care and vocational rehabilitation

Other: Integrated mental health care and vocational rehabilitation

Interventions

Integrated mental health care and vocational rehabilitationOTHER

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

IBBIS integrated MCH and VR
IBBIS mental health care and standard vocational rehabilitationBEHAVIORAL

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

IBBIS MHC

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mental Health Services of the Capital Region of Denmark

Copenhagen, Capital Region of Denmark, 2100, Denmark

Location

Related Publications (3)

  • Hoff A, Poulsen RM, Fisker JP, Hjorthoj C, Nordentoft M, Christensen U, Bojesen AB, Eplov LF. Integrated Mental Healthcare and Vocational Rehabilitation for People on Sick Leave with Anxiety or Depression: 24-Month Follow-up of the Randomized IBBIS Trial. J Occup Rehabil. 2023 Sep;33(3):570-580. doi: 10.1007/s10926-023-10094-7. Epub 2023 Feb 27.

    PMID: 36849841DERIVED

  • Hoff A, Poulsen RM, Fisker J, Hjorthoj C, Rosenberg N, Nordentoft M, Bojesen AB, Eplov LF. Integrating vocational rehabilitation and mental healthcare to improve the return-to-work process for people on sick leave with depression or anxiety: results from a three-arm, parallel randomised trial. Occup Environ Med. 2022 Feb;79(2):134-142. doi: 10.1136/oemed-2021-107894. Epub 2021 Dec 16.

    PMID: 34916330DERIVED

  • Poulsen R, Hoff A, Fisker J, Hjorthoj C, Eplov LF. Integrated mental health care and vocational rehabilitation to improve return to work rates for people on sick leave because of depression and anxiety (the Danish IBBIS trial): study protocol for a randomized controlled trial. Trials. 2017 Dec 2;18(1):578. doi: 10.1186/s13063-017-2272-1.

    PMID: 29197414DERIVED

MeSH Terms

Conditions

Generalized Anxiety DisorderPhobia, SocialPanic DisorderDepressionAnxiety Disorders

Interventions

Rehabilitation, Vocational

Condition Hierarchy (Ancestors)

Mental DisordersPhobic DisordersBehavioral SymptomsBehavior

Intervention Hierarchy (Ancestors)

RehabilitationAftercareContinuity of Patient CarePatient CareTherapeuticsHealth ServicesHealth Care Facilities Workforce and Services

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
MD, PhD

Study Record Dates

First Submitted

August 15, 2016

First Posted

August 18, 2016

Study Start

April 1, 2016

Primary Completion

June 1, 2019

Study Completion

June 1, 2020

Last Updated

February 4, 2026

Record last verified: 2026-02

Locations

DK(1)