Skip to main content
Top
Published in: Trials 1/2022

Open Access 01-12-2022 | Care | Study protocol

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

Authors: Thomas Nordahl Christensen, Chalotte Heinsvig Poulsen, Bea Kolbe Ebersbach, Lene Falgaard Eplov

Published in: Trials | Issue 1/2022

Login to get access

Abstract

Background

Mental illness has an estimated financial burden on the Danish economy of 3.4% of the 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% are treated for their mental illness. 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 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.

Methods

The trial is designed as an investigator-initiated, randomized, two-group parallel, assessor-blinded, superior trial. A total of 900 participants with a common mental illness will randomly be assigned into two groups: (1) IBBIS-II, consisting of integrated mental health care and vocational rehabilitation, or (2) service as usual (SAU), at two sites in Denmark. The primary outcome is the difference between the two groups in time to return to work (RTW) at 12 months using data from the Danish Register for Evaluation of Marginalization (DREAM) database.

Discussion

This study will contribute with new knowledge on vocational recovery and integrated vocational and health care interventions in a Scandinavian context.

Trial registration

ClinicalTrials.​govNCT04432129. Registered on June 16, 2020
Literature
2.
go back to reference Poulsen R, Fisker J, Hoff A, Hjorthøj C, Eplov LF. Integrated mental health care and vocational rehabilitation to improve return to work rates for people on sick leave because of exhaustion disorder, adjustment disorder, and distress (the Danish IBBIS trial): study protocol for a randomized controlled trial. Trials. 2017;18:1–14. Poulsen R, Fisker J, Hoff A, Hjorthøj C, Eplov LF. Integrated mental health care and vocational rehabilitation to improve return to work rates for people on sick leave because of exhaustion disorder, adjustment disorder, and distress (the Danish IBBIS trial): study protocol for a randomized controlled trial. Trials. 2017;18:1–14.
3.
go back to reference Poulsen R, Hoff A, Fisker J, Hjorthøj 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;18:578.CrossRef Poulsen R, Hoff A, Fisker J, Hjorthøj 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;18:578.CrossRef
5.
go back to reference Sørensen K, Vinther Nielsen C, Hjort J, Christensen KS, Ørnbøl E, Fink P. Om sygefravær Med fokus på sygemeldte i 8. fraværsuge; 2007. Sørensen K, Vinther Nielsen C, Hjort J, Christensen KS, Ørnbøl E, Fink P. Om sygefravær Med fokus på sygemeldte i 8. fraværsuge; 2007.
6.
go back to reference Moran P, Romaniuk H, Coffey C, Chanen A, Degenhardt L, Borschmann R, et al. The influence of personality disorder on the future mental health and social adjustment of young adults: a population-based, longitudinal cohort study. Lancet Psychiatry. 2016;3:636–45.CrossRef Moran P, Romaniuk H, Coffey C, Chanen A, Degenhardt L, Borschmann R, et al. The influence of personality disorder on the future mental health and social adjustment of young adults: a population-based, longitudinal cohort study. Lancet Psychiatry. 2016;3:636–45.CrossRef
7.
go back to reference Mikkelsen MB, Rosholm M. Videnskortlægning af beskæftigelsesindsatser for sygemeldte borgere med lettere psykiske lidelser; 2017. Mikkelsen MB, Rosholm M. Videnskortlægning af beskæftigelsesindsatser for sygemeldte borgere med lettere psykiske lidelser; 2017.
8.
go back to reference Boutron I, Altman DG, Moher D, Schulz KF, Ravaud P, CONSORT NPT Group. CONSORT statement for randomized trials of nonpharmacologic treatments: a 2017 update and a CONSORT extension for nonpharmacologic trial abstracts. Ann Intern Med. 2017;167:40–7.CrossRef Boutron I, Altman DG, Moher D, Schulz KF, Ravaud P, CONSORT NPT Group. CONSORT statement for randomized trials of nonpharmacologic treatments: a 2017 update and a CONSORT extension for nonpharmacologic trial abstracts. Ann Intern Med. 2017;167:40–7.CrossRef
9.
go back to reference Sheehan DV, Lecrubier Y, Sheehan KH, Amorim P, Janavs J, Weiller E, et al. The Mini-International Neuropsychiatric Interview (M.I.N.I.): the development and validation of a structured diagnostic psychiatric interview for DSM-IV and ICD-10. J Clin Psychiatry. 1998;59:22–33.PubMed Sheehan DV, Lecrubier Y, Sheehan KH, Amorim P, Janavs J, Weiller E, et al. The Mini-International Neuropsychiatric Interview (M.I.N.I.): the development and validation of a structured diagnostic psychiatric interview for DSM-IV and ICD-10. J Clin Psychiatry. 1998;59:22–33.PubMed
11.
go back to reference Moran P, Leese M, Lee T, Walters P, Thornicroft G, Mann A. Standardised Assessment of Personality - Abbreviated Scale (SAPAS): preliminary validation of a brief screen for personality disorder. Br J Psychiatry. 2003;183:228–32.CrossRef Moran P, Leese M, Lee T, Walters P, Thornicroft G, Mann A. Standardised Assessment of Personality - Abbreviated Scale (SAPAS): preliminary validation of a brief screen for personality disorder. Br J Psychiatry. 2003;183:228–32.CrossRef
13.
go back to reference Christensen KS, Fink P, Toft T, Frostholm L, Ørnbøl E, Olesen F. A brief case-finding questionnaire for common mental disorders: the CMDQ. Fam Pract. 2005;22:448–57.CrossRef Christensen KS, Fink P, Toft T, Frostholm L, Ørnbøl E, Olesen F. A brief case-finding questionnaire for common mental disorders: the CMDQ. Fam Pract. 2005;22:448–57.CrossRef
14.
go back to reference Kessler RC, Adler L, Ames M, Demler O, Faraone S, Hiripi E, et al. The World Health Organization adult ADHD Self-Report Scale (ASRS): a short screening scale for use in the general population. Psychol Med. 2005;35:245–56.CrossRef Kessler RC, Adler L, Ames M, Demler O, Faraone S, Hiripi E, et al. The World Health Organization adult ADHD Self-Report Scale (ASRS): a short screening scale for use in the general population. Psychol Med. 2005;35:245–56.CrossRef
15.
go back to reference Terluin B, van Marwijk HWJ, Adèr HJ, de Vet HCW, Penninx BWJH, Hermens MLM, et al. The Four-Dimensional Symptom Questionnaire (4DSQ): a validation study of a multidimensional self-report questionnaire to assess distress, depression, anxiety and somatization. BMC Psychiatry. 2006;6:34.CrossRef Terluin B, van Marwijk HWJ, Adèr HJ, de Vet HCW, Penninx BWJH, Hermens MLM, et al. The Four-Dimensional Symptom Questionnaire (4DSQ): a validation study of a multidimensional self-report questionnaire to assess distress, depression, anxiety and somatization. BMC Psychiatry. 2006;6:34.CrossRef
16.
go back to reference Mundt JC, Marks IM, Shear MK, Greist JH. The Work and Social Adjustment Scale: a simple measure of impairment in functioning. Br J Psychiatry. 2002;180:461–4.CrossRef Mundt JC, Marks IM, Shear MK, Greist JH. The Work and Social Adjustment Scale: a simple measure of impairment in functioning. Br J Psychiatry. 2002;180:461–4.CrossRef
18.
go back to reference Sheehan DV, Harnett-Sheehan K, Raj BA. The measurement of disability. Int Clin Psychopharmacol. 1996;11:89–95 Lippincott Williams and Wilkins.CrossRef Sheehan DV, Harnett-Sheehan K, Raj BA. The measurement of disability. Int Clin Psychopharmacol. 1996;11:89–95 Lippincott Williams and Wilkins.CrossRef
20.
go back to reference Lagerveld SE, Blonk RWB, Brenninkmeijer V, Schaufeli WB. Return to work among employees with mental health problems: development and validation of a self-efficacy questionnaire. Work Stress. 2010;24:359–75 Taylor & Francis Group.CrossRef Lagerveld SE, Blonk RWB, Brenninkmeijer V, Schaufeli WB. Return to work among employees with mental health problems: development and validation of a self-efficacy questionnaire. Work Stress. 2010;24:359–75 Taylor & Francis Group.CrossRef
24.
go back to reference Chan AW, Tetzlaff JM, Gøtzsche PC, Altman DG, Mann H, Berlin JA, et al. SPIRIT 2013 explanation and elaboration: guidance for protocols of clinical trials. BMJ. 2013;346:1–42.CrossRef Chan AW, Tetzlaff JM, Gøtzsche PC, Altman DG, Mann H, Berlin JA, et al. SPIRIT 2013 explanation and elaboration: guidance for protocols of clinical trials. BMJ. 2013;346:1–42.CrossRef
Metadata
Title
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
Authors
Thomas Nordahl Christensen
Chalotte Heinsvig Poulsen
Bea Kolbe Ebersbach
Lene Falgaard Eplov
Publication date
01-12-2022
Publisher
BioMed Central
Keyword
Care
Published in
Trials / Issue 1/2022
Electronic ISSN: 1745-6215
DOI
https://doi.org/10.1186/s13063-022-06718-7

Other articles of this Issue 1/2022

Trials 1/2022 Go to the issue