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

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

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.gov NCT04432129 . Registered on June 16, 2020.

Keywords: Common mental illness; Integrated mental health care; Randomized controlled trial; Vocational rehabilitation.

Conflict of interest statement

The authors declare that they have no competing interests.

© 2022. The Author(s).

Figures

Fig. 1
Fig. 1
Flowchart of the RCT

References

    1. OECD. Mental Health and Work: Denmark, Mental Health and Work. Paris: OECD Publishing; 2013. 10.1787/9789264188631-en.
    1. 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.
    1. 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. doi: 10.1186/s13063-017-2272-1.
    1. Søgaard H. Psykisk sygelighed hos langtidssygemeldte. 2007.
    1. Sørensen K, Vinther Nielsen C, Hjort J, Christensen KS, Ørnbøl E, Fink P. Om sygefravær Med fokus på sygemeldte i 8. fraværsuge. 2007.
    1. 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;3:636–645. doi: 10.1016/S2215-0366(16)30029-3.
    1. Mikkelsen MB, Rosholm M. Videnskortlægning af beskæftigelsesindsatser for sygemeldte borgere med lettere psykiske lidelser. 2017.
    1. 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;167:40–47. doi: 10.7326/M17-0046.
    1. 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.
    1. Duncan E, Best C, Hagen S. Shared decision making interventions for people with mental health conditions. Cochrane Database Syst Rev. 2010;Issue 1. 10.1002/14651858.CD007297.pub2.
    1. 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;183:228–232. doi: 10.1192/bjp.183.3.228.
    1. Bach B, Hutsebaut J. Level of Personality Functioning Scale–Brief Form 2.0: utility in capturing personality problems in psychiatric outpatients and incarcerated addicts. J Pers Assess. 2018;100:660–670. doi: 10.1080/00223891.2018.1428984.
    1. 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;22:448–457. doi: 10.1093/fampra/cmi025.
    1. 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;35:245–256. doi: 10.1017/S0033291704002892.
    1. 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. doi: 10.1186/1471-244X-6-34.
    1. 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;180:461–464. doi: 10.1192/bjp.180.5.461.
    1. Saboonchi F, Perski A, Grossi G. Validation of Karolinska Exhaustion Scale: psychometric properties of a measure of exhaustion syndrome. Scand J Caring Sci. 2013;27:1010–1017. doi: 10.1111/j.1471-6712.2012.01089.x.
    1. Sheehan DV, Harnett-Sheehan K, Raj BA. The measurement of disability. Int Clin Psychopharmacol. 1996;11:89–95. doi: 10.1097/00004850-199606003-00015.
    1. Leon AC, Olfson M, Portera L, Farber L, Sheehan DV. Assessing psychiatric impairment in primary care with the Sheehan Disability Scale. Int J Psychiatry Med. 1997;27:93–105. doi: 10.2190/T8EM-C8YH-373N-1UWD.
    1. 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;24:359–375. doi: 10.1080/02678373.2010.532644.
    1. Amtmann D, Bamer AM, Cook KF, Askew RL, Noonan VK, Brockway JA. University of Washington Self-Efficacy Scale: a new self-efficacy scale for people with disabilities. Arch Phys Med Rehabil. 2012;93:1757–1765. doi: 10.1016/j.apmr.2012.05.001.
    1. Burckhardt CS, Anderson KL. The Quality of Life Scale (QOLS): reliability, validity, and utilization. Health Qual Life Outcomes. 2003;1:60. doi: 10.1186/1477-7525-1-60.
    1. Turner N, Campbell J, Peters TJ, Wiles N, Hollinghurst S. A comparison of four different approaches to measuring health utility in depressed patients. Health Qual Life Outcomes. 2013;11:81. doi: 10.1186/1477-7525-11-81.
    1. 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. doi: 10.1136/bmj.e7586.

Source: PubMed

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