Protocol for the Individual Placement and Support (IPS) in Pain Trial: A randomized controlled trial investigating the effectiveness of IPS for patients with chronic pain

Lene Therese B Linnemørken, Vigdis Sveinsdottir, Thomas Knutzen, Linn Rødevand, Kjersti Helene Hernæs, Silje Endresen Reme, Lene Therese B Linnemørken, Vigdis Sveinsdottir, Thomas Knutzen, Linn Rødevand, Kjersti Helene Hernæs, Silje Endresen Reme

Abstract

Background: Work disability involves large costs to the society as well as to the individual. Work disability is common among people with chronic pain conditions, yet few effective interventions exist. Individual Placement and Support (IPS) is an evidence-based work rehabilitation model originally developed to help people with severe mental illness obtain and maintain employment. The effectiveness of IPS for patients with severe mental illness is well documented, but the model has never before been tested for patients with chronic pain.

Methods/design: The aim of the IPS in Pain trial is to investigate the effectiveness of IPS as an integrated part of the interdisciplinary treatment for patients with chronic pain in a hospital outpatient clinic. The study is a randomized controlled trial comparing pain treatment with integrated IPS to treatment as usual in unemployed patients suffering from various chronic pain conditions. The primary outcome of the study is labor market participation during 12 months after enrollment, and secondary outcomes include physical and mental health and well-being, collected at baseline, 6, and 12 months. Finally, there will be an additional long-term follow-up for the primary outcome, which will be collected through a brief phone interview at 24 months.

Discussion: The IPS in Pain trial will be the first report of the effectiveness of the IPS model of supported employment applied in an outpatient setting for chronic pain patients. It will thus provide important information about the effectiveness of repurposing IPS to a new patient group in great need of job support.

Trial registration: Clinicaltrials.gov: NCT02697656 . Registered January 15th, 2016.

Keywords: Chronic pain; Coping; Individual placement and support; Integrated care; Randomized controlled trial; Supported employment; Unemployment; Vocational rehabilitation; Work disability.

Conflict of interest statement

Ethical approval and consent to participate

The project was submitted to the Norwegian Regional Ethical Committee and therefrom referred to the Data Protection Officer at Oslo University Hospital, who approved the study (project number: 2015/14224). All the principles of the Helsinki declaration will be followed. After a complete description of the study’s process and purposes has been given, each participant will sign a declaration of voluntary participation. The right to withdraw from the study at any time without any explanation, and without any consequences for the further treatment at the clinic, will be emphasized.

Consent for publication

Not applicable.

Competing interests

TK is the sole proprietor of IPS Norway, a company that provides IPS services and consulting services. The remaining authors declare that they have no competing interests.

Publisher’s Note

Springer Nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations.

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References

    1. Rustoen T, Wahl AK, Hanestad BR, Lerdal A, Paul S, Miaskowski C. Prevalence and characteristics of chronic pain in the general Norwegian population. Eur J Pain. 2004;8(6):555–565. doi: 10.1016/j.ejpain.2004.02.002.
    1. Landmark T, Romundstad P, Dale O, Borchgrevink PC, Kaasa S. Estimatgging the prevalence of chronic pain: validation of recall against longitudinal reporting (the HUNT pain study) Pain. 2012;153(7):1368–1373. doi: 10.1016/j.pain.2012.02.004.
    1. Overland S, Harvey SB, Knudsen AK, Mykletun A, Hotopf M. Widespread pain and medically certified disability pension in the Hordaland health study. Eur J Pain. 2012;16(4):611–620. doi: 10.1016/j.ejpain.2011.08.005.
    1. Breivik H, Collett B, Ventafridda V, Cohen R, Gallacher D. Survey of chronic pain in Europe: prevalence, impact on daily life, and treatment. Eur J Pain. 2006;10(4):287–333. doi: 10.1016/j.ejpain.2005.06.009.
    1. Lame IE, Peters ML, Vlaeyen JW, Kleef M, Patijn J. Quality of life in chronic pain is more associated with beliefs about pain, than with pain intensity. Eur J Pain. 2005;9(1):15–24. doi: 10.1016/j.ejpain.2004.02.006.
    1. Rueda S, Chambers L, Wilson M, Mustard C, Rourke SB, Bayoumi A, Raboud J, Lavis J. Association of returning to work with better health in working-aged adults: a systematic review. Am J Public Health. 2012;102(3):541–556. doi: 10.2105/AJPH.2011.300401.
    1. Paul KI, Moser K. Unemployment impairs mental health: meta-analyses. J Vocat Behav. 2009;74(3):264–282. doi: 10.1016/j.jvb.2009.01.001.
    1. Ihlebæk C, Lærum E. Plager flest - koster mest - muskel- og skjelettlidelser i Norge. Oslo: Nasjonalt ryggnettverk; 2004.
    1. Schatman ME. Interdisciplinary Chronic Pain Management: International Perspectives. In: Pain Clinical Updates. 2012;20(7). .
    1. Lambeek LC, Bosmans JE, Van Royen BJ, Van Tulder MW, Van Mechelen W, Anema JR. Effect of integrated care for sick listed patients with chronic low back pain: economic evaluation alongside a randomised controlled trial. BMJ. 2010;341:c6414. doi: 10.1136/bmj.c6414.
    1. OECD . Mental health and work: Norway. 2013.
    1. Nilsen G, Elstad I. Arbeid og verdighet. Pasienters fortellinger fra livet med langvarige smerter. Nordisk Tidsskrift for Helseforskning. 2006;4(2):27–39.
    1. Bond GR, Becker DR, Drake RE, Rapp CA, Meisler N, Lehman AF, Bell MD, Blyler CR. Implementing supported employment as an evidence-based practice. Psychiatr Serv. 2001;52(3):313–322. doi: 10.1176/appi.ps.52.3.313.
    1. Drake RE, McHugo GJ, Bebout RR, Becker DR, Harris M, Bond GR, Quimby E. A randomized clinical trial of supported employment for inner-city patients with severe mental disorders. Arch Gen Psychiatry. 1999;56(7):627–633. doi: 10.1001/archpsyc.56.7.627.
    1. Bond GR. Making the case for IPS supported employment. Adm Paolicy Ment Health. 2012;41(1):69–73. doi: 10.1007/s10488-012-0444-6.
    1. Corrigan PW. Place-then-train: an alternative service paradigm for persons with psychiatric disabilities. Clin Psychol Sci Pract. 2001;8(3):334–349. doi: 10.1093/clipsy.8.3.334.
    1. Drake RE, Bond GR, Goldman HH, Hogan MF, Karakus M. Individual placement and support services boost employment for people with serious mental illnesses, but funding is lacking. Health Aff (Millwood) 2016;35(6):1098–1105. doi: 10.1377/hlthaff.2016.0001.
    1. Luciano A, Bond GR, Drake RE. Does employment alter the course and outcome of schizophrenia and other severe mental illnesses? A systematic review of longitudinal research. Schizophr Res. 2014;159(2–3):312–321. doi: 10.1016/j.schres.2014.09.010.
    1. Auvray M, Myin E, Spence C. The sensory-discriminative and affective-motivational aspects of pain. Neurosci Biobehav Rev. 2010;34(2):214–223. doi: 10.1016/j.neubiorev.2008.07.008.
    1. International Association for the Study of Pain . IASP taxonomy. 2012.
    1. Villano CL, Rosenblum A, Magura S, Fong C, Cleland C, Betzler TF. Prevalence and correlates of posttraumatic stress disorder and chronic severe pain in psychiatric outpatients. J Rehabil Res Dev. 2007;44:167–78. doi: 10.1682/JRRD.2006.05.0052.
    1. Reme SE, Tangen T, Moe T, Eriksen HR. Prevalence of psychiatric disorders in sick listed chronic low back pain patients. Eur J Pain. 2011;15(10):1075–1080. doi: 10.1016/j.ejpain.2011.04.012.
    1. Dersh J, Gatchel RJ, Mayer T, Polatin P, Temple OR. Prevalence of psychiatric disorders in patients with chronic disabling occupational spinal disorders. Spine (Phila Pa 1976) 2006;31(10):1156–1162. doi: 10.1097/01.brs.0000216441.83135.6f.
    1. Von Korff M, Crane P, Lane M, Miglioretti DL, Simon G, Saunders K, Stang P, Brandenburg N, Kessler R. Chronic spinal pain and physical-mental comorbidity in the United States: results from the national comorbidity survey replication. Pain. 2005;113(3):331–339. doi: 10.1016/j.pain.2004.11.010.
    1. Rodevand L, Ljosaa TM, Granan LP, Knutzen T, Jacobsen HB, Reme SE. A pilot study of the individual placement and support model for patients with chronic pain. BMC Musculoskelet Disord. 2017;18(1):550. doi: 10.1186/s12891-017-1908-3.
    1. Bejerholm U, Areberg C, Hofgren C, Sandlund M, Rinaldi M. Individual placement and support in Sweden - a randomized controlled trial. Nord J Psychiatry. 2015;69(1):57–66. doi: 10.3109/08039488.2014.929739.
    1. Bond GR, Campbell K, Drake RE. Standardizing measures in four domains of employment outcomes for individual placement and support. Psychiatr Serv. 2012;63(8):751–757. doi: 10.1176/appi.ps.201100270.
    1. EuroQol G. EuroQol - a new facility for the measurement of health-related quality of life. Health Policy. 1990;16(3):199–208. doi: 10.1016/0168-8510(90)90421-9.
    1. Fairbank JC, Pynsent PB. The Oswestry disability index. Spine (Phila Pa 1976) 2000;25(22):2940–2952. doi: 10.1097/00007632-200011150-00017.
    1. Derogatis LR, Lipman RS, Rickels K, Uhlenhuth EH, Covi L. The Hopkins symptom checklist (HSCL). A measure of primary symptom dimensions. Mod Probl Pharmacopsychiatry. 1974;7(0):79–110. doi: 10.1159/000395070.
    1. Swanson S, Becker DR. Individual Placement and Support; en praktisk veileder In. Oslo: Edited by Afføringsbedriftene; 2013.
    1. Drake RE, Bond GR, Becker DR. IPS supported employment: an evidence-based approach to supported employment. New York: Oxford University Press; 2012.
    1. Malterud K, Siersma VD, Guassora AD. Sample size in qualitative interview studies: guided by information power. Qual Health Res. 2015; .
    1. Bond GR, Drake RE, Becker DR. An update on randomized controlled trials of evidence-based supported employment. Psychiatr Rehabil J. 2008;31(4):280–290. doi: 10.2975/31.4.2008.280.290.
    1. Bond GR, Peterson AE, Becker DR, Drake RE. Validation of the revised individual placement and support Fidelity scale (IPS-25) Psychiatr Serv. 2012;63(8):758–763. doi: 10.1176/appi.ps.201100476.
    1. IPS Fidelity Scale - Norwegian version [].
    1. Becker DR, Swanson SJ, Reese SL, Bond GR, McLeman BM: Supported employment Fidelity review manual: a companion guide to the evidence-based IPS supported employment Fidelity scale third edn; 2015.

Source: PubMed

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