A randomized controlled trial to examine the impacts of disclosing personalized depression risk information on the outcomes of individuals who are at high risk of developing major depression: a research protocol

JianLi Wang, Glenda MacQueen, Scott Patten, Douglas Manuel, Bonnie Lashewicz, Norbert Schmitz, JianLi Wang, Glenda MacQueen, Scott Patten, Douglas Manuel, Bonnie Lashewicz, Norbert Schmitz

Abstract

Background: Major depressive disorder is one of the most prevalent and disabling forms of mental illness in the general population. One public health strategy that may reduce the disease burden is early identification and prevention - identifying people who are at high risk and intervening to prevent symptoms from progressing into a major depressive episode (MDE). Multivariable risk predictive algorithms (MVRP) have been developed to estimate personalized risk (probability) of an MDE. The purpose of this trial is to answer the questions: (1) Does disclosure of personalized depression risk information promote high-risk individuals to take preventive actions? (2) Will disclosure of personalized depression risk information negatively affect the mental health of those at high risk?

Methods: We are recruiting 350 high-risk men and 350 high-risk women across the country. Individuals are eligible, if they: (1) are 18 years or older, (2) have not had a depressive episode in the past two months, (3) are at high risk of MDE based on the MVRPs (predicted risk of 6.5% + for men and of 11.2% + for women), (4) can communicate in either English or French, and (5) agree to be contacted for follow-up interviews. The MVRPs were developed and validated using longitudinal data from over 10,000 Canadians across the country. Eligible participants are randomized into (1) the control group, and (2) the group receiving personalized depression risk information. The participants are assessed at baseline, 6 and 12 months regarding accuracy of risk perception, use of self-help strategies and changes in psychological distress and functioning. Qualitative interviews are conducted in sub-samples of the intervention groups to explore how the personalized information affects risk perception, self-help behaviors and mental health.

Discussion: MVRPs can be used for risk stratification and planning preventive actions. The personalized risk information produced by MVRPs may also empower users to actively engage in self-management. This trial will contribute to the knowledge base about the potential health benefits and psychological harms associated with the provision of personalized depression risk information that will inform future implementation and patient-physician communication in the clinical settings.

Trial registration: NCT02943876 . Date of trial registration: October 21st, 2016.

Keywords: Early identification; General population; High risk; Major depression; Multivariable risk predictive algorithms; Psychological distress; Self-help.

Conflict of interest statement

The authors declare that they have no competing interests.

Figures

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Fig. 1
Project operational flowchart

References

    1. Whiteford Harvey A, Degenhardt Louisa, Rehm Jürgen, Baxter Amanda J, Ferrari Alize J, Erskine Holly E, Charlson Fiona J, Norman Rosana E, Flaxman Abraham D, Johns Nicole, Burstein Roy, Murray Christopher JL, Vos Theo. Global burden of disease attributable to mental and substance use disorders: findings from the Global Burden of Disease Study 2010. The Lancet. 2013;382(9904):1575–1586. doi: 10.1016/S0140-6736(13)61611-6.
    1. Jorm AF, Patten SB, Brugha TS, Mojtabai R. Has increased provision of treatment reduced the prevalence of common mental disorders? Review of the evidence from four countries. World Psychiatry. 2017;16(1):90–99. doi: 10.1002/wps.20388.
    1. Anderson KM, Wilson PW, Odell PM, Kannel WB. An updated coronary risk profile. A statement for health professionals. Circulation. 1991;83(1):356–362. doi: 10.1161/01.CIR.83.1.356.
    1. Wang JL, Manuel D, Williams J, et al. Development and validation of prediction algorithms for major depressive episode in the general population. J Affect Disord. 2013;151(1):39–45. doi: 10.1016/j.jad.2013.05.045.
    1. Edwards AGK, Naik G, Ahmed H, et al. Personalised risk communication for informed decision making about taking screening tests. Cochrane Database Syst Rev. 2013;(2013, 2):1–96. 10.1002/14651858.CD001865.pub3.
    1. Sheridan SL, Viera AJ, Krantz MJ, et al. The effect of giving global coronary risk information to adults: a systematic review. Arch Intern Med. 2010;170(3):230–239. doi: 10.1001/archinternmed.2009.516.
    1. Grant BF, Hasin DS, Stinson FS, et al. Co-occurrence of 12-month mood and anxiety disorders and personality disorders in the US: results from the national epidemiologic survey on alcohol and related conditions. J Psychiatr Res. 2005;39(1):1–9. doi: 10.1016/j.jpsychires.2004.05.004.
    1. Moher David, Hopewell Sally, Schulz Kenneth F., Montori Victor, Gøtzsche Peter C., Devereaux P.J., Elbourne Diana, Egger Matthias, Altman Douglas G. CONSORT 2010 Explanation and Elaboration: updated guidelines for reporting parallel group randomised trials. Journal of Clinical Epidemiology. 2010;63(8):e1–e37. doi: 10.1016/j.jclinepi.2010.03.004.
    1. Wang J, Smailes E, Sareen J, Fick GH, Schmitz N, Patten SB. The prevalence of mental disorders in the working population over the period of global economic crisis. Can J Psychiatr. 2010;55(9):598–605. doi: 10.1177/070674371005500908.
    1. Wang J, Patten SB, Currie S, Sareen J, Schmitz N. A population-based longitudinal study on work environmental factors and the risk of major depressive disorder. Am J Epidemiol. 2012;176(1):52–59. doi: 10.1093/aje/kwr473.
    1. Wang J, Patten SB, Lam RW, et al. The effects of an E-mental health program and job coaching on the risk of major depression and productivity in Canadian male workers: protocol for a randomized controlled trial. JMIR Res Protoc. 2016;5(4):e218. doi: 10.2196/resprot.6350.
    1. Adair CE, Holland AC, Patterson ML, Mason KS, Goering PN, Hwang SW. Cognitive interviewing methods for questionnaire pre-testing in homeless persons with mental disorders. J Urban Heal. 2012;89(1):36–52. doi: 10.1007/s11524-011-9632-z.
    1. Lerman C, Lustbader E, Rimer B, et al. Effects of individualized breast cancer risk counseling: a randomized trial. J Natl Cancer Inst. 1995;87(4):286–292. doi: 10.1093/jnci/87.4.286.
    1. Rimer BK, Halabi S, Sugg Skinner C, et al. Effects of a mammography decision-making intervention at 12 and 24 months. Am J Prev Med. 2002;22(4):247–257. doi: 10.1016/S0749-3797(02)00417-8.
    1. Morgan AJ, Jorm AF. Self-help strategies that are helpful for sub-threshold depression: a Delphi consensus study. J Affect Disord. 2009;115(1–2):196–200. doi: 10.1016/j.jad.2008.08.004.
    1. Christensen H, Griffiths K, Jorm A. Delivering interventions for depression by using the internet: randomised controlled trial. BMJ. 2004;328(7434):265. doi: 10.1136/.
    1. Day V, McGrath PJ, Wojtowicz M. Internet-based guided self-help for university students with anxiety, depression and stress: a randomized controlled clinical trial. Behav Res Ther. 2013;51(7):344–351. doi: 10.1016/j.brat.2013.03.003.
    1. Kessler RC, Andrews G, Colpe LJ, et al. Short screening scales to monitor population prevalences and trends in non-specific psychological distress. Psychol Med. 2002;32(6):959–976. doi: 10.1017/S0033291702006074.
    1. Lloyd-Jones DM. Cardiovascular risk prediction: basic concepts, current status, and future directions. Circulation. 2010;121(15):1768–1777. doi: 10.1161/CIRCULATIONAHA.109.849166.
    1. American Psychiatric Association . Diagnostic and statistical manual of mental disorders. 4 1994.
    1. Kessler R, Mroczek D. Scoring of the UM-CIDI short forms. Ann Arbor: The University of Michigan Institute for Social Research/Survey Research Center; 1994.
    1. Creswell J. Research Design: Qualitative, Quantitative, and Mixed Methods Approaches. Thousand oak: SAGE; 2009.
    1. Berg B. Qualitative research methods for the social sciences. Boston: Pearson Education; 2004.
    1. Meinert C. Bias. In: Meinert C, editor. Clinical trials: design, conduct, and analysis. 2. New York: Oxford University Press; 2012. pp. 68–73.

Source: PubMed

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