MYPLAN -mobile phone application to manage crisis of persons at risk of suicide: study protocol for a randomized controlled trial

Kate Andreasson, Jesper Krogh, Per Bech, Hanne Frandsen, Niels Buus, Barbara Stanley, Ad Kerkhof, Merete Nordentoft, Annette Erlangsen, Kate Andreasson, Jesper Krogh, Per Bech, Hanne Frandsen, Niels Buus, Barbara Stanley, Ad Kerkhof, Merete Nordentoft, Annette Erlangsen

Abstract

Background: Persons with a past episode of self-harm or severe suicidal ideation are at elevated risk of self-harm as well as dying by suicide. It is well established that suicidal ideation fluctuates over time. Previous studies have shown that a personal safety plan can assist in providing support, when a person experiences suicide ideation, and help seeking professional assistance if needed. The aim of the trial is to determine whether a newly developed safety mobile app is more effective in reducing suicide ideation and other symptoms, compared to a safety plan on paper.

Methods/design: The trial is designed as a two-arm, observer-blinded, parallel-group randomized clinical superiority trial, where participants will either receive: (1) Experimental intervention: the safety plan provided as the app MyPlan, or (2) Treatment as Usual: the safety plan in the original paper format. Based on a power calculation, a total of 546 participants, 273 in each arm will be included. They will be recruited from Danish Suicide Prevention Clinics. Both groups will receive standard psychosocial therapeutic care, up to 8-10 sessions of supportive psychotherapy. Primary outcome will be reduction in suicide ideation after 12 months. Follow-up interviews will be conducted at 3, 6, 9, and 12 months after date of inclusion.

Discussion: A safety plan is a mandatory part of the treatment in the Suicide Prevention Clinics in Demark. There are no studies investigating the effectiveness of a safety plan app compared to a safety plan on paper on reducing suicide ideation in patients with suicide ideation and suicidal behavior. The trial will gain new knowledge of whether modern technology can augment the effects of traditional personalized safety planning.

Trial registration: ClinicalTrials.gov, NCT02877316 . Registered on 19 August 2016.

Keywords: RCT; Safety plan; Suicide behavior; Suicide ideation; Suicide prevention.

Figures

Fig. 1
Fig. 1
Flow diagram of MyPlan trial

References

    1. Christiansen E, Jensen BF. Register for Suicide Attempts. Dan Med Bull. 2004;51(4):415–7.
    1. Reuter Britt M, Soegaard B, Nordentoft M, Erlangsen A. Incidence rates of deliberate self-harm in Denmark 1994–2011: a nationwide register study. Cris J Cris Interv Suicide Prev. 2016. doi:10.1027/0227-5910/a000391.
    1. Maris RW, Berman AL, Silverman MM. Comprehensive textbook of suicidology. New York: The Guilford Press; 2000.
    1. Stanley B, Brown GK. Safety planning intervention: a brief intervention to mitigate suicide risk. Cogn Behav Pract. 2012;19(2):256–64. doi: 10.1016/j.cbpra.2011.01.001.
    1. Stanley B, Brown G, Brent DA, et al. Cognitive-behavioral therapy for suicide prevention (CBT-SP): treatment model, feasibility, and acceptability. J Am Acad Child Adolesc Psychiatry. 2009;48(10):1005–13. doi: 10.1097/CHI.0b013e3181b5dbfe.
    1. Brown GK, Wenzel AMY, Rudd MD. Cognitive therapy for suicidal patients. In: Cognitive Therapy For Suicidal Patients: Scientific and Clinical Applications. American Psychological Association.Vol ; 2009:273-291. #.
    1. Joiner T. Why people die by suicide. Cambridge: Harvard University Press; 2005.
    1. Brown GK, Ten Have T, Henriques GR, Xie SX, Hollander JE, Beck AT. Cognitive therapy for the prevention of suicide attempts: a randomized controlled trial. JAMA. 2005;294(5):563–70. doi: 10.1001/jama.294.5.563.
    1. Danish Statistic. Electronics at home. 2016. . Accessed 13 Mar 2017.
    1. World Health Organization (WHO) Preventing suicide: a global imperative. Geneva: WHO; 2014.
    1. Donker T, Petrie K, Proudfoot J, Clarke J, Birch MR, Christensen H. Smartphones for smarter delivery of mental health programs: a systematic review. J Med Internet Res. 2013;15(11). doi:10.2196/jmir.2791.
    1. Torous J, Friedman R, Keshvan M. Smartphone ownership and interest in mobile applications to monitor symptoms of mental health conditions. J Med Internet Res. 2014;16(1). doi:10.2196/mhealth.2994.
    1. Larsen ME, Nicholas J, Christensen H. A systematic assessment of smartphone tools for suicide prevention. PLoS One. 2016;11(4). doi:10.1371/journal.pone.0152285.
    1. Larsen JLS, Frandsen H, Erlangsen A. MYPLAN – A Mobile Phone Application for Supporting People at Risk of Suicide. Cris. 2016;37:236–40. doi: 10.1027/0227-5910/a000371.
    1. Erlangsen A, Lind BD, Stuart EA, et al. Short-term and long-term effects of psychosocial therapy for people after deliberate self-harm: a register-based, nationwide multicentre study using propensity score matching. Lancet Psychiatry. 2015;2(1):49–58. doi: 10.1016/S2215-0366(14)00083-2.
    1. Birkbak J, Stuart EA, Lind BD, et al. Psychosocial therapy and causes of death after deliberate self-harm: a register-based, nationwide multicentre study using propensity score matching. Psychol Med. September 2016:1–9. doi:10.1017/S0033291716001872.
    1. Beck AT, Kovacs M, Weissman A. Assessment of suicidal intention: the Scale for Suicide Ideation. J Consult Clin Psychol. 1979;47(2):343–52. doi: 10.1037/0022-006X.47.2.343.
    1. Beck A, Rush J, Shaw B, Emery G. Cognitive therapy of depression. New York: The Guilford Press; 1979.
    1. Beck AT, Brown G, Berchick RJ, Stewart BL, Steer RA. Relationship between hopelessness and ultimate suicide: a replication with psychiatric outpatients. Am J Psychiatry. 1990;147(2):190–5. doi:10.1176/ajp.147.2.190.
    1. Beck AT. Beck Hopelessness Scale. J Clin Psychol. 1998;54:1063–78. doi: 10.1002/(SICI)1097-4679(199812)54:8<1063::AID-JCLP6>;2-Z.
    1. Bech P, Rasmussen N-A, Olsen LR, Noerholm V, Abildgaard W. The sensitivity and specificity of the Major Depression Inventory, using the Present State Examination as the index of diagnostic validity. J Affect Disord. 2001;66:159–64. doi: 10.1016/S0165-0327(00)00309-8.
    1. National Institute for Health Care and Excellence (NICE) Quality standard for self-harm. 2013. . Accessed 13 Mar 2017.
    1. Bech P. Clinical psychometrics. Oxford: Wiley-Blackwell; 2012.
    1. Topp CW, Østergaard SD, Søndergaard S, Bech P. The WHO-5 Well-Being Index: a systematic review of the literature. Psychother Psychosom. 2015;84(3):167–76. doi: 10.1159/000376585.
    1. Ellis TE, Rufino KA, Allen JG, Fowler JC, Jobes DA. Impact of a suicide-specific intervention within inpatient psychiatric care: the Collaborative Assessment and Management of Suicidality. Suicide Life Threat Behav. January 2015. doi: 10.1111/sltb.12151.
    1. Guthrie E, Kapur N, Mackway-Jones K, et al. Randomised controlled trial of brief psychological intervention after deliberate self poisoning. BMJ. 2001;323(7305):135–8. doi: 10.1136/bmj.323.7305.135.
    1. Littell RC, Pendergast J, Natarajan R. Modelling covariance structure in the analysis of repeated measures data. Stat Med. 2000;19(13):1793–819. doi: 10.1002/1097-0258(20000715)19:13<1793::AID-SIM482>;2-Q.
    1. Jobes DA. Managing suicidal risk: a collaborative approach. New York: The Guilford Press; 2006.
    1. Jobes DA, Drozd JF. The CAMS approach to working with suicidal patients. J Contemp Psychother. 2004;34(1):73–85. doi: 10.1023/B:JOCP.0000010914.98781.6a.
    1. Chan AW, Tetzlaff JM, Altman DG, Dickersin K, Moher D. SPIRIT 2013: New guidance for content of clinical trial protocols. Lancet. 2013;381(9861):91–2. doi: 10.1016/S0140-6736(12)62160-6.

Source: PubMed

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