Smartphone-based Ecological Momentary Intervention for secondary prevention of suicidal thoughts and behaviour: protocol for the SmartCrisis V.2.0 randomised clinical trial

Maria Luisa Barrigon, Alejandro Porras-Segovia, Philippe Courtet, Jorge Lopez-Castroman, Sofian Berrouiguet, María-Mercedes Pérez-Rodríguez, Antonio Artes, MEmind Study Group, Enrique Baca-Garcia, Antonio Artes-Rodríguez, Enrique Baca-García, Sofian Berrouiguet, Romain Billot, Juan José Carballo-Belloso, Philippe Courtet, David Delgado-Gomez, Jorge Lopez-Castroman, Mercedes Perez-Rodríguez, Marta Migoya-Borja, Nora Palomar-Ciria, Alba Sedano-Capdevila, Sofía Abascal-Peiró, Susana Amodeo-Escriban, Ana de Granda, Rodrigo Carmona, Elena Gil-Benito, Laura Mata-Iturralde, Laura Muñoz-Lorenzo, Rocío Navarro-Jiménez, Santiago Ovejero, Sergio Sánchez-Alonso, Ezequiel Di Stasio, José Luis Palomo, Pedro Martín-Calvo, Ana José Ortega, Marta Segura-Valverde, María Luisa Martin-Calvo, Raquel Álvarez-García, Pablo Portillo-de Antonio, Pablo Puras-Rico, Eva María Romero-Gómez, Maria Luisa Barrigon, Alejandro Porras-Segovia, Philippe Courtet, Jorge Lopez-Castroman, Sofian Berrouiguet, María-Mercedes Pérez-Rodríguez, Antonio Artes, MEmind Study Group, Enrique Baca-Garcia, Antonio Artes-Rodríguez, Enrique Baca-García, Sofian Berrouiguet, Romain Billot, Juan José Carballo-Belloso, Philippe Courtet, David Delgado-Gomez, Jorge Lopez-Castroman, Mercedes Perez-Rodríguez, Marta Migoya-Borja, Nora Palomar-Ciria, Alba Sedano-Capdevila, Sofía Abascal-Peiró, Susana Amodeo-Escriban, Ana de Granda, Rodrigo Carmona, Elena Gil-Benito, Laura Mata-Iturralde, Laura Muñoz-Lorenzo, Rocío Navarro-Jiménez, Santiago Ovejero, Sergio Sánchez-Alonso, Ezequiel Di Stasio, José Luis Palomo, Pedro Martín-Calvo, Ana José Ortega, Marta Segura-Valverde, María Luisa Martin-Calvo, Raquel Álvarez-García, Pablo Portillo-de Antonio, Pablo Puras-Rico, Eva María Romero-Gómez

Abstract

Introduction: Suicide is one of the leading public health issues worldwide. Mobile health can help us to combat suicide through monitoring and treatment. The SmartCrisis V.2.0 randomised clinical trial aims to evaluate the effectiveness of a smartphone-based Ecological Momentary Intervention to prevent suicidal thoughts and behaviour.

Methods and analysis: The SmartCrisis V.2.0 study is a randomised clinical trial with two parallel groups, conducted among patients with a history of suicidal behaviour treated at five sites in France and Spain. The intervention group will be monitored using Ecological Momentary Assessment (EMA) and will receive an Ecological Momentary Intervention called 'SmartSafe' in addition to their treatment as usual (TAU). TAU will consist of mental health follow-up of the patient (scheduled appointments with a psychiatrist) in an outpatient Suicide Prevention programme, with predetermined clinical appointments according to the Brief Intervention Contact recommendations (1, 2, 4, 7 and 11 weeks and 4, 6, 9 and 12 months). The control group would receive TAU and be monitored using EMA.

Ethics and dissemination: This study has been approved by the Ethics Committee of the University Hospital Fundación Jiménez Díaz. It is expected that, in the near future, our mobile health intervention and monitoring system can be implemented in routine clinical practice. Results will be disseminated through peer-reviewed journals and psychiatric congresses. Reference number EC005-21_FJD. Participants gave informed consent to participate in the study before taking part.

Trial registration number: NCT04775160.

Keywords: health informatics; mental health; psychiatry; suicide & self-harm.

Conflict of interest statement

Competing interests: None declared.

© Author(s) (or their employer(s)) 2022. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.

Figures

Figure 1
Figure 1
Recruitment, randomisation and follow-up process.

References

    1. Porras-Segovia A, Baca-García E, Courtet P, et al. . If suicide were COVID-19: a neglected cause of premature death. J Clin Psychiatry 2021;82. doi:10.4088/JCP.20l13702. [Epub ahead of print: 23 02 2021].
    1. World Health Organization . Mental health: suicide prevention, 2021. Available: [Accessed 16 Feb 2021].
    1. Instituto Nacional de Estadística (INE) . Tasas de suicidios POR edad Y sexo POR 100.000 habitantes de CADA Grupo. Available: [Accessed 12 Dec 2021].
    1. Euronews . Suicide: one person dies every 40 seconds, says World health organisation; 2021. [Accessed 12 Dec 2021].
    1. Borges G, Nock MK, Haro Abad JM, et al. . Twelve-month prevalence of and risk factors for suicide attempts in the World Health organization world mental health surveys. J Clin Psychiatry 2010;71:1617–28. 10.4088/JCP.08m04967blu
    1. Yang B, Lester D. Recalculating the economic cost of suicide. Death Stud 2007;31:351–61. 10.1080/07481180601187209
    1. Bostwick JM, Pabbati C, Geske JR, et al. . Suicide attempt as a risk factor for completed suicide: even more lethal than we knew. Am J Psychiatry 2016;173:1094–100. 10.1176/appi.ajp.2016.15070854
    1. Ghanbari B, Malakouti SK, Nojomi M, et al. . Suicide prevention and follow-up services: a narrative review. Glob J Health Sci 2015;8:145–53. 10.5539/gjhs.v8n5p145
    1. Franklin JC, Ribeiro JD, Fox KR, et al. . Risk factors for suicidal thoughts and behaviors: a meta-analysis of 50 years of research. Psychol Bull 2017;143:187–232. 10.1037/bul0000084
    1. O'Connor RC, Portzky G. Looking to the future: a synthesis of new developments and challenges in suicide research and prevention. Front Psychol 2018;9:2139. 10.3389/fpsyg.2018.02139
    1. Porras-Segovia A, Molina-Madueño RM, Berrouiguet S, et al. . Smartphone-based ecological momentary assessment (EMA) in psychiatric patients and student controls: a real-world feasibility study. J Affect Disord 2020;274:733–41. 10.1016/j.jad.2020.05.067
    1. Shiffman S, Stone AA, Hufford MR. Ecological momentary assessment. Annu Rev Clin Psychol 2008;4:1–32. 10.1146/annurev.clinpsy.3.022806.091415
    1. Davidson CL, Anestis MD, Gutierrez PM. Ecological momentary assessment is a neglected methodology in suicidology. Arch Suicide Res 2017;21:1–11. 10.1080/13811118.2015.1004482
    1. Barrigon ML, Courtet P, Oquendo M, et al. . Precision medicine and suicide: an opportunity for digital health. Curr Psychiatry Rep 2019;21:131. 10.1007/s11920-019-1119-8
    1. Seppälä J, De Vita I, Jämsä T, Vita D, et al. . Mobile phone and wearable Sensor-based mHealth approaches for psychiatric disorders and symptoms: systematic review. JMIR Ment Health 2019;6:e9819. 10.2196/mental.9819
    1. Ben-Zeev D, Morris SB, Morris SB, et al. . Predictors of Self-Stigma in schizophrenia: new insights using mobile technologies. J Dual Diagn 2012;8:305–14. 10.1080/15504263.2012.723311
    1. Kleiman EM, Turner BJ, Fedor S, et al. . Examination of real-time fluctuations in suicidal ideation and its risk factors: results from two ecological momentary assessment studies. J Abnorm Psychol 2017;126:726–38. 10.1037/abn0000273
    1. Kleiman EM, Turner BJ, Fedor S, et al. . Digital phenotyping of suicidal thoughts. Depress Anxiety 2018;35:601–8. 10.1002/da.22730
    1. Czyz EK, Glenn CR, Busby D, et al. . Daily patterns in nonsuicidal self-injury and coping among recently hospitalized youth at risk for suicide. Psychiatry Res 2019;281:112588. 10.1016/j.psychres.2019.112588
    1. Hallensleben N, Glaesmer H, Forkmann T, et al. . Predicting suicidal ideation by interpersonal variables, hopelessness and depression in real-time. an ecological momentary assessment study in psychiatric inpatients with depression. Eur Psychiatry 2019;56:43–50. 10.1016/j.eurpsy.2018.11.003
    1. Spangenberg L, Glaesmer H, Hallensleben N, et al. . (In)stability of capability for suicide in psychiatric inpatients: longitudinal assessment using ecological momentary assessments. Suicide Life Threat Behav 2019;49:1560–72. 10.1111/sltb.12547
    1. Oquendo MA, Galfalvy HC, Choo T-H, et al. . Highly variable suicidal ideation: a phenotypic marker for stress induced suicide risk. Mol Psychiatry 2021;2610.1038/s41380-020-0819-0. [Epub ahead of print: Epub ahead of print].
    1. Victor SE, Scott LN, Stepp SD, et al. . I want you to want me: interpersonal stress and affective experiences as within-person predictors of nonsuicidal self-injury and suicide urges in daily life. Suicide Life Threat Behav 2019;49:1157–77. 10.1111/sltb.12513
    1. Smith KE, Juarascio A. From ecological momentary assessment (EMA) to ecological momentary intervention (EMI): past and future directions for ambulatory assessment and interventions in eating disorders. Curr Psychiatry Rep 2019;21:53. 10.1007/s11920-019-1046-8
    1. McDevitt-Murphy ME, Luciano MT, Zakarian RJ. Use of ecological momentary assessment and intervention in treatment with adults. Focus 2018;16:370–5. 10.1176/appi.focus.20180017
    1. Ćosić K, Popović S, Šarlija M, et al. . Impact of human disasters and COVID-19 pandemic on mental health: potential of digital psychiatry. Psychiatr Danub 2020;32:25–31. 10.24869/psyd.2020.25
    1. Berrouiguet S, Perez-Rodriguez MM, Larsen M, et al. . From eHealth to iHealth: transition to participatory and personalized medicine in mental health. J Med Internet Res 2018;20:e2. 10.2196/jmir.7412
    1. Melvin GA, Gresham D, Beaton S, et al. . Evaluating the feasibility and effectiveness of an Australian safety planning smartphone application: a pilot study within a tertiary mental health service. Suicide Life Threat Behav 2019;49:846–58. 10.1111/sltb.12490
    1. Stallard P, Porter J, Grist R. A smartphone app (BlueIce) for young people who self-harm: open phase 1 pre-post trial. JMIR Mhealth Uhealth 2018;6:e32. 10.2196/mhealth.8917
    1. Jeong YW, Chang HJ, Kim JA. Development and feasibility of a safety plan mobile application for adolescent suicide attempt survivors. Comput Inform Nurs 2020;38:382–92. 10.1097/CIN.0000000000000592
    1. Morgiève M, Genty C, Azé J, Dubois J, et al. . A digital companion, the emma app, for ecological momentary assessment and prevention of suicide: quantitative case series study. JMIR Mhealth Uhealth 2020;8:e15741. 10.2196/15741
    1. Nuij C, van Ballegooijen W, Ruwaard J, et al. . Smartphone-based safety planning and self-monitoring for suicidal patients: rationale and study protocol of the CASPAR (continuous assessment for suicide prevention and research) study. Internet Interv 2018;13:16–23. 10.1016/j.invent.2018.04.005
    1. Mann JJ, Michel CA, Auerbach RP. Improving suicide prevention through evidence-based strategies: a systematic review. Am J Psychiatry 2021;17810.1176/appi.ajp.2020.20060864. [Epub ahead of print: Epub ahead of print].
    1. Fleischmann A, Bertolote JM, Wasserman D, et al. . Effectiveness of brief intervention and contact for suicide attempters: a randomized controlled trial in five countries. Bull World Health Organ 2008;86:703–9. 10.2471/blt.07.046995
    1. Posner K, Brown GK, Stanley B, et al. . The Columbia-Suicide severity rating scale: initial validity and internal consistency findings from three multisite studies with adolescents and adults. Am J Psychiatry 2011;168:1266–77. 10.1176/appi.ajp.2011.10111704
    1. Ducasse D, Jaussent I, Arpon-Brand V, et al. . Acceptance and commitment therapy for the management of suicidal patients: a randomized controlled trial. Psychother Psychosom 2018;87:211–22. 10.1159/000488715
    1. Jiménez-Muñoz L, Peñuelas-Calvo I, Díaz-Oliván I, et al. . Suicide prevention in your pocket: a systematic review of ecological momentary interventions for the management of suicidal thoughts and behaviors. Harv Rev Psychiatry 2022;30:85–99. 10.1097/HRP.0000000000000331
    1. García-Nieto R, Uribe P, Palao D. Protocolo breve de evaluación del suicidio: fiabilidad interexaminadores [Brief suicide questionnaire inter-rater reliability]. Rev Psiquiatr Salud Ment 2012;5:24–36. 10.1016/j.rpsm.2011.10.001
    1. Migoya-Borja M, Delgado-Gómez D, Carmona-Camacho R, et al. . Feasibility of a virtual reality-based psychoeducational tool (VRight) for depressive patients. Cyberpsychol Behav Soc Netw 2020;23:246–52. 10.1089/cyber.2019.0497
    1. Sheehan DV, Lecrubier Y, Sheehan KH, 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 Suppl 20:22–57.
    1. Trivedi MH, Rush AJ, Ibrahim HM, et al. . The inventory of depressive symptomatology, clinician rating (IDS-C) and self-report (IDS-SR), and the quick inventory of depressive symptomatology, clinician rating (QIDS-C) and self-report (QIDS-SR) in public sector patients with mood disorders: a psychometric evaluation. Psychol Med 2004;34:73–82. 10.1017/s0033291703001107
    1. Spitzer RL, Kroenke K, Williams JBW, et al. . A brief measure for assessing generalized anxiety disorder: the GAD-7. Arch Intern Med 2006;166:1092–7. 10.1001/archinte.166.10.1092
    1. Young RC, Biggs JT, Ziegler VE, et al. . A rating scale for mania: reliability, validity and sensitivity. Br J Psychiatry 1978;133:429–35. 10.1192/bjp.133.5.429
    1. Kay SR, Fiszbein A, Opler LA. The positive and negative syndrome scale (PANSS) for schizophrenia. Schizophr Bull 1987;13:261–76. 10.1093/schbul/13.2.261
    1. Federici S, Bracalenti M, Meloni F, et al. . World Health organization disability assessment schedule 2.0: an international systematic review. Disabil Rehabil 2017;39:2347–80. 10.1080/09638288.2016.1223177
    1. Brugha TS, Cragg D. The list of threatening experiences: the reliability and validity of a brief life events questionnaire. Acta Psychiatr Scand 1990;82:77–81. 10.1111/j.1600-0447.1990.tb01360.x
    1. Carlson J, Ochoa S, Haro JM, et al. . Adaptation and validation of the quality-of-life scale: satisfaction with life domains scale by baker and intagliata. Compr Psychiatry 2009;50:76–80. 10.1016/j.comppsych.2008.05.008
    1. Davis R, Cook D, Cohen L. A community resilience approach to reducing ethnic and racial disparities in health. Am J Public Health 2005;95:2168–73. 10.2105/AJPH.2004.050146
    1. Piccinelli M, Tessari E, Bortolomasi M, et al. . Efficacy of the alcohol use disorders identification test as a screening tool for hazardous alcohol intake and related disorders in primary care: a validity study. BMJ 1997;314:420–4. 10.1136/bmj.314.7078.420
    1. Fagerström KO. Measuring degree of physical dependence to tobacco smoking with reference to individualization of treatment. Addict Behav 1978;3:235–41. 10.1016/0306-4603(78)90024-2
    1. Skinner HA. The drug abuse screening test. Addict Behav 1982;7:363–71. 10.1016/0306-4603(82)90005-3
    1. Patton JH, Stanford MS, Barratt ES. Factor structure of the barratt impulsiveness scale. J Clin Psychol 1995;51:768–74. 10.1002/1097-4679(199511)51:6<768::AID-JCLP2270510607>;2-1
    1. Millon T. The Millon clinical Multiaxial inventory. 3rd ED. Minneapolis: MN: National Computer Systems, 1994.
    1. Barrigón ML, Berrouiguet S, Carballo JJ, et al. . User profiles of an electronic mental health tool for ecological momentary assessment: MEmind. Int J Methods Psychiatr Res 2017;26:e1554. 10.1002/mpr.1554
    1. Berrouiguet S, Barrigón ML, Castroman JL, et al. . Combining mobile-health (mHealth) and artificial intelligence (AI) methods to avoid suicide attempts: the smartcrises study protocol. BMC Psychiatry 2019;19:277. 10.1186/s12888-019-2260-y
    1. Irigoyen M, Porras-Segovia A, Galván L, et al. . Predictors of re-attempt in a cohort of suicide attempters: a survival analysis. J Affect Disord 2019;247:20–8. 10.1016/j.jad.2018.12.050
    1. Fartacek C, Schiepek G, Kunrath S, et al. . Real-time monitoring of non-linear suicidal dynamics: methodology and a demonstrative case report. Front Psychol 2016;7:130. 10.3389/fpsyg.2016.00130
    1. Kroenke K, Spitzer RL, Williams JB. The PHQ-9: validity of a brief depression severity measure. J Gen Intern Med 2001;16:606–13. 10.1046/j.1525-1497.2001.016009606.x
    1. Watson D, Clark LA, Tellegen A. Development and validation of brief measures of positive and negative affect: the PANAS scales. J Pers Soc Psychol 1988;54:1063–70. 10.1037//0022-3514.54.6.1063
    1. Van Orden KA, Cukrowicz KC, Witte TK, et al. . Thwarted belongingness and perceived burdensomeness: construct validity and psychometric properties of the interpersonal needs questionnaire. Psychol Assess 2012;24:197–215. 10.1037/a0025358
    1. Stanley B, Brown GK. Safety planning intervention: a brief intervention to mitigate suicide risk. Cogn Behav Pract 2012;19:256–64. 10.1016/j.cbpra.2011.01.001
    1. Berrouiguet S, Alavi Z, Vaiva G, et al. . Siam (suicide intervention assisted by messages): the development of a post-acute crisis text messaging outreach for suicide prevention. BMC Psychiatry 2014;14:294. 10.1186/s12888-014-0294-8
    1. Motto JA, Bostrom AG. A randomized controlled trial of postcrisis suicide prevention. Psychiatr Serv 2001;52:828–33. 10.1176/appi.ps.52.6.828
    1. Riblet NBV, Shiner B, Young-Xu Y, et al. . Strategies to prevent death by suicide: meta-analysis of randomised controlled trials. Br J Psychiatry 2017;210:396–402. 10.1192/bjp.bp.116.187799
    1. World Medical Association . World Medical association declaration of helsinki: ethical principles for medical research involving human subjects. JAMA 2013;310:2191–4. 10.1001/jama.2013.281053
    1. Nordentoft M, Erlangsen A. Suicide-turning the tide. Science 2019;365:725. 10.1126/science.aaz1568

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