Smartphone-based Ecological Momentary Intervention for Suicide Prevention: a Randomised Clinical Trial

NCT04775160 | Unknown

• 1 other identifier: EC005-21_FJD
• Study Type: interventional
• Target: 220
• Locations: 1 country
• Sites: 1

Brief Summary

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 2.0 randomized 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 2.0 study is a randomized clinical trial with two parallel groups, conducted among patients with a history of suicidal behaviour treated at the University Hospital Fundación Jiménez Díaz. The intervention group will be monitored using Ecological Momentary Assessment and will receive an Ecological Momentary Intervention called 'SmartSafe' in addition to their treatment as usual (TAU). TAU will consist of psychiatric follow-up of the patient (scheduled appointments with a psychiatrist) in our outpatient Suicide Prevention clinic, 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, the mobile applications MEmind and eB2 can be implemented in routine clinical practice. Results will be disseminated through peer-reviewed journals and psychiatric congresses.

Conditions

Suicide

Outcome Measures

Primary Outcomes (2)

• Reduction of suicidal ideation

  Our primary outcome will be reduction of suicidal ideation, measured at follow-up using the Columbia Suicide Severity Rating Scale

  6 months

• Reduction of suicidal ideation

  Our primary outcome will be reduction of suicidal ideation, measured at follow-up using the Columbia Suicide Severity Rating Scale

  1 year

Secondary Outcomes (8)

• Acceptability of the mobile health applications

  6 months

• Acceptability of the mobile health applications

  1 year

• Feasibility of the project: Compliance

  6 months

• Feasibility of the project: Compliance

  1 year

• Feasibility of the project: Participation

  1 year

Study Arms (2)

Control group

NO INTERVENTION

The control group will be monitored using smartphone-based active and passive Ecological Momentary Assessment through the MEmind and eB2 mobile applications, and will receive treatment as usual, which will consist of psychiatric follow-up (scheduled appointments with their psychiatrist) in an outpatient Secondary Suicide Prevention Programme, with predetermined clinical reviews according to the Brief Intervention Contact recommendations (1, 2, 4, 7 and 11 weeks, and 4, 6, 9 and 12 months)

Intervention group

EXPERIMENTAL

The intervention group will receive an Ecological Momentary Intervention called SmartSafe, will be monitored using smartphone-based active and passive Ecological Momentary Assessment through the MEmind and eB2 mobile applications, and their treatment as usual, which will consist of psychiatric follow-up (scheduled appointments with their psychiatrist) in an outpatient Secondary Suicide Prevention Programme, with predetermined clinical reviews according to the Brief Intervention Contact recommendations (1, 2, 4, 7 and 11 weeks, and 4, 6, 9 and 12 months)

Device: SmartSafe

Interventions

SmartSafe DEVICE

The SmartSafe Ecological Momentary Intervention is contained in the MEmind smartphone application and consists of a Safety plan, an Enhanced contact via app (app-EC) intervention, and a "mental toolbox". The Safety plan is a set of personalized coping strategies that the patient can use in a suicidal crisis. Our safety plan was adapted to a digital environment, including the possibility to activate pre-recorded messages, lead to websites with health resources, or put the patient in contact with the emergency services. The Enhanced contact via app (app-EC) intervention is inspired by the SIAM project and consists in messages that will be sent via the MEmind app inquiring patients about their mental well-being and informing them of the means to request preferential or urgent care. The mental toolbox contains videos relaxation techniques videos and behavioral activation and mentalization exercises.

Also known as: The SmartSafe Ecological Momentary Intervention

Intervention group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Presenting with a SA or an emergency referral for SI in the past month.
• Being able to understand and sign the informed consent form.
• Being fluent in Spanish
• Owning a smartphone with internet access and iOS or Android operating system.

You may not qualify if:

• Refusal to install the mobile application
• Inability to understand and sign the informed consent form for any reason.
• Institutionalized or incarcerated patients, without access to regular mobile phone use.

Sponsors & Collaborators

• Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz: lead
• Centre Hospitalier Régional Universitaire Montpellier: collaborator

Study Sites (1)

Hospital Universitario Fundación Jiménez Díaz

Madrid, 28040, Spain

Location

Related Publications (27)

• Barrigon ML, Courtet P, Oquendo M, Baca-Garcia E. Precision Medicine and Suicide: an Opportunity for Digital Health. Curr Psychiatry Rep. 2019 Nov 28;21(12):131. doi: 10.1007/s11920-019-1119-8.

  PMID: 31776806 BACKGROUND

• Berrouiguet S, Alavi Z, Vaiva G, Courtet P, Baca-Garcia E, Vidailhet P, Gravey M, Guillodo E, Brandt S, Walter M. SIAM (Suicide intervention assisted by messages): the development of a post-acute crisis text messaging outreach for suicide prevention. BMC Psychiatry. 2014 Nov 18;14:294. doi: 10.1186/s12888-014-0294-8.

  PMID: 25404215 BACKGROUND

• Borges G, Nock MK, Haro Abad JM, Hwang I, Sampson NA, Alonso J, Andrade LH, Angermeyer MC, Beautrais A, Bromet E, Bruffaerts R, de Girolamo G, Florescu S, Gureje O, Hu C, Karam EG, Kovess-Masfety V, Lee S, Levinson D, Medina-Mora ME, Ormel J, Posada-Villa J, Sagar R, Tomov T, Uda H, Williams DR, Kessler RC. Twelve-month prevalence of and risk factors for suicide attempts in the World Health Organization World Mental Health Surveys. J Clin Psychiatry. 2010 Dec;71(12):1617-28. doi: 10.4088/JCP.08m04967blu. Epub 2010 Aug 24.

  PMID: 20816034 BACKGROUND

• Bostwick JM, Pabbati C, Geske JR, McKean AJ. Suicide Attempt as a Risk Factor for Completed Suicide: Even More Lethal Than We Knew. Am J Psychiatry. 2016 Nov 1;173(11):1094-1100. doi: 10.1176/appi.ajp.2016.15070854. Epub 2016 Aug 13.

  PMID: 27523496 BACKGROUND

• Czyz EK, Horwitz AG, Arango A, King CA. Short-term change and prediction of suicidal ideation among adolescents: a daily diary study following psychiatric hospitalization. J Child Psychol Psychiatry. 2019 Jul;60(7):732-741. doi: 10.1111/jcpp.12974. Epub 2018 Sep 24.

  PMID: 30246870 BACKGROUND

• Davidson CL, Anestis MD, Gutierrez PM. Ecological Momentary Assessment is a Neglected Methodology in Suicidology. Arch Suicide Res. 2017 Jan 2;21(1):1-11. doi: 10.1080/13811118.2015.1004482. Epub 2016 Jan 29.

  PMID: 26821811 BACKGROUND

• Ford-Gilboe M, Varcoe C, Scott-Storey K, Wuest J, Case J, Currie LM, Glass N, Hodgins M, MacMillan H, Perrin N, Wathen CN. A tailored online safety and health intervention for women experiencing intimate partner violence: the iCAN Plan 4 Safety randomized controlled trial protocol. BMC Public Health. 2017 Mar 21;17(1):273. doi: 10.1186/s12889-017-4143-9.

  PMID: 28327116 BACKGROUND

• Franklin JC, Ribeiro JD, Fox KR, Bentley KH, Kleiman EM, Huang X, Musacchio KM, Jaroszewski AC, Chang BP, Nock MK. Risk factors for suicidal thoughts and behaviors: A meta-analysis of 50 years of research. Psychol Bull. 2017 Feb;143(2):187-232. doi: 10.1037/bul0000084. Epub 2016 Nov 14.

  PMID: 27841450 BACKGROUND

• Ghanbari B, Malakouti SK, Nojomi M, Alavi K, Khaleghparast S. Suicide Prevention and Follow-Up Services: A Narrative Review. Glob J Health Sci. 2015 Sep 28;8(5):145-53. doi: 10.5539/gjhs.v8n5p145.

  PMID: 26652085 BACKGROUND

• Hallensleben N, Glaesmer H, Forkmann T, Rath D, Strauss M, Kersting A, Spangenberg L. 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 Feb;56:43-50. doi: 10.1016/j.eurpsy.2018.11.003. Epub 2018 Dec 5.

  PMID: 30530103 BACKGROUND

• Kawohl W, Nordt C. COVID-19, unemployment, and suicide. Lancet Psychiatry. 2020 May;7(5):389-390. doi: 10.1016/S2215-0366(20)30141-3. No abstract available.

  PMID: 32353269 BACKGROUND

• Kay SR, Fiszbein A, Opler LA. The positive and negative syndrome scale (PANSS) for schizophrenia. Schizophr Bull. 1987;13(2):261-76. doi: 10.1093/schbul/13.2.261.

  PMID: 3616518 BACKGROUND

• Kleiman EM, Coppersmith DDL, Millner AJ, Franz PJ, Fox KR, Nock MK. Are suicidal thoughts reinforcing? A preliminary real-time monitoring study on the potential affect regulation function of suicidal thinking. J Affect Disord. 2018 May;232:122-126. doi: 10.1016/j.jad.2018.02.033. Epub 2018 Feb 17.

  PMID: 29481996 BACKGROUND

• Kleiman EM, Turner BJ, Fedor S, Beale EE, Picard RW, Huffman JC, Nock MK. Digital phenotyping of suicidal thoughts. Depress Anxiety. 2018 Jul;35(7):601-608. doi: 10.1002/da.22730. Epub 2018 Apr 10.

  PMID: 29637663 BACKGROUND

• Motto JA, Bostrom AG. A randomized controlled trial of postcrisis suicide prevention. Psychiatr Serv. 2001 Jun;52(6):828-33. doi: 10.1176/appi.ps.52.6.828.

  PMID: 11376235 BACKGROUND

• Nordentoft M, Erlangsen A. Suicide-turning the tide. Science. 2019 Aug 23;365(6455):725. doi: 10.1126/science.aaz1568. No abstract available.

  PMID: 31439766 BACKGROUND

• O'Connor RC, Portzky G. Looking to the Future: A Synthesis of New Developments and Challenges in Suicide Research and Prevention. Front Psychol. 2018 Nov 27;9:2139. doi: 10.3389/fpsyg.2018.02139. eCollection 2018.

  PMID: 30538647 BACKGROUND

• Oquendo MA, Galfalvy HC, Choo TH, Kandlur R, Burke AK, Sublette ME, Miller JM, Mann JJ, Stanley BH. Highly variable suicidal ideation: a phenotypic marker for stress induced suicide risk. Mol Psychiatry. 2021 Sep;26(9):5079-5086. doi: 10.1038/s41380-020-0819-0. Epub 2020 Jun 23.

  PMID: 32576966 BACKGROUND

• Porras-Segovia A, Molina-Madueno RM, Berrouiguet S, Lopez-Castroman J, Barrigon ML, Perez-Rodriguez MS, Marco JH, Diaz-Olivan I, de Leon S, Courtet P, Artes-Rodriguez A, Baca-Garcia E. Smartphone-based ecological momentary assessment (EMA) in psychiatric patients and student controls: A real-world feasibility study. J Affect Disord. 2020 Sep 1;274:733-741. doi: 10.1016/j.jad.2020.05.067. Epub 2020 May 26.

  PMID: 32664009 BACKGROUND

• Reger MA, Stanley IH, Joiner TE. Suicide Mortality and Coronavirus Disease 2019-A Perfect Storm? JAMA Psychiatry. 2020 Nov 1;77(11):1093-1094. doi: 10.1001/jamapsychiatry.2020.1060. No abstract available.

  PMID: 32275300 BACKGROUND

• Seppala J, De Vita I, Jamsa T, Miettunen J, Isohanni M, Rubinstein K, Feldman Y, Grasa E, Corripio I, Berdun J, D'Amico E; M-RESIST Group; Bulgheroni M. Mobile Phone and Wearable Sensor-Based mHealth Approaches for Psychiatric Disorders and Symptoms: Systematic Review. JMIR Ment Health. 2019 Feb 20;6(2):e9819. doi: 10.2196/mental.9819.

  PMID: 30785404 BACKGROUND

• Shiffman S, Stone AA, Hufford MR. Ecological momentary assessment. Annu Rev Clin Psychol. 2008;4:1-32. doi: 10.1146/annurev.clinpsy.3.022806.091415.

  PMID: 18509902 BACKGROUND

• 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 Jun 4;21(7):53. doi: 10.1007/s11920-019-1046-8.

  PMID: 31161276 BACKGROUND

• Spangenberg L, Glaesmer H, Hallensleben N, Rath D, Forkmann T. (In)stability of Capability for Suicide in Psychiatric Inpatients: Longitudinal Assessment Using Ecological Momentary Assessments. Suicide Life Threat Behav. 2019 Dec;49(6):1560-1572. doi: 10.1111/sltb.12547. Epub 2019 Mar 4.

  PMID: 30834576 BACKGROUND

• Stanley B, Brown GK. Safety planning intervention: a brief intervention to mitigate suicide risk. Cogn Behav Pract. 2012;19(2):256-64.

  BACKGROUND

• Yang B, Lester D. Recalculating the economic cost of suicide. Death Stud. 2007 Apr;31(4):351-61. doi: 10.1080/07481180601187209.

  PMID: 17378112 BACKGROUND

• Barrigon ML, Porras-Segovia A, Courtet P, Lopez-Castroman J, Berrouiguet S, Perez-Rodriguez MM, Artes A; MEmind Study Group; Baca-Garcia E. Smartphone-based Ecological Momentary Intervention for secondary prevention of suicidal thoughts and behaviour: protocol for the SmartCrisis V.2.0 randomised clinical trial. BMJ Open. 2022 Sep 20;12(9):e051807. doi: 10.1136/bmjopen-2021-051807.

  PMID: 36127081 DERIVED

MeSH Terms

Conditions

Suicide

Condition Hierarchy (Ancestors)

Self-Injurious Behavior; Behavioral Symptoms; Behavior

Study Officials

• Maria L Barrigon, PhD

  Instituto de Investigación Fundación Jiménez Díaz

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Alejandro A Porras-Segovia, PhD

CONTACT

0034915 50 48 00; alejandro.porras@quironsalud.es

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 21, 2021
• First Posted: March 1, 2021
• Study Start: May 20, 2022
• Primary Completion: May 19, 2025
• Study Completion: December 31, 2025
• Last Updated: September 8, 2021

Record last verified: 2021-09

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)