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Smartphone-based Ecological Momentary Intervention for Suicide Prevention: a Randomised Clinical Trial (SmartCrisis2)

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ClinicalTrials.gov Identifier: NCT04775160
Recruitment Status : Not yet recruiting
First Posted : March 1, 2021
Last Update Posted : September 8, 2021
Sponsor:
Collaborator:
Centre Hospitalier Régional Universitaire Montpellier
Information provided by (Responsible Party):
Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz

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.


Condition or disease Intervention/treatment Phase
Suicide Device: SmartSafe Not Applicable

Show Show detailed description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 220 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Smartphone-based Ecological Momentary Intervention for Secondary Prevention of Suicidal Thoughts and Behavior: a Randomised Clinical Trial
Estimated Study Start Date : May 20, 2022
Estimated Primary Completion Date : May 19, 2025
Estimated Study Completion Date : December 31, 2025

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Suicide

Arm Intervention/treatment
No Intervention: Control group
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)
Experimental: Intervention group
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
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.
Other Name: The SmartSafe Ecological Momentary Intervention




Primary Outcome Measures :
  1. Reduction of suicidal ideation [ Time Frame: 6 months ]
    Our primary outcome will be reduction of suicidal ideation, measured at follow-up using the Columbia Suicide Severity Rating Scale

  2. Reduction of suicidal ideation [ Time Frame: 1 year ]
    Our primary outcome will be reduction of suicidal ideation, measured at follow-up using the Columbia Suicide Severity Rating Scale


Secondary Outcome Measures :
  1. Acceptability of the mobile health applications [ Time Frame: 6 months ]
    Acceptability of the mobile health applications measured by user satisfaction using satisfaction surveys

  2. Acceptability of the mobile health applications [ Time Frame: 1 year ]
    Acceptability of the mobile health applications measured by user satisfaction using satisfaction surveys

  3. Feasibility of the project: Compliance [ Time Frame: 6 months ]
    Feasibility measured by compliance with EMA questions (% of questions answered)

  4. Feasibility of the project: Compliance [ Time Frame: 1 year ]
    Feasibility measured by compliance with EMA questions (% of questions answered)

  5. Feasibility of the project: Participation [ Time Frame: 1 year ]
    Feasibility measured by participation rate (% of patients that accept to be enrolled in the project out of those invited to participate)

  6. Feasibility of the project: Retention [ Time Frame: 1 year ]
    Feasibility measured by retention rate (% of patients that remain in the study when the follow-up period is completed)

  7. Reduction of suicide attempts [ Time Frame: 6 months ]
    Reduction in the occurrence of suicide attempts registered as a clinical event (attended in the emergency room verified through the electronical clnical record)

  8. Reduction of suicide attempts [ Time Frame: 1 year ]
    Reduction in the occurrence of suicide attempts registered as a clinical event (attended in the emergency room verified through the electronical clnical record)



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04775160


Contacts
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Contact: Alejandro A Porras-Segovia, PhD 0034915 50 48 00 alejandro.porras@quironsalud.es

Locations
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Spain
Hospital Universitario Fundación Jiménez Díaz
Madrid, Spain, 28040
Contact: Alejandro Porras Segovia, PhD    +34 915 50 48 00    alexposeg@gmail.com   
Sponsors and Collaborators
Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz
Centre Hospitalier Régional Universitaire Montpellier
Investigators
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Principal Investigator: Maria L Barrigon, PhD Instituto de Investigación Fundación Jiménez Díaz
Publications:
Stanley B, Brown GK. Safety planning intervention: a brief intervention to mitigate suicide risk. Cogn Behav Pract. 2012;19(2):256-64.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz
ClinicalTrials.gov Identifier: NCT04775160    
Other Study ID Numbers: EC005-21_FJD
First Posted: March 1, 2021    Key Record Dates
Last Update Posted: September 8, 2021
Last Verified: September 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Suicide
Self-Injurious Behavior
Behavioral Symptoms