Table 1

Objectives and hypotheses of the SmartCrisis V.2.0 project

AreaObjectiveHypothesis
Effectiveness: prevention of STBTo test the effectiveness of the SmartSafe intervention for preventing STB in patients at high risk of suicideThe intervention group will experience a significant reduction in suicide ideation measured with the CSSRS. This reduction will be greater than in the control group.
The intervention group will experience a significant reduction in n° of SAs. This reduction will be greater than in the control group.
Effectiveness: quality of lifeTo test the effectiveness of the SmartSafe intervention for improving quality of life in patients at high risk of suicideThe intervention group will experience a significant improvement in quality of life measured with the SLDS. This improvement will be greater than in the control group.
Effectiveness: functionalityTo test the effectiveness of the SmartSafe intervention for improving functionality in patients at high risk of suicideThe intervention group will experience a significant improvement in functionality measured with the WHODAS 2.0. This improvement will be greater than in the control group.
Feasibility: participationTo test the feasibility of the SmartCrisis project in terms of participation, retention, and compliance with EMA questionsBoth groups will present participation rates over 75%
Feasibility: retentionRetention will be significantly greater in the intervention group than in the control group
Feasibility: complianceCompliance with EMA questions will be significantly greater in the intervention group than in the control group
AcceptabilityTo test the acceptability of the SmartCrisis project in terms of satisfaction with the SmartSafe intervention and with the EMA monitoringThe intervention group will obtain significantly higher scores in the satisfaction survey than the control group.
PredictionTo test the accuracy of the eB2 and MEmind monitoring systems to predict clinical suicidal events (suicide attempts, emergency referral for suicide ideation and non-suicidal self-injury).Alterations in normal behavioural patterns detected with eB2 and psychiatric symptoms detected with MEmind will correlate with clinical suicidal events
  • CSSRS, Columbia Suicide Severity Rating Scale; EMA, Ecological Momentary Assessment; SA, suicide attempt; SLDS, Satisfaction with Life Domains Scale; WHODAS 2.0, World Health Organization Disability Assessment Schedule 2.