Real-time Intervention for Suicide Risk Reduction

Study Overview
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Brief Summary
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The goal of this study is to provide an initial pilot test of an Ecological Momentary Intervention (EMI) designed the reduce the distress associated with negative emotion among individuals at risk for suicide that pairs content from a smartphone with a wearable physiological monitor. Participants will be 25 suicidal adult inpatients who will complete three brief therapy sessions with a study therapist and then complete exercises associated with the study for the duration of the inpatient period and for 28 days after they leave the hospital.

Detailed Description
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The goal of this study is to provide an initial pilot test of an Ecological Momentary Intervention (EMI) designed the reduce the distress associated with negative emotion among individuals at risk for suicide that pairs content from a smartphone with a wearable physiological monitor. Participants will be 25 suicidal adult inpatients who will complete three brief therapy sessions with a study therapist and then complete exercises associated with the study for the duration of the inpatient period and for 28 days after they leave the hospital. During the time they are in the study, participants will be asked to install on their smartphone a mobile application to deliver the therapeutic content and will wear a physiological monitoring device on their wrist (Empatica Embrace) which will monitor objective signals of physiological distress (e.g., skin conductance).

Official Title
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Real-time Intervention for Suicide Risk Reduction

Conditions
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Suicide, Attempted, Suicide and Self-harm

Intervention / Treatment
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* Behavioral: Ecological momentary intervention


Participation Criteria
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Eligibility Criteria
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Inclusion criteria: A recent suicide attempt or serious suicidal ideation (i.e., ideation with at least 70% intent or a suicide plan with access to lethal means), The ability to speak and write English fluently, access to an internet-capable smartphone (e.g., an iPhone or Android phone) Providing at least one collateral contact in cases where the investigators cannot reach the participant. Exclusion criteria: The presence of any factor that impairs an individual's ability to comprehend and effectively participate in the study including: An inability to speak or write English fluently The presence of gross cognitive impairment due to florid psychosis, intellectual disability, dementia, or acute intoxication. The presence of extremely agitated or violent behavior.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Ecological Momentary Intervention<br>This group will receive three intervention prompts and three assessment prompts on their smartphone each day. | Behavioral: Ecological momentary intervention<br>* Content of this intervention is based on pre-established transdiagnostic protocols for addressing the negative emotion associated with suicidal thoughts and behaviors.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in momentary levels of self-reported distress | Assessed via smartphone assessments | Through study completion (duration of inpatient stay + 4 weeks post-discharge) | 
| Change in momentary levels of physiological distress | Skin conductance (assessed with wearable device) | Through study completion (duration of inpatient stay + 4 weeks post-discharge) | 
| Change in momentary levels of suicidal thinking | Assessed via smartphone assessments | Through study completion (duration of inpatient stay + 4 weeks post-discharge) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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ecological momentary assessment, ecological momentary intervention, distress