Real-time Intervention for Suicide Risk Reduction

President and Fellows of Harvard College

Status: Unknown

Conditions: Suicide, Attempted; Suicide and Self-harm

Treatments: Behavioral: Ecological momentary intervention

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT03950765

R34MH113757-01A1 (U.S. NIH Grant/Contract)

IRB18-1813

Details and patient eligibility

About

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.

Full description

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).

Enrollment: 25 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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25 participants in 1 patient group

Ecological Momentary Intervention

Experimental group

Description:

This group will receive three intervention prompts and three assessment prompts on their smartphone each day.

Treatment:

Behavioral: Ecological momentary intervention