Real-time Intervention for Suicide Risk Reduction

Not Applicable

• Conditions: Suicide, Attempted; Suicide and Self-harm
• Interventions: Behavioral: Ecological momentary intervention

• Registration Number: NCT03950765
• Lead Sponsor: Harvard University

Brief Summary

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

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).

Study Timeline

• Study First Submitted: 2019-05-09
• Study First Submitted QC: 2019-05-13
• Study First Posted: 2019-05-15
• Status Verified: 2019-07
• Study Start: 2019-07-29
• Last Update Submitted: 2019-07-30
• Last Update Posted: 2019-08-01
• Primary Completion: 2020-03-31
• Study Completion: 2020-07-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 25

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Ecological Momentary Intervention	Ecological momentary intervention	This group will receive three intervention prompts and three assessment prompts on their smartphone each day.

Primary Outcome Measures

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

Trial Locations

Locations (1)

Massachusetts General Hospital; 🇺🇸 Boston, Massachusetts, United States