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Clinical Trials/NCT03950765
NCT03950765
Unknown
Not Applicable

Real-time Intervention for Suicide Risk Reduction

Harvard University1 site in 1 country25 target enrollmentJuly 29, 2019

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Suicide, Attempted
Sponsor
Harvard University
Enrollment
25
Locations
1
Primary Endpoint
Change in momentary levels of self-reported distress
Last Updated
6 years ago

Overview

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).

Registry
clinicaltrials.gov
Start Date
July 29, 2019
End Date
July 31, 2020
Last Updated
6 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Evan Kleiman

Principal Investigator

Harvard University

Eligibility Criteria

Inclusion Criteria

  • Not provided

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

Change in momentary levels of self-reported distress

Time Frame: Through study completion (duration of inpatient stay + 4 weeks post-discharge)

Assessed via smartphone assessments

Change in momentary levels of physiological distress

Time Frame: Through study completion (duration of inpatient stay + 4 weeks post-discharge)

Skin conductance (assessed with wearable device)

Change in momentary levels of suicidal thinking

Time Frame: Through study completion (duration of inpatient stay + 4 weeks post-discharge)

Assessed via smartphone assessments

Study Sites (1)

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