Real-time Intervention for Suicide Risk Reduction

Suicide, Attempted Clinical Trial

Official title:

Real-time Intervention for Suicide Risk Reduction

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03950765
• Other study ID #: IRB18-1813
• Secondary ID: R34MH113757-01A1
• Status: Recruiting
• Phase: N/A
• Start date: July 29, 2019
• Est. completion date: July 31, 2020

Study information

• Verified date: July 2019
• Source: Harvard University
• Contact: Evan M Kleiman, Ph.D.
• Phone: 8484458123
• Email: ekleiman[@]fas.harvard.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 25
• Est. completion date: July 31, 2020
• Est. primary completion date: March 31, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Suicide
• Suicide and Self-harm
• Suicide, Attempted

Intervention

Behavioral:
• Ecological momentary intervention
Content of this intervention is based on pre-established transdiagnostic protocols for addressing the negative emotion associated with suicidal thoughts and behaviors.

Locations

Country	Name	City	State
United States	Massachusetts General Hospital	Boston	Massachusetts

Sponsors (3)

Lead Sponsor	Collaborator
Harvard University	Massachusetts General Hospital, National Institute of Mental Health (NIMH)

Country where clinical trial is conducted

United States, 

Outcome

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