Real-time Intervention for Suicide Risk Reduction

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.

Study Overview

• Status: Unknown
• Conditions: Suicide, Attempted; Suicide and Self-harm
• Intervention / Treatment: Behavioral: Ecological momentary intervention

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 Type: Interventional
• Enrollment (Anticipated): 25
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Evan M Kleiman, Ph.D.; Phone Number: 8484458123; Email: ekleiman@fas.harvard.edu

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02114
      • Recruiting
      • Massachusetts General Hospital
      • Contact: Jeff C Huffman, MD; Email: jhuffman@partners.org
      • Principal Investigator: Jeff C Huffman, MD
      • Sub-Investigator: Kate H Bentley, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Ecological Momentary Intervention; This group will receive three intervention prompts and three assessment prompts on their smartphone each day.	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.

What is the study measuring?

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)

Collaborators and Investigators

• Sponsor: Harvard University
• Collaborators: National Institute of Mental Health (NIMH); Massachusetts General Hospital
• Investigators: Principal Investigator: Evan Kleiman, Harvard University

Study record dates

Study Major Dates

• Study Start (Actual): July 29, 2019
• Primary Completion (Anticipated): March 31, 2020
• Study Completion (Anticipated): July 31, 2020

Study Registration Dates

• First Submitted: May 9, 2019
• First Submitted That Met QC Criteria: May 13, 2019
• First Posted (Actual): May 15, 2019

Study Record Updates

• Last Update Posted (Actual): August 1, 2019
• Last Update Submitted That Met QC Criteria: July 30, 2019
• Last Verified: July 1, 2019

More Information

Terms related to this study

• Keywords: distress; ecological momentary assessment; ecological momentary intervention
• Additional Relevant MeSH Terms: Behavioral Symptoms; Suicide; Suicide, Attempted; Self-Injurious Behavior
• Other Study ID Numbers: IRB18-1813; R34MH113757-01A1 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Data will be shared in accordance with NIH data sharing policies.
• IPD Sharing Time Frame: Data will be available within 6 months of the completion of the final participant.
• IPD Sharing Access Criteria: Data will be released to the NIMH's data repository and anyone with access to the repository can access these data.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No