Back to resultsReal-time Intervention for Suicide Risk Reduction
Primary Purpose
Suicide, Attempted, Suicide and Self-harm
Status
Unknown status
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Ecological momentary intervention
Sponsored by
About this trial
This is an interventional treatment trial for Suicide, Attempted focused on measuring ecological momentary assessment, ecological momentary intervention, distress
Eligibility Criteria
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.
Sites / Locations
- Massachusetts General HospitalRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Ecological Momentary Intervention
Arm Description
This group will receive three intervention prompts and three assessment prompts on their smartphone each day.
Outcomes
Primary Outcome Measures
Change in momentary levels of self-reported distress
Assessed via smartphone assessments
Change in momentary levels of physiological distress
Skin conductance (assessed with wearable device)
Change in momentary levels of suicidal thinking
Assessed via smartphone assessments
Secondary Outcome Measures
Full Information
NCT ID
NCT03950765
First Posted
May 9, 2019
Last Updated
July 30, 2019
Sponsor
Harvard University
Collaborators
National Institute of Mental Health (NIMH), Massachusetts General Hospital
1. Study Identification
Unique Protocol Identification Number
NCT03950765
Brief Title
Real-time Intervention for Suicide Risk Reduction
Official Title
Real-time Intervention for Suicide Risk Reduction
Study Type
Interventional
2. Study Status
Record Verification Date
July 2019
Overall Recruitment Status
Unknown status
Study Start Date
July 29, 2019 (Actual)
Primary Completion Date
March 31, 2020 (Anticipated)
Study Completion Date
July 31, 2020 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Harvard University
Collaborators
National Institute of Mental Health (NIMH), Massachusetts General Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Suicide, Attempted, Suicide and Self-harm
Keywords
ecological momentary assessment, ecological momentary intervention, distress
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
25 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Ecological Momentary Intervention
Arm Type
Experimental
Arm Description
This group will receive three intervention prompts and three assessment prompts on their smartphone each day.
Intervention Type
Behavioral
Intervention Name(s)
Ecological momentary intervention
Intervention Description
Content of this intervention is based on pre-established transdiagnostic protocols for addressing the negative emotion associated with suicidal thoughts and behaviors.
Primary Outcome Measure Information:
Title
Change in momentary levels of self-reported distress
Description
Assessed via smartphone assessments
Time Frame
Through study completion (duration of inpatient stay + 4 weeks post-discharge)
Title
Change in momentary levels of physiological distress
Description
Skin conductance (assessed with wearable device)
Time Frame
Through study completion (duration of inpatient stay + 4 weeks post-discharge)
Title
Change in momentary levels of suicidal thinking
Description
Assessed via smartphone assessments
Time Frame
Through study completion (duration of inpatient stay + 4 weeks post-discharge)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Evan M Kleiman, Ph.D.
Phone
8484458123
Email
ekleiman@fas.harvard.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Evan Kleiman
Organizational Affiliation
Harvard University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Massachusetts General Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jeff C Huffman, MD
Email
jhuffman@partners.org
First Name & Middle Initial & Last Name & Degree
Jeff C Huffman, MD
First Name & Middle Initial & Last Name & Degree
Kate H Bentley, PhD
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing 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.
Learn more about this trial
Real-time Intervention for Suicide Risk Reduction
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