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Trial record 14 of 123 for:    Behaviors and Mental Disorders[CONDITION-BROWSE-BRANCH] | Recruiting, Not yet recruiting, Available Studies | ( Map: Massachusetts, United States ) | NIH, U.S. Fed

Real-time Intervention for Suicide Risk Reduction

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ClinicalTrials.gov Identifier: NCT03950765
Recruitment Status : Not yet recruiting
First Posted : May 15, 2019
Last Update Posted : May 15, 2019
Sponsor:
Collaborators:
National Institute of Mental Health (NIMH)
Massachusetts General Hospital
Information provided by (Responsible Party):
Evan Kleiman, 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.

Condition or disease Intervention/treatment Phase
Suicide, Attempted Suicide and Self-harm Behavioral: Ecological momentary intervention Not Applicable

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).

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 25 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Real-time Intervention for Suicide Risk Reduction
Estimated Study Start Date : July 1, 2019
Estimated Primary Completion Date : December 31, 2019
Estimated Study Completion Date : July 31, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Suicide

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.




Primary Outcome Measures :
  1. 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

  2. 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)

  3. Change in momentary levels of suicidal thinking [ Time Frame: Through study completion (duration of inpatient stay + 4 weeks post-discharge) ]
    Assessed via smartphone assessments



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03950765


Contacts
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Contact: Evan M Kleiman, Ph.D. 8484458123 ekleiman@fas.harvard.edu

Locations
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United States, Massachusetts
Massachusetts General Hospital Not yet recruiting
Boston, Massachusetts, United States, 02114
Contact: Jeff C Huffman, MD       jhuffman@partners.org   
Principal Investigator: Jeff C Huffman, MD         
Sub-Investigator: Kate H Bentley, PhD         
Sponsors and Collaborators
Harvard University
National Institute of Mental Health (NIMH)
Massachusetts General Hospital
Investigators
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Principal Investigator: Evan Kleiman Harvard University

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Responsible Party: Evan Kleiman, Principal Investigator, Harvard University
ClinicalTrials.gov Identifier: NCT03950765     History of Changes
Other Study ID Numbers: IRB18-1813
R34MH113757-01A1 ( U.S. NIH Grant/Contract )
First Posted: May 15, 2019    Key Record Dates
Last Update Posted: May 15, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Data will be shared in accordance with NIH data sharing policies.
Supporting Materials: Study Protocol
Time Frame: Data will be available within 6 months of the completion of the final participant.
Access Criteria: Data will be released to the NIMH's data repository and anyone with access to the repository can access these data.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Evan Kleiman, Harvard University:
ecological momentary assessment
ecological momentary intervention
distress

Additional relevant MeSH terms:
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Suicide
Suicide, Attempted
Self-Injurious Behavior
Behavioral Symptoms