Real-time Intervention for Suicide Risk Reduction

NCT ID: NCT03950765

Last Updated: 2019-08-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

25 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-07-29

Study Completion Date

2020-07-31

Brief Summary

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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

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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).

Conditions

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Suicide, Attempted Suicide and Self-harm

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Ecological Momentary Intervention

This group will receive three intervention prompts and three assessment prompts on their smartphone each day.

Group Type EXPERIMENTAL

Ecological momentary intervention

Intervention Type BEHAVIORAL

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

Interventions

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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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Institute of Mental Health (NIMH)

NIH

Sponsor Role collaborator

Massachusetts General Hospital

OTHER

Sponsor Role collaborator

Harvard University

OTHER

Sponsor Role lead

Responsible Party

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Evan Kleiman

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Evan Kleiman

Role: PRINCIPAL_INVESTIGATOR

Harvard University

Locations

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Massachusetts General Hospital

Boston, Massachusetts, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Evan M Kleiman, Ph.D.

Role: CONTACT

8484458123

Facility Contacts

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Jeff C Huffman, MD

Role: primary

Other Identifiers

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R34MH113757-01A1

Identifier Type: NIH

Identifier Source: secondary_id

View Link

IRB18-1813

Identifier Type: -

Identifier Source: org_study_id

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