Real-time Intervention for Suicide Risk Reduction

NCT03950765 | Unknown DMC

• 2 other identifiers: IRB18-1813R34MH113757-01A1
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

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.

Conditions

Suicide, Attempted; Suicide and Self-harm

Keywords

ecological momentary assessment; ecological momentary intervention; distress

Outcome Measures

Primary Outcomes (3)

• 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)

Study Arms (1)

Ecological Momentary Intervention

EXPERIMENTAL

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

Behavioral: Ecological momentary intervention

Interventions

Ecological momentary intervention BEHAVIORAL

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

Ecological Momentary Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Harvard University: lead
• National Institute of Mental Health (NIMH): collaborator
• Massachusetts General Hospital: collaborator

Study Sites (1)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

RECRUITING

MeSH Terms

Conditions

Suicide, Attempted; Suicide; Self-Injurious Behavior

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior

Study Officials

• Evan Kleiman

  Harvard University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Evan M Kleiman, Ph.D.

CONTACT

8484458123; ekleiman@fas.harvard.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: May 9, 2019
• First Posted: May 15, 2019
• Study Start: July 29, 2019
• Primary Completion: March 31, 2020
• Study Completion: July 31, 2020
• Last Updated: August 1, 2019

Record last verified: 2019-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: 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.

Locations

US (1)