Recruiting

Suicide Risk

Sponsor:

Harvard University

Code:

NCT03950765

Conditions

Suicide, Attempted

Suicide and Self-harm

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Ecological momentary intervention

Study Details

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

Study ID

NCT03950765

Start date

Jul 29, 2019

Status verified date

Jul, 2019

Completion date

Jul 31, 2020

Anticipated

Primary completion date

Mar 31, 2020

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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 Design

Enrollment

25 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Ecological Momentary Intervention

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

Interventions

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 measure

  • Change in momentary levels of self-reported distress [ Time Frame: Through study completion (duration of inpatient stay + 4 weeks post-discharge) ]
  • Change in momentary levels of physiological distress [ Time Frame: Through study completion (duration of inpatient stay + 4 weeks post-discharge) ]
  • Change in momentary levels of suicidal thinking [ Time Frame: Through study completion (duration of inpatient stay + 4 weeks post-discharge) ]

Central Contacts and Locations

Central contacts

Evan M Kleiman, Ph.D.

8484458123ekleiman@fas.harvard.edu

Locations

Massachusetts General Hospital

Recruiting

Boston, Massachusetts, United States, 02114

Contacts

Jeff C Huffman, MD

jhuffman@partners.org

Principal Investigator:

Jeff C Huffman, MD

More Information

Sponsor

Harvard University

Last update posted

Aug 1, 2019

Last verified

Jul, 2019

Keywords

  • ecological momentary assessment
  • ecological momentary intervention
  • distress

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Harvard University on 2019-08-01.