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Real-time Intervention for Suicide Risk Reduction

Real-time Intervention for Suicide Risk Reduction

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03950765
Enrollment
25
Registered
2019-05-15
Start date
2019-07-29
Completion date
2020-07-31
Last updated
2019-08-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Suicide, Attempted, Suicide and Self-harm

Keywords

ecological momentary assessment, ecological momentary intervention, distress

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).

Interventions

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

Sponsors

National Institute of Mental Health (NIMH)
CollaboratorNIH
Massachusetts General Hospital
CollaboratorOTHER
Harvard University
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Change in momentary levels of self-reported distressThrough study completion (duration of inpatient stay + 4 weeks post-discharge)Assessed via smartphone assessments
Change in momentary levels of physiological distressThrough study completion (duration of inpatient stay + 4 weeks post-discharge)Skin conductance (assessed with wearable device)
Change in momentary levels of suicidal thinkingThrough study completion (duration of inpatient stay + 4 weeks post-discharge)Assessed via smartphone assessments

Countries

United States

Contacts

Primary ContactEvan M Kleiman, Ph.D.
ekleiman@fas.harvard.edu8484458123

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026