Clinical trial NCT03950765: Real-time Intervention for Suicide Risk Reduction
Official title: Real-time Intervention for Suicide Risk Reduction
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Suicide, Attempted
Suicide and Self-harm
Keywords: ecological momentary assessment
ecological momentary intervention
distress
Lead sponsor: Harvard University
Sponsor class: OTHER
Collaborators: name: National Institute of Mental Health (NIMH)
name: Massachusetts General Hospital
First posted: 2019-05-15
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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).

Eligibility 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.

Primary outcomes:
measure: Change in momentary levels of self-reported distress
timeFrame: Through study completion (duration of inpatient stay + 4 weeks post-discharge)
measure: Change in momentary levels of physiological distress
timeFrame: Through study completion (duration of inpatient stay + 4 weeks post-discharge)
measure: Change in momentary levels of suicidal thinking
timeFrame: Through study completion (duration of inpatient stay + 4 weeks post-discharge)
Secondary outcomes:
Other outcomes:
Locations:
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
Study officials:
affiliation: Harvard University
name: Evan Kleiman
role: PRINCIPAL_INVESTIGATOR
References: