Suicide, Attempted, Suicide and Self-harm
Conditions
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
BEHAVIORALEcological momentary intervention
Content of this intervention is based on pre-established transdiagnostic protocols for addressing the negative emotion associated with suicidal thoughts and behaviors.
Sponsors
Rutgers, The State University of New Jersey
National Institute of Mental Health (NIMH)
Massachusetts General Hospital
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
| Measure | Time frame | Description |
|---|---|---|
| Self Reported Distress | Immediately before and immediately after each in-app skills-practice exercise, over days 1-28 post-discharge. Each participant's pre-practice and post-practice ratings were averaged across all exercises completed during this period. | Self-reported momentary distress, computed as the sum of four items (hopelessness, anger, burdensomeness, agitation), each rated 0-10. Composite range 0-40. Higher scores indicate greater (worse) distress. |
| Skin Conductance Response | Up to 42 days (from enrollment during the inpatient psychiatric stay, up to 14 days, through 28 days after hospital discharge) | Total number of skin conductance responses, assessed via electrodermal activity recorded with a wrist-worn wearable device. |
| Momentary Suicidal Thinking | Up to 42 days (from enrollment during the inpatient psychiatric stay, up to 14 days, through 28 days after hospital discharge) | This is an 11-point scale. A score of 0 is equivalent to no suicidal thinking at all ("not at all"), a score of 10 is a score of very extreme suicidal thinking ("Extremely"). Lower scores equal less severe suicidal thinking (i.e., a better outcome). Ratings were collected immediately before and immediately after each in-app skills-practice exercise. Each participant's pre-practice and post-practice ratings were averaged across all exercises completed during the study period; values are the mean (SD) across participants of these per-participant averages. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATOREvan Kleiman
Harvard University
Participant flow
Recruitment details
Participants (n = 25) were recruited as part of a registered clinical trial (NCT03950765) from the Massachusetts General Hospital inpatient psychiatry service between July 2019 and March 2020.
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 25 Participants |
| Age, Continuous | 33.48 years STANDARD_DEVIATION 13.84 |
| Patient-Reported Outcomes Measurement Information System Self-efficacy for managing emotions | 33.53 t-score STANDARD_DEVIATION 4.66 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 4 Participants |
| Race (NIH/OMB) Black or African American | 2 Participants |
| Race (NIH/OMB) More than one race | 1 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 3 Participants |
| Race (NIH/OMB) White | 15 Participants |
| Region of Enrollment United States | 25 participants |
| Sex: Female, Male Female | 14 Participants |
| Sex: Female, Male Male | 11 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 25 |
| other Total, other adverse events | 0 / 25 |
| serious Total, serious adverse events | 0 / 25 |
Outcome results
None listed