Suicidal Ideation, Suicide, Suicide and Self-harm, Suicide, Attempted
Conditions
Brief summary
The primary aim of the present study is leverage existing infrastructure to develop novel technological features for a novel personalized smartphone intervention system, called the Mobile Application to Prevent Suicide (MAPS), and to establish feasibility, acceptability, safety, and estimate key parameters for secondary outcomes (i.e., suicidal ideation and behavior; re-hospitalization).
Interventions
Safety Planning Intervention, ecological momentary intervention smartphone app system, and bidirectional communication with study clinician.
Sponsors
Butler Hospital
National Institute of Mental Health (NIMH)
Brown University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
* Presence of suicidal ideation and/or suicidal behavior in the past month * Between the ages of 18 and 70 * Able to read, write, and understand English well enough to complete study procedures * Owns a smartphone
Exclusion criteria
* Current psychotic or manic symptoms severe enough to interfere with completion of study procedures
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Patient Satisfaction | Following intervention (assessed at 1-month follow-up) | Measured using the Client Satisfaction Questionnaire, a self-report measure of satisfaction with treatment. Scores range from 8 to 32, with higher scores representing higher satisfaction. |
| Acceptability of Research (Recruitment) | Baseline | The acceptability of research outcome is measured by the recruitment rate (number of patients enrolled divided by the total number of patients approached). |
| Acceptability of Research (Dropout) | Baseline through 1-month follow-up | Acceptability of research is measured by dropout rate (number of participants who dropped out over the entire number of participants enrolled). This does not include participants who were lost to follow-up. |
| Satisfaction With MAPS Intervention | Following intervention (assessed at 1-month follow-up) | Satifaction with the MAPS intervention was measured by protocol completion rate. |
| Ecological Momentary Assessment (EMA) Adherence | During 28 days of intervention | The Ecological Momentary Assessment (EMA) adherence outcome is measured by the percentage of EMA surveys completed. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Suicidal Ideation Severity | Comparing 28 days prior to baseline to the 28 days using MAPS intervention | Will be assessed using the Columbia Suicide Severity Rating Scale, which provides a suicidal ideation severity score ranging from 0 to 5 with higher scores representing more severe ideation. |
| Number of Suicide Attempts | During the 28 days of the intervention | Total number of suicide attempts reported among participants using MAPS (across whole sample). |
| Rehospitalization | During the 28 days of the intervention | Average number of inpatient rehospitalizations will be assessed using the Treatment History Interview and medical records review. |
| Emergency Department Visits | During the 28 days of the intervention | Average number of emergency department visits will be assessed using the Treatment History Interview and medical records review. |
Countries
United States
Participant flow
Pre-assignment details
Results displayed here refer to the open trial phase of this study only. Information regarding the randomized pilot trial phase can be found in the record NCT05202756.
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Continuous | 33.2 Age (years) STANDARD_DEVIATION 13.57 |
| Columbia Suicide Severity Rating Scale (C-SSRS) Most severe ideation (0) | 0 Participants |
| Columbia Suicide Severity Rating Scale (C-SSRS) Most severe ideation (1) | 0 Participants |
| Columbia Suicide Severity Rating Scale (C-SSRS) Most severe ideation (2) | 2 Participants |
| Columbia Suicide Severity Rating Scale (C-SSRS) Most severe ideation (3) | 4 Participants |
| Columbia Suicide Severity Rating Scale (C-SSRS) Most severe ideation (4) | 4 Participants |
| Columbia Suicide Severity Rating Scale (C-SSRS) Most severe ideation (5) | 0 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 10 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants |
| Race (NIH/OMB) More than one race | 2 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 8 Participants |
| Region of Enrollment United States | 10 Participants |
| Sex/Gender, Customized Female | 5 Participants |
| Sex/Gender, Customized Intersex | 0 Participants |
| Sex/Gender, Customized Male | 5 Participants |
| Treatment History Interview | .4 Number of ED visits STANDARD_DEVIATION 0.52 |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 10 |
| other Total, other adverse events | 0 / 10 |
| serious Total, serious adverse events | 1 / 10 |
Outcome results
None listed