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 primary outcomes (i.e., suicidal ideation and behavior; re-hospitalization), and target mechanisms.
Interventions
Safety Planning Intervention, ecological momentary intervention smartphone app system, and bidirectional communication with study clinician.
BEHAVIORALEMA Monitoring Only
Safety Planning Intervention; ecological momentary assessment only
Sponsors
Butler Hospital
National Institute of Mental Health (NIMH)
Brown University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
SINGLE (Outcomes Assessor)
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 | 1 month | 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 | Measured by recruitment rate. |
| Acceptability of Research (Dropout) | 6 months | Measured by dropout rate. |
| Acceptability of Research Procedures | 1 month | Feedback on qualitative interview. |
| Acceptability of MAPS Intervention | 1 month | Feedback on qualitative interview. |
| Satisfaction with MAPS Intervention | 4 weeks | Measured by protocol completion rate. |
| Ecological Momentary Assessment (EMA) Adherence | 4 weeks | Number of assessments completed out of total |
| Suicidal Ideation and Behavior | 6 months | Will be assessed using the Columbia Suicide Severity Rating Scale, items from the Modified Scale for Suicidal Ideation, and ecological momentary assessment of suicidal ideation and behavior. The Columbia Suicide Severity Rating Scale can provide presence/absence of suicidal ideation and suicidal behavior, as well as a suicidal ideation score ranging from 0 to 5 with higher scores representing more severe ideation, and a suicidal ideation intensity rating from 0-25 with higher scores representing more intense ideation. |
| Rehospitalization | 6 months | Number of inpatient rehospitalizations will be assessed using the Treatment History Interview and medical records review. |
| Emergency Department Visits | 6 months | Number of emergency department visits will be assessed using the Treatment History Interview and medical records review. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Use of MAPS Intervention-delivered Coping Strategies (target mechanism) | 4 weeks | Coping strategy use will be measured in three ways: (1) when participants are prompted to use a coping strategy via MAPS, followup prompts ask whether or not they used the coping skill, (2) in each EMA survey, participants are asked whether or not they used any coping skills since the last survey, and (3) the system provides output with regard to how many times participants dial a support contact phone number through the MAPS app. |
| Reduction of Negative Affect (target mechanism) | 4 weeks | Negative affect will be measured using Positive and Negative Affect Scale (PANAS-X) items on ecological momentary assessment surveys. Each emotion item on the PANAS-X is rated on a 1-5 scale based on how participants feel, with 1 indicating "very slightly or not at all" and 5 indicating "extremely." |
| Self-Efficacy (target mechanism) | 4 weeks | Coping self-efficacy will be measured using the Coping Self-Efficacy Scale. Self-efficacy for seeking mental health care will be measured by the Self-Efficacy to Seek Mental Health Care Scale. The total score can range from 0-260; the higher the score, the higher the level of coping self-efficacy. |
Countries
United States
Outcome results
None listed