Feasibility, Acceptability, and Preliminary Efficacy of a Novel Personalized Mobile Intervention for Suicide - Randomized Trial

Study Overview
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Brief Summary
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The primary aim of this grant is to conduct pilot testing on a novel personalized mobile intervention for suicide - Mobile Application to Prevent Suicide (MAPS) - and to establish feasibility, acceptability, safety, and primary outcomes (i.e., suicidal ideation and behavior; re-hospitalization).

Official Title
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Feasibility, Acceptability, and Preliminary Efficacy of a Novel Personalized Mobile Intervention for Suicide

Conditions
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Suicide, Suicide and Self-harm, Suicide, Attempted, Suicidal Ideation

Intervention / Treatment
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* Behavioral: Mobile Application to Prevent Suicide (MAPS)
* Behavioral: Treatment as Usual + Ecological Momentary Assessment (TAU + EMA)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Suicidal ideation and/or suicidal behavior in the past month verified by the C-SSRS Between the ages of 18 and 26 English proficiency Comfortable with smartphone technology Deemed by the treatment team to be stable enough to complete study procedures Exclusion Criteria: Current psychotic or manic symptoms severe enough to interfere with study procedures

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 26 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Mobile Application to Prevent Suicide (MAPS)<br>Participants receiving MAPS will receive the Safety Planning Intervention (SPI) which will be uploaded into the smartphone app. They will be prompted four times per day to complete a brief ecological momentary assessment check-in inquiring about their cognitions, affect, and behavior, including suicidal thoughts and behaviors. Based on these responses, they will be provided with coping strategies from their safety plans and from a database of coping strategies created by study staff. They will also have access to emergency phone numbers, the coping strategies database, and can communicate with their study clinician through a text-like interface in the app. They will receive this intervention for one month. | Behavioral: Mobile Application to Prevent Suicide (MAPS)<br>* Safety Planning Intervention, ecological momentary intervention smartphone app system, and bidirectional communication with study clinician.<br>|
| Active Comparator: Treatment As Usual + Ecological Momentary Assessment (TAU+EMA)<br>In the TAU+EMA condition, participants will receive the Safety Planning Intervention (SPI), and engage in psychiatric treatment as recommended in their discharge plan. They will receive ecological momentary assessment (EMA) prompts on the same schedule as participants in the MAPS condition (to control for attention and intervention effects resulting solely from responding to surveys) but they will not receive the MAPS intervention. | Behavioral: Treatment as Usual + Ecological Momentary Assessment (TAU + EMA)<br>* Safety Planning Intervention; ecological momentary assessment only<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Acceptability of Research (Recruitment) | Measured by recruitment rate. | Baseline | 
| Acceptability of Research (Recruitment) | Measured by dropout rate. | 6 months | 
| Acceptability of Research Procedures | Feedback on qualitative interview | 1 month | 
| Patient Satisfaction | 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. | 1 month | 
| Acceptability of MAPS Intervention | Feedback on qualitative interview. | 1 month | 
| Satisfaction with MAPS Intervention | Measured by protocol completion rate. | 4 weeks | 
| Ecological Momentary Assessment (EMA) Adherence | Number of assessments completed out of total. | 4 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Suicidal Ideation and Behavior | 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. | 6 months | 
| Rehospitalization | Will be assessed using the Treatment History Interview and medical records review. | 1 month |