Examining Feasibility, Acceptability, and Sustainability of a Novel Personalized Smartphone Intervention for Suicide - Randomized Trial

Examining Feasibility, Acceptability, and Sustainability of a Novel Personalized Smartphone Intervention for Suicide

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.

Study Overview

• Status: Completed
• Conditions: Suicidal Ideation; Suicide, Attempted; Suicide; Suicide and Self-harm
• Intervention / Treatment: Behavioral: Mobile Application to Prevent Suicide (MAPS); Behavioral: EMA Monitoring Only

• Study Type: Interventional
• Enrollment (Actual): 31
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Rhode Island
    • Providence, Rhode Island, United States, 02912
      • Brown University
    • Providence, Rhode Island, United States, 02906
      • Butler Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Mobile Application to Prevent Suicide (MAPS); 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); Safety Planning Intervention, ecological momentary intervention smartphone app system, and bidirectional communication with study clinician.
Active Comparator: EMA Monitoring Only (EMO); Participants in this condition will receive the Safety Planning Intervention (SPI) and will receive ecological momentary assessment prompts on the same schedule as the MAPS condition. However, they will not have access to any other MAPS features.	Behavioral: EMA Monitoring Only; Safety Planning Intervention; ecological momentary assessment only

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Acceptability of Research (Recruitment)	Measured by recruitment rate.	Baseline
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
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
Acceptability of Research Procedures	Feedback on qualitative interview.	1 month
Acceptability of Research (Dropout)	Measured by dropout rate.	6 months
Ecological Momentary Assessment (EMA) Adherence	Number of assessments completed out of total	4 weeks
Rehospitalization	Number of inpatient rehospitalizations will be assessed using the Treatment History Interview and medical records review.	6 months
Emergency Department Visits	Number of emergency department visits will be assessed using the Treatment History Interview and medical records review.	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Use of MAPS Intervention-delivered Coping Strategies (target mechanism)	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.	4 weeks
Reduction of Negative Affect (target mechanism)	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."	4 weeks
Self-Efficacy (target mechanism)	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.	4 weeks

Collaborators and Investigators

• Sponsor: Butler Hospital
• Collaborators: National Institute of Mental Health (NIMH); Brown University

Study record dates

Study Major Dates

• Study Start (Actual): June 14, 2024
• Primary Completion (Actual): April 30, 2025
• Study Completion (Actual): April 30, 2025

Study Registration Dates

• First Submitted: January 3, 2022
• First Submitted That Met QC Criteria: January 19, 2022
• First Posted (Actual): January 21, 2022

Study Record Updates

• Last Update Posted (Estimated): September 5, 2025
• Last Update Submitted That Met QC Criteria: August 29, 2025
• Last Verified: August 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Behavioral Symptoms; Behavior; Suicide; Suicidal Ideation; Self-Injurious Behavior; Suicide, Attempted
• Other Study ID Numbers: 1678556; R34MH124971 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: After all data have been collected and the results of the studies published, de-identified data will be made available to other qualified researchers on request.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No