Examining Feasibility, Acceptability, and Sustainability of a Novel Personalized Smartphone Intervention for Suicide - Open 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 secondary outcomes (i.e., suicidal ideation and behavior; re-hospitalization).

Study Overview

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

• Study Type: Interventional
• Enrollment (Actual): 10
• 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: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Following intervention (assessed at 1-month follow-up)
Acceptability of Research (Recruitment)	The acceptability of research outcome is measured by the recruitment rate (number of patients enrolled divided by the total number of patients approached).	Baseline
Acceptability of Research (Dropout)	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.	Baseline through 1-month follow-up
Satisfaction With MAPS Intervention	Satifaction with the MAPS intervention was measured by protocol completion rate.	Following intervention (assessed at 1-month follow-up)
Ecological Momentary Assessment (EMA) Adherence	The Ecological Momentary Assessment (EMA) adherence outcome is measured by the percentage of EMA surveys completed.	During 28 days of intervention

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Suicidal Ideation Severity	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.	Comparing 28 days prior to baseline to the 28 days using MAPS intervention
Number of Suicide Attempts	Total number of suicide attempts reported among participants using MAPS (across whole sample).	During the 28 days of the intervention
Rehospitalization	Average number of inpatient rehospitalizations will be assessed using the Treatment History Interview and medical records review.	During the 28 days of the intervention
Emergency Department Visits	Average number of emergency department visits will be assessed using the Treatment History Interview and medical records review.	During the 28 days of the intervention

Collaborators and Investigators

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

Publications and helpful links

General Publications

• Schatten HT, Hughes CD, Kimble SK, Wallace G, Benz MB, Kraines MA, Germain E, Brick L, Armey MF, Elwy AR, Weinstock LM, Miller IW, Primack J. Development and Pilot Testing of the Mobile Application to Prevent Suicide (MAPS). Cognit Ther Res. 2025 Jun;49(3):497-511. doi: 10.1007/s10608-024-10568-9. Epub 2025 Jan 9.

Study record dates

Study Major Dates

• Study Start (Actual): December 5, 2023
• Primary Completion (Actual): February 25, 2025
• Study Completion (Actual): April 30, 2025

Study Registration Dates

• First Submitted: January 3, 2022
• First Submitted That Met QC Criteria: January 5, 2022
• First Posted (Actual): January 6, 2022

Study Record Updates

• Last Update Posted (Actual): September 14, 2026
• Last Update Submitted That Met QC Criteria: August 19, 2026
• 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: 202012-001; 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