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

NCT05202756 | Completed

• 2 other identifiers: 1678556R34MH124971
• Study Type: interventional
• Target: 31
• Locations: 1 country
• Sites: 2

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.

Conditions

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

Outcome Measures

Primary Outcomes (10)

• 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 Research (Recruitment)

  Measured by recruitment rate.

  Baseline

• Acceptability of Research (Dropout)

  Measured by dropout rate.

  6 months

• Acceptability of Research Procedures

  Feedback on qualitative interview.

  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

• 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

  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 Outcomes (3)

• Use of MAPS Intervention-delivered Coping Strategies (target mechanism)

  4 weeks

• Reduction of Negative Affect (target mechanism)

  4 weeks

• Self-Efficacy (target mechanism)

  4 weeks

Study Arms (2)

Mobile Application to Prevent Suicide (MAPS)

EXPERIMENTAL

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)

EMA Monitoring Only (EMO)

ACTIVE COMPARATOR

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

Interventions

Mobile Application to Prevent Suicide (MAPS) BEHAVIORAL

Safety Planning Intervention, ecological momentary intervention smartphone app system, and bidirectional communication with study clinician.

Mobile Application to Prevent Suicide (MAPS)

EMA Monitoring Only BEHAVIORAL

Safety Planning Intervention; ecological momentary assessment only

EMA Monitoring Only (EMO)

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Current psychotic or manic symptoms severe enough to interfere with completion of study procedures

Sponsors & Collaborators

• Butler Hospital: lead
• National Institute of Mental Health (NIMH): collaborator
• Brown University: collaborator

Study Sites (2)

Butler Hospital

Providence, Rhode Island, 02906, United States

Location

Brown University

Providence, Rhode Island, 02912, United States

Location

MeSH Terms

Conditions

Suicide; Self-Injurious Behavior; Suicide, Attempted; Suicidal Ideation

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 3, 2022
• First Posted: January 21, 2022
• Study Start: June 14, 2024
• Primary Completion: April 30, 2025
• Study Completion: April 30, 2025
• Last Updated: September 5, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will share

Locations

US (2)