NCT05180383

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 secondary outcomes (i.e., suicidal ideation and behavior; re-hospitalization).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Dec 2023

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 3, 2022

Completed
3 days until next milestone

First Posted

Study publicly available on registry

January 6, 2022

Completed
1.9 years until next milestone

Study Start

First participant enrolled

December 5, 2023

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 25, 2025

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2025

Completed
Last Updated

September 5, 2025

Status Verified

August 1, 2025

Enrollment Period

1.2 years

First QC Date

January 3, 2022

Last Update Submit

August 29, 2025

Conditions

Outcome Measures

Primary Outcomes (7)

  • 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.

    1 month

  • 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

Secondary Outcomes (3)

  • Suicidal Ideation and Behavior

    1 month

  • Rehospitalization

    1 month

  • Emergency Department Visits

    1 month

Study Arms (1)

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)

Interventions

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

Mobile Application to Prevent Suicide (MAPS)

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Butler Hospital

Providence, Rhode Island, 02906, United States

Location

Brown University

Providence, Rhode Island, 02912, United States

Location

MeSH Terms

Conditions

SuicideSelf-Injurious BehaviorSuicide, AttemptedSuicidal Ideation

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehavior

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 3, 2022

First Posted

January 6, 2022

Study Start

December 5, 2023

Primary Completion

February 25, 2025

Study Completion

April 30, 2025

Last Updated

September 5, 2025

Record last verified: 2025-08

Data Sharing

IPD Sharing
Will share

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.

Locations