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

NCT ID: NCT05202756

Last Updated: 2025-09-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

31 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-06-14

Study Completion Date

2025-04-30

Brief Summary

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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.

Detailed Description

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Conditions

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Suicide and Self-harm Suicide Suicide, Attempted Suicidal Ideation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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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.

Group Type EXPERIMENTAL

Mobile Application to Prevent Suicide (MAPS)

Intervention Type BEHAVIORAL

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

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.

Group Type ACTIVE_COMPARATOR

EMA Monitoring Only

Intervention Type BEHAVIORAL

Safety Planning Intervention; ecological momentary assessment only

Interventions

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Mobile Application to Prevent Suicide (MAPS)

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

Intervention Type BEHAVIORAL

EMA Monitoring Only

Safety Planning Intervention; ecological momentary assessment only

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Institute of Mental Health (NIMH)

NIH

Sponsor Role collaborator

Brown University

OTHER

Sponsor Role collaborator

Butler Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Butler Hospital

Providence, Rhode Island, United States

Site Status

Brown University

Providence, Rhode Island, United States

Site Status

Countries

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United States

Other Identifiers

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R34MH124971

Identifier Type: NIH

Identifier Source: secondary_id

View Link

1678556

Identifier Type: -

Identifier Source: org_study_id

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