Feasibility, Acceptability, and Preliminary Efficacy of a Novel Personalized Mobile Intervention for Suicide - Open Trial (2)

NCT05180344 | Recruiting

• 2 other identifiers: 1710-001SRG-1-119-18
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

The primary aim of this grant is to conduct pilot testing on a novel personalized mobile intervention for suicide - Mobile Application to Prevent Suicide (MAPS) - and to establish feasibility, acceptability, safety, and primary outcomes (i.e., suicidal ideation and behavior; re-hospitalization).

Conditions

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

Outcome Measures

Primary Outcomes (7)

• Acceptability of Research (Recruitment)

  Measured by recruitment rate.

  Baseline

• Acceptability of Research (Recruitment)

  Measured by dropout rate.

  1 month

• Acceptability of Research Procedures

  Feedback on qualitative interview

  1 month

• 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

• Ecological Momentary Assessment (EMA) Adherence

  Number of assessments completed out of total.

  4 weeks

Secondary Outcomes (2)

• Suicidal Ideation and Behavior

  1 month

• Rehospitalization

  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

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)

Eligibility Criteria

• Age: 18 Years - 26 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Suicidal ideation and/or suicidal behavior in the past month verified by the C-SSRS
• Between the ages of 18 and 26
• English proficiency
• Comfortable with smartphone technology
• Deemed by the treatment team to be stable enough to complete study procedures

You may not qualify if:

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

Sponsors & Collaborators

• Butler Hospital: lead
• American Foundation for Suicide Prevention (AFSP): collaborator

Study Sites (1)

Butler Hospital

Providence, Rhode Island, 02906, United States

RECRUITING

MeSH Terms

Conditions

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

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior

Central Study Contacts

Cheryl Cordeiro

CONTACT

401-455-6654; ccordeiro@butler.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• 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: July 25, 2024
• Primary Completion: October 1, 2025
• Study Completion: October 1, 2025
• Last Updated: July 17, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will share

Locations

US (1)