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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT05180344
Other study ID # 1710-001
Secondary ID SRG-1-119-18
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date July 1, 2024
Est. completion date May 31, 2025

Study information

Verified date April 2024
Source Butler Hospital
Contact Cheryl Cordeiro
Phone 401-455-6654
Email ccordeiro@butler.org
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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).


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 10
Est. completion date May 31, 2025
Est. primary completion date May 31, 2025
Accepts healthy volunteers No
Gender All
Age group 18 Years to 26 Years
Eligibility Inclusion Criteria: - 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 Exclusion Criteria: - Current psychotic or manic symptoms severe enough to interfere with study procedures

Study Design


Intervention

Behavioral:
Mobile Application to Prevent Suicide (MAPS)
Safety Planning Intervention, ecological momentary intervention smartphone app system, and bidirectional communication with study clinician.
Treatment as Usual + Ecological Momentary Assessment (TAU + EMA)
Safety Planning Intervention; ecological momentary assessment only

Locations

Country Name City State
United States Butler Hospital Providence Rhode Island

Sponsors (2)

Lead Sponsor Collaborator
Butler Hospital American Foundation for Suicide Prevention (AFSP)

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Acceptability of Research (Recruitment) Measured by recruitment rate. Baseline
Primary Acceptability of Research (Recruitment) Measured by dropout rate. 1 month
Primary Acceptability of Research Procedures Feedback on qualitative interview 1 month
Primary 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
Primary Acceptability of MAPS Intervention Feedback on qualitative interview. 1 month
Primary Satisfaction with MAPS Intervention Measured by protocol completion rate. 4 weeks
Primary Ecological Momentary Assessment (EMA) Adherence Number of assessments completed out of total. 4 weeks
Secondary 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. 1 month
Secondary Rehospitalization Will be assessed using the Treatment History Interview and medical records review. 1 month
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