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

Not Applicable

Completed

• Conditions: Suicide; Suicide and Self-harm; Suicide, Attempted; Suicidal Ideation

• Registration Number: NCT05180383
• Lead Sponsor: Butler Hospital

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).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-01-03
• Study First Submitted QC: 2022-01-05
• Study First Posted: 2022-01-06
• Study Start: 2023-12-04
• Primary Completion: 2024-05-16
• Study Completion: 2024-05-16
• Status Verified: 2024-07
• Last Update Submitted: 2024-07-18
• Last Update Posted: 2024-07-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 10

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Acceptability of Research (Recruitment)	Baseline	Measured by recruitment rate.
Satisfaction with MAPS Intervention	4 weeks	Measured by protocol completion rate.
Ecological Momentary Assessment (EMA) Adherence	4 weeks	Number of assessments completed out of total.
Patient Satisfaction	1 month	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.
Acceptability of Research Procedures	1 month	Feedback on qualitative interview.
Acceptability of MAPS Intervention	1 month	Feedback on qualitative interview.
Acceptability of Research (Dropout)	1 month	Measured by dropout rate.

Secondary Outcome Measures

Name	Time	Method
Suicidal Ideation and Behavior	1 month	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.
Emergency Department Visits	1 month	Number of emergency department visits will be assessed using the Treatment History Interview and medical records review.
Rehospitalization	1 month	Number of inpatient rehospitalizations will be assessed using the Treatment History Interview and medical records review.

Trial Locations

Locations (2)

Butler Hospital; 🇺🇸 Providence, Rhode Island, United States

Brown University; 🇺🇸 Providence, Rhode Island, United States