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

Not Applicable

Completed

• Conditions: Suicide; Suicide, Attempted; Suicidal Ideation; Suicide and Self-harm
• Interventions: Behavioral: Mobile Application to Prevent Suicide (MAPS)

• Registration Number: NCT05180331
• Lead Sponsor: Butler Hospital

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).

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: 2023-12-14
• Primary Completion: 2024-05-20
• Study Completion: 2024-05-20
• 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

• 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

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Mobile Application to Prevent Suicide (MAPS)	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.

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Rehospitalization	1 month	Will be assessed using the Treatment History Interview and medical records review.
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.

Trial Locations

Locations (1)

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