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

Suicide Clinical Trial

Official title:

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

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
• 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
• 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

Related Conditions & MeSH terms

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

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