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

Suicide Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05202756
• Other study ID #: 1678556
• Secondary ID: R34MH124971
• 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 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 primary outcomes (i.e., suicidal ideation and behavior; re-hospitalization), and target mechanisms.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 50
• Est. completion date: May 31, 2025
• Est. primary completion date: May 31, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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

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.
• EMA Monitoring Only
Safety Planning Intervention; ecological momentary assessment only

Locations

Country	Name	City	State
United States	Brown University	Providence	Rhode Island
United States	Butler Hospital	Providence	Rhode Island

Sponsors (3)

Lead Sponsor	Collaborator
Butler Hospital	Brown University, National Institute of Mental Health (NIMH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
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 Research (Recruitment)	Measured by recruitment rate.	Baseline
Primary	Acceptability of Research (Dropout)	Measured by dropout rate.	6 months
Primary	Acceptability of Research Procedures	Feedback on qualitative interview.	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
Primary	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.	6 months
Primary	Rehospitalization	Number of inpatient rehospitalizations will be assessed using the Treatment History Interview and medical records review.	6 months
Primary	Emergency Department Visits	Number of emergency department visits will be assessed using the Treatment History Interview and medical records review.	6 months
Secondary	Use of MAPS Intervention-delivered Coping Strategies (target mechanism)	Coping strategy use will be measured in three ways: (1) when participants are prompted to use a coping strategy via MAPS, followup prompts ask whether or not they used the coping skill, (2) in each EMA survey, participants are asked whether or not they used any coping skills since the last survey, and (3) the system provides output with regard to how many times participants dial a support contact phone number through the MAPS app.	4 weeks
Secondary	Reduction of Negative Affect (target mechanism)	Negative affect will be measured using Positive and Negative Affect Scale (PANAS-X) items on ecological momentary assessment surveys. Each emotion item on the PANAS-X is rated on a 1-5 scale based on how participants feel, with 1 indicating "very slightly or not at all" and 5 indicating "extremely."	4 weeks
Secondary	Self-Efficacy (target mechanism)	Coping self-efficacy will be measured using the Coping Self-Efficacy Scale. Self-efficacy for seeking mental health care will be measured by the Self-Efficacy to Seek Mental Health Care Scale. The total score can range from 0-260; the higher the score, the higher the level of coping self-efficacy.	4 weeks