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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
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 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

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.
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
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