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

Not Applicable

Recruiting

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

• Registration Number: NCT05202756
• 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 primary outcomes (i.e., suicidal ideation and behavior; re-hospitalization), and target mechanisms.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-01-03
• Study First Submitted QC: 2022-01-19
• Study First Posted: 2022-01-21
• Status Verified: 2024-04
• Study Start: 2024-06-12
• Last Update Submitted: 2024-07-18
• Last Update Posted: 2024-07-19
• Primary Completion: 2025-05-31
• Study Completion: 2025-05-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 50

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

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Exclusion Criteria

• Current psychotic or manic symptoms severe enough to interfere with completion of study procedures

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
EMA Monitoring Only (EMO)	EMA Monitoring Only	Participants in this condition will receive the Safety Planning Intervention (SPI) and will receive ecological momentary assessment prompts on the same schedule as the MAPS condition. However, they will not have access to any other MAPS features.
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
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.
Ecological Momentary Assessment (EMA) Adherence	4 weeks	Number of assessments completed out of total
Emergency Department Visits	6 months	Number of emergency department visits will be assessed using the Treatment History Interview and medical records review.
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)	6 months	Measured by dropout rate.
Satisfaction with MAPS Intervention	4 weeks	Measured by protocol completion rate.
Suicidal Ideation and Behavior	6 months	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.
Rehospitalization	6 months	Number of inpatient rehospitalizations will be assessed using the Treatment History Interview and medical records review.

Secondary Outcome Measures

Name	Time	Method
Use of MAPS Intervention-delivered Coping Strategies (target mechanism)	4 weeks	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.
Self-Efficacy (target mechanism)	4 weeks	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.
Reduction of Negative Affect (target mechanism)	4 weeks	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."

Trial Locations

Locations (2)

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

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