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

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

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).

Study Overview

• Status: Completed
• Conditions: Suicidal Ideation; Suicide, Attempted; Suicide; Suicide and Self-harm
• Intervention / Treatment: Behavioral: Mobile Application to Prevent Suicide (MAPS)

• Study Type: Interventional
• Enrollment (Actual): 10
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Rhode Island
    • Providence, Rhode Island, United States, 02906
      • Butler Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 26 years (Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: 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.

Behavioral: Mobile Application to Prevent Suicide (MAPS); Safety Planning Intervention, ecological momentary intervention smartphone app system, and bidirectional communication with study clinician.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
Rehospitalization	Will be assessed using the Treatment History Interview and medical records review.	1 month

Collaborators and Investigators

• Sponsor: Butler Hospital
• Collaborators: American Foundation for Suicide Prevention (AFSP)

Study record dates

Study Major Dates

• Study Start (Actual): December 14, 2023
• Primary Completion (Actual): May 20, 2024
• Study Completion (Actual): May 20, 2024

Study Registration Dates

• First Submitted: January 3, 2022
• First Submitted That Met QC Criteria: January 5, 2022
• First Posted (Actual): January 6, 2022

Study Record Updates

• Last Update Posted (Actual): July 19, 2024
• Last Update Submitted That Met QC Criteria: July 18, 2024
• Last Verified: July 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Behavioral Symptoms; Self-Injurious Behavior; Suicide; Suicidal Ideation; Suicide, Attempted
• Other Study ID Numbers: 1124944; SRG-1-119-18 (Other Grant/Funding Number: American Foundation for Suicide Prevention])

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: After all data have been collected and the results of the studies published, de-identified data will be made available to other qualified researchers on request.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No