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

Primary Purpose

Suicide and Self-harm, Suicide, Suicide, Attempted

Status
Not yet recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Mobile Application to Prevent Suicide (MAPS)
Sponsored by
Butler Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Suicide and Self-harm

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Butler Hospital
  • Brown University

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Mobile Application to Prevent Suicide (MAPS)

Arm Description

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.

Outcomes

Primary Outcome Measures

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.
Acceptability of Research (Recruitment)
Measured by recruitment rate.
Acceptability of Research (Dropout)
Measured by dropout rate.
Acceptability of Research Procedures
Feedback on qualitative interview.
Acceptability of MAPS Intervention
Feedback on qualitative interview.
Satisfaction with MAPS Intervention
Measured by protocol completion rate.
Ecological Momentary Assessment (EMA) Adherence
Number of assessments completed out of total.

Secondary Outcome Measures

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.
Rehospitalization
Number of inpatient rehospitalizations will be assessed using the Treatment History Interview and medical records review.
Emergency Department Visits
Number of emergency department visits will be assessed using the Treatment History Interview and medical records review.

Full Information

First Posted
January 3, 2022
Last Updated
August 1, 2023
Sponsor
Butler Hospital
Collaborators
National Institute of Mental Health (NIMH), Brown University
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1. Study Identification

Unique Protocol Identification Number
NCT05180383
Brief Title
Examining Feasibility, Acceptability, and Sustainability of a Novel Personalized Smartphone Intervention for Suicide - Open Trial
Official Title
Examining Feasibility, Acceptability, and Sustainability of a Novel Personalized Smartphone Intervention for Suicide
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
August 31, 2023 (Anticipated)
Primary Completion Date
December 31, 2023 (Anticipated)
Study Completion Date
December 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Butler Hospital
Collaborators
National Institute of Mental Health (NIMH), Brown University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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 secondary outcomes (i.e., suicidal ideation and behavior; re-hospitalization).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Suicide and Self-harm, Suicide, Suicide, Attempted, Suicidal Ideation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
10 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Mobile Application to Prevent Suicide (MAPS)
Arm Type
Experimental
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Mobile Application to Prevent Suicide (MAPS)
Intervention Description
Safety Planning Intervention, ecological momentary intervention smartphone app system, and bidirectional communication with study clinician.
Primary Outcome Measure Information:
Title
Patient Satisfaction
Description
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.
Time Frame
1 month
Title
Acceptability of Research (Recruitment)
Description
Measured by recruitment rate.
Time Frame
Baseline
Title
Acceptability of Research (Dropout)
Description
Measured by dropout rate.
Time Frame
1 month
Title
Acceptability of Research Procedures
Description
Feedback on qualitative interview.
Time Frame
1 month
Title
Acceptability of MAPS Intervention
Description
Feedback on qualitative interview.
Time Frame
1 month
Title
Satisfaction with MAPS Intervention
Description
Measured by protocol completion rate.
Time Frame
4 weeks
Title
Ecological Momentary Assessment (EMA) Adherence
Description
Number of assessments completed out of total.
Time Frame
4 weeks
Secondary Outcome Measure Information:
Title
Suicidal Ideation and Behavior
Description
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.
Time Frame
1 month
Title
Rehospitalization
Description
Number of inpatient rehospitalizations will be assessed using the Treatment History Interview and medical records review.
Time Frame
1 month
Title
Emergency Department Visits
Description
Number of emergency department visits will be assessed using the Treatment History Interview and medical records review.
Time Frame
1 month

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Cheryl Cordeiro
Phone
401-455-6654
Email
ccordeiro@butler.org
Facility Information:
Facility Name
Butler Hospital
City
Providence
State/Province
Rhode Island
ZIP/Postal Code
02906
Country
United States
Facility Name
Brown University
City
Providence
State/Province
Rhode Island
ZIP/Postal Code
02912
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing 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.

Learn more about this trial

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

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