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Examining Feasibility, Acceptability, and Sustainability of a Novel Personalized Smartphone Intervention for Suicide - Randomized 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)
EMA Monitoring Only
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 2

Arm Type

Experimental

Active Comparator

Arm Label

Mobile Application to Prevent Suicide (MAPS)

EMA Monitoring Only (EMO)

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.

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.

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
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.

Secondary Outcome Measures

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.
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."
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.

Full Information

First Posted
January 3, 2022
Last Updated
April 4, 2023
Sponsor
Butler Hospital
Collaborators
National Institute of Mental Health (NIMH), Brown University
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1. Study Identification

Unique Protocol Identification Number
NCT05202756
Brief Title
Examining Feasibility, Acceptability, and Sustainability of a Novel Personalized Smartphone Intervention for Suicide - Randomized 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
April 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
September 1, 2023 (Anticipated)
Primary Completion Date
May 1, 2024 (Anticipated)
Study Completion Date
May 1, 2024 (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 primary outcomes (i.e., suicidal ideation and behavior; re-hospitalization), and target mechanisms.

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
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
50 (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.
Arm Title
EMA Monitoring Only (EMO)
Arm Type
Active Comparator
Arm Description
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.
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.
Intervention Type
Behavioral
Intervention Name(s)
EMA Monitoring Only
Intervention Description
Safety Planning Intervention; ecological momentary assessment only
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
6 months
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
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
6 months
Title
Rehospitalization
Description
Number of inpatient rehospitalizations will be assessed using the Treatment History Interview and medical records review.
Time Frame
6 months
Title
Emergency Department Visits
Description
Number of emergency department visits will be assessed using the Treatment History Interview and medical records review.
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Use of MAPS Intervention-delivered Coping Strategies (target mechanism)
Description
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.
Time Frame
4 weeks
Title
Reduction of Negative Affect (target mechanism)
Description
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."
Time Frame
4 weeks
Title
Self-Efficacy (target mechanism)
Description
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.
Time Frame
4 weeks

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
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Stacey Soares
First Name & Middle Initial & Last Name & Degree
Leslie Brick, PhD
First Name & Middle Initial & Last Name & Degree
Rani Elwy, PhD
First Name & Middle Initial & Last Name & Degree
Lauren Weinstock, PhD

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 - Randomized Trial

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