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

Primary Purpose

Suicide, Suicide and Self-harm, Suicide, Attempted

Status
Not yet recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Mobile Application to Prevent Suicide (MAPS)
Treatment as Usual + Ecological Momentary Assessment (TAU + EMA)
Sponsored by
Butler Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Suicide

Eligibility Criteria

18 Years - 26 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Butler Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Mobile Application to Prevent Suicide (MAPS)

Treatment As Usual + Ecological Momentary Assessment (TAU+EMA)

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.

In the TAU+EMA condition, participants will receive the Safety Planning Intervention (SPI), and engage in psychiatric treatment as recommended in their discharge plan. They will receive ecological momentary assessment (EMA) prompts on the same schedule as participants in the MAPS condition (to control for attention and intervention effects resulting solely from responding to surveys) but they will not receive the MAPS intervention.

Outcomes

Primary Outcome Measures

Acceptability of Research (Recruitment)
Measured by recruitment rate.
Acceptability of Research (Recruitment)
Measured by dropout rate.
Acceptability of Research Procedures
Feedback on qualitative interview
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 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
Will be assessed using the Treatment History Interview and medical records review.

Full Information

First Posted
January 3, 2022
Last Updated
April 4, 2023
Sponsor
Butler Hospital
Collaborators
American Foundation for Suicide Prevention (AFSP)
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1. Study Identification

Unique Protocol Identification Number
NCT05180344
Brief Title
Feasibility, Acceptability, and Preliminary Efficacy of a Novel Personalized Mobile Intervention for Suicide - Randomized Trial
Official Title
Feasibility, Acceptability, and Preliminary Efficacy of a Novel Personalized Mobile 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
American Foundation for Suicide Prevention (AFSP)

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 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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Suicide, Suicide and Self-harm, 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
40 (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
Treatment As Usual + Ecological Momentary Assessment (TAU+EMA)
Arm Type
Active Comparator
Arm Description
In the TAU+EMA condition, participants will receive the Safety Planning Intervention (SPI), and engage in psychiatric treatment as recommended in their discharge plan. They will receive ecological momentary assessment (EMA) prompts on the same schedule as participants in the MAPS condition (to control for attention and intervention effects resulting solely from responding to surveys) but they will not receive the MAPS intervention.
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)
Treatment as Usual + Ecological Momentary Assessment (TAU + EMA)
Intervention Description
Safety Planning Intervention; ecological momentary assessment only
Primary Outcome Measure Information:
Title
Acceptability of Research (Recruitment)
Description
Measured by recruitment rate.
Time Frame
Baseline
Title
Acceptability of Research (Recruitment)
Description
Measured by dropout rate.
Time Frame
6 months
Title
Acceptability of Research Procedures
Description
Feedback on qualitative interview
Time Frame
1 month
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 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
6 months
Title
Rehospitalization
Description
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
26 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
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

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

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

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