CClinicalTrials.gg
CompletedNCT05180331Updated Jul 19, 2024

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

An interventional study of Mobile Application to Prevent Suicide (MAPS) in Suicide, Suicide and Self-harm and Suicide, Attempted, sponsored by Butler Hospital. Completed at 1 site in United States. Open to participants aged 18 Years to 26 Years. Per ClinicalTrials.gov, last updated 2024-07-19.

Sponsored by Butler Hospital · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
10
Allocation
Not applicable
Ages
18 Years to 26 Years
Sex
All
01

Study 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).

02

Conditions studied

  • Suicide
  • Suicide and Self-harm
  • Suicide, Attempted
  • Suicidal Ideation
03

In context

Suicide

701 studies on the registry are indexed under Suicide; 183 are open to participants now.

This study's enrollment of 10 is below the median of 104 across 560 interventional studies indexed under Suicide.

Browse Suicide studies →

Lead sponsor

Butler Hospital is the lead sponsor of 113 studies on the registry; 11 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 26 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

Exclusion Criteria:

  • Current psychotic or manic symptoms severe enough to interfere with study procedures
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
10 participants (actual)

Study arms

  • 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)

Interventions

  • BehavioralMobile Application to Prevent Suicide (MAPS)

    Safety Planning Intervention, ecological momentary intervention smartphone app system, and bidirectional communication with study clinician.

06

What researchers measure

Primary outcomes

  1. Acceptability of Research (Recruitment)

    Measured by recruitment rate.

    Time frame: Baseline

  2. Acceptability of Research (Dropout)

    Measured by dropout rate.

    Time frame: 1 month

  3. Acceptability of Research Procedures

    Feedback on qualitative interview

    Time frame: 1 month

  4. 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.

    Time frame: 1 month

  5. Acceptability of MAPS Intervention

    Feedback on qualitative interview.

    Time frame: 1 month

  6. Satisfaction with MAPS Intervention

    Measured by protocol completion rate.

    Time frame: 4 weeks

  7. Ecological Momentary Assessment (EMA) Adherence

    Number of assessments completed out of total.

    Time frame: 4 weeks

Secondary outcomes

  1. 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.

    Time frame: 1 month

  2. Rehospitalization

    Will be assessed using the Treatment History Interview and medical records review.

    Time frame: 1 month

07

Study locations

1 site
  • Butler Hospital
    Providence, Rhode Island 02906, United States
08

References and documents

Individual participant data

Plan to share: Yes — 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.

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 19, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05180331
Lead sponsor
Butler Hospital
Collaborators
American Foundation for Suicide Prevention (AFSP)
Responsible party
Sponsor
First posted
Jan 6, 2022
Start date
Dec 14, 2023
Primary completion
May 20, 2024
Completion
May 20, 2024
Last update
Jul 19, 2024

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jul 2024. You cannot join it, but the record below documents what was studied.

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