Suicide and Self-harmNCT05180383
Examining Feasibility, Acceptability, and Sustainability of a Novel Personalized Smartphone Intervention for Suicide - Open Trial
A study testing Mobile Application to Prevent Suicide (MAPS) in people with Suicide and Self-harm and Suicide, run by Butler Hospital at 2 sites in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Suicide and Self-harm, Suicide, Suicide, Attempted
- What is being tested?
- Mobile Application to Prevent Suicide (MAPS)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 2 sitesUnited States
- Study dates
- 5 Dec 2023to 30 Apr 2025
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Current psychotic or manic symptoms severe enough to interfere with completion of study procedures
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Butler Hospital
Providence, Rhode Island, 02906
Brown University
Providence, Rhode Island, 02912
About this study
Official title: Examining Feasibility, Acceptability, and Sustainability of a Novel Personalized Smartphone Intervention for Suicide
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).
- Conditions
- Suicide and Self-harm, Suicide, Suicide, Attempted, Suicidal Ideation
- Being tested
- Mobile Application to Prevent Suicide (MAPS)
- Medical subject headings
- Suicide, Self-Injurious Behavior, Suicide, Attempted, Suicidal Ideation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mobile Application to Prevent Suicide (MAPS)Behavioural
Safety Planning Intervention, ecological momentary intervention smartphone app system, and bidirectional communication with study clinician.
| Study group | Role | What they receive |
|---|---|---|
| Mobile Application to Prevent Suicide (MAPS) | Experimental | 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. Receives: Behavioral: Mobile Application to Prevent Suicide (MAPS) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Following intervention (assessed at 1-month follow-up)
Acceptability of Research (Recruitment)
The acceptability of research outcome is measured by the recruitment rate (number of patients enrolled divided by the total number of patients approached).
Measured: Baseline
Acceptability of Research (Dropout)
Acceptability of research is measured by dropout rate (number of participants who dropped out over the entire number of participants enrolled). This does not include participants who were lost to follow-up.
Measured: Baseline through 1-month follow-up
Satisfaction With MAPS Intervention
Satifaction with the MAPS intervention was measured by protocol completion rate.
Measured: Following intervention (assessed at 1-month follow-up)
Ecological Momentary Assessment (EMA) Adherence
The Ecological Momentary Assessment (EMA) adherence outcome is measured by the percentage of EMA surveys completed.
Measured: During 28 days of intervention
Secondary outcomes (4)
Change in Suicidal Ideation Severity
Will be assessed using the Columbia Suicide Severity Rating Scale, which provides a suicidal ideation severity score ranging from 0 to 5 with higher scores representing more severe ideation.
Measured: Comparing 28 days prior to baseline to the 28 days using MAPS intervention
Number of Suicide Attempts
Total number of suicide attempts reported among participants using MAPS (across whole sample).
Measured: During the 28 days of the intervention
Rehospitalization
Average number of inpatient rehospitalizations will be assessed using the Treatment History Interview and medical records review.
Measured: During the 28 days of the intervention
Emergency Department Visits
Average number of emergency department visits will be assessed using the Treatment History Interview and medical records review.
Measured: During the 28 days of the intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jan 2022
- Study start5 Dec 2023
- Primary completion25 Feb 2025
- Study completion30 Apr 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Suicide and Self-harmStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Butler Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH), Brown University
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05180383
- Sponsor's protocol ID
- 202012-001
- Other IDs
- R34MH124971
- Status last verified
- Aug 2025
- First submitted
- 3 Jan 2022
- Last updated
- 14 Sep 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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.
Publications
Schatten HT, Hughes CD, Kimble SK, Wallace G, Benz MB, Kraines MA, Germain E, Brick L, Armey MF, Elwy AR, Weinstock LM, Miller IW, Primack J. Development and Pilot Testing of the Mobile Application to Prevent Suicide (MAPS). Cognit Ther Res. 2025 Jun;49(3):497-511. doi: 10.1007/s10608-024-10568-9. Epub 2025 Jan 9.
PubMed 41725711