SuicideNCT05180331
Feasibility, Acceptability, and Preliminary Efficacy of a Novel Personalized Mobile Intervention for Suicide - Open Trial
A study testing Mobile Application to Prevent Suicide (MAPS) in people with Suicide and Suicide and Self-harm, run by Butler Hospital at 1 site in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 26 years
- Conditions the study is for
- Suicide, Suicide and Self-harm, 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
- 1 siteUnited States
- Study dates
- 14 Dec 2023to 20 May 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 26 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- Current psychotic or manic symptoms severe enough to interfere with study procedures
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Feasibility, Acceptability, and Preliminary Efficacy of a Novel Personalized Mobile Intervention for Suicide
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).
- Conditions
- Suicide, Suicide and Self-harm, 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.
Acceptability of Research (Recruitment)
Measured by recruitment rate.
Measured: Baseline
Acceptability of Research (Dropout)
Measured by dropout rate.
Measured: 1 month
Acceptability of Research Procedures
Feedback on qualitative interview
Measured: 1 month
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: 1 month
Acceptability of MAPS Intervention
Feedback on qualitative interview.
Measured: 1 month
Satisfaction with MAPS Intervention
Measured by protocol completion rate.
Measured: 4 weeks
Ecological Momentary Assessment (EMA) Adherence
Number of assessments completed out of total.
Measured: 4 weeks
Secondary outcomes (2)
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.
Measured: 1 month
Rehospitalization
Will be assessed using the Treatment History Interview and medical records review.
Measured: 1 month
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 start14 Dec 2023
- Primary completion20 May 2024
- Study completion20 May 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for SuicideStudies 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
- Treatment
- 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
- American Foundation for Suicide Prevention
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05180331
- Sponsor's protocol ID
- 1124944
- Other IDs
- SRG-1-119-18
- Status last verified
- Jul 2024
- First submitted
- 3 Jan 2022
- Last updated
- 19 Jul 2024
- Results posted
- No
- 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
Study at a glance
From the registry record, last updated by the sponsor on 19 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility, Acceptability, and Preliminary Efficacy of a Novel Personalized Mobile Intervention for Suicide
- ClinicalTrials.gov ID
- NCT05180331
- Acronym / sponsor ID
- 1124944
- Conditions
- Suicide, Suicide and Self-harm, Suicide, Attempted, Suicidal Ideation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Butler HospitalUniversity, hospital or other
- Collaborators
- American Foundation for Suicide Prevention
- Study start
- 14 Dec 2023 (actual)
- Primary completion
- 20 May 2024 (actual)
- Study completion
- 20 May 2024 (actual)
- First posted
- 6 Jan 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Mobile Application to Prevent Suicide (MAPS) | Experimental | Behavioral: 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. |
Who may qualify
- Ages
- 18 to 26 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (1 listed)
- Current psychotic or manic symptoms severe enough to interfere with study procedures
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mobile Application to Prevent Suicide (MAPS)Safety Planning Intervention, ecological momentary intervention smartphone app system, and bidirectional communication with study clinician. | Behavioural | Mobile Application to Prevent Suicide (MAPS) |
Primary outcome
Acceptability of Research (Recruitment)
Time frame: Baseline
Measured by recruitment rate.
Acceptability of Research (Dropout)
Time frame: 1 month
Measured by dropout rate.
Acceptability of Research Procedures
Time frame: 1 month
Feedback on qualitative interview
Patient Satisfaction
Time frame: 1 month
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
Time frame: 1 month
Feedback on qualitative interview.
Satisfaction with MAPS Intervention
Time frame: 4 weeks
Measured by protocol completion rate.
Ecological Momentary Assessment (EMA) Adherence
Time frame: 4 weeks
Number of assessments completed out of total.
2 secondary outcomes
Suicidal Ideation and Behavior
Time frame: 1 month
Rehospitalization
Time frame: 1 month
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jul 2024.
- Derived from this study: PubMed 41725711Schatten 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.
- Individual participant dataSharing planned: 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mobile Application to Prevent Suicide (MAPS) in people with Suicide and Suicide and Self-harm, run by Butler Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Acceptability of Research (Recruitment) (time frame: Baseline). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05180331, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Jul 2024.