Suicide and Self-harmNCT05202756
Examining Feasibility, Acceptability, and Sustainability of a Novel Personalized Smartphone Intervention for Suicide - Randomized Trial
A study testing Mobile Application to Prevent Suicide (MAPS) and EMA Monitoring Only 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 primary… 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) and EMA Monitoring Only
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 31 participants
- Where
- 2 sitesUnited States
- Study dates
- 14 Jun 2024to 1 Dec 2025
- 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 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 primary outcomes (i.e., suicidal ideation and behavior; re-hospitalization), and target mechanisms.
- Conditions
- Suicide and Self-harm, Suicide, Suicide, Attempted, Suicidal Ideation
- Being tested
- Mobile Application to Prevent Suicide (MAPS), EMA Monitoring Only
- 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.
EMA Monitoring OnlyBehavioural
Safety Planning Intervention; ecological momentary assessment only
| 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) |
| EMA Monitoring Only (EMO) | Active comparator | 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. Receives: Behavioral: EMA Monitoring Only |
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: 1 month
Acceptability of Research (Recruitment)
Measured by recruitment rate.
Measured: Baseline
Acceptability of Research (Dropout)
Measured by dropout rate.
Measured: 6 months
Acceptability of Research Procedures
Feedback on qualitative interview.
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
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: 6 months
Rehospitalization
Number of inpatient rehospitalizations will be assessed using the Treatment History Interview and medical records review.
Measured: 6 months
Emergency Department Visits
Number of emergency department visits will be assessed using the Treatment History Interview and medical records review.
Measured: 6 months
Secondary outcomes (3)
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.
Measured: 4 weeks
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."
Measured: 4 weeks
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.
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jan 2022
- Study start14 Jun 2024
- Primary completion17 Sep 2025
- Study completion1 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 31 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
- NCT05202756
- Sponsor's protocol ID
- 1678556
- Other IDs
- R34MH124971
- Status last verified
- Aug 2025
- First submitted
- 3 Jan 2022
- Last updated
- 24 Jun 2026
- 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.
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Examining Feasibility, Acceptability, and Sustainability of a Novel Personalized Smartphone Intervention for Suicide
- ClinicalTrials.gov ID
- NCT05202756
- Acronym / sponsor ID
- 1678556
- Conditions
- Suicide and Self-harm, Suicide, Suicide, Attempted, Suicidal Ideation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 31 participants (actual)
- Lead sponsor
- Butler HospitalUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH), Brown University
- Study start
- 14 Jun 2024 (actual)
- Primary completion
- 17 Sep 2025 (actual)
- Study completion
- 1 Dec 2025 (actual)
- First posted
- 21 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 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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| 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. |
| EMA Monitoring Only (EMO) | Active comparator | Behavioral: EMA Monitoring OnlyParticipants 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. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (1 listed)
- Current psychotic or manic symptoms severe enough to interfere with completion of 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) |
| EMA Monitoring OnlySafety Planning Intervention; ecological momentary assessment only | Behavioural | EMA Monitoring Only (EMO) |
Primary outcome
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 Research (Recruitment)
Time frame: Baseline
Measured by recruitment rate.
Acceptability of Research (Dropout)
Time frame: 6 months
Measured by dropout rate.
Acceptability of Research Procedures
Time frame: 1 month
Feedback on qualitative interview.
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
Suicidal Ideation and Behavior
Time frame: 6 months
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
Time frame: 6 months
Number of inpatient rehospitalizations will be assessed using the Treatment History Interview and medical records review.
Emergency Department Visits
Time frame: 6 months
Number of emergency department visits will be assessed using the Treatment History Interview and medical records review.
3 secondary outcomes
Use of MAPS Intervention-delivered Coping Strategies (target mechanism)
Time frame: 4 weeks
Reduction of Negative Affect (target mechanism)
Time frame: 4 weeks
Self-Efficacy (target mechanism)
Time frame: 4 weeks
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 24 Jun 2026.
- 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.
Related trials for Suicide and Self-harm
RecruitingObservational study
Student Precarity and Psychiatry
Depressive Disorder, Major, Generalized Anxiety Disorder
Not yet recruiting
A MRT to Optimize a JITAI for Alcohol Craving and Suicide Ideation
Alcohol Use Disorder (AUD), Suicide Ideation
Not yet recruiting
Examining the Relationship Between Ongoing Alcohol Use, Suicidal Thoughts and Behaviors and Related Constructs, and Behavioral Economic Decision-Making.
Alcohol Use Disorder (AUD), Suicidal Ideation
Not yet recruiting
Deaf CBT-TS to Reduce Suicide Risk
Depression - Major Depressive Disorder, Anxiety
Recruiting
Preventing Suicidal Behavior With Diverse High-Risk Youth in Acute Care Settings
Suicide, Attempted, Suicide Ideation
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.
2 sites 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) and EMA Monitoring Only in people with Suicide and Self-harm and Suicide, run by Butler Hospital at 2 sites 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 4 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 24 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Patient Satisfaction (time frame: 1 month). The study lists 10 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 24 Jun 2026.