Suicide, AttemptedNCT03950765
Real-time Intervention for Suicide Risk Reduction: Primary Open Pilot
A study testing Ecological momentary intervention in people with Suicide, Attempted and Suicide and Self-harm, run by Rutgers, The State University of New Jersey at 1 site in United States.
Trial summary
The goal of this study is to provide an initial pilot test of an Ecological Momentary Intervention (EMI) designed the reduce the distress associated with negative emotion among individuals at risk for suicide that pairs content from a smartphone with a wearable physiological monitor. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Suicide, Attempted, Suicide and Self-harm
- What is being tested?
- Ecological momentary intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteUnited States
- Study dates
- 29 Jul 2019to 15 Apr 2020
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- A recent suicide attempt or serious suicidal ideation (i.e., ideation with at least 70% intent or a suicide plan with access to lethal means),
- The ability to speak and write English fluently, access to an internet-capable smartphone (e.g., an iPhone or Android phone)
- Providing at least one collateral contact in cases where the investigators cannot reach the participant.
Who cannot join
- The presence of any factor that impairs an individual's ability to comprehend and effectively participate in the study including:
- An inability to speak or write English fluently
- The presence of gross cognitive impairment due to florid psychosis, intellectual disability, dementia, or acute intoxication.
- The presence of extremely agitated or violent behavior.
Trial locations and contacts
1 site in 1 country.
United States1 site
Massachusetts General Hospital
Boston, Massachusetts, 02114
About this study
Official title: Real-time Intervention for Suicide Risk Reduction
The goal of this study is to provide an initial pilot test of an Ecological Momentary Intervention (EMI) designed the reduce the distress associated with negative emotion among individuals at risk for suicide that pairs content from a smartphone with a wearable physiological monitor. Participants will be 25 suicidal adult inpatients who will complete three brief therapy sessions with a study therapist and then complete exercises associated with the study for the duration of the inpatient period and for 28 days after they leave the hospital.
Read the detailed description
The goal of this study is to provide an initial pilot test of an Ecological Momentary Intervention (EMI) designed the reduce the distress associated with negative emotion among individuals at risk for suicide that pairs content from a smartphone with a wearable physiological monitor. Participants will be 25 suicidal adult inpatients who will complete three brief therapy sessions with a study therapist and then complete exercises associated with the study for the duration of the inpatient period and for 28 days after they leave the hospital. During the time they are in the study, participants will be asked to install on their smartphone a mobile application to deliver the therapeutic content and will wear a physiological monitoring device on their wrist (Empatica Embrace) which will monitor objective signals of physiological distress (e.g., skin conductance).
- Conditions
- Suicide, Attempted, Suicide and Self-harm
- Being tested
- Ecological momentary intervention
- Keywords
- ecological momentary assessment, ecological momentary intervention, distress
- Medical subject headings
- Suicide, Attempted, Suicide, Self-Injurious Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ecological momentary interventionBehavioural
Content of this intervention is based on pre-established transdiagnostic protocols for addressing the negative emotion associated with suicidal thoughts and behaviors.
| Study group | Role | What they receive |
|---|---|---|
| Ecological Momentary Intervention | Experimental | This group will receive three intervention prompts and three assessment prompts on their smartphone each day. Receives: Behavioral: Ecological momentary intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Self Reported Distress
Self-reported momentary distress, computed as the sum of four items (hopelessness, anger, burdensomeness, agitation), each rated 0-10. Composite range 0-40. Higher scores indicate greater (worse) distress.
Measured: Immediately before and immediately after each in-app skills-practice exercise, over days 1-28 post-discharge. Each participant's pre-practice and post-practice ratings were averaged across all exercises completed during this period.
Skin Conductance Response
Total number of skin conductance responses, assessed via electrodermal activity recorded with a wrist-worn wearable device.
Measured: Up to 42 days (from enrollment during the inpatient psychiatric stay, up to 14 days, through 28 days after hospital discharge)
Momentary Suicidal Thinking
This is an 11-point scale. A score of 0 is equivalent to no suicidal thinking at all ("not at all"), a score of 10 is a score of very extreme suicidal thinking ("Extremely"). Lower scores equal less severe suicidal thinking (i.e., a better outcome). Ratings were collected immediately before and immediately after each in-app skills-practice exercise. Each participant's pre-practice and post-practice ratings were averaged across all exercises completed during the study period; values are the mean (SD) across participants of these per-participant averages.
Measured: Up to 42 days (from enrollment during the inpatient psychiatric stay, up to 14 days, through 28 days after hospital discharge)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 May 2019
- Study start29 Jul 2019
- Primary completion2 Apr 2020
- Study completion15 Apr 2020
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.
- Other trials for Suicide, AttemptedStudies 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
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rutgers, The State University of New Jersey
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH), Massachusetts General Hospital
- Responsible party
- Principal investigator, Evan M. Kleiman, Ph.D., Rutgers, The State University of New Jersey
- Investigators
- Evan Kleiman, Principal investigator, Harvard University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03950765
- Sponsor's protocol ID
- IRB18-1813
- Other IDs
- R34MH113757-01A1
- Status last verified
- Apr 2026
- First submitted
- 9 May 2019
- Last updated
- 27 Oct 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Data will be shared in accordance with NIH data sharing policies.
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Real-time Intervention for Suicide Risk Reduction
- ClinicalTrials.gov ID
- NCT03950765
- Acronym / sponsor ID
- IRB18-1813
- Conditions
- Suicide, Attempted, Suicide and Self-harm
- Keywords
- ecological momentary assessment, ecological momentary intervention, distress
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Rutgers, The State University of New JerseyUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH), Massachusetts General Hospital
- Study start
- 29 Jul 2019 (actual)
- Primary completion
- 2 Apr 2020 (actual)
- Study completion
- 15 Apr 2020 (actual)
- First posted
- 15 May 2019 (actual)
- Results
- Posted 27 Oct 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this study is to provide an initial pilot test of an Ecological Momentary Intervention (EMI) designed the reduce the distress associated with negative emotion among individuals at risk for suicide that pairs content from a smartphone with a wearable physiological monitor. Participants will be 25 suicidal adult inpatients who will complete three brief therapy sessions with a study therapist and then complete exercises associated with the study for the duration of the inpatient period and for 28 days after they leave the hospital.
Detailed description
The goal of this study is to provide an initial pilot test of an Ecological Momentary Intervention (EMI) designed the reduce the distress associated with negative emotion among individuals at risk for suicide that pairs content from a smartphone with a wearable physiological monitor. Participants will be 25 suicidal adult inpatients who will complete three brief therapy sessions with a study therapist and then complete exercises associated with the study for the duration of the inpatient period and for 28 days after they leave the hospital. During the time they are in the study, participants will be asked to install on their smartphone a mobile application to deliver the therapeutic content and will wear a physiological monitoring device on their wrist (Empatica Embrace) which will monitor objective signals of physiological distress (e.g., skin conductance).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Ecological Momentary Intervention | Experimental | Behavioral: Ecological momentary interventionThis group will receive three intervention prompts and three assessment prompts on their smartphone each day. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- A recent suicide attempt or serious suicidal ideation (i.e., ideation with at least 70% intent or a suicide plan with access to lethal means),
- The ability to speak and write English fluently, access to an internet-capable smartphone (e.g., an iPhone or Android phone)
- Providing at least one collateral contact in cases where the investigators cannot reach the participant.
Key exclusion criteria (4 listed)
- The presence of any factor that impairs an individual's ability to comprehend and effectively participate in the study including:
- An inability to speak or write English fluently
- The presence of gross cognitive impairment due to florid psychosis, intellectual disability, dementia, or acute intoxication.
- The presence of extremely agitated or violent behavior.
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 |
|---|---|---|
| Ecological momentary interventionContent of this intervention is based on pre-established transdiagnostic protocols for addressing the negative emotion associated with suicidal thoughts and behaviors. | Behavioural | Ecological Momentary Intervention |
Primary outcome
Self Reported Distress
Time frame: Immediately before and immediately after each in-app skills-practice exercise, over days 1-28 post-discharge. Each participant's pre-practice and post-practice ratings were averaged across all exercises completed during this period.
Self-reported momentary distress, computed as the sum of four items (hopelessness, anger, burdensomeness, agitation), each rated 0-10. Composite range 0-40. Higher scores indicate greater (worse) distress.
Skin Conductance Response
Time frame: Up to 42 days (from enrollment during the inpatient psychiatric stay, up to 14 days, through 28 days after hospital discharge)
Total number of skin conductance responses, assessed via electrodermal activity recorded with a wrist-worn wearable device.
Momentary Suicidal Thinking
Time frame: Up to 42 days (from enrollment during the inpatient psychiatric stay, up to 14 days, through 28 days after hospital discharge)
This is an 11-point scale. A score of 0 is equivalent to no suicidal thinking at all ("not at all"), a score of 10 is a score of very extreme suicidal thinking ("Extremely"). Lower scores equal less severe suicidal thinking (i.e., a better outcome). Ratings were collected immediately before and immediately after each in-app skills-practice exercise. Each participant's pre-practice and post-practice ratings were averaged across all exercises completed during the study period; values are the mean (SD) across participants of these per-participant averages.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Oct 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Yes. Data will be shared in accordance with NIH data sharing policies.
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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.
Evan Kleiman principal investigator
Harvard University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ecological momentary intervention in people with Suicide, Attempted and Suicide and Self-harm, run by Rutgers, The State University of New Jersey 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 3 inclusion and 4 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 27 Oct 2026. 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?
Yes. Results are posted in the registry (first posted 27 Oct 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Self Reported Distress (time frame: Immediately before and immediately after each in-app skills-practice exercise, over days 1-28 post-discharge. Each participant's pre-practice and post-practice ratings were averaged across all exercises completed during this period.). The study lists 3 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 27 Oct 2026.