SuicidalNCT06614946
Improving Coping to Reduce Suicide Risk Following ED Discharge
A study testing Electronic Safety Plan (ESP) and Text support in people with Suicidal and Suicide, Attempted, run by University of Michigan at 1 site in United States.
Trial summary
The researchers hope to learn whether an electronic safety plan (ESP) and a supportive text messaging program are feasible and acceptable to adult patients with recent suicidal thoughts or behavior after emergency department (ED) discharge. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Suicidal, Suicide, Attempted, Suicidal Ideation
- What is being tested?
- Electronic Safety Plan (ESP) and Text support
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteUnited States
- Study dates
- 12 May 2026to Feb 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Individuals presenting to an ED with either:
- actual, interrupted, or aborted attempt in the last 4 weeks
- suicidal ideation within the last week
Who cannot join
- Severe cognitive impairment or altered mental status (psychosis, manic state)
- Severe aggression/agitation,
- Being admitted or transferred into inpatient care,
- Patient not owning a cell phone with text messaging capability
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of Michigan
Ann Arbor, Michigan, 48109
Ewa Czyz, 734-764-9466, ewac@umich.edu
Adam Horwitz, Ph.D., 734-764-0231, ahor@med.umich.edu
About this study
Official title: Facilitating Effective Coping to Reduce Suicide Risk Following ED Discharge: A Micro-randomized Trial to Develop an Adaptive Text-based Intervention
The researchers hope to learn whether an electronic safety plan (ESP) and a supportive text messaging program are feasible and acceptable to adult patients with recent suicidal thoughts or behavior after emergency department (ED) discharge. From this study, the researchers also hope to learn how to best carry out the ESP and text messaging program to improve outcomes for patients after ED discharge.
- Conditions
- Suicidal, Suicide, Attempted, Suicidal Ideation
- Being tested
- Electronic Safety Plan (ESP), Text support
- Keywords
- Emergency Department
- Medical subject headings
- Suicide, Attempted, Suicidal Ideation, Emergencies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Electronic Safety Plan (ESP)Behavioural
Participants will receive an electronic safety plan in the ED. ESP focuses on developing a personalized coping plan to manage suicidal thoughts and urges.
Text supportBehavioural
Those in the text-based support program will receive up to 2 texts per day for a month with varying levels of tailoring, based on ESP and dynamic personalized feedback.
| Study group | Role | What they receive |
|---|---|---|
| Electronic safety plan (ESP) + Text-Based Support | Experimental | Participants who are randomized to this arm will receive ESP during ED care and receive a text-based support program for 4 weeks after discharge, with up to 2 messages per day. The text-based program includes a microrandomized trial (MRT), where participants are randomized twice daily to receive or not receive a message. Receives: Behavioral: Electronic Safety Plan (ESP); Behavioral: Text support |
| Enhanced electronic safety plan (ESP) enhanced with 2 reminder text messages with ESP link | Experimental | Not described Receives: Behavioral: Electronic Safety Plan (ESP) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of eligible individuals who agree to participate
Measured: At the time of ED 1 day visit
Completion of the one-month follow-up assessment survey
Measured: One month post-discharge from the ED
Completion of the three-month follow-up assessment survey
Measured: Three months post-discharge from the ED
Number of withdrawals
Measured: Up to 3 months post-discharge from the ED
Percentage of participants who remain active (in text-support condition only)
Measured: Up to 28 days post-discharge from the ED
Participant satisfaction with the intervention components
Measured with a modified Client Satisfaction Questionnaire (CSQ).
Measured: Up to 1 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Sep 2024
- Study start12 May 2026
- Primary completionFeb 2027 (estimated)
- Study completionFeb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SuicidalStudies of the same condition, open and under way.
- More trials run by University of MichiganThe sponsor's other registered studies.
- 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- There are 2 arms: ESP only and ESP with text-based program. The ESP with text-based program arm includes twice daily (within-person) randomizations.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Michigan
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Responsible party
- Principal investigator, Ewa Czyz, University of Michigan
- Investigators
- Ewa Czyz, Ph.D., Principal investigator, University of Michigan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06614946
- Sponsor's protocol ID
- HUM00244094
- Other IDs
- R34MH133057
- Status last verified
- Jul 2026
- First submitted
- 24 Sep 2024
- Last updated
- 16 Jul 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Facilitating Effective Coping to Reduce Suicide Risk Following ED Discharge: A Micro-randomized Trial to Develop an Adaptive Text-based Intervention
- ClinicalTrials.gov ID
- NCT06614946
- Acronym / sponsor ID
- HUM00244094
- Conditions
- Suicidal, Suicide, Attempted, Suicidal Ideation
- Keywords
- Emergency Department
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- University of MichiganUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Study start
- 12 May 2026 (actual)
- Primary completion
- Feb 2027 (estimated)
- Study completion
- Feb 2027 (estimated)
- First posted
- 26 Sep 2024 (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 researchers hope to learn whether an electronic safety plan (ESP) and a supportive text messaging program are feasible and acceptable to adult patients with recent suicidal thoughts or behavior after emergency department (ED) discharge. From this study, the researchers also hope to learn how to best carry out the ESP and text messaging program to improve outcomes for patients after ED discharge.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- There are 2 arms: ESP only and ESP with text-based program. The ESP with text-based program arm includes twice daily (within-person) randomizations.
| Arm | Type | Receives |
|---|---|---|
| Electronic safety plan (ESP) + Text-Based Support | Experimental | Behavioral: Electronic Safety Plan (ESP), Behavioral: Text supportParticipants who are randomized to this arm will receive ESP during ED care and receive a text-based support program for 4 weeks after discharge, with up to 2 messages per day. The text-based program includes a microrandomized trial (MRT), where participants are randomized twice daily to receive or not receive a message. |
| Enhanced electronic safety plan (ESP) enhanced with 2 reminder text messages with ESP link | Experimental | Behavioral: Electronic Safety Plan (ESP) |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- actual, interrupted, or aborted attempt in the last 4 weeks
- suicidal ideation within the last week
Key exclusion criteria (4 listed)
- Severe cognitive impairment or altered mental status (psychosis, manic state)
- Severe aggression/agitation,
- Being admitted or transferred into inpatient care,
- Patient not owning a cell phone with text messaging capability
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 |
|---|---|---|
| Electronic Safety Plan (ESP)Participants will receive an electronic safety plan in the ED. ESP focuses on developing a personalized coping plan to manage suicidal thoughts and urges. | Behavioural | Electronic safety plan (ESP) + Text-Based Support, Enhanced electronic safety plan (ESP) enhanced with 2 reminder text messages with ESP link |
| Text supportThose in the text-based support program will receive up to 2 texts per day for a month with varying levels of tailoring, based on ESP and dynamic personalized feedback. | Behavioural | Electronic safety plan (ESP) + Text-Based Support |
Primary outcome
Percentage of eligible individuals who agree to participate
Time frame: At the time of ED 1 day visit
Completion of the one-month follow-up assessment survey
Time frame: One month post-discharge from the ED
Completion of the three-month follow-up assessment survey
Time frame: Three months post-discharge from the ED
Number of withdrawals
Time frame: Up to 3 months post-discharge from the ED
Percentage of participants who remain active (in text-support condition only)
Time frame: Up to 28 days post-discharge from the ED
Participant satisfaction with the intervention components
Time frame: Up to 1 months
Measured with a modified Client Satisfaction Questionnaire (CSQ).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jul 2026.
- Individual participant dataSharing planned: No
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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.
Ewa Czyz, Ph.D. principal investigator
University of Michigan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Electronic Safety Plan (ESP) and Text support in people with Suicidal and Suicide, Attempted, run by University of Michigan 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: looking for participants now, as of the sponsor's last update on 16 Jul 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ewa Czyz (734-764-9466, ewac@umich.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of eligible individuals who agree to participate (time frame: At the time of ED 1 day visit). The study lists 6 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 16 Jul 2026.