- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06614946
Improving Coping to Reduce Suicide Risk Following ED Discharge
March 30, 2026 updated by: Ewa Czyz, University of Michigan
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.
Study Overview
Status
Not yet recruiting
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Estimated)
120
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Ewa Czyz
- Phone Number: 734-764-9466
- Email: ewac@umich.edu
Study Locations
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-
Michigan
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Ann Arbor, Michigan, United States, 48109
- University of Michigan
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Contact:
- Ewa Czyz
- Phone Number: 734-764-9466
- Email: ewac@umich.edu
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Contact:
- Adam Horwitz, Ph.D.
- Phone Number: 734-764-0231
- Email: ahor@med.umich.edu
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Principal Investigator:
- Ewa Czyz, Ph.D.
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Principal Investigator:
- Adam Horwitz, Ph.D.
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
Individuals presenting to an ED with either:
- actual, interrupted, or aborted attempt in the last 4 weeks
- suicidal ideation within the last week
Exclusion Criteria:
- 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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Electronic safety plan (ESP) + Text-Based Support
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.
|
Participants will receive an electronic safety plan in the ED.
ESP focuses on developing a personalized coping plan to manage suicidal thoughts and urges.
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.
|
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Experimental: Enhanced electronic safety plan (ESP) enhanced with 2 reminder text messages with ESP link
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Participants will receive an electronic safety plan in the ED.
ESP focuses on developing a personalized coping plan to manage suicidal thoughts and urges.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Percentage of eligible individuals who agree to participate
Time Frame: At the time of ED 1 day visit
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At the time of ED 1 day visit
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Completion of the one-month follow-up assessment survey
Time Frame: One month post-discharge from the ED
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One month post-discharge from the ED
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Completion of the three-month follow-up assessment survey
Time Frame: Three months post-discharge from the ED
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Three months post-discharge from the ED
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Number of withdrawals
Time Frame: Up to 3 months post-discharge from the ED
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Up to 3 months post-discharge from the ED
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Percentage of participants who remain active (in text-support condition only)
Time Frame: Up to 28 days post-discharge from the ED
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Up to 28 days post-discharge from the ED
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Participant satisfaction with the intervention components
Time Frame: Up to 1 months
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Measured with a modified Client Satisfaction Questionnaire (CSQ).
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Up to 1 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Ewa Czyz, Ph.D., University of Michigan
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Estimated)
May 1, 2026
Primary Completion (Estimated)
February 1, 2027
Study Completion (Estimated)
February 1, 2027
Study Registration Dates
First Submitted
September 24, 2024
First Submitted That Met QC Criteria
September 25, 2024
First Posted (Actual)
September 26, 2024
Study Record Updates
Last Update Posted (Actual)
March 31, 2026
Last Update Submitted That Met QC Criteria
March 30, 2026
Last Verified
March 1, 2026
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- HUM00244094
- R34MH133057 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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