NCT06614946

Brief 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. 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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
120

participants targeted

Target at P50-P75 for not_applicable

Timeline
6mo left

Started May 2026

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress32%
May 2026Feb 2027

First Submitted

Initial submission to the registry

September 24, 2024

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 26, 2024

Completed
1.6 years until next milestone

Study Start

First participant enrolled

May 12, 2026

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2027

Last Updated

July 16, 2026

Status Verified

July 1, 2026

Enrollment Period

9 months

First QC Date

September 24, 2024

Last Update Submit

July 14, 2026

Conditions

Keywords

Emergency Department

Outcome Measures

Primary Outcomes (6)

  • Percentage of eligible individuals who agree to participate

    At the time of ED 1 day visit

  • Completion of the one-month follow-up assessment survey

    One month post-discharge from the ED

  • Completion of the three-month follow-up assessment survey

    Three months post-discharge from the ED

  • Number of withdrawals

    Up to 3 months post-discharge from the ED

  • Percentage of participants who remain active (in text-support condition only)

    Up to 28 days post-discharge from the ED

  • Participant satisfaction with the intervention components

    Measured with a modified Client Satisfaction Questionnaire (CSQ).

    Up to 1 months

Study Arms (2)

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.

Behavioral: Electronic Safety Plan (ESP)Behavioral: Text support

Enhanced electronic safety plan (ESP) enhanced with 2 reminder text messages with ESP link

EXPERIMENTAL
Behavioral: Electronic Safety Plan (ESP)

Interventions

Participants will receive an electronic safety plan in the ED. ESP focuses on developing a personalized coping plan to manage suicidal thoughts and urges.

Electronic safety plan (ESP) + Text-Based SupportEnhanced electronic safety plan (ESP) enhanced with 2 reminder text messages with ESP link
Text supportBEHAVIORAL

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.

Electronic safety plan (ESP) + Text-Based Support

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Individuals presenting to an ED with either:
  • actual, interrupted, or aborted attempt in the last 4 weeks
  • suicidal ideation within the last week

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Michigan

Ann Arbor, Michigan, 48109, United States

RECRUITING

MeSH Terms

Conditions

Suicide, AttemptedSuicidal IdeationEmergencies

Condition Hierarchy (Ancestors)

SuicideSelf-Injurious BehaviorBehavioral SymptomsBehaviorDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Ewa Czyz, Ph.D.

    University of Michigan

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor of Psychiatry

Study Record Dates

First Submitted

September 24, 2024

First Posted

September 26, 2024

Study Start

May 12, 2026

Primary Completion (Estimated)

February 1, 2027

Study Completion (Estimated)

February 1, 2027

Last Updated

July 16, 2026

Record last verified: 2026-07

Data Sharing

IPD Sharing
Will not share

Locations