ESP + Text Support for Suicide Prevention

Overseen By Ewa Czyz

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Michigan

Disqualifiers: Severe cognitive impairment, Severe aggression, Inpatient care, No cell phone, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 2

Duration: 4 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if an electronic safety plan (ESP), combined with text message support, can assist individuals who have recently experienced suicidal thoughts or actions after leaving the emergency department. Participants may receive up to two supportive texts daily for four weeks to assess the approach's helpfulness and feasibility. The study seeks individuals who have attempted suicide in the past four weeks or experienced suicidal thoughts in the last week. A cell phone with texting capabilities is required to join. As an unphased trial, this study provides a unique opportunity to explore innovative support methods that could significantly impact managing suicidal thoughts.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What prior data suggests that this electronic safety plan and text support are safe for patients after ED discharge?

A previous study found that using a digital safety plan, such as the Electronic Safety Plan (ESP), reduced the risk of future emergency visits for suicide-related issues by half. This finding suggests that digital safety plans might help individuals manage suicidal thoughts more effectively.

Research on a text messaging program for individuals at risk of suicide found it was well-received and helped reduce suicidal thoughts and behaviors. This indicates that supportive texts can be a valuable tool for those struggling.

Both ESP and text messaging are digital tools designed to reduce suicidal thoughts and emergency visits. They appear to be well-accepted, with no reports of serious safety issues in studies so far. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the ESP + Text Support for Suicide Prevention because it introduces a novel approach to supporting individuals after a crisis. Unlike traditional methods, which may rely heavily on in-person therapy or medication, this treatment combines an electronic safety plan with a text-based support system. The unique feature here is the use of microrandomization, where participants receive personalized support messages up to twice daily, offering timely and flexible intervention. This method has the potential to provide immediate support and reminders, making it a groundbreaking step in suicide prevention strategies.

What evidence suggests that the electronic safety plan and text support are effective for suicide prevention?

Studies have shown that using a digital safety plan can greatly reduce suicidal thoughts and actions. Specifically, individuals who used an electronic safety plan were 50% less likely to attempt suicide in the future. Research also indicates that safety plans, in general, help decrease suicidal thoughts and behaviors. In this trial, one group of participants will receive an Electronic Safety Plan (ESP) combined with text-based support, which evidence suggests can lead to a 22% drop in repeated self-harm incidents. Another group will receive an enhanced ESP with reminder text messages. Combining a safety plan with text support might offer even better protection by providing ongoing and personalized help. Overall, both methods have shown promise in assisting those at risk. ^{1 3 4 6 7}

Who Is on the Research Team?

Ewa Czyz, PhD

Principal Investigator

University of Michigan

Are You a Good Fit for This Trial?

This trial is for adults who have had suicidal thoughts or attempts in the past month and visited an emergency department (ED). They must own a cell phone with text messaging. It's not for those with severe mental impairment, extreme aggression, or if they're being admitted to inpatient care.

Inclusion Criteria

Individuals presenting to an ED with either: actual, interrupted, or aborted attempt in the last 4 weeks

I have had thoughts of harming myself in the past week.

Exclusion Criteria

Severe cognitive impairment or altered mental status (psychosis, manic state)

Patient not owning a cell phone with text messaging capability

I am currently admitted or will be admitted to the hospital.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants receive an electronic safety plan (ESP) during ED care and a text-based support program for 4 weeks after discharge

4 weeks

Text messages up to 2 times daily

Follow-up

Participants are monitored for satisfaction with the intervention components

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Electronic Safety Plan (ESP)
• Text support

Trial Overview

The study tests whether an electronic safety plan (ESP) along with a supportive text message program can help patients cope after leaving the ED. The goal is to see if these methods are workable and helpful in reducing suicide risk post-discharge.

How Is the Trial Designed?

Group I: Enhanced electronic safety plan (ESP) enhanced with 2 reminder text messages with ESP link Experimental Treatment 1 Intervention

Group II: Electronic safety plan (ESP) + Text-Based Support Experimental Treatment 2 Interventions

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.

Who Is Running the Clinical Trial?

University of Michigan

Lead Sponsor

Trials

1,891

Recruited

6,458,000+

National Institute of Mental Health (NIMH)

Collaborator

Trials

3,007

Recruited

2,852,000+

Published Research Related to This Trial

A pilot study of a text-messaging intervention for youths discharged from the hospital after suicidal thoughts showed it was feasible and well-received, helping to reduce suicidal thoughts and behaviors.

The positive results of this intervention led to the Maryland Department of Health expanding the program to offer similar support to all Maryland residents, highlighting its potential effectiveness in suicide prevention.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Brief Text-Messaging Intervention for Suicidal Youths After Emergency Department Discharge. Ryan, TC., Chambers, S., Gravey, M., et al.[2022]

A qualitative study involving experienced suicide researchers revealed significant challenges in defining and reporting adverse events (AEs) and serious adverse events (SAEs) in suicide prevention trials, which complicates safety evaluations.

Participants emphasized the urgent need for clear and consistent definitions and reporting standards for AEs and SAEs to improve the comparability of studies and enhance safety monitoring in at-risk populations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Variability in the definition and reporting of adverse events in suicide prevention trials: an examination of the issues and a proposed solution. Oquendo, MA., Feldman, S., Silverman, E., et al.[2022]

The pilot phase of the SmartCrisis 2.0 trial demonstrated that a smartphone-based safety plan for patients with recent suicidal behavior is feasible and well-accepted, with a participation rate of 77% and high satisfaction ratings (overall satisfaction score of 9.6 out of 10).

Patients found the safety plan useful (7.4/10) and easy to use (8.9/10), with common coping strategies including walking and exercise, indicating that the app could be a valuable tool in clinical practice for supporting mental health.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Smartphone-based safety plan for suicidal crisis: The SmartCrisis 2.0 pilot study. Porras-Segovia, A., De Granda-Beltrán, AM., Gallardo, C., et al.[2023]

An automated, self-guided Internet-based safety plan (IBSP) was developed and evaluated by 150 participants who reported suicidality, showing moderate perceived utility among users.

Participants generally believed the IBSP could be more helpful for others than for themselves, indicating a potential gap in personal recognition of its benefits, and males were less likely to complete the safety plan steps.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Perceived Utility of the Internet-Based Safety Plan in a Sample of Internet Users Screening Positive for Suicidality. Spangler, DA., Muñoz, RF., Chu, J., et al.[2022]

MYPLAN is a mobile application developed to help individuals at risk of suicide create personalized safety plans, making it more accessible than traditional paper versions.

Since its launch in 2013, MYPLAN has been positively received, with nearly 8,000 downloads in Denmark and Norway, indicating its potential utility in supporting at-risk individuals, especially among younger populations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

MYPLAN - A Mobile Phone Application for Supporting People at Risk of Suicide. Skovgaard Larsen, JL., Frandsen, H., Erlangsen, A.[2022]

The CASPAR study aims to evaluate the feasibility of using mobile health applications for safety planning and daily self-monitoring in 80 patients with major depressive disorder or dysthymia at risk for suicidal behavior.

By integrating mobile safety plans and symptom tracking into routine care, the study seeks to enhance understanding of the suicidal process and improve treatment outcomes for high-risk patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Smartphone-based safety planning and self-monitoring for suicidal patients: Rationale and study protocol of the CASPAR (Continuous Assessment for Suicide Prevention And Research) study. Nuij, C., van Ballegooijen, W., Ruwaard, J., et al.[2023]

A 1-hour virtual training significantly improved clinicians' knowledge and self-efficacy in using electronic safety plans for suicide prevention, with lasting effects observed at a 6-month follow-up.

Among clinicians working with suicidal youth, 81% attempted to use the electronic safety plan template, and 63% completed it, indicating that this training can enhance the implementation of safety planning in community settings despite some challenges like technology issues.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Impact of a Virtual Suicide Safety Planning Training on Clinician Knowledge, Self-Efficacy, and Use of Safety Plans in Community Mental Health Clinics. Whitmyre, ED., Esposito-Smythers, C., Goldberg, DG., et al.[2023]

The Safety Planning Intervention (SPI) is effective in reducing suicidal ideation and behavior, as well as improving depression and treatment engagement among adults experiencing suicide-related distress, based on a systematic review of 26 studies.

The SPI is adaptable and can be delivered in various formats (in-person or online) and as a standalone or combined intervention, making it a flexible tool in suicide prevention practices.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Effectiveness of the Safety Planning Intervention for Adults Experiencing Suicide-Related Distress: A Systematic Review. Ferguson, M., Rhodes, K., Loughhead, M., et al.[2022]

This trial will assess the effectiveness of a mobile app (MyPlan) for safety planning in reducing suicidal ideation compared to a traditional paper safety plan, involving 546 participants from Danish Suicide Prevention Clinics over a 12-month period.

Both groups will receive standard psychosocial care, allowing researchers to determine if the app can enhance the support provided by traditional safety plans in preventing self-harm and suicide.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

MYPLAN -mobile phone application to manage crisis of persons at risk of suicide: study protocol for a randomized controlled trial. Andreasson, K., Krogh, J., Bech, P., et al.[2022]

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Safety planning is a brief, ED-feasible intervention which has been demonstrated to save lives and has been universally recommended by every recent expert ...