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

120 Participants Needed

Trial Summary

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 data supports the effectiveness of the treatment ESP + Text Support for Suicide Prevention?

Research shows that text messaging interventions can help reduce suicidal thoughts and behaviors in youths after hospital discharge, and safety planning is an effective method for preventing suicide. These findings suggest that combining electronic safety plans with text support could be beneficial for suicide prevention. ^{1 2 3 4 5}

Is the ESP + Text Support treatment generally safe for humans?

The available research suggests that smartphone-based safety plans, similar to ESP + Text Support, are generally well-received and considered feasible by patients, with high satisfaction and usability ratings. However, there is limited specific safety data, and the need for clear definitions and reporting of adverse events in suicide prevention trials is highlighted. ^{2 3 6 7 8}

How is the ESP + Text Support treatment for suicide prevention different from other treatments?

The ESP + Text Support treatment is unique because it combines an electronic safety plan with text support, making it more accessible and immediate compared to traditional paper safety plans. This digital approach is designed to be more readily available during a crisis, leveraging technology to provide timely support and resources. ^{3 7 9 10 11}

What is the purpose of this trial?

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.

Research Team

Ewa Czyz, PhD

Principal Investigator

University of Michigan

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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 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 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]

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]

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]

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]

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]

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]

References

1. United States pubmed.ncbi.nlm.nih.gov

A Brief Text-Messaging Intervention for Suicidal Youths After Emergency Department Discharge. [2022]

2. England 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. [2023]

3. England pubmed.ncbi.nlm.nih.gov

Smartphone-based safety plan for suicidal crisis: The SmartCrisis 2.0 pilot study. [2023]

4. England pubmed.ncbi.nlm.nih.gov

The Effectiveness of the Safety Planning Intervention for Adults Experiencing Suicide-Related Distress: A Systematic Review. [2022]

5. Switzerland pubmed.ncbi.nlm.nih.gov

Suicide Safety Planning: Clinician Training, Comfort, and Safety Plan Utilization. [2020]

6. England 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. [2022]

7. England 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. [2022]

8. Netherlands 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. [2023]

9. Canada pubmed.ncbi.nlm.nih.gov

Perceived Utility of the Internet-Based Safety Plan in a Sample of Internet Users Screening Positive for Suicidality. [2022]

10. United States pubmed.ncbi.nlm.nih.gov

Meeting Youth Where They Live: How to Use a QR Code in Safety Planning. [2023]

11. Canada pubmed.ncbi.nlm.nih.gov

MYPLAN - A Mobile Phone Application for Supporting People at Risk of Suicide. [2022]