Caring Contacts for Suicide Prevention

(SPRING Trial)

Age: Any Age

Sex: Any

Trial Phase: Academic

Sponsor: St. Luke's Health System, Boise, Idaho

Disqualifiers: Previous trial participation, Cognitive impairment, others

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

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 3

Duration: 12 months

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests different methods of sending supportive text messages to individuals at risk of suicide to determine the most helpful approach. Participants will receive either two-way texts, which allow replies, one-way texts without reply options, or a combination of usual care practices. The goal is to assess whether these caring messages, known as Caring Contacts, can effectively reduce suicide risk. Individuals identified as at risk for suicide who can send and receive texts might find this trial suitable. As an unphased trial, this study provides a unique opportunity to contribute to innovative research that could enhance support for those at risk of suicide.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It is best to discuss this with the trial coordinators or your healthcare provider.

What prior data suggests that Caring Contacts text messages are safe for suicide prevention?

Research has shown that Caring Contacts interventions are safe for participants. In past studies, people responded well to this method. Caring Contacts involves sending text messages that express care and concern. These messages are short, easy to understand, and sent regularly.

Early results suggest that these messages can help lower the risk of suicide, especially for those who have recently thought about or attempted self-harm. This method has been tested with different groups, including military personnel and veterans, and has been well-received.

No known negative effects have been reported from receiving these texts. Participants in previous studies did not report any problems from the messages. This makes Caring Contacts a low-risk option for preventing suicide. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Caring Contacts for Suicide Prevention trial because it explores a novel approach beyond traditional interventions like therapy, medication, and crisis hotlines. The trial investigates the impact of supportive text messages, which can either be one-way (CC1) or two-way (CC2). These messages aim to provide ongoing, low-pressure support and connection, enhancing the usual care participants receive. This method is distinctive because it leverages technology to maintain a sense of connection and care, potentially reaching individuals who might not engage with traditional mental health services. By offering a simple, scalable, and personalized way to support individuals, researchers hope to uncover a new, effective layer of care in suicide prevention.

What evidence suggests that this trial's treatments could be effective for suicide prevention?

Research has shown that Caring Contacts can help reduce suicidal thoughts and actions. In this trial, participants will join different arms to evaluate the effectiveness of these interventions. One arm will receive one-way text messages, offering support without pressure and helping individuals feel cared for, thus reducing suicidal thoughts. Another arm will receive two-way text messages, enabling conversation and personalized replies, which might enhance effectiveness. Overall, Caring Contacts are a promising tool in efforts to prevent suicide. ^{2 3 5 6 7}

Who Is on the Research Team?

Anna K Radin, DrPH, MPH

Principal Investigator

St. Luke's Health System

Are You a Good Fit for This Trial?

The SPRING Trial is for adolescents (12-17 years) and adults (18+) who show signs of suicide risk based on the Columbia Suicide Severity Rating Scale or provider notes. Participants must be able to communicate via text, phone calls, and emails in English. Those with hearing impairments can receive accommodations.

Inclusion Criteria

You can receive phone calls.

If you've said "yes" to at least one question on the Columbia Suicide Severity Rating Scale (C-SSRS) at a St. Luke's Health System clinic, or if your health record or a note from a visit shows that you might be at risk for suicide.

You can get emails.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either two-way or one-way Caring Contacts text messages, or enhanced usual care for suicide prevention

12 months

Text messages sent periodically

Follow-up

Participants are monitored for safety and effectiveness after treatment

12 months

Baseline, 3 months, 6 months, 12 months

What Are the Treatments Tested in This Trial?

Interventions

• Caring Contacts

Trial Overview This trial tests suicide prevention strategies by comparing two-way vs. one-way Caring Contacts text messages against enhanced usual care to see which is more effective in preventing suicide among at-risk individuals.

How Is the Trial Designed?

Group I: Two-Way Caring Contacts Texts (CC2) Experimental Treatment 1 Intervention

In addition to receiving enhanced usual care as described below, a series of 25 standardized outgoing Caring Contacts text messages will be sent to participants randomized to the CC2 intervention arm through our online texting platform. To remind participants that they can respond, the outgoing texts will periodically invite replies in a non-demanding way, e.g., "Hope you're doing well this week, Anna. Feel free to text me back if you feel like it, I'm here for you." Responses to CC2 participant replies will be unscripted and individually tailored.

Group II: One-Way Caring Contacts Texts (CC1) Experimental Treatment 1 Intervention

In addition to receiving enhanced usual care as described below, CC1 participants will be sent 25 caring texts, such as "Even though know we do not personally know each other, we truly value your wellbeing and are thinking of you. If you'd like to connect with someone, feel free to call or text 988 anytime - their team would be happy to hear from you." CC1 participants will not be able to reply to the texts and the online texting platform will block incoming messages. This will be clearly communicated to CC1 participants during the informed consent process and they will be asked to sign off on understanding this and other key points before enrolling in the study.

Group III: Enhanced Usual Care (UC) Active Control 1 Intervention

Participants randomized to the UC arm will receive best available usual care from the health system, such as standardized clinical assessments, the safety planning intervention or other intervention(s), appropriate referrals and/or medication management through a system wide electronic health record system-assisted suicide care clinical workflow. Usual care will vary based on patient clinical needs, availability of providers/staff, and provider clinical judgment. Following study enrollment, all participants will be given a list of resources, offered a warm hand-off to 988, and encouragement to call or text 988 as needed. During the baseline survey, participants will have the opportunity to opt into a call from the follow-up team to develop or revise a safety plan.

Caring Contacts is already approved in United States, European Union for the following indications:

Approved in United States as Caring Contacts for:

• Suicide prevention in adults and adolescents

Approved in European Union as Caring Contacts for:

• Suicide prevention in high-risk individuals

Who Is Running the Clinical Trial?

St. Luke's Health System, Boise, Idaho

Lead Sponsor

Trials

4

Recruited

3,000+

University of Washington

Collaborator

Trials

1,858

Recruited

2,023,000+

Idaho Crisis & Suicide Hotline

Collaborator

Trials

3

Recruited

3,000+

American Foundation for Suicide Prevention

Collaborator

Trials

36

Recruited

10,500+

Idaho Crisis & Suicide Hotline

Collaborator

Trials

3

Recruited

3,000+

Published Research Related to This Trial

A nursing discharge plan that includes thorough information about health status and post-hospitalization care significantly improves treatment adherence among psychiatric patients, as shown in a study of 135 patients.

Higher patient satisfaction with nursing care is linked to better adherence to treatment plans, suggesting that effective communication and education from nurses empower patients to manage their conditions more effectively.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The effectiveness of a nursing discharge programme to improve medication adherence and patient satisfaction in the psychiatric intensive care unit. Virgolesi, M., Pucciarelli, G., Colantoni, AM., et al.[2018]

A follow-up phone call from a pharmacist two days after hospital discharge significantly increased patient satisfaction with medication instructions (86% vs. 61% for the control group).

The intervention also led to better health outcomes, with only 10% of patients in the phone call group returning to the emergency department within 30 days, compared to 24% in the control group.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The impact of follow-up telephone calls to patients after hospitalization. Dudas, V., Bookwalter, T., Kerr, KM., et al.[2022]

About 63% of long-term care facilities in the Czech Republic have some form of adverse event reporting process, but many of these systems are underdeveloped and rely mainly on paper records.

Interviews revealed that while staff recognize the importance of reporting adverse events, there is a significant gap in knowledge and skills needed to create effective reporting systems, indicating a need for better training and resources.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adverse event reporting in Czech long-term care facilities. Hěib, Z., Vychytil, P., Marx, D.[2016]

Switching from manual white boards to electronic bed boards significantly improved the quality of patient data communication among caregivers.

The implementation involved a process redesign team that focused on enhancing the processes of patient care, leading to standardized data display across care centers.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

From airports to care centers. Transferring information technology to support patient care reengineering. Vogel, LH., Bonomo, C., Yang, A.[2019]

The quality improvement project aimed to enhance patient education and satisfaction while also reducing 30-day readmission rates for stroke patients.

A follow-up telephone call was made 72 hours after discharge to assess and support patients, indicating a proactive approach to post-discharge care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Stroke Transitions of Care. Ross, SY., Roberts, S., Taggart, H., et al.[2018]

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 study analyzed 90 caring messages written by 15 peer veterans, revealing three key themes: Shared Military Service, Care, and Overcoming Adversity, which reflect the unique experiences and support among veterans.

These peer-generated messages may enhance feelings of belonging and social support for veterans after psychiatric treatment, potentially improving the effectiveness of existing suicide prevention interventions like Caring Letters.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Peer-Written Caring Letters for Veterans after a Suicidal Crisis. Ton, AT., Carter, SP., Leitner, R., et al.[2023]

The study aims to adapt the Caring Contacts suicide prevention approach for use in a VA emergency department, targeting veterans during a critical transition period after discharge.

A pilot program will be conducted to gather qualitative data from staff and stakeholders, which will help create an implementation toolkit for spreading this effective intervention to other VA facilities.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adapting and implementing Caring Contacts in a Department of Veterans Affairs emergency department: a pilot study protocol. Landes, SJ., Kirchner, JE., Areno, JP., et al.[2022]

The Copenhagen Hospital Corporation successfully implemented a reporting system for adverse events, resulting in 6011 reported incidents over three years, indicating a strong safety culture among staff.

The organization conducted 92 root cause analyses during this period, focusing on both optional and mandatory reports, which highlights their commitment to understanding and preventing future adverse events.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Adverse events management. Methods and results of a development project]. Rabøl, LI., Jensen, EB., Hellebek, AH., et al.[2006]

Caring Contacts, which are supportive text messages sent to military personnel at risk of suicide, showed a significant reduction in the odds of experiencing suicidal ideation and attempts compared to standard care, suggesting they may be a valuable addition to mental health interventions.

While the primary outcomes did not show significant effects, the secondary outcomes indicated that participants receiving Caring Contacts had lower rates of suicidal ideation and attempts, highlighting the potential of this low-cost intervention in preventing suicidality among military service members.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of Augmenting Standard Care for Military Personnel With Brief Caring Text Messages for Suicide Prevention: A Randomized Clinical Trial. Comtois, KA., Kerbrat, AH., DeCou, CR., et al.[2022]

A study involving 666 participants (331 patients and 335 healthcare providers) found that adding an introductory phone call to Caring Contacts did not significantly reduce loneliness compared to sending messages without the call.

The results suggest that Caring Contacts can be effectively implemented without the added complexity of introductory calls, maintaining their potential to support individuals with adverse mental health outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparative effectiveness of two versions of a caring contacts intervention in healthcare providers, staff, and patients for reducing loneliness and mental distress: A randomized controlled trial. Radin, AK., Shaw, J., Brown, SP., et al.[2023]

In a pilot study involving 100 recently discharged psychiatric patients, Caring Contacts showed a potential benefit in reducing the worsening of mental health symptoms and suicidal ideation shortly after discharge, particularly on day 4 post-discharge.

Although there were no significant differences between the Caring Contacts and control groups overall, the results suggest that Caring Contacts may help mitigate distress in the immediate post-discharge period, indicating the need for further research with larger sample sizes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Caring Contacts to Reduce Psychiatric Morbidity Following Hospitalization During the COVID-19 Pandemic: A Pilot Randomized Controlled Trial. Holman, S., Steinberg, R., Sinyor, M., et al.[2023]

A total of 11,999 Adverse Drug Events (ADEs) were identified from 244,992 hospital admissions, indicating a prevalence of 4.9 ADEs per 100 admissions, particularly affecting older adults and linked to longer hospital stays.

Clinical Coding Surveillance (CCS) proved to be a reliable method for monitoring ADEs, with 91% accuracy in classifying ADEs based on clinical documentation, suggesting it can effectively enhance patient safety in hospitals.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Feasibility and reliability of clinical coding surveillance for the routine monitoring of adverse drug events in New Zealand hospitals. Ng, J., Andrew, P., Muir, P., et al.[2019]

In the ED-SAFE study, structured telephone follow-up assessments were crucial for identifying adverse events (AEs), detecting 45% of total AEs that were missed by chart reviews alone.

The detection of suicide attempts varied significantly by method, with structured follow-ups identifying 59% of attempts compared to only 18% through chart reviews, highlighting the importance of using multiple detection methods in suicide research.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Using structured telephone follow-up assessments to improve suicide-related adverse event detection. Arias, SA., Zhang, Z., Hillerns, C., et al.[2021]

A follow-up phone call from a pharmacist two days after hospital discharge significantly increased patient satisfaction with medication instructions (86% vs. 61% for the control group).

The intervention also led to better health outcomes, with only 10% of patients in the phone call group returning to the emergency department within 30 days, compared to 24% in the control group.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The impact of follow-up telephone calls to patients after hospitalization. Dudas, V., Bookwalter, T., Kerr, KM., et al.[2019]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11419934/

Qualitative Evaluation of a Caring Letters Suicide Prevention ... Systematic reviews and meta-analyses suggest Caring Letters can reduce suicide behaviors in other populations. Additional research is needed to ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10304492/

Comparative effectiveness of two versions of a caring ... Caring Contacts can effectively reduce suicide ideation, attempts, and death. In published clinical trials, Caring Contacts were sent by someone who knew ...

3. researchprotocols.org researchprotocols.org/2025/1/e72140

Exploring the Impact of the Caring Contacts Intervention on ... It reduces suicide risk among individuals with recent suicidal ideation or attempts and has demonstrated acceptability in military and veteran ...

4. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1551714425000333

Comparative effectiveness of two-way caring contacts texts ... Caring Contacts — non-demanding messages of care and support — can significantly reduce suicide risk, but important implementation questions remain. Two-way ...

5. afsp.org afsp.org/grant/effectiveness-of-two-way-caring-texts-vs-one-way-caring-texts-vs-usual-care-a-pra

Effectiveness of Two-Way Caring Texts vs One ... Caring texts, postcards, or letters have been proven to reduce suicidal ideation, behavior, and even deaths. However, there are important questions remaining ...

6. floridahealth.gov floridahealth.gov/programs-and-services/prevention/suicide-prevention/index.html

Suicide Prevention | Florida Department of Health If you are having thoughts of harming yourself, call or text the Suicide Prevention Lifeline at 988 or reach out through chat by visiting 988lifeline.org/chat.

7. mirecc.va.gov mirecc.va.gov/visn19/cpg/recs/16/

16: Caring Communications - MIRECC / CoE Caring Communications is a suicide prevention approach that involves sending brief, non-demanding expressions of care and concern at specified intervals over a ...