Caring Contacts for Suicide Prevention

(CARE Trial)

Recruiting at 2 trial locations

Overseen By Katherine Anne Comtois, PhD, MPH

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Washington State University

Disqualifiers: Cognitive impairment, others

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

Compensation: Varies

Number of Visits: Unknown

711 Participants Needed

Trial Summary

What is the purpose of this trial?

Suicide is the second leading cause of death for American Indians and Alaska Natives aged 18 years and older. This study will evaluate Caring Contacts, a low-cost, sustainable intervention for suicide prevention that sends caring messages to people at risk. The investigators will implement the intervention at four tribal sites, leveraging community strengths and values to address this tragic health disparity in an underserved minority population.

Do I need to stop my current medications to join the trial?

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

What data supports the effectiveness of the treatment Caring Contacts Messages for suicide prevention?

Research shows that caring text messages sent to youths after hospital discharge for suicide risk were feasible and helped reduce suicidal thoughts and behaviors. Additionally, the VA recommends caring contacts for veterans at risk for suicide, and veterans found the intervention acceptable. ^{1 2 3 4 5}

Is Caring Contacts safe for humans?

Caring Contacts, which involves sending supportive messages, has been used in various studies to help prevent suicide and reduce distress. There is no specific mention of safety concerns or harmful effects in the research, suggesting it is generally safe for humans. ^{6 7 8 9 10}

How is the Caring Contacts treatment different from other suicide prevention treatments?

Caring Contacts is unique because it involves sending brief, caring messages to individuals at risk of suicide, expressing unconditional care and concern. Unlike other treatments, it is a low-cost, scalable intervention that does not require the sender to know the recipient personally, making it accessible and easy to implement. ^{4 7 11 12 13}

Research Team

Lonnie A Nelson, PhD

Principal Investigator

Washington State University

Eligibility Criteria

This trial is for American Indian or Alaska Native adults who are at least 18 years old, can speak and read English, have had suicidal thoughts or an attempt within the past year, and are willing to receive messages by text, email, or mail. It's not for those unable to consent independently.

Inclusion Criteria

Speak and read English

Self-identify as American Indian or Alaska Native

I am okay with being contacted through text, email, or mail.

Exclusion Criteria

I am unable to understand or sign the consent form by myself.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention

Participants receive Caring Contacts messages via text, email, and postal mail to promote connectedness and prevent suicide

12 months

Ongoing contact through messages

Follow-up

Participants are monitored for suicidal ideation, attempts, and hospitalizations

18 months

Treatment Details

Interventions

• Caring Contacts Messages

Trial Overview The study tests 'Caring Contacts', a suicide prevention approach that involves sending supportive messages to individuals at risk. The effectiveness of this low-cost intervention will be evaluated across four tribal communities.

Participant Groups

Group I: Usual Care + Caring Contacts messages Experimental Treatment 2 Interventions

Usual care services plus caring contacts messages

Group II: Usual Care Active Control 1 Intervention

Usual care services provided in that community following identification of suicidal ideation or behavior.

Who Is Running the Clinical Trial?

Washington State University

Lead Sponsor

Trials

114

Recruited

58,800+

University of Washington

Collaborator

Trials

1,858

Recruited

2,023,000+

National Institute of Mental Health (NIMH)

Collaborator

Trials

3,007

Recruited

2,852,000+

Findings from Research

A quality improvement project at a large VA health care system successfully enrolled 29% of hospitalized veterans at risk for suicide in caring contacts interventions, highlighting the potential for this approach to support veterans post-hospitalization.

Despite high acceptability of the intervention among veterans, barriers such as staff availability and veteran homelessness limited enrollment, indicating a need for strategies to enhance participation in future implementations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Lessons Learned From Implementing a Caring Contacts Clinical Practice Guideline Recommendation. Liu, L., Porter, SA., Gebhardt, H., et al.[2023]

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]

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]

A two-hour suicide care educational intervention significantly improved family caregivers' ability to care for suicidal individuals and fostered more positive attitudes towards them, based on a study of 74 participants.

While the intervention did not reduce caregivers' stress levels, it highlighted the importance of providing education to family members, which is often overlooked in suicide prevention programs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Short-term effects of a suicide education intervention for family caregivers of people who are suicidal. Sun, FK., Chiang, CY., Lin, YH., et al.[2013]

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]

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]

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 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]

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]

The Caring Contacts suicide prevention intervention is effective and cost-efficient, but patient characteristics have minimal impact on preferences for the intervention's format and delivery, based on a study of 154 veterans.

Older veterans showed a preference for receiving messages as physical letters, while younger veterans preferred handwritten notes with colorful envelopes, suggesting that minor adaptations may enhance engagement for different age groups.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Differential Preferences for the Caring Contacts Suicide Prevention Intervention Based on Patient Characteristics. Ammerman, BA., Gebhardt, HM., Lee, JM., et al.[2022]

References

1. England pubmed.ncbi.nlm.nih.gov

Effects of different telephone intervention styles with suicidal callers at two suicide prevention centers: an empirical investigation. [2022]

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

Lessons Learned From Implementing a Caring Contacts Clinical Practice Guideline Recommendation. [2023]

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

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

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

Peer-Written Caring Letters for Veterans after a Suicidal Crisis. [2023]

5. England pubmed.ncbi.nlm.nih.gov

Short-term effects of a suicide education intervention for family caregivers of people who are suicidal. [2013]

6. England pubmed.ncbi.nlm.nih.gov

Adapting and implementing Caring Contacts in a Department of Veterans Affairs emergency department: a pilot study protocol. [2022]

7. United States 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. [2022]

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

Caring Contacts to Reduce Psychiatric Morbidity Following Hospitalization During the COVID-19 Pandemic: A Pilot Randomized Controlled Trial. [2023]

9. 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]

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

Caring contacts for suicide prevention: A systematic review and meta-analysis. [2023]

11. Netherlands 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. [2023]

12. England pubmed.ncbi.nlm.nih.gov

What would you say to the person on the roof? A suicide prevention text. [2022]

13. England pubmed.ncbi.nlm.nih.gov

Differential Preferences for the Caring Contacts Suicide Prevention Intervention Based on Patient Characteristics. [2022]