Caring Contacts for Emotional Distress in Veterans

(COVE Trial)

Overseen By Anna E Evanson, BS/BA

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Washington

Disqualifiers: Cognitive limitations, Insufficient English

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: 12

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores ways to assist veterans and service members experiencing stress or distress by comparing two approaches. The study will evaluate the effects of a program called Caring Contacts, which includes supportive messages combined with the best available resources, against using the resources alone. It aims to determine if these supportive messages can reduce distress and prevent suicidal thoughts. Veterans or service members who have recently left the military, are unemployed, facing financial struggles, or experiencing depression or loneliness might be suitable candidates. Participants should be open to receiving messages by text, email, or mail. As an unphased trial, this study offers a unique opportunity to contribute to innovative mental health support approaches.

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 Caring Contacts is safe for veterans?

Research has shown that Caring Contacts are generally safe. Studies have found that this method effectively reduces the risk of suicide in individuals who have recently experienced suicidal thoughts or attempts. Military personnel and veterans especially appreciate this approach.

Caring Contacts involve sending supportive messages to individuals, often including helpful resources to boost mental well-being. Published studies have used these messages without reporting any serious side effects.

Overall, evidence suggests that Caring Contacts are well-received and positively impact mental health. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Caring Contacts approach for emotional distress in veterans because it offers a simple yet potentially powerful way to support mental health. Unlike traditional therapy or medication, which can be costly and time-consuming, Caring Contacts involves sending brief, supportive messages to veterans, helping them feel connected and valued. This method could be easily implemented on a large scale, providing ongoing emotional support without the need for in-person visits. Additionally, the trial explores both intensive and non-intensive variations, aiming to identify the most effective way to maintain veterans' well-being with minimal intrusion into their daily lives.

What evidence suggests that Caring Contacts could be effective for reducing distress in veterans?

Research has shown that Caring Contacts can help reduce suicidal thoughts, attempts, and deaths. One study found that adding Caring Contacts to regular care lowered the risk of suicidal behavior in U.S. Marines and Army Soldiers. Another study showed that sending Caring Contacts was linked to more veterans using outpatient mental health services. While not all studies found a direct link to fewer suicide attempts, this approach has shown promise in encouraging people to seek mental health support. In this trial, some participants will receive Caring Contacts along with the best available resources, either with or without intensive assessment. Overall, Caring Contacts appear to be a useful addition for reducing distress and preventing suicidal thoughts among veterans. ^{1 2 5 6 7}

Who Is on the Research Team?

Katherine A Comtois, PhD/MPH

Principal Investigator

University of Washington

Are You a Good Fit for This Trial?

This trial is for US veterans or service members over 18, living in the US, who are stressed due to life transitions like military separation or financial strain, or distressed from isolation, depression, substance use. Participants must be open to receiving periodic texts and emails or postal mail.

Inclusion Criteria

US service member or veteran

I am currently facing significant stress or emotional distress.

Lives in the United States

Exclusion Criteria

Unable to consent due to inability to understand the consent form due to cognitive limitations or insufficient English (as determined by inability to pass the consent quiz items)

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Baseline Assessment

Participants undergo baseline assessments including Ecological Momentary Assessment (EMA) for 14 days

2 weeks

Daily EMA assessments

Intervention

Participants receive Caring Contacts plus best available resources, with monthly EMAs during study year

12 months

Monthly EMA assessments

Follow-up

Participants are monitored for changes in depression, suicidal ideation, and other psychological measures

12 months

12 month follow-up assessments

What Are the Treatments Tested in This Trial?

Interventions

• Caring Contacts

Trial Overview

The study examines if 'Caring Contacts'—a method of sending thoughtful messages periodically—combined with the best available resources helps reduce emotional distress and suicidal thoughts more effectively than just resources alone.

How Is the Trial Designed?

Group I: Experimental Condition without intensive assessment Experimental Treatment 2 Interventions

Caring Contacts plus best available resources, without monthly EMAs during study year

Group II: Experimental Condition with intensive assessment Experimental Treatment 2 Interventions

Caring Contacts plus best available resources, with monthly EMAs during study year

Group III: Control Condition with intensive assessment Active Control 1 Intervention

Best available resources, with monthly EMAs during study year

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?

University of Washington

Lead Sponsor

Trials

1,858

Recruited

2,023,000+

Face the Fight

Collaborator

Trials

1

Recruited

510+

Published Research Related to This Trial

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]

Cancer professionals recognize the importance of detecting emotional distress (ED) in patients, with clinical nurse specialists (CNSs) being particularly relied upon for assessment and management, despite limited experience with screening tools.

There are significant barriers to effective management of ED, including inadequate access to specialist psychological support and a lack of referral guidance, suggesting that routine screening and better training could enhance care for cancer patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The detection and management of emotional distress in cancer patients: the views of health-care professionals. Absolom, K., Holch, P., Pini, S., et al.[2022]

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]

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]

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]

In a study involving 1012 cancer patients across 13 wards, a stepped psychooncological care approach significantly increased referrals to consultation-liaison (CL) services, with 22% of patients referred compared to only 3% in standard care (odds ratio 10.0, P < .001).

Despite the increased referrals, the emotional well-being of patients did not show significant improvement after 6 months, indicating that while stepped care enhances access to services, it may not directly translate to better emotional outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of stepped psychooncological care on referral to psychosocial services and emotional well-being in cancer patients: A cluster-randomized phase III trial. Singer, S., Danker, H., Roick, J., et al.[2018]

In a study of 128 chemotherapy patients, only 20% expressed a perceived need for help with emotional problems, and among those experiencing distress, only 36% indicated a desire for assistance.

While asking about the desire for help improved the specificity of identifying depression, it reduced sensitivity, suggesting that this approach may not be the best standalone method for screening psychological symptoms but can help identify patients open to support.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Desire for psychological support in cancer patients with depression or distress: validation of a simple help question. Baker-Glenn, EA., Park, B., Granger, L., et al.[2022]

The implementation of Centralized Caring Letters (CCL) significantly increased the use of Caring Letters among veterans at two VA facilities, rising from 3% to 43% of at-risk veterans after CCL was introduced.

Clinicians found the centralized support helpful, although 30% of Caring Letters were discontinued due to issues like bad addresses or relocation, indicating some logistical challenges remain despite the increased utilization.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Implementation strategy to increase clinicians' use of the caring letters suicide prevention intervention. Reger, MA., Jegley, SM., Porter, SA., et al.[2023]

A study involving 296 oncology patients at the Dayton VAMC used the NCCN Distress Thermometer to assess distress levels, revealing that while overall distress scores did not significantly decrease over time, the number of reported problems did decline, indicating improved management of patient concerns.

Referrals to support services such as nutrition, mental health, and social work increased over the study period, suggesting that addressing distress early can lead to better resource utilization, even if distress levels remain stable.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Distress evaluation in a veteran affairs oncology clinic. Jayani, R., Markert, RJ., Heard, A., et al.[2021]

Psychosocial distress is a common issue among cancer patients, but it is often under-diagnosed and poorly managed in the U.S. healthcare system, highlighting a significant gap in care.

Interviews with 25 healthcare professionals revealed that access to psychosocial services often relies on the subjective judgment of clinicians, suggesting that improved information technology could enhance the assessment and management of psychosocial distress in cancer care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Delivery of psychosocial care for cancer patients: a pilot investigation. Abrahamson, K., Durham, M., Norton, K., et al.[2011]

Citations

1.

pmc.ncbi.nlm.nih.gov

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

Qualitative Evaluation of a Caring Letters Suicide Prevention ...

This paper describes results of qualitative interviews conducted with veterans who received Caring Letters to better understand their experiences.

2.

researchprotocols.org

researchprotocols.org/2025/1/e72140

Exploring the Impact of the Caring Contacts Intervention on ...

Objective: We aim to evaluate if receiving Caring Contacts reduces suicide risk among veterans and active service members recruited based on ...

3.

hsrd.research.va.gov

hsrd.research.va.gov/research/citations/PubBriefs/articles.cfm?RecordID=1251

Caring Letters Not Associated with Suicide Attempts Following ...

Caring Letters were not associated with suicide attempts following Veterans Crisis Line contact, but were associated with higher probability of VHA outpatient ...

4.

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 ...

5.

msrc.fsu.edu

msrc.fsu.edu/funded-research/reviewing-effects-caring-contacts-recon-long-term-follow-study-military-continuity-project/

Reviewing the Effects of Caring Contacts (RECON)

Comtois found that adding a Caring Contacts intervention to the usual treatment reduced the likelihood of U.S. Marines and Army Soldiers experiencing suicidal ...

6.

pediatrics.jmir.org

pediatrics.jmir.org/2024/1/e51570/

Development and Implementation of Postdischarge Text ...

In this study, caring contacts texts are supportive messages paired with hopeful images that include local and national youth crisis resources.

7.

onlinelibrary.wiley.com

onlinelibrary.wiley.com/doi/10.1111/sltb.13108

Implementation of caring contacts using patient feedback to ...

Caring Contacts (CCs) are brief communications delivered post-discharge that can help to improve mental health outcomes. Method. This three- ...