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

510 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 Caring Contacts for emotional distress in veterans?

The research highlights the importance of addressing emotional distress in patients, as it can negatively impact quality of life and treatment compliance. While the studies focus on cancer patients, they suggest that early identification and referral to appropriate resources can help manage distress, which may be relevant to the Caring Contacts approach for veterans. ^{1 2 3 4 5}

How is the Caring Contacts treatment different from other treatments for emotional distress in veterans?

Caring Contacts is unique because it involves sending brief, periodic messages that express care and concern, which is a simple, cost-effective approach to prevent suicide among veterans. Unlike traditional therapies, it doesn't require in-person sessions and can be delivered through letters or text messages, making it accessible and easy to implement. ^{6 7 8 9 10}

What is the purpose of this trial?

The goal of this clinical trial is to study stressed or distressed veterans and service members. Researchers will compare Caring Contacts plus best available resources to best available resources alone to see if reduces distress and prevents thoughts of suicide.

Research Team

Katherine A Comtois, PhD/MPH

Principal Investigator

University of Washington

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

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]

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]

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 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]

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]

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]

References

1. England 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. [2018]

2. Germany pubmed.ncbi.nlm.nih.gov

Distress evaluation in a veteran affairs oncology clinic. [2021]

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

Desire for psychological support in cancer patients with depression or distress: validation of a simple help question. [2022]

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

The detection and management of emotional distress in cancer patients: the views of health-care professionals. [2022]

5. Netherlands pubmed.ncbi.nlm.nih.gov

Delivery of psychosocial care for cancer patients: a pilot investigation. [2011]

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

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

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

Implementation strategy to increase clinicians' use of the caring letters suicide prevention intervention. [2023]

9. England pubmed.ncbi.nlm.nih.gov

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

10. England pubmed.ncbi.nlm.nih.gov

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