Caring Contact Postcards for Loneliness

Recruiting at 2 trial locations

Overseen By Aaron A Call

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: VA Office of Research and Development

Disqualifiers: Neurocognitive disorder, Cognitive impairment, others

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

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 4

Duration: 12 months

974 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 this treatment for loneliness?

Research shows that Caring Contacts can reduce feelings of distress and suicidal thoughts, especially after psychiatric care, which suggests they might also help with loneliness. Additionally, crisis postcards have been effective in managing suicide risk, indicating that similar postcard interventions could be beneficial for loneliness. ^{1 2 3 4 5}

How is the Caring Contacts treatment for loneliness different from other treatments?

Caring Contacts is unique because it involves sending brief, periodic messages that express care and concern, which can be delivered by someone known or unknown to the recipient. This approach is simple, cost-effective, and has been shown to reduce loneliness and mental distress, making it different from more traditional, in-person therapies or medications. ^{1 2 6 7 8}

What is the purpose of this trial?

The main purpose is to learn if sending messages from the VA (called "Caring Contacts") reduces loneliness and improves mental health. The investigators want to understand if these messages are effective in Veterans aged 60 and above who have missed appointments at the VA even though they have health problems. Participants will receive up to 10 postcards mailed in envelopes from a fellow Veteran (Peer Specialist) from their local VA, and will be asked to fill out four surveys. The investigators are recruiting 920 Veterans aged 50 years and older who have felt isolated and have missed appointments at the VA to join this study.

Research Team

Alan R. Teo, MD MS

Principal Investigator

VA Portland Health Care System, Portland, OR

Eligibility Criteria

This trial is for Veterans aged 50 or older who feel isolated, have missed VA appointments despite health issues, and have at least two comorbidities. They must not be part of an existing Caring Contacts program or have cognitive impairments that affect decision-making.

Inclusion Criteria

a) Zero completed appointments in the past 6 months and zero appointments scheduled, or b) In the 90th percentile or higher in terms of no-shows or appointments canceled by patient in the prior 12 months

I am 50 years old or older.

Have at least four VA appointments in the prior 6-18 months in primary care or mental health

Exclusion Criteria

I have a condition that affects my ability to make decisions.

No valid mailing address

No valid phone number

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive up to 10 postcards mailed in envelopes from a fellow Veteran (Peer Specialist) from their local VA

12 months

Postcards sent periodically

Follow-up

Participants are monitored for safety and effectiveness after treatment

12 months

4 surveys

Treatment Details

Interventions

• Control post cards
• Crisis Caring Contacts post cards

Trial Overview The study tests if 'Caring Contacts' postcards can reduce loneliness in Veterans. Participants will receive up to 10 messages from a Peer Specialist and complete four surveys to help determine the effectiveness of this intervention.

Participant Groups

Group I: Treatment Experimental Treatment 1 Intervention

Participants in the treatment arm will receive the intervention post cards

Group II: Control Placebo Group 1 Intervention

Participants in the control arm will receive the control post cards

Crisis Caring Contacts post cards is already approved in United States for the following indications:

Approved in United States as Caring Contacts for:

• Reducing loneliness
• Improving mental health

Who Is Running the Clinical Trial?

VA Office of Research and Development

Lead Sponsor

Trials

1,691

Recruited

3,759,000+

Findings from Research

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 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]

A study involving 154 veteran psychiatric inpatients found that 85% preferred to receive Caring Contacts from mental health counselors or primary care physicians, indicating strong support for this intervention among high-risk individuals.

Participants rated Caring Contacts as helpful, with 84% believing it could assist suicidal individuals, and preferred receiving these contacts monthly via postal mail for up to a year.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Veteran Preferences for the Caring Contacts Suicide Prevention Intervention. Reger, MA., Gebhardt, HM., Lee, JM., et al.[2022]

The Caring Cards (CC) intervention, which involves Veterans creating supportive cards for peers at risk of suicide, is being evaluated for its feasibility and acceptability among Veterans with a history of suicide risk, with 30 card makers and 50 card recipients participating in the study.

This innovative approach aims to enhance social connectedness and reduce suicidal ideation by fostering a sense of community and support, with the potential for a larger efficacy trial if initial results are positive.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A peer approach to suicide prevention and recovery: Study protocol for a feasibility and acceptability trial of Caring Cards for veterans. Ehret, BC., Chalker, SA., Pozun, CT., et al.[2022]

In a randomized controlled trial involving 761 participants, the use of crisis postcards did not show a significant effect on preventing suicide reattempts in the intention-to-treat analysis, suggesting that the intervention may not be effective overall.

However, the per-protocol analysis indicated a strong benefit of the crisis postcard intervention, showing a 61% reduction in the risk of reattempts, highlighting the need for further research to optimize the intervention and improve follow-up rates.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Employing crisis postcards with case management in Kaohsiung, Taiwan: 6-month outcomes of a randomised controlled trial for suicide attempters. Chen, WJ., Ho, CK., Shyu, SS., 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]

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]

References

1. 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]

2. 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]

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

Veteran Preferences for the Caring Contacts Suicide Prevention Intervention. [2022]

4. Netherlands pubmed.ncbi.nlm.nih.gov

A peer approach to suicide prevention and recovery: Study protocol for a feasibility and acceptability trial of Caring Cards for veterans. [2022]

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

Employing crisis postcards with case management in Kaohsiung, Taiwan: 6-month outcomes of a randomised controlled trial for suicide attempters. [2022]

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. England pubmed.ncbi.nlm.nih.gov

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

8. 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]