Caring Cards to and From Veterans: A Peer Approach to Suicide Prevention

Feasibility Clinical Trial

Official title:

Caring Cards to and From Veterans: Feasibility and Acceptability of a Peer Approach to Suicide Prevention and Recovery

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04486677
• Other study ID #: D3445-P
• Status: Completed
• Phase: N/A
• Start date: January 1, 2021
• Est. completion date: November 30, 2022

Study information

• Verified date: April 2024
• Source: VA Office of Research and Development
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Veteran suicide is a national problem; social disconnection is an important contributor to suicide risk. This pilot study will recruit Veterans to take part in a peer-centered intervention called Caring Cards (CC). CC gives Veterans who have a history of increased suicide risk the opportunity to make cards that are then sent to Veterans who are currently at high-risk for suicide. This study will directly benefit Veterans and contribute to the quality of services provided by VA by creating a safe, creative space for Veterans with lived experience related to suicide risk to join together to provide messages of hope, community, and resilience to their peers at risk for suicide. Helping Veterans support one another provides a bridge for social connection, which may help prevent Veteran suicide. This intervention may also improve Veterans' satisfaction with VA healthcare and engagement with mental health treatment.

Description:

There is a strong need to develop, evaluate, and implement translatable interventions aimed at reducing Veteran suicide. Caring contacts for suicide prevention (i.e., staff send supportive letters to patients following psychiatric inpatient stays) is an empirically supported, low-cost method for meaningfully reducing suicide risk and hospitalization readmissions and, has been studied and applied in Veterans/VA settings. Peer support (i.e., persons with lived mental health experience) in mental health recovery is another empirically supported approach. Peers' involvement in mental healthcare improves patients' social functioning and community integration, as well as reduces self-stigma and functional impairment. This study focuses on the Caring Cards (CC) intervention, which is a novel integration of caring contacts and peers. In CC, outpatient Veterans with lived mental health experience (peers) create hope-filled and inspiring cards that are then sent to other Veterans struggling with mental health concerns. By design, CC increases social connectedness among participants to reduce suicide risk, which is strongly associated with social disconnectedness. Indeed, there are two evidence-based social risk factors of suicide: thwarted belongingness (TB; feeling like one does not belong) and perceived burdensomeness (PB; feeling as though one's existence is a burden on others). CC combines both caring contacts and peers to specifically target reductions in TB and PB by increasing social connectedness. This study aims to establish the feasibility and acceptability of CC. The investigators' initial quality improvement project provided strong preliminary evidence for the feasibility and acceptability of the CC. The current study is a single-site, 2-year pilot trial that employs an open-trial, pre/post research design. The investigators propose to recruit outpatient Veterans with a history of high suicide risk to make up the CC group and serve as the card-makers (CMs). The investigators will recruit outpatient Veterans who are currently at high-risk for suicide to be the card-recipients (CRs). The primary outcome (Aim 1) is to establish feasibility and acceptability of CC. Aim 2 will examine CC's ability to reduce the primary outcomes (TB and PB) among CMs and CRs. Aim 3 will preliminary evaluate CC's ability to increase social connectedness, as well as reduce suicide risk (i.e., suicidal ideation and behavior) among CMs and CRs. CMs will meet in weekly groups, each for six months, over the course of one year; CRs will receive a total of six cards, one per month. Monthly meet-up groups will also be an optional venue for CMs and CRs to meet each other in-person. Baseline and follow-up assessments will be completed at start and one month after final group for CMs, or one month after the final card for CRs. This project builds on the investigators' preliminary data which indicate that Veteran CMs are interested in and find participating in CC groups highly meaningful, and Veteran CRs enjoy receiving the cards, want to receive more, and describe them as inspirational and empowering. This project is innovative in its utilization of peers to facilitate suicide prevention and social recovery among Veterans at risk for suicide by specifically targeting TB and PB. It is also unique in that it simultaneously targets two populations (outpatient Veterans with a history of, and those with current suicide risk), which have not previously been examined with traditional caring contacts. This research directly responds to the National Prioritized Research Agenda for Suicide Prevention. This study directly supports RR&D's mission and is aligned with VA's 2018-2028 National Strategy for Preventing Veteran Suicide. The investigators expect that these data will inform best practices in suicide prevention and social recovery for Veterans at risk for suicide.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: November 30, 2022
• Est. primary completion date: September 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• For card-makers:

• VA San Diego Healthcare System (VASDHS) Veteran with an inactive high-risk flag,

• 18 years of age or older,

• access to transportation to attend the group (if held in person)

• if groups are held remotely due to COVID-19, access to reliable technology and WiFi to participate via WebEx

• decisional capacity.

• For card-recipients:

• VASDHS Veteran with an active high-risk flag,

• 18 years of age or older, and

• decisional capacity.

Exclusion Criteria:

-For card-makers and recipients:

• the absence of a mailing address or working phone number,

• inability to read and writer in English, and

• previous or current experience with Caring Cards.

Related Conditions & MeSH terms

• Acceptability
• Feasibility
• Perceived Burdensomeness
• Social Connectedness
• Suicide
• Suicide Prevention
• Suicide Risk
• Thwarted Belongingness

Intervention

Behavioral:
• Caring Cards Group
Group of Veteran card-makers.
• Caring Cards Recipients
Group of Veteran card-recipients.

Locations

Country	Name	City	State
United States	VA San Diego Healthcare System, San Diego, CA	San Diego	California

Sponsors (1)

Lead Sponsor	Collaborator
VA Office of Research and Development

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Feasibility	Feasibility will be measured by the proportion of Veterans 1) referred for screening, 2) determined eligible, 3) enrolled/completed baseline, and 4) complete follow-up assessments.	Through study completion, approximately 1 year, 8 months
Primary	Intervention Satisfaction Questionnaire (Acceptability)	Intervention Satisfaction Questionnaire will be collected from participants following intervention delivery to measure acceptability of the Caring Cards intervention.	Through study completion, approximately 1 year, 8 months
Secondary	Interpersonal Needs Questionnaire (INQ-15)	At baseline and follow-up, Veterans will complete the INQ-12 to assess for thwarted belongingness and perceived burdensomeness. Each item on the INQ is rated on a 1-7 Likert scale so the full range of the measure is 12-105, with scores meaning higher thwarted belongingness and perceived burdensomeness (i.e., a worse outcome).	Change from baseline, an average of 9 months
Secondary	Suicide Risk	At baseline and follow-up, Veterans' suicide risk was assessed using the Beck Scale for Suicide Ideation (BSSI). It is a 19 item measure on a 0-2 point scale for a range of 0-38, with higher scores indicating higher suicidal ideation or worse outcomes. There are two additional questions about suicide attempts that are not included in the total score.	Change from baseline, an average of 9 months
Secondary	NIH Toolbox Adult Social Relationships Scales	At baseline and follow-up, Veterans will complete the NIH Toolbox Adult Social Relationships Scales to assess social connectedness. There were three subscales included: Perceived Rejection, Loneliness, and Emotional Support. Each includes items rated on a 1-5 scale. Perceived Rejection is 8 items for a range of 8-40, Loneliness is 5 items for a range of 5-25, and Emotional Support is 8 items for a range of 8-40. Higher scores are associated with worse outcomes for Perceived Rejection and Loneliness, while higher scores are associated with better outcomes for Emotional Support.	Change from baseline, an average of 9 months