Clinical Trial Details
— Status: Completed
Administrative data
NCT number |
NCT04486677 |
Other study ID # |
D3445-P |
Secondary ID |
|
Status |
Completed |
Phase |
N/A
|
First received |
|
Last updated |
|
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 |
Health authority |
|
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.