Clinical trial NCT04486677: Caring Cards to and From Veterans: A Peer Approach to Suicide Prevention
Official title: Caring Cards to and From Veterans: Feasibility and Acceptability of a Peer Approach to Suicide Prevention and Recovery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Feasibility
Acceptability
Thwarted Belongingness
Perceived Burdensomeness
Suicide Risk
Social Connectedness
Keywords: Veterans
Suicide
Thwarted belongingness
Perceived burdensomeness
Social connectedness
Lead sponsor: VA Office of Research and Development
Sponsor class: FED
First posted: 2020-07-24
Enrollment: 80
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Intervention model description: The current study is a single-site, 2-year pilot trial that employs an open-trial, pre/post research design. This study's primary aim is to establish the feasibility and acceptability of Caring Cards for Veterans, a peer-centered intervention that facilitates suicide prevention and social connectedness.
Primary purpose: TREATMENT

Brief 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.

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Feasibility
timeFrame: Through study completion, approximately 1 year, 8 months
measure: Intervention Satisfaction Questionnaire (Acceptability)
timeFrame: Through study completion, approximately 1 year, 8 months
Secondary outcomes:
measure: Interpersonal Needs Questionnaire (INQ-15)
timeFrame: Change from baseline, an average of 9 months
measure: Suicide Risk
timeFrame: Change from baseline, an average of 9 months
measure: NIH Toolbox Adult Social Relationships Scales
timeFrame: Change from baseline, an average of 9 months
Other outcomes:
Locations:
city: San Diego
country: United States
facility: VA San Diego Healthcare System, San Diego, CA
state: California
Study officials:
affiliation: VA San Diego Healthcare System, San Diego, CA
name: Eric L Granholm, PhD
role: PRINCIPAL_INVESTIGATOR
References: