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

NCT ID: NCT04486677

Last Updated: 2024-05-02

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-01-01

Study Completion Date

2022-11-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Feasibility Acceptability Thwarted Belongingness Perceived Burdensomeness Suicide Risk Social Connectedness

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

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 Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Caring Cards Group

Group of Veteran card-makers.

Group Type OTHER

Caring Cards Group

Intervention Type BEHAVIORAL

Group of Veteran card-makers.

Caring Cards Recipients

Group of Veteran card-recipients.

Group Type OTHER

Caring Cards Recipients

Intervention Type BEHAVIORAL

Group of Veteran card-recipients.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Caring Cards Group

Group of Veteran card-makers.

Intervention Type BEHAVIORAL

Caring Cards Recipients

Group of Veteran card-recipients.

Intervention Type BEHAVIORAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

VA Office of Research and Development

FED

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Eric L Granholm, PhD

Role: PRINCIPAL_INVESTIGATOR

VA San Diego Healthcare System, San Diego, CA

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

VA San Diego Healthcare System, San Diego, CA

San Diego, California, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

Provided Documents

Download supplemental materials such as informed consent forms, study protocols, or participant manuals.

Document Type: Study Protocol

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

D3445-P

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Couple-Based Crisis Safety Planning
NCT07012824 NOT_YET_RECRUITING NA
Suicide Risk Interventions
NCT05931289 RECRUITING PHASE2
Veterans Coordinated Community Care (3C) Study
NCT05272176 ACTIVE_NOT_RECRUITING NA
Testing the Efficacy of ACT for Life
NCT04829682 ENROLLING_BY_INVITATION NA
Crisis Line Facilitation
NCT02459587 COMPLETED NA