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

April 30, 2024 updated by: VA Office of Research and Development

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
80

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • San Diego, California, United States, 92161-0002
        • VA San Diego Healthcare System, San Diego, CA

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Other: Caring Cards Group
Group of Veteran card-makers.
Behavioral: Caring Cards Group
Group of Veteran card-makers.
Other: Caring Cards Recipients
Group of Veteran card-recipients.
Behavioral: Caring Cards Recipients
Group of Veteran card-recipients.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Feasibility
Time Frame: Through study completion, approximately 1 year, 8 months
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
Intervention Satisfaction Questionnaire (Acceptability)
Time Frame: Through study completion, approximately 1 year, 8 months
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 Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Interpersonal Needs Questionnaire (INQ-15)
Time Frame: Change from baseline, an average of 9 months
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
Suicide Risk
Time Frame: Change from baseline, an average of 9 months
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
NIH Toolbox Adult Social Relationships Scales
Time Frame: Change from baseline, an average of 9 months
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
VA Office of Research and Development

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Eric L Granholm, PhD, VA San Diego Healthcare System, San Diego, CA

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 1, 2021

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 1, 2022

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
November 30, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 29, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 21, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 24, 2020

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 2, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 30, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • D3445-P

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

One or more data sets without personal identifiers will be generated during the data analysis phase of this study. The data sets will include all data underlying any publications generated by this study and therefore these will be sufficient to reproduce or verify any published findings. Data sets without personal identifiers will be generated. Any HIPAA identifiers, or combinations of variables that could be used for re-identification, will be excluded, as will any proprietary information. The plan does not include any access to individually identifiable or proprietary data. Therefore, this plan will ensure the protection of personal privacy, the confidentiality of individually identifiable private information, and the security of proprietary data and information.

IPD Sharing Time Frame

Beginning 3 months and ending 5 years following article publication.

IPD Sharing Access Criteria

Final data sets underlying publications resulting from this research will be shared upon written request. Requests for access must be made in writing signed by a requestor from the United States and include an email address for delivery and an assurance that the recipient will not attempt to identify or re-identify any individual. The request should reference the publication underlying the request. Requests may be made to the Principal Investigator/lead point-of-contact for the publication. If the investigator leaves the VASDHS the requests may be sent to the Associate Chief of Staff for Research.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • ANALYTIC_CODE
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings