- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04486677
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
Completed
Conditions
Intervention / 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.
Study Type
Interventional
Enrollment (Actual)
80
Phase
- 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
-
-
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
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 |
Intervention / Treatment |
|---|---|
|
Other: Caring Cards Group
Group of Veteran card-makers.
|
Group of Veteran card-makers.
|
|
Other: Caring Cards Recipients
Group of Veteran card-recipients.
|
Group of Veteran card-recipients.
|
What is the study measuring?
Primary Outcome Measures
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
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.
Investigators
- 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)
January 1, 2021
Primary Completion (Actual)
September 1, 2022
Study Completion (Actual)
November 30, 2022
Study Registration Dates
First Submitted
June 29, 2020
First Submitted That Met QC Criteria
July 21, 2020
First Posted (Actual)
July 24, 2020
Study Record Updates
Last Update Posted (Actual)
May 2, 2024
Last Update Submitted That Met QC Criteria
April 30, 2024
Last Verified
April 1, 2024
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID 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.
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