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

Primary Purpose

Feasibility, Acceptability, Thwarted Belongingness

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Caring Cards Group
Caring Cards Recipients
Sponsored by
VA Office of Research and Development
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Feasibility focused on measuring Veterans, Suicide, Thwarted belongingness, Perceived burdensomeness, Social connectedness

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • VA San Diego Healthcare System, San Diego, CA

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Other

Arm Label

Caring Cards Group

Caring Cards Recipients

Arm Description

Group of Veteran card-makers.

Group of Veteran card-recipients.

Outcomes

Primary Outcome Measures

Feasibility
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.
Intervention Satisfaction Questionnaire (Acceptability)
Intervention Satisfaction Questionnaire will be collected from participants following intervention delivery to measure acceptability of the Caring Cards intervention.

Secondary Outcome Measures

Interpersonal Needs Questionnaire (INQ-12) Change from Baseline
At baseline and follow-up, Veterans will complete the INQ-12 to assess for thwarted belongingness and perceived burdensomeness.
Suicide Risk Change from Baseline
At baseline and follow-up, Veterans' suicide risk will be assessed.
NIH Toolbox Adult Social Relationships Scales Change from Baseline
At baseline and follow-up, Veterans will complete the NIH Toolbox Adult Social Relationships Scales to assess social connectedness.

Full Information

First Posted
June 29, 2020
Last Updated
May 2, 2023
Sponsor
VA Office of Research and Development
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1. Study Identification

Unique Protocol Identification Number
NCT04486677
Brief Title
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 toSuicide Prevention and Recovery
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Completed
Study Start Date
January 1, 2021 (Actual)
Primary Completion Date
September 1, 2022 (Actual)
Study Completion Date
November 30, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
VA Office of Research and Development

4. Oversight

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
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Feasibility, Acceptability, Thwarted Belongingness, Perceived Burdensomeness, Suicide Risk, Social Connectedness
Keywords
Veterans, Suicide, Thwarted belongingness, Perceived burdensomeness, Social connectedness

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
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.
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
80 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Caring Cards Group
Arm Type
Other
Arm Description
Group of Veteran card-makers.
Arm Title
Caring Cards Recipients
Arm Type
Other
Arm Description
Group of Veteran card-recipients.
Intervention Type
Behavioral
Intervention Name(s)
Caring Cards Group
Intervention Description
Group of Veteran card-makers.
Intervention Type
Behavioral
Intervention Name(s)
Caring Cards Recipients
Intervention Description
Group of Veteran card-recipients.
Primary Outcome Measure Information:
Title
Feasibility
Description
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.
Time Frame
Through study completion, an average of 2 years
Title
Intervention Satisfaction Questionnaire (Acceptability)
Description
Intervention Satisfaction Questionnaire will be collected from participants following intervention delivery to measure acceptability of the Caring Cards intervention.
Time Frame
Through study completion, an average of 2 years
Secondary Outcome Measure Information:
Title
Interpersonal Needs Questionnaire (INQ-12) Change from Baseline
Description
At baseline and follow-up, Veterans will complete the INQ-12 to assess for thwarted belongingness and perceived burdensomeness.
Time Frame
Change from baseline, an average of 9 months
Title
Suicide Risk Change from Baseline
Description
At baseline and follow-up, Veterans' suicide risk will be assessed.
Time Frame
Change from baseline, an average of 9 months
Title
NIH Toolbox Adult Social Relationships Scales Change from Baseline
Description
At baseline and follow-up, Veterans will complete the NIH Toolbox Adult Social Relationships Scales to assess social connectedness.
Time Frame
Change from baseline, an average of 9 months

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Eric L Granholm, PhD
Organizational Affiliation
VA San Diego Healthcare System, San Diego, CA
Official's Role
Principal Investigator
Facility Information:
Facility Name
VA San Diego Healthcare System, San Diego, CA
City
San Diego
State/Province
California
ZIP/Postal Code
92161-0002
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing 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.

Learn more about this trial

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

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