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

Sponsor
VA Office of Research and Development (U.S. Fed)
Overall Status
Active, not recruiting
CT.gov ID
NCT04486677
Collaborator
(none)
80
1
2
22.9
3.5

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Caring Cards Group
  • Behavioral: Caring Cards Recipients
N/A

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 Design

Study Type:
Interventional
Actual Enrollment :
80 participants
Allocation:
Non-Randomized
Intervention Model:
Single Group Assignment
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.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)
Primary Purpose:
Treatment
Official Title:
Caring Cards to and From Veterans: Feasibility and Acceptability of a Peer Approach toSuicide Prevention and Recovery
Actual Study Start Date :
Jan 1, 2021
Anticipated Primary Completion Date :
Sep 1, 2022
Anticipated Study Completion Date :
Nov 30, 2022

Arms and Interventions

Arm Intervention/Treatment
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.

Outcome Measures

Primary Outcome Measures

  1. Feasibility [Through study completion, an average of 2 years]

    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.

  2. Intervention Satisfaction Questionnaire (Acceptability) [Through study completion, an average of 2 years]

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

Secondary Outcome Measures

  1. Interpersonal Needs Questionnaire (INQ-12) Change from Baseline [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.

  2. Suicide Risk Change from Baseline [Change from baseline, an average of 9 months]

    At baseline and follow-up, Veterans' suicide risk will be assessed.

  3. NIH Toolbox Adult Social Relationships Scales Change from Baseline [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
N/A and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 VA San Diego Healthcare System, San Diego, CA San Diego California United States 92161

Sponsors and Collaborators

  • VA Office of Research and Development

Investigators

  • Principal Investigator: Blaire Ehret, PhD, VA San Diego Healthcare System, San Diego, CA

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
VA Office of Research and Development
ClinicalTrials.gov Identifier:
NCT04486677
Other Study ID Numbers:
  • D3445-P
First Posted:
Jul 24, 2020
Last Update Posted:
Feb 15, 2022
Last Verified:
Feb 1, 2022
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
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
Keywords provided by VA Office of Research and Development
Additional relevant MeSH terms:

Study Results

No Results Posted as of Feb 15, 2022