NCT04486677

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
80

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2021

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 29, 2020

Completed
25 days until next milestone

First Posted

Study publicly available on registry

July 24, 2020

Completed
5 months until next milestone

Study Start

First participant enrolled

January 1, 2021

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2022

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 30, 2022

Completed
1.4 years until next milestone

Results Posted

Study results publicly available

May 2, 2024

Completed
Last Updated

May 2, 2024

Status Verified

April 1, 2024

Enrollment Period

1.7 years

First QC Date

June 29, 2020

Results QC Date

September 1, 2023

Last Update Submit

April 30, 2024

Conditions

Keywords

VeteransSuicideThwarted belongingnessPerceived burdensomenessSocial connectedness

Outcome Measures

Primary Outcomes (2)

  • 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.

    Through study completion, approximately 1 year, 8 months

  • Intervention Satisfaction Questionnaire (Acceptability)

    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 Outcomes (3)

  • Interpersonal Needs Questionnaire (INQ-15)

    Change from baseline, an average of 9 months

  • Suicide Risk

    Change from baseline, an average of 9 months

  • NIH Toolbox Adult Social Relationships Scales

    Change from baseline, an average of 9 months

Study Arms (2)

Caring Cards Group

OTHER

Group of Veteran card-makers.

Behavioral: Caring Cards Group

Caring Cards Recipients

OTHER

Group of Veteran card-recipients.

Behavioral: Caring Cards Recipients

Interventions

Group of Veteran card-makers.

Caring Cards Group

Group of Veteran card-recipients.

Caring Cards Recipients

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • For card-makers:
  • VA San Diego Healthcare System (VASDHS) Veteran with an inactive high-risk flag,
  • 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,
  • years of age or older, and
  • decisional capacity.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

VA San Diego Healthcare System, San Diego, CA

San Diego, California, 92161-0002, United States

Location

MeSH Terms

Conditions

Suicide

Condition Hierarchy (Ancestors)

Self-Injurious BehaviorBehavioral SymptomsBehavior

Results Point of Contact

Title
Dr. Emily Treichler
Organization
VA San Diego

Study Officials

  • Eric L Granholm, PhD

    VA San Diego Healthcare System, San Diego, CA

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: 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.
Sponsor Type
FED
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 29, 2020

First Posted

July 24, 2020

Study Start

January 1, 2021

Primary Completion

September 1, 2022

Study Completion

November 30, 2022

Last Updated

May 2, 2024

Results First Posted

May 2, 2024

Record last verified: 2024-04

Data Sharing

IPD Sharing
Will share

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.

Shared Documents
STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
Time Frame
Beginning 3 months and ending 5 years following article publication.
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.

Locations