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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Caring Cards Group | Other | Group of Veteran card-makers. |
|
| Caring Cards Recipients | Other | Group of Veteran card-recipients. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Caring Cards Group | Behavioral | Group of Veteran card-makers. |
| |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Interpersonal Needs Questionnaire (INQ-15) | 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 |
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Inclusion Criteria:
For card-makers:
For card-recipients:
Exclusion Criteria:
-For card-makers and recipients:
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| Name | Affiliation | Role |
|---|---|---|
| Eric L Granholm, PhD | VA San Diego Healthcare System, San Diego, CA | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| VA San Diego Healthcare System, San Diego, CA | San Diego | California | 92161-0002 | United States |
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.
Beginning 3 months and ending 5 years following article publication.
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.
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| ID | Title | Description |
|---|---|---|
| FG000 | Caring Cards Group | Group of Veteran card-makers. Caring Cards Group: Group of Veteran card-makers. |
| FG001 | Caring Cards Recipients | Group of Veteran card-recipients. Caring Cards Recipients: Group of Veteran card-recipients. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Caring Cards Group | Group of Veteran card-makers. Caring Cards Group: Group of Veteran card-makers. |
| BG001 | Caring Cards Recipients | Group of Veteran card-recipients. Caring Cards Recipients: Group of Veteran card-recipients. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Posted | Count of Participants | Participants | Through study completion, approximately 1 year, 8 months |
|
Adverse event data was collected from the time of participant entry into the study until final assessment, which averaged 9 months.
Systematic method:
Veterans with active high-risk suicide flags are closely monitored and assessed by VA Suicide Prevention Coordinator (SPCs). At baseline and follow-up, participants are administered two suicide screening measures. Veterans who screen positive immediately meet with a licensed provider. Any new suicidal behavior will be documented in a VA-required report. Trained staff will assess and refer Veterans who require immediate medical attention or psychiatric treatment.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Caring Cards Group | Group of Veteran card-makers. Caring Cards Group: Group of Veteran card-makers. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Suicide attempt | Psychiatric disorders | Systematic Assessment | These two attempts resulted in hospitalization |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Suicide attempt | Psychiatric disorders | Systematic Assessment | These attempts did not result in hospitalization; participants remained stable in outpatient treatment with suicide prevention coordinator oversight. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Emily Treichler | VA San Diego | 6192288075 | emily.treichler@va.gov |
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Nov 22, 2022 | Apr 30, 2024 | Prot_001.pdf |
| ICF | No | No | Yes | Informed Consent Form | Aug 27, 2020 | May 2, 2023 | ICF_000.pdf |
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| ID | Term |
|---|---|
| D013405 | Suicide |
| ID | Term |
|---|---|
| D016728 | Self-Injurious Behavior |
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
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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.
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| Caring Cards Recipients |
| Behavioral |
Group of Veteran card-recipients. |
|
| Suicide Risk | 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 | 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 |
| BG002 | Total | Total of all reporting groups |
| Participants |
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| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Count of Participants | Participants |
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| Era of Military Service | Count of Participants | Participants |
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| Units | Counts |
|---|---|
| Participants |
|
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| Primary | Intervention Satisfaction Questionnaire (Acceptability) | Intervention Satisfaction Questionnaire will be collected from participants following intervention delivery to measure acceptability of the Caring Cards intervention. | Posted | Count of Participants | Participants | Through study completion, approximately 1 year, 8 months |
|
|
|
| Secondary | Interpersonal Needs Questionnaire (INQ-15) | 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). | Posted | Mean | Standard Deviation | score on a scale | Change from baseline, an average of 9 months |
|
|
|
| Secondary | Suicide Risk | 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. | Posted | Mean | Standard Deviation | score on a scale | Change from baseline, an average of 9 months |
|
|
|
| Secondary | NIH Toolbox Adult Social Relationships Scales | 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. | Posted | Mean | Standard Deviation | score on a scale | Change from baseline, an average of 9 months |
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| 0 |
| 30 |
| 0 |
| 30 |
| 0 |
| 30 |
| EG001 | Caring Cards Recipients | Group of Veteran card-recipients. Caring Cards Recipients: Group of Veteran card-recipients. | 0 | 50 | 2 | 50 | 6 | 50 |
|
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| Baseline (Loneliness) |
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| Follow up (Loneliness) |
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| Baseline (Emotional support) |
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| Follow up (Emotional support) |
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