<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT04486677</url>
  </required_header>
  <id_info>
    <org_study_id>D3445-P</org_study_id>
    <nct_id>NCT04486677</nct_id>
  </id_info>
  <brief_title>Caring Cards to and From Veterans: A Peer Approach to Suicide Prevention</brief_title>
  <official_title>Caring Cards to and From Veterans: Feasibility and Acceptability of a Peer Approach toSuicide Prevention and Recovery</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>VA Office of Research and Development</agency>
      <agency_class>U.S. Fed</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>VA Office of Research and Development</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      Veteran suicide is a national problem; social disconnection is an important contributor to&#xD;
      suicide risk. This pilot study will recruit Veterans to take part in a peer-centered&#xD;
      intervention called Caring Cards (CC). CC gives Veterans who have a history of increased&#xD;
      suicide risk the opportunity to make cards that are then sent to Veterans who are currently&#xD;
      at high-risk for suicide. This study will directly benefit Veterans and contribute to the&#xD;
      quality of services provided by VA by creating a safe, creative space for Veterans with lived&#xD;
      experience related to suicide risk to join together to provide messages of hope, community,&#xD;
      and resilience to their peers at risk for suicide. Helping Veterans support one another&#xD;
      provides a bridge for social connection, which may help prevent Veteran suicide. This&#xD;
      intervention may also improve Veterans' satisfaction with VA healthcare and engagement with&#xD;
      mental health treatment.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      There is a strong need to develop, evaluate, and implement translatable interventions aimed&#xD;
      at reducing Veteran suicide. Caring contacts for suicide prevention (i.e., staff send&#xD;
      supportive letters to patients following psychiatric inpatient stays) is an empirically&#xD;
      supported, low-cost method for meaningfully reducing suicide risk and hospitalization&#xD;
      readmissions and, has been studied and applied in Veterans/VA settings. Peer support (i.e.,&#xD;
      persons with lived mental health experience) in mental health recovery is another empirically&#xD;
      supported approach. Peers' involvement in mental healthcare improves patients' social&#xD;
      functioning and community integration, as well as reduces self-stigma and functional&#xD;
      impairment. This study focuses on the Caring Cards (CC) intervention, which is a novel&#xD;
      integration of caring contacts and peers. In CC, outpatient Veterans with lived mental health&#xD;
      experience (peers) create hope-filled and inspiring cards that are then sent to other&#xD;
      Veterans struggling with mental health concerns. By design, CC increases social connectedness&#xD;
      among participants to reduce suicide risk, which is strongly associated with social&#xD;
      disconnectedness. Indeed, there are two evidence-based social risk factors of suicide:&#xD;
      thwarted belongingness (TB; feeling like one does not belong) and perceived burdensomeness&#xD;
      (PB; feeling as though one's existence is a burden on others). CC combines both caring&#xD;
      contacts and peers to specifically target reductions in TB and PB by increasing social&#xD;
      connectedness. This study aims to establish the feasibility and acceptability of CC. The&#xD;
      investigators' initial quality improvement project provided strong preliminary evidence for&#xD;
      the feasibility and acceptability of the CC. The current study is a single-site, 2-year pilot&#xD;
      trial that employs an open-trial, pre/post research design. The investigators propose to&#xD;
      recruit outpatient Veterans with a history of high suicide risk to make up the CC group and&#xD;
      serve as the card-makers (CMs). The investigators will recruit outpatient Veterans who are&#xD;
      currently at high-risk for suicide to be the card-recipients (CRs). The primary outcome (Aim&#xD;
      1) is to establish feasibility and acceptability of CC. Aim 2 will examine CC's ability to&#xD;
      reduce the primary outcomes (TB and PB) among CMs and CRs. Aim 3 will preliminary evaluate&#xD;
      CC's ability to increase social connectedness, as well as reduce suicide risk (i.e., suicidal&#xD;
      ideation and behavior) among CMs and CRs. CMs will meet in weekly groups, each for six&#xD;
      months, over the course of one year; CRs will receive a total of six cards, one per month.&#xD;
      Monthly meet-up groups will also be an optional venue for CMs and CRs to meet each other&#xD;
      in-person. Baseline and follow-up assessments will be completed at start and one month after&#xD;
      final group for CMs, or one month after the final card for CRs. This project builds on the&#xD;
      investigators' preliminary data which indicate that Veteran CMs are interested in and find&#xD;
      participating in CC groups highly meaningful, and Veteran CRs enjoy receiving the cards, want&#xD;
      to receive more, and describe them as inspirational and empowering. This project is&#xD;
      innovative in its utilization of peers to facilitate suicide prevention and social recovery&#xD;
      among Veterans at risk for suicide by specifically targeting TB and PB. It is also unique in&#xD;
      that it simultaneously targets two populations (outpatient Veterans with a history of, and&#xD;
      those with current suicide risk), which have not previously been examined with traditional&#xD;
      caring contacts. This research directly responds to the National Prioritized Research Agenda&#xD;
      for Suicide Prevention. This study directly supports RR&amp;D's mission and is aligned with VA's&#xD;
      2018-2028 National Strategy for Preventing Veteran Suicide. The investigators expect that&#xD;
      these data will inform best practices in suicide prevention and social recovery for Veterans&#xD;
      at risk for suicide.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 1, 2021</start_date>
  <completion_date type="Actual">November 30, 2022</completion_date>
  <primary_completion_date type="Actual">September 1, 2022</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <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.</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Feasibility</measure>
    <time_frame>Through study completion, an average of 2 years</time_frame>
    <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.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Intervention Satisfaction Questionnaire (Acceptability)</measure>
    <time_frame>Through study completion, an average of 2 years</time_frame>
    <description>Intervention Satisfaction Questionnaire will be collected from participants following intervention delivery to measure acceptability of the Caring Cards intervention.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Interpersonal Needs Questionnaire (INQ-12) Change from Baseline</measure>
    <time_frame>Change from baseline, an average of 9 months</time_frame>
    <description>At baseline and follow-up, Veterans will complete the INQ-12 to assess for thwarted belongingness and perceived burdensomeness.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Suicide Risk Change from Baseline</measure>
    <time_frame>Change from baseline, an average of 9 months</time_frame>
    <description>At baseline and follow-up, Veterans' suicide risk will be assessed.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>NIH Toolbox Adult Social Relationships Scales Change from Baseline</measure>
    <time_frame>Change from baseline, an average of 9 months</time_frame>
    <description>At baseline and follow-up, Veterans will complete the NIH Toolbox Adult Social Relationships Scales to assess social connectedness.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">80</enrollment>
  <condition>Feasibility</condition>
  <condition>Acceptability</condition>
  <condition>Thwarted Belongingness</condition>
  <condition>Perceived Burdensomeness</condition>
  <condition>Suicide Risk</condition>
  <condition>Social Connectedness</condition>
  <arm_group>
    <arm_group_label>Caring Cards Group</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Group of Veteran card-makers.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Caring Cards Recipients</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Group of Veteran card-recipients.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Caring Cards Group</intervention_name>
    <description>Group of Veteran card-makers.</description>
    <arm_group_label>Caring Cards Group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Caring Cards Recipients</intervention_name>
    <description>Group of Veteran card-recipients.</description>
    <arm_group_label>Caring Cards Recipients</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  For card-makers:&#xD;
&#xD;
               -  VA San Diego Healthcare System (VASDHS) Veteran with an inactive high-risk flag,&#xD;
&#xD;
               -  18 years of age or older,&#xD;
&#xD;
               -  access to transportation to attend the group (if held in person)&#xD;
&#xD;
               -  if groups are held remotely due to COVID-19, access to reliable technology and&#xD;
                  WiFi to participate via WebEx&#xD;
&#xD;
               -  decisional capacity.&#xD;
&#xD;
          -  For card-recipients:&#xD;
&#xD;
               -  VASDHS Veteran with an active high-risk flag,&#xD;
&#xD;
               -  18 years of age or older, and&#xD;
&#xD;
               -  decisional capacity.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        -For card-makers and recipients:&#xD;
&#xD;
          -  the absence of a mailing address or working phone number,&#xD;
&#xD;
          -  inability to read and writer in English, and&#xD;
&#xD;
          -  previous or current experience with Caring Cards.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Eric L Granholm, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>VA San Diego Healthcare System, San Diego, CA</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>VA San Diego Healthcare System, San Diego, CA</name>
      <address>
        <city>San Diego</city>
        <state>California</state>
        <zip>92161-0002</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>May 2023</verification_date>
  <study_first_submitted>June 29, 2020</study_first_submitted>
  <study_first_submitted_qc>July 21, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 24, 2020</study_first_posted>
  <last_update_submitted>May 2, 2023</last_update_submitted>
  <last_update_submitted_qc>May 2, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">May 6, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Veterans</keyword>
  <keyword>Suicide</keyword>
  <keyword>Thwarted belongingness</keyword>
  <keyword>Perceived burdensomeness</keyword>
  <keyword>Social connectedness</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Suicide</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_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_description>
    <ipd_info_type>Study Protocol</ipd_info_type>
    <ipd_info_type>Statistical Analysis Plan (SAP)</ipd_info_type>
    <ipd_info_type>Informed Consent Form (ICF)</ipd_info_type>
    <ipd_info_type>Clinical Study Report (CSR)</ipd_info_type>
    <ipd_info_type>Analytic Code</ipd_info_type>
    <ipd_time_frame>Beginning 3 months and ending 5 years following article publication.</ipd_time_frame>
    <ipd_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_access_criteria>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Informed Consent Form</document_type>
      <document_has_protocol>No</document_has_protocol>
      <document_has_icf>Yes</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>August 27, 2020</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/77/NCT04486677/ICF_000.pdf</document_url>
    </provided_document>
  </provided_document_section>
  <pending_results>
    <submitted>September 1, 2023</submitted>
  </pending_results>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT04486677
org study id: D3445-P
nct id: NCT04486677
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
is us export: No
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.
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.
primary purpose: Treatment
masking: None (Open Label)
measure: Feasibility
time frame: Through study completion, an average of 2 years
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.
measure: Intervention Satisfaction Questionnaire (Acceptability)
time frame: Through study completion, an average of 2 years
description: Intervention Satisfaction Questionnaire will be collected from participants following intervention delivery to measure acceptability of the Caring Cards intervention.
measure: Interpersonal Needs Questionnaire (INQ-12) Change from Baseline
time frame: Change from baseline, an average of 9 months
description: At baseline and follow-up, Veterans will complete the INQ-12 to assess for thwarted belongingness and perceived burdensomeness.
measure: Suicide Risk Change from Baseline
time frame: Change from baseline, an average of 9 months
description: At baseline and follow-up, Veterans' suicide risk will be assessed.
measure: NIH Toolbox Adult Social Relationships Scales Change from Baseline
time frame: Change from baseline, an average of 9 months
description: At baseline and follow-up, Veterans will complete the NIH Toolbox Adult Social Relationships Scales to assess social connectedness.
arm group label: Caring Cards Group
arm group type: Other
description: Group of Veteran card-makers.
arm group label: Caring Cards Recipients
arm group type: Other
description: Group of Veteran card-recipients.
intervention type: Behavioral
intervention name: Caring Cards Group
description: Group of Veteran card-makers.
arm group label: Caring Cards Group
intervention type: Behavioral
intervention name: Caring Cards Recipients
description: Group of Veteran card-recipients.
arm group label: Caring Cards Recipients
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: No
last name: Eric L Granholm, PhD
role: Principal Investigator
affiliation: VA San Diego Healthcare System, San Diego, CA
facility: 
country: United States
responsible party type: Sponsor
mesh term: Suicide
sharing ipd: Yes
ipd 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 info type: Study Protocol
ipd info type: Statistical Analysis Plan (SAP)
ipd info type: Informed Consent Form (ICF)
ipd info type: Clinical Study Report (CSR)
ipd info type: Analytic Code
ipd time frame: Beginning 3 months and ending 5 years following article publication.
ipd 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.
provided document: 
submitted: September 1, 2023