<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/NCT04456062</url>
  </required_header>
  <id_info>
    <org_study_id>1804</org_study_id>
    <nct_id>NCT04456062</nct_id>
  </id_info>
  <brief_title>Using Caring Contacts to Reduce Psychiatric Morbidity Following Hospitalization During the COVID-19 Pandemic</brief_title>
  <official_title>Using Caring Contacts to Reduce Psychiatric Morbidity Following Hospitalization During the COVID-19 Pandemic</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Sunnybrook Health Sciences Centre</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Sunnybrook Health Sciences Centre</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Subjects will be recently discharged patients from Sunnybrook Inpatient Psychiatry Unit.&#xD;
      Subjects will be randomized in a 1:1 ratio to either the Caring Contact intervention or usual&#xD;
      care. 75 subjects will be enrolled in each arm. In additional to usual discharge-related&#xD;
      care, subjects in the caring contact group will receive brief emails that convey a message of&#xD;
      hope and provide resources. These emails will be sent on days 4, 21, and 56 post-discharge.&#xD;
      The specific content of these emails will be pre-determined varying slightly by time point.&#xD;
      In contrast, the control group will only receive usual discharge-related care, including&#xD;
      discharge planning and also a sheet of resources normally provided to patients. A widely used&#xD;
      and validated measure will be employed to assess depression and anxiety symptoms. The 25-item&#xD;
      self-report Hopkins Symptom Checklist will be emailed to all subjects at baseline, day 4, 21,&#xD;
      and 56 post-discharge, along with the Caring Contact communication. It is hypothesized that&#xD;
      there will be a significantly greater reduction in mental health symptoms among patients&#xD;
      receiving Caring Contacts compared to those who receive usual care.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">August 4, 2020</start_date>
  <completion_date type="Actual">July 31, 2021</completion_date>
  <primary_completion_date type="Actual">July 31, 2021</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Health Services Research</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Hopkins Symptom Checklist-25 (HSCL-25)</measure>
    <time_frame>Baseline, day 4, day 21, day 56 post-discharge</time_frame>
    <description>The HSCL-25 is a widely-used and validated self-report questionnaire using a Likert scale to measure symptoms of anxiety and depression. Change scores in anxiety and depression will be used to assess effectiveness of intervention.</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">102</enrollment>
  <condition>Psychiatric Hospitalization</condition>
  <arm_group>
    <arm_group_label>Caring Contacts Group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Standard Treatment Group</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Caring Contacts</intervention_name>
    <description>Caring Contacts are brief email communications sent to the patient post-discharge. They convey messages of hope, support, promote a sense of belonging, and provide information on resources for care. They are not written uniquely for each patient but are purposefully crafted to intervene on those specific vulnerabilities that form the core of many patients' experiences with intense emotional distress and suicidal thoughts.</description>
    <arm_group_label>Caring Contacts Group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Provision of written informed consent&#xD;
&#xD;
          -  Inpatient status in Sunnybrook Inpatient Psychiatry Unit at time of recruitment&#xD;
&#xD;
          -  Have an email or mailing address&#xD;
&#xD;
          -  Ability to read and understand English&#xD;
&#xD;
          -  The ability to understand and comply with the requirements of the study and capable of&#xD;
             providing informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  A primary Major Neurocognitive Disorder diagnosis&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Ayal Schaffer, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Sunnybrook Health Sciences Centre</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Rosalie Steinberg, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Sunnybrook Health Sciences Centre</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Sunnybrook Health Sciences Centre</name>
      <address>
        <city>Toronto</city>
        <state>Ontario</state>
        <zip>M4N 3M5</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Canada</country>
  </location_countries>
  <verification_date>August 2022</verification_date>
  <study_first_submitted>June 30, 2020</study_first_submitted>
  <study_first_submitted_qc>June 30, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 2, 2020</study_first_posted>
  <last_update_submitted>August 23, 2022</last_update_submitted>
  <last_update_submitted_qc>August 23, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">August 24, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Sunnybrook Health Sciences Centre</investigator_affiliation>
    <investigator_full_name>Dr. Ayal Schaffer</investigator_full_name>
    <investigator_title>Staff Psychiatrist</investigator_title>
  </responsible_party>
  <keyword>Caring Contacts</keyword>
  <keyword>Suicide Prevention</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>COVID-19</mesh_term>
  </condition_browse>
  <!-- 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/NCT04456062
org study id: 1804
nct id: NCT04456062
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
Subjects will be recently discharged patients from Sunnybrook Inpatient Psychiatry Unit.
      Subjects will be randomized in a 1:1 ratio to either the Caring Contact intervention or usual
      care. 75 subjects will be enrolled in each arm. In additional to usual discharge-related
      care, subjects in the caring contact group will receive brief emails that convey a message of
      hope and provide resources. These emails will be sent on days 4, 21, and 56 post-discharge.
      The specific content of these emails will be pre-determined varying slightly by time point.
      In contrast, the control group will only receive usual discharge-related care, including
      discharge planning and also a sheet of resources normally provided to patients. A widely used
      and validated measure will be employed to assess depression and anxiety symptoms. The 25-item
      self-report Hopkins Symptom Checklist will be emailed to all subjects at baseline, day 4, 21,
      and 56 post-discharge, along with the Caring Contact communication. It is hypothesized that
      there will be a significantly greater reduction in mental health symptoms among patients
      receiving Caring Contacts compared to those who receive usual care.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Health Services Research
masking: None (Open Label)
measure: Hopkins Symptom Checklist-25 (HSCL-25)
time frame: Baseline, day 4, day 21, day 56 post-discharge
description: The HSCL-25 is a widely-used and validated self-report questionnaire using a Likert scale to measure symptoms of anxiety and depression. Change scores in anxiety and depression will be used to assess effectiveness of intervention.
arm group label: Caring Contacts Group
arm group type: Experimental
arm group label: Standard Treatment Group
arm group type: No Intervention
intervention type: Other
intervention name: Caring Contacts
description: Caring Contacts are brief email communications sent to the patient post-discharge. They convey messages of hope, support, promote a sense of belonging, and provide information on resources for care. They are not written uniquely for each patient but are purposefully crafted to intervene on those specific vulnerabilities that form the core of many patients' experiences with intense emotional distress and suicidal thoughts.
arm group label: Caring Contacts Group
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Ayal Schaffer, MD
role: Principal Investigator
affiliation: Sunnybrook Health Sciences Centre
last name: Rosalie Steinberg, MD
role: Principal Investigator
affiliation: Sunnybrook Health Sciences Centre
facility: 
country: Canada
responsible party type: Principal Investigator
investigator affiliation: Sunnybrook Health Sciences Centre
investigator full name: Dr. Ayal Schaffer
investigator title: Staff Psychiatrist
mesh term: COVID-19