<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/NCT04409821</url>
  </required_header>
  <id_info>
    <org_study_id>P-2020-544</org_study_id>
    <secondary_id>0216-00030B</secondary_id>
    <nct_id>NCT04409821</nct_id>
  </id_info>
  <brief_title>Tele-based Psychological Emotional Support for Informal CARegivers of COVID-19 Patients in Intensive Care</brief_title>
  <acronym>CO-CarES</acronym>
  <official_title>COVID-19 Caregiver Emotional Support</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Rigshospitalet, Denmark</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Rigshospitalet, Denmark</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>
  </oversight_info>
  <brief_summary>
    <textblock>
      The experience of a loved one's stay in a COVID-19 intensive care unit (ICU), either&#xD;
      intubated or on respiratory support, forces family caregivers (hereafter 'caregivers') to&#xD;
      face core existential fears, such as uncertainty and death. It also poses a serious threat to&#xD;
      basic human needs for autonomy, competence, and relatedness, as family caregivers have no&#xD;
      control over the illness, and limited prior competence in dealing with critical illness.&#xD;
      COVID-19 likely aggravates this experience, as social distancing cuts caregivers off from&#xD;
      visiting patients in the ICU, from using their usual social supportive network and the threat&#xD;
      of infection extends to caregivers themselves, their children and family. Combined, these&#xD;
      extreme circumstances put caregivers in emotional turmoil and in need of psychological&#xD;
      support and assistance in managing difficult emotions. ICU caregivers are at risk of&#xD;
      developing clinically relevant symptoms of anxiety or posttraumatic stress. During the&#xD;
      patient's ICU stay, caregivers experience peri-traumatic distress, such as helplessness,&#xD;
      grief, frustration and anger, that may predict later posttraumatic stress disorder (PTSD).&#xD;
      Symptoms of anxiety and PTSD may last for months to years after the patient's discharge.&#xD;
      Further, caregivers of patients who die in an ICU may be at greater risk of prolonged grief&#xD;
      disorder. Supportive interventions may reduce psychological late effects in ICU caregivers,&#xD;
      but the primary focus of the majority of interventions has been on communication or surrogate&#xD;
      decision making. The CO-CarES study aims to develop and test the feasibility of a&#xD;
      tele-delivered psychological intervention to enable caregivers of ICU patients with COVID-19&#xD;
      to better endure the overwhelming uncertainty and emotional strain and reduce the risk of&#xD;
      posttraumatic stress and prolonged grief. The study hypothesizes that providing psychological&#xD;
      intervention during and after the patients' hospitalization, can decrease peri-traumatic&#xD;
      distress during ICU hospitalization and decrease risk of post-traumatic stress, anxiety,&#xD;
      depression and perceived stress following discharge, as well as prolonged grief in&#xD;
      bereavement. A secondary hypothesis is that changes in emotion regulation mediate effects of&#xD;
      the intervention on long-term psychological outcomes.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Active, not recruiting</overall_status>
  <start_date type="Actual">May 29, 2020</start_date>
  <completion_date type="Anticipated">February 2023</completion_date>
  <primary_completion_date type="Actual">May 31, 2022</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <intervention_model_description>Feasibility study</intervention_model_description>
    <primary_purpose>Supportive Care</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Recruitment rate</measure>
    <time_frame>At inclusion</time_frame>
    <description>Rate of consent among informed eligible participants</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Completion rate</measure>
    <time_frame>During and post-intervention (1 month)</time_frame>
    <description>Rates of completion of intervention sessions among participants</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Peri-traumatic distress inventory (negative emotions)</measure>
    <time_frame>Pre-post intervention (1 month after discharge/death)</time_frame>
    <description>Symptoms of peri-traumatic distress, min. score 0, max score 24, higher score corresponds to worse distress</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Impact of Events Scale (6 item)</measure>
    <time_frame>1 month post intervention</time_frame>
    <description>Posttraumatic stress, min. score 6, max score 24, higher score corresponds to worse distress</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Impact of Events Scale (6 item)</measure>
    <time_frame>6 months post intervention</time_frame>
    <description>Posttraumatic stress, min. score 6, max score 24, higher score corresponds to worse distress</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Impact of Events Scale (6 item)</measure>
    <time_frame>12/13 months post intervention</time_frame>
    <description>Posttraumatic stress, min. score 6, max score 24, higher score corresponds to worse distress</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Prolonged Grief-13-scale</measure>
    <time_frame>6 and 13 months</time_frame>
    <description>Prolonged Grief, scored according to diagnostic criteria for prolonged grief disorder</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>PROMIS Depression (8 item scale)</measure>
    <time_frame>Baseline to 1, 6, and 12/13 months</time_frame>
    <description>Symptoms of depression, min. score 8, max score 40, higher score corresponds to worse symptoms</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>PROMIS Anxiety (8 item scale)</measure>
    <time_frame>Baseline to 1, 6, and 12/13 months</time_frame>
    <description>Symptoms of anxiety, min. score 8, max score 40, higher score corresponds to worse symptoms</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Perceived Stress Scale (4 item)</measure>
    <time_frame>Baseline to 1, 6, and 12/13 months</time_frame>
    <description>Perceived stress, min. score 0, max score 16, higher score corresponds to worse stress</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Short Penn State Worry Questionnaire (3 items)</measure>
    <time_frame>Baseline to 1, 6, and 12/13 months</time_frame>
    <description>Worry, min. score 3, max score 15, higher score corresponds to greater worry</description>
  </other_outcome>
  <other_outcome>
    <measure>Brooding subscale of Ruminative Responses Scale</measure>
    <time_frame>Baseline to 1, 6, and 12/13 months</time_frame>
    <description>Brooding, min. score 5, max score 20, higher score corresponds to greater brooding/rumination</description>
  </other_outcome>
  <other_outcome>
    <measure>Intolerance of uncertainty Scale (2 item)</measure>
    <time_frame>Baseline to 1, 6, and 12/13 months</time_frame>
    <description>Intolerance of uncertainty, min score 2, max score 8, greater score indicates greater uncertainty intolerance</description>
  </other_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">50</enrollment>
  <condition>Posttraumatic Stress Disorder</condition>
  <condition>Prolonged Grief Disorder</condition>
  <condition>COVID</condition>
  <arm_group>
    <arm_group_label>Tele-delivered psychological intervention</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Weekly tele-delivered psychological intervention</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Tele-delivered psychological intervention</intervention_name>
    <description>The intervention consists of two (or one, if preferred by caregivers) weekly tele-sessions during the ICU stay, lasting up to 30 minutes, and two sessions in the month after discharge from or death in the ICU. Sessions will be conducted via phone-calls or video-conferencing. Therapists will 1) validate caregivers' subjective experience, 2) normalize and psychoeducate about emotional reactions, and 3) offer emotion regulation drawing on contemporary cognitive treatment packages of decentering, acceptance and emotion tolerance. Sessions for bereaved caregivers will include psycho-education about grief, assessment of risk for adverse outcomes and information about available support, if needed. The intervention will be performed based on an intervention manual. The content of the intervention will be continually adapted and tailored to the needs of the participating caregivers by involving all caregivers in co-creating the intervention trough brief post-session interviews.</description>
    <arm_group_label>Tele-delivered psychological intervention</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  close relatives or friends of a patient hospitalized in an intensive care or&#xD;
             intermediary care wards with COVID-19&#xD;
&#xD;
          -  capable of completing online questionnaires&#xD;
&#xD;
          -  speak Danish sufficiently for a therapeutic dialogue&#xD;
&#xD;
          -  provide informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  suffering from a severe psychiatric disorder (such as schizophrenia) or in ongoing&#xD;
             psychotherapeutic treatment for a psychiatric disorder (such as major depression&#xD;
             generalized anxiety disorder or others), that cannot be paused&#xD;
&#xD;
          -  unable to complete verbal phone- or videoconferencing calls&#xD;
&#xD;
          -  unable to complete electronic questionnaires&#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>Annika von Heymann, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Department of Oncology, Rigshospitalet, Denmark</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Skejby Hospital</name>
      <address>
        <city>Aarhus</city>
        <country>Denmark</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Rigshospitalet</name>
      <address>
        <city>Copenhagen</city>
        <zip>2100</zip>
        <country>Denmark</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospitalsenheden Vest, Horsens</name>
      <address>
        <city>Horsens</city>
        <country>Denmark</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hvidovre Hospital</name>
      <address>
        <city>Hvidovre</city>
        <country>Denmark</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Sygehus Lillebælt, Kolding</name>
      <address>
        <city>Kolding</city>
        <country>Denmark</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Odense University Hospital</name>
      <address>
        <city>Odense</city>
        <country>Denmark</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Denmark</country>
  </location_countries>
  <verification_date>October 2022</verification_date>
  <study_first_submitted>May 22, 2020</study_first_submitted>
  <study_first_submitted_qc>May 28, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 1, 2020</study_first_posted>
  <last_update_submitted>October 27, 2022</last_update_submitted>
  <last_update_submitted_qc>October 27, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">October 28, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Rigshospitalet, Denmark</investigator_affiliation>
    <investigator_full_name>Annika von Heymann</investigator_full_name>
    <investigator_title>Postdoc</investigator_title>
  </responsible_party>
  <keyword>Informal caregiver</keyword>
  <keyword>COVID-19</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>COVID-19</mesh_term>
    <mesh_term>Stress Disorders, Post-Traumatic</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- 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/NCT04409821
org study id: P-2020-544
secondary id: 0216-00030B
nct id: NCT04409821
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The experience of a loved one's stay in a COVID-19 intensive care unit (ICU), either
      intubated or on respiratory support, forces family caregivers (hereafter 'caregivers') to
      face core existential fears, such as uncertainty and death. It also poses a serious threat to
      basic human needs for autonomy, competence, and relatedness, as family caregivers have no
      control over the illness, and limited prior competence in dealing with critical illness.
      COVID-19 likely aggravates this experience, as social distancing cuts caregivers off from
      visiting patients in the ICU, from using their usual social supportive network and the threat
      of infection extends to caregivers themselves, their children and family. Combined, these
      extreme circumstances put caregivers in emotional turmoil and in need of psychological
      support and assistance in managing difficult emotions. ICU caregivers are at risk of
      developing clinically relevant symptoms of anxiety or posttraumatic stress. During the
      patient's ICU stay, caregivers experience peri-traumatic distress, such as helplessness,
      grief, frustration and anger, that may predict later posttraumatic stress disorder (PTSD).
      Symptoms of anxiety and PTSD may last for months to years after the patient's discharge.
      Further, caregivers of patients who die in an ICU may be at greater risk of prolonged grief
      disorder. Supportive interventions may reduce psychological late effects in ICU caregivers,
      but the primary focus of the majority of interventions has been on communication or surrogate
      decision making. The CO-CarES study aims to develop and test the feasibility of a
      tele-delivered psychological intervention to enable caregivers of ICU patients with COVID-19
      to better endure the overwhelming uncertainty and emotional strain and reduce the risk of
      posttraumatic stress and prolonged grief. The study hypothesizes that providing psychological
      intervention during and after the patients' hospitalization, can decrease peri-traumatic
      distress during ICU hospitalization and decrease risk of post-traumatic stress, anxiety,
      depression and perceived stress following discharge, as well as prolonged grief in
      bereavement. A secondary hypothesis is that changes in emotion regulation mediate effects of
      the intervention on long-term psychological outcomes.
allocation: N/A
intervention model: Single Group Assignment
intervention model description: Feasibility study
primary purpose: Supportive Care
masking: None (Open Label)
measure: Recruitment rate
time frame: At inclusion
description: Rate of consent among informed eligible participants
measure: Completion rate
time frame: During and post-intervention (1 month)
description: Rates of completion of intervention sessions among participants
measure: Peri-traumatic distress inventory (negative emotions)
time frame: Pre-post intervention (1 month after discharge/death)
description: Symptoms of peri-traumatic distress, min. score 0, max score 24, higher score corresponds to worse distress
measure: Impact of Events Scale (6 item)
time frame: 1 month post intervention
description: Posttraumatic stress, min. score 6, max score 24, higher score corresponds to worse distress
measure: Impact of Events Scale (6 item)
time frame: 6 months post intervention
description: Posttraumatic stress, min. score 6, max score 24, higher score corresponds to worse distress
measure: Impact of Events Scale (6 item)
time frame: 12/13 months post intervention
description: Posttraumatic stress, min. score 6, max score 24, higher score corresponds to worse distress
measure: Prolonged Grief-13-scale
time frame: 6 and 13 months
description: Prolonged Grief, scored according to diagnostic criteria for prolonged grief disorder
measure: PROMIS Depression (8 item scale)
time frame: Baseline to 1, 6, and 12/13 months
description: Symptoms of depression, min. score 8, max score 40, higher score corresponds to worse symptoms
measure: PROMIS Anxiety (8 item scale)
time frame: Baseline to 1, 6, and 12/13 months
description: Symptoms of anxiety, min. score 8, max score 40, higher score corresponds to worse symptoms
measure: Perceived Stress Scale (4 item)
time frame: Baseline to 1, 6, and 12/13 months
description: Perceived stress, min. score 0, max score 16, higher score corresponds to worse stress
measure: Short Penn State Worry Questionnaire (3 items)
time frame: Baseline to 1, 6, and 12/13 months
description: Worry, min. score 3, max score 15, higher score corresponds to greater worry
measure: Brooding subscale of Ruminative Responses Scale
time frame: Baseline to 1, 6, and 12/13 months
description: Brooding, min. score 5, max score 20, higher score corresponds to greater brooding/rumination
measure: Intolerance of uncertainty Scale (2 item)
time frame: Baseline to 1, 6, and 12/13 months
description: Intolerance of uncertainty, min score 2, max score 8, greater score indicates greater uncertainty intolerance
arm group label: Tele-delivered psychological intervention
arm group type: Experimental
description: Weekly tele-delivered psychological intervention
intervention type: Behavioral
intervention name: Tele-delivered psychological intervention
description: The intervention consists of two (or one, if preferred by caregivers) weekly tele-sessions during the ICU stay, lasting up to 30 minutes, and two sessions in the month after discharge from or death in the ICU. Sessions will be conducted via phone-calls or video-conferencing. Therapists will 1) validate caregivers' subjective experience, 2) normalize and psychoeducate about emotional reactions, and 3) offer emotion regulation drawing on contemporary cognitive treatment packages of decentering, acceptance and emotion tolerance. Sessions for bereaved caregivers will include psycho-education about grief, assessment of risk for adverse outcomes and information about available support, if needed. The intervention will be performed based on an intervention manual. The content of the intervention will be continually adapted and tailored to the needs of the participating caregivers by involving all caregivers in co-creating the intervention trough brief post-session interviews.
arm group label: Tele-delivered psychological intervention
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Annika von Heymann, PhD
role: Principal Investigator
affiliation: Department of Oncology, Rigshospitalet, Denmark
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
country: Denmark
responsible party type: Principal Investigator
investigator affiliation: Rigshospitalet, Denmark
investigator full name: Annika von Heymann
investigator title: Postdoc
mesh term: COVID-19
mesh term: Stress Disorders, Post-Traumatic
sharing ipd: No