<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/NCT04501445</url>
  </required_header>
  <id_info>
    <org_study_id>20071101</org_study_id>
    <nct_id>NCT04501445</nct_id>
  </id_info>
  <brief_title>Psychological Symptoms and Families of COVID-19 Patients</brief_title>
  <official_title>Relieving the Burden of Psychological Symptoms Among Families of Critically Ill Patients With COVID-19</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Rush University Medical Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Central Michigan University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Rush University Medical Center</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>
      Families of patients in Intensive Care Units (ICUs) are at increased risk for developing&#xD;
      psychological symptoms that can last for months after the patient is discharged. These&#xD;
      symptoms can have significant impact on both the patient and family member's quality of life.&#xD;
&#xD;
      The investigators have found that families of patients admitted to the Rush University&#xD;
      Medical Center ICU during to the COVID-19 pandemic were more likely to develop clinically&#xD;
      significant psychological symptoms than families of patients admitted prior to the COVID-19&#xD;
      pandemic. The investigators suspect that this finding is due in part to the hospital-wide no&#xD;
      visitation policy that altered our standard communication practices and may have prevented&#xD;
      families from being active participants in the patient's medical care.&#xD;
&#xD;
      The goals of this project are 1) to determine the prevalence of psychological disorders among&#xD;
      families of COVID-19 patients after ICU discharge 2) to determine the characteristics of ICU&#xD;
      care that were associated with the development of psychological disorders among family&#xD;
      members and 3) to pilot a program in which families with psychological disorders after ICU&#xD;
      discharge receive therapy from mental health professionals.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Part 1- Post-ICU discharge survey and Interview Upon enrollment in this post-ICU discharge&#xD;
      follow-up study, the subject (surrogate of the ICU patient) will complete a survey dealing&#xD;
      with the patient's course since Rush discharge&#xD;
&#xD;
        1. Is the patient still alive?&#xD;
&#xD;
             1. If deceased, did the patient pass away at Rush or after discharge from Rush?&#xD;
&#xD;
             2. If alive, is the patient at home?&#xD;
&#xD;
           i. If at home, for how long? Is he/she receiving home health services?&#xD;
&#xD;
        2. If the patient did not pass away at Rush, did the patient spend time in a rehabilitation&#xD;
           hospital, nursing home, or long-term acute care hospital after discharge from Rush?&#xD;
&#xD;
        3. Is the patient currently having any of the following symptoms (check all that apply).&#xD;
&#xD;
             1. Fatigue&#xD;
&#xD;
             2. Trouble Breathing&#xD;
&#xD;
             3. Difficulty speaking&#xD;
&#xD;
             4. Difficulty eating&#xD;
&#xD;
             5. Difficulty thinking or paying attention&#xD;
&#xD;
             6. Pain or discomfort&#xD;
&#xD;
             7. Anxiety&#xD;
&#xD;
             8. Depressed mood&#xD;
&#xD;
             9. Difficulty moving or walking&#xD;
&#xD;
            10. Difficulty performing activities of daily living such as dressing or bathing&#xD;
&#xD;
        4. Have the subject used mental health services since the time the patient was admitted?&#xD;
&#xD;
        5. What is the subject's overall impression of mental health services (choices ranging from&#xD;
           very unhelpful to very helpful)&#xD;
&#xD;
      Subjects will be asked to complete the 1) Critical Care Family Needs Inventory (CCFNI)&#xD;
      questionnaire, 2) Hospital Anxiety and Depression Scale (HADS), and 3) Impact of Events Scale&#xD;
      Revised (IES-R) questionnaire.&#xD;
&#xD;
      Subjects will participate in a 30-minute phone interview with a member of the study team. The&#xD;
      interviewer will review the subject's responses to the above surveys and ask follow-up&#xD;
      questions. The interviewer will ask how the subject has been coping with any psychological&#xD;
      symptoms (i.e. anxiety, depression, post-traumatic stress)&#xD;
&#xD;
      The psychologist will describe different types of interventions for people coping&#xD;
      psychological symptoms and assess the subject's interest in pursuing any of them.&#xD;
&#xD;
      Part 2 - Post-ICU psychological intervention Subjects with clinically significant&#xD;
      psychologist symptoms based on either their survey or interview responses will be invited to&#xD;
      participate in 6-week trauma-focused intervention with a psychologist.&#xD;
&#xD;
      The program will be brief and delivered online to test the acceptability and feasible of the&#xD;
      program, and to gather a preliminary estimate of effect size. We will pilot a group-based&#xD;
      intervention (n =3-5) online over Zoom and deliver the intervention across six sessions&#xD;
      outlined below. Sessions will last 60-75 minutes depending on participant questions and&#xD;
      discussion. Experiential exercises will be drawn from Acceptance and Commitment Therapy, a&#xD;
      related contemporary cognitive behavioral treatment (Hayes, Strosahl, &amp; Wilson, 2012). Some&#xD;
      commentary of Viktor Frankl's (1985) work on meaning making will be made in group discussion.&#xD;
      Activity scheduling worksheets from Martell, Dimijian and Herman-Dunn (2013) will be used for&#xD;
      out of session homework.&#xD;
&#xD;
      We plan two phases for the study. The first phase, sessions 1-3, focus on introducing the&#xD;
      model of behavioral activation and guide the participants to identify activities that will&#xD;
      being pleasant, meaningful, or offer a sense of accomplishment and mastery. The first session&#xD;
      aims to normalize diverse responses to health-related stress and loss by introducing the&#xD;
      behavioral model of depression, and the rationale for behavioral activation. In the second&#xD;
      session participants then clarify their values, so that they can begin scheduling pleasant&#xD;
      and/or meaningful activities in the third session. These activities are tailored based on&#xD;
      each participant's individuals goals, priorities and values. The second phase, sessions 4-6,&#xD;
      aims to reinforce and sustain positive gains made via behavioral activation and pleasant&#xD;
      activity scheduling. Session 4 offers suggestions for problem-solving ways to overcome&#xD;
      unhelpful avoidance, a transdiagnostic vulnerability that sustains a number of emotional and&#xD;
      psychiatric disorders. Session 5 offers suggestions for overcoming rumination including&#xD;
      instruction in mindfulness, and attentional techniques that help participants attend to the&#xD;
      outcomes and experiences of the pleasant activities they engage in. Session 6 concludes the&#xD;
      program, and guides participants to consider plans to maintain commitment to pleasant&#xD;
      activities.&#xD;
&#xD;
      Session 1 Psychoeducation Introductions. Question to group: Why are we here?&#xD;
&#xD;
        -  Normalize the grieving process and the challenges of COVID safety guidelines&#xD;
&#xD;
             -  grief, boredom, loneliness&#xD;
&#xD;
             -  1/3 of USA adults report depression and anxiety&#xD;
&#xD;
        -  Discuss the behavioral model of depression - loss of reward and meaningful events as a&#xD;
           prelude to negative moods of all types&#xD;
&#xD;
        -  Behavioral Activation as a strategy to enhance reward and meaning&#xD;
&#xD;
        -  Experiential: Contemplate a time in life when you felt you were doing well. How were you&#xD;
           engaging the world around you?&#xD;
&#xD;
        -  Homework: Start Activity tracking. Worksheets will be provided, but we allow a more&#xD;
           feasible approach of jotting down 1-2 words about activity and providing a subjective&#xD;
           mood rating.&#xD;
&#xD;
      Session 2 Value Clarification Question to the group: How do we bring purpose into our living?&#xD;
&#xD;
        -  Consider values as the foundation of meaning and purpose&#xD;
&#xD;
        -  Discuss meaning in life and Dr. Viktor Frankl's thesis that humans are driven to find&#xD;
           meaning&#xD;
&#xD;
           o &quot;We do not ask life what the meaning of life is. Life asks us, what is the meaning of&#xD;
           your life. And life demands our answer.&quot;&#xD;
&#xD;
        -  What gives/gave meaning to your loved one's life? What would make them smile? If you&#xD;
           share values with this person, how can you honor those values you share in your own&#xD;
           commitments and activities?&#xD;
&#xD;
        -  Experiential: Contemplate your 80th Birthday, Retirement Speech, family remembering you&#xD;
           far in the future, etc, Homework: Values Compass. Participants will complete the values&#xD;
           compass worksheet in which they rate their perceived importance and engagement in&#xD;
           various domains of living (e.g, family life, learning, spirituality).&#xD;
&#xD;
      Session 3 Scheduling Activities Question to group: What does it mean to be committed?&#xD;
&#xD;
        -  Discuss a role model or mentor who demonstrated commitment to something important. How&#xD;
           did they do it? Do they share values with the patient they care(d) for? How do these&#xD;
&#xD;
        -  Selecting and scheduling pleasant events. Regardless of how you feel, take action to&#xD;
           experience:&#xD;
&#xD;
             -  Pleasure&#xD;
&#xD;
             -  Mastery&#xD;
&#xD;
             -  Purpose&#xD;
&#xD;
             -  Health habits: steady sleep, diet, exercise&#xD;
&#xD;
        -  Experiential: Participants visualize, write or discuss steps needed to engage a plan.&#xD;
           Visualize yourself overcoming a roadblock or barrier.&#xD;
&#xD;
        -  Homework: Activity Schedule. Participants will schedule several pleasant/meaningful&#xD;
           events for the coming week. They will rate their mood while engaged in these activities&#xD;
           and journal about their experiences.&#xD;
&#xD;
      Session 4 Overcoming Avoidance What do we do with fear?&#xD;
&#xD;
        -  Getting out of the TRAP (Trigger-Response-Avoidance Pattern) to get on Track (Trigger&#xD;
           Response Adaptive Coping)&#xD;
&#xD;
        -  Often we hurt when something that matters is threatened. We should protect what matters&#xD;
           not the momentary feeling. Discuss &quot;fear as an arrow&quot; that can be useful for pointing to&#xD;
           ones values (e.g., we typically do not fear losing things we do not care about).&#xD;
&#xD;
        -  Experiential: Flipping the coins of avoidance. Participants look to how fears, and&#xD;
           frustrations relate to other prosocial and personally valued events and experiences.&#xD;
&#xD;
        -  Homework: Activity Schedule. This repeats the homework from the prior week.&#xD;
&#xD;
      Session 5 Working with thoughts Question to the group: How do we prevent going on autopilot&#xD;
      so we stay focused on what matters?&#xD;
&#xD;
        -  Staying present to notice when actions are working. Being better at tracking outcomes.&#xD;
&#xD;
        -  Mindfulness versus rumination&#xD;
&#xD;
        -  Experiential: Mindfulness of the present. Participants are guided in a mindfulness&#xD;
           exercise to attend to sense experiences in the present moment. The goal of the exercise&#xD;
           is to introduce a skill for re-orienting to the present moment. This is particularly&#xD;
           needed for attending to and noticing the pleasant and meaningful experiences that come&#xD;
           from behavioral activation.&#xD;
&#xD;
        -  Homework: Activity Schedule Session 6 Recap and review Question to the group: How do we&#xD;
           carry these lessons with us? How do we share these lessons with others?&#xD;
&#xD;
        -  The goal of this session is to review and to provide additional practice with any of the&#xD;
           prior skills discussed in previous sessions.&#xD;
&#xD;
        -  Relapse prevention concepts will be discussed. Participants will be encouraged to&#xD;
           continue to maintain pleasant activity scheduling, and to consider how these activities&#xD;
           can be reinforced through social commitments, and daily reflection.&#xD;
&#xD;
        -  Consider making a symbol. Picture, photo, card, note to self to remind oneself of a&#xD;
           valued activity. This can be displayed in a prominent place (e.g., family photo on the&#xD;
           mantle, photo of exercise on bathroom mirror, religious text on coffee table). Should&#xD;
           evoke pleasant memory, and motivation.&#xD;
&#xD;
      Prior to beginning the intervention and at the completion of the intervention, surrogates&#xD;
      will complete the 1) Hospital Anxiety and Depression Scale (HADS), and 2) Impact of Events&#xD;
      Scale Revised (IES-R) questionnaire.&#xD;
&#xD;
      At the completion of the intervention, subjects will participate in another 30-minute phone&#xD;
      interview with a study investigator. The study investigator will review the subject's&#xD;
      responses to the above surveys and ask follow-up questions. The study investigator will ask&#xD;
      how the subject has been coping with any psychological symptoms (i.e. anxiety, depression,&#xD;
      post-traumatic stress).&#xD;
&#xD;
      All interviews will be audio recorded and transcribed. Two members study staff will review&#xD;
      the transcriptions and use thematic content analysis to determine the types of psychological&#xD;
      symptoms that are present and the reason(s) they may be present.&#xD;
&#xD;
      When analyzing subject responses, the investigators will account for the following variables&#xD;
&#xD;
        -  Whether the patient is deceased or not&#xD;
&#xD;
        -  Length of time since hospital discharge&#xD;
&#xD;
        -  Whether the subject received mental health services on their own or not&#xD;
&#xD;
        -  Whether the subject received daily written summaries in the ICU or not&#xD;
&#xD;
      Statistical Analysis The investigators expect ~100 subjects to meet inclusion criteria. The&#xD;
      investigators expect ~70-100 to complete Part 1 (Post-ICU discharge survey and Interview).&#xD;
      The investigators will determine the prevalence of psychological symptoms and opinions on ICU&#xD;
      care by reviewing survey responses and interview recordings. The investigators expect ~30 to&#xD;
      complete Part 2 (Post-ICU discharge survey and Interview). The investigators compare pre- to&#xD;
      post-intervention survey responses for each subject using a paired t-test. Part 2 will be&#xD;
      considered a pilot study. The investigators will use the results to plan a future, adequately&#xD;
      powered study.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">September 14, 2020</start_date>
  <completion_date type="Actual">July 31, 2021</completion_date>
  <primary_completion_date type="Actual">April 8, 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>Supportive Care</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Symptoms of Post-Traumatic Stress Disorder (PTSD) Initial</measure>
    <time_frame>Measured once upon enrollment</time_frame>
    <description>Score on Impact of Events Scale Revised (IES-R) questionnaire. 22 questions. Score 0-88 with higher scores indicating more stress.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Symptoms of Anxiety and Depression Initial</measure>
    <time_frame>Measured once upon enrollment</time_frame>
    <description>Score on Hospital Anxiety and Depression Scale (HADS). Total score 0-21 for anxiety (7 questions) and 0-21 for depression (7 questions). Higher scores indicate greater symptom burden.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Surrogate Satisfaction With the Patient's ICU Care:</measure>
    <time_frame>Measured once upon enrollment</time_frame>
    <description>Score on the Critical Care Family Needs Inventory (CCFNI) questionnaire. 14 questions. Total score range 14-56 with lower scores indicating better satisfaction.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Symptoms of Post-Traumatic Stress Disorder (PTSD) Final</measure>
    <time_frame>Measured before behavioral intervention (6-12 weeks after enrollment)</time_frame>
    <description>IES-R score before intervention&#xD;
The IES-R yields a total score (ranging from 0 to 88) with higher scores indicative of more severe PTSD</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Symptoms of Post-Traumatic Stress Disorder (PTSD) Final</measure>
    <time_frame>Measured after behavioral intervention (12-24 weeks after enrollment)</time_frame>
    <description>IES-R after intervention&#xD;
The IES-R yields a total score (ranging from 0 to 88) with higher scores indicative of more severe PTSD</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Symptoms of Anxiety and Depression Final</measure>
    <time_frame>Measured before behavioral intervention (6-12 weeks after enrollment)</time_frame>
    <description>Score on Hospital Anxiety and Depression Scale (HADS). Total score 0-21 for anxiety (7 questions) and 0-21 for depression (7 questions). Higher scores indicate greater symptom burden.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Symptoms of Anxiety and Depression Final</measure>
    <time_frame>Measured after behavioral intervention (12-24 weeks after enrollment)</time_frame>
    <description>Score on Hospital Anxiety and Depression Scale (HADS). Total score 0-21 for anxiety (7 questions) and 0-21 for depression (7 questions). Higher scores indicate greater symptom burden.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Interview Initial</measure>
    <time_frame>Measured once upon enrollment</time_frame>
    <description>Qualitative analysis of phone interview to determine the presence and reason(s) for psychological symptoms</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Interview Final</measure>
    <time_frame>Measured after behavioral intervention (12-24 weeks after enrollment)</time_frame>
    <description>Qualitative analysis of phone interview to determine the presence and reason(s) for psychological symptoms</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">90</enrollment>
  <condition>Family Members</condition>
  <condition>Post Intensive Care Unit Syndrome</condition>
  <condition>Post Traumatic Stress Disorder</condition>
  <arm_group>
    <arm_group_label>Rounding Summary</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Surrogates who were assigned to the intervention group received a written rounding summary every day or every other day that the patient is in the ICU.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Usual Care</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Written Summary of Rounds</intervention_name>
    <description>The summary was organized as follows for each of the most important ICU problems: 1) Description of the problem, 2) Ways the ICU team is addressing the problem i.e. consultations, diagnostic tests, and treatments. 3) An assessment of whether the problem is improving or worsening.</description>
    <arm_group_label>Rounding Summary</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  The patient's surrogate was enrolled in &quot;ICU Rounding Summaries for Families of&#xD;
             Critically Ill Patients&quot; (NCT03969810) and the patient had COVID-19&#xD;
&#xD;
          -  The patient has been discharged from the hospital&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        - None&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Rush University Medical Center</name>
      <address>
        <city>Chicago</city>
        <state>Illinois</state>
        <zip>60612</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <reference>
    <citation>Davidson JE, Jones C, Bienvenu OJ. Family response to critical illness: postintensive care syndrome-family. Crit Care Med. 2012 Feb;40(2):618-24. doi: 10.1097/CCM.0b013e318236ebf9.</citation>
    <PMID>22080636</PMID>
  </reference>
  <reference>
    <citation>Nelson JE, Hanson LC, Keller KL, Carson SS, Cox CE, Tulsky JA, White DB, Chai EJ, Weiss SP, Danis M. The Voice of Surrogate Decision-Makers. Family Responses to Prognostic Information in Chronic Critical Illness. Am J Respir Crit Care Med. 2017 Oct 1;196(7):864-872. doi: 10.1164/rccm.201701-0201OC.</citation>
    <PMID>28387538</PMID>
  </reference>
  <reference>
    <citation>Davidson JE, Aslakson RA, Long AC, Puntillo KA, Kross EK, Hart J, Cox CE, Wunsch H, Wickline MA, Nunnally ME, Netzer G, Kentish-Barnes N, Sprung CL, Hartog CS, Coombs M, Gerritsen RT, Hopkins RO, Franck LS, Skrobik Y, Kon AA, Scruth EA, Harvey MA, Lewis-Newby M, White DB, Swoboda SM, Cooke CR, Levy MM, Azoulay E, Curtis JR. Guidelines for Family-Centered Care in the Neonatal, Pediatric, and Adult ICU. Crit Care Med. 2017 Jan;45(1):103-128. doi: 10.1097/CCM.0000000000002169.</citation>
    <PMID>27984278</PMID>
  </reference>
  <verification_date>July 2022</verification_date>
  <study_first_submitted>August 4, 2020</study_first_submitted>
  <study_first_submitted_qc>August 5, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">August 6, 2020</study_first_posted>
  <results_first_submitted>February 3, 2022</results_first_submitted>
  <results_first_submitted_qc>July 5, 2022</results_first_submitted_qc>
  <results_first_posted type="Actual">April 27, 2023</results_first_posted>
  <last_update_submitted>July 5, 2022</last_update_submitted>
  <last_update_submitted_qc>July 5, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">April 27, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Stress Disorders, Traumatic</mesh_term>
    <mesh_term>Stress Disorders, Post-Traumatic</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol and Statistical Analysis Plan</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>December 16, 2020</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/45/NCT04501445/Prot_SAP_000.pdf</document_url>
    </provided_document>
    <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 17, 2020</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/45/NCT04501445/ICF_001.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <recruitment_details>Subjects who completed surveys after ICU discharge</recruitment_details>
      <group_list>
        <group group_id="P1">
          <title>Surveyed After ICU Discharge</title>
          <description>Surveyed after ICU discharge</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="90"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="90"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Surveyed After ICU Discharge</title>
          <description>Surveyed after ICU discharge</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="90"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>&lt;=18 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Between 18 and 65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="84"/>
                  </measurement_list>
                </category>
                <category>
                  <title>&gt;=65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="49" spread="12"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="72"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="18"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Ethnicity (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="49"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="40"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>American Indian or Alaska Native</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Native Hawaiian or Other Pacific Islander</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="18"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="14"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="58"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>United States</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="90"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Symptoms of Post-Traumatic Stress Disorder (PTSD) Initial</title>
        <description>Score on Impact of Events Scale Revised (IES-R) questionnaire. 22 questions. Score 0-88 with higher scores indicating more stress.</description>
        <time_frame>Measured once upon enrollment</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Surveyed After ICU Discharge</title>
            <description>Survey after ICU discharge</description>
          </group>
        </group_list>
        <measure>
          <title>Symptoms of Post-Traumatic Stress Disorder (PTSD) Initial</title>
          <description>Score on Impact of Events Scale Revised (IES-R) questionnaire. 22 questions. Score 0-88 with higher scores indicating more stress.</description>
          <units>score on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="90"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="27.9" spread="17.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Symptoms of Anxiety and Depression Initial</title>
        <description>Score on Hospital Anxiety and Depression Scale (HADS). Total score 0-21 for anxiety (7 questions) and 0-21 for depression (7 questions). Higher scores indicate greater symptom burden.</description>
        <time_frame>Measured once upon enrollment</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Surveyed After ICU Discharge</title>
            <description>Surveyed after ICU discharge</description>
          </group>
        </group_list>
        <measure>
          <title>Symptoms of Anxiety and Depression Initial</title>
          <description>Score on Hospital Anxiety and Depression Scale (HADS). Total score 0-21 for anxiety (7 questions) and 0-21 for depression (7 questions). Higher scores indicate greater symptom burden.</description>
          <units>score on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="90"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="12.8" spread="8.9"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Surrogate Satisfaction With the Patient's ICU Care:</title>
        <description>Score on the Critical Care Family Needs Inventory (CCFNI) questionnaire. 14 questions. Total score range 14-56 with lower scores indicating better satisfaction.</description>
        <time_frame>Measured once upon enrollment</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Surveyed After ICU Discharge</title>
            <description>Survey after ICU discharge</description>
          </group>
        </group_list>
        <measure>
          <title>Surrogate Satisfaction With the Patient's ICU Care:</title>
          <description>Score on the Critical Care Family Needs Inventory (CCFNI) questionnaire. 14 questions. Total score range 14-56 with lower scores indicating better satisfaction.</description>
          <units>score on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="90"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="16.8" spread="6.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Symptoms of Post-Traumatic Stress Disorder (PTSD) Final</title>
        <description>IES-R score before intervention&#xD;
The IES-R yields a total score (ranging from 0 to 88) with higher scores indicative of more severe PTSD</description>
        <time_frame>Measured before behavioral intervention (6-12 weeks after enrollment)</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Received Group Intervention</title>
            <description>Received group intervention</description>
          </group>
        </group_list>
        <measure>
          <title>Symptoms of Post-Traumatic Stress Disorder (PTSD) Final</title>
          <description>IES-R score before intervention&#xD;
The IES-R yields a total score (ranging from 0 to 88) with higher scores indicative of more severe PTSD</description>
          <units>score on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="26"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="36.9" spread="17.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Symptoms of Post-Traumatic Stress Disorder (PTSD) Final</title>
        <description>IES-R after intervention&#xD;
The IES-R yields a total score (ranging from 0 to 88) with higher scores indicative of more severe PTSD</description>
        <time_frame>Measured after behavioral intervention (12-24 weeks after enrollment)</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Surveyed After ICU Discharge</title>
            <description>Survey after ICU discharge</description>
          </group>
        </group_list>
        <measure>
          <title>Symptoms of Post-Traumatic Stress Disorder (PTSD) Final</title>
          <description>IES-R after intervention&#xD;
The IES-R yields a total score (ranging from 0 to 88) with higher scores indicative of more severe PTSD</description>
          <units>score on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="19"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="24.1" spread="13.5"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Symptoms of Anxiety and Depression Final</title>
        <description>Score on Hospital Anxiety and Depression Scale (HADS). Total score 0-21 for anxiety (7 questions) and 0-21 for depression (7 questions). Higher scores indicate greater symptom burden.</description>
        <time_frame>Measured before behavioral intervention (6-12 weeks after enrollment)</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Surveyed After ICU Discharge</title>
            <description>Survey after ICU discharge</description>
          </group>
        </group_list>
        <measure>
          <title>Symptoms of Anxiety and Depression Final</title>
          <description>Score on Hospital Anxiety and Depression Scale (HADS). Total score 0-21 for anxiety (7 questions) and 0-21 for depression (7 questions). Higher scores indicate greater symptom burden.</description>
          <units>score on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="26"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="15.9" spread="9.4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Symptoms of Anxiety and Depression Final</title>
        <description>Score on Hospital Anxiety and Depression Scale (HADS). Total score 0-21 for anxiety (7 questions) and 0-21 for depression (7 questions). Higher scores indicate greater symptom burden.</description>
        <time_frame>Measured after behavioral intervention (12-24 weeks after enrollment)</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Surveyed After ICU Discharge</title>
            <description>Survey after ICU discharge</description>
          </group>
        </group_list>
        <measure>
          <title>Symptoms of Anxiety and Depression Final</title>
          <description>Score on Hospital Anxiety and Depression Scale (HADS). Total score 0-21 for anxiety (7 questions) and 0-21 for depression (7 questions). Higher scores indicate greater symptom burden.</description>
          <units>score on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="19"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="11.7" spread="7.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Interview Initial</title>
        <description>Qualitative analysis of phone interview to determine the presence and reason(s) for psychological symptoms</description>
        <time_frame>Measured once upon enrollment</time_frame>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Interview Final</title>
        <description>Qualitative analysis of phone interview to determine the presence and reason(s) for psychological symptoms</description>
        <time_frame>Measured after behavioral intervention (12-24 weeks after enrollment)</time_frame>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>3-6 months after enrollment</time_frame>
      <group_list>
        <group group_id="E1">
          <title>Received Group Intervention</title>
          <description>Received group intervention</description>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="19"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="19"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="19"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>All Principal Investigators ARE employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. </restrictive_agreement>
    </certain_agreements>
    <limitations_and_caveats>small sample size, single center</limitations_and_caveats>
    <point_of_contact>
      <name_or_title>Jared A Greenberg</name_or_title>
      <organization>Rush University Medical Center</organization>
      <phone>312-942-6744</phone>
      <email>jared_greenberg@rush.edu</email>
    </point_of_contact>
  </clinical_results>
</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/NCT04501445
org study id: 20071101
nct id: NCT04501445
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
is us export: No
Families of patients in Intensive Care Units (ICUs) are at increased risk for developing
      psychological symptoms that can last for months after the patient is discharged. These
      symptoms can have significant impact on both the patient and family member's quality of life.

      The investigators have found that families of patients admitted to the Rush University
      Medical Center ICU during to the COVID-19 pandemic were more likely to develop clinically
      significant psychological symptoms than families of patients admitted prior to the COVID-19
      pandemic. The investigators suspect that this finding is due in part to the hospital-wide no
      visitation policy that altered our standard communication practices and may have prevented
      families from being active participants in the patient's medical care.

      The goals of this project are 1) to determine the prevalence of psychological disorders among
      families of COVID-19 patients after ICU discharge 2) to determine the characteristics of ICU
      care that were associated with the development of psychological disorders among family
      members and 3) to pilot a program in which families with psychological disorders after ICU
      discharge receive therapy from mental health professionals.
Part 1- Post-ICU discharge survey and Interview Upon enrollment in this post-ICU discharge
      follow-up study, the subject (surrogate of the ICU patient) will complete a survey dealing
      with the patient's course since Rush discharge

        1. Is the patient still alive?

             1. If deceased, did the patient pass away at Rush or after discharge from Rush?

             2. If alive, is the patient at home?

           i. If at home, for how long? Is he/she receiving home health services?

        2. If the patient did not pass away at Rush, did the patient spend time in a rehabilitation
           hospital, nursing home, or long-term acute care hospital after discharge from Rush?

        3. Is the patient currently having any of the following symptoms (check all that apply).

             1. Fatigue

             2. Trouble Breathing

             3. Difficulty speaking

             4. Difficulty eating

             5. Difficulty thinking or paying attention

             6. Pain or discomfort

             7. Anxiety

             8. Depressed mood

             9. Difficulty moving or walking

            10. Difficulty performing activities of daily living such as dressing or bathing

        4. Have the subject used mental health services since the time the patient was admitted?

        5. What is the subject's overall impression of mental health services (choices ranging from
           very unhelpful to very helpful)

      Subjects will be asked to complete the 1) Critical Care Family Needs Inventory (CCFNI)
      questionnaire, 2) Hospital Anxiety and Depression Scale (HADS), and 3) Impact of Events Scale
      Revised (IES-R) questionnaire.

      Subjects will participate in a 30-minute phone interview with a member of the study team. The
      interviewer will review the subject's responses to the above surveys and ask follow-up
      questions. The interviewer will ask how the subject has been coping with any psychological
      symptoms (i.e. anxiety, depression, post-traumatic stress)

      The psychologist will describe different types of interventions for people coping
      psychological symptoms and assess the subject's interest in pursuing any of them.

      Part 2 - Post-ICU psychological intervention Subjects with clinically significant
      psychologist symptoms based on either their survey or interview responses will be invited to
      participate in 6-week trauma-focused intervention with a psychologist.

      The program will be brief and delivered online to test the acceptability and feasible of the
      program, and to gather a preliminary estimate of effect size. We will pilot a group-based
      intervention (n =3-5) online over Zoom and deliver the intervention across six sessions
      outlined below. Sessions will last 60-75 minutes depending on participant questions and
      discussion. Experiential exercises will be drawn from Acceptance and Commitment Therapy, a
      related contemporary cognitive behavioral treatment (Hayes, Strosahl, & Wilson, 2012). Some
      commentary of Viktor Frankl's (1985) work on meaning making will be made in group discussion.
      Activity scheduling worksheets from Martell, Dimijian and Herman-Dunn (2013) will be used for
      out of session homework.

      We plan two phases for the study. The first phase, sessions 1-3, focus on introducing the
      model of behavioral activation and guide the participants to identify activities that will
      being pleasant, meaningful, or offer a sense of accomplishment and mastery. The first session
      aims to normalize diverse responses to health-related stress and loss by introducing the
      behavioral model of depression, and the rationale for behavioral activation. In the second
      session participants then clarify their values, so that they can begin scheduling pleasant
      and/or meaningful activities in the third session. These activities are tailored based on
      each participant's individuals goals, priorities and values. The second phase, sessions 4-6,
      aims to reinforce and sustain positive gains made via behavioral activation and pleasant
      activity scheduling. Session 4 offers suggestions for problem-solving ways to overcome
      unhelpful avoidance, a transdiagnostic vulnerability that sustains a number of emotional and
      psychiatric disorders. Session 5 offers suggestions for overcoming rumination including
      instruction in mindfulness, and attentional techniques that help participants attend to the
      outcomes and experiences of the pleasant activities they engage in. Session 6 concludes the
      program, and guides participants to consider plans to maintain commitment to pleasant
      activities.

      Session 1 Psychoeducation Introductions. Question to group: Why are we here?

        -  Normalize the grieving process and the challenges of COVID safety guidelines

             -  grief, boredom, loneliness

             -  1/3 of USA adults report depression and anxiety

        -  Discuss the behavioral model of depression - loss of reward and meaningful events as a
           prelude to negative moods of all types

        -  Behavioral Activation as a strategy to enhance reward and meaning

        -  Experiential: Contemplate a time in life when you felt you were doing well. How were you
           engaging the world around you?

        -  Homework: Start Activity tracking. Worksheets will be provided, but we allow a more
           feasible approach of jotting down 1-2 words about activity and providing a subjective
           mood rating.

      Session 2 Value Clarification Question to the group: How do we bring purpose into our living?

        -  Consider values as the foundation of meaning and purpose

        -  Discuss meaning in life and Dr. Viktor Frankl's thesis that humans are driven to find
           meaning

           o "We do not ask life what the meaning of life is. Life asks us, what is the meaning of
           your life. And life demands our answer."

        -  What gives/gave meaning to your loved one's life? What would make them smile? If you
           share values with this person, how can you honor those values you share in your own
           commitments and activities?

        -  Experiential: Contemplate your 80th Birthday, Retirement Speech, family remembering you
           far in the future, etc, Homework: Values Compass. Participants will complete the values
           compass worksheet in which they rate their perceived importance and engagement in
           various domains of living (e.g, family life, learning, spirituality).

      Session 3 Scheduling Activities Question to group: What does it mean to be committed?

        -  Discuss a role model or mentor who demonstrated commitment to something important. How
           did they do it? Do they share values with the patient they care(d) for? How do these

        -  Selecting and scheduling pleasant events. Regardless of how you feel, take action to
           experience:

             -  Pleasure

             -  Mastery

             -  Purpose

             -  Health habits: steady sleep, diet, exercise

        -  Experiential: Participants visualize, write or discuss steps needed to engage a plan.
           Visualize yourself overcoming a roadblock or barrier.

        -  Homework: Activity Schedule. Participants will schedule several pleasant/meaningful
           events for the coming week. They will rate their mood while engaged in these activities
           and journal about their experiences.

      Session 4 Overcoming Avoidance What do we do with fear?

        -  Getting out of the TRAP (Trigger-Response-Avoidance Pattern) to get on Track (Trigger
           Response Adaptive Coping)

        -  Often we hurt when something that matters is threatened. We should protect what matters
           not the momentary feeling. Discuss "fear as an arrow" that can be useful for pointing to
           ones values (e.g., we typically do not fear losing things we do not care about).

        -  Experiential: Flipping the coins of avoidance. Participants look to how fears, and
           frustrations relate to other prosocial and personally valued events and experiences.

        -  Homework: Activity Schedule. This repeats the homework from the prior week.

      Session 5 Working with thoughts Question to the group: How do we prevent going on autopilot
      so we stay focused on what matters?

        -  Staying present to notice when actions are working. Being better at tracking outcomes.

        -  Mindfulness versus rumination

        -  Experiential: Mindfulness of the present. Participants are guided in a mindfulness
           exercise to attend to sense experiences in the present moment. The goal of the exercise
           is to introduce a skill for re-orienting to the present moment. This is particularly
           needed for attending to and noticing the pleasant and meaningful experiences that come
           from behavioral activation.

        -  Homework: Activity Schedule Session 6 Recap and review Question to the group: How do we
           carry these lessons with us? How do we share these lessons with others?

        -  The goal of this session is to review and to provide additional practice with any of the
           prior skills discussed in previous sessions.

        -  Relapse prevention concepts will be discussed. Participants will be encouraged to
           continue to maintain pleasant activity scheduling, and to consider how these activities
           can be reinforced through social commitments, and daily reflection.

        -  Consider making a symbol. Picture, photo, card, note to self to remind oneself of a
           valued activity. This can be displayed in a prominent place (e.g., family photo on the
           mantle, photo of exercise on bathroom mirror, religious text on coffee table). Should
           evoke pleasant memory, and motivation.

      Prior to beginning the intervention and at the completion of the intervention, surrogates
      will complete the 1) Hospital Anxiety and Depression Scale (HADS), and 2) Impact of Events
      Scale Revised (IES-R) questionnaire.

      At the completion of the intervention, subjects will participate in another 30-minute phone
      interview with a study investigator. The study investigator will review the subject's
      responses to the above surveys and ask follow-up questions. The study investigator will ask
      how the subject has been coping with any psychological symptoms (i.e. anxiety, depression,
      post-traumatic stress).

      All interviews will be audio recorded and transcribed. Two members study staff will review
      the transcriptions and use thematic content analysis to determine the types of psychological
      symptoms that are present and the reason(s) they may be present.

      When analyzing subject responses, the investigators will account for the following variables

        -  Whether the patient is deceased or not

        -  Length of time since hospital discharge

        -  Whether the subject received mental health services on their own or not

        -  Whether the subject received daily written summaries in the ICU or not

      Statistical Analysis The investigators expect ~100 subjects to meet inclusion criteria. The
      investigators expect ~70-100 to complete Part 1 (Post-ICU discharge survey and Interview).
      The investigators will determine the prevalence of psychological symptoms and opinions on ICU
      care by reviewing survey responses and interview recordings. The investigators expect ~30 to
      complete Part 2 (Post-ICU discharge survey and Interview). The investigators compare pre- to
      post-intervention survey responses for each subject using a paired t-test. Part 2 will be
      considered a pilot study. The investigators will use the results to plan a future, adequately
      powered study.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Supportive Care
masking: None (Open Label)
measure: Symptoms of Post-Traumatic Stress Disorder (PTSD) Initial
time frame: Measured once upon enrollment
description: Score on Impact of Events Scale Revised (IES-R) questionnaire. 22 questions. Score 0-88 with higher scores indicating more stress.
measure: Symptoms of Anxiety and Depression Initial
time frame: Measured once upon enrollment
description: Score on Hospital Anxiety and Depression Scale (HADS). Total score 0-21 for anxiety (7 questions) and 0-21 for depression (7 questions). Higher scores indicate greater symptom burden.
measure: Surrogate Satisfaction With the Patient's ICU Care:
time frame: Measured once upon enrollment
description: Score on the Critical Care Family Needs Inventory (CCFNI) questionnaire. 14 questions. Total score range 14-56 with lower scores indicating better satisfaction.
measure: Symptoms of Post-Traumatic Stress Disorder (PTSD) Final
time frame: Measured before behavioral intervention (6-12 weeks after enrollment)
description: IES-R score before intervention
The IES-R yields a total score (ranging from 0 to 88) with higher scores indicative of more severe PTSD
measure: Symptoms of Post-Traumatic Stress Disorder (PTSD) Final
time frame: Measured after behavioral intervention (12-24 weeks after enrollment)
description: IES-R after intervention
The IES-R yields a total score (ranging from 0 to 88) with higher scores indicative of more severe PTSD
measure: Symptoms of Anxiety and Depression Final
time frame: Measured before behavioral intervention (6-12 weeks after enrollment)
description: Score on Hospital Anxiety and Depression Scale (HADS). Total score 0-21 for anxiety (7 questions) and 0-21 for depression (7 questions). Higher scores indicate greater symptom burden.
measure: Symptoms of Anxiety and Depression Final
time frame: Measured after behavioral intervention (12-24 weeks after enrollment)
description: Score on Hospital Anxiety and Depression Scale (HADS). Total score 0-21 for anxiety (7 questions) and 0-21 for depression (7 questions). Higher scores indicate greater symptom burden.
measure: Interview Initial
time frame: Measured once upon enrollment
description: Qualitative analysis of phone interview to determine the presence and reason(s) for psychological symptoms
measure: Interview Final
time frame: Measured after behavioral intervention (12-24 weeks after enrollment)
description: Qualitative analysis of phone interview to determine the presence and reason(s) for psychological symptoms
arm group label: Rounding Summary
arm group type: Experimental
description: Surrogates who were assigned to the intervention group received a written rounding summary every day or every other day that the patient is in the ICU.
arm group label: Usual Care
arm group type: No Intervention
intervention type: Behavioral
intervention name: Written Summary of Rounds
description: The summary was organized as follows for each of the most important ICU problems: 1) Description of the problem, 2) Ways the ICU team is addressing the problem i.e. consultations, diagnostic tests, and treatments. 3) An assessment of whether the problem is improving or worsening.
arm group label: Rounding Summary
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
facility: 
country: United States
citation: Davidson JE, Jones C, Bienvenu OJ. Family response to critical illness: postintensive care syndrome-family. Crit Care Med. 2012 Feb;40(2):618-24. doi: 10.1097/CCM.0b013e318236ebf9.
PMID: 22080636
citation: Nelson JE, Hanson LC, Keller KL, Carson SS, Cox CE, Tulsky JA, White DB, Chai EJ, Weiss SP, Danis M. The Voice of Surrogate Decision-Makers. Family Responses to Prognostic Information in Chronic Critical Illness. Am J Respir Crit Care Med. 2017 Oct 1;196(7):864-872. doi: 10.1164/rccm.201701-0201OC.
PMID: 28387538
citation: Davidson JE, Aslakson RA, Long AC, Puntillo KA, Kross EK, Hart J, Cox CE, Wunsch H, Wickline MA, Nunnally ME, Netzer G, Kentish-Barnes N, Sprung CL, Hartog CS, Coombs M, Gerritsen RT, Hopkins RO, Franck LS, Skrobik Y, Kon AA, Scruth EA, Harvey MA, Lewis-Newby M, White DB, Swoboda SM, Cooke CR, Levy MM, Azoulay E, Curtis JR. Guidelines for Family-Centered Care in the Neonatal, Pediatric, and Adult ICU. Crit Care Med. 2017 Jan;45(1):103-128. doi: 10.1097/CCM.0000000000002169.
PMID: 27984278
responsible party type: Sponsor
mesh term: Stress Disorders, Traumatic
mesh term: Stress Disorders, Post-Traumatic
sharing ipd: Undecided
provided document: 
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
limitations and caveats: small sample size, single center
point of contact: 