Psychological Symptoms and Families of COVID-19 Patients
Psychological Symptoms and Families of COVID-19 Patients
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.
Inclusion Criteria:

 -  The patient's surrogate was enrolled in "ICU Rounding Summaries for Families of
 Critically Ill Patients" (NCT03969810) and the patient had COVID-19

 -  The patient has been discharged from the hospital

 Exclusion Criteria:

 - None