Relieving the Burden of Psychological Symptoms Among Families of Critically Ill Patients With COVID-19
Phase: NA
Conditions: Family Members, Post Intensive Care Unit Syndrome, Post Traumatic Stress Disorder
Sponsor: Rush University Medical Center

COVER PAGE  
PROTOCOL AND ANALYSIS PLAN FOR: 
Relieving the Burden of Psychological Symptoms Among Families of Critically Ill Patients with COVID-19  
NCT04501445  
Document Date 12/16/20  
 
 

 
 
Relieving the Burden of Psychological Symptoms Among Families of Critically Ill Patients 
with COVID-19 
 
Date: 12/16/20 
 
Principle Investigator: Jared Greenberg, MD, MSc, Assistant Professor, Division of Pulmonary 
and Critical Care Medicine, Rush University Medical Center 
 
Co-Investigator: James Gerhart, PhD. Assistant Professor, Division of Behavioral Sciences, 
Rush Medical College and Department of Psychology, Central Michigan University 
 
Background 
The prevalence of psychological symptoms such as anxiety, depression, and acute stress is high 
among families of critically ill patients. The medical care of an ICU patient may be negatively 
impacted if these symptoms interfere with a family member assuming the role of surrogate 
decision maker. Mental health disorders such as complicated grief and post-traumatic stress 
disorder (PTSD) among families may also develop in the months after the patient is discharged 
from the ICU, which has been referred to Post-Intensive Care Syndrome-Family.1  Psychological 
symptoms negatively affect the family member’s quality of life and may hamper his or her 
ability to act as a caregiver of the patient who is recovering from critical illness.2 
 
In March 2020, Rush University Medical Center, along with most healthcare systems, adopted a 
hospital-wide no visitation policy to limit the spread of COVID-19. Previously, families of Rush 
ICU patients were encouraged to visit and be active participants in the patient’s medical care. 
This type of “family engagement,” which was our standard of care, is believed to help reduce the 
risk of developing Post-Intensive Care Syndrome-Family.3 
 
For the last year, my research group has been enrolling families in a clinical trial evaluating the 
impact of providing them with daily written summaries of ICU rounds on their experience 
(NCT03969810). Using validated instruments, we have measured symptoms of anxiety, 
depression, and acute stress among family members at multiple time points during the ICU stay. 
During the hospitalization, families also participated in interviews dealing with their experiences. 
Compared to the 96 family members who were enrolled prior to the COVID-19 pandemic, the 88 
family members who have been enrolled during the COVID-19 pandemic were more likely to 
develop clinically significant depressive symptoms (27% vs. 13%, p=0.03 for difference) and 
tended to develop clinically significant acute stress symptoms (61% vs 48%, p=0.11 for 
difference). There were similar levels of clinically significant symptoms of anxiety before and 
during the COVID-19 pandemic (42% vs. 35%, p=0.43 for difference) (manuscript in 
preparation). It is likely that restrictions on family visitation and challenges with communication 
during the COVID-19 pandemic contributed to the high psychological symptom burden among 
family members during this time period. 
 
The best practices for clinicians to engage with family members in times when they cannot visit 
their loved ones in the ICU are poorly understood. It is unclear the degree to which families of 

COVID-19 patients continue to have psychological symptoms after the patient is discharged and 
how these symptoms may be impacting quality of life and the patient’s recovery. For family 
members who develop mental health disorders, it is likely that many do not seek out professional 
help. To address these gaps in knowledge, we propose the following three specific aims.  
 
1. To determine the extent to which families of COVID-19 patients have psychological 
symptoms 3-6 months after the patient was discharged from the hospital. We will reconsent 
family members who participated in our initial study during the COVID-19 pandemic. We will 
conduct one phone interview and use validated instruments to determine the prevalence of 
anxiety, depression, and post-traumatic stress disorder. 
 
2. To determine the characteristics of ICU care delivery during the COVID-19 pandemic 
that were associated with the development of psychological symptoms among families. To 
achieve this goal, we analyze phone interviews conducted during and after the hospitalization. 
We compare themes among families who developed psychological symptoms to those who did 
not. 
 
3. To determine whether a trauma-focused cognitive behavioral therapy intervention helps 
reduce the burden of symptoms among family members with psychological symptoms. We 
will pilot a program in which family members with clinically significant psychological 
symptoms will be offered up to six phone/video counseling sessions with mental health 
professionals. To determine the effect of this therapy, we will conduct phone interviews and use 
validated instruments to determine the prevalence of anxiety, depression, and post-traumatic 
stress disorder after the intervention.  
 
Methods 
Enrollment 
Surrogates of ICU patients with COVID-19 who were enrolled in the study “ICU Rounding 
Summaries for Families of Critically Ill Patients” (19042604-IRB01) will be approached to 
participate in a follow-up study dealing with their mental health after patient discharge. We will 
email and call surrogates to describe the project and provide an informed consent form for them 
to review. 
 
Inclusion criteria 
• The patient’s surrogate was enrolled in “ICU Rounding Summaries for Families of 
Critically Ill Patients” (19042604-IRB01) and the patient had COVID-19 
• The patient has been discharged from the hospital 
 
Exclusion criteria  
• None 
 
Intervention 
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? 

a. If deceased, did the patient pass away at Rush or after discharge from Rush? 
b. 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). 
a. Fatigue 
b. Trouble Breathing 
c. Difficulty speaking 
d. Difficulty eating 
e. Difficulty thinking or paying attention 
f. Pain or discomfort 
g. Anxiety 
h. Depressed mood 
i. Difficulty moving or walking 
j. Difficulty performing activities of daily living such as dressing or bathing 
4. Have you used mental health services since the time the patient was admitted?  
5. What is your 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. (Appendix) 
 
Subjects will participate in a 30-minute phone interview with a psychologist. The psychologist 
will review the subject’s responses to the above surveys and ask follow-up questions 
(Appendix). The psychologist 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. 
 
We will not begin Part 2 until 10 subjects have completed “Part 1- Post-ICU discharge survey 
and Interview.” We will review survey responses and interview transcripts for the first 10 
subjects. Based on responses will determine the type(s) of support interventions that will be 
offered for subjects in this study. An amendment to the study protocol will be made at this time. 
 
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.  
 
 
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. 
 
Outcomes 
Part 1- Post-ICU discharge survey and Interview 
• Critical Care Family Needs Inventory (CCFNI) questionnaire, a 14-question instrument 
with each question scored 1-4 
• Hospital Anxiety and Depression Scale (HADS), 14-questions each question scored on 0-
3 scale.   
• Impact of Events Scale Revised (IES-R) questionnaire (measure of PTSD symptoms). 
This instrument contains 22 questions scored on 0–4 scale.  

• Qualitative analysis of interview to determine the prevalence and reason(s) for 
psychological symptoms 
 
Part 2- Post-ICU discharge survey and Interview 
• Each subject’s post-intervention HADS score relative to pre-intervention HADS score 
• Each subject’s post-intervention IES-R score relative to pre-intervention IES-R score 
• Qualitative analysis of interview to determine the prevalence and reason(s) for 
psychological symptoms and effectiveness of the intervention. 
 
When analyzing subject responses, we 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 
We expect ~100 subjects to meet inclusion criteria. We expect ~70 to complete Part 1 (Post-ICU 
discharge survey and Interview). We will determine the prevalence of psychological symptoms 
and opinions on ICU care by reviewing survey responses and interview recordings. We expect 
~30 to complete Part 2 (Post-ICU discharge survey and Interview). We compare pre- to post-
intervention survey responses for each subject using a paired t-test. Part 2 will be considered a 
pilot study. We will use the results to plan a future, adequately powered study. 
 
 
References 
 
Davidson JE, Jones C, Bienvenu OJ: Family response to critical illness: postintensive care 
syndrome-family. Crit Care Med 2012, 40(2):618-624. 
 
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, 196(7):864-872. 
 
Davidson JE, Aslakson RA, Long AC, Puntillo KA, Kross EK, Hart J, et al. Guidelines for 
family-centered care in the neonatal, pediatric, and adult ICU. Crit Care Med 2017;45:103–128. 
 
Frankl, V. E. (1985). Man's search for meaning. Simon and Schuster. 
 
Hayes, S. C., Strosahl, K. D., & Wilson, K. G. (2011). Acceptance and commitment therapy: The 
process and practice of mindful change. Guilford Press. 
 
Martell, C. R., Dimidjian, S., & Herman-Dunn, R. (2013). Behavioral activation for depression: 
A clinician's guide. Guilford Press. 
 

Papa, A., Sewell, M. T., Garrison-Diehn, C., & Rummel, C. (2013). A randomized open trial 
assessing the feasibility of behavioral activation for pathological grief responding. Behavior 
Therapy, 44(4), 639-650. 
 
 

Appendix  - Critical Care Family Needs Inventory (CCFNI) questionnaire 
 
 
 
 
 
 

Hospital Anxiety and Depression Scale (HADS), 
 
 
 
 
 

Impact of Events Scale Revised (IES-R) questionnaire 
 
 
 
 
 

INTERVIEW GUIDE 
 
Prepping for the interview 
• Review the above information 
• Adopt an empathic stance. Use open-ended questions to elicit large themes. Clarifying 
and close-ended questions can be used to narrow themes. Use reflective statements, and 
paraphrasing to let the participant know you’re listening. Use your tone of voice to 
convey interest and empathy.  
 
The Interview 
• Ask for consent to record the interview to aid in note taking. 
• Introduce yourself, and remind participants that this stage of the study involves an 
interview. Encourage participants to be open and forthcoming, and remind them that the 
information they provide may be useful for supporting other surrogates in the future. 
• Tell the participant that the interview focuses on his/her experience during two periods – 
1) while his/her loved one was hospitalized at Rush and 2) the time since his/her loved 
one was hospitalized at Rush. 
(The questions are organized to elicit general observations, negative aspects of the ICU 
experience, and then to elicit positives. This order was chosen for two-reasons. First, to end the 
interview on a more “positive” tone. Second, to prompt participants to home in on aspects that 
could be addressed on the coaching intervention phase of the study) 
 
Questions about your ICU experience 
• What are your thoughts about your experience with the ICU? 
• What are your thoughts about the ways the COVID-19 pandemic affected your 
experience in the ICU? 
• What about your ICU experience was difficult? 
o Were there aspects of ICU care i.e lack of visitation, issues with communication? 
Were there external factors i.e job loss, family situation? 
o Did you have added responsibilities to other family members while your loved 
one was in the ICU 
• What was most useful for coping? 
• Refer to survey responses during ICU stay that stood out, ask to elaborate 
 
Questions about your post-ICU experience 
• Tell me how life has been after ICU discharge (note if the patient is alive or not) 
• What are your thoughts about the ways the COVID-19 pandemic affected your 
experience after ICU discharge. 
• What about your experience has been difficult after ICU discharge? 
o When asking this question, review whether the patient is now at home and/or is 
having ongoing symptoms 
o Have you had added responsibilities to other family members since your loved 
one was in the ICU 
• What has been most useful for coping? 

o When asking this question, review whether the subject has sought out help from a 
mental health provider 
o When asking this question, review whether the subject was in the daily email 
update group or control group. Has the subject referenced the summaries after 
ICU discharge? 
• Refer to survey responses after ICU stay that stood out, ask to elaborate 
• Going forward, what resources would help you or others in similar situations recover 
from your experience with the ICU? 
 
Assess interest in a support intervention. 
• Refer to whether the subject has sought out help from a mental health provider 
o Has this been helpful? Why or why not 
• Refer to the subject’s impression of the helpfulness of mental health.  
o Why might it be helpful or unhelpful 
• Use the subject’s responses to the whole interview to suggest possible types of support 
interventions and gauge the subject’s interest (we are expecting about half of the subjects 
who complete this interview to complete the support intervention) 
 
 
Thank the participant for their participation. Is there anything else you would like us to know?