Trial Outcomes & Findings for Psychological Symptoms and Families of COVID-19 Patients (NCT NCT04501445)
NCT ID: NCT04501445
Last Updated: 2023-04-27
Results Overview
Score on Impact of Events Scale Revised (IES-R) questionnaire. 22 questions. Score 0-88 with higher scores indicating more stress.
COMPLETED
NA
90 participants
Measured once upon enrollment
2023-04-27
Participant Flow
Subjects who completed surveys after ICU discharge
Participant milestones
| Measure |
Surveyed After ICU Discharge
Surveyed after ICU discharge
|
|---|---|
|
Overall Study
STARTED
|
90
|
|
Overall Study
COMPLETED
|
90
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Psychological Symptoms and Families of COVID-19 Patients
Baseline characteristics by cohort
| Measure |
Surveyed After ICU Discharge
n=90 Participants
Surveyed after ICU discharge
|
|---|---|
|
Age, Categorical
<=18 years
|
1 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
84 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
5 Participants
n=5 Participants
|
|
Age, Continuous
|
49 years
STANDARD_DEVIATION 12 • n=5 Participants
|
|
Sex: Female, Male
Female
|
72 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
18 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
49 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
40 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
18 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
14 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
58 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
90 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Measured once upon enrollmentScore on Impact of Events Scale Revised (IES-R) questionnaire. 22 questions. Score 0-88 with higher scores indicating more stress.
Outcome measures
| Measure |
Surveyed After ICU Discharge
n=90 Participants
Survey after ICU discharge
|
|---|---|
|
Symptoms of Post-Traumatic Stress Disorder (PTSD) Initial
|
27.9 score on a scale
Standard Deviation 17.9
|
PRIMARY outcome
Timeframe: Measured once upon enrollmentScore 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.
Outcome measures
| Measure |
Surveyed After ICU Discharge
n=90 Participants
Survey after ICU discharge
|
|---|---|
|
Symptoms of Anxiety and Depression Initial
|
12.8 score on a scale
Standard Deviation 8.9
|
SECONDARY outcome
Timeframe: Measured once upon enrollmentScore on the Critical Care Family Needs Inventory (CCFNI) questionnaire. 14 questions. Total score range 14-56 with lower scores indicating better satisfaction.
Outcome measures
| Measure |
Surveyed After ICU Discharge
n=90 Participants
Survey after ICU discharge
|
|---|---|
|
Surrogate Satisfaction With the Patient's ICU Care:
|
16.8 score on a scale
Standard Deviation 6.0
|
SECONDARY outcome
Timeframe: Measured before behavioral intervention (6-12 weeks after enrollment)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
Outcome measures
| Measure |
Surveyed After ICU Discharge
n=26 Participants
Survey after ICU discharge
|
|---|---|
|
Symptoms of Post-Traumatic Stress Disorder (PTSD) Final
|
36.9 score on a scale
Standard Deviation 17.0
|
SECONDARY outcome
Timeframe: Measured after behavioral intervention (12-24 weeks after enrollment)IES-R after intervention The IES-R yields a total score (ranging from 0 to 88) with higher scores indicative of more severe PTSD
Outcome measures
| Measure |
Surveyed After ICU Discharge
n=19 Participants
Survey after ICU discharge
|
|---|---|
|
Symptoms of Post-Traumatic Stress Disorder (PTSD) Final
|
24.1 score on a scale
Standard Deviation 13.5
|
SECONDARY outcome
Timeframe: Measured before behavioral intervention (6-12 weeks after enrollment)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.
Outcome measures
| Measure |
Surveyed After ICU Discharge
n=26 Participants
Survey after ICU discharge
|
|---|---|
|
Symptoms of Anxiety and Depression Final
|
15.9 score on a scale
Standard Deviation 9.4
|
SECONDARY outcome
Timeframe: Measured after behavioral intervention (12-24 weeks after enrollment)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.
Outcome measures
| Measure |
Surveyed After ICU Discharge
n=19 Participants
Survey after ICU discharge
|
|---|---|
|
Symptoms of Anxiety and Depression Final
|
11.7 score on a scale
Standard Deviation 7.0
|
SECONDARY outcome
Timeframe: Measured once upon enrollmentQualitative analysis of phone interview to determine the presence and reason(s) for psychological symptoms
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Measured after behavioral intervention (12-24 weeks after enrollment)Qualitative analysis of phone interview to determine the presence and reason(s) for psychological symptoms
Outcome measures
Outcome data not reported
Adverse Events
Received Group Intervention
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place