Psychological Impact of COVID-19 on Intensive Care Survivors

Study Overview
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Brief Summary
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Psychological distress is commonly experienced by survivors of an intensive care admission, including patients treated during previous pandemics. Whilst data emerges about the short-term impact of COVID-19 on patients and healthcare systems, the long term impact remains unclear. The purpose of this trainee-led, multi-centre longitudinal study is to assess the short- and long-term psychological impact on patients who have survived an admission to intensive care due to COVID-19, and identify possible predictors of anxiety, depression and trauma symptoms in this patient group.

Detailed Description
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The primary objective is to identify the proportion of patients surviving an admission to intensive care due to COVID-19 who experience anxiety, depression and/or trauma symptoms in the 6 months post discharge. Whilst the secondary objectives are to identify demographic, clinical, physical and/or psychosocial predictors of depression, anxiety and/or trauma symptoms at 3-, 6- and 12-months post discharge from ICU. And to assess the feasibility of using a self-reported online questionnaire to assess anxiety, depression and/or trauma symptoms in patients following ICU admission. An amendment was approved by the East Midlands - Derby Research Ethics Committee on 17 March 2022, to conduct three sub-studies: Semi-structured interviews - to explore the experiences of critical care survivors following COVID-19 infection during their recovery phase, including perceptions about the care received and support available to them. Survey of follow-up services offered to ICU survivors - to assess geographical differences in the availability and structure of follow-up services offered to patients with critical COVID-19 after hospital discharge. Survey of study team members - to gain feedback from the study team members on their involvement in the study.

Official Title
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The Psychological Impact of Surviving an Intensive Care Admission Due to Coronavirus Disease 2019 (COVID-19) on Patients in the United Kingdom

Conditions
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COVID-19, Psychological Distress, Depression, Anxiety, Post-traumatic Stress Disorder, Post Intensive Care Syndrome

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Adult patients ≥18 years Survival to intensive care / high dependency unit discharge following an admission of ≥24 hours Treated for COVID-19 Exclusion Criteria: Unable to complete questionnaires Unable or unwilling to consent Unable to speak, understand or communicate in English Patients with diagnosed, pre-existing cognitive impairment (at the time of ICU admission) Patients without a fixed abode, at which postal questionnaires might be received, and who have no access to a personal email address.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Anxiety | Hospital Anxiety and Depression Scale (HADS) where a score of 0-7= normal, 8-10= borderline abnormal (borderline case), 11-21= abnormal (case). | 6 months post intensive care unit (ICU) discharge | 
| Depression | Hospital Anxiety and Depression Scale (HADS) where a score of 0-7= normal, 8-10= borderline abnormal (borderline case), 11-21= abnormal (case). | 6 months post ICU discharge | 
| Symptoms of trauma | Impact of Event Scale-6 (IES-6) where the mean score ranges between 0 and 4 and the cut off score is 1.75. | 6 months post ICU discharge | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Anxiety | Hospital Anxiety and Depression Scale (HADS) where a score of 0-7= normal, 8-10= borderline abnormal (borderline case), 11-21= abnormal (case). | 3 and/or 12 months post ICU discharge | 
| Depression | Hospital Anxiety and Depression Scale (HADS) where a score of 0-7= normal, 8-10= borderline abnormal (borderline case), 11-21= abnormal (case). | 3 and/or 12 months post ICU discharge | 
| Symptoms of trauma | Impact of Event Scale-6 (IES-6) where the mean score ranges between 0 and 4 and the cut off score is 1.75. | 3 and/or 12 months post ICU discharge | 
| Metacognitive beliefs and processes | Cognitive Attentional Syndrome Scale-1 (Revised; CAS-1R), which is a 10-item measure with responses scaled from 0%-100%, which are summed to produce a total score. Higher scores indicate greater conviction in metacognitive beliefs and greater use of maladaptive coping strategies to manage distress. | 3, 6 and/or 12 months post ICU discharge | 
| Health-related quality of life | EuroQol 5-dimension, 5-level questionnaire (EQ-5D-5L) comprises health status measures (mobility, self-care, usual activities, pain/discomfort and anxiety/depression) divided into five levels of perceived problems and a visual analogue scale of health status ranging from 0-100. | 3, 6 and/or 12 months post ICU discharge | 
| Feasibility of using self-reported questionnaire to assess psychological outcomes in ICU survivors with COVID-19 | Response rate to invitations to participate/questionnaires. | Study duration, up to 1 year |