Psychological Impact of COVID-19 on Intensive Care Survivors
- Conditions
- AnxietyPsychological DistressCOVID-19DepressionPost-traumatic Stress DisorderPost Intensive Care Syndrome
- Registration Number
- NCT05092529
- Lead Sponsor
- Royal Liverpool University Hospital
- Brief Summary
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
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:
1. 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.
2. 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.
3. Survey of study team members - to gain feedback from the study team members on their involvement in the study.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 1620
- Adult patients ≥18 years
- Survival to intensive care / high dependency unit discharge following an admission of ≥24 hours
- Treated for COVID-19
- 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.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Depression 6 months post ICU discharge Hospital Anxiety and Depression Scale (HADS) where a score of 0-7= normal, 8-10= borderline abnormal (borderline case), 11-21= abnormal (case).
Anxiety 6 months post intensive care unit (ICU) discharge Hospital Anxiety and Depression Scale (HADS) where a score of 0-7= normal, 8-10= borderline abnormal (borderline case), 11-21= abnormal (case).
Symptoms of trauma 6 months post ICU discharge Impact of Event Scale-6 (IES-6) where the mean score ranges between 0 and 4 and the cut off score is 1.75.
- Secondary Outcome Measures
Name Time Method Depression 3 and/or 12 months post ICU discharge Hospital Anxiety and Depression Scale (HADS) where a score of 0-7= normal, 8-10= borderline abnormal (borderline case), 11-21= abnormal (case).
Metacognitive beliefs and processes 3, 6 and/or 12 months post ICU discharge 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.
Anxiety 3 and/or 12 months post ICU discharge Hospital Anxiety and Depression Scale (HADS) where a score of 0-7= normal, 8-10= borderline abnormal (borderline case), 11-21= abnormal (case).
Symptoms of trauma 3 and/or 12 months post ICU discharge Impact of Event Scale-6 (IES-6) where the mean score ranges between 0 and 4 and the cut off score is 1.75.
Feasibility of using self-reported questionnaire to assess psychological outcomes in ICU survivors with COVID-19 Study duration, up to 1 year Response rate to invitations to participate/questionnaires.
Health-related quality of life 3, 6 and/or 12 months post ICU discharge 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.
Trial Locations
- Locations (50)
Pinderfields General Hospital
🇬🇧Wakefield, England, United Kingdom
Lewisham and Greenwich Hospitals
🇬🇧London, England, United Kingdom
Royal Blackburn Hospital
🇬🇧Blackburn, England, United Kingdom
Chesterfield Royal Hospital
🇬🇧Chesterfield, England, United Kingdom
Musgrove Park Hospital
🇬🇧Taunton, England, United Kingdom
Ipswich Hospital
🇬🇧Ipswich, England, United Kingdom
Royal Cornwall Hospital
🇬🇧Truro, Cornwall, United Kingdom
Cumberland Infirmary
🇬🇧Carlisle, England, United Kingdom
James Cook University Hospital
🇬🇧Middlesbrough, England, United Kingdom
Newcastle upon Tyne Hospitals Foundation Trust
🇬🇧Newcastle Upon Tyne, England, United Kingdom
Royal Oldham Hospital
🇬🇧Oldham, England, United Kingdom
Aintree University Hospital
🇬🇧Liverpool, England, United Kingdom
Macclesfield District General Hospital
🇬🇧Macclesfield, England, United Kingdom
Nottingham University Hospitals
🇬🇧Nottingham, England, United Kingdom
Ulster Hospital
🇬🇧Belfast, Northern Ireland, United Kingdom
Royal Glamorgan Hospital
🇬🇧Pontyclun, Wales, United Kingdom
King's College Hospital NHS Foundation Trust
🇬🇧London, England, United Kingdom
Sheffield Teaching Hospitals NHS Foundation Trust
🇬🇧Sheffield, England, United Kingdom
King's Mill Hospital
🇬🇧Sutton In Ashfield, England, United Kingdom
Barnsley Hospital
🇬🇧Barnsley, England, United Kingdom
Basildon Hospital
🇬🇧Basildon, England, United Kingdom
Bedford Hospital
🇬🇧Bedford, England, United Kingdom
Pilgrim Hospital
🇬🇧Boston, England, United Kingdom
Royal Papworth Hospital
🇬🇧Cambridge, England, United Kingdom
Countess of Chester Hospital
🇬🇧Chester, England, United Kingdom
Leighton Hospital
🇬🇧Crewe, England, United Kingdom
Queen Elizabeth Hospital
🇬🇧Gateshead, England, United Kingdom
Kingston Hospital
🇬🇧Kingston Upon Thames, England, United Kingdom
Wonford Hospital
🇬🇧Exeter, England, United Kingdom
Colchester Hospital
🇬🇧Colchester, England, United Kingdom
Lincoln County Hospital
🇬🇧Lincoln, England, United Kingdom
Maidstone Hospital
🇬🇧Maidstone, England, United Kingdom
Rotherham General Hospital
🇬🇧Rotherham, England, United Kingdom
Whiston Hospital
🇬🇧Prescot, England, United Kingdom
Derriford Hospital
🇬🇧Plymouth, England, United Kingdom
Lister Hospital
🇬🇧Stevenage, England, United Kingdom
Tunbridge Wells Hospital
🇬🇧Tunbridge Wells, England, United Kingdom
Royal Albert Edward Infirmary
🇬🇧Wigan, England, United Kingdom
Watford General Hospital
🇬🇧Watford, England, United Kingdom
University Hospital of Wales
🇬🇧Cardiff, Wales, United Kingdom
Forth Valley Royal Hospital
🇬🇧Larbert, Scotland, United Kingdom
Morriston Hospital
🇬🇧Swansea, Wales, United Kingdom
Manchester Royal Infirmary
🇬🇧Manchester, United Kingdom
North Middlesex University Hospital
🇬🇧London, United Kingdom
Southend University Hospital
🇬🇧London, United Kingdom
Barking, Havering and Redbridge University Hospitals NHS Trust
🇬🇧Romford, United Kingdom
North Manchester General Hospital
🇬🇧Manchester, United Kingdom
Northampton General Hospital
🇬🇧Northampton, England, United Kingdom
Northumbria Healthcare NHS Foundation Trust
🇬🇧Newcastle Upon Tyne, England, United Kingdom
Royal Liverpool University Hospital
🇬🇧Liverpool, England, United Kingdom