Depression Clinical Trial
— PIM-COVIDOfficial title:
The Psychological Impact of Surviving an Intensive Care Admission Due to Coronavirus Disease 2019 (COVID-19) on Patients in the United Kingdom
Verified date | November 2023 |
Source | Royal Liverpool University Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
Status | Completed |
Enrollment | 1620 |
Est. completion date | November 17, 2023 |
Est. primary completion date | February 14, 2023 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
United Kingdom | Barnsley Hospital | Barnsley | England |
United Kingdom | Basildon Hospital | Basildon | England |
United Kingdom | Bedford Hospital | Bedford | England |
United Kingdom | Ulster Hospital | Belfast | Northern Ireland |
United Kingdom | Royal Blackburn Hospital | Blackburn | England |
United Kingdom | Pilgrim Hospital | Boston | England |
United Kingdom | Royal Papworth Hospital | Cambridge | England |
United Kingdom | University Hospital of Wales | Cardiff | Wales |
United Kingdom | Cumberland Infirmary | Carlisle | England |
United Kingdom | Countess of Chester Hospital | Chester | England |
United Kingdom | Chesterfield Royal Hospital | Chesterfield | England |
United Kingdom | Colchester Hospital | Colchester | England |
United Kingdom | Leighton Hospital | Crewe | England |
United Kingdom | Wonford Hospital | Exeter | England |
United Kingdom | Queen Elizabeth Hospital | Gateshead | England |
United Kingdom | Ipswich Hospital | Ipswich | England |
United Kingdom | Kingston Hospital | Kingston Upon Thames | England |
United Kingdom | Forth Valley Royal Hospital | Larbert | Scotland |
United Kingdom | Lincoln County Hospital | Lincoln | England |
United Kingdom | Aintree University Hospital | Liverpool | England |
United Kingdom | Royal Liverpool University Hospital | Liverpool | England |
United Kingdom | King's College Hospital NHS Foundation Trust | London | England |
United Kingdom | Lewisham and Greenwich Hospitals | London | England |
United Kingdom | North Middlesex University Hospital | London | |
United Kingdom | Southend University Hospital | London | |
United Kingdom | Macclesfield District General Hospital | Macclesfield | England |
United Kingdom | Maidstone Hospital | Maidstone | England |
United Kingdom | Manchester Royal Infirmary | Manchester | |
United Kingdom | North Manchester General Hospital | Manchester | |
United Kingdom | James Cook University Hospital | Middlesbrough | England |
United Kingdom | Newcastle upon Tyne Hospitals Foundation Trust | Newcastle Upon Tyne | England |
United Kingdom | Northumbria Healthcare NHS Foundation Trust | Newcastle Upon Tyne | England |
United Kingdom | Northampton General Hospital | Northampton | England |
United Kingdom | Nottingham University Hospitals | Nottingham | England |
United Kingdom | Royal Oldham Hospital | Oldham | England |
United Kingdom | Derriford Hospital | Plymouth | England |
United Kingdom | Royal Glamorgan Hospital | Pontyclun | Wales |
United Kingdom | Whiston Hospital | Prescot | England |
United Kingdom | Barking, Havering and Redbridge University Hospitals NHS Trust | Romford | |
United Kingdom | Rotherham General Hospital | Rotherham | England |
United Kingdom | Sheffield Teaching Hospitals NHS Foundation Trust | Sheffield | England |
United Kingdom | Lister Hospital | Stevenage | England |
United Kingdom | King's Mill Hospital | Sutton In Ashfield | England |
United Kingdom | Morriston Hospital | Swansea | Wales |
United Kingdom | Musgrove Park Hospital | Taunton | England |
United Kingdom | Royal Cornwall Hospital | Truro | Cornwall |
United Kingdom | Tunbridge Wells Hospital | Tunbridge Wells | England |
United Kingdom | Pinderfields General Hospital | Wakefield | England |
United Kingdom | Watford General Hospital | Watford | England |
United Kingdom | Royal Albert Edward Infirmary | Wigan | England |
Lead Sponsor | Collaborator |
---|---|
Royal Liverpool University Hospital |
United Kingdom,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | |
Primary | 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 | |
Primary | 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 | 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 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 |
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