COVID-19PIM-COVIDNCT05092529
Psychological Impact of COVID-19 on Intensive Care Survivors
An observational study of COVID-19 and Psychological Distress, run by Royal Liverpool University Hospital at 50 sites in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- COVID-19, Psychological Distress, Depression
- How many people
- 1,620 participants
- Where
- 50 sitesUnited Kingdom
- Study dates
- 17 Nov 2020to 17 Nov 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Intensive care survivors
Who may be able to join
- Adult patients ≥18 years
- Survival to intensive care / high dependency unit discharge following an admission of ≥24 hours
- Treated for COVID-19
Who cannot join
- 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.
Trial locations and contacts
50 sites in 1 country.
50 sites in 1 country
United Kingdom50 sites
Barnsley Hospital
Barnsley, England, S75 2EP
Basildon Hospital
Basildon, England, SS16 5NL
Bedford Hospital
Bedford, England, MK42 9DJ
Ulster Hospital
Belfast, Northern Ireland, BT16 1RH
Royal Blackburn Hospital
Blackburn, England, BB2 3HH
Pilgrim Hospital
Boston, England, PE21 9QS
Royal Papworth Hospital
Cambridge, England, CB2 0AY
University Hospital of Wales
Cardiff, Wales, CF14 4XW
Cumberland Infirmary
Carlisle, England, CA2 7HY
Countess of Chester Hospital
Chester, England, CH2 1UL
Chesterfield Royal Hospital
Chesterfield, England, S44 5BL
Colchester Hospital
Colchester, England, CO4 5JL
Leighton Hospital
Crewe, England, CW1 4QJ
Wonford Hospital
Exeter, England, EX2 5DW
Queen Elizabeth Hospital
Gateshead, England, NE9 6SX
Ipswich Hospital
Ipswich, England, IP4 5PD
Kingston Hospital
Kingston upon Thames, England, KT2 7QB
Forth Valley Royal Hospital
Larbert, Scotland, FK5 4WR
Lincoln County Hospital
Lincoln, England, LN2 5QY
Royal Liverpool University Hospital
Liverpool, England, L7 8XP
Aintree University Hospital
Liverpool, England, WD18 0HB
Lewisham and Greenwich Hospitals
London, England, SE13 6LH
King's College Hospital NHS Foundation Trust
London, England, SE5 9RS
North Middlesex University Hospital
London, N18 1QX
Southend University Hospital
London, SS2 6XT
Macclesfield District General Hospital
Macclesfield, England, SK10 3BL
Maidstone Hospital
Maidstone, England, ME16 9QQ
Manchester Royal Infirmary
Manchester, M13 9WL
North Manchester General Hospital
Manchester, M8 5RB
James Cook University Hospital
Middlesbrough, England, TS4 3BW
Northumbria Healthcare NHS Foundation Trust
Newcastle upon Tyne, England, NE27 0QJ
Newcastle upon Tyne Hospitals Foundation Trust
Newcastle upon Tyne, England, NE7 7DN
Northampton General Hospital
Northampton, England, NN1 5BD
Nottingham University Hospitals
Nottingham, England, NG5 1PB
Royal Oldham Hospital
Oldham, England, OL1 2JH
Derriford Hospital
Plymouth, England, PL6 8DH
Royal Glamorgan Hospital
Pont-y-clun, Wales, CF72 8XR
Whiston Hospital
Prescot, England, L35 5DR
Barking, Havering and Redbridge University Hospitals NHS Trust
Romford, RM7 0AG
Rotherham General Hospital
Rotherham, England, S60 2UD
Tunbridge Wells Hospital
Royal Tunbridge Wells, England, TN2 4QJ
Sheffield Teaching Hospitals NHS Foundation Trust
Sheffield, England, S10 2JF
Lister Hospital
Stevenage, England, SG1 4AB
King's Mill Hospital
Sutton in Ashfield, England, NG17 4JL
Morriston Hospital
Swansea, Wales, SA6 6NL
Musgrove Park Hospital
Taunton, England, TA1 5DA
Royal Cornwall Hospital
Truro, Cornwall, TR1 3LJ
Pinderfields General Hospital
Wakefield, England, WF1 4DG
Watford General Hospital
Watford, England, WD18 0HB
Royal Albert Edward Infirmary
Wigan, England, WN1 2NN
About this study
Official title: The Psychological Impact of Surviving an Intensive Care Admission Due to Coronavirus Disease 2019 (COVID-19) on Patients in the United Kingdom
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.
Read the 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:
- 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.
- Conditions
- COVID-19, Psychological Distress, Depression, Anxiety, Post-traumatic Stress Disorder, Post Intensive Care Syndrome
- Medical subject headings
- COVID-19, Depression, Anxiety Disorders, Stress Disorders, Post-Traumatic, postintensive care syndrome
What is being measured
The primary outcome is the main question the study is designed to answer.
Anxiety
Hospital Anxiety and Depression Scale (HADS) where a score of 0-7= normal, 8-10= borderline abnormal (borderline case), 11-21= abnormal (case).
Measured: 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).
Measured: 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.
Measured: 6 months post ICU discharge
Secondary outcomes (6)
Anxiety
Hospital Anxiety and Depression Scale (HADS) where a score of 0-7= normal, 8-10= borderline abnormal (borderline case), 11-21= abnormal (case).
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Study duration, up to 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Oct 2021
- Study start17 Nov 2020
- Primary completion14 Feb 2023
- Study completion17 Nov 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for COVID-19Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,620 participants (actual)
Sponsor and investigators
- Lead sponsor
- Royal Liverpool University Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Alicia Waite, Royal Liverpool University Hospital
- Investigators
- Alicia AC Waite, Principal investigator, Royal Liverpool University HospitalIngeborg D Welters, Principal investigator, University of Liverpool
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05092529
- Sponsor's protocol ID
- SP0316
- Other IDs
- IRAS 282400, NIHR CPMS 47545
- Acronym
- PIM-COVID
- Status last verified
- Nov 2023
- First submitted
- 18 Oct 2021
- Last updated
- 28 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Upon the conclusion of the study, the dataset may be made available from the corresponding author on reasonable request.
Publications
Waite AAC, Johnston BW, Boyle AJ, Cherry MG, Fisher P, Brown SL, Jones C, Williams K, Welters ID. PIM-COVID study: protocol for a multicentre, longitudinal study measuring the psychological impact of surviving an intensive care admission due to COVID-19 on patients in the UK. BMJ Open. 2023 Sep 27;13(9):e071730. doi: 10.1136/bmjopen-2023-071730.
PubMed 37758678
Study at a glance
From the registry record, last updated by the sponsor on 28 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Psychological Impact of Surviving an Intensive Care Admission Due to Coronavirus Disease 2019 (COVID-19) on Patients in the United Kingdom
- ClinicalTrials.gov ID
- NCT05092529
- Acronym / sponsor ID
- PIM-COVID / SP0316
- Conditions
- COVID-19, Psychological Distress, Depression, Anxiety, Post-traumatic Stress Disorder, Post Intensive Care Syndrome
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,620 participants (actual)
- Lead sponsor
- Royal Liverpool University HospitalOther government
- Study start
- 17 Nov 2020 (actual)
- Primary completion
- 14 Feb 2023 (actual)
- Study completion
- 17 Nov 2023 (actual)
- First posted
- 25 Oct 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Intensive care survivors
Key inclusion criteria (3 listed)
- Adult patients ≥18 years
- Survival to intensive care / high dependency unit discharge following an admission of ≥24 hours
- Treated for COVID-19
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Anxiety
Time frame: 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).
Depression
Time frame: 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).
Symptoms of trauma
Time frame: 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.
6 secondary outcomes
Anxiety
Time frame: 3 and/or 12 months post ICU discharge
Depression
Time frame: 3 and/or 12 months post ICU discharge
Symptoms of trauma
Time frame: 3 and/or 12 months post ICU discharge
Metacognitive beliefs and processes
Time frame: 3, 6 and/or 12 months post ICU discharge
Health-related quality of life
Time frame: 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
Time frame: Study duration, up to 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Nov 2023.
- Derived from this study: PubMed 37758678Waite AAC, Johnston BW, Boyle AJ, Cherry MG, Fisher P, Brown SL, Jones C, Williams K, Welters ID. PIM-COVID study: protocol for a multicentre, longitudinal study measuring the psychological impact of surviving an intensive care admission due to COVID-19 on patients in the UK. BMJ Open. 2023 Sep 27;13(9):e071730. doi: 10.1136/bmjopen-2023-071730.
- Trainee Research in Intensive Care Network websiteLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided. Upon the conclusion of the study, the dataset may be made available from the corresponding author on reasonable request.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alicia AC Waite principal investigator
Royal Liverpool University Hospital
Ingeborg D Welters principal investigator
University of Liverpool
50 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of COVID-19 and Psychological Distress, run by Royal Liverpool University Hospital at 50 sites in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 50 sites in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Anxiety (time frame: 6 months post intensive care unit (ICU) discharge). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05092529, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Nov 2023.