Psychological Impact of COVID-19 on Intensive Care Survivors

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT05092529

Acronym

PIM-COVID

Enrollment

1620

Registered

2021-10-25

Start date

2020-11-17

Completion date

2023-11-17

Last updated

2023-11-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame	Description
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).
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).
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

Measure	Time frame	Description
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).
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).
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.
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.
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.
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.

Countries

United Kingdom

Outcome results