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Completed

NCT Number: NCT05092529

Psychological Impact of COVID-19 on Intensive Care Survivors

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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. 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).

  2. 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).

  3. 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.

Secondary outcomes

  1. Anxiety

    Time frame: 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).

  2. Depression

    Time frame: 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).

  3. Symptoms of trauma

    Time frame: 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.

  4. Metacognitive beliefs and processes

    Time frame: 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.

  5. Health-related quality of life

    Time frame: 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.

  6. Feasibility of using self-reported questionnaire to assess psychological outcomes in ICU survivors with COVID-19

    Time frame: Study duration, up to 1 year

    Response rate to invitations to participate/questionnaires.

Sponsors and collaborators

Lead sponsor

Royal Liverpool University Hospital

Other Gov

Registry information

Official study title

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

Acronym: PIM-COVID

Important dates

Study start
2020
Primary completion
2023
Study completion
2023
First posted
Oct 25, 2021
Registry last updated
Nov 28, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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