Severe COVID anxiety among adults in the United Kingdom: protocol for a cohort study and nested feasibility trial of modified Cognitive Behaviour Therapy for Health Anxiety.
File(s)
Published version
Author(s)
Type
Journal Article
Abstract
Introduction
Some people are so anxious about COVID that it impairs their functioning. However, little is known about the course of severe COVID anxiety or what can be done to help people who experience it.
Methods and analysis
Cohort study with a nested feasibility trial with follow-up at three and six months. We recruited 306 people who were aged 18 and over, lived in the United Kingdom and had severe COVID anxiety (indicated by a score of nine or more on the Coronavirus Anxiety Scale). To take part in the nested feasibility trial, participants also had to have a score of 20 or more on the Short Health Anxiety Inventory. We excluded people from the trial if they had had COVID-19 within the previous four weeks, if they were currently self-isolating or if they were already receiving psychological treatment.
We publicised the study nationally through adverts, social media and posts on chat boards. We also recruited participants via clinicians working in primary and secondary care NHS services in London. All those in the active arm will be offered five to ten sessions of remotely delivered modified Cognitive Behaviour Therapy for Health Anxiety (CBT-HA). We will examine the proportion of participants who remain above threshold on the Coronavirus Anxiety Scale at three and six months and factors that influence levels of COVID anxiety over six months using mixed-effects logistic regression. The key feasibility metrics for the nested trial are the level of uptake of CBT-HA and the rate of follow-up.
Ethics and dissemination
Approved by Leicester Central Research Ethics Committee (reference: 20/EM/0238). The results of the study will be published in peer-reviewed scientific journals.
Trial registration: International Standard Randomised Control Trial Number Register - ISRCTN14973494
Some people are so anxious about COVID that it impairs their functioning. However, little is known about the course of severe COVID anxiety or what can be done to help people who experience it.
Methods and analysis
Cohort study with a nested feasibility trial with follow-up at three and six months. We recruited 306 people who were aged 18 and over, lived in the United Kingdom and had severe COVID anxiety (indicated by a score of nine or more on the Coronavirus Anxiety Scale). To take part in the nested feasibility trial, participants also had to have a score of 20 or more on the Short Health Anxiety Inventory. We excluded people from the trial if they had had COVID-19 within the previous four weeks, if they were currently self-isolating or if they were already receiving psychological treatment.
We publicised the study nationally through adverts, social media and posts on chat boards. We also recruited participants via clinicians working in primary and secondary care NHS services in London. All those in the active arm will be offered five to ten sessions of remotely delivered modified Cognitive Behaviour Therapy for Health Anxiety (CBT-HA). We will examine the proportion of participants who remain above threshold on the Coronavirus Anxiety Scale at three and six months and factors that influence levels of COVID anxiety over six months using mixed-effects logistic regression. The key feasibility metrics for the nested trial are the level of uptake of CBT-HA and the rate of follow-up.
Ethics and dissemination
Approved by Leicester Central Research Ethics Committee (reference: 20/EM/0238). The results of the study will be published in peer-reviewed scientific journals.
Trial registration: International Standard Randomised Control Trial Number Register - ISRCTN14973494
Date Issued
2022-09-07
Date Acceptance
2022-08-18
Citation
BMJ Open, 2022, 12 (9), pp.1-9
ISSN
2044-6055
Publisher
BMJ Journals
Start Page
1
End Page
9
Journal / Book Title
BMJ Open
Volume
12
Issue
9
Copyright Statement
© Author(s) (or their employer(s)) 2022. Re-use permitted under CC BY. Published by BMJ. https://creativecommons.org/licenses/by/4.0/
This is an open access article distributed in accordance with the Creative Commons Attribution 4.0 Unported (CC BY 4.0) license, which permits others to copy, redistribute, remix, transform and build upon this work for any purpose, provided the original work is properly cited, a link to the licence is given, and indication of whether changes were made. See: https://creativecommons.org/licenses/by/4.0/.
This is an open access article distributed in accordance with the Creative Commons Attribution 4.0 Unported (CC BY 4.0) license, which permits others to copy, redistribute, remix, transform and build upon this work for any purpose, provided the original work is properly cited, a link to the licence is given, and indication of whether changes were made. See: https://creativecommons.org/licenses/by/4.0/.
License URL
Sponsor
Imperial College Healthcare NHS Trust- BRC Funding
Identifier
https://bmjopen.bmj.com/content/12/9/e059321.info
Grant Number
RDA01
Subjects
1103 Clinical Sciences
1117 Public Health and Health Services
1199 Other Medical and Health Sciences
Publication Status
Published
Date Publish Online
2022-09-07