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

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