Severe COVID-19 anxiety among adults in the UK: protocol for a cohort study and nested feasibility trial of modified cognitive–behavioural therapy for health anxiety

Abstract

Introduction Some people are so anxious about COVID-19 that it impairs their functioning. However, little is known about the course of severe COVID-19 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 3 and 6 months. We recruited 306 people who were aged 18 and over, lived in the UK and had severe COVID-19 anxiety (indicated by a score of 9 or more on the Coronavirus Anxiety Scale (CAS)). 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 4 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 message 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 5–10 sessions of remotely delivered modified cognitive–behavioural therapy for health anxiety (CBT-HA). We will examine the proportion of participants who remain above threshold on the CAS at 3 and 6 months and factors that influence levels of COVID-19 anxiety over 6 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 number NCT14973494.

The association of severe COVID anxiety with poor social functioning, quality of life, and protective behaviours among adults in United Kingdom: a cross-sectional study

“…This two-step analytic cross-sectional study uses data collected at baseline from Imperial College London’s COVID-19 Anxiety Project (CAP), a longitudinal study of people with severe COVID anxiety, a full description of which has been published elsewhere [ 35 ]. This article was written in line with STROBE guidelines for cross-sectional studies [ 36 ].…”

Trajectory of severe COVID anxiety and predictors for recovery in an 18-month cohort

“…21 participants were excluded from these analyses as they received a course of adapted CBT for Health Anxiety as part of the nested feasibility trial which we anticipated would influence the natural trajectory of severe COVID anxiety. (21) There were significant rates of mental health conditions in this cohort, and otherwise nationally representative rates of at-risk health conditions. A full description of baseline cohort characteristics has been reported previously.…”

“…We previously conducted analysis on this same cohort at the 6-month time-point (22) which identified that older age, higher baseline levels of generalised and health anxiety, and greater reductions in health anxiety and depressive symptoms were significantly associated in multivariable models with greater reductions in COVID anxiety. These findings are again demonstrated one year later at the 18-month follow-up timepoint, however the effect of baseline mental health scores become no longer predictive of the longer-term trajectory of severe COVID anxiety.…”

“…Given our findings that greater decreases in depressive and health anxiety symptoms were associated with greater declines in COVID anxiety, we might suggest that there is cause to believe that established mental health interventions proven to reduce these symptoms have a theoretical basis for also improving COVID anxiety. And to note reciprocally, that randomised clinical trials of interventions specifically targeting COVID anxiety, particularly online CBT based interventions (22,39,40) appear to improve other mental health outcomes too.…”

“…306 people (30.4%) scored nine or more on the 20-point COVID Anxiety Scale (CAS) (20) indicating severe COVID anxiety, provided written consent and met other eligibility criteria including not having a history of psychotic illness, nor having had COVID-19 in the preceding four weeks. (21) The cohort recruited participants until there were enough people meeting further criteria to power a nested randomised feasibility trial of CBT for health anxiety. ( 22)…”