COVID Anxiety Project
Research type
Research Study
Full title
The COVID Anxiety Project
IRAS ID
284331
Contact name
Mike Crawford
Contact email
Sponsor organisation
Imperial College London
ISRCTN Number
ISRCTN14973494
Duration of Study in the UK
1 years, 7 months, 31 days
Research summary
In addition to risks to physical health, covid-19 is having a major impact on mental health as people struggle to cope with the psychological impact of the disease. Some people develop “health anxiety” and these can have a major impact on a person’s life and functioning. The risks and consequences of covid anxiety are not known, and data are needed to help ensure that people with severe covid anxiety receive effective treatment and support.
Cognitive Behavioural Therapy for Health Anxiety (CBT-HA) has been shown to improve the mental health of people with health anxiety. However, the benefit for people with severe anxiety triggered by a pandemic have not been tested. It is possible that repeated public warnings about the dangers of the virus may affect the acceptability, uptake and impact of the intervention.
This study aims to examine the impact, course and risk factors for covid anxiety, and to test the feasibility of conducting a randomised trial of CBT-HA for people with covid anxiety. Potential participants will be identified by mental health services and public facing advertising. Adults scoring 9+ on the Covid Anxiety Scale will be asked about their thoughts and feelings, their health and use of health services, occupational and social functioning, and demographic information. They will be invited to answer some of the same questions at 3-month and 6-month follow-up.
Those that score 20+ on the Health Anxiety Inventory at baseline will also be invited to take part in a 1:1 randomised trial of CBT-HA. Those allocated to CBT-HA will receive 5-10 sessions of therapy, delivered remotely by telephone or video-call. We will look at the questionnaire responses of the trial participants over time and compare the groups to see whether people that were given CBT improved when compared to those that were not given CBT.
Lay summary of study results: General information about the study.
This study was conducted by a team of researchers at Imperial College London, University College London, and City University of London. It was funded by the National Institute for Health Research Imperial Biomedical Research Centre and a National Institute for Health Research Senior Investigator award held by Professor Crawford.
Six members of the public with lived experience of poor mental health were involved in designing the study and reporting the results. Members of the group helped us develop the study questionnaires, work out how to recruit people and interpret the results of the study.
We recruited people into the study between February 2021 and September 2021 and followed people up for six months. We recruited people online and from primary care services in London.
We conducted the study after we became aware during the first phase of the COVID pandemic that some people had become so anxious about the virus that they were unable to do the things they needed to do. For instance, some people were not going out at all or were keeping their children away from school, even after schools had re-opened.
Before the pandemic, some of us had worked on a study of Health Anxiety – a condition in which people become so anxious about their health that they are unable to function properly. We completed a clinical trial of a psychological intervention called ‘Cognitive Behaviour Therapy for Health Anxiety’ (CBT-HA) and found that it helped improve people’s mental health. After the pandemic started, we designed a new study to find out what factors influenced how anxious people felt about COVID. We also wanted to find out if it would be possible to conduct a clinical trial of CBT-HA for people who had severe COVID anxiety.Methods used to conduct the study.
We set up an online survey and publicised it through social media platforms including Facebook and Instagram, through websites of mental health charities and through text messages sent to patients registered with primary care practices in North West London.
We asked people who were so anxious about COVID that it was stopping them from getting on with their lives to consider taking part. Potential participants were asked to look at a website to find out about the study and read a Participant Information Sheet. People who wanted to take part were asked to complete a consent form and study questionnaires. These included questions about age, gender, living circumstances, mental health, physical health, social functioning and steps that people were taking to avoid catching COVID.
We asked people who took part in the study to repeat the survey three and six months later. We approached some people who took part in the study and asked them if they would be willing to take part in the clinical trial of CBT-HA. Half the people who agreed to take part in the clinical trial were then randomised to CBT-HA sessions. This meant that everyone who took part in the clinical trial had a 50% chance of receiving the sessions.
All those who took part in the study were offered a self-help booklet giving general advice about how to improve mental health during the pandemic. People who took part in the clinical trial and were randomised to CBT-HA were also offered up to 10 online sessions with a trained mental healthcare practitioner. During these sessions people were asked about their thoughts and fears about COVID. Practitioners talked to people about things they may be doing that were making it harder for them to cope and to try out different ways of doing things to see if this helped them cope better with their fears.
All people who completed study interviews were offered vouchers to thank them for taking part.Results of the study.
306 people took part in the study. Of these, 40 took part in the clinical trial. Most people who took part in the study were in their 30s and 40s, and about 80% were women. Seven out of 10 people who took part in the study had high levels of health anxiety.
We found that the level of COVID anxiety people experienced halved over the six months that we followed them up. Reductions in COVID anxiety were less among older people, those living with a person who was vulnerable to the effects of COVID, and among those who had higher levels of health anxiety at the start of the study.
Among the 40 people who took part in the clinical trial, 21 were offered CBT-HA. Of these 21 people, 17 attended four or more sessions of CBT-HA. We found improved mental health and social functioning among people who were offered CBT-HA. We did not see this among those who were not offered the CBT-HA sessions.How the study helped patients and researchers.
Although the COVID virus has become less harmful and most people have developed some resistance to the virus, we believe that lessons learned in this study could be helpful when another pandemic occurs.
The results provide some reassurance for members of the public that high levels of anxiety many people experience at the start if a pandemic could reduce. They also show that people with high levels of health anxiety, may be at greater risk of remaining anxious. The results of our small clinical trial of CBT-HA suggest that this approach may be acceptable to people who experience severe anxiety at the start of a pandemic. Our results also suggest that it may be possible to conduct a large-scale trial of on-line CBT-HA during a future pandemic, to see if this helps people who are severely anxious, recover more quickly.Future planned research.
We are in the process of analysing information collected from study participants 18 months after they completed the first survey, to find out what happened to them.Where can I learn more about the study?
Detailed results of the study have been published in BMC Psychiatry and can be found by following this link: https://gbr01.safelinks.protection.outlook.com/?url=https%3A%2F%2Fu2790089.ct.sendgrid.net%2Fls%2Fclick%3Fupn%3Du001.QwnS5iG-2B4nwcunWxC03fkDgINS4i-2F3jYTE2ETPElaAgFgxPxzXdReYh7PcAVDguxU-2F1YO-2F5pu0iwwBLINMvmSlpRLSO1kcUssWdRUaIyduA-3DkOLM_a04dWCHmDh7gi4hRuvmsd-2FMEDkPNm6D0IRdq0o1v81fgEhS6bLj-2Fvh9BEHuM8sItb-2BZVpaixv7sjLydyuT3lu2G84-2FX4PCx-2FuQnRwqSfwePcXsdp9WfUE78zwPnW9cR3e401DsyfCXf0xiH6y9RXy2swxz-2BMMcsnC2FMncveLUb2VcMNiYV6Cbgr62WT7gJOtjAP8JZQ90nKQTOPid7Z-2Fw-3D-3D&data=05%7C02%7Cleicestercentral.rec%40hra.nhs.uk%7C67b6bd643ce14e0a231008dc49a83e84%7C8e1f0acad87d4f20939e36243d574267%7C0%7C0%7C638466234152563327%7CUnknown%7CTWFpbGZsb3d8eyJWIjoiMC4wLjAwMDAiLCJQIjoiV2luMzIiLCJBTiI6Ik1haWwiLCJXVCI6Mn0%3D%7C0%7C%7C%7C&sdata=Dp1nbWtVpoqxpN7o8wvhsMjCv%2BtDqDT8uUxdLqDMkGY%3D&reserved=0
We would like to thank all those people who took the time to take part in the study and help us learn how it may be possible to provide support to people during a future pandemic.
the URL to summary results: https://gbr01.safelinks.protection.outlook.com/?url=https%3A%2F%2Fu2790089.ct.sendgrid.net%2Fls%2Fclick%3Fupn%3Du001.QwnS5iG-2B4nwcunWxC03fkBqunO9Zl-2FOD1tWNDrwSyPoazhz3DG7but-2F-2Fuq6Qb5Njxn6z_a04dWCHmDh7gi4hRuvmsd-2FMEDkPNm6D0IRdq0o1v81fgEhS6bLj-2Fvh9BEHuM8sItrn1bky6fUyYEK7XIpFp1v-2Byl2eli6fkLYKoz5e8akzTUT5-2B5pXigqXwzYiipx1zAsdGI4Z6NvZK88pPo1xxmTDCh9Wom4jkFo7yrSgdD8th8AcjfMtavd5tI6-2FU-2FmriqKsYtHZa9FCm2l60Jm9NWFw-3D-3D&data=05%7C02%7Cleicestercentral.rec%40hra.nhs.uk%7C67b6bd643ce14e0a231008dc49a83e84%7C8e1f0acad87d4f20939e36243d574267%7C0%7C0%7C638466234152570165%7CUnknown%7CTWFpbGZsb3d8eyJWIjoiMC4wLjAwMDAiLCJQIjoiV2luMzIiLCJBTiI6Ik1haWwiLCJXVCI6Mn0%3D%7C0%7C%7C%7C&sdata=CnKyV0d4OQy6oZQjj8frrPDp8gRWDibF6o6%2BxAN4Sf4%3D&reserved=0
"Results article"
> https://gbr01.safelinks.protection.outlook.com/?url=https%3A%2F%2Fu2790089.ct.sendgrid.net%2Fls%2Fclick%3Fupn%3Du001.QwnS5iG-2B4nwcunWxC03fkHWszZdTUktK-2FA8QcG1E8EnRjENeo5e2rHgCumxWqDXaN3Jv2mdDftnL5a40W3YBoNL-2BykiMrjU-2FOoKcj8ONRXOvazGgWpqiytsqVho1dgoI258s_a04dWCHmDh7gi4hRuvmsd-2FMEDkPNm6D0IRdq0o1v81fgEhS6bLj-2Fvh9BEHuM8sItewlM0C-2FTbg3eBYOyHPbdJ-2FA3S4Zo-2B13L8x1EByzjjQGNb9FNGyvaNQiSPPrA7l6BA5D-2BVNQC1qAmgkQ-2BbqL6rWcCAHLhjkCOWzwk40AeMKpuZFElSasoPtBJE18J2-2FbhUjVWC7-2Fxtu2-2FON7oI24-2FOw-3D-3D&data=05%7C02%7Cleicestercentral.rec%40hra.nhs.uk%7C67b6bd643ce14e0a231008dc49a83e84%7C8e1f0acad87d4f20939e36243d574267%7C0%7C0%7C638466234152576150%7CUnknown%7CTWFpbGZsb3d8eyJWIjoiMC4wLjAwMDAiLCJQIjoiV2luMzIiLCJBTiI6Ik1haWwiLCJXVCI6Mn0%3D%7C0%7C%7C%7C&sdata=ZSUKL%2B%2BgWUEEBtC5Jd77lP5TrdAtrd%2B%2F1JkkwvI6LSE%3D&reserved=0REC name
East Midlands - Leicester Central Research Ethics Committee
REC reference
20/EM/0238
Date of REC Opinion
27 Oct 2020
REC opinion
Further Information Favourable Opinion