Condition category
Mental and Behavioural Disorders
Date applied
28/04/2020
Date assigned
04/05/2020
Last edited
04/05/2020
Prospective/Retrospective
Retrospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

Plain English Summary

Background and study aims
COVID-19 is a condition caused by the coronavirus (called SARS-CoV-2) that was first identified in late 2019. This virus can infect the respiratory (breathing) system. Some people do not have symptoms but can carry the virus and pass it on to others. People who have developed the condition may develop a fever and/or a continuous cough among other symptoms. This can develop into pneumonia. Pneumonia is a chest infection where the small air pockets of the lungs, called alveoli, fill with liquid and make it more difficult to breathe.

In 2020, the virus has spread to many countries around the world and neither a vaccine against the virus or specific treatment for COVID-19 has yet been developed. As of March 2020, it is advised that people minimize travel and social contact, and regularly wash their hands to reduce the spread of the virus.

Groups who are at a higher risk from infection with the virus, and therefore of developing COVID-19, include people aged over 70 years, people who have long-term health conditions (such as asthma or diabetes), people who have a weakened immune system and people who are pregnant. People in these groups, and people who might come into contact with them, can reduce this risk by following the up-to-date advice to reduce the spread of the virus.

Due to COVID-19, large numbers of people across the UK are going into isolation for potentially significant periods of time. It remain unknown how this will affect the mental health and social functioning of individuals. Further, it is unclear whether socio-demographic factors or individual characteristics might make some individuals more at risk of deteriorating mental health, or whether certain home-based activities could buffer against adverse effects.

This study aims to identify how the news about coronavirus is affecting people, whether people are having to isolate, and their experiences of isolating. It aims to inform understanding about the effects of social isolation measures on people's mental health. The findings will be used to help develop ways to support people psychologically and socially during this outbreak.

Who can participate?
Adults (18+ years) residing in the UK

What does the study involve?
Participants answer an online weekly survey and the researchers plan to use longitudinal statistical methods to track changes in their experiences over time. The study will be ongoing for the duration of this pandemic in the UK. The researchers are supplementing this with a qualitative study involving telephone interviews with those groups the researchers expect to be under-represented in the quantitative study.

What are the possible benefits and risks of participating?
Large numbers of people may be feeling bored or ‘inactive’ during their isolation and may be wishing they could do things to help. Engagement in this research study may help them feel they are supporting efforts relating to COVID-19 as the study aims to inform understanding about the effects of social isolation measures on people’s mental health and the findings will be used to help develop ways to support people psychologically and socially during this outbreak. At the end of the survey, we point people to the NHS advice page on coronavirus and also to a web page with lots of ideas for activities to do in isolation, so these may help individuals’ experiences.

It is possible that participants may become more aware of their mental health as a result of taking this questionnaire. However, we have provided the link to the NHS website and the Samaritans on any page that contains questions about mental health.

Where is the study run from?
University College London, Research Department of Behavioural Science and Health (UK)

When is the study starting and how long is it expected to run for?
March 2020 to December 2020

Who is funding the study?
Nuffield Foundation (UK)

Who is the main contact?
Vas James, v.james@ucl.ac.uk

Trial website

http://www.covid19study.org

Contact information

Type

Public

Primary contact

Ms Vas James

ORCID ID

http://orcid.org/0000-0002-6952-334X

Contact details

Research Department of Behavioural Science and Health
Institute of Epidemiology & Health Care
University College London
1-19 Torrington Place
London
WC1E 7HB
United Kingdom
+ 44 (0) 20 3108 3407
v.james@ucl.ac.uk

Additional identifiers

EudraCT number

Nil known

ClinicalTrials.gov number

Nil known

Protocol/serial number

Project ID/Title: 12467/005

Study information

Scientific title

Enforced social isolation and mental health: an observational study of the psychosocial effects of quarantine during COVID-19

Acronym

Study hypothesis

1. What are the psychosocial experiences of people in isolation? What is the new social reality for people, and how is it affecting their identity and wellbeing?
2. How do trajectories of mental health and loneliness change over time for people in isolation? Is there a critical pivot point (e.g. 5 weeks into isolating) at which mental health starts to decline fast?
3. Which groups are greater risk of experiencing adverse effects of isolation than others? Do certain socio-demographic characteristics, work roles, or psychological traits predispose some people to poorer psychosocial experiences during from this pandemic?
4. How are individuals’ health behaviours being affected? What are the barriers that mean some individuals are not adhering to official advice?
5. Which activities help to buffer potential adverse effects of isolation? Could we be providing more specific guidance on how people spend their time in isolation?

Ethics approval

Approved 23/03/2020, University College London Research Ethics Committee (Office for the Vice Provost Research, University College London, 2 Taviton Street, London, UK; +44 (0)20 7679 8717; ethics@ucl.ac.uk), ref: Project ID/Title: 12467/005

Study design

Observational longitudinal quantitative study with qualitative sub study.

Primary study design

Observational

Secondary study design

Longitudinal study

Trial setting

Other

Trial type

Quality of life

Patient information sheet

https://redcap.idhs.ucl.ac.uk/surveys/?s=TTXKND8JMK

Condition

Mental Health during the COVID-19 epidemic and during the UK lockdown

Intervention

Participants answer an online weekly survey and the researchers plan to use longitudinal statistical methods to track changes in their experiences over time. The study will be ongoing for the duration of this pandemic in the UK.

The researchers are supplementing this with a qualitative study involving telephone interviews with those groups the researchers expect to be under-represented in the quantitative study, including adolescents, healthy adults not adhering to the social distancing advice, high-risk adults with existing health conditions, adults with existing mental illness, adults who are pregnant, and older adults. These interviews will draw on psychological and behavioural frameworks including the COM-B behaviour change model and the social networks framework and data will be coded thematically to gain a richer understanding of how these particular groups are being affected.

Intervention type

Other

Phase

Drug names

Primary outcome measure

Measured weekly:
1. Depression (using the patient health questionnaire PHQ-9)
2. Anxiety (using the generalised anxiety disorder assessment GAD-7)

Secondary outcome measures

Measured weekly:
1. Wellbeing (using the ONS Wellbeing measures of happiness, life satisfaction, and meaning)
2. Loneliness (using both the 3-item UCLA loneliness scale)
3. Isolation (using a question on frequency of contact with family or friends)

Weekly reports can be found here: https://www.marchnetwork.org/research

Overall trial start date

23/03/2020

Overall trial end date

31/12/2020

Reason abandoned (if study stopped)

Eligibility

Participant inclusion criteria

Adults (18+ years) residing in the UK

Participant type

All

Age group

Adult

Gender

Both

Target number of participants

1,000,000+; we are aiming to recruit a large cohort

Participant exclusion criteria

Does not meet inclusion criteria

Recruitment start date

23/03/2020

Recruitment end date

30/09/2020

Locations

Countries of recruitment

United Kingdom

Trial participating centre

University College London
Research Department of Behavioural Science and Health Institute of Epidemiology & Health Care University College London 1-19 Torrington Place
London
WC1E 7HB
United Kingdom

Sponsor information

Organisation

University College London

Sponsor details

Office of the Vice Provost Research
2 Taviton Street
University College London
London
WC1H 0BW
United Kingdom
+44 (0)20 7679 8717
ethics@ucl.ac.uk

Sponsor type

University/education

Website

http://www.ucl.ac.uk/

Funders

Funder type

Charity

Funder name

Nuffield Foundation

Alternative name(s)

Funding Body Type

private sector organisation

Funding Body Subtype

Trusts, charities, foundations (both public and private)

Location

United Kingdom

Results and Publications

Publication and dissemination plan

The research team will provide a publicly-available weekly summary of supportive descriptive findings (e.g. showing protective activities people could be doing at home). They will also be providing data on more sensitive topics (e.g. trajectories of mental illness in the country) to key stakeholders within public health, the NHS, and government.

IPD sharing statement:
The datasets generated during and/or analysed during the current study will be stored in a publically available repository.

Intention to publish date

01/09/2020

Participant level data

Stored in repository

Basic results (scientific)

Publication list

Publication citations

Additional files

Editorial Notes

01/05/2020: Trial’s existence confirmed by University College London Research Ethics Committee.