COVID-19 social study: the effects of quarantine on mental health

ISRCTN ISRCTN97041334
DOI https://doi.org/10.1186/ISRCTN97041334
Secondary identifying numbers Project ID/Title: 12467/005
Submission date
28/04/2020
Registration date
04/05/2020
Last edited
09/11/2022
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Mental and Behavioural Disorders
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

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 March 2022 (updated 24/03/2021, previously: December 2020)

Who is funding the study?
Nuffield Foundation (UK)

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

Study website

Contact information

Dr Elise Paul
Public

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

ORCiD logoORCID ID 0000-0002-9193-3740
Email e.paul@ucl.ac.uk

Study information

Study designObservational longitudinal quantitative study with qualitative sub study.
Primary study designObservational
Secondary study designLongitudinal study
Study setting(s)Other
Study typeQuality of life
Participant information sheet https://redcap.idhs.ucl.ac.uk/surveys/?s=TTXKND8JMK
Scientific titleEnforced social isolation and mental health: an observational study of the psychosocial effects of quarantine during COVID-19
Study hypothesis1. 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(s)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
ConditionMental Health during the COVID-19 epidemic and during the UK lockdown
InterventionParticipants 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 typeOther
Primary outcome measureMeasured weekly:
1. Depression (using the patient health questionnaire PHQ-9)
2. Anxiety (using the generalised anxiety disorder assessment GAD-7)
Secondary outcome measuresMeasured 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 study start date23/03/2020
Overall study end date23/03/2022

Eligibility

Participant type(s)All
Age groupAdult
Lower age limit18 Years
SexBoth
Target number of participants1,000,000+; we are aiming to recruit a large cohort
Total final enrolment73217
Participant inclusion criteriaAdults (18+ years) residing in the UK
Participant exclusion criteriaDoes not meet inclusion criteria
Recruitment start date23/03/2020
Recruitment end date31/12/2020

Locations

Countries of recruitment

  • England
  • United Kingdom

Study 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

University College London
University/education

Office of the Vice Provost Research
2 Taviton Street
University College London
London
WC1H 0BW
England
United Kingdom

Phone +44 (0)20 7679 8717
Email ethics@ucl.ac.uk
Website http://www.ucl.ac.uk/
ROR logo "ROR" https://ror.org/02jx3x895

Funders

Funder type

Charity

Nuffield Foundation
Private sector organisation / Trusts, charities, foundations (both public and private)
Location
United Kingdom

Results and Publications

Intention to publish date23/03/2022
Individual participant data (IPD) Intention to shareYes
IPD sharing plan summaryStored in publicly available repository
Publication and dissemination planThe 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 planThe datasets generated during and/or analysed during the current study will be stored in a publically available repository.

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Other publications link to live results data at 24/03/2021 Yes No
Preprint results 25/05/2022 09/11/2022 No No

Editorial Notes

09/11/2022: Preprint added.
25/03/2021: The following changes were made to the trial record:
1. The recruitment end date was changed from 23/03/2022 to 31/12/2020.
2. The contact was changed.
3. The total final enrolment was added.
24/03/2021: The following changes were made to the trial record:
1. The recruitment end date was changed from 30/09/2020 to 23/03/2022.
2. The overall end date was changed from 31/12/2020 to 23/03/2022.
3. The intention to publish date was changed from 01/09/2020 to 23/03/2022.
4. The plain English summary was updated to reflect these changes.
5. Link to results data added.
01/05/2020: Trial’s existence confirmed by University College London Research Ethics Committee.