Condition category
Mental and Behavioural Disorders
Date applied
22/07/2020
Date assigned
30/07/2020
Last edited
23/07/2020
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims:
The COVID-19 outbreak has caused widespread problems across the world which are likely to have adverse effects on the mental health and well-being of many people across many sectors of the population. The major aims of the present study were to determine levels of mental health problems and well-being difficulties across the population of Wales during the current COVID-19 pandemic and how these difficulties are influenced by some simple demographics such as gender, age, and levels of economic deprivation.

Who can participate?
Individuals aged 16 and over, who lived in Wales during the COVID-19 pandemic.

What does the study involve?
The study consisted of a 10-15 minute online survey. The survey comprised of six sections. The first section consisted of questions relating to various demographic factors. The second section contained questions relating to mental well-being. The third section asked about the individuals levels of psychological distress. The fourth section asked participants to complete measures of stress immunity and resilience. The fifth section asked participants about which of a series of potential stressors they had experienced during the Covid-19 pandemic. The final section asked participants if they had experienced any positive aspects of life during lock-down in Wales during the Covid-19 pandemic.

What are the possible benefits and risks of participating?
As this is a 10-15 minute online survey, there are no benefits or risks involved in participating.

Where is the study run from?
This study is an online study, available across Wales. It is being managed by a team of academics and mental health practitioners based in Swansea University, Cardiff University, and the seven Health Boards in Wales.

When is the study starting and how long does it expect to run for?
May 2020 to July 2020

Who is funding the study?
Investigator initiated and funded

Who is the main contact?
Professor Nicola Gray, Nicola.s.gray@swansea.ac.uk

Trial website

https://wales-wellbeing.co.uk/

Contact information

Type

Scientific

Primary contact

Prof Nicola Gray

ORCID ID

http://orcid.org/0000-0003-3849-8118

Contact details

Department of Psychology
Swansea University
Swansea
SA2 8PP
United Kingdom
+44 (0)1792 292006
nicola.s.gray@swansea.ac.uk

Additional identifiers

EudraCT number

Nil known

ClinicalTrials.gov number

Nil known

Protocol/serial number

Nil known

Study information

Scientific title

The impact of the COVID-19 pandemic on mental health and well-being: the effects in Wales

Acronym

Study hypothesis

The ongoing Covid-19 pandemic has resulted in significant physical, social, and psychological implications for the population of the UK. It has led to a nationwide lockdown, school closures, large percentages of the population being furloughed or losing their jobs, and the temporary halting of all unessential services. This situation is unprecedented, and it is not clear how severely it will affect the mental health and well-being of the population, if at all.

In order to help meet the ongoing needs of the population during the current circumstances, Health Boards and their partners need to:
1. Understand the extent to which Covid-19 has impacted upon the mental health and well-being of the population; and
2. Identify which sub-divisions of the community are experiencing the most severe difficulties with their mental health and well-being.

Ethics approval

Approved 28/05/2020, Department of Psychology Ethics Committee, Swansea University (Department of Psychology, College of Human & Health Sciences, Swansea University, SA2 8PP, UK; +44 (0)1792 295082; g.jiga@swansea.ac.uk), ref: 4908

Study design

Observational cross-sectional study

Primary study design

Observational

Secondary study design

Cross sectional study

Trial setting

Internet

Trial type

Other

Patient information sheet

Not available in web format, please use contact details to request a participant information sheet.

Condition

Mental health and well-being

Intervention

This study is an online survey. Paper copies of the survey will be made available by post for a minority of individuals without access to the internet or electronic device in order to facilitate access to hard to reach members of the population. A dedicated phone line will be used for members of the population to request paper copies of the survey and a stamped addressed envelope.

Recruitment will take place via an online, snow-balling technique. The survey will be advertised via a programme of adverts and emails designed to cover the population of Wales. This will include emails and tweets being sent to any organizations across Wales asking them to publicise the existence of the survey and giving the URL to be able to access the survey. Many organisations have agreed to advertise the survey including the health boards across Wales, the police service, may large employers across Wales, care homes, homelessness organisations, GPs, farmer’s union, first responders, etc. The survey will also be advertised via newspapers, radio programmes, and celebrity tweets.

The survey will take roughly 10-15 minutes to complete and consisted of six sections:
1. Demographics. In the demographics section, participants will be asked for their primary language, postcode (which serves as a measure of multiple deprivation, see Welsh Index of Multiple Deprivation; www.wimd.gov.wales), local authority, age bracket, gender, employment status, relationship status, ethnicity, whether they live alone, whether they have access to a garden, whether they are a key worker, whether they have had Covid-19, whether they are in a vulnerable group at risk of severe illness due to Covid-19, and whether they have a history of mental health difficulties
2. Well-Being. This section will consist of:
2.1. An edited version of the Personal Well-Being ONS4 survey. This is a four-item measure developed by the Office of National Statistics that aims to briefly assess general personal well-being, current coping, and future worries; and
2.2. The Warwick and Edinburgh Mental Well-being Scale (WEMWBS). This is a 14-item scale designed to evaluate well-being in the general population
3. Psychological distress. The K10 will be used to measure psychological distress. The K10 is a 10-item widely used measure of non-specific psychological distress. There will also be an additional item that asks about recent feelings of anger
4. Stress Immunity/Resilience. Participants will complete the Stress Immunity sub-scale of the TriPM questionnaire as a measure of resilience and stress immunity. There will also be a one item measure of resilience included
5. Stressors. In the stressors section, participants will be asked to rate whether they have experienced a range of Covid-19 related stressors both in the 12-month period before the Covid-19 crisis and in the period since the beginning of the pandemic. Stressors will include a wide range of difficulties, including financial, social, domestic abuse, bereavement, educational, and physical stressors. We will also ask participants about whether they have experienced suicidal thoughts and behaviours pre- and post- Covid-19 within this section. Participants will then rate the extent to which each of these stressors has negatively impacted their psychological well-being on a scale of 1-10 (not at all to severely)
6. Positive aspects. Participants will be asked if there have been any aspects of the Covid-19 situation that they have enjoyed. Participants can select a range of options from a drop-down list

Intervention type

Other

Phase

Drug names

Primary outcome measure

Measured at a single time point:
1. Mental Well-being will be measured using the Warwick-Edinburgh Mental Well-being Scale (WEMWBS)
2. Psychological distress will be measured using the Kessler-10 (K10) scale


Secondary outcome measures

Measured at a single time point:
1. The presence of suicidal thoughts will be measured using a single item measure assessing the presence of suicidal thoughts
2. Suicidal behaviours will be measured using a single item measure assessing the presence of suicidal actions or behaviours intended to end life

Overall trial start date

04/05/2020

Overall trial end date

13/07/2020

Reason abandoned (if study stopped)

Eligibility

Participant inclusion criteria

Individuals aged 16 years and above who lived in Wales between the dates of 9/06/2020 - 13/07/2020

Participant type

All

Age group

Mixed

Gender

Both

Target number of participants

We aimed to get at least 250 participants from each of the 22 Local Authorities in Wales. Therefore we aimed to recruit a minimum of 5,500 participants.

Total final enrolment

15469

Participant exclusion criteria

1. Did not complete over 50% of the survey
2. Did not give informed consent

Recruitment start date

09/06/2020

Recruitment end date

13/07/2020

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Swansea University
Singleton Park Sketty
Swansea
SA2 8PP
United Kingdom

Sponsor information

Organisation

Swansea University

Sponsor details

Singleton Park
Sketty
Swansea
SA2 8PP
United Kingdom
+44 (0)1792 205678
generalenquiries@swansea.ac.uk

Sponsor type

University/education

Website

http://www.swansea.ac.uk/

Funders

Funder type

Other

Funder name

Investigator initiated and funded

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

We plan to publish the main results of this research in a high-impact peer reviewed journal.
We also plan to release a summary of our main findings in a lay-person friendly manner on our website at https://wales-wellbeing.co.uk/.
The key findings will also be disseminated to senior leaders working in mental health services in the seven Health Boards in Wales and in Welsh Government via internal reports.
We also plan on disseminating the key results to NHS senior leaders and key stakeholders (e.g. police, ambulance service, fire & rescue services, and third sector partner organisations) at a series of workshops located within each of the seven Health Board locations across Wales. During these workshops the National data will be presented, along with any key differences for the Health Board locality. The NHS and partner agencies will then be able to discuss the best interventional response to meet any changes in need for mental health and wellbeing within the population of Wales. Provision of these workshops in each Health Board region of Wales will be dependent on securing funding to provide these. Funding has been applied for.

Plans to share the raw data via open access platforms and data repository will be developed following funding review.

IPD sharing statement:
The current data sharing plans for this study are unknown and will be available at a later date.

Intention to publish date

01/09/2020

Participant level data

To be made available at a later date

Basic results (scientific)

Publication list

Publication citations

Additional files

Editorial Notes

23/07/2020: Trial’s existence confirmed by Department of Psychology Ethics Committee, Swansea University.