Condition category
Mental and Behavioural Disorders
Date applied
21/12/2020
Date assigned
11/01/2021
Last edited
11/01/2021
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
Frontline staff are at risk of poor mental health during pandemics. Ths study aims to use a digital platform to facilitate NHS Highland staffs' psychological self-care strategies and monitor their mood and anxiety in a way that gives them feedback and provides a method of evaluating the intervention.

Who can participate?
NHS Highland staff

What does the study involve?
Participants will be randomly allocated to either receive access to additional support or to no additional support. The study will use participatory methods that enable participants to develop personalised mental health strategies via a digital platform. These strategies are rooted in evidence-based positive psychology principles (such as mindfulness-based interventions) and will be used with the aim of treating both psychological distress and enhance resilience during the COVID-19 pandemic. Ongoing feedback and interactive messaging will promote self-awareness and prompt participants to utilise their strategies optimally.

What are the possible benefits and risks of participating?
Participants who are randomly allocated to receive the intervention will have extra mental health support during the pandemic.

There make be some level of emotional upset relating to the issues discussed, but no other risks are anticipated.

Where is the study run from?
The University of the Highlands and Islands (UK)

When is the study starting and how long will it run for?
From June 2020 to September 2020

Who is funding the study?
The Chief Scientist Office (CSO) of the Scottish Government (UK)

Who is the main contact?
Dr Hannes de Kock
hannes.dekock@uhi.ac.uk

Trial website

Contact information

Type

Scientific

Primary contact

Dr Hannes de Kock

ORCID ID

http://orcid.org/0000-0002-2468-5572

Contact details

Department of Rural Health and Well-being
University of the Highlands and Islands
Centre for Health Science
Old Perth Road
Inverness
IV2 3JH
United Kingdom
+44 (0)7519581432
hannes.dekock@uhi.ac.uk

Additional identifiers

EudraCT number

Nil known

ClinicalTrials.gov number

Nil known

Protocol/serial number

IRAS 284547, v5 04/06/2020

Study information

Scientific title

Using participatory digital platforms to enhance resilience and mental health of Scottish frontline health and care staff during COVID-19

Acronym

Study hypothesis

1. To investigate whether digital psychological interventions have a positive influence on NHS Highland frontline staff psychological well-being and resilience during the COVID-19 pandemic.
2. To investigate whether digital psychological interventions have a mitigating influence on NHS Highland frontline staff levels of depression and anxiety during the COVID-19 pandemic.

Ethics approval

Approved 24/06/2020, South West - Frenchay REC (Level 3, Block B, Whitefriars, Lewins Mead, Bristol, BS1 2NT; +44 (0)207 104 8028; frenchay.rec@hra.nhs.uk), ref: 20/SW/0098

Study design

A single centre randomized controlled trial with a cross sectional survey

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Quality of life

Patient information sheet

https://uhi.onlinesurveys.ac.uk/covid-19-participatory-digital-mental-health-intervention-4

Condition

Mental wellbeing of NHS staff during the COVID-19 pandemic

Intervention

The three arms of the pilot RCT were made up of the intervention (The NHS Highland Staff Wellbeing Project), treatment as usual app (MPS), and a control condition (wait list). The NHS Highland Staff Wellbeing Project is a digital platform providing personalised mental health strategies, monitoring of anxiety and mood, and feedback and interactive messaging to support NHS staff in maintaining or improving their mental health during the COVID-19 pandemic. The roll-out of the intervention to the waitlist control group will take place after the RCT. Recruited participants were randomly assigned (1:1:1) to one of the three conditions prior to the RCT.

From the literature, PPI feedback, and the funding call to provide rapid research into COVID-19, the research team decided to restrict the intervention (and all other conditions) to 4 weeks. The first two weeks of the intervention focused on building resilience and the character strength of gratitude, whilst the last two weeks focused on dealing successfully with low mood and anxiety. The treatment as usual intervention was a generic NHS trusted app designed to support psychological well-being and decrease depression and anxiety.

All participants were contacted via email and text in preparation of the RCT starting on 7 September. Participants allocated to different conditions will receive different messages via email and text. The treatment as usual and intervention ntervention groups’ emails (from UHI) and texts (automated) were designed to appear very similar (as to blind these participants from knowing which app they will be receiving). The control group received an email (from UHI) & text message (from MPS) stating that they are on the waiting list and that they will receive the app after the RCT.

All participants will complete a series of questionnaires using OnlineSurveys.ac.uk at the start, middle and end of the study.

Intervention type

Behavioural

Phase

Drug names

Primary outcome measure

1. Psychological changes:
1.1. Anxiety symptoms and depressive symptoms measured using the Patient Health Questionnaire (PHQ-9) and Generalised Anxiety Disorder Assessment (GAD-7) at baseline, 2, and 4 weeks
1.2. Psychological well-being and mental toughness measured using the Edinburgh Well-being Scale (WEWBS) and Mental Toughness Index (MTI) at baseline, 2, and 4 weeks

Secondary outcome measures

1. State of participants' mental health measured using the and Gratitude Questionnaire (GQ-6) survey at baseline, 2, and 4 weeks

Overall trial start date

26/03/2020

Overall trial end date

14/10/2020

Reason abandoned (if study stopped)

Eligibility

Participant inclusion criteria

1. Aged ≥18 years
2. Front line health care staff employed by NHS Highland
3. Capacity to give consent

Participant type

Health professional

Age group

Adult

Gender

Both

Target number of participants

180

Total final enrolment

180

Participant exclusion criteria

Does not meet inclusion criteria

Recruitment start date

15/06/2020

Recruitment end date

14/09/2020

Locations

Countries of recruitment

United Kingdom

Trial participating centre

NHS Highland
Assynt House Beechwood Park Old Perth Road
Inverness
IV2 3BW
United Kingdom

Sponsor information

Organisation

NHS Highland

Sponsor details

Assynt House
Beechwood Park
Old Perth Road
Inverness
IV2 3BW
United Kingdom
+44 (0)1463 255912
frances.hines@nhs.scot

Sponsor type

Hospital/treatment centre

Website

Organisation

University of the Highlands and Islands

Sponsor details

Executive Office
12b Ness Walk
Inverness
IV3 5SQ
United Kingdom
+44 (0) 1463 279000
Sarah-Anne.Munoz@uhi.ac.uk

Sponsor type

University/education

Website

https://www.uhi.ac.uk/en/

Funders

Funder type

Government

Funder name

Chief Scientist Office, Scottish Government Health and Social Care Directorate

Alternative name(s)

The Chief Scientist Office, CSO

Funding Body Type

government organisation

Funding Body Subtype

Local government

Location

United Kingdom

Results and Publications

Publication and dissemination plan

Planned publication in a high-impact peer-reviewed journal.

IPD sharing statement:
The datasets generated during and/or analysed during the current study will be stored in a non-publically available repository (https://myuhi.sharepoint.com/sites/eo-crhwb/Psychological_Resilience/SRUC%20Shared%20Documents/SitePages/Home.aspx). The data is stored securely in the university’s SharePoint site. Only anonymised data will be shared with statisticians. Only the research team will have access to raw data and the data will be kept only for the duration of the data analyses.

Intention to publish date

01/11/2021

Participant level data

Not expected to be available

Basic results (scientific)

Publication list

Publication citations

Additional files

Editorial Notes

22/12/2020: Trial’s existence confirmed by the Health Research Authority (HRA).