Participatory digital interventions for front-line staff during the coronavirus (COVID-19) pandemic

ISRCTN	ISRCTN18107122
DOI	https://doi.org/10.1186/ISRCTN18107122
IRAS number	284547
Secondary identifying numbers	IRAS 284547, v5 04/06/2020

Submission date: 21/12/2020
Registration date: 11/01/2021
Last edited: 20/01/2022

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 of protocol

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 may 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 October 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

Contact information

Dr Hannes de Kock
Scientific

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

ORCID ID	0000-0002-2468-5572
Phone	+44 (0)7519581432
Email	hannes.dekock@uhi.ac.uk

Study information

Study design	A single centre randomized controlled trial with a cross sectional survey
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Hospital
Study type	Quality of life
Participant information sheet	https://uhi.onlinesurveys.ac.uk/covid-19-participatory-digital-mental-health-intervention-4
Scientific title	Using participatory digital platforms to enhance resilience and mental health of Scottish frontline health and care staff during COVID-19
Study objectives	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(s)	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
Health condition(s) or problem(s) studied	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
Primary outcome measure	Current primary outcome measure as of 10/11/2021: 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 measured using the Edinburgh Well-being Scale (WEWBS) at baseline, 2, and 4 weeks Previous 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	Current secondary outcome measures as of 10/11/2021: 1. State of participants' mental toughness measured using the Mental Toughness Index (MTI) at baseline, 2, and 4 weeks 2. State of participants' mental health measured using the and Gratitude Questionnaire (GQ-6) survey at baseline, 2, and 4 weeks Previous 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 study start date	26/03/2020
Completion date	14/10/2020

Eligibility

Participant type(s)	Health professional
Age group	Adult
Lower age limit	18 Years
Sex	Both
Target number of participants	180
Total final enrolment	180
Key inclusion criteria	1. Aged ≥18 years 2. Front line health care staff employed by NHS Highland 3. Capacity to give consent
Key exclusion criteria	Does not meet inclusion criteria
Date of first enrolment	15/06/2020
Date of final enrolment	14/09/2020

Locations

Countries of recruitment

Scotland
United Kingdom

Study participating centre

NHS Highland

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

Sponsor information

NHS Highland
Hospital/treatment centre

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

Phone	+44 (0)1463 255912
Email	frances.hines@nhs.scot
"ROR"	https://ror.org/010ypq317

University of the Highlands and Islands
University/education

Executive Office
12b Ness Walk
Inverness
IV3 5SQ
Scotland
United Kingdom

Phone	+44 (0) 1463 279000
Email	Sarah-Anne.Munoz@uhi.ac.uk
Website	https://www.uhi.ac.uk/en/
"ROR"	https://ror.org/02s08xt61

Funders

Funder type

Government

Chief Scientist Office, Scottish Government Health and Social Care Directorate
Government organisation / Local government

Alternative name(s): Chief Scientist Office, Scottish Government Health Directorate CSO, Chief Scientist Office, Scottish Government Health Directorates, Chief Scientist Office of the Scottish Government Health Directorates, Scottish Government Health and Social Care Directorate of the Chief Scientist Office, Scottish Government Health Directorate Chief Scientist Office, The Chief Scientist Office, CSO
Location: United Kingdom

Results and Publications

Intention to publish date	01/11/2021
Individual participant data (IPD) Intention to share	Yes
IPD sharing plan summary	Stored in non-publicly available repository
Publication and dissemination plan	Planned publication in a high-impact peer-reviewed journal.
IPD sharing plan	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.

Study outputs

Output type	Date created	Date added	Peer reviewed?	Patient-facing?
Preprint results	03/10/2021	10/11/2021	No	No
Results article	16/01/2022	20/01/2022	Yes	No
HRA research summary		28/06/2023	No	No

Editorial Notes

20/01/2022: Publication reference added.
10/11/2021: The primary and secondary outcome measures were updated. Preprint added.
22/12/2020: Trial’s existence confirmed by the Health Research Authority (HRA).