Embedded RCT Short Title: Smartphone app-based mental health and wellbeing intervention for healthcare workers during Covid-19.

ABSTRACT

ConditionMental Health and Wellbeing of Healthcare Staff;Therapeutic area Psychiatry and Psychology [F] - Mental Disorders [F03]

Intervention
Trade Name Foundations App - Koa Health
Product Name Foundations App
Product Code N/A
Pharmaceutical Form



Primary outcome:Main Objective: To evaluate whether the use of Foundations mobile application impacts stress, wellbeing, anxiety, depression, functioning, resilience and sleep in a real-world, high-risk healthcare worker cohort. ;Secondary Objective: Not Applicable;Primary end point(s) 1. The GHQ-12 is a 12-item scale which screens for general (non-psychotic) psychiatric morbidity, (Goldberg et al., 1992).;Timepoint(s) of evaluation of this end point 4 and 8 weeks (alongside baseline)

CriteriaInclusion criteria
1. Be aged 18 and over.
2. Be an NHS-affiliated member of staff, working at, or with, the participating eighteen NHS CHECK sites.
3. Completed baseline survey with NHS CHECK Cohort study and have consented to be contacted for further research as part of study.
4. Be able to give informed consent to take part in research.
5. Be able to understand and communicate in English.
6. Have access to the internet to complete the surveys.
7. Have access to an email address to facilitate application registration and receive survey links.
8. Own a smartphone with access to the Apple and Google Application Stores.

The following 18 NHS Trusts have been selected to include a mixture of urban and rural settings

Avon and Wiltshire Mental Health Mental Health Partnership Trust
Cambridge University Hospitals NHS Foundation Trust
Cambridgeshire and Peterborough NHS Foundation Trust
Cornwall Partnership NHS Foundation Trust
Devon Partnership NHS Foundation Trust
East Suffolk and North Essex NHS Foundation Trust
Gloucestershire Hospitals NHS Foundation Trust
Guys and St Thomas' NHS Foundation Trust
King's College Hospital NHS Foundation Trust
Lancashire and South Cumbria NHS Foundation Trust
Norfolk and Norwich University Hospitals Foundation Trust
Nottinghamshire Healthcare NHS Foundation Trust
Royal Papworth Hospital NHS Foundation Trust
Sheffield Health and Social Care NHS Foundation Trust
South London and Maudsley NHS Foundation Trust
Tees Esk and Wear Valleys NHS Foundation Trust
University Hospitals of Derby and Burton NHS Foundation Trust
University Hospitals of Leicester NHS Foundation Trust
Are the trial subjects under 18? no
Number of subjects for this age range
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 650
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 50


Exclusion criteria
1. Plans to start new interventions after randomisation during eight week trial period (e.g. apps, psychological therapies and pharmacological therapies).