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

Overall Study Name: NHS CHECK - Health & Experiences of staff working at NHS Trusts and Nightingale Hospitals. Embedded RCT Full Title: Effectiveness of a smartphone app-based intervention in improving stress, resilience, wellbeing and mental health outcomes in a high-risk healthcare worker population during Covid-19: a randomised controlled parallel group trial.

Status
Unknown
Phases
Phase 4
Study type
Interventional
Source
EU CTR
Registry ID
EUCTR2021-001279-18-Outside-EU/EEA
Enrollment
Unknown
Registered
2021-03-09
Start date
Unknown
Completion date
Unknown
Last updated
2021-03-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Mental Health and Wellbeing of Healthcare Staff

Interventions

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

Sponsors

King’s College London
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion 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

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

Design outcomes

Primary

MeasureTime frame
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)

Secondary

MeasureTime frame
Secondary end point(s): 2. The Brief Resilience Scale (BRS) to measure resilience is a 6-item participant self-report measure, which assesses an individual’s ability to bounce back or recover from stress. (Smith et al., 2008). 3. The GAD-7 is a well validated and widely used 7-item measure of anxiety. A change of 4 or more on the GAD has been found to be clinically significant across anxiety disorders. (Spitzer et al., 2006). 4. The PHQ-9 is the 9-item depression module from the full PHQ. There is strong evidence for the validity of the PHQ-9 as a brief measure of depression severity. (Kroenke et al., 2001). 5. The Warwick-Edinburgh Mental Well-being Scale (WEMWBS) is a 7-item measure to enable the monitoring of subjective well-being and psychological functioning compared to the general population (all items are worded positively and address aspects of positive mental health) (Tennant et al., 2007). 6. The 5-item Work and Social Adjustment Scale (WSAS) (Mundt et al., 2002). 7. The 6-item Stanford Presenteeism Scale (SPS-6) (Koopman et al., 2002). 8. The Minimal Insomnia Symptom Scale (MISS) is a 3-item scale which provides a brief measure of sleeping difficulties (Broman et al., 2008). ;Timepoint(s) of evaluation of this end point: 4 and 8 weeks (alongside baseline)

Countries

United Kingdom

Contacts

Public ContactResearch and Development

King’s College London

Thomas.foulkes@kcl.ac.uk+4402071886206

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 11, 2026