Testing the mHealth app SyD to improve the physical and mental wellbeing of UK healthcare workers
| ISRCTN | ISRCTN41061413 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN41061413 |
| IRAS number | 294071 |
| Secondary identifying numbers | IRAS 294071, CPMS 48382 |
- Submission date
- 14/03/2023
- Registration date
- 12/04/2023
- Last edited
- 13/06/2023
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Mental and Behavioural Disorders
Plain English Summary
Background and study aims
Preventable diseases like heart disease, diabetes, and joint problems can make people sick and reduce their quality of life. Mental health problems like stress, anxiety, and depression affect a lot of people too. The COVID-19 pandemic has made things worse. People may have trouble following lifestyle changes to improve their health, but things like self-monitoring and goal-setting can help. Using mobile health (mHealth) interventions, like an app called SYD, can personalize recommendations to help people make these changes. We want to see if using SYD can improve people's quality of life and mental health.
Who can participate?
Active NHS staff with an NHS email address, aged at least 18 years, own a smartphone, Hospital Anxiety and Depression Scale (HADS) test score between 8 and 14 inclusive, indicating mild to moderate anxiety or depressive symptoms
What does the study involve?
As part of the study you will be asked to:
1. Engage with the SYD application on your smartphone
2. Complete study assessments involving questions regarding your quality of life and wellbeing using a study website
What are the possible benefits and risks of participating?
Potential participants who score between 8-14 inclusive will be eligible, as these scores indicate individuals most likely to benefit from interventions of wellbeing like SYD and to be considered safe as higher scores may indicate depression/anxiety levels needing formal psychological evaluation.
We do not anticipate there being any risk associated with participating in this study. All information provided on the SYD app is intended for general information and educational purposes only, not as medical advice or a substitute for medical advice provided by a doctor or other qualified health practitioner.
Where is the study run from?
Southern Health NHS Foundation Trust (UK)
When is the study starting and how long is it expected to run for?
December 2020 to March 2022
Who is funding the study?
iamYiam (UK)
Who is the main contact?
Prof Shanaya Rathod, shanayarathod@nhs.net
Sana Sajid, Sana.Sajid@southernhealth.nhs.uk
Contact information
Scientific
Moorgreen Hospital
Botley Road
Southampton
SO30 3JB
United Kingdom
 ORCID ID |
0000-0001-9950-3254 |
|---|---|
| Phone | +44 7557541943 |
| peter.phiri@southernhealth.nhs.uk |
Principal Investigator
Research and Development
Clinical Trials Facility
Tom Rudd Unit Moorgreen Hospital
Southampton
SO30 3JB
United Kingdom
| Phone | +44 2380 47 5112 |
|---|---|
| shanaya.Rathod@southernhealth.nhs.uk |
Scientific
iamYiam
Floor 3
207 Regent Street
London
W1B 3HH
United Kingdom
| pedro.henriques@iamyiam.com |
Public
Research & Innovation Department
Southern Health NHS Foundation Trust
Tom Rudd Unit
Moorgreen Hospital
Botley Rd
West End
Southampton
SO30 3JB
United Kingdom
| Sana.Sajid@southernhealth.nhs.uk |
Study information
| Study design | Interventional randomized controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Internet/virtual |
| Study type | Quality of life |
| Participant information sheet | 43354 SYD_PIS_and_ICF_v1.8_26.10.2021.pdf |
| Scientific title | Randomised controlled trial of the mHealth app SyD to improve the physical and mental wellbeing of UK healthcare workers |
| Study hypothesis | To quantify the change in Quality of Life (QOL) following an intervention with SYD, a personalised preventive mHealth partner. Measures of mental health (stress, anxiety and depression) will also be tracked as a way to assess the wellbeing potential of this non-clinical intervention. |
| Ethics approval(s) | Approved 15/02/2021, HRA and Health Care Research Wales (Health and Care Research Wales Support and Delivery Centre, Castlebridge 4, 15-19 Cowbridge Road East, Cardiff, CF11 9AB, UK; +44 2920 230457; healthandcareresearch@wales.nhs.uk), ref: 21/HRA/0308 |
| Condition | Mental health (anxiety, depression, stress), quality of life |
| Intervention | The trial is designed carefully and deliberately to fully and prospectively elucidate all elements of comparison of the impact of SYD. Participants would be randomly assigned to one of the two trials cohorts (PHE, 2020). For cohort one, the study allows data collection as part of a ‘Before and After Study’, with SYD as the intervention provided to participants, to engage with, for 3 months as a minimum. Additionally, by having a further cohort (cohort two) without SYD being engaged for the first 3 months, the study allows ‘Case Controlled’ cross comparisons between the two cohorts. Additionally, by collecting data on the first cohort further to 6 months, we can review persistence of effects from 3 to 6 months of SYD and whether participants voluntarily continue using SYD or not beyond the primary endpoint. Bringing on board the second cohort to have SYD switched on after 3 months, allows a comparison within this cohort ‘Before and After’ at a different time-point to the switch on for cohort one. This allows for any effects of SYD to be evaluated as COVID-19 levels themselves change over time. Meanwhile comparing the two cohorts after the second cohort is exposed to SYD will allow comparisons of an early (in second cohort) versus a more experienced group (first cohort) using SYD contemporaneously. Intervention Group: Participants in the Intervention Group will be asked to complete baseline assessments (Month 0) and download / interact with the SYD app (Months 0-3). Participants will complete monthly assessments for a period of 3 months (Months 1-3) to analyse the primary endpoint. A final assessment will be performed at Month 6, to monitor longer term effects of the intervention. Control Group: Participants in the Control Group will be asked to complete baseline assessments (Month 0) and monthly assessments (Months 1-3) to provide control data in a comparable population |
| Intervention type | Device |
| Pharmaceutical study type(s) | |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | SyD app |
| Primary outcome measure | 1. WHO Quality of Life-BREF (WHOQOL-BREF) survey assessed global quality of life in the Control and Intervention group at Baseline, Month 1, 2, 3 & 6 2. EuroQoL EQ-5D-5L assessed Health-related quality of life in the Control and Intervention group at Baseline, Month 1, 2, 3 & 6 |
| Secondary outcome measures | 1. Perceived Stress Scale (PSS-4) was used for the Control and Intervention group at Baseline, Month 1, 2, 3 & 6 2. Hospital Anxiety and Depression Scale (HADS) was used for the Control and Intervention group at Baseline, Month 1, 2, 3 & 6 |
| Overall study start date | 21/12/2020 |
| Overall study end date | 31/03/2022 |
Eligibility
| Participant type(s) | Health professional |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 500 |
| Total final enrolment | 595 |
| Participant inclusion criteria | 1. NHS staff with an NHS email address which can be used for this study 2. Age ≥ 18 years 3. Own a personal smartphone device (iOS or Android-based) which can be used for this study 4. Sufficient English language ability to familiarise themselves with and engage with SYD and study assessments 5. Hospital Anxiety and Depression Scale (HADS) test score between 8 and 14 inclusive, indicating mild to moderate anxiety or depressive symptoms 6. Provision of informed consent |
| Participant exclusion criteria | 1. Unwilling or unable to participate 2. Any other concurrent psychological interventions 3. Concurrent participation in an interventional clinical trial 4. People considered clinically extremely vulnerable from COVID-19: https://www.gov.uk/government/publications/guidance-on-shielding-and-protecting-extremely-vulnerable-persons-from-covid-19/guidance-on-shielding-and-protecting-extremely-vulnerable-persons-from-covid-19) |
| Recruitment start date | 01/06/2021 |
| Recruitment end date | 15/04/2022 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
West End
Southampton
SO30 3JB
United Kingdom
Sponsor information
Research organisation
Tom Rudd Unit
Moorgreen Hospital
Botley Road
Southampton
SO30 3JB
England
United Kingdom
| Phone | +44 2380475258 |
|---|---|
| research@southernhealth.nhs.uk | |
| Website | https://www.southernhealth.nhs.uk/about-us/research/research-and-innovation |
"ROR" |
https://ror.org/03qesm017 |
Funders
Funder type
Industry
No information available
Results and Publications
| Intention to publish date | 30/06/2023 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not expected to be made available |
| Publication and dissemination plan | Research outputs and outcomes will be submitted for publication in healthcare journals and may be presented at relevant conferences or used for any subsequent guidance discussions with NHS executive bodies. |
| IPD sharing plan | Data will not be shared with anyone outside of the Sponsor and iamYiam research project teams, unless needed to independently verify results at the request of regulators. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Participant information sheet | version 1.8 | 26/10/2021 | 29/03/2023 | No | Yes |
| Protocol file | version 2.0 | 13/04/2022 | 29/03/2023 | No | No |
| Basic results | 13/06/2023 | 13/06/2023 | No | No |
Additional files
Editorial Notes
13/06/2023: Basic results uploaded.
02/05/2023: Internal review.
29/03/2023: Trial's existence confirmed by NHS HRA.
