Reducing stress in the workplace using a digital intervention designed to improve employee wellbeing and help them stay engaged and productive in work

ISRCTN ISRCTN31161020
DOI https://doi.org/10.1186/ISRCTN31161020
Secondary identifying numbers BSREC 45/20-21
Submission date
13/05/2021
Registration date
08/06/2021
Last edited
26/05/2023
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

Background and study aims
Mental health problems affect one in six workers each year and are the leading cause of sickness absence, where stress, anxiety and depression are responsible for approximately half of the working days lost. The estimated annual cost of poor mental health has increased 16% since 2017, and is now up to £45 billion. It is estimated that approximately 41.8% of the UK population are at high risk of mental health problems due to their economic vulnerability and exposure to a negative economic shock as a result of the COVID-19 outbreak.
This project, funded by the Midlands Engine, comprises the initial pilot study of an intervention to improve workforce mental health and productivity as part of the Mental Health and Productivity Pilot program (https://mhpp.me/). REST is a digital intervention informed by cognitive behavioural therapy that aims to improve stress, depression and anxiety symptoms and productivity across the Midlands.

The aim of this study is to investigate how practical and feasible a multisite waitlist randomised trial would be in the Midlands to examines whether an iCBT treatment for mild to clinical levels of depression and anxiety reduces symptom severity for employees in the workplace. The study also aims to explore the feasibility of the methodological approach, focusing particularly upon:
1. The willingness of organisations to participate in a trial
2. The willingness of employees to participate in a trial
3. The adherence of participants to the treatment as measured through platform user data
4. Appropriateness of the analytical approach
5. Acceptability of the intervention based on participants experiences

The results of this study will be used to inform a future, fully powered RCT which will be undertaken to understand whether an iCBT treatment can help to reduce symptom severity and improve mental health for employees in the workplace. This trial therefore has a twofold contribution to the literature: it serves as an early indication of the potential benefits of iCBT in the workplace, and it provides evidence of the feasibility of this type of in-business trial in the Midlands and nationally for mental health and productivity. Such trials can inform improvements in employer mental health policies and practices, benefitting both the organisations and their employees.

Who can participate?
Adults over 18 years, currently in employment, who suffer from insomnia and anxiety but are not currently receiving treatment.

What does the study involve?
REST will last for 8 weeks using a randomised waitlist-controlled trial design, where the control group will receive the intervention after eight weeks.
Those in the REST intervention will be offered an 8-week self-guided, digital intervention. The intervention will consist of an hour weekly commitment. Those in the waitlist control group will be asked to continue life as usual for 8-week (i.e. they will not receive the 8-week digital intervention or provided with any other treatment). Subsequently, participants will be offered the 8-week digital intervention. Participants will then be contacted after two months to complete the follow-up questionnaires.
Overall, the REST trial will last for 4 months, if participants are initially placed in the intervention group (8 weeks in intervention arm + follow up after 2 months). If a participant is initially placed in the waitlist control group, they will be offered the intervention after an 8-week delay, and be in the study for 6 months (8 weeks in waitlist control arm + 8 weeks in intervention arm + follow up after 2 months)
Upon completion of the 8-week study period, a qualitative evaluation will be conducted of the 8-week intervention programme using semi-structured interviews, aiming to explore effectiveness, acceptability, barriers, and facilitators of the intervention. This will be completed with a randomly selected 25 participants, who have completed the intervention, and consented to be contacted again for the qualitative part of the study.

What are the possible benefits and risks of participating?
We do not anticipate any major disadvantages, side effects or risks in taking part in this study. The PHQ-9 questionnaire of the study asks about self-harming and suicidal behaviour (item 9), which would require participants to disclose sensitive information. In addition, scores between 15-28 on the ISI, and scores between 15-27 on the PHQ-9 and GAD-7 questionnaires may indicate clinically significant conditions. This could highlight an undiagnosed severe mental-health condition for which the participant is not receiving care.

Where is the study run from?
University of Warwick (UK)

When is the study starting and how long is it expected to run for?
January 2021 to April 2022

Who is funding the study?
Midlands Engine (UK)

Who is the main contact?
Charlotte Kershaw, Charlotte.Kershaw@warwick.ac.uk
Dr Carla Toro, Carla.Toro@warwick.ac.uk

Study website

Contact information

Ms Charlotte Kershaw
Public

University of Warwick
Coventry
CV4 7AL
United Kingdom

Email Charlotte.Kershaw@warwick.ac.uk
Dr Carla Toro
Scientific

University of Warwick
Coventry
CV4 7AL
United Kingdom

Email Carla.Toro@warwick.ac.uk

Study information

Study designMulticentre interventional waitlist randomized-controlled feasibility trial
Primary study designInterventional
Secondary study designRandomised waitlist controlled trial
Study setting(s)Internet/virtual
Study typeTreatment
Participant information sheet Not available in web format, please use contact details to request participant information sheet.
Scientific titleREducing STress in the workplace
Study acronymREST
Study hypothesisCurrent study hypothesis as of 29/10/2021:
A future, fully powered multisite waitlist-controlled RCT will enable us to assess the effect of the REST intervention on anxiety and depression scores on the General Anxiety Disorder-7 (GAD-7) and Patient Health Questionnaire-9 (PHQ-9).

Previous study hypothesis:
The REST intervention will reduce anxiety and depression scores on the General Anxiety Disorder-7 (GAD-7) and Patient Health Questionnaire-9 (PHQ-9) respectively compared to those initially assigned to the waitlist control group at 8 weeks.
Ethics approval(s)Approved 25/01/2021, Biomedical Sciences Research Ethics Committee (University of Warwick, Coventry, CV4 7AL, UK; +44 (0)24 765 73123; BSREC@warwick.ac.uk), ref: BSREC 45/20-21
ConditionPrevention and treatment of anxiety and depression in employees from across the Midlands region in the United Kingdom.
InterventionParticipants are randomly allocated through blocked randomised with stratification into the REST intervention or a waitlist control. We stratify across different employer sites in the Midlands to ensure weighting approximate to staff size and representative of the larger population.

Those in the REST intervention will be offered an 8-week self-guided, digital intervention. The intervention will consist of an hour weekly commitment. Content for the self-guided intervention will be digitised and presented via an online platform, with each component being tailored to maximise relevance of the treatment as a workplace intervention and generalisability of the treatment across industries.

The core components of the REST intervention will include:
1. Psychoeducation on stress, depression and anxiety
2. Emotion regulation skills training (non-judgmental awareness, acceptance and tolerance, effective self-support, analysis and modification)
3. Problem solving skills training and goal setting
4. Managing negative thoughts and cognitive restructuring
5. Mental health in times of COVID-19 (e.g. work life balance, psychological detachment from work when working from home)
6. Healthy lifestyle (e.g. physical activity, relaxation and mindfulness, eating habits and sleep)
7. Self-compassion and resiliency
Intervention typeBehavioural
Primary outcome measureCurrent primary outcome measure as of 28/10/2021:
1. Number of organisations contacted and participating in the trial measured using recruitment and participation data collected during the recruitment process and throughout the trial
2. Number of employees registering interest, screening for, and participating in the trial measured using recruitment and participation data collected during the recruitment process and throughout the trial
3. Number of topics covered by each participant on platform measured using usage data collected by the platform over the 8 week intervention period
4. Average duration to cover each topic by each participant measured using usage data collected by the platform over the 8 week intervention period

Previous primary outcome measure:
1. Anxiety is measured using the General Anxiety Disorder-7 at baseline, post-intervention (8-weeks) and follow-up (12-weeks)
2. Depression is measured using the Patient Health Questionnaire-9 at baseline, post-intervention (8-weeks) and follow-up (12-weeks)
Secondary outcome measuresCurrent secondary outcome measures as of 28/10/2021:
1. Anxiety is measured using the General Anxiety Disorder-7 at baseline, post-intervention (8-weeks) and follow-up (12-weeks)
2. Depression is measured using the Patient Health Questionnaire-9 at baseline, post-intervention (8-weeks) and follow-up (12-weeks)
3. Job productivity measured through Work Productivity and Activity Impairment: General Health v2.0 at baseline, post-intervention (8-weeks) and follow up (12-weeks)
4. Job satisfaction measured using the Indiana Job Satisfaction Scale at baseline, post-intervention (8-weeks) and follow up (12-weeks)
5. Well-being measured using the Warwick-Edinburgh Mental Health Well-being Scale at baseline, post-intervention (8-weeks) and follow up (12-weeks)
6. Quality of life measured using the EuroQOL EQ-5D-5L questionnaire at baseline, post-intervention (8-weeks) and follow up (12-weeks)


Previous secondary outcome measures:
1. Job productivity measured through Work Productivity and Activity Impairment: General Health v2.0 at baseline, post-intervention (8-weeks) and follow up (12-weeks)
2. Job satisfaction measured using the Indiana Job Satisfaction Scale at baseline, post-intervention (8-weeks) and follow up (12-weeks)
3. Well-being measured using the Warwick-Edinburgh Mental Health Well-being Scale at baseline, post-intervention (8-weeks) and follow up (12-weeks)
4. Quality of life measured using the EuroQOL EQ-5D-5L questionnaire at baseline, post-intervention (8-weeks) and follow up (12-weeks)
5. User Experience behaviour of platform usage measured using the number of “log-in”-s and “counts” of activities completed on the platform over the 8 weeks intervention period
Overall study start date25/01/2021
Overall study end date01/04/2022

Eligibility

Participant type(s)Patient
Age groupAdult
Lower age limit18 Years
SexBoth
Target number of participantsMinimum required sample size: 420; Number of sites: 45
Total final enrolment53
Participant inclusion criteria1. Able to give informed consent
2. English-speaking
3. In employment (including being on furlough)
4. Insomnia Severity Index score <8
5. General Anxiety Disorder-7 score >5 or Patient Health Questionnaire-9 score >5
6. ≥18 years of age
Participant exclusion criteria1. Currently receiving treatment (psychological or pharmacological) from mental health services (e.g. GP, private clinic, Improving Access to Psychological Therapies (IAPT) services, specialist and community mental health services)
2. Retiring in the next 10 months
3. Currently taking part in other psychological intervention trials
Recruitment start date11/06/2021
Recruitment end date31/12/2021

Locations

Countries of recruitment

  • England
  • United Kingdom

Study participating centres

New Cross Hospital
Royal Wolverhampton NHS Trust
Wolverhampton
WV10 0QP
United Kingdom
ICFC
King stadium
Filbert way
Leicester
LE2 7FL
United Kingdom
Conference Care
Hinckley
Leicestershire
LE10 3EY
United Kingdom
Pathfinder schools
Havelock Infant School
Desborough
Northamptonshire
NN14 2LU
United Kingdom
Birmingham City council
Birmingham
B1 1BB
United Kingdom
Noble Events
Leicestershire
LE7 4UZ
United Kingdom
The University of Warwick
University Road
Coventry
CV4 7AL
United Kingdom
JLR
Banbury Road
Abbey road
Whitley
Coventry
CV4 7AL
United Kingdom
CCM Group
Nunn Brook road
Huthwaite
NG17 2HU
United Kingdom
Mice and Dice
Newcastle-under-Lyme
Newcastle
ST5 2RP
United Kingdom
NTT
Darwin House
Lichfield South
Birmingham Road
Lichfield
WS14 0QP
United Kingdom
H&W Chamber of commerce
Severn House
Prescott Drive
Worcester
WR4 9NE
United Kingdom
Micronclean
Skegness Roman Bank
Skegness
PE25 1SQ
United Kingdom
WJ
North 7
Brock way
Newcastle under Lyme
ST5 6AZ
United Kingdom
Colas Rail
Plant Depot
Mill Road
Rugby
CV21 1BE
United Kingdom
Perfect Home
Eagle Court 2
Hatchford Way
Sheldon
Birmingham
B26 3RZ
United Kingdom
Streets Heaver
Lincoln
LN6 3QN
United Kingdom
Capgemini UK
Stafford Park 11
Telford
TF3 3AY
United Kingdom
D2N2 Ltd
8 Experian Way
ng2 Business Park
Nottingham
NG2 1EP
United Kingdom

Sponsor information

University of Warwick
University/education

University House
Coventry
C4 7AL
United Kingdom

Phone +44 (0)2476 575386
Email Sponsorship@warwick.ac.uk
Website https://warwick.ac.uk/services/ris/research_integrity/sponsorship
ROR logo "ROR" https://ror.org/01a77tt86

Funders

Funder type

Government

Midlands Engine

No information available

Results and Publications

Intention to publish date30/06/2023
Individual participant data (IPD) Intention to shareYes
IPD sharing plan summaryStored in publicly available repository
Publication and dissemination planPlanned publication in high-impact peer-reviewed journals.
IPD sharing planThe datasets generated during and/or analysed during the current study will be stored in a publicly available repository, the Open Science Framework (OSF) (https://osf.io/v8c5j/).

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Protocol (preprint) 14/10/2022 03/11/2022 No No
Protocol article 09/12/2022 06/01/2023 Yes No
Basic results 26/05/2023 No No

Additional files

ISRCTN31161020 BasicResults.pdf

Editorial Notes

26/05/2023: The basic results have been uploaded as an additional file.
18/05/2023: The intention to publish date was changed from 01/04/2023 to 30/06/2023.
06/01/2023: Publication reference added.
03/11/2022: Protocol (not peer reviewed), total final enrolment and IPD sharing statement added.
29/10/2021: The study hypothesis has been updated.
28/10/2021: The following changes have been made:
1. The recruitment end date has been changed from 30/10/2021 to 31/12/2021.
2. The study design has been changed from "Multicentre interventional waitlist randomized-controlled trial" to "Multicentre interventional waitlist randomized-controlled feasibility trial".
3. The primary outcome measure has been updated.
4. The secondary outcome measures have been updated.
5. The plain English summary has been updated.
15/09/2021: The recruitment end date was changed from 17/09/2021 to 30/10/2021.
17/05/2021: Trial's existence confirmed by University of Warwick.