Condition category
Mental and Behavioural Disorders
Date applied
13/02/2017
Date assigned
17/02/2017
Last edited
17/02/2017
Prospective/Retrospective
Prospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

Plain English Summary

Background and study aims
Stress, anxiety and depression are significant causes of sickness absence among NHS employees, and contribute to the NHS having higher rates of sickness absence than any other public sector organisation in the UK. The effects of mental distress not only impacts healthcare workers as individuals, but can also have negative consequences for their patients via a compromised quality of care. Mindfulness is a technique which involves a specific way of paying attention, non-judgmentally, to the present moment. The development of mindfulness skills can lead to a number of therapeutic benefits including increased compassion for oneself and others, and reductions in negative emotional states. Recent studies have shown that traditionally delivered, face-to-face mindfulness-based treatments among NHS employees, and mindfulness-based self-help (MBSH) treatments among medical students can be effective. Given shortages of trained therapists and the 24/7 nature of NHS working hours, MBSH may offer particular potential among NHS employees in terms of flexibility, accessibility and cost-effectiveness. The primary aim of this study is to investigate the effectiveness of a smartphone-delivered MBSH program called ‘Headspace’ in reducing stress among NHS staff.

Who can participate?
Adults who are currently employed by an NHS trust in Kent, Surrey or Sussex who meet the inclusion criteria.

What does the study involve?
Participants are randomly allocated to one of two groups. Those in group one are given access to Headspace which is a website and smartphone application (app) that primarily provides users with mindfulness meditation practices. Those in group two are told to use Moodzone which is a NHS website that has advice and ideas on how to deal with stress from work. Participants in both groups are asked to use the treatments every day for one month for at least ten minutes per day. They are encouraged to continue to use the websites for a further three months. Participants are followed up at the end of the study to measure their levels of stress.

What are the possible benefits and risks of participating?
Participants may benefit from learning a variety of techniques on how to reduce stress, anxiety and depression as well as a year’s free subscription to the Headspace mobile application and website, while Moodzone is free to use. There are no direct risks of participating however participants may find it difficult to reflect on their thoughts, feelings and experiences and may feel distress.

Where is the study run from?
This study is run from the University of Sussex and takes place in NHS trusts in Kent, Surrey and Sussex.

When is the study starting and how long is it expected to run for?
October 2015 to October 2018

Who is funding the study?
1. Economic and Social Research Council (UK)
2. Headspace Meditation Limited (UK)

Who is the main contact?
Ms Heather Taylor
ht207@sussex.ac.uk

Trial website

Contact information

Type

Public

Primary contact

Ms Heather Taylor

ORCID ID

Contact details

School of Psychology
Pevensey Building
University of Sussex
Falmer
BN1 9QH
United Kingdom
+44 1273 678594
ht207@sussex.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

32617

Study information

Scientific title

A definitive randomised controlled trial investigating two online wellbeing interventions to reduce NHS staff stress

Acronym

Study hypothesis

The primary aim of this study is to investigate the effectiveness of smartphone-delivered mindfulness-based self-help (MBSH) intervention ‘Headspace’ in reducing stress among NHS staff.

Ethics approval

1. University of Sussex, Sciences & Technology C-REC, 15/10/2016, ref: ER/HT207/8
2. Health Research Authority (HRA), 23/01/ 2017, ref: 16/HRA/ 5525

Study design

Randomised; Interventional; Design type: Treatment, Prevention, Education or Self-Management, Psychological & Behavioural

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

No participant information sheet available

Condition

Specialty: Mental Health, Primary sub-specialty: Anxiety - stress; UKCRC code/ Disease: Mental Health/ Neurotic, stress-related and somatoform disorders

Intervention

Participants are allocated to one of two unguided online wellbeing interventions, using block randomisation within the survey platform, Qualtrics.

Participants in the experimental arm are given access to Headspace which is a mindfulness app and website. Headspace can be viewed via either smartphone app (Apple or Android) or website and offers participants psychoeducation and guided mindfulness meditation practices.

Participants in the active-control arm are directed to Moodzone which is a NHS website for helping people to deal with work-related stress. Moodzone is delivered via a NHS webpage and offers advice and exercises designed to help manage work-related stress.

Participants in both arms are asked to engage with the exercises suggested within their given intervention for a minimum of ten minutes per day for the initial 30-days of the study, and are encouraged to continue to engage with their given intervention for a follow-up period of 120-days. Objective and subjective measures of engagement are measured at follow up. Also, meditation and moderation analysis conducted in order to establish the processes and factors influencing mindfulness-based self-help (MBSH) engagement and outcomes.

Intervention type

Other

Phase

Drug names

Primary outcome measures

Stress is measured using the Depression, Anxiety and Stress Scale (DASS – 21; Lovibond & Lovinbond, 1995) at baseline and 125 days.

Secondary outcome measures

1. Depression is measured using the DASS-21 at baseline, day 35 and 125
2. Anxiety is measured using the DASS-21 at baseline, day 35 and 125
3. Mindfulness is measured using the Five-Facet Mindfulness Questionnaire – Fifteen Items (FFMQ-15; Baer et al., 2008; Gu et al., 2016) at baseline, day 35 and 125
4. Self-compassion is measured using the Self-Compassion Scale – Short Form (SCS-SF; Raes, Pommier, Neff, & Gucht, 2011) at baseline, day 35 and 125
5. Well-being is measured using the Short Warwick-Edinburgh Mental Well-being Scale (SWEMWS; NHS Health Scotland, University of Warwick & University of Edinburgh, 2007) at baseline, day 35 and 125
6. Burn-out is measured using the Maslach Burnout Inventory (MBI; Maslach & Jackson, 1986) at baseline, day 35 and 125
7. Compassion-for-others is measured using the Compassionate Love For Humanity Scale (CLS; Sprecher, & Fehr, 2005) at baseline, day 35 and 125
8. Rumination is measured using the Ruminative Response Scale (RRS; Nolen-Hoeksema & Morro, 1991; Treynor, Gonzalez, & Nolen-Hoeksema, 2003) at baseline, day 35 and 125
9. Worry is measured using the Penn State Worry Questionarre (PSWQ; Mayer, Miller, Metzger, & Borkovek, 1990) at baseline, day 35 and 125
10. Sickness absence concerning the 3 months prior to the intervention, and the 3 months following the initial 30-day intervention period is measured using a non-validated questionnaire at baseline and 125-days, and where consent has been obtained, via objective sickness absence data provided by NHS Human Resources departments, after trial completion.
11. Adherence to and engagement with both interventions is measured using non-validated questionnaires and objective usage data provided by Headspace for participants assigned to the Headspace condition, at day 35 and 125
12. Beliefs about engaging with Headspace is measured using a non-validated questionnaire at baseline and 35 days
13. Expectations of Headspace and Moodzone is measured using non-validated questionnaires at baseline
14. A control variable of prior mindfulness experience is measured using a non-validated questionnaire at 125-days
15. Stress (as a secondary outcome when measured at these timepoints) is measured using the DASS-21 at baseline and day 35

Overall trial start date

01/10/2015

Overall trial end date

01/10/2018

Reason abandoned

Eligibility

Participant inclusion criteria

1. Aged 18 years or older
2. Currently employed by an NHS trust in Kent, Surrey or Sussex
3. Work in a role that involves direct contact with patients for at least one day per week .
4. Currently in work (i.e. are not on long term sickness absence)
5. Not currently undertaking and/ or are willing to refrain from engaging in any other psychological intervention during the 125-day course of the study
6. Self-reported sufficient English language ability to read and listen to the MBSH intervention materials
7. Regular personal access to an Apple or Android smartphone/ tablet or to a computer with internet access

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

Planned Sample Size: 2108; UK Sample Size: 2108

Participant exclusion criteria

Not meeting inclusion criteria.

Recruitment start date

20/02/2017

Recruitment end date

31/12/2017

Locations

Countries of recruitment

United Kingdom

Trial participating centre

University of Sussex (Lead centre)
University of Sussex Falmer
Brighton
BN1 9QH
United Kingdom

Trial participating centre

NHS Trusts in Kent, Surrey and Sussex
-
-
United Kingdom

Sponsor information

Organisation

University of Sussex

Sponsor details

Research and Enterprise Services
Falmer
Brighton
BN1 9RH
United Kingdom
+44 1273 872748
antony.walsh@sussex.ac.uk

Sponsor type

University/education

Website

Funders

Funder type

Research council

Funder name

Economic and Social Research Council

Alternative name(s)

ESRC

Funding Body Type

government organisation

Funding Body Subtype

Federal/National Government

Location

United Kingdom

Funder name

Headspace Meditation Limited

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Planned publication in a high impact journal by 01/10/2019.

IPD sharing plan:
The current data sharing plans for the current study are unknown and will be made available at a later date

Intention to publish date

01/01/2019

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes