Well-being, Work StressNCT01661569
A Randomised Controlled Trial to Investigate the Effects of a Mindfulness Smartphone App on Well-being in the Workplace
A study testing Headspace On-the-go app in people with Well-being, Work Stress, run by University College, London at 1 site in United Kingdom.
Trial summary
We propose a randomised controlled trial in a workplace setting to investigate whether a smartphone-delivered programme of mindfulness meditation influences psychological and biological indicators of well-being. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Well-being, Work Stress
- What is being tested?
- Headspace On-the-go app
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Aug 2012to Jan 2013
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Employees of a UK high-tech company
- Raised levels of work stress (overcommitment>2) or depression (CESD>1)
Who cannot join
- treated for anxiety, depression or hypertension
- taking medication containing steroids
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
UK high-tech company office
London
Sophie K Bostock, BMedSci, MSc
About this study
Official title: A Randomised Controlled Trial to Investigate the Effects of the Headspace Mindfulness Smartphone App on Psychological Well-being and Biological Indicators of Stress in the Workplace
We propose a randomised controlled trial in a workplace setting to investigate whether a smartphone-delivered programme of mindfulness meditation influences psychological and biological indicators of well-being.
We hypothesise that after 8 weeks participants who complete the meditation programme will show increases in psychological well-being and reduced activation of stress-related biological pathways.
Read the detailed description
Mindfulness-based therapies can reduce depressive symptoms in patients and healthy subjects. Therapies such as MBSR (mindfulness-based stress reduction) typically consist of 8 group sessions led by an experienced practitioner, plus home practice and one full day of meditation. In this study we aim to investigate whether a mindfulness programme delivered as a series of podcasts on a mobile phone app could lead to gains in well-being and a reduction in stress.
- Conditions
- Well-being, Work Stress
- Being tested
- Headspace On-the-go app
- Keywords
- Mindfulness, meditation, stress, well-being, work stress, blood pressure, cortisol
- Medical subject headings
- Occupational Stress
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Headspace On-the-go appOther
Also called Mindfulness meditation smartphone app
Participants will be given access to a 45-day programme of mindfulness meditation, created and branded by Headspace. They will be encouraged to listen to one meditation podcast each day, or as frequently as possible over 8 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Headspace On-the-go app | Experimental | Participants were given access to a 45-day mindfulness meditation programme via the Headspace smartphone app Receives: Other: Headspace On-the-go app |
| Waitlist control | No intervention | Participants will be asked to wait for 8 weeks before starting the intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Well-being
Psychological well-being will be assessed using the Warwick Edinburgh Mental Well-Being Scale
Measured: 8 weeks
Secondary outcomes (1)
Blood pressure
Blood pressure over the working day will be measured as an indicator of activation of the stress response
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Aug 2012 (estimated)
- Study startAug 2012
- Primary completionJan 2013 (estimated)
- Study completionJan 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Well-being, Work StressStudies of the same condition, open and under way.
- More trials run by University College, LondonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University College, London
- Sponsor type
- University, hospital or other
- Collaborators
- British Heart Foundation, Headspace Meditation Limited, Technische Universität Dresden
- Responsible party
- Sponsor
- Investigators
- Andrew Steptoe, DPhil, DSc, FMedSci, Principal investigator, University College, London
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01661569
- Sponsor's protocol ID
- 3035/002
- Status last verified
- Aug 2012
- First submitted
- 7 Aug 2012
- Last updated
- 9 Aug 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Aug 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomised Controlled Trial to Investigate the Effects of the Headspace Mindfulness Smartphone App on Psychological Well-being and Biological Indicators of Stress in the Workplace
- ClinicalTrials.gov ID
- NCT01661569
- Acronym / sponsor ID
- 3035/002
- Conditions
- Well-being, Work Stress
- Keywords
- Mindfulness, meditation, stress, well-being, work stress, blood pressure, cortisol
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- University College, LondonUniversity, hospital or other
- Collaborators
- British Heart Foundation, Headspace Meditation Limited, Technische Universität Dresden
- Study start
- Aug 2012
- Primary completion
- Jan 2013 (estimated)
- Study completion
- Jan 2013 (estimated)
- First posted
- 9 Aug 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
We propose a randomised controlled trial in a workplace setting to investigate whether a smartphone-delivered programme of mindfulness meditation influences psychological and biological indicators of well-being.
We hypothesise that after 8 weeks participants who complete the meditation programme will show increases in psychological well-being and reduced activation of stress-related biological pathways.
Detailed description
Mindfulness-based therapies can reduce depressive symptoms in patients and healthy subjects. Therapies such as MBSR (mindfulness-based stress reduction) typically consist of 8 group sessions led by an experienced practitioner, plus home practice and one full day of meditation. In this study we aim to investigate whether a mindfulness programme delivered as a series of podcasts on a mobile phone app could lead to gains in well-being and a reduction in stress.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Headspace On-the-go app | Experimental | Other: Headspace On-the-go appParticipants were given access to a 45-day mindfulness meditation programme via the Headspace smartphone app |
| Waitlist control | No intervention | –Participants will be asked to wait for 8 weeks before starting the intervention |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Employees of a UK high-tech company
- Raised levels of work stress (overcommitment>2) or depression (CESD>1)
Key exclusion criteria (2 listed)
- treated for anxiety, depression or hypertension
- taking medication containing steroids
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Headspace On-the-go appAlso: Mindfulness meditation smartphone appParticipants will be given access to a 45-day programme of mindfulness meditation, created and branded by Headspace. They will be encouraged to listen to one meditation podcast each day, or as frequently as possible over 8 weeks. | Other | Headspace On-the-go app |
Primary outcome
Well-being
Time frame: 8 weeks
Psychological well-being will be assessed using the Warwick Edinburgh Mental Well-Being Scale
1 secondary outcome
Blood pressure
Time frame: 8 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Aug 2012.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Andrew Steptoe, DPhil, DSc, FMedSci principal investigator
University College, London
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Headspace On-the-go app in people with Well-being, Work Stress, run by University College, London at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 9 Aug 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Sophie K Bostock, BMedSci, MSc (+44 (0)7779578733, sophie.bostock.09@ucl.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Well-being (time frame: 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Aug 2012; AzTrials last refreshed its copy on 7 Nov 2026.