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A Randomised Controlled Trial to Investigate the Effects of a Mindfulness Smartphone App on Well-being in the Workplace

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ClinicalTrials.gov Identifier: NCT01661569
Recruitment Status : Unknown
Verified August 2012 by University College, London.
Recruitment status was:  Not yet recruiting
First Posted : August 9, 2012
Last Update Posted : August 9, 2012
Sponsor:
Collaborators:
British Heart Foundation
Headspace Meditation Limited
Technical University Dresden
Information provided by (Responsible Party):
University College, London

Study Description
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Brief 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.

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.


Condition or disease Intervention/treatment Phase
Well-being, Work Stress Other: Headspace On-the-go app Not Applicable

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
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Study Start Date : August 2012
Estimated Primary Completion Date : January 2013
Estimated Study Completion Date : January 2013
Arms and Interventions
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Arm Intervention/treatment
Experimental: Headspace On-the-go app
Participants were given access to a 45-day mindfulness meditation programme via the Headspace smartphone app
 Other: Headspace On-the-go 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.
Other Name: Mindfulness meditation smartphone app
No Intervention: Waitlist control
Participants will be asked to wait for 8 weeks before starting the intervention


Outcome Measures
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Primary Outcome Measures :
  1. Well-being [ Time Frame: 8 weeks ]
    Psychological well-being will be assessed using the Warwick Edinburgh Mental Well-Being Scale


Secondary Outcome Measures :
  1. Blood pressure [ Time Frame: 8 weeks ]
    Blood pressure over the working day will be measured as an indicator of activation of the stress response


Other Outcome Measures:
  1. Psychological stress [ Time Frame: 8 weeks ]
    Stress will be measured using the Perceived Stress Scale and measures of job strain, based on Karasek (where job strain is a combination of high demands and low control).

  2. Cortisol [ Time Frame: 8 weeks ]
    Hair cortisol concentration, as an indicator of activation of the HPA axis


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Employees of a UK high-tech company
  • Raised levels of work stress (overcommitment>2) or depression (CESD>1)

Exclusion Criteria:

  • treated for anxiety, depression or hypertension
  • taking medication containing steroids
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01661569


Contacts
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Contact: Sophie K Bostock, BMedSci, MSc +44 (0)7779578733 sophie.bostock.09@ucl.ac.uk

Locations
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United Kingdom
UK high-tech company office
London, United Kingdom
Principal Investigator: Sophie K Bostock, BMedSci, MSc         
Sponsors and Collaborators
University College, London
British Heart Foundation
Headspace Meditation Limited
Technical University Dresden
Investigators
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Principal Investigator: Andrew Steptoe, DPhil, DSc, FMedSci University College, London
More Information
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Responsible Party: University College, London
ClinicalTrials.gov Identifier: NCT01661569    
Other Study ID Numbers: 3035/002
First Posted: August 9, 2012    Key Record Dates
Last Update Posted: August 9, 2012
Last Verified: August 2012
Keywords provided by University College, London:
Mindfulness
meditation
stress
well-being
 work stress
blood pressure
cortisol
Additional relevant MeSH terms:
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Occupational Stress
Occupational Diseases
Stress, Psychological
Behavioral Symptoms