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

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Well-being, Work Stress

Intervention / Treatment
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* Other: Headspace On-the-go app


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Headspace On-the-go app<br>Participants were given access to a 45-day mindfulness meditation programme via the Headspace smartphone app | Other: Headspace On-the-go app<br>* 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.<br>* Other names: Mindfulness meditation smartphone app;|
| No Intervention: Waitlist control<br>Participants will be asked to wait for 8 weeks before starting the intervention | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Well-being | Psychological well-being will be assessed using the Warwick Edinburgh Mental Well-Being Scale | 8 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Blood pressure | Blood pressure over the working day will be measured as an indicator of activation of the stress response | 8 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Mindfulness, meditation, stress, well-being, work stress, blood pressure, cortisol