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

August 7, 2012 updated by: University College, London

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

120

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / 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 Names:
  • Mindfulness meditation smartphone app
No Intervention: Waitlist control
Participants will be asked to wait for 8 weeks before starting the intervention

What is the study measuring?

Primary Outcome Measures

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

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
8 weeks
Cortisol
Time Frame: 8 weeks
Hair cortisol concentration, as an indicator of activation of the HPA axis
8 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University College, London

Collaborators

British Heart Foundation
Headspace Meditation Limited
Technical University Dresden

Investigators

  • Principal Investigator: Andrew Steptoe, DPhil, DSc, FMedSci, University College, London

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2012

Primary Completion (Anticipated)

January 1, 2013

Study Completion (Anticipated)

January 1, 2013

Study Registration Dates

First Submitted

August 7, 2012

First Submitted That Met QC Criteria

August 7, 2012

First Posted (Estimate)

August 9, 2012

Study Record Updates

Last Update Posted (Estimate)

August 9, 2012

Last Update Submitted That Met QC Criteria

August 7, 2012

Last Verified

August 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 3035/002

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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