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

Primary Purpose

Well-being, Work Stress

Status

Unknown status

Phase

Not Applicable

Locations

United Kingdom

Study Type

Interventional

Intervention

Headspace On-the-go app

About this trial

This is an interventional treatment trial for Well-being, Work Stress focused on measuring Mindfulness, meditation, stress, well-being, work stress, blood pressure, cortisol

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

UK high-tech company office

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Headspace On-the-go app

Waitlist control

Arm Description

Participants were given access to a 45-day mindfulness meditation programme via the Headspace smartphone app

Participants will be asked to wait for 8 weeks before starting the intervention

Outcomes

Primary Outcome Measures

Well-being

Psychological well-being will be assessed using the Warwick Edinburgh Mental Well-Being Scale

Secondary Outcome Measures

Blood pressure

Blood pressure over the working day will be measured as an indicator of activation of the stress response

Full Information

NCT ID

NCT01661569

First Posted

August 7, 2012

Last Updated

August 7, 2012

Sponsor

University College, London

Collaborators

British Heart Foundation, Headspace Meditation Limited, Technical University Dresden

1. Study Identification

Unique Protocol Identification Number

NCT01661569

Brief Title

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

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 Type

Interventional

2. Study Status

Record Verification Date

August 2012

Overall Recruitment Status

Unknown status

Study Start Date

August 2012 (undefined)

Primary Completion Date

January 2013 (Anticipated)

Study Completion Date

January 2013 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

University College, London

Collaborators

British Heart Foundation, Headspace Meditation Limited, Technical University Dresden

4. Oversight

Data Monitoring Committee

5. Study Description

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Well-being, Work Stress

Keywords

Mindfulness, meditation, stress, well-being, work stress, blood pressure, cortisol

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

120 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Headspace On-the-go app

Arm Type

Experimental

Arm Description

Participants were given access to a 45-day mindfulness meditation programme via the Headspace smartphone app

Arm Title

Waitlist control

Arm Type

No Intervention

Arm Description

Participants will be asked to wait for 8 weeks before starting the intervention

Intervention Type

Other

Intervention Name(s)

Headspace On-the-go app

Other Intervention Name(s)

Mindfulness meditation smartphone app

Intervention Description

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.

Primary Outcome Measure Information:

Title

Well-being

Description

Psychological well-being will be assessed using the Warwick Edinburgh Mental Well-Being Scale

Time Frame

8 weeks

Secondary Outcome Measure Information:

Title

Blood pressure

Description

Blood pressure over the working day will be measured as an indicator of activation of the stress response

Time Frame

8 weeks

Other Pre-specified Outcome Measures:

Title

Psychological stress

Description

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).

Time Frame

8 weeks

Title

Cortisol

Description

Hair cortisol concentration, as an indicator of activation of the HPA axis

Time Frame

8 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility 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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Sophie K Bostock, BMedSci, MSc

Phone

+44 (0)7779578733

sophie.bostock.09@ucl.ac.uk

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Andrew Steptoe, DPhil, DSc, FMedSci

Organizational Affiliation

University College, London

Official's Role

Principal Investigator

Facility Information:

Facility Name

UK high-tech company office

City

London

Country

United Kingdom

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Sophie K Bostock, BMedSci, MSc

12. IPD Sharing Statement

Learn more about this trial

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

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