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

Well-being, Work Stress Clinical Trial

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT01661569
• Other study ID #: 3035/002
• Status: Not yet recruiting
• Phase: N/A
• First received: August 7, 2012
• Last updated: August 7, 2012
• Start date: August 2012
• Est. completion date: January 2013

Study information

• Verified date: August 2012
• Source: University College, London
• Contact: Sophie K Bostock, BMedSci, MSc
• Phone: +44 (0)7779578733
• Email: sophie.bostock.09[@]ucl.ac.uk
• Is FDA regulated: No
• Health authority: United Kingdom: Research Ethics Committee
• Study type: Interventional

Clinical 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.

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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 120
• Est. completion date: January 2013
• Est. primary completion date: January 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Well-being, Work Stress

Intervention

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.

Locations

Country	Name	City	State
United Kingdom	UK high-tech company office	London

Sponsors (4)

Lead Sponsor	Collaborator
University College, London	British Heart Foundation, Headspace Meditation Ltd, Technical University Dresden

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Psychological stress	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	No
Other	Cortisol	Hair cortisol concentration, as an indicator of activation of the HPA axis	8 weeks	No
Primary	Well-being	Psychological well-being will be assessed using the Warwick Edinburgh Mental Well-Being Scale	8 weeks	No
Secondary	Blood pressure	Blood pressure over the working day will be measured as an indicator of activation of the stress response	8 weeks	No