NCT01661569

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
120

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Aug 2012

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2012

Completed
6 days until next milestone

First Submitted

Initial submission to the registry

August 7, 2012

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 9, 2012

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2013

Completed
Last Updated

August 9, 2012

Status Verified

August 1, 2012

Enrollment Period

5 months

First QC Date

August 7, 2012

Last Update Submit

August 7, 2012

Conditions

Keywords

Mindfulnessmeditationstresswell-beingwork stressblood pressurecortisol

Outcome Measures

Primary Outcomes (1)

  • Well-being

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

    8 weeks

Secondary Outcomes (1)

  • Blood pressure

    8 weeks

Other Outcomes (2)

  • Psychological stress

    8 weeks

  • Cortisol

    8 weeks

Study Arms (2)

Headspace On-the-go app

EXPERIMENTAL

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

Other: Headspace On-the-go app

Waitlist control

NO INTERVENTION

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

Interventions

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.

Also known as: Mindfulness meditation smartphone app
Headspace On-the-go app

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • treated for anxiety, depression or hypertension
  • taking medication containing steroids

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UK high-tech company office

London, United Kingdom

Location

MeSH Terms

Conditions

Occupational Stress

Condition Hierarchy (Ancestors)

Occupational DiseasesStress, PsychologicalBehavioral SymptomsBehavior

Study Officials

  • Andrew Steptoe, DPhil, DSc, FMedSci

    University College, London

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Sophie K Bostock, BMedSci, MSc

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 7, 2012

First Posted

August 9, 2012

Study Start

August 1, 2012

Primary Completion

January 1, 2013

Study Completion

January 1, 2013

Last Updated

August 9, 2012

Record last verified: 2012-08

Locations