<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT01661569</url>
  </required_header>
  <id_info>
    <org_study_id>3035/002</org_study_id>
    <nct_id>NCT01661569</nct_id>
  </id_info>
  <brief_title>A Randomised Controlled Trial to Investigate the Effects of a Mindfulness Smartphone App on Well-being in the Workplace</brief_title>
  <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</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University College, London</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>British Heart Foundation</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Headspace Meditation Limited</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
    <collaborator>
      <agency>Technical University Dresden</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University College, London</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      We propose a randomised controlled trial in a workplace setting to investigate whether a&#xD;
      smartphone-delivered programme of mindfulness meditation influences psychological and&#xD;
      biological indicators of well-being.&#xD;
&#xD;
      We hypothesise that after 8 weeks participants who complete the meditation programme will&#xD;
      show increases in psychological well-being and reduced activation of stress-related&#xD;
      biological pathways.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Mindfulness-based therapies can reduce depressive symptoms in patients and healthy subjects.&#xD;
      Therapies such as MBSR (mindfulness-based stress reduction) typically consist of 8 group&#xD;
      sessions led by an experienced practitioner, plus home practice and one full day of&#xD;
      meditation. In this study we aim to investigate whether a mindfulness programme delivered as&#xD;
      a series of podcasts on a mobile phone app could lead to gains in well-being and a reduction&#xD;
      in stress.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date>August 2012</start_date>
  <completion_date type="Anticipated">January 2013</completion_date>
  <primary_completion_date type="Anticipated">January 2013</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Well-being</measure>
    <time_frame>8 weeks</time_frame>
    <description>Psychological well-being will be assessed using the Warwick Edinburgh Mental Well-Being Scale</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Blood pressure</measure>
    <time_frame>8 weeks</time_frame>
    <description>Blood pressure over the working day will be measured as an indicator of activation of the stress response</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Psychological stress</measure>
    <time_frame>8 weeks</time_frame>
    <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).</description>
  </other_outcome>
  <other_outcome>
    <measure>Cortisol</measure>
    <time_frame>8 weeks</time_frame>
    <description>Hair cortisol concentration, as an indicator of activation of the HPA axis</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">120</enrollment>
  <condition>Well-being, Work Stress</condition>
  <arm_group>
    <arm_group_label>Headspace On-the-go app</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants were given access to a 45-day mindfulness meditation programme via the Headspace smartphone app</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Waitlist control</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Participants will be asked to wait for 8 weeks before starting the intervention</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Headspace On-the-go app</intervention_name>
    <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.</description>
    <arm_group_label>Headspace On-the-go app</arm_group_label>
    <other_name>Mindfulness meditation smartphone app</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Employees of a UK high-tech company&#xD;
&#xD;
          -  Raised levels of work stress (overcommitment&gt;2) or depression (CESD&gt;1)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  treated for anxiety, depression or hypertension&#xD;
&#xD;
          -  taking medication containing steroids&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Andrew Steptoe, DPhil, DSc, FMedSci</last_name>
    <role>Principal Investigator</role>
    <affiliation>University College, London</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Sophie K Bostock, BMedSci, MSc</last_name>
    <phone>+44 (0)7779578733</phone>
    <email>sophie.bostock.09@ucl.ac.uk</email>
  </overall_contact>
  <location>
    <facility>
      <name>UK high-tech company office</name>
      <address>
        <city>London</city>
        <country>United Kingdom</country>
      </address>
    </facility>
    <investigator>
      <last_name>Sophie K Bostock, BMedSci, MSc</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>United Kingdom</country>
  </location_countries>
  <verification_date>August 2012</verification_date>
  <study_first_submitted>August 7, 2012</study_first_submitted>
  <study_first_submitted_qc>August 7, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 9, 2012</study_first_posted>
  <last_update_submitted>August 7, 2012</last_update_submitted>
  <last_update_submitted_qc>August 7, 2012</last_update_submitted_qc>
  <last_update_posted type="Estimate">August 9, 2012</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Mindfulness</keyword>
  <keyword>meditation</keyword>
  <keyword>stress</keyword>
  <keyword>well-being</keyword>
  <keyword>work stress</keyword>
  <keyword>blood pressure</keyword>
  <keyword>cortisol</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Occupational Stress</mesh_term>
  </condition_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT01661569
org study id: 3035/002
nct id: NCT01661569
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
has dmc: No
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.
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.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Well-being
time frame: 8 weeks
description: Psychological well-being will be assessed using the Warwick Edinburgh Mental Well-Being Scale
measure: Blood pressure
time frame: 8 weeks
description: Blood pressure over the working day will be measured as an indicator of activation of the stress response
measure: Psychological stress
time frame: 8 weeks
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).
measure: Cortisol
time frame: 8 weeks
description: Hair cortisol concentration, as an indicator of activation of the HPA axis
arm group label: Headspace On-the-go app
arm group type: Experimental
description: Participants were given access to a 45-day mindfulness meditation programme via the Headspace smartphone app
arm group label: Waitlist control
arm group type: No Intervention
description: Participants will be asked to wait for 8 weeks before starting the intervention
intervention type: Other
intervention name: Headspace On-the-go app
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.
arm group label: Headspace On-the-go app
other name: Mindfulness meditation smartphone app
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Andrew Steptoe, DPhil, DSc, FMedSci
role: Principal Investigator
affiliation: University College, London
last name: Sophie K Bostock, BMedSci, MSc
phone: +44 (0)7779578733
email: sophie.bostock.09@ucl.ac.uk
facility: 
investigator: 
country: United Kingdom
responsible party type: Sponsor
mesh term: Occupational Stress