<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/NCT03030040</url>
  </required_header>
  <id_info>
    <org_study_id>EmilyIronmongerMRP2016</org_study_id>
    <secondary_id>IRAS ID: 215054</secondary_id>
    <nct_id>NCT03030040</nct_id>
  </id_info>
  <brief_title>A Randomised Controlled Trial of Self-help Mindfulness-based Cognitive Therapy for Health Workers</brief_title>
  <acronym>MindSHINE2</acronym>
  <official_title>A Randomised Controlled Trial of a Mindfulness-based Cognitive Therapy Self-help Intervention for UK National Health Service Employees</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Canterbury Christ Church University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Sussex Partnership NHS Foundation Trust</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>University of Sussex</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Canterbury Christ Church University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study examines whether a mindfulness-based self-help book is effective at reducing&#xD;
      healthcare workers' levels of stress and improving their wellbeing.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This study is a randomised controlled trial (RCT) examining the efficacy of a&#xD;
      mindfulness-based cognitive therapy self-help book ('Mindfulness: A practice guide to finding&#xD;
      peace in a frantic world') relative to a wait-list control, in healthcare staff. It builds on&#xD;
      a previous pilot RCT (http://www.isrctn.com/ISRCTN16486066). A battery of measures will be&#xD;
      administered at baseline (week 0), post-intervention (week 9) and follow-up (week 21). This&#xD;
      trial is designed to test the following hypotheses.&#xD;
&#xD;
      Primary Hypothesis&#xD;
&#xD;
      -Mindfulness-based cognitive therapy self-help (MBCT-SH) participants, in comparison to&#xD;
      waitlist control participants, will show a reduction in symptoms of stress by the end of&#xD;
      MBCT-SH (week 9).&#xD;
&#xD;
      Secondary Hypotheses&#xD;
&#xD;
        -  The improvement detailed in the primary hypothesis will be maintained at a follow-up 12&#xD;
           weeks after the end of the MBCT-SH (week 21).&#xD;
&#xD;
        -  MBCT-SH participants, in comparison to waitlist control participants, will show&#xD;
           improvements in mindfulness, other-compassion, self-compassion, anxiety, depression,&#xD;
           burnout and mental well-being by the end of MBCT-SH (week 9), and these improvements&#xD;
           will be maintained at a follow-up 12 weeks after the end of the MBCT-SH (week 21).&#xD;
&#xD;
        -  MBCT-SH participants, in comparison to waitlist control participants, will show a&#xD;
           reduction in the number of sickness absence days from the three months preceding the&#xD;
           intervention to the three months following the intervention.&#xD;
&#xD;
        -  Increases in self-compassion and mindfulness from week 0 to week 9, will mediate the&#xD;
           effects of MBCT-SH (relative to waitlist control) on levels of stress, depression,&#xD;
           anxiety, wellbeing and burnout.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 26, 2017</start_date>
  <completion_date type="Actual">June 22, 2018</completion_date>
  <primary_completion_date type="Actual">June 22, 2018</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>Single (Investigator)</masking>
    <masking_description>Random allocation of participants to arms will be conducted by a statistician independent of the study.</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Stress</measure>
    <time_frame>Post-intervention (i.e. 9-weeks after baseline)</time_frame>
    <description>Change from baseline at 9-weeks on the Stress sub-scale of the Depression, Anxiety and Stress Scale-21</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Stress (follow-up)</measure>
    <time_frame>Follow-up (i.e. 21 weeks after baseline)</time_frame>
    <description>Change from baseline at 21-weeks on the Stress sub-scale of the Depression, Anxiety and Stress Scale-21</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Depression</measure>
    <time_frame>Post-intervention (i.e. 9-weeks after baseline)</time_frame>
    <description>Change from baseline at 9-weeks on the Depression sub-scale of the Depression, Anxiety and Stress Scale-21</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Depression (follow-up)</measure>
    <time_frame>Follow-up (i.e. 21 weeks after baseline)</time_frame>
    <description>Change from baseline at 21-weeks on the Depression sub-scale of the Depression, Anxiety and Stress Scale-21</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Anxiety</measure>
    <time_frame>Post-intervention (i.e. 9-weeks after baseline)</time_frame>
    <description>Change from baseline at 9-weeks on the Anxiety sub-scale of the Depression, Anxiety and Stress Scale-21</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Anxiety (follow-up)</measure>
    <time_frame>Follow-up (i.e. 21 weeks after baseline)</time_frame>
    <description>Change from baseline at 21-weeks on the Anxiety sub-scale of the Depression, Anxiety and Stress Scale-21</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Compassion for others</measure>
    <time_frame>Post-intervention (i.e. 9-weeks after baseline)</time_frame>
    <description>Change from baseline at 9-weeks on the Compassion Scale</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Compassion for others (follow-up)</measure>
    <time_frame>Follow-up (i.e. 21 weeks after baseline)</time_frame>
    <description>Change from baseline at 21-weeks on the Compassion Scale</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Self-compassion</measure>
    <time_frame>Post-intervention (i.e. 9-weeks after baseline)</time_frame>
    <description>Change from baseline at 9-weeks on the Self-compassion Scale - Short Form</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Self-compassion (follow-up)</measure>
    <time_frame>Follow-up (i.e. 21 weeks after baseline)</time_frame>
    <description>Change from baseline at 21-weeks on the Self-compassion Scale - Short Form</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mindfulness</measure>
    <time_frame>Post-intervention (i.e. 9-weeks after baseline)</time_frame>
    <description>Change from baseline at 9-weeks on the Five-Facet Mindfulness Questionnaire - Short Form</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mindfulness (follow-up)</measure>
    <time_frame>Follow-up (i.e. 21 weeks after baseline)</time_frame>
    <description>Change from baseline at 21-weeks on the Five-Facet Mindfulness Questionnaire - Short Form</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Burnout</measure>
    <time_frame>Post-intervention (i.e. 9-weeks after baseline)</time_frame>
    <description>Change from baseline at 9-weeks on the Maslach Burnout Inventory</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Burnout (follow-up)</measure>
    <time_frame>Follow-up (i.e. 21 weeks after baseline)</time_frame>
    <description>Change from baseline at 21-weeks on the Maslach Burnout Inventory</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mental Wellbeing</measure>
    <time_frame>Post-intervention (i.e. 9-weeks after baseline)</time_frame>
    <description>Change from baseline at 9-weeks on the Short Warwick-Edinburgh Mental Well-being Scale</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mental Wellbeing (follow-up)</measure>
    <time_frame>Follow-up (i.e. 21 weeks after baseline)</time_frame>
    <description>Change from baseline at 21-weeks on the Short Warwick-Edinburgh Mental Well-being Scale</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Sickness absence</measure>
    <time_frame>Follow-up (i.e. 21 weeks after baseline)</time_frame>
    <description>Change from baseline in the number of days of sickness absence over the previous 12 weeks at 21 weeks.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">102</enrollment>
  <condition>Psychological Stress</condition>
  <arm_group>
    <arm_group_label>MBCT-SH</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>MBCT-SH will be an unguided, mindfulness-based cognitive therapy, book-based self-help intervention.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>A wait list control group who will receive no intervention during the 21 weeks of the study. Control participants will be provided with the self-help book that the MBCT-SH group received after week 21.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>The self-help book: Williams, M. &amp; Penman, D. (2011). Mindfulness: A practical guide to finding peace in a frantic world. London: Piatkus.</intervention_name>
    <description>Participants will be provided with a copy of the self-help book, and asked to read it and follow the activities outlined in it, over eight weeks. They will receive weekly standardized emails, to provide information about mindfulness and encouragement to engage with the self-help book.</description>
    <arm_group_label>MBCT-SH</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Being currently employed by Sussex Partnership NHS Foundation Trust (in the UK) in a&#xD;
             role or roles that involve direct delivery of healthcare.&#xD;
&#xD;
          2. Having at least one day per week of direct contact with UK National Health Service&#xD;
             service users.&#xD;
&#xD;
          3. Agreeing to refrain from engaging in another form of psychological therapy during the&#xD;
             course of the study.&#xD;
&#xD;
          4. Having self-reported sufficient English language reading ability to read and&#xD;
             understand the self-help book&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Being currently on leave of absence from work.&#xD;
&#xD;
          2. Having previously received a minimum dose (defined as 50% of a course or more) of a&#xD;
             mindfulness-based intervention.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Emily C Ironmonger, MSc</last_name>
    <role>Principal Investigator</role>
    <affiliation>Canterbury Christ Church University</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Clara Strauss, PhD</last_name>
    <role>Study Director</role>
    <affiliation>Sussex Partnership NHS Foundation Trust &amp; University of Sussex</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Kate Cavanagh, PhD</last_name>
    <role>Study Director</role>
    <affiliation>University of Sussex</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Fergal Jones, PhD</last_name>
    <role>Study Director</role>
    <affiliation>Canterbury Christ Church University &amp; Sussex Partnership NHS Foundation Trust</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Oxleas NHS Foundation Trust</name>
      <address>
        <city>Dartford</city>
        <state>Kent</state>
        <zip>DA2 7WG</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Sussex Partnership NHS Foundation Trust</name>
      <address>
        <city>Hove</city>
        <state>Sussex</state>
        <zip>BN3 7HZ</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United Kingdom</country>
  </location_countries>
  <verification_date>March 2019</verification_date>
  <study_first_submitted>January 20, 2017</study_first_submitted>
  <study_first_submitted_qc>January 20, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 24, 2017</study_first_posted>
  <last_update_submitted>March 20, 2019</last_update_submitted>
  <last_update_submitted_qc>March 20, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">March 22, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>mindfulness-based cognitive therapy</keyword>
  <keyword>self-help</keyword>
  <keyword>healthcare staff</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Stress, Psychological</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- 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/NCT03030040
org study id: EmilyIronmongerMRP2016
secondary id: IRAS ID: 215054
nct id: NCT03030040
lead sponsor: 
collaborator: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This study examines whether a mindfulness-based self-help book is effective at reducing
      healthcare workers' levels of stress and improving their wellbeing.
This study is a randomised controlled trial (RCT) examining the efficacy of a
      mindfulness-based cognitive therapy self-help book ('Mindfulness: A practice guide to finding
      peace in a frantic world') relative to a wait-list control, in healthcare staff. It builds on
      a previous pilot RCT (http://www.isrctn.com/ISRCTN16486066). A battery of measures will be
      administered at baseline (week 0), post-intervention (week 9) and follow-up (week 21). This
      trial is designed to test the following hypotheses.

      Primary Hypothesis

      -Mindfulness-based cognitive therapy self-help (MBCT-SH) participants, in comparison to
      waitlist control participants, will show a reduction in symptoms of stress by the end of
      MBCT-SH (week 9).

      Secondary Hypotheses

        -  The improvement detailed in the primary hypothesis will be maintained at a follow-up 12
           weeks after the end of the MBCT-SH (week 21).

        -  MBCT-SH participants, in comparison to waitlist control participants, will show
           improvements in mindfulness, other-compassion, self-compassion, anxiety, depression,
           burnout and mental well-being by the end of MBCT-SH (week 9), and these improvements
           will be maintained at a follow-up 12 weeks after the end of the MBCT-SH (week 21).

        -  MBCT-SH participants, in comparison to waitlist control participants, will show a
           reduction in the number of sickness absence days from the three months preceding the
           intervention to the three months following the intervention.

        -  Increases in self-compassion and mindfulness from week 0 to week 9, will mediate the
           effects of MBCT-SH (relative to waitlist control) on levels of stress, depression,
           anxiety, wellbeing and burnout.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Investigator)
masking description: Random allocation of participants to arms will be conducted by a statistician independent of the study.
measure: Stress
time frame: Post-intervention (i.e. 9-weeks after baseline)
description: Change from baseline at 9-weeks on the Stress sub-scale of the Depression, Anxiety and Stress Scale-21
measure: Stress (follow-up)
time frame: Follow-up (i.e. 21 weeks after baseline)
description: Change from baseline at 21-weeks on the Stress sub-scale of the Depression, Anxiety and Stress Scale-21
measure: Depression
time frame: Post-intervention (i.e. 9-weeks after baseline)
description: Change from baseline at 9-weeks on the Depression sub-scale of the Depression, Anxiety and Stress Scale-21
measure: Depression (follow-up)
time frame: Follow-up (i.e. 21 weeks after baseline)
description: Change from baseline at 21-weeks on the Depression sub-scale of the Depression, Anxiety and Stress Scale-21
measure: Anxiety
time frame: Post-intervention (i.e. 9-weeks after baseline)
description: Change from baseline at 9-weeks on the Anxiety sub-scale of the Depression, Anxiety and Stress Scale-21
measure: Anxiety (follow-up)
time frame: Follow-up (i.e. 21 weeks after baseline)
description: Change from baseline at 21-weeks on the Anxiety sub-scale of the Depression, Anxiety and Stress Scale-21
measure: Compassion for others
time frame: Post-intervention (i.e. 9-weeks after baseline)
description: Change from baseline at 9-weeks on the Compassion Scale
measure: Compassion for others (follow-up)
time frame: Follow-up (i.e. 21 weeks after baseline)
description: Change from baseline at 21-weeks on the Compassion Scale
measure: Self-compassion
time frame: Post-intervention (i.e. 9-weeks after baseline)
description: Change from baseline at 9-weeks on the Self-compassion Scale - Short Form
measure: Self-compassion (follow-up)
time frame: Follow-up (i.e. 21 weeks after baseline)
description: Change from baseline at 21-weeks on the Self-compassion Scale - Short Form
measure: Mindfulness
time frame: Post-intervention (i.e. 9-weeks after baseline)
description: Change from baseline at 9-weeks on the Five-Facet Mindfulness Questionnaire - Short Form
measure: Mindfulness (follow-up)
time frame: Follow-up (i.e. 21 weeks after baseline)
description: Change from baseline at 21-weeks on the Five-Facet Mindfulness Questionnaire - Short Form
measure: Burnout
time frame: Post-intervention (i.e. 9-weeks after baseline)
description: Change from baseline at 9-weeks on the Maslach Burnout Inventory
measure: Burnout (follow-up)
time frame: Follow-up (i.e. 21 weeks after baseline)
description: Change from baseline at 21-weeks on the Maslach Burnout Inventory
measure: Mental Wellbeing
time frame: Post-intervention (i.e. 9-weeks after baseline)
description: Change from baseline at 9-weeks on the Short Warwick-Edinburgh Mental Well-being Scale
measure: Mental Wellbeing (follow-up)
time frame: Follow-up (i.e. 21 weeks after baseline)
description: Change from baseline at 21-weeks on the Short Warwick-Edinburgh Mental Well-being Scale
measure: Sickness absence
time frame: Follow-up (i.e. 21 weeks after baseline)
description: Change from baseline in the number of days of sickness absence over the previous 12 weeks at 21 weeks.
arm group label: MBCT-SH
arm group type: Experimental
description: MBCT-SH will be an unguided, mindfulness-based cognitive therapy, book-based self-help intervention.
arm group label: Control
arm group type: No Intervention
description: A wait list control group who will receive no intervention during the 21 weeks of the study. Control participants will be provided with the self-help book that the MBCT-SH group received after week 21.
intervention type: Behavioral
intervention name: The self-help book: Williams, M. & Penman, D. (2011). Mindfulness: A practical guide to finding peace in a frantic world. London: Piatkus.
description: Participants will be provided with a copy of the self-help book, and asked to read it and follow the activities outlined in it, over eight weeks. They will receive weekly standardized emails, to provide information about mindfulness and encouragement to engage with the self-help book.
arm group label: MBCT-SH
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Emily C Ironmonger, MSc
role: Principal Investigator
affiliation: Canterbury Christ Church University
last name: Clara Strauss, PhD
role: Study Director
affiliation: Sussex Partnership NHS Foundation Trust & University of Sussex
last name: Kate Cavanagh, PhD
role: Study Director
affiliation: University of Sussex
last name: Fergal Jones, PhD
role: Study Director
affiliation: Canterbury Christ Church University & Sussex Partnership NHS Foundation Trust
facility: 
facility: 
country: United Kingdom
responsible party type: Sponsor
mesh term: Stress, Psychological
sharing ipd: No