<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/NCT03797599</url>
  </required_header>
  <id_info>
    <org_study_id>S_Strohmaier_29-11-18</org_study_id>
    <nct_id>NCT03797599</nct_id>
  </id_info>
  <brief_title>Study Examining the Effects of Mindfulness and Similar Audio-guided Exercises.</brief_title>
  <official_title>The Effects of Length of Mindfulness Practice on Mindfulness, Depression, Anxiety and Stress: A Randomised Controlled Experiment</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Canterbury Christ Church University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </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 aims to examine whether greater length of mindfulness practice results in more&#xD;
      beneficial outcomes.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This study will randomise participants to one of three groups: (1) four sessions of medium&#xD;
      length mindfulness practice (lasting 20 mins) and 5 mins of an audio book; (2) four sessions&#xD;
      of brief mindfulness practice (lasting 5 mins) and 20 mins of an audio book; and (3) a&#xD;
      control group who just receive 4 sessions of audio book (lasting 25 mins). In the mindfulness&#xD;
      arms, in each session, the participants will receive the audio book prior to the mindfulness&#xD;
      practice. Mindfulness levels, and depression, anxiety and stress will be measured by&#xD;
      self-report at baseline, session by session, and at post-intervention.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">March 28, 2019</start_date>
  <completion_date type="Actual">December 5, 2019</completion_date>
  <primary_completion_date type="Actual">December 5, 2019</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>Basic Science</primary_purpose>
    <masking>None (Open Label)</masking>
    <masking_description>Participants will be masked to the extent that they will not be told which group they have been allocated to nor the exact nature of the the three groups. However, they will be aware of the exercises they are asked to undertake.</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Change from baseline at post-intervention (week 3) on the Five Factor Mindfulness Questionnaire -15 item version (FFMQ-15)</measure>
    <time_frame>Post-intervention (3 weeks after baseline).</time_frame>
    <description>The Five Factor Mindfulness Questionnaire -15 item version is a self-report measure of mindfulness, producing a total score between 15 and 75, with higher scores indicating greater levels of mindfulness. (Note that the observe subscale will be excluded from the calculation of the total score, as recommended in https://doi.org/10.1002/jclp.21865 and http://dx.doi.org/10.1037/pas0000263 producing a total score between 12 and 60).</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change from baseline at post-intervention (week 3) on the Depression, Anxiety and Stress Scale - 21 item version (DASS-21).</measure>
    <time_frame>Post-intervention (3 weeks after baseline).</time_frame>
    <description>The Depression, Anxiety and Stress Scale - 21 is a self-report measure of depression, anxiety and stress, producing a total score between 0 and 63, with higher scores indicating greater symptomatology.</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Sessional Five Factor Mindfulness Questionnaire -15 item version (FFMQ-15) scores.</measure>
    <time_frame>Baseline, session 2 (week 1), session 3 and 4 (week 2), and post-intervention (week 3).</time_frame>
    <description>The FFMQ-15 (described above) will be administered at the start of the first session (baseline), immediately after sessions 2 (week 1), 3 (week 2) and 4 (week 2), and at post-intervention (week 3), to examine patterns in changes in mindfulness over the course of the study.</description>
  </other_outcome>
  <other_outcome>
    <measure>Sessional Depression, Anxiety and Stress Scale - 21 item version (DASS-21) scores</measure>
    <time_frame>Baseline, session 2 (week 1), session 3 and 4 (week 2), and post-intervention (week 3).</time_frame>
    <description>The DASS-21 (described above) will be administered at the start of the first session (baseline), immediately after sessions 2 (week 1), 3 (week 2) and 4 (week 2), and at post-intervention (week 3), to to examine patterns in changes over the course of the study.</description>
  </other_outcome>
  <other_outcome>
    <measure>Session 1 Toronto Mindfulness Scale (TMS).</measure>
    <time_frame>Session 1 (week 1).</time_frame>
    <description>The TMS is a 13-item self-report measure of state mindfulness that produces scores for curiosity and decentering. The curiosity score ranges from 0 to 24, the decentering score from 0 to 28, and the total score from 0 to 52, with higher scores indicating greater curiosity, decentering and overall state mindfulness respectively.</description>
  </other_outcome>
  <other_outcome>
    <measure>Session 2 Toronto Mindfulness Scale (TMS).</measure>
    <time_frame>Session 2 (week 1).</time_frame>
    <description>As described above.</description>
  </other_outcome>
  <other_outcome>
    <measure>Session 3 Toronto Mindfulness Scale (TMS).</measure>
    <time_frame>Session 3 (week 2).</time_frame>
    <description>As described above.</description>
  </other_outcome>
  <other_outcome>
    <measure>Session 4 Toronto Mindfulness Scale (TMS).</measure>
    <time_frame>Session 4 (week 2).</time_frame>
    <description>As described above.</description>
  </other_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">71</enrollment>
  <condition>Mindfulness</condition>
  <condition>Healthy Population</condition>
  <arm_group>
    <arm_group_label>20 minutes of mindfulness practice</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Two sessions a week for two weeks of: 5 minutes listening to audio book excerpts followed by 20 minutes of audio guided mindfulness practice. Participants will be asked not to engage in formal mindfulness practice outside of these sessions during the study.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>5 minutes of mindfulness practice</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Two sessions a week for two weeks of: 20 minutes listening to audio book excerpts followed by 5 minutes of audio guided mindfulness practice. Participants will be asked not to engage in formal mindfulness practice outside of these sessions during the study.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Audio book control</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Two sessions a week for two weeks of: 25 minutes listening to audio book excerpts (with non mindfulness practice). Participants will be asked not to engage in formal mindfulness practice during the study.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>20 minutes of mindfulness practice</intervention_name>
    <description>A 20 minute audio guided mindfulness of breathing practice per session, for four sessions.</description>
    <arm_group_label>20 minutes of mindfulness practice</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>5 minutes of mindfulness practice</intervention_name>
    <description>A 5 minute audio guided mindfulness of breathing practice per session, for four sessions.</description>
    <arm_group_label>5 minutes of mindfulness practice</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>5 minute audio book</intervention_name>
    <description>5 minutes from an audio book by Bill Bryson ('A Short History of Nearly Everything') per session, for four sessions.</description>
    <arm_group_label>20 minutes of mindfulness practice</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>20 minute audio book</intervention_name>
    <description>20 minutes from an audio book by Bill Bryson ('A Short History of Nearly Everything'), per session, for four sessions.</description>
    <arm_group_label>5 minutes of mindfulness practice</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>25 minute audio book</intervention_name>
    <description>25 minutes from an audio book by Bill Bryson ('A Short History of Nearly Everything'), per session, for four sessions.</description>
    <arm_group_label>Audio book control</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Members of the general public, especially university students or staff.&#xD;
&#xD;
          -  Adequate understanding of spoken and written English&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Currently experiencing significant difficulties with their mental wellbeing.&#xD;
&#xD;
          -  Currently have a personal mindfulness practice.&#xD;
&#xD;
          -  Currently participating in a 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>Fergal Jones, PhD, PsychD</last_name>
    <role>Study Director</role>
    <affiliation>Canterbury Christ Church University</affiliation>
  </overall_official>
  <overall_official>
    <last_name>James Cane, PhD</last_name>
    <role>Study Director</role>
    <affiliation>Canterbury Christ Church University</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Sarah Strohmaier, MSc</last_name>
    <role>Principal Investigator</role>
    <affiliation>Canterbury Christ Church University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Canterbury Christ Church University</name>
      <address>
        <city>Tunbridge Wells</city>
        <state>Kent</state>
        <zip>TN1 2YG</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United Kingdom</country>
  </location_countries>
  <verification_date>September 2019</verification_date>
  <study_first_submitted>January 7, 2019</study_first_submitted>
  <study_first_submitted_qc>January 7, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 9, 2019</study_first_posted>
  <last_update_submitted>December 9, 2019</last_update_submitted>
  <last_update_submitted_qc>December 9, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">December 11, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <patient_data>
    <sharing_ipd>Undecided</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/NCT03797599
org study id: S_Strohmaier_29-11-18
nct id: NCT03797599
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This study aims to examine whether greater length of mindfulness practice results in more
      beneficial outcomes.
This study will randomise participants to one of three groups: (1) four sessions of medium
      length mindfulness practice (lasting 20 mins) and 5 mins of an audio book; (2) four sessions
      of brief mindfulness practice (lasting 5 mins) and 20 mins of an audio book; and (3) a
      control group who just receive 4 sessions of audio book (lasting 25 mins). In the mindfulness
      arms, in each session, the participants will receive the audio book prior to the mindfulness
      practice. Mindfulness levels, and depression, anxiety and stress will be measured by
      self-report at baseline, session by session, and at post-intervention.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Basic Science
masking: None (Open Label)
masking description: Participants will be masked to the extent that they will not be told which group they have been allocated to nor the exact nature of the the three groups. However, they will be aware of the exercises they are asked to undertake.
measure: Change from baseline at post-intervention (week 3) on the Five Factor Mindfulness Questionnaire -15 item version (FFMQ-15)
time frame: Post-intervention (3 weeks after baseline).
description: The Five Factor Mindfulness Questionnaire -15 item version is a self-report measure of mindfulness, producing a total score between 15 and 75, with higher scores indicating greater levels of mindfulness. (Note that the observe subscale will be excluded from the calculation of the total score, as recommended in https://doi.org/10.1002/jclp.21865 and http://dx.doi.org/10.1037/pas0000263 producing a total score between 12 and 60).
measure: Change from baseline at post-intervention (week 3) on the Depression, Anxiety and Stress Scale - 21 item version (DASS-21).
time frame: Post-intervention (3 weeks after baseline).
description: The Depression, Anxiety and Stress Scale - 21 is a self-report measure of depression, anxiety and stress, producing a total score between 0 and 63, with higher scores indicating greater symptomatology.
measure: Sessional Five Factor Mindfulness Questionnaire -15 item version (FFMQ-15) scores.
time frame: Baseline, session 2 (week 1), session 3 and 4 (week 2), and post-intervention (week 3).
description: The FFMQ-15 (described above) will be administered at the start of the first session (baseline), immediately after sessions 2 (week 1), 3 (week 2) and 4 (week 2), and at post-intervention (week 3), to examine patterns in changes in mindfulness over the course of the study.
measure: Sessional Depression, Anxiety and Stress Scale - 21 item version (DASS-21) scores
time frame: Baseline, session 2 (week 1), session 3 and 4 (week 2), and post-intervention (week 3).
description: The DASS-21 (described above) will be administered at the start of the first session (baseline), immediately after sessions 2 (week 1), 3 (week 2) and 4 (week 2), and at post-intervention (week 3), to to examine patterns in changes over the course of the study.
measure: Session 1 Toronto Mindfulness Scale (TMS).
time frame: Session 1 (week 1).
description: The TMS is a 13-item self-report measure of state mindfulness that produces scores for curiosity and decentering. The curiosity score ranges from 0 to 24, the decentering score from 0 to 28, and the total score from 0 to 52, with higher scores indicating greater curiosity, decentering and overall state mindfulness respectively.
measure: Session 2 Toronto Mindfulness Scale (TMS).
time frame: Session 2 (week 1).
description: As described above.
measure: Session 3 Toronto Mindfulness Scale (TMS).
time frame: Session 3 (week 2).
description: As described above.
measure: Session 4 Toronto Mindfulness Scale (TMS).
time frame: Session 4 (week 2).
description: As described above.
arm group label: 20 minutes of mindfulness practice
arm group type: Experimental
description: Two sessions a week for two weeks of: 5 minutes listening to audio book excerpts followed by 20 minutes of audio guided mindfulness practice. Participants will be asked not to engage in formal mindfulness practice outside of these sessions during the study.
arm group label: 5 minutes of mindfulness practice
arm group type: Active Comparator
description: Two sessions a week for two weeks of: 20 minutes listening to audio book excerpts followed by 5 minutes of audio guided mindfulness practice. Participants will be asked not to engage in formal mindfulness practice outside of these sessions during the study.
arm group label: Audio book control
arm group type: Placebo Comparator
description: Two sessions a week for two weeks of: 25 minutes listening to audio book excerpts (with non mindfulness practice). Participants will be asked not to engage in formal mindfulness practice during the study.
intervention type: Behavioral
intervention name: 20 minutes of mindfulness practice
description: A 20 minute audio guided mindfulness of breathing practice per session, for four sessions.
arm group label: 20 minutes of mindfulness practice
intervention type: Behavioral
intervention name: 5 minutes of mindfulness practice
description: A 5 minute audio guided mindfulness of breathing practice per session, for four sessions.
arm group label: 5 minutes of mindfulness practice
intervention type: Other
intervention name: 5 minute audio book
description: 5 minutes from an audio book by Bill Bryson ('A Short History of Nearly Everything') per session, for four sessions.
arm group label: 20 minutes of mindfulness practice
intervention type: Other
intervention name: 20 minute audio book
description: 20 minutes from an audio book by Bill Bryson ('A Short History of Nearly Everything'), per session, for four sessions.
arm group label: 5 minutes of mindfulness practice
intervention type: Other
intervention name: 25 minute audio book
description: 25 minutes from an audio book by Bill Bryson ('A Short History of Nearly Everything'), per session, for four sessions.
arm group label: Audio book control
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Fergal Jones, PhD, PsychD
role: Study Director
affiliation: Canterbury Christ Church University
last name: James Cane, PhD
role: Study Director
affiliation: Canterbury Christ Church University
last name: Sarah Strohmaier, MSc
role: Principal Investigator
affiliation: Canterbury Christ Church University
facility: 
country: United Kingdom
responsible party type: Sponsor
sharing ipd: Undecided