<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/NCT03769233</url>
  </required_header>
  <id_info>
    <org_study_id>E2018-349</org_study_id>
    <nct_id>NCT03769233</nct_id>
  </id_info>
  <brief_title>Mindfulness for Emerging Adults Experiencing Anxious and/or Depressive Symptoms</brief_title>
  <official_title>A 5-week Mindfulness Program for Emerging Adults Experiencing Anxious and/or Depressive Symptoms</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>York University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>York 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>
      Emerging adults (EA; 18 to 29 years old) in Canada are among the age group with highest risk&#xD;
      of developing mental health issues. Despite this, they experience especially long wait-times&#xD;
      for mental health services. To date, there has been minimal research into developmentally&#xD;
      appropriate treatment options for the EA population. Mindfulness-based interventions (MBIs)&#xD;
      are emerging as a potential treatment to address this need. MBIs are group-based&#xD;
      psychological treatments for coping with distress, with the goal of improving mental health.&#xD;
      Unfortunately, these 'traditional' MBIs are very demanding in terms of time and homework and&#xD;
      are therefore not sufficiently feasible for the demanding schedules of EA university&#xD;
      students. Instead, recent studies suggest a role for briefer MBIs in addressing mental health&#xD;
      symptom burden, well-being and reducing acute stress symptoms. The brevity of these&#xD;
      interventions make them theoretically better suited for EA university populations. High&#xD;
      quality research, including controlled clinical trials are needed to demonstrate whether MBIs&#xD;
      can provide efficacious treatment to improve the lives of EA university students. The current&#xD;
      study will test the efficacy of a five-week MBI baseline within-subject controlled trial.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">December 14, 2018</start_date>
  <completion_date type="Actual">May 1, 2019</completion_date>
  <primary_completion_date type="Actual">May 1, 2019</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change from Baseline Depressive Symptoms at 2.5 Weeks, 5 Weeks, 7.5 Weeks and 11.5 Weeks</measure>
    <time_frame>Baseline (Week 0), Pre- (Week 2.5), Mid- (Week 5), Post-Treatment (Week 7.5), and 1-month Follow-up (Week 11.5</time_frame>
    <description>Patient Health Questionnaire-9 (PHQ-9): Scale used to measure Depressive Symptoms, with higher scores reflecting greater levels of depressive symptoms</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change from Baseline Anxious Symptoms at 2.5 Weeks, 5 Weeks, 7.5 Weeks and 11.5 Weeks</measure>
    <time_frame>Baseline (Week 0), Pre- (Week 2.5), Mid- (Week 5), Post-Treatment (Week 7.5), and 1-month Follow-up (Week 11.5)</time_frame>
    <description>Generalized Anxiety Disorder-7 (GAD-7): Scale used to measure Anxious Symptoms, with higher scores reflecting greater levels of anxious symptoms</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change from Baseline Mental Wellbeing at 2.5 Weeks, 5 Weeks, 7.5 Weeks and 11.5 Weeks</measure>
    <time_frame>Baseline (Week 0), Pre- (Week 2.5), Mid- (Week 5), Post-Treatment (Week 7.5), and 1-month Follow-up (Week 11.5)</time_frame>
    <description>Warwick-Edinburgh Mental Wellbeing Scale (WEMWBS): Scale used to measure Mental Wellbeing, with higher scores reflecting greater levels of mental wellbeing</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change from Baseline Perceived Stress at 2.5 Weeks, 5 Weeks, 7.5 Weeks and 11.5</measure>
    <time_frame>Baseline (Week 0), Pre- (Week 2.5), Mid- (Week 5), Post-Treatment (Week 7.5), and 1-month Follow-up (Week 11.5)</time_frame>
    <description>10-item Perceived Stress Scale (PSS-10): Scale used to measure Perceived Stress, with higher scores reflecting greater levels of perceived stress</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from Baseline Emotion Regulation Strategies at 2.5 Weeks, 5 Weeks, 7.5 Weeks and 11.5</measure>
    <time_frame>Baseline (Week 0), Pre- (Week 2.5), Mid- (Week 5), Post-Treatment (Week 7.5), and 1-month Follow-up (Week 11.5)</time_frame>
    <description>Emotion Regulation Questionnaire (ERQ): Scale used to measure Emotion Regulation, with higher scores reflecting greater levels of emotion regulation strategies</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from Baseline Self-Compassion at 2.5 Weeks, 5 Weeks, 7.5 Weeks and 11.5</measure>
    <time_frame>Baseline (Week 0), Pre- (Week 2.5), Mid- (Week 5), Post-Treatment (Week 7.5), and 1-month Follow-up (Week 11.5)</time_frame>
    <description>Self-Compassion Scale - Short Form (SCS-SF): Scale used to measure self-compassion, with higher scores reflecting greater levels of self-compassion</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from Baseline Mindful Awareness at 2.5 Weeks, 5 Weeks, 7.5 Weeks and 11.5</measure>
    <time_frame>Baseline (Week 0), Pre- (Week 2.5), Mid- (Week 5), Post-Treatment (Week 7.5), and 1-month Follow-up (Week 11.5)</time_frame>
    <description>Five-Facet Mindfulness Questionnaires (FFMQ): Scale used to measure mindful awareness, with higher scores reflecting greater levels of mindfulness facets</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">55</enrollment>
  <condition>Depressive Symptoms</condition>
  <condition>Anxious Symptoms</condition>
  <arm_group>
    <arm_group_label>Mindfulness-based Intervention</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>5 week, manual-based group MBI treatment for depressive and anxious symptoms</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Mindfulness-based Intervention</intervention_name>
    <description>MBI will be delivered in group format, 90 minutes per week, for 5 consecutive weeks with 6-15 participants per group.</description>
    <arm_group_label>Mindfulness-based Intervention</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  consenting Emerging Adults&#xD;
&#xD;
          -  Ability to communicate, in written and spoken English&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Minimal depressive and anxious symptoms (score below 10 and 8 on the PHQ-9/GAD-7&#xD;
&#xD;
          -  Current substance abuse or dependence, psychosis or mania&#xD;
&#xD;
          -  Current self-injurious behavior of past suicide attempt&#xD;
&#xD;
          -  Previously completed &gt;4 weeks of an MBI, or general Cognitive behavioral Therapy, in&#xD;
             the past 3 years&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>29 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Dr. Jennine S Rawana, PhD,C.Psych.</last_name>
    <role>Principal Investigator</role>
    <affiliation>York University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>York University</name>
      <address>
        <city>North York</city>
        <state>Ontario</state>
        <zip>M3J 1P3</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Canada</country>
  </location_countries>
  <verification_date>April 2021</verification_date>
  <study_first_submitted>December 6, 2018</study_first_submitted>
  <study_first_submitted_qc>December 6, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 7, 2018</study_first_posted>
  <last_update_submitted>April 12, 2021</last_update_submitted>
  <last_update_submitted_qc>April 12, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">April 13, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>York University</investigator_affiliation>
    <investigator_full_name>Dr. Jennine Rawana</investigator_full_name>
    <investigator_title>Associate Professor &amp; Clinical Developmental Psychologist</investigator_title>
  </responsible_party>
  <keyword>Mindfulness</keyword>
  <keyword>Well-being</keyword>
  <keyword>Emotion Regulation</keyword>
  <keyword>Perceived Stress</keyword>
  <keyword>Self-Compassion</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Depression</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/NCT03769233
org study id: E2018-349
nct id: NCT03769233
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Emerging adults (EA; 18 to 29 years old) in Canada are among the age group with highest risk
      of developing mental health issues. Despite this, they experience especially long wait-times
      for mental health services. To date, there has been minimal research into developmentally
      appropriate treatment options for the EA population. Mindfulness-based interventions (MBIs)
      are emerging as a potential treatment to address this need. MBIs are group-based
      psychological treatments for coping with distress, with the goal of improving mental health.
      Unfortunately, these 'traditional' MBIs are very demanding in terms of time and homework and
      are therefore not sufficiently feasible for the demanding schedules of EA university
      students. Instead, recent studies suggest a role for briefer MBIs in addressing mental health
      symptom burden, well-being and reducing acute stress symptoms. The brevity of these
      interventions make them theoretically better suited for EA university populations. High
      quality research, including controlled clinical trials are needed to demonstrate whether MBIs
      can provide efficacious treatment to improve the lives of EA university students. The current
      study will test the efficacy of a five-week MBI baseline within-subject controlled trial.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Change from Baseline Depressive Symptoms at 2.5 Weeks, 5 Weeks, 7.5 Weeks and 11.5 Weeks
time frame: Baseline (Week 0), Pre- (Week 2.5), Mid- (Week 5), Post-Treatment (Week 7.5), and 1-month Follow-up (Week 11.5
description: Patient Health Questionnaire-9 (PHQ-9): Scale used to measure Depressive Symptoms, with higher scores reflecting greater levels of depressive symptoms
measure: Change from Baseline Anxious Symptoms at 2.5 Weeks, 5 Weeks, 7.5 Weeks and 11.5 Weeks
time frame: Baseline (Week 0), Pre- (Week 2.5), Mid- (Week 5), Post-Treatment (Week 7.5), and 1-month Follow-up (Week 11.5)
description: Generalized Anxiety Disorder-7 (GAD-7): Scale used to measure Anxious Symptoms, with higher scores reflecting greater levels of anxious symptoms
measure: Change from Baseline Mental Wellbeing at 2.5 Weeks, 5 Weeks, 7.5 Weeks and 11.5 Weeks
time frame: Baseline (Week 0), Pre- (Week 2.5), Mid- (Week 5), Post-Treatment (Week 7.5), and 1-month Follow-up (Week 11.5)
description: Warwick-Edinburgh Mental Wellbeing Scale (WEMWBS): Scale used to measure Mental Wellbeing, with higher scores reflecting greater levels of mental wellbeing
measure: Change from Baseline Perceived Stress at 2.5 Weeks, 5 Weeks, 7.5 Weeks and 11.5
time frame: Baseline (Week 0), Pre- (Week 2.5), Mid- (Week 5), Post-Treatment (Week 7.5), and 1-month Follow-up (Week 11.5)
description: 10-item Perceived Stress Scale (PSS-10): Scale used to measure Perceived Stress, with higher scores reflecting greater levels of perceived stress
measure: Change from Baseline Emotion Regulation Strategies at 2.5 Weeks, 5 Weeks, 7.5 Weeks and 11.5
time frame: Baseline (Week 0), Pre- (Week 2.5), Mid- (Week 5), Post-Treatment (Week 7.5), and 1-month Follow-up (Week 11.5)
description: Emotion Regulation Questionnaire (ERQ): Scale used to measure Emotion Regulation, with higher scores reflecting greater levels of emotion regulation strategies
measure: Change from Baseline Self-Compassion at 2.5 Weeks, 5 Weeks, 7.5 Weeks and 11.5
time frame: Baseline (Week 0), Pre- (Week 2.5), Mid- (Week 5), Post-Treatment (Week 7.5), and 1-month Follow-up (Week 11.5)
description: Self-Compassion Scale - Short Form (SCS-SF): Scale used to measure self-compassion, with higher scores reflecting greater levels of self-compassion
measure: Change from Baseline Mindful Awareness at 2.5 Weeks, 5 Weeks, 7.5 Weeks and 11.5
time frame: Baseline (Week 0), Pre- (Week 2.5), Mid- (Week 5), Post-Treatment (Week 7.5), and 1-month Follow-up (Week 11.5)
description: Five-Facet Mindfulness Questionnaires (FFMQ): Scale used to measure mindful awareness, with higher scores reflecting greater levels of mindfulness facets
arm group label: Mindfulness-based Intervention
arm group type: Experimental
description: 5 week, manual-based group MBI treatment for depressive and anxious symptoms
intervention type: Behavioral
intervention name: Mindfulness-based Intervention
description: MBI will be delivered in group format, 90 minutes per week, for 5 consecutive weeks with 6-15 participants per group.
arm group label: Mindfulness-based Intervention
criteria: 
gender: All
minimum age: 18 Years
maximum age: 29 Years
healthy volunteers: No
last name: Dr. Jennine S Rawana, PhD,C.Psych.
role: Principal Investigator
affiliation: York University
facility: 
country: Canada
responsible party type: Principal Investigator
investigator affiliation: York University
investigator full name: Dr. Jennine Rawana
investigator title: Associate Professor & Clinical Developmental Psychologist
mesh term: Depression