<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/NCT03273699</url>
  </required_header>
  <id_info>
    <org_study_id>196-2016</org_study_id>
    <nct_id>NCT03273699</nct_id>
  </id_info>
  <brief_title>Mindfulness Meditation Utilizing an EEG Biofeedback Device for the Treatment for Obsessive Compulsive Disorder</brief_title>
  <official_title>Evaluating the Use of Mindfulness Meditation Utilizing a Consumer-Grade EEG Biofeedback Device for Patients Awaiting Treatment for Obsessive Compulsive Disorder</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Sunnybrook Health Sciences Centre</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Sunnybrook Health Sciences Centre</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>
      The Frederick W. Thompson Anxiety Disorders Centre has experienced significant demand for&#xD;
      services related to the treatment of Obsessive Compulsive Disorder (OCD), resulting in a&#xD;
      significant wait time for service. Although Cognitive Behavior Therapy (CBT) is the most&#xD;
      efficacious treatment intervention for OCD, there is a growing literature indicating the&#xD;
      mindfulness based approaches can be beneficial in terms of managing acute mood and anxiety&#xD;
      symptoms as well as reducing relapse risk following treatment.The goal of this study is to&#xD;
      examine the potential benefits of using a consumer grade EEG-based biofeedback device that&#xD;
      allows clients to engage in home based mindfulness meditation practices while they are&#xD;
      waiting to receive clinical services. Specifically, this study will investigate the effects&#xD;
      of meditation home practice on symptom alleviation, as related to specific OCD related&#xD;
      cognitive processes.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The goal of this study is to examine the potential benefits of using a consumer grade&#xD;
      EEG-based biofeedback device that allows clients to engage in home based mindfulness&#xD;
      meditation practices while they are waiting to receive clinical services. Specifically, this&#xD;
      study will investigate the effects of meditation home practice on symptom alleviation, as&#xD;
      related to specific OCD related cognitive processes.The study will be a randomized trial&#xD;
      where subjects (N=100) will be randomly assigned to receive either 1) an eight week&#xD;
      meditation program involving use of an EEG-based biofeedback device, or 2) wait list as per&#xD;
      usual. The experimental design is a 2 (treatment condition: Group 1: Mindfulness, Group 2:&#xD;
      Control) by 3 (assessment phase: baseline (week 0), mid-treatment (week 4), post-treatment&#xD;
      (week 8)) repeated measures factorial design. Group randomization will be completed by the&#xD;
      principal investigator, using the &quot;GraphPad Quick Calcs&quot; online calculator which offers&#xD;
      simple random allocation into equal-sized groups.Outcome measures will involve ratings of OCD&#xD;
      symptom severity, OCD beliefs, mindfulness, and use of thought control strategies. At&#xD;
      baseline, mid treatment (session 4), and post intervention, participants will complete the&#xD;
      Yale-Brown Obsessive Compulsive Scale, Obsessive Compulsive Inventory, Obsessive Beliefs&#xD;
      Questionnaire, Five Factor Mindfulness Questionnaire, Thought Control Questionnaire,&#xD;
      Acceptance and Action Questionnaire, Mind Wandering Scale and the Metacognitions&#xD;
      Questionnaire. Once per week, participants will complete the YBOCS, TCQ, and MW. This weekly&#xD;
      data will be collected online using the &quot;Survey Monkey&quot; web portal. Daily practice data from&#xD;
      the EEG headsets will be automatically uploaded to an encrypted server.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">April 10, 2017</start_date>
  <completion_date type="Actual">January 31, 2019</completion_date>
  <primary_completion_date type="Actual">January 31, 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>
    <intervention_model_description>A repeated measures multivariate analysis of variance (MANOVA) will be conducted with the two groups (guided mindfulness meditation or control wait list group) as the between-group variable and OCD symptom scores as the dependent variables. A mediation analysis will examine whether obsessive beliefs, engagement in thought control strategies, psychological flexibility, and mind wandering mediates treatment related changes in OCD symptom scores (YBOCS, OCI). Daily practice data from the EEG headsets will be automatically uploaded to an encrypted server. These data will be made anonymous from the start of the study; subjects will be identified using their subject I.D. EEG data will be preprocessed and analyzed using EEG Lab (Delorme &amp; Makeig, 2004).</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Yale-Brown Obsessive Compulsive Scale (YBOCS)</measure>
    <time_frame>Completed once per week, for eight weeks</time_frame>
    <description>A self-report inventory of obsessive compulsive symptoms</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Obsessive Compulsive Inventory</measure>
    <time_frame>Completed at three timepoints - week 1, week 4, week 8</time_frame>
    <description>Self-report measure of obsessive compulsive symptoms</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Obsessive Beliefs Questionnaire</measure>
    <time_frame>Completed at three timepoints - week 1, week 4, week 8</time_frame>
    <description>Self-report measure of OCD beliefs</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Five Factor Mindfulness Questionnaire</measure>
    <time_frame>Completed at three timepoints - week 1, week 4, week 8</time_frame>
    <description>Self-report measure of mindfulness</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Thought Control Questionnaire</measure>
    <time_frame>Completed at three timepoints - week 1, week 4, week 8</time_frame>
    <description>Self-report measure of use of thought control strategies</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Acceptance and Action Questionnaire</measure>
    <time_frame>Completed at three timepoints - week 1, week 4, week 8</time_frame>
    <description>Self-report measure of experiential avoidance</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mind Wandering Scale</measure>
    <time_frame>Completed at three timepoints - week 1, week 4, week 8</time_frame>
    <description>Self-report measure of mind wandering</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Metacognitions Questionnaire</measure>
    <time_frame>Completed at three timepoints - week 1, week 4, week 8</time_frame>
    <description>Self-report measure of metacognitive strategies</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">71</enrollment>
  <condition>Obsessive-Compulsive Disorder</condition>
  <arm_group>
    <arm_group_label>Mindfulness</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The study will be a randomized trial where subjects (N=100) will be randomly assigned to receive either 1) an eight week meditation program involving use of an EEG-based biofeedback device, or 2) wait list as per usual. The experimental design is a 2 (treatment condition: Group 1: Mindfulness, Group 2: Control) by 3 (assessment phase: baseline (week 0), mid-treatment (week 4), post-treatment (week 8)) repeated measures factorial design. Group randomization will be completed by the principal investigator, using the &quot;GraphPad Quick Calcs&quot; online calculator which offers simple random allocation into equal-sized groups</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>The study will be a randomized trial where subjects (N=100) will be randomly assigned to receive either 1) an eight week meditation program involving use of an EEG-based biofeedback device, or 2) wait list as per usual. The experimental design is a 2 (treatment condition: Group 1: Mindfulness, Group 2: Control) by 3 (assessment phase: baseline (week 0), mid-treatment (week 4), post-treatment (week 8)) repeated measures factorial design. Group randomization will be completed by the principal investigator, using the &quot;GraphPad Quick Calcs&quot; online calculator which offers simple random allocation into equal-sized groups</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Mindfulness</intervention_name>
    <description>Clients will use a consumer grade EEG device that provides guided mindfulness home practices</description>
    <arm_group_label>Mindfulness</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  All inclusion and exclusion criteria are consistent with the established guidelines&#xD;
             for our service - there are no additional study specific criteria. Potential subjects&#xD;
             are referred to the service with a query of OCD. Due to the nature of the assessment&#xD;
             procedures, which include English-language self-report questionnaires and scales, the&#xD;
             ability to communicate in written and spoken English is an inclusion criterion.&#xD;
             disorder&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Exclusion criteria include a) those with active substance abuse/dependence, b)&#xD;
             suspected organic pathology, c) recent suicide attempt/active suicidality, d) active&#xD;
             bipolar, psychotic disorder or post-traumatic stress&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>60 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Peggy Richter, M.D.</last_name>
    <role>Study Director</role>
    <affiliation>Sunnybrook Health Sciences Centre</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Sunnybrook Health Sciences Centre</name>
      <address>
        <city>Toronto</city>
        <state>Ontario</state>
        <zip>M4N3M5</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Canada</country>
  </location_countries>
  <reference>
    <citation>Bhayee S, Tomaszewski P, Lee DH, Moffat G, Pino L, Moreno S, Farb NA. Attentional and affective consequences of technology supported mindfulness training: a randomised, active control, efficacy trial. BMC Psychol. 2016 Nov 29;4(1):60. doi: 10.1186/s40359-016-0168-6.</citation>
    <PMID>27894358</PMID>
  </reference>
  <verification_date>April 2019</verification_date>
  <study_first_submitted>August 31, 2017</study_first_submitted>
  <study_first_submitted_qc>September 5, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 6, 2017</study_first_posted>
  <last_update_submitted>April 8, 2019</last_update_submitted>
  <last_update_submitted_qc>April 8, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">April 10, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Compulsive Personality Disorder</mesh_term>
    <mesh_term>Obsessive-Compulsive Disorder</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol and Statistical Analysis Plan</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>September 1, 2017</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/99/NCT03273699/Prot_SAP_000.pdf</document_url>
    </provided_document>
    <provided_document>
      <document_type>Informed Consent Form</document_type>
      <document_has_protocol>No</document_has_protocol>
      <document_has_icf>Yes</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>September 1, 2017</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/99/NCT03273699/ICF_001.pdf</document_url>
    </provided_document>
  </provided_document_section>
  <!-- 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/NCT03273699
org study id: 196-2016
nct id: NCT03273699
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The Frederick W. Thompson Anxiety Disorders Centre has experienced significant demand for
      services related to the treatment of Obsessive Compulsive Disorder (OCD), resulting in a
      significant wait time for service. Although Cognitive Behavior Therapy (CBT) is the most
      efficacious treatment intervention for OCD, there is a growing literature indicating the
      mindfulness based approaches can be beneficial in terms of managing acute mood and anxiety
      symptoms as well as reducing relapse risk following treatment.The goal of this study is to
      examine the potential benefits of using a consumer grade EEG-based biofeedback device that
      allows clients to engage in home based mindfulness meditation practices while they are
      waiting to receive clinical services. Specifically, this study will investigate the effects
      of meditation home practice on symptom alleviation, as related to specific OCD related
      cognitive processes.
The goal of this study is to examine the potential benefits of using a consumer grade
      EEG-based biofeedback device that allows clients to engage in home based mindfulness
      meditation practices while they are waiting to receive clinical services. Specifically, this
      study will investigate the effects of meditation home practice on symptom alleviation, as
      related to specific OCD related cognitive processes.The study will be a randomized trial
      where subjects (N=100) will be randomly assigned to receive either 1) an eight week
      meditation program involving use of an EEG-based biofeedback device, or 2) wait list as per
      usual. The experimental design is a 2 (treatment condition: Group 1: Mindfulness, Group 2:
      Control) by 3 (assessment phase: baseline (week 0), mid-treatment (week 4), post-treatment
      (week 8)) repeated measures factorial design. Group randomization will be completed by the
      principal investigator, using the "GraphPad Quick Calcs" online calculator which offers
      simple random allocation into equal-sized groups.Outcome measures will involve ratings of OCD
      symptom severity, OCD beliefs, mindfulness, and use of thought control strategies. At
      baseline, mid treatment (session 4), and post intervention, participants will complete the
      Yale-Brown Obsessive Compulsive Scale, Obsessive Compulsive Inventory, Obsessive Beliefs
      Questionnaire, Five Factor Mindfulness Questionnaire, Thought Control Questionnaire,
      Acceptance and Action Questionnaire, Mind Wandering Scale and the Metacognitions
      Questionnaire. Once per week, participants will complete the YBOCS, TCQ, and MW. This weekly
      data will be collected online using the "Survey Monkey" web portal. Daily practice data from
      the EEG headsets will be automatically uploaded to an encrypted server.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: A repeated measures multivariate analysis of variance (MANOVA) will be conducted with the two groups (guided mindfulness meditation or control wait list group) as the between-group variable and OCD symptom scores as the dependent variables. A mediation analysis will examine whether obsessive beliefs, engagement in thought control strategies, psychological flexibility, and mind wandering mediates treatment related changes in OCD symptom scores (YBOCS, OCI). Daily practice data from the EEG headsets will be automatically uploaded to an encrypted server. These data will be made anonymous from the start of the study; subjects will be identified using their subject I.D. EEG data will be preprocessed and analyzed using EEG Lab (Delorme & Makeig, 2004).
primary purpose: Treatment
masking: None (Open Label)
measure: Yale-Brown Obsessive Compulsive Scale (YBOCS)
time frame: Completed once per week, for eight weeks
description: A self-report inventory of obsessive compulsive symptoms
measure: Obsessive Compulsive Inventory
time frame: Completed at three timepoints - week 1, week 4, week 8
description: Self-report measure of obsessive compulsive symptoms
measure: Obsessive Beliefs Questionnaire
time frame: Completed at three timepoints - week 1, week 4, week 8
description: Self-report measure of OCD beliefs
measure: Five Factor Mindfulness Questionnaire
time frame: Completed at three timepoints - week 1, week 4, week 8
description: Self-report measure of mindfulness
measure: Thought Control Questionnaire
time frame: Completed at three timepoints - week 1, week 4, week 8
description: Self-report measure of use of thought control strategies
measure: Acceptance and Action Questionnaire
time frame: Completed at three timepoints - week 1, week 4, week 8
description: Self-report measure of experiential avoidance
measure: Mind Wandering Scale
time frame: Completed at three timepoints - week 1, week 4, week 8
description: Self-report measure of mind wandering
measure: Metacognitions Questionnaire
time frame: Completed at three timepoints - week 1, week 4, week 8
description: Self-report measure of metacognitive strategies
arm group label: Mindfulness
arm group type: Experimental
description: The study will be a randomized trial where subjects (N=100) will be randomly assigned to receive either 1) an eight week meditation program involving use of an EEG-based biofeedback device, or 2) wait list as per usual. The experimental design is a 2 (treatment condition: Group 1: Mindfulness, Group 2: Control) by 3 (assessment phase: baseline (week 0), mid-treatment (week 4), post-treatment (week 8)) repeated measures factorial design. Group randomization will be completed by the principal investigator, using the "GraphPad Quick Calcs" online calculator which offers simple random allocation into equal-sized groups
arm group label: Control
arm group type: No Intervention
description: The study will be a randomized trial where subjects (N=100) will be randomly assigned to receive either 1) an eight week meditation program involving use of an EEG-based biofeedback device, or 2) wait list as per usual. The experimental design is a 2 (treatment condition: Group 1: Mindfulness, Group 2: Control) by 3 (assessment phase: baseline (week 0), mid-treatment (week 4), post-treatment (week 8)) repeated measures factorial design. Group randomization will be completed by the principal investigator, using the "GraphPad Quick Calcs" online calculator which offers simple random allocation into equal-sized groups
intervention type: Device
intervention name: Mindfulness
description: Clients will use a consumer grade EEG device that provides guided mindfulness home practices
arm group label: Mindfulness
criteria: 
gender: All
minimum age: 18 Years
maximum age: 60 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Peggy Richter, M.D.
role: Study Director
affiliation: Sunnybrook Health Sciences Centre
facility: 
country: Canada
citation: Bhayee S, Tomaszewski P, Lee DH, Moffat G, Pino L, Moreno S, Farb NA. Attentional and affective consequences of technology supported mindfulness training: a randomised, active control, efficacy trial. BMC Psychol. 2016 Nov 29;4(1):60. doi: 10.1186/s40359-016-0168-6.
PMID: 27894358
responsible party type: Sponsor
mesh term: Compulsive Personality Disorder
mesh term: Obsessive-Compulsive Disorder
sharing ipd: No
provided document: 
provided document: 