<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/NCT02217995</url>
  </required_header>
  <id_info>
    <org_study_id>138-2014</org_study_id>
    <nct_id>NCT02217995</nct_id>
  </id_info>
  <brief_title>Mindfulness-Based Cognitive Therapy in a Clinical Sample of OCD Patients</brief_title>
  <official_title>A Pilot Randomized Trial Testing Mindfulness-Based Cognitive Therapy in a Clinical Sample of OCD Patients</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>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Obsessive Compulsive Disorder (OCD) is a chronic and debilitating disorder known to have&#xD;
      reported lifetime prevalence in the range of 2%. OCD is most commonly treated with Cognitive&#xD;
      Behavioural Therapy (CBT) and/or pharmacotherapy. However, some studies suggest challenges&#xD;
      with CBT in retaining gains long term, and while 60-80% of OCD patients respond to SRI&#xD;
      treatment, partial symptom reduction is substantial. Investigations into the effectiveness of&#xD;
      alternative, cost-effective treatment modalities are thus needed. Mindfulness, defined as&#xD;
      paying attention in a particular way (on purpose, in the present moment and nonjudgmentally),&#xD;
      promotes awareness and attention to internal experience and has been shown to reduce symptoms&#xD;
      of anxiety and depression. A number of controlled studies have found Mindfulness-Based&#xD;
      Cognitive Therapy (MBCT) to be effective for depression, social anxiety disorder, and&#xD;
      generalized anxiety disorder, but few have tested its effect on obsessive compulsive disorder&#xD;
      (OCD). Moreover, those studies examining MBCT in OCD focused on clinical case studies and&#xD;
      non-clinical samples. This study proposes to examine the effect of MBCT in clinical practice,&#xD;
      in a randomized sample of patients with OCD whom are on a clinic wait list. As patients are&#xD;
      allocated to the wait list, they will be randomly assigned to receive either 10 weeks of&#xD;
      group MBCT or wait list as per usual. It is hypothesized that subjects randomly assigned to&#xD;
      the MBCT treatment group, compared to those in the wait list control group, will see greater&#xD;
      reductions in self-reported measures of OCD symptom severity and improvement in other&#xD;
      measures of mindfulness, mood and level of functioning. The results of this pilot study, if&#xD;
      successful, will provide evidence towards another route by which patients can improve their&#xD;
      OCD while waiting for clinic services or consultation. Results will also lend more evidence&#xD;
      as to whether MBCT is effective as a stand-alone treatment for clinical OCD, which will&#xD;
      inform further investigations into the potential addition of mindfulness techniques to&#xD;
      standard care.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>September 2014</start_date>
  <completion_date type="Actual">September 28, 2017</completion_date>
  <primary_completion_date type="Actual">August 2017</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>Factorial Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in Symptom Severity from Baseline in OCD Measures</measure>
    <time_frame>10 weeks</time_frame>
    <description>OCD measures will include: a self-report version of the Yale-Brown Obsessive Compulsive Scale (YBOCS-SR), the Obsessive Compulsive Inventory -Revised (OCI-R), consisting of six subscales (Washing, Checking, Ordering, Obsessing, Hoarding and Neutralising), and the Obsessive Beliefs Questionnaire-44 (OBQ-44), a measure of three OCD-related belief domains (Perfectionism/Certainty, Importance/Control of thoughts, and Responsibility/Threat estimation)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in Level of Impairment from Baseline</measure>
    <time_frame>10 weeks</time_frame>
    <description>The Sheehan Disability Scale will be used to measure level of functional impairment in three inter-related domains (work/school, social and family life).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Mood from Baseline</measure>
    <time_frame>10 weeks</time_frame>
    <description>The Beck Depression Inventory -II (BDI-II), will be used to assess depression severity.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Mindfulness from Baseline</measure>
    <time_frame>10 weeks</time_frame>
    <description>Mindfulness measures include: The Five Facet Mindfulness Questionnaire (FFMQ), used to measure the five constructs central to mindfulness (Observing, Describing, Acting with Awareness, Non-judgment of Inner Experience, and Non-reactivity to Inner Experience), and the the Self-Compassion Scale-Short Form (SCS-SF) measuring 6 components of self-compassion (Self-Kindness, Self-Judgment, Common Humanity, Isolation, Mindfulness &amp; Over-Identification).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Retention of Gains at Follow-up</measure>
    <time_frame>16 weeks</time_frame>
    <description>All self-report measures will be re-administered at 6-week follow-up to measure robustness of gains post-treatment.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">32</enrollment>
  <condition>Obsessive-Compulsive Disorder</condition>
  <arm_group>
    <arm_group_label>Mindfulness-Based Cognitive Therapy (MBCT)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>MBCT will be delivered in ten 2.5 hour group sessions with 15 participants per group.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Waitlist</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Wait list as per usual.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Mindfulness-Based Cognitive Therapy (MBCT)</intervention_name>
    <description>MBCT teaches patients to become more aware of, and to relate differently to, their thoughts, feelings, and bodily sensations. Through MBCT, patients will learn skills that allow them to disengage from habitual (&quot;automatic&quot;) dysfunctional cognitive routines, such as obsessional thinking. As an example, patients are encouraged to relate to thoughts and feelings as passing events in the mind, rather than to identify with them or treat them as accurate representations of reality. The MBCT protocol for OCD patients is adapted from Segal et al.'s original MBCT manual for depression (Segal, Williams &amp; Teasdale, 2002).</description>
    <arm_group_label>Mindfulness-Based Cognitive Therapy (MBCT)</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Referred for treatment services at the Frederick W. Thompson Anxiety Disorder Centre&#xD;
             at Sunnybrook Health Sciences Centre&#xD;
&#xD;
          -  Primary Diagnosis of OCD&#xD;
&#xD;
          -  Ability to communicate in written and spoken English&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Those with active substance abuse/dependence within 3 months&#xD;
&#xD;
          -  Suspected organic pathology&#xD;
&#xD;
          -  Recent suicide attempt/active suicidality&#xD;
&#xD;
          -  Current self-injurious behaviour&#xD;
&#xD;
          -  Active bipolar or psychotic disorder&#xD;
&#xD;
          -  Previous completion of an MBCT course (≥ 8 weeks)&#xD;
&#xD;
          -  Previous completion of an OCD-specific course of CBT (≥ 8 weeks)&#xD;
&#xD;
          -  Previous completion of a general course of CBT (≥ 8 weeks) in the past 3 years&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>The Frederick W. Thompson Anxiety Disorders Centre, Sunnybrook Health Sciences Centre</name>
      <address>
        <city>Toronto</city>
        <state>Ontario</state>
        <zip>M4N 3M5</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Canada</country>
  </location_countries>
  <verification_date>September 2018</verification_date>
  <study_first_submitted>August 13, 2014</study_first_submitted>
  <study_first_submitted_qc>August 13, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 15, 2014</study_first_posted>
  <last_update_submitted>September 4, 2018</last_update_submitted>
  <last_update_submitted_qc>September 4, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">September 6, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Sunnybrook Health Sciences Centre</investigator_affiliation>
    <investigator_full_name>Dr. Neil Rector</investigator_full_name>
    <investigator_title>Research Scientist and Psychologist</investigator_title>
  </responsible_party>
  <keyword>Mindfulness-Based Cognitive Therapy</keyword>
  <keyword>Mindfulness</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Obsessive-Compulsive Disorder</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/NCT02217995
org study id: 138-2014
nct id: NCT02217995
lead sponsor: 
has dmc: Yes
Obsessive Compulsive Disorder (OCD) is a chronic and debilitating disorder known to have
      reported lifetime prevalence in the range of 2%. OCD is most commonly treated with Cognitive
      Behavioural Therapy (CBT) and/or pharmacotherapy. However, some studies suggest challenges
      with CBT in retaining gains long term, and while 60-80% of OCD patients respond to SRI
      treatment, partial symptom reduction is substantial. Investigations into the effectiveness of
      alternative, cost-effective treatment modalities are thus needed. Mindfulness, defined as
      paying attention in a particular way (on purpose, in the present moment and nonjudgmentally),
      promotes awareness and attention to internal experience and has been shown to reduce symptoms
      of anxiety and depression. A number of controlled studies have found Mindfulness-Based
      Cognitive Therapy (MBCT) to be effective for depression, social anxiety disorder, and
      generalized anxiety disorder, but few have tested its effect on obsessive compulsive disorder
      (OCD). Moreover, those studies examining MBCT in OCD focused on clinical case studies and
      non-clinical samples. This study proposes to examine the effect of MBCT in clinical practice,
      in a randomized sample of patients with OCD whom are on a clinic wait list. As patients are
      allocated to the wait list, they will be randomly assigned to receive either 10 weeks of
      group MBCT or wait list as per usual. It is hypothesized that subjects randomly assigned to
      the MBCT treatment group, compared to those in the wait list control group, will see greater
      reductions in self-reported measures of OCD symptom severity and improvement in other
      measures of mindfulness, mood and level of functioning. The results of this pilot study, if
      successful, will provide evidence towards another route by which patients can improve their
      OCD while waiting for clinic services or consultation. Results will also lend more evidence
      as to whether MBCT is effective as a stand-alone treatment for clinical OCD, which will
      inform further investigations into the potential addition of mindfulness techniques to
      standard care.
allocation: Randomized
intervention model: Factorial Assignment
primary purpose: Treatment
masking: Single (Outcomes Assessor)
measure: Change in Symptom Severity from Baseline in OCD Measures
time frame: 10 weeks
description: OCD measures will include: a self-report version of the Yale-Brown Obsessive Compulsive Scale (YBOCS-SR), the Obsessive Compulsive Inventory -Revised (OCI-R), consisting of six subscales (Washing, Checking, Ordering, Obsessing, Hoarding and Neutralising), and the Obsessive Beliefs Questionnaire-44 (OBQ-44), a measure of three OCD-related belief domains (Perfectionism/Certainty, Importance/Control of thoughts, and Responsibility/Threat estimation)
measure: Change in Level of Impairment from Baseline
time frame: 10 weeks
description: The Sheehan Disability Scale will be used to measure level of functional impairment in three inter-related domains (work/school, social and family life).
measure: Change in Mood from Baseline
time frame: 10 weeks
description: The Beck Depression Inventory -II (BDI-II), will be used to assess depression severity.
measure: Change in Mindfulness from Baseline
time frame: 10 weeks
description: Mindfulness measures include: The Five Facet Mindfulness Questionnaire (FFMQ), used to measure the five constructs central to mindfulness (Observing, Describing, Acting with Awareness, Non-judgment of Inner Experience, and Non-reactivity to Inner Experience), and the the Self-Compassion Scale-Short Form (SCS-SF) measuring 6 components of self-compassion (Self-Kindness, Self-Judgment, Common Humanity, Isolation, Mindfulness & Over-Identification).
measure: Retention of Gains at Follow-up
time frame: 16 weeks
description: All self-report measures will be re-administered at 6-week follow-up to measure robustness of gains post-treatment.
arm group label: Mindfulness-Based Cognitive Therapy (MBCT)
arm group type: Experimental
description: MBCT will be delivered in ten 2.5 hour group sessions with 15 participants per group.
arm group label: Waitlist
arm group type: No Intervention
description: Wait list as per usual.
intervention type: Behavioral
intervention name: Mindfulness-Based Cognitive Therapy (MBCT)
description: MBCT teaches patients to become more aware of, and to relate differently to, their thoughts, feelings, and bodily sensations. Through MBCT, patients will learn skills that allow them to disengage from habitual ("automatic") dysfunctional cognitive routines, such as obsessional thinking. As an example, patients are encouraged to relate to thoughts and feelings as passing events in the mind, rather than to identify with them or treat them as accurate representations of reality. The MBCT protocol for OCD patients is adapted from Segal et al.'s original MBCT manual for depression (Segal, Williams & Teasdale, 2002).
arm group label: Mindfulness-Based Cognitive Therapy (MBCT)
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: No
facility: 
country: Canada
responsible party type: Principal Investigator
investigator affiliation: Sunnybrook Health Sciences Centre
investigator full name: Dr. Neil Rector
investigator title: Research Scientist and Psychologist
mesh term: Obsessive-Compulsive Disorder