<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/NCT01704456</url>
  </required_header>
  <id_info>
    <org_study_id>H12-02358</org_study_id>
    <nct_id>NCT01704456</nct_id>
  </id_info>
  <brief_title>Integrated Mindfulness-based Cognitive Behaviour Therapy Versus Cognitive Behaviour Therapy for Provoked Vestibulodynia</brief_title>
  <acronym>COMFORT</acronym>
  <official_title>Integrated Mindfulness-based Cognitive Behaviour Therapy Versus Cognitive Behaviour Therapy for Provoked Vestibulodynia</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of British Columbia</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of British Columbia</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This randomized trial, nicknamed the COMFORT (Cognitive therapy or Mindfulness FOR Treatment&#xD;
      of pvd) study, will compare the effects of an 8-session group Mindfulness-based Cognitive&#xD;
      Therapy (MBCT) to an 8-session group Cognitive Behavioural Therapy (CBT) for women with&#xD;
      provoked vestibulodynia (PVD). Women with PVD will be randomly assigned to attend either&#xD;
      eight sessions of group MBCT or CBT. Each session is 2.25 hours long and spaced 1 week apart.&#xD;
      The purpose of this study is to determine whether the 8-session MBCT intervention for PVD is&#xD;
      no worse than an 8-session CBT intervention for decreasing women's pain intensity, sexual&#xD;
      distress, catastrophizing and hypervigilance towards pain.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      PURPOSE:&#xD;
&#xD;
      The purpose of this study is to determine whether an 8-session MBCT intervention for PVD is&#xD;
      no worse than an 8-session CBT intervention for improving women's pain intensity and reducing&#xD;
      their sexual distress, catastrophizing and hypervigilance towards pain. The investigators&#xD;
      will also examine whether pain improvements at follow-up are mediated by changes in&#xD;
      self-compassion and mindfulness (in the MBCT arm only) and moderated by pre-treatment&#xD;
      credibility, personality, and anxiety sensitivity.&#xD;
&#xD;
      HYPOTHESES:&#xD;
&#xD;
        1. At follow-up (4 weeks, 6 months and 12 months post-treatment), women in the MBCT arm&#xD;
           will experience a greater decline (vs. pre-treatment) in vestibular pain intensity&#xD;
           compared to women in the CBT arm.&#xD;
&#xD;
        2. At follow-up (4 weeks, 6 months and 12 months post-treatment), women in the MBCT arm&#xD;
           will experience a greater decline (vs. pre-treatment) in sex-related distress, pain&#xD;
           catastrophizing, hypervigilance, and self-reported pain during intercourse/other&#xD;
           penetrative sex compared to women in the CBT arm.&#xD;
&#xD;
        3. The investigators hypothesize that improvements in pain intensity during vestibular&#xD;
           touch will be mediated by changes in self-compassion and mindfulness in the MBCT arm&#xD;
           only at 6 and 12 months follow-up.&#xD;
&#xD;
        4. The investigators hypothesize that pre-treatment credibility, personality, and anxiety&#xD;
           sensitivity will significantly moderate improvements in pain intensity during vestibular&#xD;
           touch at 6 and 12 months follow-up.&#xD;
&#xD;
        5. The investigators hypothesize improvements in both arms on the &quot;Patient Global&#xD;
           Impression of Change Scale&quot; and significantly greater improvements in the MBCT arm&#xD;
           relative to the CBT arm at follow-up (4 weeks, 6 months and 12 months post-treatment).&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>October 2012</start_date>
  <completion_date type="Actual">September 2017</completion_date>
  <primary_completion_date type="Actual">September 2016</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>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in Vulvslgesiometer Pain Rating From Baseline to One Month Post-treatment to 6 Months Post-treatment</measure>
    <time_frame>Pre-treatment, one month post-treatment and 6 months post-treatment.</time_frame>
    <description>The investigators have selected pain intensity during a controlled examination as the primary endpoint in this study. Specifically, pain intensity at the vulvar vestibule will be assessed using a vulvalgesiometer. The vulvalgesiometer is an instrument that provides a measure of pain/sensitivity that can be standardized across time points. The vulvalgesiometer is calibrated to exert a fixed amount of pressure. In this study, 30 grams of pressure at the 1, 3, 4, 6, 8, 9, and 11 o'clock positions (randomly) around the vestibule will be applied using the vulvalgestiometer. Women will also report their pain at each site using a numeric rating scale from 0 (no pain) to 10 (worst pain ever).</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Self-reported Pain During Penetration</measure>
    <time_frame>Pre-treatment,one month post-treatment, and 6 months follow-up.</time_frame>
    <description>The investigators will measure self-report of pain during attempted or completed intercourse (or dildo entry for non-heterosexual women). Numeric Rating Scale that asked participants to rate the &quot;intensity of pain during vaginal penetration attempts with sexual intercourse or penetration over the past 4 weeks&quot; This question was rated on a 0 to 10 scale from no pain (0) to worst possible pain (10).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Sexual Function</measure>
    <time_frame>Pre-treatment, one month post-treatment, and 6 months post-treatment.</time_frame>
    <description>The investigators will examine women's self-reported sexual function by administering the Female Sexual Function Index (FSFI). The Female Sexual Function Index (FSFI) is a 19-item self-report questionnaire which assesses sexual function in women. It covers six sexual domains: lubrication, arousal, desire, pain, orgasm and satisfaction. Scores range from 7.2 - 36 where increase in sexual dysfunction is represented by lower scores.&#xD;
Subscales:&#xD;
Desire- 2, 3 [Subscale scores Range: 1.2 - 6] Arousal- 5,6,7,8 [Subscale Scores Range: 1.2 - 6] Lubrication- 9,10,11,12 [Subscale Scores Range: 1.2 - 6] Orgasm- 13, 14, 15 [Subscale Scores Range: 1.2 - 6] Satisfaction- 1, 16, 17 [Subscale Scores Range: 1.2 - 6] Pain- 18, 19, 20 [Subscale Scores Range: 1.2 - 6] Extra item: (4) have you been sexually active in past 4 weeks? (yes/no) [Scores Range 0 (no) - 1 (yes)]&#xD;
Note: Ranges applicable only if question 4 was answered &quot;yes&quot;.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Sexual Distress</measure>
    <time_frame>Pre-treatment, one month post-treatment, and 6 months post-treatment.</time_frame>
    <description>The investigators will examine women's self-reported sexual distress by administering the Female Sexual Distress Scale-Revised. This is a 12-item self-report questionnaire assessing for sexuality related personal distress. Scores on the scale range from 0 - 48, where higher scores represent higher levels of distress.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pain Catastrophizing</measure>
    <time_frame>Pre-treatment, one month post-treatment, and 6 months post-treatment..</time_frame>
    <description>The investigators will examine women's self-reported pain catastrophizing by administering the Pain Catastrophizing Scale. The Pain Catastrophizing Scale (PCS) is a self-report questionnaire that asks participants to think about past painful experiences, or a specific experience of pain, and to indicate the degree to which they have any of the presented thoughts or feelings when they are experiencing pain. Each one of the 13-items is rated on a Likert scale from 0 (not at all) to 4 (all the time), where a higher total score indicates higher pain catastrophizing.&#xD;
Subscales: Rumination- (4 items) 8, 9, 10, and 11 [Scores Range: 0 - 16] Magnification- (3 items) 6, 7, and 13 [Scores Range: 0 - 12] Helplessness- (6 items) 1, 2, 3, 4, 5, and 12 [Scores Range: 0 - 24] Sum of all items [Overall Range: 0 - 52]</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pain Hypervigilance</measure>
    <time_frame>Pre-treatment, one month post-treatment, and 6 months post treatment.</time_frame>
    <description>The investigators will examine women's self-reported hypervigilance about pain by administering the Pain Vigilance and Awareness Questionnaire. The Pain Vigilance and Awareness Questionnaire (PVAQ) is a 16 item self-report measure to assess the awareness, vigilance, preoccupation and observation of pain. Sum total score [Scores Range: 0 - 80].</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Chronic Pain Acceptance, Activities Engagement</measure>
    <time_frame>Pre-treatment, one month post-treatment, and 6 months post-treatment.</time_frame>
    <description>The investigators will examine women's self-reported pain acceptance, activities engagement, by administering the CPAQ chronic pain acceptance questionnaire. The Chronic Pain Acceptance Questionnaire (CPAQ) measures the degree of acceptance of pain by chronic pain patients. It consists of 20 items measuring two domains, Activities Engagement and Pain Willingness. Total score range is from 0 - 120, with higher scores indicating higher levels of pain acceptance.&#xD;
Subscales:&#xD;
Activities engagement (11 items)- Q 1, 2, 3, 5, 6, 8, 9, 10, 12, 15, 19 [Scores Range: 0 - 66] Pain willingness (9 items)- Q 4, 7, 11, 13, 14, 16, 17, 18, 20 [Scores Range: 0 - 54]</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Chronic Pain Acceptance, CPAQ Pain Willingness</measure>
    <time_frame>Pre-treatment, one month post-treatment, and 6 months post treatment.</time_frame>
    <description>The investigators will examine women's self-reported pain acceptance, activities engagement, by administering the CPAQ chronic pain acceptance questionnaire. The Chronic Pain Acceptance Questionnaire (CPAQ) measures the degree of acceptance of pain by chronic pain patients. It consists of 20 items measuring two domains: Activities Engagement and Pain Willingness. Total score range is from 0 - 120, with higher scores indicating higher levels of pain acceptance.&#xD;
Subscales:&#xD;
Activities engagement (11 items)- Q 1, 2, 3, 5, 6, 8, 9, 10, 12, 15, 19 [Scores Range: 0 - 66] Pain willingness (9 items)- Q 4, 7, 11, 13, 14, 16, 17, 18, 20 [Scores Range: 0 - 54]</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">130</enrollment>
  <condition>Provoked Vestibulodynia</condition>
  <arm_group>
    <arm_group_label>Mindfulness-based cognitive therapy (MBCT)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Women in the MBCT Group Treatment arm will receive the treatment in small group format (8-9 women). Each session will be 2.25 hours in duration and there will be eight, weekly sessions over the course of 2 months. Session content includes education about chronic pain, PVD, stress and sexual response, mindfulness practices, and cognitive techniques to notice thought patterns that contribute to increased pain.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Cognitive Behavioural Therapy (CBT)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Women in the CBT Group Treatment arm will receive the treatment in small group format (8-9 women). Each session will be 2.25 hrs in duration and there will be eight, weekly sessions over the course of 2 months. Session content includes education about chronic pain, PVD, stress and sexual response, behavioural techniques such as progressive muscle relaxation, cognitive techniques to challenge unhealthy thinking patterns, and communication skills training.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Mindfulness-based Cognitive Therapy</intervention_name>
    <description>The MBCT intervention will be administered in small group format (8-9 women). Each session will be 2.25 hours in duration and there will be eight, weekly sessions over the course of 2 months. Session content includes education about chronic pain, PVD, stress and sexual response, mindfulness practices, and cognitive techniques to notice thought patterns that contribute to increased pain.</description>
    <arm_group_label>Mindfulness-based cognitive therapy (MBCT)</arm_group_label>
    <other_name>MBCT</other_name>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Cognitive Behavioural Therapy</intervention_name>
    <description>The CBT intervention will be administered to women in small group format (8-9 women). Each session will be 2.25-hrs in duration and there will be eight, weekly sessions over the course of 2 months. Session content includes education about chronic pain, PVD, stress and sexual response, behavioural techniques such as progressive muscle relaxation, cognitive techniques to challenge unhealthy thinking patterns, and communication skills training.</description>
    <arm_group_label>Cognitive Behavioural Therapy (CBT)</arm_group_label>
    <other_name>CBT</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  diagnosis of provoked vestibulodynia (PVD)&#xD;
&#xD;
          -  19 years of age or older&#xD;
&#xD;
          -  premenopausal&#xD;
&#xD;
          -  fluent in English&#xD;
&#xD;
          -  during the study, women must agree not to change any medications they are taking for&#xD;
             PVD.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  unprovoked vulvar pain, other pathology causing pain with penetration, or chronic&#xD;
             pelvic pain&#xD;
&#xD;
          -  being uncomfortable and unwilling to participate in a group setting.&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>19 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Lori A Brotto, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of British Columbia</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>British Columbia Centre for Sexual Medicine</name>
      <address>
        <city>Vancouver</city>
        <state>British Columbia</state>
        <zip>V5Z 1M9</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Department of Gynaecology</name>
      <address>
        <city>Vancouver</city>
        <state>British Columbia</state>
        <zip>V5Z 1M9</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Canada</country>
  </location_countries>
  <link>
    <url>http://brottolab.med.ubc.ca</url>
    <description>UBC Sexual Health Lab</description>
  </link>
  <link>
    <url>https://med-fom-brotto.sites.olt.ubc.ca/files/2019/07/Brotto-et-al.-A-comparison-of-mindfulness2019.pdf</url>
    <description>Published Paper</description>
  </link>
  <verification_date>February 2020</verification_date>
  <study_first_submitted>August 22, 2012</study_first_submitted>
  <study_first_submitted_qc>October 9, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 11, 2012</study_first_posted>
  <results_first_submitted>October 9, 2019</results_first_submitted>
  <results_first_submitted_qc>February 25, 2020</results_first_submitted_qc>
  <results_first_posted type="Actual">March 10, 2020</results_first_posted>
  <last_update_submitted>February 25, 2020</last_update_submitted>
  <last_update_submitted_qc>February 25, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">March 10, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of British Columbia</investigator_affiliation>
    <investigator_full_name>Lori Brotto</investigator_full_name>
    <investigator_title>Associate Professor</investigator_title>
  </responsible_party>
  <keyword>provoked vestibulodynia</keyword>
  <keyword>dyspareunia</keyword>
  <keyword>vulvodynia</keyword>
  <keyword>mindfulness</keyword>
  <keyword>cognitive behavioural therapy</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Vulvodynia</mesh_term>
    <mesh_term>Vulvar Vestibulitis</mesh_term>
  </condition_browse>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Mindfulness-based Cognitive Therapy (MBCT)</title>
          <description>Women in the MBCT Group Treatment arm will receive the treatment in small group format (8-9 women). Each session will be 2.25 hours in duration and there will be eight, weekly sessions over the course of 2 months. Session content includes education about chronic pain, PVD, stress and sexual response, mindfulness practices, and cognitive techniques to notice thought patterns that contribute to increased pain.&#xD;
Mindfulness-based Cognitive Therapy: The MBCT intervention will be administered in small group format (8-9 women). Each session will be 2.25 hours in duration and there will be eight, weekly sessions over the course of 2 months. Session content includes education about chronic pain, PVD, stress and sexual response, mindfulness practices, and cognitive techniques to notice thought patterns that contribute to increased pain.</description>
        </group>
        <group group_id="P2">
          <title>Cognitive Behavioural Therapy (CBT)</title>
          <description>Women in the CBT Group Treatment arm will receive the treatment in small group format (8-9 women). Each session will be 2.25 hrs in duration and there will be eight, weekly sessions over the course of 2 months. Session content includes education about chronic pain, PVD, stress and sexual response, behavioural techniques such as progressive muscle relaxation, cognitive techniques to challenge unhealthy thinking patterns, and communication skills training.&#xD;
Cognitive Behavioural Therapy: The CBT intervention will be administered to women in small group format (8-9 women). Each session will be 2.25-hrs in duration and there will be eight, weekly sessions over the course of 2 months. Session content includes education about chronic pain, PVD, stress and sexual response, behavioural techniques such as progressive muscle relaxation, cognitive techniques to challenge unhealthy thinking patterns, and communication skills training.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="67"/>
                <participants group_id="P2" count="63"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="59"/>
                <participants group_id="P2" count="49"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="8"/>
                <participants group_id="P2" count="14"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Lost to Follow-up</title>
              <participants_list>
                <participants group_id="P1" count="8"/>
                <participants group_id="P2" count="14"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <population>Participants comprised a total of 130 women diagnosed with PVD by a physician.</population>
      <group_list>
        <group group_id="B1">
          <title>Mindfulness-based Cognitive Therapy (MBCT)</title>
          <description>Women in the MBCT Group Treatment arm will receive the treatment in small group format (8-9 women). Each session will be 2.25 hours in duration and there will be eight, weekly sessions over the course of 2 months. Session content includes education about chronic pain, PVD, stress and sexual response, mindfulness practices, and cognitive techniques to notice thought patterns that contribute to increased pain.&#xD;
Mindfulness-based Cognitive Therapy: The MBCT intervention will be administered in small group format (8-9 women). Each session will be 2.25 hours in duration and there will be eight, weekly sessions over the course of 2 months. Session content includes education about chronic pain, PVD, stress and sexual response, mindfulness practices, and cognitive techniques to notice thought patterns that contribute to increased pain.</description>
        </group>
        <group group_id="B2">
          <title>Cognitive Behavioural Therapy (CBT)</title>
          <description>Women in the CBT Group Treatment arm will receive the treatment in small group format (8-9 women). Each session will be 2.25 hrs in duration and there will be eight, weekly sessions over the course of 2 months. Session content includes education about chronic pain, PVD, stress and sexual response, behavioural techniques such as progressive muscle relaxation, cognitive techniques to challenge unhealthy thinking patterns, and communication skills training.&#xD;
Cognitive Behavioural Therapy: The CBT intervention will be administered to women in small group format (8-9 women). Each session will be 2.25-hrs in duration and there will be eight, weekly sessions over the course of 2 months. Session content includes education about chronic pain, PVD, stress and sexual response, behavioural techniques such as progressive muscle relaxation, cognitive techniques to challenge unhealthy thinking patterns, and communication skills training.</description>
        </group>
        <group group_id="B3">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="67"/>
            <count group_id="B2" value="63"/>
            <count group_id="B3" value="130"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="33.72" spread="7.48"/>
                    <measurement group_id="B2" value="31.24" spread="8.99"/>
                    <measurement group_id="B3" value="32.35" spread="8.21"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="67"/>
                    <measurement group_id="B2" value="63"/>
                    <measurement group_id="B3" value="130"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race/Ethnicity, Customized</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>Euro-Canadian</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="46"/>
                    <measurement group_id="B2" value="38"/>
                    <measurement group_id="B3" value="84"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>South/East Asian</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="10"/>
                    <measurement group_id="B2" value="11"/>
                    <measurement group_id="B3" value="21"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Other</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="9"/>
                    <measurement group_id="B2" value="12"/>
                    <measurement group_id="B3" value="21"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Prefer Not To Answer</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                    <measurement group_id="B2" value="2"/>
                    <measurement group_id="B3" value="4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Relationship status</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Married / Common Law</title>
                  <measurement_list>
                    <measurement group_id="B1" value="45"/>
                    <measurement group_id="B2" value="41"/>
                    <measurement group_id="B3" value="86"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Dating</title>
                  <measurement_list>
                    <measurement group_id="B1" value="11"/>
                    <measurement group_id="B2" value="13"/>
                    <measurement group_id="B3" value="24"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Single</title>
                  <measurement_list>
                    <measurement group_id="B1" value="11"/>
                    <measurement group_id="B2" value="8"/>
                    <measurement group_id="B3" value="19"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Did Not Disclose</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Length of relationship</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="7.77" spread="6.16"/>
                    <measurement group_id="B2" value="7.56" spread="6.79"/>
                    <measurement group_id="B3" value="7.67" spread="7.52"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Satisfaction with relationship closeness (/10)</title>
          <description>How satisfied are you with the level of closeness in your relationship on a scale where 0=completely dissatisfied and 10=completely satisfied</description>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="7.26" spread="2.29"/>
                    <measurement group_id="B2" value="7.79" spread="1.99"/>
                    <measurement group_id="B3" value="7.52" spread="2.15"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Education</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>High School</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="2"/>
                    <measurement group_id="B3" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Some College</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="10"/>
                    <measurement group_id="B2" value="17"/>
                    <measurement group_id="B3" value="27"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>University Degree</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="31"/>
                    <measurement group_id="B2" value="24"/>
                    <measurement group_id="B3" value="55"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Post-Graduate</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="17"/>
                    <measurement group_id="B2" value="13"/>
                    <measurement group_id="B3" value="30"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Prefer Not To Answer</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="8"/>
                    <measurement group_id="B2" value="7"/>
                    <measurement group_id="B3" value="15"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Level of typical pain (/10)</title>
          <description>Numeric Rating Scale that asked participants to rate the &quot;intensity of pain during vaginal penetration attempts with sexual intercourse or penetration over the past 4 weeks.&quot; This question was rated on a 0 to 10 scale from no pain (0) to worst possible pain (10).</description>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="6.04" spread="1.82"/>
                    <measurement group_id="B2" value="5.96" spread="2.11"/>
                    <measurement group_id="B3" value="6.00" spread="1.96"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Level of worst pain (/10)</title>
          <description>Numeric Rating Scale that asked participants to rate the &quot;intensity of pain during vaginal penetration attempts with sexual intercourse or penetration over the past 4 weeks&quot; This question was rated on a 0 to 10 scale from no pain (0) to worst possible pain (10)</description>
          <units>units on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="8.23" spread="1.10"/>
                    <measurement group_id="B2" value="8.23" spread="1.32"/>
                    <measurement group_id="B3" value="8.23" spread="1.21"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Years since diagnosis</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="9.85" spread="7.72"/>
                    <measurement group_id="B2" value="6.02" spread="4.72"/>
                    <measurement group_id="B3" value="7.95" spread="6.67"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>PVD history</title>
          <description>Lifelong vs Aquired PVD</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>Lifelong</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="43"/>
                    <measurement group_id="B2" value="37"/>
                    <measurement group_id="B3" value="80"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Aquired</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="24"/>
                    <measurement group_id="B2" value="26"/>
                    <measurement group_id="B3" value="50"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Past treatments received</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="36"/>
                    <measurement group_id="B2" value="29"/>
                    <measurement group_id="B3" value="65"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Past medications received</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="8"/>
                    <measurement group_id="B2" value="11"/>
                    <measurement group_id="B3" value="19"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Change in Vulvslgesiometer Pain Rating From Baseline to One Month Post-treatment to 6 Months Post-treatment</title>
        <description>The investigators have selected pain intensity during a controlled examination as the primary endpoint in this study. Specifically, pain intensity at the vulvar vestibule will be assessed using a vulvalgesiometer. The vulvalgesiometer is an instrument that provides a measure of pain/sensitivity that can be standardized across time points. The vulvalgesiometer is calibrated to exert a fixed amount of pressure. In this study, 30 grams of pressure at the 1, 3, 4, 6, 8, 9, and 11 o'clock positions (randomly) around the vestibule will be applied using the vulvalgestiometer. Women will also report their pain at each site using a numeric rating scale from 0 (no pain) to 10 (worst pain ever).</description>
        <time_frame>Pre-treatment, one month post-treatment and 6 months post-treatment.</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Mindfulness-based Cognitive Therapy (MBCT)</title>
            <description>Women in the MBCT Group Treatment arm will receive the treatment in small group format (8-9 women). Each session will be 2.25 hours in duration and there will be eight, weekly sessions over the course of 2 months. Session content includes education about chronic pain, PVD, stress and sexual response, mindfulness practices, and cognitive techniques to notice thought patterns that contribute to increased pain.&#xD;
Mindfulness-based Cognitive Therapy: The MBCT intervention will be administered in small group format (8-9 women). Each session will be 2.25 hours in duration and there will be eight, weekly sessions over the course of 2 months. Session content includes education about chronic pain, PVD, stress and sexual response, mindfulness practices, and cognitive techniques to notice thought patterns that contribute to increased pain.</description>
          </group>
          <group group_id="O2">
            <title>Cognitive Behavioural Therapy (CBT)</title>
            <description>Women in the CBT Group Treatment arm will receive the treatment in small group format (8-9 women). Each session will be 2.25 hrs in duration and there will be eight, weekly sessions over the course of 2 months. Session content includes education about chronic pain, PVD, stress and sexual response, behavioural techniques such as progressive muscle relaxation, cognitive techniques to challenge unhealthy thinking patterns, and communication skills training.&#xD;
Cognitive Behavioural Therapy: The CBT intervention will be administered to women in small group format (8-9 women). Each session will be 2.25-hrs in duration and there will be eight, weekly sessions over the course of 2 months. Session content includes education about chronic pain, PVD, stress and sexual response, behavioural techniques such as progressive muscle relaxation, cognitive techniques to challenge unhealthy thinking patterns, and communication skills training.</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Vulvslgesiometer Pain Rating From Baseline to One Month Post-treatment to 6 Months Post-treatment</title>
          <description>The investigators have selected pain intensity during a controlled examination as the primary endpoint in this study. Specifically, pain intensity at the vulvar vestibule will be assessed using a vulvalgesiometer. The vulvalgesiometer is an instrument that provides a measure of pain/sensitivity that can be standardized across time points. The vulvalgesiometer is calibrated to exert a fixed amount of pressure. In this study, 30 grams of pressure at the 1, 3, 4, 6, 8, 9, and 11 o'clock positions (randomly) around the vestibule will be applied using the vulvalgestiometer. Women will also report their pain at each site using a numeric rating scale from 0 (no pain) to 10 (worst pain ever).</description>
          <units>score on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="67"/>
                <count group_id="O2" value="63"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>pre-treatment</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6.66" spread="2.17"/>
                    <measurement group_id="O2" value="6.62" spread="2.19"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>one month post-treatment</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.21" spread="1.96"/>
                    <measurement group_id="O2" value="3.60" spread="2.14"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>6 months follow up</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2.92" spread="2.31"/>
                    <measurement group_id="O2" value="2.86" spread="1.89"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Self-reported Pain During Penetration</title>
        <description>The investigators will measure self-report of pain during attempted or completed intercourse (or dildo entry for non-heterosexual women). Numeric Rating Scale that asked participants to rate the &quot;intensity of pain during vaginal penetration attempts with sexual intercourse or penetration over the past 4 weeks&quot; This question was rated on a 0 to 10 scale from no pain (0) to worst possible pain (10).</description>
        <time_frame>Pre-treatment,one month post-treatment, and 6 months follow-up.</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Mindfulness-based Cognitive Therapy (MBCT)</title>
            <description>Women in the MBCT Group Treatment arm will receive the treatment in small group format (8-9 women). Each session will be 2.25 hours in duration and there will be eight, weekly sessions over the course of 2 months. Session content includes education about chronic pain, PVD, stress and sexual response, mindfulness practices, and cognitive techniques to notice thought patterns that contribute to increased pain.&#xD;
Mindfulness-based Cognitive Therapy: The MBCT intervention will be administered in small group format (8-9 women). Each session will be 2.25 hours in duration and there will be eight, weekly sessions over the course of 2 months. Session content includes education about chronic pain, PVD, stress and sexual response, mindfulness practices, and cognitive techniques to notice thought patterns that contribute to increased pain.</description>
          </group>
          <group group_id="O2">
            <title>Cognitive Behavioural Therapy (CBT)</title>
            <description>Women in the CBT Group Treatment arm will receive the treatment in small group format (8-9 women). Each session will be 2.25 hrs in duration and there will be eight, weekly sessions over the course of 2 months. Session content includes education about chronic pain, PVD, stress and sexual response, behavioural techniques such as progressive muscle relaxation, cognitive techniques to challenge unhealthy thinking patterns, and communication skills training.&#xD;
Cognitive Behavioural Therapy: The CBT intervention will be administered to women in small group format (8-9 women). Each session will be 2.25-hrs in duration and there will be eight, weekly sessions over the course of 2 months. Session content includes education about chronic pain, PVD, stress and sexual response, behavioural techniques such as progressive muscle relaxation, cognitive techniques to challenge unhealthy thinking patterns, and communication skills training.</description>
          </group>
        </group_list>
        <measure>
          <title>Self-reported Pain During Penetration</title>
          <description>The investigators will measure self-report of pain during attempted or completed intercourse (or dildo entry for non-heterosexual women). Numeric Rating Scale that asked participants to rate the &quot;intensity of pain during vaginal penetration attempts with sexual intercourse or penetration over the past 4 weeks&quot; This question was rated on a 0 to 10 scale from no pain (0) to worst possible pain (10).</description>
          <units>score on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="67"/>
                <count group_id="O2" value="63"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Pre-treatment</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="6.69" spread="1.91"/>
                    <measurement group_id="O2" value="5.86" spread="2.13"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>One Month Post-Treatment</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.34" spread="2.22"/>
                    <measurement group_id="O2" value="4.65" spread="2.21"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>6 months follow up</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="3.39" spread="1.89"/>
                    <measurement group_id="O2" value="4.03" spread="2.11"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Sexual Function</title>
        <description>The investigators will examine women's self-reported sexual function by administering the Female Sexual Function Index (FSFI). The Female Sexual Function Index (FSFI) is a 19-item self-report questionnaire which assesses sexual function in women. It covers six sexual domains: lubrication, arousal, desire, pain, orgasm and satisfaction. Scores range from 7.2 - 36 where increase in sexual dysfunction is represented by lower scores.&#xD;
Subscales:&#xD;
Desire- 2, 3 [Subscale scores Range: 1.2 - 6] Arousal- 5,6,7,8 [Subscale Scores Range: 1.2 - 6] Lubrication- 9,10,11,12 [Subscale Scores Range: 1.2 - 6] Orgasm- 13, 14, 15 [Subscale Scores Range: 1.2 - 6] Satisfaction- 1, 16, 17 [Subscale Scores Range: 1.2 - 6] Pain- 18, 19, 20 [Subscale Scores Range: 1.2 - 6] Extra item: (4) have you been sexually active in past 4 weeks? (yes/no) [Scores Range 0 (no) - 1 (yes)]&#xD;
Note: Ranges applicable only if question 4 was answered &quot;yes&quot;.</description>
        <time_frame>Pre-treatment, one month post-treatment, and 6 months post-treatment.</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Mindfulness-based Cognitive Therapy (MBCT)</title>
            <description>Women in the MBCT Group Treatment arm will receive the treatment in small group format (8-9 women). Each session will be 2.25 hours in duration and there will be eight, weekly sessions over the course of 2 months. Session content includes education about chronic pain, PVD, stress and sexual response, mindfulness practices, and cognitive techniques to notice thought patterns that contribute to increased pain.&#xD;
Mindfulness-based Cognitive Therapy: The MBCT intervention will be administered in small group format (8-9 women). Each session will be 2.25 hours in duration and there will be eight, weekly sessions over the course of 2 months. Session content includes education about chronic pain, PVD, stress and sexual response, mindfulness practices, and cognitive techniques to notice thought patterns that contribute to increased pain.</description>
          </group>
          <group group_id="O2">
            <title>Cognitive Behavioural Therapy (CBT)</title>
            <description>Women in the CBT Group Treatment arm will receive the treatment in small group format (8-9 women). Each session will be 2.25 hrs in duration and there will be eight, weekly sessions over the course of 2 months. Session content includes education about chronic pain, PVD, stress and sexual response, behavioural techniques such as progressive muscle relaxation, cognitive techniques to challenge unhealthy thinking patterns, and communication skills training.&#xD;
Cognitive Behavioural Therapy: The CBT intervention will be administered to women in small group format (8-9 women). Each session will be 2.25-hrs in duration and there will be eight, weekly sessions over the course of 2 months. Session content includes education about chronic pain, PVD, stress and sexual response, behavioural techniques such as progressive muscle relaxation, cognitive techniques to challenge unhealthy thinking patterns, and communication skills training.</description>
          </group>
        </group_list>
        <measure>
          <title>Sexual Function</title>
          <description>The investigators will examine women's self-reported sexual function by administering the Female Sexual Function Index (FSFI). The Female Sexual Function Index (FSFI) is a 19-item self-report questionnaire which assesses sexual function in women. It covers six sexual domains: lubrication, arousal, desire, pain, orgasm and satisfaction. Scores range from 7.2 - 36 where increase in sexual dysfunction is represented by lower scores.&#xD;
Subscales:&#xD;
Desire- 2, 3 [Subscale scores Range: 1.2 - 6] Arousal- 5,6,7,8 [Subscale Scores Range: 1.2 - 6] Lubrication- 9,10,11,12 [Subscale Scores Range: 1.2 - 6] Orgasm- 13, 14, 15 [Subscale Scores Range: 1.2 - 6] Satisfaction- 1, 16, 17 [Subscale Scores Range: 1.2 - 6] Pain- 18, 19, 20 [Subscale Scores Range: 1.2 - 6] Extra item: (4) have you been sexually active in past 4 weeks? (yes/no) [Scores Range 0 (no) - 1 (yes)]&#xD;
Note: Ranges applicable only if question 4 was answered &quot;yes&quot;.</description>
          <units>score on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="67"/>
                <count group_id="O2" value="63"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Pre-Treatment</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="19.57" spread="6.29"/>
                    <measurement group_id="O2" value="21.18" spread="6.10"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>One Month Post-Treatment</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="21.79" spread="6.83"/>
                    <measurement group_id="O2" value="23.41" spread="5.72"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>6 months follow up</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="24.75" spread="5.62"/>
                    <measurement group_id="O2" value="23.20" spread="5.45"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Sexual Distress</title>
        <description>The investigators will examine women's self-reported sexual distress by administering the Female Sexual Distress Scale-Revised. This is a 12-item self-report questionnaire assessing for sexuality related personal distress. Scores on the scale range from 0 - 48, where higher scores represent higher levels of distress.</description>
        <time_frame>Pre-treatment, one month post-treatment, and 6 months post-treatment.</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Mindfulness-based Cognitive Therapy (MBCT)</title>
            <description>Women in the MBCT Group Treatment arm will receive the treatment in small group format (8-9 women). Each session will be 2.25 hours in duration and there will be eight, weekly sessions over the course of 2 months. Session content includes education about chronic pain, PVD, stress and sexual response, mindfulness practices, and cognitive techniques to notice thought patterns that contribute to increased pain.&#xD;
Mindfulness-based Cognitive Therapy: The MBCT intervention will be administered in small group format (8-9 women). Each session will be 2.25 hours in duration and there will be eight, weekly sessions over the course of 2 months. Session content includes education about chronic pain, PVD, stress and sexual response, mindfulness practices, and cognitive techniques to notice thought patterns that contribute to increased pain.</description>
          </group>
          <group group_id="O2">
            <title>Cognitive Behavioural Therapy (CBT)</title>
            <description>Women in the CBT Group Treatment arm will receive the treatment in small group format (8-9 women). Each session will be 2.25 hrs in duration and there will be eight, weekly sessions over the course of 2 months. Session content includes education about chronic pain, PVD, stress and sexual response, behavioural techniques such as progressive muscle relaxation, cognitive techniques to challenge unhealthy thinking patterns, and communication skills training.&#xD;
Cognitive Behavioural Therapy: The CBT intervention will be administered to women in small group format (8-9 women). Each session will be 2.25-hrs in duration and there will be eight, weekly sessions over the course of 2 months. Session content includes education about chronic pain, PVD, stress and sexual response, behavioural techniques such as progressive muscle relaxation, cognitive techniques to challenge unhealthy thinking patterns, and communication skills training.</description>
          </group>
        </group_list>
        <measure>
          <title>Sexual Distress</title>
          <description>The investigators will examine women's self-reported sexual distress by administering the Female Sexual Distress Scale-Revised. This is a 12-item self-report questionnaire assessing for sexuality related personal distress. Scores on the scale range from 0 - 48, where higher scores represent higher levels of distress.</description>
          <units>score on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="67"/>
                <count group_id="O2" value="63"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Pre-Treatment</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="34.28" spread="11.18"/>
                    <measurement group_id="O2" value="35.68" spread="10.43"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>One Month Post-Treatment</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="26.60" spread="13.35"/>
                    <measurement group_id="O2" value="24.93" spread="91.31"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>6 months follow up</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="22.81" spread="12.98"/>
                    <measurement group_id="O2" value="23.77" spread="9.61"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Pain Catastrophizing</title>
        <description>The investigators will examine women's self-reported pain catastrophizing by administering the Pain Catastrophizing Scale. The Pain Catastrophizing Scale (PCS) is a self-report questionnaire that asks participants to think about past painful experiences, or a specific experience of pain, and to indicate the degree to which they have any of the presented thoughts or feelings when they are experiencing pain. Each one of the 13-items is rated on a Likert scale from 0 (not at all) to 4 (all the time), where a higher total score indicates higher pain catastrophizing.&#xD;
Subscales: Rumination- (4 items) 8, 9, 10, and 11 [Scores Range: 0 - 16] Magnification- (3 items) 6, 7, and 13 [Scores Range: 0 - 12] Helplessness- (6 items) 1, 2, 3, 4, 5, and 12 [Scores Range: 0 - 24] Sum of all items [Overall Range: 0 - 52]</description>
        <time_frame>Pre-treatment, one month post-treatment, and 6 months post-treatment..</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Mindfulness-based Cognitive Therapy (MBCT)</title>
            <description>Women in the MBCT Group Treatment arm will receive the treatment in small group format (8-9 women). Each session will be 2.25 hours in duration and there will be eight, weekly sessions over the course of 2 months. Session content includes education about chronic pain, PVD, stress and sexual response, mindfulness practices, and cognitive techniques to notice thought patterns that contribute to increased pain.&#xD;
Mindfulness-based Cognitive Therapy: The MBCT intervention will be administered in small group format (8-9 women). Each session will be 2.25 hours in duration and there will be eight, weekly sessions over the course of 2 months. Session content includes education about chronic pain, PVD, stress and sexual response, mindfulness practices, and cognitive techniques to notice thought patterns that contribute to increased pain.</description>
          </group>
          <group group_id="O2">
            <title>Cognitive Behavioural Therapy (CBT)</title>
            <description>Women in the CBT Group Treatment arm will receive the treatment in small group format (8-9 women). Each session will be 2.25 hrs in duration and there will be eight, weekly sessions over the course of 2 months. Session content includes education about chronic pain, PVD, stress and sexual response, behavioural techniques such as progressive muscle relaxation, cognitive techniques to challenge unhealthy thinking patterns, and communication skills training.&#xD;
Cognitive Behavioural Therapy: The CBT intervention will be administered to women in small group format (8-9 women). Each session will be 2.25-hrs in duration and there will be eight, weekly sessions over the course of 2 months. Session content includes education about chronic pain, PVD, stress and sexual response, behavioural techniques such as progressive muscle relaxation, cognitive techniques to challenge unhealthy thinking patterns, and communication skills training.</description>
          </group>
        </group_list>
        <measure>
          <title>Pain Catastrophizing</title>
          <description>The investigators will examine women's self-reported pain catastrophizing by administering the Pain Catastrophizing Scale. The Pain Catastrophizing Scale (PCS) is a self-report questionnaire that asks participants to think about past painful experiences, or a specific experience of pain, and to indicate the degree to which they have any of the presented thoughts or feelings when they are experiencing pain. Each one of the 13-items is rated on a Likert scale from 0 (not at all) to 4 (all the time), where a higher total score indicates higher pain catastrophizing.&#xD;
Subscales: Rumination- (4 items) 8, 9, 10, and 11 [Scores Range: 0 - 16] Magnification- (3 items) 6, 7, and 13 [Scores Range: 0 - 12] Helplessness- (6 items) 1, 2, 3, 4, 5, and 12 [Scores Range: 0 - 24] Sum of all items [Overall Range: 0 - 52]</description>
          <units>score on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="67"/>
                <count group_id="O2" value="63"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Pre-Treatment</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="26.92" spread="12.86"/>
                    <measurement group_id="O2" value="25.62" spread="11.97"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>One Month Post-Treatment</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="15.64" spread="12.54"/>
                    <measurement group_id="O2" value="12.57" spread="8.13"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>6 months follow up</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="11.55" spread="9.91"/>
                    <measurement group_id="O2" value="10.83" spread="7.66"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Pain Hypervigilance</title>
        <description>The investigators will examine women's self-reported hypervigilance about pain by administering the Pain Vigilance and Awareness Questionnaire. The Pain Vigilance and Awareness Questionnaire (PVAQ) is a 16 item self-report measure to assess the awareness, vigilance, preoccupation and observation of pain. Sum total score [Scores Range: 0 - 80].</description>
        <time_frame>Pre-treatment, one month post-treatment, and 6 months post treatment.</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Mindfulness-based Cognitive Therapy (MBCT)</title>
            <description>Women in the MBCT Group Treatment arm will receive the treatment in small group format (8-9 women). Each session will be 2.25 hours in duration and there will be eight, weekly sessions over the course of 2 months. Session content includes education about chronic pain, PVD, stress and sexual response, mindfulness practices, and cognitive techniques to notice thought patterns that contribute to increased pain.&#xD;
Mindfulness-based Cognitive Therapy: The MBCT intervention will be administered in small group format (8-9 women). Each session will be 2.25 hours in duration and there will be eight, weekly sessions over the course of 2 months. Session content includes education about chronic pain, PVD, stress and sexual response, mindfulness practices, and cognitive techniques to notice thought patterns that contribute to increased pain.</description>
          </group>
          <group group_id="O2">
            <title>Cognitive Behavioural Therapy (CBT)</title>
            <description>Women in the CBT Group Treatment arm will receive the treatment in small group format (8-9 women). Each session will be 2.25 hrs in duration and there will be eight, weekly sessions over the course of 2 months. Session content includes education about chronic pain, PVD, stress and sexual response, behavioural techniques such as progressive muscle relaxation, cognitive techniques to challenge unhealthy thinking patterns, and communication skills training.&#xD;
Cognitive Behavioural Therapy: The CBT intervention will be administered to women in small group format (8-9 women). Each session will be 2.25-hrs in duration and there will be eight, weekly sessions over the course of 2 months. Session content includes education about chronic pain, PVD, stress and sexual response, behavioural techniques such as progressive muscle relaxation, cognitive techniques to challenge unhealthy thinking patterns, and communication skills training.</description>
          </group>
        </group_list>
        <measure>
          <title>Pain Hypervigilance</title>
          <description>The investigators will examine women's self-reported hypervigilance about pain by administering the Pain Vigilance and Awareness Questionnaire. The Pain Vigilance and Awareness Questionnaire (PVAQ) is a 16 item self-report measure to assess the awareness, vigilance, preoccupation and observation of pain. Sum total score [Scores Range: 0 - 80].</description>
          <units>score on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="67"/>
                <count group_id="O2" value="63"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Pre-Treatment</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="43.24" spread="14.67"/>
                    <measurement group_id="O2" value="42.46" spread="12.12"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>One Month Post-Treatment</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="39.74" spread="13.72"/>
                    <measurement group_id="O2" value="40.32" spread="14.19"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>6 months follow up</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="38.50" spread="13.88"/>
                    <measurement group_id="O2" value="38.76" spread="14.47"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Chronic Pain Acceptance, Activities Engagement</title>
        <description>The investigators will examine women's self-reported pain acceptance, activities engagement, by administering the CPAQ chronic pain acceptance questionnaire. The Chronic Pain Acceptance Questionnaire (CPAQ) measures the degree of acceptance of pain by chronic pain patients. It consists of 20 items measuring two domains, Activities Engagement and Pain Willingness. Total score range is from 0 - 120, with higher scores indicating higher levels of pain acceptance.&#xD;
Subscales:&#xD;
Activities engagement (11 items)- Q 1, 2, 3, 5, 6, 8, 9, 10, 12, 15, 19 [Scores Range: 0 - 66] Pain willingness (9 items)- Q 4, 7, 11, 13, 14, 16, 17, 18, 20 [Scores Range: 0 - 54]</description>
        <time_frame>Pre-treatment, one month post-treatment, and 6 months post-treatment.</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Mindfulness-based Cognitive Therapy (MBCT)</title>
            <description>Women in the MBCT Group Treatment arm will receive the treatment in small group format (8-9 women). Each session will be 2.25 hours in duration and there will be eight, weekly sessions over the course of 2 months. Session content includes education about chronic pain, PVD, stress and sexual response, mindfulness practices, and cognitive techniques to notice thought patterns that contribute to increased pain.&#xD;
Mindfulness-based Cognitive Therapy: The MBCT intervention will be administered in small group format (8-9 women). Each session will be 2.25 hours in duration and there will be eight, weekly sessions over the course of 2 months. Session content includes education about chronic pain, PVD, stress and sexual response, mindfulness practices, and cognitive techniques to notice thought patterns that contribute to increased pain.</description>
          </group>
          <group group_id="O2">
            <title>Cognitive Behavioural Therapy (CBT)</title>
            <description>Women in the CBT Group Treatment arm will receive the treatment in small group format (8-9 women). Each session will be 2.25 hrs in duration and there will be eight, weekly sessions over the course of 2 months. Session content includes education about chronic pain, PVD, stress and sexual response, behavioural techniques such as progressive muscle relaxation, cognitive techniques to challenge unhealthy thinking patterns, and communication skills training.&#xD;
Cognitive Behavioural Therapy: The CBT intervention will be administered to women in small group format (8-9 women). Each session will be 2.25-hrs in duration and there will be eight, weekly sessions over the course of 2 months. Session content includes education about chronic pain, PVD, stress and sexual response, behavioural techniques such as progressive muscle relaxation, cognitive techniques to challenge unhealthy thinking patterns, and communication skills training.</description>
          </group>
        </group_list>
        <measure>
          <title>Chronic Pain Acceptance, Activities Engagement</title>
          <description>The investigators will examine women's self-reported pain acceptance, activities engagement, by administering the CPAQ chronic pain acceptance questionnaire. The Chronic Pain Acceptance Questionnaire (CPAQ) measures the degree of acceptance of pain by chronic pain patients. It consists of 20 items measuring two domains, Activities Engagement and Pain Willingness. Total score range is from 0 - 120, with higher scores indicating higher levels of pain acceptance.&#xD;
Subscales:&#xD;
Activities engagement (11 items)- Q 1, 2, 3, 5, 6, 8, 9, 10, 12, 15, 19 [Scores Range: 0 - 66] Pain willingness (9 items)- Q 4, 7, 11, 13, 14, 16, 17, 18, 20 [Scores Range: 0 - 54]</description>
          <units>score on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="67"/>
                <count group_id="O2" value="63"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Pre-Treatment</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="42.40" spread="10.91"/>
                    <measurement group_id="O2" value="42.39" spread="10.14"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>One Month Post-Treatment</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="47.97" spread="10.26"/>
                    <measurement group_id="O2" value="46.63" spread="9.34"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>6 months follow up</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="49.24" spread="9.29"/>
                    <measurement group_id="O2" value="47.83" spread="8.70"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Chronic Pain Acceptance, CPAQ Pain Willingness</title>
        <description>The investigators will examine women's self-reported pain acceptance, activities engagement, by administering the CPAQ chronic pain acceptance questionnaire. The Chronic Pain Acceptance Questionnaire (CPAQ) measures the degree of acceptance of pain by chronic pain patients. It consists of 20 items measuring two domains: Activities Engagement and Pain Willingness. Total score range is from 0 - 120, with higher scores indicating higher levels of pain acceptance.&#xD;
Subscales:&#xD;
Activities engagement (11 items)- Q 1, 2, 3, 5, 6, 8, 9, 10, 12, 15, 19 [Scores Range: 0 - 66] Pain willingness (9 items)- Q 4, 7, 11, 13, 14, 16, 17, 18, 20 [Scores Range: 0 - 54]</description>
        <time_frame>Pre-treatment, one month post-treatment, and 6 months post treatment.</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Mindfulness-based Cognitive Therapy (MBCT)</title>
            <description>Women in the MBCT Group Treatment arm will receive the treatment in small group format (8-9 women). Each session will be 2.25 hours in duration and there will be eight, weekly sessions over the course of 2 months. Session content includes education about chronic pain, PVD, stress and sexual response, mindfulness practices, and cognitive techniques to notice thought patterns that contribute to increased pain.&#xD;
Mindfulness-based Cognitive Therapy: The MBCT intervention will be administered in small group format (8-9 women). Each session will be 2.25 hours in duration and there will be eight, weekly sessions over the course of 2 months. Session content includes education about chronic pain, PVD, stress and sexual response, mindfulness practices, and cognitive techniques to notice thought patterns that contribute to increased pain.</description>
          </group>
          <group group_id="O2">
            <title>Cognitive Behavioural Therapy (CBT)</title>
            <description>Women in the CBT Group Treatment arm will receive the treatment in small group format (8-9 women). Each session will be 2.25 hrs in duration and there will be eight, weekly sessions over the course of 2 months. Session content includes education about chronic pain, PVD, stress and sexual response, behavioural techniques such as progressive muscle relaxation, cognitive techniques to challenge unhealthy thinking patterns, and communication skills training.&#xD;
Cognitive Behavioural Therapy: The CBT intervention will be administered to women in small group format (8-9 women). Each session will be 2.25-hrs in duration and there will be eight, weekly sessions over the course of 2 months. Session content includes education about chronic pain, PVD, stress and sexual response, behavioural techniques such as progressive muscle relaxation, cognitive techniques to challenge unhealthy thinking patterns, and communication skills training.</description>
          </group>
        </group_list>
        <measure>
          <title>Chronic Pain Acceptance, CPAQ Pain Willingness</title>
          <description>The investigators will examine women's self-reported pain acceptance, activities engagement, by administering the CPAQ chronic pain acceptance questionnaire. The Chronic Pain Acceptance Questionnaire (CPAQ) measures the degree of acceptance of pain by chronic pain patients. It consists of 20 items measuring two domains: Activities Engagement and Pain Willingness. Total score range is from 0 - 120, with higher scores indicating higher levels of pain acceptance.&#xD;
Subscales:&#xD;
Activities engagement (11 items)- Q 1, 2, 3, 5, 6, 8, 9, 10, 12, 15, 19 [Scores Range: 0 - 66] Pain willingness (9 items)- Q 4, 7, 11, 13, 14, 16, 17, 18, 20 [Scores Range: 0 - 54]</description>
          <units>score on a scale</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="67"/>
                <count group_id="O2" value="63"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Pre-Treatment</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="23.99" spread="9.29"/>
                    <measurement group_id="O2" value="22.91" spread="8.05"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>One Month Post-Treatment</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="29.34" spread="10.07"/>
                    <measurement group_id="O2" value="29.20" spread="8.42"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>6 months follow up</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="33.72" spread="8.80"/>
                    <measurement group_id="O2" value="31.29" spread="8.51"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>The entire duration of the study up to 6 months post treatment.</time_frame>
      <desc>Adverse event data was not collected; only reason for withdrawal. We interpreted risk as being due to a medication and this was a behavioral trial. We did not exclude participants with symptoms of anxiety or depression, and it is possible that those symptoms may have put participants at risk.</desc>
      <group_list>
        <group group_id="E1">
          <title>Mindfulness-based Cognitive Therapy (MBCT)</title>
          <description>Women in the MBCT Group Treatment arm will receive the treatment in small group format (8-9 women). Each session will be 2.25 hours in duration and there will be eight, weekly sessions over the course of 2 months. Session content includes education about chronic pain, PVD, stress and sexual response, mindfulness practices, and cognitive techniques to notice thought patterns that contribute to increased pain.&#xD;
Mindfulness-based Cognitive Therapy: The MBCT intervention will be administered in small group format (8-9 women). Each session will be 2.25 hours in duration and there will be eight, weekly sessions over the course of 2 months. Session content includes education about chronic pain, PVD, stress and sexual response, mindfulness practices, and cognitive techniques to notice thought patterns that contribute to increased pain.</description>
        </group>
        <group group_id="E2">
          <title>Cognitive Behavioural Therapy (CBT)</title>
          <description>Women in the CBT Group Treatment arm will receive the treatment in small group format (8-9 women). Each session will be 2.25 hrs in duration and there will be eight, weekly sessions over the course of 2 months. Session content includes education about chronic pain, PVD, stress and sexual response, behavioural techniques such as progressive muscle relaxation, cognitive techniques to challenge unhealthy thinking patterns, and communication skills training.&#xD;
Cognitive Behavioural Therapy: The CBT intervention will be administered to women in small group format (8-9 women). Each session will be 2.25-hrs in duration and there will be eight, weekly sessions over the course of 2 months. Session content includes education about chronic pain, PVD, stress and sexual response, behavioural techniques such as progressive muscle relaxation, cognitive techniques to challenge unhealthy thinking patterns, and communication skills training.</description>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="0"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="0"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="0"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="0"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>Principal Investigators are NOT employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. </restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Dr Lori Brotto</name_or_title>
      <organization>UBC</organization>
      <phone>604-875-4111 ext 68898</phone>
      <email>lori.brotto@vch.ca</email>
    </point_of_contact>
  </clinical_results>
</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/NCT01704456
org study id: H12-02358
nct id: NCT01704456
lead sponsor: 
has dmc: No
This randomized trial, nicknamed the COMFORT (Cognitive therapy or Mindfulness FOR Treatment
      of pvd) study, will compare the effects of an 8-session group Mindfulness-based Cognitive
      Therapy (MBCT) to an 8-session group Cognitive Behavioural Therapy (CBT) for women with
      provoked vestibulodynia (PVD). Women with PVD will be randomly assigned to attend either
      eight sessions of group MBCT or CBT. Each session is 2.25 hours long and spaced 1 week apart.
      The purpose of this study is to determine whether the 8-session MBCT intervention for PVD is
      no worse than an 8-session CBT intervention for decreasing women's pain intensity, sexual
      distress, catastrophizing and hypervigilance towards pain.
PURPOSE:

      The purpose of this study is to determine whether an 8-session MBCT intervention for PVD is
      no worse than an 8-session CBT intervention for improving women's pain intensity and reducing
      their sexual distress, catastrophizing and hypervigilance towards pain. The investigators
      will also examine whether pain improvements at follow-up are mediated by changes in
      self-compassion and mindfulness (in the MBCT arm only) and moderated by pre-treatment
      credibility, personality, and anxiety sensitivity.

      HYPOTHESES:

        1. At follow-up (4 weeks, 6 months and 12 months post-treatment), women in the MBCT arm
           will experience a greater decline (vs. pre-treatment) in vestibular pain intensity
           compared to women in the CBT arm.

        2. At follow-up (4 weeks, 6 months and 12 months post-treatment), women in the MBCT arm
           will experience a greater decline (vs. pre-treatment) in sex-related distress, pain
           catastrophizing, hypervigilance, and self-reported pain during intercourse/other
           penetrative sex compared to women in the CBT arm.

        3. The investigators hypothesize that improvements in pain intensity during vestibular
           touch will be mediated by changes in self-compassion and mindfulness in the MBCT arm
           only at 6 and 12 months follow-up.

        4. The investigators hypothesize that pre-treatment credibility, personality, and anxiety
           sensitivity will significantly moderate improvements in pain intensity during vestibular
           touch at 6 and 12 months follow-up.

        5. The investigators hypothesize improvements in both arms on the "Patient Global
           Impression of Change Scale" and significantly greater improvements in the MBCT arm
           relative to the CBT arm at follow-up (4 weeks, 6 months and 12 months post-treatment).
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Change in Vulvslgesiometer Pain Rating From Baseline to One Month Post-treatment to 6 Months Post-treatment
time frame: Pre-treatment, one month post-treatment and 6 months post-treatment.
description: The investigators have selected pain intensity during a controlled examination as the primary endpoint in this study. Specifically, pain intensity at the vulvar vestibule will be assessed using a vulvalgesiometer. The vulvalgesiometer is an instrument that provides a measure of pain/sensitivity that can be standardized across time points. The vulvalgesiometer is calibrated to exert a fixed amount of pressure. In this study, 30 grams of pressure at the 1, 3, 4, 6, 8, 9, and 11 o'clock positions (randomly) around the vestibule will be applied using the vulvalgestiometer. Women will also report their pain at each site using a numeric rating scale from 0 (no pain) to 10 (worst pain ever).
measure: Self-reported Pain During Penetration
time frame: Pre-treatment,one month post-treatment, and 6 months follow-up.
description: The investigators will measure self-report of pain during attempted or completed intercourse (or dildo entry for non-heterosexual women). Numeric Rating Scale that asked participants to rate the "intensity of pain during vaginal penetration attempts with sexual intercourse or penetration over the past 4 weeks" This question was rated on a 0 to 10 scale from no pain (0) to worst possible pain (10).
measure: Sexual Function
time frame: Pre-treatment, one month post-treatment, and 6 months post-treatment.
description: The investigators will examine women's self-reported sexual function by administering the Female Sexual Function Index (FSFI). The Female Sexual Function Index (FSFI) is a 19-item self-report questionnaire which assesses sexual function in women. It covers six sexual domains: lubrication, arousal, desire, pain, orgasm and satisfaction. Scores range from 7.2 - 36 where increase in sexual dysfunction is represented by lower scores.
Subscales:
Desire- 2, 3 [Subscale scores Range: 1.2 - 6] Arousal- 5,6,7,8 [Subscale Scores Range: 1.2 - 6] Lubrication- 9,10,11,12 [Subscale Scores Range: 1.2 - 6] Orgasm- 13, 14, 15 [Subscale Scores Range: 1.2 - 6] Satisfaction- 1, 16, 17 [Subscale Scores Range: 1.2 - 6] Pain- 18, 19, 20 [Subscale Scores Range: 1.2 - 6] Extra item: (4) have you been sexually active in past 4 weeks? (yes/no) [Scores Range 0 (no) - 1 (yes)]
Note: Ranges applicable only if question 4 was answered "yes".
measure: Sexual Distress
time frame: Pre-treatment, one month post-treatment, and 6 months post-treatment.
description: The investigators will examine women's self-reported sexual distress by administering the Female Sexual Distress Scale-Revised. This is a 12-item self-report questionnaire assessing for sexuality related personal distress. Scores on the scale range from 0 - 48, where higher scores represent higher levels of distress.
measure: Pain Catastrophizing
time frame: Pre-treatment, one month post-treatment, and 6 months post-treatment..
description: The investigators will examine women's self-reported pain catastrophizing by administering the Pain Catastrophizing Scale. The Pain Catastrophizing Scale (PCS) is a self-report questionnaire that asks participants to think about past painful experiences, or a specific experience of pain, and to indicate the degree to which they have any of the presented thoughts or feelings when they are experiencing pain. Each one of the 13-items is rated on a Likert scale from 0 (not at all) to 4 (all the time), where a higher total score indicates higher pain catastrophizing.
Subscales: Rumination- (4 items) 8, 9, 10, and 11 [Scores Range: 0 - 16] Magnification- (3 items) 6, 7, and 13 [Scores Range: 0 - 12] Helplessness- (6 items) 1, 2, 3, 4, 5, and 12 [Scores Range: 0 - 24] Sum of all items [Overall Range: 0 - 52]
measure: Pain Hypervigilance
time frame: Pre-treatment, one month post-treatment, and 6 months post treatment.
description: The investigators will examine women's self-reported hypervigilance about pain by administering the Pain Vigilance and Awareness Questionnaire. The Pain Vigilance and Awareness Questionnaire (PVAQ) is a 16 item self-report measure to assess the awareness, vigilance, preoccupation and observation of pain. Sum total score [Scores Range: 0 - 80].
measure: Chronic Pain Acceptance, Activities Engagement
time frame: Pre-treatment, one month post-treatment, and 6 months post-treatment.
description: The investigators will examine women's self-reported pain acceptance, activities engagement, by administering the CPAQ chronic pain acceptance questionnaire. The Chronic Pain Acceptance Questionnaire (CPAQ) measures the degree of acceptance of pain by chronic pain patients. It consists of 20 items measuring two domains, Activities Engagement and Pain Willingness. Total score range is from 0 - 120, with higher scores indicating higher levels of pain acceptance.
Subscales:
Activities engagement (11 items)- Q 1, 2, 3, 5, 6, 8, 9, 10, 12, 15, 19 [Scores Range: 0 - 66] Pain willingness (9 items)- Q 4, 7, 11, 13, 14, 16, 17, 18, 20 [Scores Range: 0 - 54]
measure: Chronic Pain Acceptance, CPAQ Pain Willingness
time frame: Pre-treatment, one month post-treatment, and 6 months post treatment.
description: The investigators will examine women's self-reported pain acceptance, activities engagement, by administering the CPAQ chronic pain acceptance questionnaire. The Chronic Pain Acceptance Questionnaire (CPAQ) measures the degree of acceptance of pain by chronic pain patients. It consists of 20 items measuring two domains: Activities Engagement and Pain Willingness. Total score range is from 0 - 120, with higher scores indicating higher levels of pain acceptance.
Subscales:
Activities engagement (11 items)- Q 1, 2, 3, 5, 6, 8, 9, 10, 12, 15, 19 [Scores Range: 0 - 66] Pain willingness (9 items)- Q 4, 7, 11, 13, 14, 16, 17, 18, 20 [Scores Range: 0 - 54]
arm group label: Mindfulness-based cognitive therapy (MBCT)
arm group type: Experimental
description: Women in the MBCT Group Treatment arm will receive the treatment in small group format (8-9 women). Each session will be 2.25 hours in duration and there will be eight, weekly sessions over the course of 2 months. Session content includes education about chronic pain, PVD, stress and sexual response, mindfulness practices, and cognitive techniques to notice thought patterns that contribute to increased pain.
arm group label: Cognitive Behavioural Therapy (CBT)
arm group type: Experimental
description: Women in the CBT Group Treatment arm will receive the treatment in small group format (8-9 women). Each session will be 2.25 hrs in duration and there will be eight, weekly sessions over the course of 2 months. Session content includes education about chronic pain, PVD, stress and sexual response, behavioural techniques such as progressive muscle relaxation, cognitive techniques to challenge unhealthy thinking patterns, and communication skills training.
intervention type: Behavioral
intervention name: Mindfulness-based Cognitive Therapy
description: The MBCT intervention will be administered in small group format (8-9 women). Each session will be 2.25 hours in duration and there will be eight, weekly sessions over the course of 2 months. Session content includes education about chronic pain, PVD, stress and sexual response, mindfulness practices, and cognitive techniques to notice thought patterns that contribute to increased pain.
arm group label: Mindfulness-based cognitive therapy (MBCT)
other name: MBCT
intervention type: Behavioral
intervention name: Cognitive Behavioural Therapy
description: The CBT intervention will be administered to women in small group format (8-9 women). Each session will be 2.25-hrs in duration and there will be eight, weekly sessions over the course of 2 months. Session content includes education about chronic pain, PVD, stress and sexual response, behavioural techniques such as progressive muscle relaxation, cognitive techniques to challenge unhealthy thinking patterns, and communication skills training.
arm group label: Cognitive Behavioural Therapy (CBT)
other name: CBT
criteria: 
gender: Female
minimum age: 19 Years
maximum age: N/A
healthy volunteers: No
last name: Lori A Brotto, PhD
role: Principal Investigator
affiliation: University of British Columbia
facility: 
facility: 
country: Canada
url: http://brottolab.med.ubc.ca
description: UBC Sexual Health Lab
url: https://med-fom-brotto.sites.olt.ubc.ca/files/2019/07/Brotto-et-al.-A-comparison-of-mindfulness2019.pdf
description: Published Paper
responsible party type: Principal Investigator
investigator affiliation: University of British Columbia
investigator full name: Lori Brotto
investigator title: Associate Professor
mesh term: Vulvodynia
mesh term: Vulvar Vestibulitis
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outcome list: 
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