<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/NCT01704443</url>
  </required_header>
  <id_info>
    <org_study_id>H08-00885</org_study_id>
    <nct_id>NCT01704443</nct_id>
  </id_info>
  <brief_title>Integrated Mindfulness for Provoked Vestibulodynia</brief_title>
  <acronym>IMPROVED</acronym>
  <official_title>Integrated Mindfulness 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 study aims to test the efficacy of a 4-session intervention (Group psychoeducational&#xD;
      treatment) using a randomized study design. Participants will be randomized in to 'immediate&#xD;
      treatment' or 'waitlist control'. Women in the wait-list condition will receive the 4-session&#xD;
      IMPROVED treatment, just as women randomized to the experimental group, after the end of&#xD;
      their wait-list period.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>April 2008</start_date>
  <completion_date type="Actual">April 2013</completion_date>
  <primary_completion_date type="Actual">November 2012</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>Pain intensity</measure>
    <time_frame>one week pre-treatment to one week post treatment</time_frame>
    <description>Pain intensity will be measured with the Q-tip test- a standard method of diagnosing vestibulodynia and assessing the pain associated with the diagnosis. The Q-tip test involves the physician lightly touching a Q-tip to specific areas around the vulvar vestibule while the patient indicates how much pain they feel on a scale from 0-10 in response to this provoked touch.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Long-term pain intensity</measure>
    <time_frame>One week pre-treatment to 6 months post preatment</time_frame>
    <description>Pain intensity will be measured with the Q-tip test- a standard method of diagnosing vestibulodynia and assessing the pain associated with the diagnosis. The Q-tip test involves the physician lightly touching a Q-tip to specific areas around the vulvar vestibule while the patient indicates how much pain they feel on a scale from 0-10 in response to this provoked touch</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Sexual Distress</measure>
    <time_frame>One week pre-treatment, one week post treatment and 6-months follow up</time_frame>
    <description>The investigators will examine women's self-reported sexual distress by administering the Female Sexual Distress Scale-Revised (Derogatis et al, 2008)</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Pain Catastrophising</measure>
    <time_frame>one week pre-treatment, one week post treatment and 6-months follow-up</time_frame>
    <description>The investigators will examine women's self-reported pain catastrophising by administering the Pain Catastrophizing Scale (Sullivan, Bishop &amp; Pivik, 1995).</description>
  </other_outcome>
  <other_outcome>
    <measure>Pain hypervigilance</measure>
    <time_frame>one week pre-treatment, one week post treatment and 6-months follow-up</time_frame>
    <description>The investigators will examine women's self-report hypervigilance about pain by administering the Pain Vigilance and Awareness Questionnaire, McCracken, 1997)</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">97</enrollment>
  <condition>Provoked Vestibulodynia</condition>
  <arm_group>
    <arm_group_label>Immediate treatment</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Women in the Immediate treatment arm will receive the Group Psychoeducational treatment in the next available group. There will be 8-9 womenper group and each session will be 2.25 hours in duration and there will be 4, bi-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>Waitlist Control- delayed treatment</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Women in the Waitlist Control arm will receive no treatment for a period of approximately 8 weeks. After the waitlist period they will receive the same Group Psychoeducational treatment as the participants in the immediate treatment arm of the study.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Group Psychoeducational Treatment</intervention_name>
    <description>The Group Psychoeducational Treatment consists of treatment in small group format (8-9 women). Each session will be 2.25 hours in duration and there will be four, bi-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;
Participants in the Waitlist Control Condition will receive this treatment at the end of the waitlist period (approximately 8 weeks)</description>
    <arm_group_label>Immediate treatment</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Waitlist control</intervention_name>
    <description>No treatment will be provided during the 8 week Waitlist control period</description>
    <arm_group_label>Waitlist Control- delayed treatment</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  must be a patient at the British Columbia Centre for Sexual Medicine&#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;
        Exclusion Criteria:&#xD;
&#xD;
          -  not at patient at the BC Centre for Sexual Medicine&#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_countries>
    <country>Canada</country>
  </location_countries>
  <link>
    <url>http://www.obgyn.ubc.ca/SexualHealth/</url>
    <description>Related Info</description>
  </link>
  <verification_date>May 2017</verification_date>
  <study_first_submitted>August 24, 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>
  <last_update_submitted>May 30, 2017</last_update_submitted>
  <last_update_submitted_qc>May 30, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">June 1, 2017</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>Principal Investigator</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>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT01704443
org study id: H08-00885
nct id: NCT01704443
lead sponsor: 
has dmc: No
This study aims to test the efficacy of a 4-session intervention (Group psychoeducational
      treatment) using a randomized study design. Participants will be randomized in to 'immediate
      treatment' or 'waitlist control'. Women in the wait-list condition will receive the 4-session
      IMPROVED treatment, just as women randomized to the experimental group, after the end of
      their wait-list period.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Pain intensity
time frame: one week pre-treatment to one week post treatment
description: Pain intensity will be measured with the Q-tip test- a standard method of diagnosing vestibulodynia and assessing the pain associated with the diagnosis. The Q-tip test involves the physician lightly touching a Q-tip to specific areas around the vulvar vestibule while the patient indicates how much pain they feel on a scale from 0-10 in response to this provoked touch.
measure: Long-term pain intensity
time frame: One week pre-treatment to 6 months post preatment
description: Pain intensity will be measured with the Q-tip test- a standard method of diagnosing vestibulodynia and assessing the pain associated with the diagnosis. The Q-tip test involves the physician lightly touching a Q-tip to specific areas around the vulvar vestibule while the patient indicates how much pain they feel on a scale from 0-10 in response to this provoked touch
measure: Sexual Distress
time frame: One week pre-treatment, one week post treatment and 6-months follow up
description: The investigators will examine women's self-reported sexual distress by administering the Female Sexual Distress Scale-Revised (Derogatis et al, 2008)
measure: Pain Catastrophising
time frame: one week pre-treatment, one week post treatment and 6-months follow-up
description: The investigators will examine women's self-reported pain catastrophising by administering the Pain Catastrophizing Scale (Sullivan, Bishop & Pivik, 1995).
measure: Pain hypervigilance
time frame: one week pre-treatment, one week post treatment and 6-months follow-up
description: The investigators will examine women's self-report hypervigilance about pain by administering the Pain Vigilance and Awareness Questionnaire, McCracken, 1997)
arm group label: Immediate treatment
arm group type: Experimental
description: Women in the Immediate treatment arm will receive the Group Psychoeducational treatment in the next available group. There will be 8-9 womenper group and each session will be 2.25 hours in duration and there will be 4, bi-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: Waitlist Control- delayed treatment
arm group type: Experimental
description: Women in the Waitlist Control arm will receive no treatment for a period of approximately 8 weeks. After the waitlist period they will receive the same Group Psychoeducational treatment as the participants in the immediate treatment arm of the study.
intervention type: Behavioral
intervention name: Group Psychoeducational Treatment
description: The Group Psychoeducational Treatment consists of treatment in small group format (8-9 women). Each session will be 2.25 hours in duration and there will be four, bi-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.
Participants in the Waitlist Control Condition will receive this treatment at the end of the waitlist period (approximately 8 weeks)
arm group label: Immediate treatment
intervention type: Other
intervention name: Waitlist control
description: No treatment will be provided during the 8 week Waitlist control period
arm group label: Waitlist Control- delayed treatment
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: 
country: Canada
url: http://www.obgyn.ubc.ca/SexualHealth/
description: Related Info
responsible party type: Principal Investigator
investigator affiliation: University of British Columbia
investigator full name: Lori Brotto
investigator title: Principal Investigator
mesh term: Vulvodynia
mesh term: Vulvar Vestibulitis