<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/NCT03232801</url>
  </required_header>
  <id_info>
    <org_study_id>PRO15060240</org_study_id>
    <secondary_id>K23AG052628</secondary_id>
    <nct_id>NCT03232801</nct_id>
  </id_info>
  <brief_title>A Mindfulness-based Intervention for Older Women With Low Sexual Desire</brief_title>
  <official_title>A Mindfulness-based Intervention for Older Women With Low Sexual Desire</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Pittsburgh</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>National Institute on Aging (NIA)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
    <collaborator>
      <agency>National Institutes of Health (NIH)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Pittsburgh</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The overall aim of this research is to adapt and pilot test a multi-component,&#xD;
      mindfulness-based behavioral intervention for women age 50 and older with low sexual desire.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Specifically, the investigators will conduct a pilot randomized controlled trial to assess&#xD;
      the feasibility, acceptability, and preliminary efficacy of the intervention. Fifty women&#xD;
      will be randomized to the mindfulness intervention or an educational control group. Both&#xD;
      groups will be conducted in 3 sessions over 6 weeks in groups of 10 women. Feasibility,&#xD;
      acceptability, facilitators, and barriers will be assessed by surveys after each session and&#xD;
      after intervention completion. Preliminary efficacy will be assessed by measures of sexual&#xD;
      desire, sexual function, and overall sexual satisfaction at 6 and 12 weeks.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">October 8, 2020</start_date>
  <completion_date type="Actual">September 1, 2021</completion_date>
  <primary_completion_date type="Actual">September 1, 2021</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>Other</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Feasibility - Number of Enrolled Women Participating in All Sessions</measure>
    <time_frame>6 weeks</time_frame>
    <description>Number of enrolled women participating in all sessions</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Acceptability - Number of Women Indicating &quot;Somewhat&quot; or &quot;Very Satisfied&quot; on a 5-point Likert Scale Measure of Intervention Satisfaction</measure>
    <time_frame>6 weeks</time_frame>
    <description>Number of women indicating &quot;somewhat&quot; or &quot;very satisfied&quot; on a 5-point Likert scale measure of intervention satisfaction</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in FSFI Desire Score</measure>
    <time_frame>Baseline and 12 weeks</time_frame>
    <description>Change in Female Sexual Function Index (FSFI) desire score from baseline to 12 weeks. The FSFI Desire score is a subscale of the FSFI. Scores range from 1.0 to 5.0, with higher scores indicating worse sexual desire. Minimum score is 1.0 and maximum score is 5.0.</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Change in Overall Sexual Function</measure>
    <time_frame>Baseline and 12 weeks</time_frame>
    <description>Total Female Sexual Function Index (FSFI) score from baseline to 12 weeks. The FSFI score can range from 2.0 to 36.0, and a higher score indicates worse sexual function.</description>
  </other_outcome>
  <other_outcome>
    <measure>Comprehensive Sexual Desire</measure>
    <time_frame>6 weeks and 12 weeks</time_frame>
    <description>Sexual Interest and Desire Inventory (SIDI)</description>
  </other_outcome>
  <other_outcome>
    <measure>Sexual Distress</measure>
    <time_frame>6 weeks and 12 weeks</time_frame>
    <description>Female Sexual Distress Scale - Revised (FSDS-R)</description>
  </other_outcome>
  <other_outcome>
    <measure>Quality of Life - SF 36</measure>
    <time_frame>6 weeks and 12 weeks</time_frame>
    <description>Quality of life as measured by Short Form-36 (SF-36)</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">62</enrollment>
  <condition>Hypoactive Sexual Desire Disorder</condition>
  <condition>Sexual Dysfunction</condition>
  <condition>Female Sexual Dysfunction</condition>
  <arm_group>
    <arm_group_label>mindfulness group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>A multicomponent group-based intervention rooted in mindfulness, administered in 3 sessions over 6 weeks</description>
  </arm_group>
  <arm_group>
    <arm_group_label>educational group</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>A general midlife health and aging educational group, administered in 3 sessions over 6 weeks</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>mindfulness-based multicomponent intervention</intervention_name>
    <description>A group-based, multicomponent behavioral intervention rooted in mindfulness</description>
    <arm_group_label>mindfulness group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>general health education group</intervention_name>
    <description>A general health and aging education group</description>
    <arm_group_label>educational group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  meet criteria for a diagnosis of Female Sexual Interest/Arousal Disorder&#xD;
&#xD;
          -  English-speaking&#xD;
&#xD;
          -  have a current sexual partner with whom they are or would like to be sexually active&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  active major depression&#xD;
&#xD;
          -  active substance abuse&#xD;
&#xD;
          -  current intimate partner violence&#xD;
&#xD;
          -  partner with active major depression&#xD;
&#xD;
          -  partner with active major substance abuse&#xD;
&#xD;
          -  significant relationship dissatisfaction&#xD;
&#xD;
          -  current use of antidepressants&#xD;
&#xD;
          -  untreated dyspareunia (sexual pain)&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <gender_based>Yes</gender_based>
    <gender_description>women participants only</gender_description>
    <minimum_age>50 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>University of Pittsburgh</name>
      <address>
        <city>Pittsburgh</city>
        <state>Pennsylvania</state>
        <zip>15213</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>October 2022</verification_date>
  <study_first_submitted>March 10, 2017</study_first_submitted>
  <study_first_submitted_qc>July 25, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">July 28, 2017</study_first_posted>
  <results_first_submitted>August 16, 2022</results_first_submitted>
  <results_first_submitted_qc>October 11, 2022</results_first_submitted_qc>
  <results_first_posted type="Actual">October 13, 2022</results_first_posted>
  <last_update_submitted>October 11, 2022</last_update_submitted>
  <last_update_submitted_qc>October 11, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">October 13, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Pittsburgh</investigator_affiliation>
    <investigator_full_name>Holly Thomas</investigator_full_name>
    <investigator_title>Assistant Professor of Medicine</investigator_title>
  </responsible_party>
  <keyword>hypoactive sexual desire disorder</keyword>
  <keyword>female sexual dysfunction</keyword>
  <keyword>low libido</keyword>
  <keyword>female sexual interest-arousal disorder</keyword>
  <keyword>low desire</keyword>
  <keyword>sexual dysfunction</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Hypokinesia</mesh_term>
    <mesh_term>Sexual Dysfunctions, Psychological</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>August 1, 2022</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/01/NCT03232801/Prot_001.pdf</document_url>
    </provided_document>
    <provided_document>
      <document_type>Statistical Analysis Plan</document_type>
      <document_has_protocol>No</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>August 1, 2022</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/01/NCT03232801/SAP_002.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <pre_assignment_details>81 women were screened. 19 women were ineligible (N=62 enrolled). One woman withdrew after consent but before randomization. N=61 women were randomized.</pre_assignment_details>
      <group_list>
        <group group_id="P1">
          <title>Mindfulness Group</title>
          <description>A multicomponent group-based intervention rooted in mindfulness, administered in 3 sessions over 6 weeks&#xD;
mindfulness-based multicomponent intervention: A group-based, multicomponent behavioral intervention rooted in mindfulness</description>
        </group>
        <group group_id="P2">
          <title>Educational Group</title>
          <description>A general midlife health and aging educational group, administered in 3 sessions over 6 weeks&#xD;
general health education group: A general health and aging education group</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="31"/>
                <participants group_id="P2" count="30"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>Completed Baseline Survey</title>
              <participants_list>
                <participants group_id="P1" count="28"/>
                <participants group_id="P2" count="27"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>Attended at Least One Session</title>
              <participants_list>
                <participants group_id="P1" count="18"/>
                <participants group_id="P2" count="23"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>Completed Week 7 Follow-up</title>
              <participants_list>
                <participants group_id="P1" count="15"/>
                <participants group_id="P2" count="22"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>Completed Week 12 Follow-up</title>
              <participants_list>
                <participants group_id="P1" count="15"/>
                <participants group_id="P2" count="18"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="15"/>
                <participants group_id="P2" count="18"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="16"/>
                <participants group_id="P2" count="12"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <population>61 participants were randomized, but only 55 participants completed baseline assessments</population>
      <group_list>
        <group group_id="B1">
          <title>Mindfulness</title>
          <description>A six-session mindfulness-based intervention focused on sexual health and function. Groups met weekly for 1.5-2 hours over the course of six weeks. Groups were co-led by a primary care physician (the primary investigator) and a trained mindfulness instructor with over 10 years of experience in mindfulness meditation instruction. The intervention contained elements of mindfulness-based stress reduction and sexual psychoeducation. Intervention components including instruction in mindfulness meditation, body scan, awareness of breathing, mindful yoga, and loving kindness meditation, as well as application of these practices to sexual function. At least 30 minutes of each session were spent in mindfulness practice. Sessions also included group discussions and break-out rooms to facilitate discussinos about the practice. Based on prior qualitative research, the intervention also included information about partner sexual dysfunction, body image, and how menopause can affect sexuality. Participants were encouraged to do 60 minutes of mindfulness home practice daily and were provided with audio recordings to facilitate home practice. Home practice included sexuality-specific mindfulness exercises.</description>
        </group>
        <group group_id="B2">
          <title>Education</title>
          <description>The control condition was a six-session health education intervention. Groups met weekly for 1.5-2 hours over the course of six weeks. Groups were led by a primary care physician (the primary investigator) alone. The control intervention covered general educational topics relevant to the health of midlife women, such as osteoporosis and heart disease. Sexual health was discussed in one session, but not in detail. At the conclusion of their participation in the group, control group participants were given a brochure with local resources for learning about mindfulness meditation. Participants did not have any homework to complete for this group.</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="28"/>
            <count group_id="B2" value="27"/>
            <count group_id="B3" value="55"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>&lt;=18 years</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>
                  <title>Between 18 and 65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="25"/>
                    <measurement group_id="B2" value="24"/>
                    <measurement group_id="B3" value="49"/>
                  </measurement_list>
                </category>
                <category>
                  <title>&gt;=65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="3"/>
                    <measurement group_id="B2" value="3"/>
                    <measurement group_id="B3" value="6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <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="55.9" spread="7.1"/>
                    <measurement group_id="B2" value="55.7" spread="7.5"/>
                    <measurement group_id="B3" value="55.8" spread="7.3"/>
                  </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="28"/>
                    <measurement group_id="B2" value="27"/>
                    <measurement group_id="B3" value="55"/>
                  </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>Ethnicity (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="27"/>
                    <measurement group_id="B2" value="27"/>
                    <measurement group_id="B3" value="54"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</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 (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>American Indian or Alaska Native</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>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="3"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="3"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Native Hawaiian or Other Pacific Islander</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>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                    <measurement group_id="B2" value="3"/>
                    <measurement group_id="B3" value="5"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="20"/>
                    <measurement group_id="B2" value="24"/>
                    <measurement group_id="B3" value="44"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</title>
                  <measurement_list>
                    <measurement group_id="B1" value="3"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="3"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</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>Region of Enrollment</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>United States</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="28"/>
                    <measurement group_id="B2" value="27"/>
                    <measurement group_id="B3" value="55"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Female Sexual Function Index (FSFI)</title>
          <description>The Female Sexual Function Index (FSFI) is a 19-item self-report inventory designed to assess female sexual function. It comprises six domains: desire [two items], arousal [four items], lubrication [four items], orgasm, satisfaction, pain [three items each]. The FSFI total score is the sum of the 6 domain/subscale scores. The minimum score is 2.0. The maximum score is 36.0. Higher scores indicate worse functioning. A total score 26.0 has been validated as a cutoff score for diagnosing Female Sexual Dysfunction.</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="21.1" spread="6.1"/>
                    <measurement group_id="B2" value="20.5" spread="7.3"/>
                    <measurement group_id="B3" value="20.7" spread="6.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Female Sexual Distress Scale - Revised (FSDS-R)</title>
          <description>The Female Sexual Distress Scale-Revised (FSDS-R) was created and validated to assess distress associated with impaired sexual function. It contains 13 items. The total score, ranging from 0 to 48, provides a measure of sexual distress, in which the higher the score, the higher the level of sexual distress.</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="23.3" spread="11.9"/>
                    <measurement group_id="B2" value="18.5" spread="8.8"/>
                    <measurement group_id="B3" value="20.7" spread="10.6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Feasibility - Number of Enrolled Women Participating in All Sessions</title>
        <description>Number of enrolled women participating in all sessions</description>
        <time_frame>6 weeks</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Mindfulness</title>
            <description>Assigned to mindfulness-based intervention group</description>
          </group>
          <group group_id="O2">
            <title>Education</title>
            <description>Assigned to general menopause education group</description>
          </group>
        </group_list>
        <measure>
          <title>Feasibility - Number of Enrolled Women Participating in All Sessions</title>
          <description>Number of enrolled women participating in all sessions</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="31"/>
                <count group_id="O2" value="30"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="15"/>
                    <measurement group_id="O2" value="22"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.027</p_value>
            <method>Chi-squared</method>
            <param_type>chi-squared</param_type>
            <param_value>4.86</param_value>
            <ci_n_sides>2-Sided</ci_n_sides>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Acceptability - Number of Women Indicating &quot;Somewhat&quot; or &quot;Very Satisfied&quot; on a 5-point Likert Scale Measure of Intervention Satisfaction</title>
        <description>Number of women indicating &quot;somewhat&quot; or &quot;very satisfied&quot; on a 5-point Likert scale measure of intervention satisfaction</description>
        <time_frame>6 weeks</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Mindfulness Group</title>
            <description>A multicomponent group-based intervention rooted in mindfulness, administered in 3 sessions over 6 weeks&#xD;
mindfulness-based multicomponent intervention: A group-based, multicomponent behavioral intervention rooted in mindfulness</description>
          </group>
          <group group_id="O2">
            <title>Educational Group</title>
            <description>A general midlife health and aging educational group, administered in 3 sessions over 6 weeks&#xD;
general health education group: A general health and aging education group</description>
          </group>
        </group_list>
        <measure>
          <title>Acceptability - Number of Women Indicating &quot;Somewhat&quot; or &quot;Very Satisfied&quot; on a 5-point Likert Scale Measure of Intervention Satisfaction</title>
          <description>Number of women indicating &quot;somewhat&quot; or &quot;very satisfied&quot; on a 5-point Likert scale measure of intervention satisfaction</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="15"/>
                <count group_id="O2" value="22"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="14"/>
                    <measurement group_id="O2" value="19"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <analysis_list>
          <analysis>
            <group_id_list>
              <group_id>O1</group_id>
              <group_id>O2</group_id>
            </group_id_list>
            <non_inferiority_type>Superiority</non_inferiority_type>
            <p_value>0.503</p_value>
            <method>Chi-squared</method>
            <param_type>chi-squared</param_type>
            <param_value>0.45</param_value>
            <ci_n_sides>2-Sided</ci_n_sides>
          </analysis>
        </analysis_list>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Change in FSFI Desire Score</title>
        <description>Change in Female Sexual Function Index (FSFI) desire score from baseline to 12 weeks. The FSFI Desire score is a subscale of the FSFI. Scores range from 1.0 to 5.0, with higher scores indicating worse sexual desire. Minimum score is 1.0 and maximum score is 5.0.</description>
        <time_frame>Baseline and 12 weeks</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Mindfulness</title>
            <description>Assigned to mindfulness-based intervention group</description>
          </group>
          <group group_id="O2">
            <title>Education</title>
            <description>Assigned to general menopause education group</description>
          </group>
        </group_list>
        <measure>
          <title>Change in FSFI Desire Score</title>
          <description>Change in Female Sexual Function Index (FSFI) desire score from baseline to 12 weeks. The FSFI Desire score is a subscale of the FSFI. Scores range from 1.0 to 5.0, with higher scores indicating worse sexual desire. Minimum score is 1.0 and maximum score is 5.0.</description>
          <units>units 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="15"/>
                <count group_id="O2" value="18"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.4" spread="0.8"/>
                    <measurement group_id="O2" value="0.7" spread="0.7"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>Change in Overall Sexual Function</title>
        <description>Total Female Sexual Function Index (FSFI) score from baseline to 12 weeks. The FSFI score can range from 2.0 to 36.0, and a higher score indicates worse sexual function.</description>
        <time_frame>Baseline and 12 weeks</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Mindfulness</title>
            <description>Assigned to mindfulness-based intervention group</description>
          </group>
          <group group_id="O2">
            <title>Education</title>
            <description>Assigned to general menopause education group</description>
          </group>
        </group_list>
        <measure>
          <title>Change in Overall Sexual Function</title>
          <description>Total Female Sexual Function Index (FSFI) score from baseline to 12 weeks. The FSFI score can range from 2.0 to 36.0, and a higher score indicates worse sexual function.</description>
          <units>units 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="15"/>
                <count group_id="O2" value="18"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4.0" spread="5.1"/>
                    <measurement group_id="O2" value="1.5" spread="3.0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>Comprehensive Sexual Desire</title>
        <description>Sexual Interest and Desire Inventory (SIDI)</description>
        <time_frame>6 weeks and 12 weeks</time_frame>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>Sexual Distress</title>
        <description>Female Sexual Distress Scale - Revised (FSDS-R)</description>
        <time_frame>6 weeks and 12 weeks</time_frame>
      </outcome>
      <outcome>
        <type>Other Pre-specified</type>
        <title>Quality of Life - SF 36</title>
        <description>Quality of life as measured by Short Form-36 (SF-36)</description>
        <time_frame>6 weeks and 12 weeks</time_frame>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>2 months</time_frame>
      <group_list>
        <group group_id="E1">
          <title>Mindfulness Group</title>
          <description>A multicomponent group-based intervention rooted in mindfulness, administered in 3 sessions over 6 weeks&#xD;
mindfulness-based multicomponent intervention: A group-based, multicomponent behavioral intervention rooted in mindfulness</description>
        </group>
        <group group_id="E2">
          <title>Educational Group</title>
          <description>A general midlife health and aging educational group, administered in 3 sessions over 6 weeks&#xD;
general health education group: A general health and aging education group</description>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="30"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="31"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="30"/>
              </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="31"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="30"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>All Principal Investigators ARE 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>Holly Thomas</name_or_title>
      <organization>University of Pittsburgh</organization>
      <phone>412-586-9836</phone>
      <email>thomashn@upmc.edu</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/NCT03232801
org study id: PRO15060240
secondary id: K23AG052628
nct id: NCT03232801
lead sponsor: 
collaborator: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
The overall aim of this research is to adapt and pilot test a multi-component,
      mindfulness-based behavioral intervention for women age 50 and older with low sexual desire.
Specifically, the investigators will conduct a pilot randomized controlled trial to assess
      the feasibility, acceptability, and preliminary efficacy of the intervention. Fifty women
      will be randomized to the mindfulness intervention or an educational control group. Both
      groups will be conducted in 3 sessions over 6 weeks in groups of 10 women. Feasibility,
      acceptability, facilitators, and barriers will be assessed by surveys after each session and
      after intervention completion. Preliminary efficacy will be assessed by measures of sexual
      desire, sexual function, and overall sexual satisfaction at 6 and 12 weeks.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Other
masking: Single (Outcomes Assessor)
measure: Feasibility - Number of Enrolled Women Participating in All Sessions
time frame: 6 weeks
description: Number of enrolled women participating in all sessions
measure: Acceptability - Number of Women Indicating "Somewhat" or "Very Satisfied" on a 5-point Likert Scale Measure of Intervention Satisfaction
time frame: 6 weeks
description: Number of women indicating "somewhat" or "very satisfied" on a 5-point Likert scale measure of intervention satisfaction
measure: Change in FSFI Desire Score
time frame: Baseline and 12 weeks
description: Change in Female Sexual Function Index (FSFI) desire score from baseline to 12 weeks. The FSFI Desire score is a subscale of the FSFI. Scores range from 1.0 to 5.0, with higher scores indicating worse sexual desire. Minimum score is 1.0 and maximum score is 5.0.
measure: Change in Overall Sexual Function
time frame: Baseline and 12 weeks
description: Total Female Sexual Function Index (FSFI) score from baseline to 12 weeks. The FSFI score can range from 2.0 to 36.0, and a higher score indicates worse sexual function.
measure: Comprehensive Sexual Desire
time frame: 6 weeks and 12 weeks
description: Sexual Interest and Desire Inventory (SIDI)
measure: Sexual Distress
time frame: 6 weeks and 12 weeks
description: Female Sexual Distress Scale - Revised (FSDS-R)
measure: Quality of Life - SF 36
time frame: 6 weeks and 12 weeks
description: Quality of life as measured by Short Form-36 (SF-36)
arm group label: mindfulness group
arm group type: Experimental
description: A multicomponent group-based intervention rooted in mindfulness, administered in 3 sessions over 6 weeks
arm group label: educational group
arm group type: Active Comparator
description: A general midlife health and aging educational group, administered in 3 sessions over 6 weeks
intervention type: Behavioral
intervention name: mindfulness-based multicomponent intervention
description: A group-based, multicomponent behavioral intervention rooted in mindfulness
arm group label: mindfulness group
intervention type: Behavioral
intervention name: general health education group
description: A general health and aging education group
arm group label: educational group
criteria: 
gender: Female
gender based: Yes
gender description: women participants only
minimum age: 50 Years
maximum age: N/A
healthy volunteers: No
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: University of Pittsburgh
investigator full name: Holly Thomas
investigator title: Assistant Professor of Medicine
mesh term: Hypokinesia
mesh term: Sexual Dysfunctions, Psychological
sharing ipd: No
provided document: 
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 