<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/NCT01706406</url>
  </required_header>
  <id_info>
    <org_study_id>C05-0400-II</org_study_id>
    <nct_id>NCT01706406</nct_id>
  </id_info>
  <brief_title>Group Psychoeducational Treatment for Women With Sexual Arousal Difficulties, Phase II</brief_title>
  <acronym>Group PED</acronym>
  <official_title>Group Psychoeducational Treatment for Women With Sexual Arousal Difficulties, Phase II</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>
      The purpose of this study is to pilot test and determine the efficacy of a psychoeducational&#xD;
      intervention (PED) we recently piloted in a group format for women with acquired sexual&#xD;
      arousal disorder (FSAD).&#xD;
&#xD;
      HYPOTHESES:&#xD;
&#xD;
        1. - Compared to baseline measures, the PED will result in significant improvement in&#xD;
           self-report measures of: (a) subjective sexual arousal; (b) perception of genital&#xD;
           arousal/genital sensitivity; (c) orgasmic experience; (d) sexual desire; (e) sexual&#xD;
           distress; (f) relationship satisfaction; (g) depressive symptoms; and (h) quality of&#xD;
           life.&#xD;
&#xD;
        2. - It is unknown what effect the PED will have on actual physiological sexual arousal.&#xD;
&#xD;
        3. - The group format will be a feasible and cost-effective method of delivering&#xD;
           empirically supported treatment to women with sexual arousal difficulties and will&#xD;
           contribute towards meeting the needs for sexual health care for women on the clinic&#xD;
           wait-list at the BC Centre for Sexual Medicine.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Sexual arousal difficulties are common among women, affecting approximately 22% of women&#xD;
      between the ages of 18 and 59 (Laumann, Paik &amp; Rosen, 1999). Although there are&#xD;
      evidence-based psychological treatments available for women with orgasmic and pain disorders,&#xD;
      there are currently no empirically-supported treatments for women with acquired Sexual&#xD;
      Arousal Disorder (FSAD). Moreover, there have been numerous attempts to find evidence for a&#xD;
      pharmacological agent effective at treating women's sexual arousal complaints; however, to&#xD;
      date these studies have been inconclusive. Given the significant role that sexual health&#xD;
      plays in quality of life, the fact that effective psychological treatments for women's sexual&#xD;
      dysfunction are not widely available, and the fact that wait-lists to see health care&#xD;
      professionals with expertise in the area of sexual dysfunction are often unwieldy, there is a&#xD;
      need to establish brief, evidence-based approaches to treat women's acquired FSAD.&#xD;
      Psychological therapy in a group format is a standard practice at the BC Centre for Sexual&#xD;
      Medicine. However, in this study we would like to collect information from participants that&#xD;
      would help us in determining the specific efficacy of the PED as well as identifying&#xD;
      demographic or participant variables that might predict a positive response to the PED.&#xD;
      Because we are using this information to determine the treatment's efficacy and because we&#xD;
      will use this information as the basis for a publication, we deem this to be a research trial&#xD;
      in which ethics review is necessary.&#xD;
&#xD;
      OBJECTIVES: We have recently developed and tested a new psychoeducational treatment (PED) for&#xD;
      the treatment of FSAD due to early-stage gynecologic cancer treatment, and for healthy women&#xD;
      with FSAD. Our data show this PED to significantly improve self-reported sexual desire,&#xD;
      arousal, mood, relationship distress, and quality of life. We are currently testing the&#xD;
      efficacy of this PED in a larger sample of cancer survivors with FSAD. The goal for this&#xD;
      study is to determine the efficacy of the group PED for currently seeking treatment at the BC&#xD;
      Centre for Sexual Medicine for FSAD. By using a waitlist control group, we can determine if&#xD;
      any improvement in sexual function is due to treatment or the passage of time.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>November 2007</start_date>
  <completion_date type="Actual">June 2012</completion_date>
  <primary_completion_date type="Actual">June 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>Change in physiological sexual arousal</measure>
    <time_frame>Sexual arousal will be measured approximately one week pre-treatment and approxiately two weeks post-treatment</time_frame>
    <description>Sexual arousal will be measured physiologically with a Vaginal Photoplethysmograph (VPP). The VPP measures vaginal pulse amplitude (VPA) which has been found to be a sensitive and specific measure of genital arousal (Laan &amp; Everaerd, 1995).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Long-term change in physiological sexual arousal</measure>
    <time_frame>Sexual arousal will be assessed approximately one-week pre-treatment and approximately 6 months post treatment</time_frame>
    <description>Sexual arousal will be measured physiologically with a Vaginal Photoplethysmograph (VPP). The VPP measures vaginal pulse amplitude (VPA) which has been found to be a sensitive and specific measure of genital arousal (Laan &amp; Everaerd, 1995).</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Subjective sexual arousal</measure>
    <time_frame>Subjective sexual arousal will be assessed approximately one week pre-treatment, approximately two-weeks post-treatment and approximately 6-months post treatment</time_frame>
    <description>The Female Sexual Function Inventory (FSFI; Rosen et al. 2000) questionnaire will be used to measure subjective sexual arousal. The FSFI a 19-item self-report questionnaire which assesses sexual function in women. It covers six sexual domains: lubrication, arousal, desire, pain, orgasm and satisfaction.</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Sexual Distress</measure>
    <time_frame>Sexual distress will be assessed approximately one week pre-treatment, approximatley two weeks post-treatment and approximately 6-months post-treatment</time_frame>
    <description>Sexual distress will be measured with the Female Sexual Distress Scale (FSDS, Derogatis et al. 2002). The FSDS is a 12-item self-report questionnaire assessing for sexuality related personal distress.</description>
  </other_outcome>
  <other_outcome>
    <measure>Mood</measure>
    <time_frame>Mood will be assessed approximately one week pre-treatment, approximatley two weeks post-treatment and approximately 6-months post-treatment</time_frame>
    <description>Mood will be measured with the Beck Depression Inventory (BDI; Beck &amp; Beamesderfer, 1974), a widely-used self-report questionnaire designed to assess the severity of depressive symptoms.</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">98</enrollment>
  <condition>Low Female Sexual Arousal</condition>
  <condition>Low Female Sexual Desire</condition>
  <arm_group>
    <arm_group_label>1 treatment</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Women randomized into the &quot;treatment&quot; group will undergo pre-treatment testing (questionnaires and physiological assessment)within 14 days of beginning treatment</description>
  </arm_group>
  <arm_group>
    <arm_group_label>2 waitlist</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Women randomized to the &quot;waitlist&quot; group will undergo initial testing (questionnaires and physiological testing) and receive no treatment until the next scheduled group (4 months). They will undergo pretreatment testing and treatment on the same schedule as women in the &quot;treatment&quot; group.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Brief psychoeducational intervention for female sexual arousal disorder</intervention_name>
    <description>four 1.5 hour long group psychoeducational sessions, spaced 2 weeks apart for a total of 8 weeks.</description>
    <arm_group_label>1 treatment</arm_group_label>
    <arm_group_label>2 waitlist</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  between the ages of 19 and 65&#xD;
&#xD;
          -  currently seeking treatment at the BC Centre for Sexual Medicine&#xD;
&#xD;
          -  meet clinical criteria for acquired Female Sexual Arousal Disorder (FSAD);&#xD;
&#xD;
          -  be proficient in English and willing to take part in group sessions.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  does not meet clinical criteria for acquired Female Sexual Arousal Disorder (FSAD)&#xD;
&#xD;
          -  not currently Seeking seeking treatment at the BC Centre for Sexual Medicine&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>19 Years</minimum_age>
    <maximum_age>65 Years</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>BC Centre for Sexual Medicine</name>
      <address>
        <city>Vancouver,</city>
        <state>British Columbia</state>
        <zip>V5Z 1C6</zip>
        <country>Canada</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>UBC Sexual Health Lab, Vancouver Hospital</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>UBC Sexual Health Lab website</description>
  </link>
  <verification_date>May 2017</verification_date>
  <study_first_submitted>October 29, 2010</study_first_submitted>
  <study_first_submitted_qc>October 12, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 15, 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>female sexual arousal</keyword>
  <keyword>female sexual desire</keyword>
  <keyword>psychoeducational intervention</keyword>
  <!-- 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/NCT01706406
org study id: C05-0400-II
nct id: NCT01706406
lead sponsor: 
has dmc: No
The purpose of this study is to pilot test and determine the efficacy of a psychoeducational
      intervention (PED) we recently piloted in a group format for women with acquired sexual
      arousal disorder (FSAD).

      HYPOTHESES:

        1. - Compared to baseline measures, the PED will result in significant improvement in
           self-report measures of: (a) subjective sexual arousal; (b) perception of genital
           arousal/genital sensitivity; (c) orgasmic experience; (d) sexual desire; (e) sexual
           distress; (f) relationship satisfaction; (g) depressive symptoms; and (h) quality of
           life.

        2. - It is unknown what effect the PED will have on actual physiological sexual arousal.

        3. - The group format will be a feasible and cost-effective method of delivering
           empirically supported treatment to women with sexual arousal difficulties and will
           contribute towards meeting the needs for sexual health care for women on the clinic
           wait-list at the BC Centre for Sexual Medicine.
Sexual arousal difficulties are common among women, affecting approximately 22% of women
      between the ages of 18 and 59 (Laumann, Paik & Rosen, 1999). Although there are
      evidence-based psychological treatments available for women with orgasmic and pain disorders,
      there are currently no empirically-supported treatments for women with acquired Sexual
      Arousal Disorder (FSAD). Moreover, there have been numerous attempts to find evidence for a
      pharmacological agent effective at treating women's sexual arousal complaints; however, to
      date these studies have been inconclusive. Given the significant role that sexual health
      plays in quality of life, the fact that effective psychological treatments for women's sexual
      dysfunction are not widely available, and the fact that wait-lists to see health care
      professionals with expertise in the area of sexual dysfunction are often unwieldy, there is a
      need to establish brief, evidence-based approaches to treat women's acquired FSAD.
      Psychological therapy in a group format is a standard practice at the BC Centre for Sexual
      Medicine. However, in this study we would like to collect information from participants that
      would help us in determining the specific efficacy of the PED as well as identifying
      demographic or participant variables that might predict a positive response to the PED.
      Because we are using this information to determine the treatment's efficacy and because we
      will use this information as the basis for a publication, we deem this to be a research trial
      in which ethics review is necessary.

      OBJECTIVES: We have recently developed and tested a new psychoeducational treatment (PED) for
      the treatment of FSAD due to early-stage gynecologic cancer treatment, and for healthy women
      with FSAD. Our data show this PED to significantly improve self-reported sexual desire,
      arousal, mood, relationship distress, and quality of life. We are currently testing the
      efficacy of this PED in a larger sample of cancer survivors with FSAD. The goal for this
      study is to determine the efficacy of the group PED for currently seeking treatment at the BC
      Centre for Sexual Medicine for FSAD. By using a waitlist control group, we can determine if
      any improvement in sexual function is due to treatment or the passage of time.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Change in physiological sexual arousal
time frame: Sexual arousal will be measured approximately one week pre-treatment and approxiately two weeks post-treatment
description: Sexual arousal will be measured physiologically with a Vaginal Photoplethysmograph (VPP). The VPP measures vaginal pulse amplitude (VPA) which has been found to be a sensitive and specific measure of genital arousal (Laan & Everaerd, 1995).
measure: Long-term change in physiological sexual arousal
time frame: Sexual arousal will be assessed approximately one-week pre-treatment and approximately 6 months post treatment
description: Sexual arousal will be measured physiologically with a Vaginal Photoplethysmograph (VPP). The VPP measures vaginal pulse amplitude (VPA) which has been found to be a sensitive and specific measure of genital arousal (Laan & Everaerd, 1995).
measure: Subjective sexual arousal
time frame: Subjective sexual arousal will be assessed approximately one week pre-treatment, approximately two-weeks post-treatment and approximately 6-months post treatment
description: The Female Sexual Function Inventory (FSFI; Rosen et al. 2000) questionnaire will be used to measure subjective sexual arousal. The FSFI a 19-item self-report questionnaire which assesses sexual function in women. It covers six sexual domains: lubrication, arousal, desire, pain, orgasm and satisfaction.
measure: Sexual Distress
time frame: Sexual distress will be assessed approximately one week pre-treatment, approximatley two weeks post-treatment and approximately 6-months post-treatment
description: Sexual distress will be measured with the Female Sexual Distress Scale (FSDS, Derogatis et al. 2002). The FSDS is a 12-item self-report questionnaire assessing for sexuality related personal distress.
measure: Mood
time frame: Mood will be assessed approximately one week pre-treatment, approximatley two weeks post-treatment and approximately 6-months post-treatment
description: Mood will be measured with the Beck Depression Inventory (BDI; Beck & Beamesderfer, 1974), a widely-used self-report questionnaire designed to assess the severity of depressive symptoms.
arm group label: 1 treatment
arm group type: Experimental
description: Women randomized into the "treatment" group will undergo pre-treatment testing (questionnaires and physiological assessment)within 14 days of beginning treatment
arm group label: 2 waitlist
arm group type: Other
description: Women randomized to the "waitlist" group will undergo initial testing (questionnaires and physiological testing) and receive no treatment until the next scheduled group (4 months). They will undergo pretreatment testing and treatment on the same schedule as women in the "treatment" group.
intervention type: Behavioral
intervention name: Brief psychoeducational intervention for female sexual arousal disorder
description: four 1.5 hour long group psychoeducational sessions, spaced 2 weeks apart for a total of 8 weeks.
arm group label: 1 treatment
arm group label: 2 waitlist
criteria: 
gender: Female
minimum age: 19 Years
maximum age: 65 Years
healthy volunteers: No
last name: Lori A Brotto, PhD
role: Principal Investigator
affiliation: University of British Columbia
facility: 
facility: 
country: Canada
url: http://www.obgyn.ubc.ca/SexualHealth
description: UBC Sexual Health Lab website
responsible party type: Principal Investigator
investigator affiliation: University of British Columbia
investigator full name: Lori Brotto
investigator title: Principal Investigator