<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/NCT03780751</url>
  </required_header>
  <id_info>
    <org_study_id>VE 1083/2-1</org_study_id>
    <nct_id>NCT03780751</nct_id>
  </id_info>
  <brief_title>Waitlist Controlled Comparison of Cognitive-behavioral vs. Mindfulness-based Online-treatments for Women With Low Sexual Desire</brief_title>
  <acronym>MiSELF</acronym>
  <official_title>Randomized-controlled Comparison of Two Online-interventions: How Effective Are Cognitive-behavioral and Mindfulness-based Sexual Therapy in Improving Sexual Desire in Women With Hypoactive Sexual Desire Disorder?</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Ruhr University of Bochum</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Friedrich-Alexander-Universität Erlangen-Nürnberg</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>University of British Columbia</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Ruhr University of Bochum</source>
  <oversight_info>
    <has_dmc>No</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>
      Problems with sexual function are common and distressing. The most frequent sexual difficulty&#xD;
      in women is a lack of sexual desire with a prevalence of 20-30%. When low sexual desire is&#xD;
      experienced over several months and causes significant personal distress, a sexual&#xD;
      dysfunction can be diagnosed (ICD-10: Hypoactive Sexual Desire Disorder: HSDD). A distressing&#xD;
      lack of desire is reported by 6% of sexually active women. Psychological interventions are&#xD;
      the treatment of choice for women with HSDD. Promising treatment approaches include&#xD;
      cognitive-behavioral and mindfulness-based interventions. A recent meta-analysis also showed&#xD;
      that Internet-delivered programs are a valid alternative to face-to-face treatments. Aim of&#xD;
      this project to assess the effectivity of two eight-week online-programs consisting of&#xD;
      cognitive-behavioral (COPE) and mindfulness-based (MIND) interventions for women with HSDD.&#xD;
      Both treatments will be compared to a waitlist-control group. For this project, two&#xD;
      well-established group-treatment manuals will be translated into German and adapted to a&#xD;
      multimedia online-environment. All participants will be guided through the programs by&#xD;
      well-qualified eCoaches.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">December 18, 2018</start_date>
  <completion_date type="Actual">September 16, 2022</completion_date>
  <primary_completion_date type="Actual">September 16, 2022</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>
    <intervention_model_description>Participants are assigned to one of three groups parallel for the duration of the study. 40% of participants will be assigned to one of the two immediate treatment conditions, 20% of participants will be assigned to a waitlist and will begin active treatment after a six months waiting period.</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Sexual Interest and Desire Inventory Female (SIDI-F)</measure>
    <time_frame>at baseline, 5 weeks after baseline, 3 months after baseline, 6 months after baseline, 12 months after baseline</time_frame>
    <description>The SIDI-F is a clinician-rated instrument consisting of 13 items designed to assess HSDD severity in women. A self-report version, modified for the use in partnered and unpartnered women will be applied.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Female Sexual Distress Scale Revised (FSDS-R)</measure>
    <time_frame>at baseline, 5 weeks after baseline, 3 months after baseline, 6 months after baseline, 12 months after baseline</time_frame>
    <description>The Female Sexual Distress Scale (FSDS) is a 13-item self- assessment questionnaire for the evaluation of sexually related personal distress.</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Desire subscale of the Female Sexual Function Index</measure>
    <time_frame>at baseline, 5 weeks after baseline, 3 months after baseline, 6 months after baseline, 12 months after baseline</time_frame>
    <description>The Female Sexual Function Index measures women's sexual function with 19-items. Here, the two items assessing sexual desire will be used.</description>
  </other_outcome>
  <other_outcome>
    <measure>Patient Health Questionnaire 9 (PHQ-9)</measure>
    <time_frame>at baseline, 3 months after baseline, 6 months after baseline, 12 months after baseline</time_frame>
    <description>A 9-item self-report measure used to assess symptoms of depression.</description>
  </other_outcome>
  <other_outcome>
    <measure>Generalized Anxiety Disorder 7 (GAD-7)</measure>
    <time_frame>at baseline, 3 months after baseline, 6 months after baseline, 12 months after baseline</time_frame>
    <description>A 7-item self-report measure used to assess symptoms of anxiety.</description>
  </other_outcome>
  <other_outcome>
    <measure>Scale of Body Connection (SBC)</measure>
    <time_frame>at baseline, 3 months after baseline, 6 months after baseline, 12 months after baseline</time_frame>
    <description>A 20-item self-report measure used to assess body awareness</description>
  </other_outcome>
  <other_outcome>
    <measure>Mindful Attention and Awareness Scale (MAAS)</measure>
    <time_frame>at baseline, 3 months after baseline, 6 months after baseline, 12 months after baseline</time_frame>
    <description>A 15-item self-report measure used to assess mindfulness</description>
  </other_outcome>
  <other_outcome>
    <measure>Body Image Self-Consciousness Scale</measure>
    <time_frame>at baseline, 3 months after baseline, 6 months after baseline, 12 months after baseline</time_frame>
    <description>A 15-item self-report measure used to assess body-related self-consciousness</description>
  </other_outcome>
  <other_outcome>
    <measure>Self-Compassion Scale (SCS)</measure>
    <time_frame>at baseline, 3 months after baseline, 6 months after baseline, 12 months after baseline</time_frame>
    <description>A 12-item self-report scale used to assess self-compassion.</description>
  </other_outcome>
  <other_outcome>
    <measure>Rumination-Reflection Questionnaire - Adapted Rumination Subscale (RRQ)</measure>
    <time_frame>at baseline, 3 months after baseline, 6 months after baseline, 12 months after baseline</time_frame>
    <description>A 12-item scale that assess rumination about sexual issues</description>
  </other_outcome>
  <other_outcome>
    <measure>Health Action Process Approach (HAPA)</measure>
    <time_frame>at baseline, 3 months after baseline, 6 months after baseline, 12 months after baseline</time_frame>
    <description>Treatment adherence as measured with the HAPA scales</description>
  </other_outcome>
  <other_outcome>
    <measure>Working alliance inventory (WAI) adapted for online treatments</measure>
    <time_frame>3 months after baseline, 6 months after baseline</time_frame>
    <description>Measures working alliance with eCoaches and online-program</description>
  </other_outcome>
  <other_outcome>
    <measure>Inventory for the Assessment of Negative Effects of Psychotherapy (INEP)</measure>
    <time_frame>3 months after baseline, 6 months after baseline</time_frame>
    <description>15-item self-report measure that assesses side-effects of psychological treatments</description>
  </other_outcome>
  <other_outcome>
    <measure>Client Satisfaction Questionnaire (CSQ-8)</measure>
    <time_frame>3 months after baseline, 6 months after baseline, 12 months after baseline</time_frame>
    <description>8-item self-report measure that assesses women's satisfaction with the online treatment they received</description>
  </other_outcome>
  <other_outcome>
    <measure>Single target implicit association task (ST-IAT)</measure>
    <time_frame>at baseline, 3 months after baseline</time_frame>
    <description>An experimental paradigm used to assess implicit cognitive biases towards sexual stimuli</description>
  </other_outcome>
  <other_outcome>
    <measure>Scrambled-sentences task</measure>
    <time_frame>at baseline, 3 months after baseline</time_frame>
    <description>An experimental paradigm used to assess implicit cognitive biases towards sexual stimuli</description>
  </other_outcome>
  <other_outcome>
    <measure>Qualitative evaluation of COPE and MIND</measure>
    <time_frame>12 weeks after baseline</time_frame>
    <description>Qualitative telephone interviews with approx. 50 participants to assess perceived mechanisms of change as well as strengths and weaknesses of the programs</description>
  </other_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">266</enrollment>
  <condition>Hypoactive Sexual Desire Disorder</condition>
  <arm_group>
    <arm_group_label>Cognitive-behavioral treatment</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>COPE-program of 8 sessions (+ 1 booster session) of guided Internet-based treatment including psychoeducation, sexual education, guided masturbation, sensate focus and cognitive-behavioral interventions (e.g., thought diaries, challenging of maladaptive thought patterns, behavioral analysis). Participants are encouraged to practice exercises between sessions.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Mindfulness-based treatment</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>MIND-program of 8 sessions (+ 1 booster session) of guided Internet-based treatment including psychoeducation, sexual education, guided masturbation, sensate focus and mindfulness-based exercises (e.g., breathing meditation, body scan, sitting meditation).</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Waitlist</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Participants will receive no immediate treatment but will be able to choose either MIND or COPE after a six months waiting period.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Cognitive-behavioral treatment</intervention_name>
    <description>COPE-program of 8 sessions (+ 1 booster session) of guided Internet-based treatment including psychoeducation, sexual education, guided masturbation, sensate focus and cognitive-behavioral interventions (e.g., thought diaries, challenging of maladaptive thought patterns, behavioral analysis). Participants are encouraged to practice exercises between sessions.</description>
    <arm_group_label>Cognitive-behavioral treatment</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Mindfulness-based treatment</intervention_name>
    <description>MIND-program of 8 sessions (+ 1 booster session) of guided Internet-based treatment including psychoeducation, sexual education, guided masturbation, sensate focus and mindfulness-based exercises (e.g., breathing meditation, body scan, sitting meditation).</description>
    <arm_group_label>Mindfulness-based treatment</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  18 years or older&#xD;
&#xD;
          -  female gender&#xD;
&#xD;
          -  able to read, write and speak German&#xD;
&#xD;
          -  Meet criteria of ICD-10 criteria of Hypoactive Sexual Desire Disorder (established via&#xD;
             online-screening and telephone interview)&#xD;
&#xD;
          -  Experience significant sexuality-related personal distress (established via&#xD;
             online-screening and telephone interview)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  currently pregnant&#xD;
&#xD;
          -  ongoing medical or psychological treatment for low desire or other sexual dysfunctions&#xD;
             or plans to enter such treatment (e.g., in-person sexual therapy, couples therapy)&#xD;
             during study participation&#xD;
&#xD;
          -  suicide ideation (established via telephone interview)&#xD;
&#xD;
          -  currently experiencing significant symptoms of a mental disorder that might interfere&#xD;
             with study participation (e.g., Eating Disorders, Obsessive-Compulsive Disorder,&#xD;
             Posttraumatic Stress Disorder, Major Depression, Bipolar Disorder) as established via&#xD;
             telephone interview&#xD;
&#xD;
          -  currently experiencing significant symptoms of a physical condition that might&#xD;
             interfere with study participation (e.g., cancer, multiple sclerosis) as established&#xD;
             via telephone interview&#xD;
&#xD;
          -  current Substance-Abuse Disorder&#xD;
&#xD;
          -  current or lifetime Psychotic Disorder&#xD;
&#xD;
          -  significant relationship discord or violence&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Julia Velten, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Ruhr University Bochum</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Ruhr University Bochum</name>
      <address>
        <city>Bochum</city>
        <state>NRW</state>
        <zip>44787</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Germany</country>
  </location_countries>
  <verification_date>March 2023</verification_date>
  <study_first_submitted>December 18, 2018</study_first_submitted>
  <study_first_submitted_qc>December 18, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 19, 2018</study_first_posted>
  <last_update_submitted>March 28, 2023</last_update_submitted>
  <last_update_submitted_qc>March 28, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">March 29, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Ruhr University of Bochum</investigator_affiliation>
    <investigator_full_name>Julia Velten</investigator_full_name>
    <investigator_title>Postdoctoral Research Associate</investigator_title>
  </responsible_party>
  <keyword>Sexual dysfunction</keyword>
  <keyword>Female Sexual Interest/Arousal Disorder</keyword>
  <keyword>Internet-based intervention</keyword>
  <keyword>Mindfulness</keyword>
  <keyword>Cognitive-behavioral therapy</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>Yes</sharing_ipd>
    <ipd_description>IPD data of accepted publications will be published open access on the respective Journal's website or on the Open Science Framework.</ipd_description>
    <ipd_info_type>Study Protocol</ipd_info_type>
  </patient_data>
  <!-- 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/NCT03780751
org study id: VE 1083/2-1
nct id: NCT03780751
lead sponsor: 
collaborator: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Problems with sexual function are common and distressing. The most frequent sexual difficulty
      in women is a lack of sexual desire with a prevalence of 20-30%. When low sexual desire is
      experienced over several months and causes significant personal distress, a sexual
      dysfunction can be diagnosed (ICD-10: Hypoactive Sexual Desire Disorder: HSDD). A distressing
      lack of desire is reported by 6% of sexually active women. Psychological interventions are
      the treatment of choice for women with HSDD. Promising treatment approaches include
      cognitive-behavioral and mindfulness-based interventions. A recent meta-analysis also showed
      that Internet-delivered programs are a valid alternative to face-to-face treatments. Aim of
      this project to assess the effectivity of two eight-week online-programs consisting of
      cognitive-behavioral (COPE) and mindfulness-based (MIND) interventions for women with HSDD.
      Both treatments will be compared to a waitlist-control group. For this project, two
      well-established group-treatment manuals will be translated into German and adapted to a
      multimedia online-environment. All participants will be guided through the programs by
      well-qualified eCoaches.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Participants are assigned to one of three groups parallel for the duration of the study. 40% of participants will be assigned to one of the two immediate treatment conditions, 20% of participants will be assigned to a waitlist and will begin active treatment after a six months waiting period.
primary purpose: Treatment
masking: None (Open Label)
measure: Sexual Interest and Desire Inventory Female (SIDI-F)
time frame: at baseline, 5 weeks after baseline, 3 months after baseline, 6 months after baseline, 12 months after baseline
description: The SIDI-F is a clinician-rated instrument consisting of 13 items designed to assess HSDD severity in women. A self-report version, modified for the use in partnered and unpartnered women will be applied.
measure: Female Sexual Distress Scale Revised (FSDS-R)
time frame: at baseline, 5 weeks after baseline, 3 months after baseline, 6 months after baseline, 12 months after baseline
description: The Female Sexual Distress Scale (FSDS) is a 13-item self- assessment questionnaire for the evaluation of sexually related personal distress.
measure: Desire subscale of the Female Sexual Function Index
time frame: at baseline, 5 weeks after baseline, 3 months after baseline, 6 months after baseline, 12 months after baseline
description: The Female Sexual Function Index measures women's sexual function with 19-items. Here, the two items assessing sexual desire will be used.
measure: Patient Health Questionnaire 9 (PHQ-9)
time frame: at baseline, 3 months after baseline, 6 months after baseline, 12 months after baseline
description: A 9-item self-report measure used to assess symptoms of depression.
measure: Generalized Anxiety Disorder 7 (GAD-7)
time frame: at baseline, 3 months after baseline, 6 months after baseline, 12 months after baseline
description: A 7-item self-report measure used to assess symptoms of anxiety.
measure: Scale of Body Connection (SBC)
time frame: at baseline, 3 months after baseline, 6 months after baseline, 12 months after baseline
description: A 20-item self-report measure used to assess body awareness
measure: Mindful Attention and Awareness Scale (MAAS)
time frame: at baseline, 3 months after baseline, 6 months after baseline, 12 months after baseline
description: A 15-item self-report measure used to assess mindfulness
measure: Body Image Self-Consciousness Scale
time frame: at baseline, 3 months after baseline, 6 months after baseline, 12 months after baseline
description: A 15-item self-report measure used to assess body-related self-consciousness
measure: Self-Compassion Scale (SCS)
time frame: at baseline, 3 months after baseline, 6 months after baseline, 12 months after baseline
description: A 12-item self-report scale used to assess self-compassion.
measure: Rumination-Reflection Questionnaire - Adapted Rumination Subscale (RRQ)
time frame: at baseline, 3 months after baseline, 6 months after baseline, 12 months after baseline
description: A 12-item scale that assess rumination about sexual issues
measure: Health Action Process Approach (HAPA)
time frame: at baseline, 3 months after baseline, 6 months after baseline, 12 months after baseline
description: Treatment adherence as measured with the HAPA scales
measure: Working alliance inventory (WAI) adapted for online treatments
time frame: 3 months after baseline, 6 months after baseline
description: Measures working alliance with eCoaches and online-program
measure: Inventory for the Assessment of Negative Effects of Psychotherapy (INEP)
time frame: 3 months after baseline, 6 months after baseline
description: 15-item self-report measure that assesses side-effects of psychological treatments
measure: Client Satisfaction Questionnaire (CSQ-8)
time frame: 3 months after baseline, 6 months after baseline, 12 months after baseline
description: 8-item self-report measure that assesses women's satisfaction with the online treatment they received
measure: Single target implicit association task (ST-IAT)
time frame: at baseline, 3 months after baseline
description: An experimental paradigm used to assess implicit cognitive biases towards sexual stimuli
measure: Scrambled-sentences task
time frame: at baseline, 3 months after baseline
description: An experimental paradigm used to assess implicit cognitive biases towards sexual stimuli
measure: Qualitative evaluation of COPE and MIND
time frame: 12 weeks after baseline
description: Qualitative telephone interviews with approx. 50 participants to assess perceived mechanisms of change as well as strengths and weaknesses of the programs
arm group label: Cognitive-behavioral treatment
arm group type: Experimental
description: COPE-program of 8 sessions (+ 1 booster session) of guided Internet-based treatment including psychoeducation, sexual education, guided masturbation, sensate focus and cognitive-behavioral interventions (e.g., thought diaries, challenging of maladaptive thought patterns, behavioral analysis). Participants are encouraged to practice exercises between sessions.
arm group label: Mindfulness-based treatment
arm group type: Experimental
description: MIND-program of 8 sessions (+ 1 booster session) of guided Internet-based treatment including psychoeducation, sexual education, guided masturbation, sensate focus and mindfulness-based exercises (e.g., breathing meditation, body scan, sitting meditation).
arm group label: Waitlist
arm group type: No Intervention
description: Participants will receive no immediate treatment but will be able to choose either MIND or COPE after a six months waiting period.
intervention type: Behavioral
intervention name: Cognitive-behavioral treatment
description: COPE-program of 8 sessions (+ 1 booster session) of guided Internet-based treatment including psychoeducation, sexual education, guided masturbation, sensate focus and cognitive-behavioral interventions (e.g., thought diaries, challenging of maladaptive thought patterns, behavioral analysis). Participants are encouraged to practice exercises between sessions.
arm group label: Cognitive-behavioral treatment
intervention type: Behavioral
intervention name: Mindfulness-based treatment
description: MIND-program of 8 sessions (+ 1 booster session) of guided Internet-based treatment including psychoeducation, sexual education, guided masturbation, sensate focus and mindfulness-based exercises (e.g., breathing meditation, body scan, sitting meditation).
arm group label: Mindfulness-based treatment
criteria: 
gender: Female
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Julia Velten, PhD
role: Principal Investigator
affiliation: Ruhr University Bochum
facility: 
country: Germany
responsible party type: Principal Investigator
investigator affiliation: Ruhr University of Bochum
investigator full name: Julia Velten
investigator title: Postdoctoral Research Associate
mesh term: Hypokinesia
mesh term: Sexual Dysfunctions, Psychological
sharing ipd: Yes
ipd description: IPD data of accepted publications will be published open access on the respective Journal's website or on the Open Science Framework.
ipd info type: Study Protocol