xml: <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/NCT05997407</url>
    </required_header>
    <id_info>
      <org_study_id>IRB # 23-241</org_study_id>
      <nct_id>NCT05997407</nct_id>
    </id_info>
    <brief_title>The Effect of a Mindset Management Approach on Stress Levels in Women With Infertility</brief_title>
    <official_title>The Effect of a Mindset Management Approach on Stress Levels in Women With Infertility</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Virginia Polytechnic Institute and State University</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>Shady Grove Fertility Reproductive Science Center</agency>
        <agency_class>Other</agency_class>
      </collaborator>
    </sponsors>
    <source>Virginia Polytechnic Institute and State University</source>
    <oversight_info>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        The goal of this clinical trial is to test the effect of a mindset management intervention on&#xD;
        stress levels in women with infertility. The main question it aims to answer is:&#xD;
  &#xD;
        Can the Organic Conceptions approach decrease stress levels in women with infertility?&#xD;
  &#xD;
        Participants in both groups will be asked to complete three surveys at three time points. The&#xD;
        intervention group will complete the Organic Conceptions program, while the control group&#xD;
        will not complete an intervention.&#xD;
  &#xD;
        Researchers will compare the intervention group and control group to see if the Organic&#xD;
        Conceptions mindset management program decreases stress levels in women with infertility.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">September 2023</start_date>
    <completion_date type="Anticipated">February 2025</completion_date>
    <primary_completion_date type="Anticipated">March 2024</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>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Stress levels in women with infertility</measure>
      <time_frame>Day 0, end of week 10 (day 70), end of week 16 (day 112)</time_frame>
      <description>Measured by responses to the Copenhagen Multi-center Psychosocial Infertility Fertility Problem Stress Scale Minimum value: 14 Maximum value: 66 Higher score means higher stress level due to infertility, and a potentially worse outcome</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Patient retention</measure>
      <time_frame>Within 6 months of initial consultation</time_frame>
      <description>Returning for follow-up appointment</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Conversion to treatment</measure>
      <time_frame>Within six months of follow-up appointment</time_frame>
      <description>Beginning fertility treatment</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Completion of treatment</measure>
      <time_frame>Recorded immediately after fertility treatment (IVF, ovulation induction, etc) is completed. Depends upon the treatment and what the provider indicates the treatment path should be</time_frame>
      <description>Completed fertility treatment</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Pregnancy rates</measure>
      <time_frame>Study period (16 weeks) + 1 year</time_frame>
      <description>Pregnancy outcome measured in three surveys and through monitoring of EMR</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Satisfaction with Organic Conceptions intervention</measure>
      <time_frame>End of week 10 (day 70), end of week 16 (day 112). Intervention group only.</time_frame>
      <description>Measured by responses to Client Satisfaction Questionnaire for Internet Interventions Minimum value: 8 Maximum value: 32 Higher score means higher satisfaction with Organic Conceptions intervention.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Satisfaction with treatment</measure>
      <time_frame>End of week 10 (day 70), end of week 16 (day 112)</time_frame>
      <description>Measured by responses to survey questions (Likert scale) Minimum value = 1 Maximum value = 5 Higher score means higher satisfaction with fertility treatment.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Longevity of the effect of the intervention</measure>
      <time_frame>End of week 10 (day 70), end of week 16 (day 112)</time_frame>
      <description>Measured by comparing responses to the Copenhagen Multi-center Psychosocial Infertility Fertility Problem Stress Scale from the second and third survey. If score decreased from first to second survey, and score was similar/greater on third survey, then intervention has a long-lasting effect on stress levels.</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">66</enrollment>
    <condition>Stress</condition>
    <condition>Infertility, Female</condition>
    <arm_group>
      <arm_group_label>Organic Conceptions intervention group</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Will complete Organic Conceptions intervention.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Control group</arm_group_label>
      <arm_group_type>No Intervention</arm_group_type>
      <description>Will not complete Organic Conceptions intervention.</description>
    </arm_group>
    <intervention>
      <intervention_type>Behavioral</intervention_type>
      <intervention_name>Organic Conceptions mindset management program</intervention_name>
      <description>Organic Conceptions is a theoretical model and corresponding 9-step cognitive-based therapy program that enables people to understand where they are in their fertility journey, and provides them with coping strategies to reframe the painful emotional side effects of infertility. In addition to the 9-step program, there are mini-classes on the key triggers that people face when dealing with infertility.&#xD;
  The intervention consists of a series of assignments that participants in the intervention group will complete for a ten-week period. These assignments will take approximately three hours per week to complete. In addition, participants will complete weekly live group coaching sessions, monthly one-hour live group master classes, and monthly 30-minute welcome new members group sessions led by the founder of OC, Erin Sherman, a Certified Coach from The Life Coach School.</description>
      <arm_group_label>Organic Conceptions intervention group</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Speaks and reads English&#xD;
  &#xD;
            -  New patient at Shady Grove Fertility in Roanoke or Richmond&#xD;
  &#xD;
            -  Access to smartphone, tablet, or computer, and internet&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Has seen a fertility specialist (reproductive endocrinologist) before AND underwent&#xD;
               fertility treatment under that provider&#xD;
  &#xD;
            -  Is currently engaging with the Organic Conceptions method&#xD;
        </textblock>
      </criteria>
      <gender>Female</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>42 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_contact>
      <last_name>Emily Evans-Hoeker, MD</last_name>
      <phone>(844) 205- 3246</phone>
      <email>Emily.Evans-Hoeker@sgfertility.com</email>
    </overall_contact>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>July 26, 2023</study_first_submitted>
    <study_first_submitted_qc>August 9, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 18, 2023</study_first_posted>
    <last_update_submitted>August 9, 2023</last_update_submitted>
    <last_update_submitted_qc>August 9, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 18, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Virginia Polytechnic Institute and State University</investigator_affiliation>
      <investigator_full_name>Emily Evans-Hoeker</investigator_full_name>
      <investigator_title>Assistant Professor</investigator_title>
    </responsible_party>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Infertility</mesh_term>
      <mesh_term>Infertility, Female</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT05997407
  org study id: IRB # 23-241
  nct id: NCT05997407
  lead sponsor: 
  collaborator: 
  is fda regulated drug: No
  is fda regulated device: No
  The goal of this clinical trial is to test the effect of a mindset management intervention on
        stress levels in women with infertility. The main question it aims to answer is:
  
        Can the Organic Conceptions approach decrease stress levels in women with infertility?
  
        Participants in both groups will be asked to complete three surveys at three time points. The
        intervention group will complete the Organic Conceptions program, while the control group
        will not complete an intervention.
  
        Researchers will compare the intervention group and control group to see if the Organic
        Conceptions mindset management program decreases stress levels in women with infertility.
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Other
  masking: None (Open Label)
  measure: Stress levels in women with infertility
  time frame: Day 0, end of week 10 (day 70), end of week 16 (day 112)
  description: Measured by responses to the Copenhagen Multi-center Psychosocial Infertility Fertility Problem Stress Scale Minimum value: 14 Maximum value: 66 Higher score means higher stress level due to infertility, and a potentially worse outcome
  measure: Patient retention
  time frame: Within 6 months of initial consultation
  description: Returning for follow-up appointment
  measure: Conversion to treatment
  time frame: Within six months of follow-up appointment
  description: Beginning fertility treatment
  measure: Completion of treatment
  time frame: Recorded immediately after fertility treatment (IVF, ovulation induction, etc) is completed. Depends upon the treatment and what the provider indicates the treatment path should be
  description: Completed fertility treatment
  measure: Pregnancy rates
  time frame: Study period (16 weeks) + 1 year
  description: Pregnancy outcome measured in three surveys and through monitoring of EMR
  measure: Satisfaction with Organic Conceptions intervention
  time frame: End of week 10 (day 70), end of week 16 (day 112). Intervention group only.
  description: Measured by responses to Client Satisfaction Questionnaire for Internet Interventions Minimum value: 8 Maximum value: 32 Higher score means higher satisfaction with Organic Conceptions intervention.
  measure: Satisfaction with treatment
  time frame: End of week 10 (day 70), end of week 16 (day 112)
  description: Measured by responses to survey questions (Likert scale) Minimum value = 1 Maximum value = 5 Higher score means higher satisfaction with fertility treatment.
  measure: Longevity of the effect of the intervention
  time frame: End of week 10 (day 70), end of week 16 (day 112)
  description: Measured by comparing responses to the Copenhagen Multi-center Psychosocial Infertility Fertility Problem Stress Scale from the second and third survey. If score decreased from first to second survey, and score was similar/greater on third survey, then intervention has a long-lasting effect on stress levels.
  arm group label: Organic Conceptions intervention group
  arm group type: Experimental
  description: Will complete Organic Conceptions intervention.
  arm group label: Control group
  arm group type: No Intervention
  description: Will not complete Organic Conceptions intervention.
  intervention type: Behavioral
  intervention name: Organic Conceptions mindset management program
  description: Organic Conceptions is a theoretical model and corresponding 9-step cognitive-based therapy program that enables people to understand where they are in their fertility journey, and provides them with coping strategies to reframe the painful emotional side effects of infertility. In addition to the 9-step program, there are mini-classes on the key triggers that people face when dealing with infertility.
  The intervention consists of a series of assignments that participants in the intervention group will complete for a ten-week period. These assignments will take approximately three hours per week to complete. In addition, participants will complete weekly live group coaching sessions, monthly one-hour live group master classes, and monthly 30-minute welcome new members group sessions led by the founder of OC, Erin Sherman, a Certified Coach from The Life Coach School.
  arm group label: Organic Conceptions intervention group
  criteria: 
  gender: Female
  minimum age: 18 Years
  maximum age: 42 Years
  healthy volunteers: No
  last name: Emily Evans-Hoeker, MD
  phone: (844) 205- 3246
  email: Emily.Evans-Hoeker@sgfertility.com
  responsible party type: Principal Investigator
  investigator affiliation: Virginia Polytechnic Institute and State University
  investigator full name: Emily Evans-Hoeker
  investigator title: Assistant Professor
  mesh term: Infertility
  mesh term: Infertility, Female
  sharing ipd: No