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The Effect of a Mindset Management Approach on Stress Levels in Women With Infertility

Primary Purpose

Stress, Infertility, Female

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Organic Conceptions mindset management program
Sponsored by
Virginia Polytechnic Institute and State University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Stress

Eligibility Criteria

18 Years - 42 Years (Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria: Speaks and reads English New patient at Shady Grove Fertility in Roanoke or Richmond Access to smartphone, tablet, or computer, and internet Exclusion Criteria: Has seen a fertility specialist (reproductive endocrinologist) before AND underwent fertility treatment under that provider Is currently engaging with the Organic Conceptions method

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    No Intervention

    Arm Label

    Organic Conceptions intervention group

    Control group

    Arm Description

    Will complete Organic Conceptions intervention.

    Will not complete Organic Conceptions intervention.

    Outcomes

    Primary Outcome Measures

    Stress levels in women with infertility
    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

    Secondary Outcome Measures

    Patient retention
    Returning for follow-up appointment
    Conversion to treatment
    Beginning fertility treatment
    Completion of treatment
    Completed fertility treatment
    Pregnancy rates
    Pregnancy outcome measured in three surveys and through monitoring of EMR
    Satisfaction with Organic Conceptions intervention
    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.
    Satisfaction with treatment
    Measured by responses to survey questions (Likert scale) Minimum value = 1 Maximum value = 5 Higher score means higher satisfaction with fertility treatment.
    Longevity of the effect of the intervention
    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.

    Full Information

    First Posted
    July 26, 2023
    Last Updated
    August 9, 2023
    Sponsor
    Virginia Polytechnic Institute and State University
    Collaborators
    Shady Grove Fertility Reproductive Science Center
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05997407
    Brief Title
    The Effect of a Mindset Management Approach on Stress Levels in Women With Infertility
    Official Title
    The Effect of a Mindset Management Approach on Stress Levels in Women With Infertility
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    August 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    September 2023 (Anticipated)
    Primary Completion Date
    March 2024 (Anticipated)
    Study Completion Date
    February 2025 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Virginia Polytechnic Institute and State University
    Collaborators
    Shady Grove Fertility Reproductive Science Center

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No

    5. Study Description

    Brief Summary
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Stress, Infertility, Female

    7. Study Design

    Primary Purpose
    Other
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    66 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Organic Conceptions intervention group
    Arm Type
    Experimental
    Arm Description
    Will complete Organic Conceptions intervention.
    Arm Title
    Control group
    Arm Type
    No Intervention
    Arm Description
    Will not complete Organic Conceptions intervention.
    Intervention Type
    Behavioral
    Intervention Name(s)
    Organic Conceptions mindset management program
    Intervention 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.
    Primary Outcome Measure Information:
    Title
    Stress levels in women with infertility
    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
    Time Frame
    Day 0, end of week 10 (day 70), end of week 16 (day 112)
    Secondary Outcome Measure Information:
    Title
    Patient retention
    Description
    Returning for follow-up appointment
    Time Frame
    Within 6 months of initial consultation
    Title
    Conversion to treatment
    Description
    Beginning fertility treatment
    Time Frame
    Within six months of follow-up appointment
    Title
    Completion of treatment
    Description
    Completed fertility 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
    Title
    Pregnancy rates
    Description
    Pregnancy outcome measured in three surveys and through monitoring of EMR
    Time Frame
    Study period (16 weeks) + 1 year
    Title
    Satisfaction with Organic Conceptions intervention
    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.
    Time Frame
    End of week 10 (day 70), end of week 16 (day 112). Intervention group only.
    Title
    Satisfaction with treatment
    Description
    Measured by responses to survey questions (Likert scale) Minimum value = 1 Maximum value = 5 Higher score means higher satisfaction with fertility treatment.
    Time Frame
    End of week 10 (day 70), end of week 16 (day 112)
    Title
    Longevity of the effect of the intervention
    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.
    Time Frame
    End of week 10 (day 70), end of week 16 (day 112)

    10. Eligibility

    Sex
    Female
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    42 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Speaks and reads English New patient at Shady Grove Fertility in Roanoke or Richmond Access to smartphone, tablet, or computer, and internet Exclusion Criteria: Has seen a fertility specialist (reproductive endocrinologist) before AND underwent fertility treatment under that provider Is currently engaging with the Organic Conceptions method
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Emily Evans-Hoeker, MD
    Phone
    (844) 205- 3246
    Email
    Emily.Evans-Hoeker@sgfertility.com

    12. IPD Sharing Statement

    Plan to Share IPD
    No

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    The Effect of a Mindset Management Approach on Stress Levels in Women With Infertility

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