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
About this trial
This is an interventional other trial for Stress
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
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
NCT ID
NCT05997407
First Posted
July 26, 2023
Last Updated
August 9, 2023
Sponsor
Virginia Polytechnic Institute and State University
Collaborators
Shady Grove Fertility Reproductive Science Center
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
Learn more about this trial
The Effect of a Mindset Management Approach on Stress Levels in Women With Infertility
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