The Effect of a Mindset Management Approach on Stress Levels in Women With Infertility
Study Details
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Organic Conceptions intervention group Will complete Organic Conceptions intervention. |
Behavioral: Organic Conceptions mindset management program
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.
|
| No Intervention: Control group Will not complete Organic Conceptions intervention. |
Outcome Measures
Primary Outcome Measures
- Stress levels in women with infertility [Day 0, end of week 10 (day 70), end of week 16 (day 112)]
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 [Within 6 months of initial consultation]
Returning for follow-up appointment
- Conversion to treatment [Within six months of follow-up appointment]
Beginning fertility treatment
- Completion of treatment [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]
Completed fertility treatment
- Pregnancy rates [Study period (16 weeks) + 1 year]
Pregnancy outcome measured in three surveys and through monitoring of EMR
- Satisfaction with Organic Conceptions intervention [End of week 10 (day 70), end of week 16 (day 112). Intervention group only.]
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 [End of week 10 (day 70), end of week 16 (day 112)]
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 [End of week 10 (day 70), end of week 16 (day 112)]
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.
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Speaks and reads English
-
New patient at Shady Grove Fertility in Roanoke or Richmond
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Access to smartphone, tablet, or computer, and internet
Exclusion Criteria:
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Has seen a fertility specialist (reproductive endocrinologist) before AND underwent fertility treatment under that provider
-
Is currently engaging with the Organic Conceptions method
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- Virginia Polytechnic Institute and State University
- Shady Grove Fertility Reproductive Science Center
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- IRB # 23-241