The Effect of a Mindset Management Approach on Stress Levels in Women With Infertility
1 other identifier
interventional
66
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Nov 2023
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 26, 2023
CompletedFirst Posted
Study publicly available on registry
August 18, 2023
CompletedStudy Start
First participant enrolled
November 10, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 1, 2026
September 10, 2025
August 1, 2025
3.1 years
July 26, 2023
September 3, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
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
Day 0, end of week 10 (day 70), end of week 16 (day 112)
Secondary Outcomes (7)
Comparison of number of participants in each study group who returned for follow-up appointment within 6 months of initial consultation
Within 6 months of initial consultation
Comparison of number of participants in each study group who began fertility treatment within 6 months of follow-up appointment
Within 6 months of follow-up appointment
Comparison of number of participants in each study group who completed fertility 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
Pregnancy rates
Study period (16 weeks) + 1 year
Satisfaction with Organic Conceptions intervention
End of week 10 (day 70), end of week 16 (day 112). Intervention group only.
- +2 more secondary outcomes
Study Arms (2)
Organic Conceptions intervention group
EXPERIMENTALWill complete Organic Conceptions intervention.
Control group
NO INTERVENTIONWill not complete Organic Conceptions intervention.
Interventions
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 biweekly live support group sessions led by certified coaches and will have the option to join a Facebook support group.
Eligibility Criteria
You may qualify if:
- Speaks and reads English
- New patient at Shady Grove Fertility in Roanoke or Richmond
- Access to smartphone, tablet, or computer, and internet
You may not qualify if:
- Has seen a fertility specialist (reproductive endocrinologist) before AND underwent fertility treatment under that provider
- Is currently engaging with the Organic Conceptions method
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Shady Grove Fertility
Roanoke, Virginia, 24018, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- OTHER
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Assistant Professor
Study Record Dates
First Submitted
July 26, 2023
First Posted
August 18, 2023
Study Start
November 10, 2023
Primary Completion (Estimated)
December 1, 2026
Study Completion (Estimated)
December 1, 2026
Last Updated
September 10, 2025
Record last verified: 2025-08
Data Sharing
- IPD Sharing
- Will not share