The Effect of a Mindset Management Approach on Stress Levels in Women With Infertility
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18-42
SponsorVirginia Polytechnic Institute and State University
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Speaks and reads English
New patient at Shady Grove Fertility in Roanoke or Richmond
Access to smartphone, tablet, or computer, and internet
Disqualifiers
Has seen a fertility specialist (reproductive endocrinologist) before AND underwent fertility treatment under that provider
Is currently engaging with the Organic Conceptions method
Trial design
Design model
Parallel
Treatments tested in this trial
Organic Conceptions mindset management program
BehavioralOrganic 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.
Treatment groups
66 Participants
are divided into 2 treatment groupsGroup A: Organic Conceptions intervention groupExperimental treatment 1 intervention
Group B: Control groupNo intervention 0 interventions
Trial outcomes
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
Time frame
Day 0, end of week 10 (day 70), end of week 16 (day 112)Secondary outcomes
1
Comparison of number of participants in each study group who returned for follow-up appointment within 6 months of initial consultation
Returning for follow-up appointment
Time frame
Within 6 months of initial consultation2
Comparison of number of participants in each study group who began fertility treatment within 6 months of follow-up appointment
Beginning fertility treatment
Time frame
Within 6 months of follow-up appointment3
Comparison of number of participants in each study group who completed fertility treatment
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 be4
Pregnancy rates
Pregnancy outcome measured in three surveys and through monitoring of EMR
Time frame
Study period (16 weeks) + 1 yearSponsors and contacts
Click on the lead sponsor to view all of their trials.
Virginia Polytechnic Institute and State University
Lead sponsor
Shady Grove Fertility Reproductive Science Center
Collaborator
Source ClinicalTrials.gov