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

Part of paid clinical trials in Roanoke, Virginia.

Sponsor
Virginia Polytechnic Institute and State University
Study ID
NCT05997407
Status
Recruiting
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Conditions

  • Infertility, Female
  • Stress

Eligibility Criteria

Sex
FEMALE
Age
18 Years - 42 Years
Healthy Volunteers
Not accepted

Interventions

  • Organic Conceptions mindset management program — BEHAVIORAL
    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.

Study Details

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.

Key Dates

Start date
Nov 10, 2023
Status verified
Aug 2025
Primary completion
Dec 31, 2026
Completion
Dec 31, 2026

Study Design

Enrollment
66 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER

Arms

  • Experimental: Organic Conceptions intervention group
    Will complete Organic Conceptions intervention.
  • No Intervention: Control group
    Will not complete Organic Conceptions intervention.

Primary Outcome Measure

Stress levels in women with infertility [ Time Frame: Day 0, end of week 10 (day 70), end of week 16 (day 112) ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Shady Grove FertilityRoanokeVirginia24018
Emily Evans-Hoeker, MD
844-205-3246

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By research site
Shady Grove Fertility· Roanoke, VA

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