Mindset Management for Stress in Women With Infertility

Overseen By Emily Evans-Hoeker, MD

Age: 18 - 65

Sex: Female

Trial Phase: Academic

Sponsor: Virginia Polytechnic Institute and State University

Disqualifiers: Previous fertility treatment, Organic Conceptions, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 11

66 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial investigates whether a mindset management program, called Organic Conceptions, can help reduce stress in women dealing with infertility. Participants will split into two groups: one will try the program, and the other will not. The goal is to determine if the program significantly impacts stress levels. Women who speak English, are new patients at Shady Grove Fertility in Roanoke or Richmond, and have internet access might be suitable for the trial. As an unphased trial, this study offers a unique opportunity for participants to contribute to understanding stress management in infertility.

Do I need to stop my current medications for this trial?

The trial information does not specify whether you need to stop taking your current medications.

What prior data suggests that the Organic Conceptions mindset management program is safe for women with infertility?

Research has shown that mindset management programs, such as Organic Conceptions, are safe and easy to manage. Past studies have not reported any negative side effects. These programs resemble mindfulness techniques, which reduce stress without causing harm. As this is not a drug treatment, typical drug side effects are not a concern. The goal is to focus on emotional wellness, aiming to lower stress and improve well-being. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Organic Conceptions mindset management program because it offers a fresh approach to managing stress in women with infertility. Unlike traditional treatments that focus on medical interventions or medications, this program centers on psychological well-being by addressing mindset and emotional health. This unique method aims to empower women by providing tools and strategies to cope with stress, which could enhance overall mental health and potentially improve fertility outcomes. By shifting focus to mindset, the program explores an often-overlooked aspect of infertility treatment.

What evidence suggests that the Organic Conceptions mindset management program is effective for reducing stress in women with infertility?

Research shows that programs focused on managing mindset can help reduce stress. In this trial, participants in the Organic Conceptions intervention group will complete the Organic Conceptions program, specifically designed to help women experiencing infertility feel less stressed. Although specific data from human trials on this program remains limited, similar methods have successfully lowered stress. Early signs suggest that focusing on emotional well-being, as the Organic Conceptions program does, can effectively manage stress. Participants in mindset management often report feeling less anxious and more in control of their emotions. ^{1 2 3 6 7}

Are You a Good Fit for This Trial?

This trial is for English-speaking women who are new patients at Shady Grove Fertility in Roanoke or Richmond, have infertility issues, and can access a smartphone, tablet, or computer with internet.

Inclusion Criteria

You are proficient in both speaking and reading English.

You are a first-time patient of Shady Grove Fertility, located in either Roanoke or Richmond.

You possess a compatible device, and access to the internet.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (virtual)

Intervention

Participants in the intervention group complete the Organic Conceptions program over 10 weeks, including assignments and biweekly support group sessions.

10 weeks

Biweekly virtual support group sessions

Control

Participants in the control group receive standard fertility care without additional stress-decreasing interventions.

10 weeks

Follow-up

Participants are monitored for stress levels and satisfaction with the intervention at the end of the study period.

6 weeks

Surveys at week 10 and week 16

What Are the Treatments Tested in This Trial?

Interventions

• Organic Conceptions mindset management program

Trial Overview The study tests if the Organic Conceptions mindset management program can reduce stress levels in women with infertility. Participants will be split into two groups; one will use the program while the other won't. Their stress levels will be compared over time through surveys.

How Is the Trial Designed?

Group I: Organic Conceptions intervention group Experimental Treatment 1 Intervention

Will complete Organic Conceptions intervention.

Group II: Control group Active Control 1 Intervention

Will not complete Organic Conceptions intervention.

Who Is Running the Clinical Trial?

Virginia Polytechnic Institute and State University

Lead Sponsor

Trials

162

Recruited

26,900+

Shady Grove Fertility Reproductive Science Center

Collaborator

Trials

7

Recruited

2,900+

Published Research Related to This Trial

Mind-body interventions, such as mindfulness and yoga, have been shown to significantly reduce anxiety and depression in infertile patients undergoing fertility treatments, based on a systematic review of 12 studies.

While the reduction in psychological distress was generally low to moderate, there is also a suggestion that these interventions may improve pregnancy rates, highlighting the potential benefits of integrating mind-body practices into fertility care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The effect of mind-body interventions on psychological and pregnancy outcomes in infertile women: a systematic review. Gaitzsch, H., Benard, J., Hugon-Rodin, J., et al.[2020]

The study analyzed 220 infertile women and identified four key factors affecting their mental health: anxiety and insomnia, social dysfunction, depression, and physical symptoms, which together explained over 50% of the variance in mental health issues.

The General Health Questionnaire-28 was found to be a reliable screening tool for assessing the general health of infertile women, with a high reliability coefficient of 0.90, making it effective for identifying mental disorders in this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Factor structure of the General Health Questionnaire-28 (GHQ-28) from infertile women attending the Yazd Research and Clinical Center for Infertility. Shayan, Z., Pourmovahed, Z., Najafipour, F., et al.[2022]

The article emphasizes a multidisciplinary approach to treating couples undergoing assisted reproductive technology (ART), focusing on the psychological support for women throughout the entire treatment process, from conception to delivery.

It highlights the importance of integrating psychological interventions with medical treatments, using models like biopsychosocial and psychoneuroimmunology to address both mental and physical health in infertility treatments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

An Epistemological Perspective of Integrated Multidisciplinary Treatment When Dealing With Infertile Women With a Parenthood Goal: The Importance of Matterpsychic Perspective. Vasta, FN., Girelli, R.[2021]

In a study involving 52 overweight or obese infertile women, those who participated in an 8-week mindfulness-based program (MBP) experienced a significant reduction in waist circumference (2.9 cm) and daily energy intake (430 Kcal/day) compared to the control group, which only followed a diet.

While both groups lost weight (1.8 kg for the MBP group and 1.7 kg for the control group), the MBP did not lead to a greater overall weight loss, suggesting that while mindfulness may help with dietary habits, its direct impact on weight loss may be limited in the short term.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Mindfulness-based program to support lifestyle modification and weight loss in infertile women: randomized controlled trial. Sant'Anna, EM., Paiva, SPC., Santos, RP., et al.[2022]

Mindfulness interventions have been shown to effectively reduce mental health disorders such as stress, anxiety, and depression in women experiencing infertility, based on a systematic review of nine studies published between 2011 and 2021.

Different mindfulness techniques, like Mindfulness-Based Stress Reduction (MBSR) and Mindfulness-Based Cognitive Therapy (MBCT), are tailored to address specific mental health issues, suggesting that personalized mindfulness approaches could enhance treatment outcomes for women facing infertility challenges.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Mindfulness improves the mental health of infertile women: A systematic review. Kundarti, FI., Titisari, I., Rahayu, DE., et al.[2023]

Infertility and its treatments can lead to significant mental health issues, with women experiencing increased depressive symptoms and men showing more negative emotional responses.

The study highlights the need for integrating mental health professionals into fertility clinics in Denmark to address the psychosocial impacts of infertility and ensure comprehensive care for patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[The psychosocial consequences of infertility and fertility treatment]. Schmidt, L., Sejbæk, CS.[2012]

The eastern body-mind-spirit group intervention is designed to help infertile women cope with the emotional distress of IVF treatment by integrating Chinese philosophies and a holistic health model.

Preliminary evaluations suggest that this approach can enhance the overall well-being of women undergoing IVF, indicating potential benefits that warrant further research into its efficacy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Body-mind-spirit intervention for IVF women. Chan, CH., Chan, CL., Ng, SM., et al.[2022]

Psychosocial interventions, particularly cognitive-behavioral therapy (CBT) and body-mind approaches, have been shown to significantly reduce anxiety in infertile women, men, and couples, based on a review of studies published from 1982 to 2018.

The review highlights the importance of these interventions as recommended by medical and community associations to address the psychological challenges associated with infertility and assisted reproductive treatments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

What Psychiatric Interventions Are Used for Anxiety Disorders in Infertile Couples? A Systematic Review Study. Masoumi, SZ., Parsa, P., Kalhori, F., et al.[2020]

The pilot study involving 71 women with infertility showed that an internet-based Mind/Body Program significantly reduced distress related to anxiety, depression, and stress, with medium-to-large effect sizes, indicating its potential effectiveness.

Participants in the intervention group had a 4.47 times higher likelihood of becoming pregnant compared to the wait-list control group, suggesting that the program may not only help with emotional well-being but also enhance fertility outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

An internet-based mind/body intervention to mitigate distress in women experiencing infertility: A randomized pilot trial. Clifton, J., Parent, J., Seehuus, M., et al.[2020]

A 10-week mind-body intervention for 51 women facing fertility challenges significantly reduced depressive symptoms and perceived stress while increasing social support, demonstrating its psychological benefits.

Participants showed good adherence to the intervention, practicing relaxation techniques nearly 6 days a week, and 51% continued these practices a year later, indicating the long-term feasibility of the program.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Mind-body group treatment for women coping with infertility: a pilot study. Psaros, C., Kagan, L., Shifren, JL., et al.[2016]

A study of 107 infertile women revealed that the psychological stress they experience evolves over time; initially, it is related to feelings of physical inferiority, but later shifts to concerns about external perceptions.

As infertility treatment continues, women tend to experience increased levels of depression and anxiety, indicating a need for tailored counseling that addresses their changing emotional needs throughout the treatment process.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Stress of female infertility: relations to length of treatment. Chiba, H., Mori, E., Morioka, Y., et al.[2018]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT05997407

The Effect of a Mindset Management Approach on Stress ... The goal of this clinical trial is to test the effect of a mindset management intervention on stress levels in women with infertility.

2. fertstert.org fertstert.org/article/S0015-0282(24)01698-4/fulltext

THE EFFECT OF A MINDSET MANAGEMENT ... The primary objective is to determine if the Organic Conceptions (OC) mindset management approach decreases stress levels in women with infertility.

3. withpower.com withpower.com/trial/phase-infertility-8-2023-806db

Mindset Management for Stress in Women With Infertility The goal of this clinical trial is to test the effect of a mindset management intervention on stress levels in women with infertility.

4. fertstert.org fertstert.org/article/S0015-0282(24)01698-4/abstract

THE EFFECT OF A MINDSET MANAGEMENT ... The study aims to determine if the Organic Conceptions (OC) mindset management approach decreases stress levels in women with infertility.

5. organic-conceptions.com organic-conceptions.com/

Organic Conceptions: Your Fertility Journey, Reimagined Trying to conceive? Organic Conceptions offers an emotional wellness program to help reduce stress and restore joy.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7295259/

Application of Mindfulness-Based Psychological Interventions ... This review unravels the therapeutic power of mindfulness meditation in the context of infertility distress.

7. ashwoodfertilitycare.com ashwoodfertilitycare.com/organic-conceptions.html

Organic Conceptions - ashwood fertilitycare center This unique self discovery program designed to optimize your emotional health and well-being. Through a multi-year research project Organic Conceptions has ...