Mindset Management for Stress in Women With Infertility

Age: 18 - 65

Sex: Female

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: Virginia Polytechnic Institute and State University

Disqualifiers: Previous fertility treatment, Organic Conceptions, others

No Placebo Group

Trial Summary

What is the purpose of 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.

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 data supports the effectiveness of the treatment Organic Conceptions mindset management program for stress in women with infertility?

Research shows that mind-body interventions, like mindfulness and yoga, can help reduce anxiety and depression in women dealing with infertility. These approaches may also improve the chances of pregnancy, suggesting that similar treatments could be beneficial. ^{1 2 3 4 5}

Is the mindset management program safe for women with infertility?

The available research on mind-body interventions, which includes programs like the mindset management approach, suggests they are generally safe for women with infertility. These interventions have been associated with reduced anxiety and depression, with no significant safety concerns reported. ^{1 3 4 6 7}

How is the Organic Conceptions mindset management program different from other treatments for stress in women with infertility?

The Organic Conceptions mindset management program is unique because it focuses on changing the mindset and reducing stress through a structured approach, unlike traditional treatments that may focus on medication or physical interventions. This program is part of mind-body interventions, which have shown promise in reducing anxiety and depression in infertile women, potentially improving mental health and pregnancy outcomes. ^{1 8 9 10 11}

Eligibility Criteria

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.

Trial Timeline

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

Treatment Details

Interventions

• Organic Conceptions mindset management program (Behavioral Intervention)

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.

Participant Groups

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+

Findings from Research

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 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]

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]

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]

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]

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]

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]

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]

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]

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]

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]

References

1. Austria pubmed.ncbi.nlm.nih.gov

The effect of mind-body interventions on psychological and pregnancy outcomes in infertile women: a systematic review. [2020]

2. Switzerland 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. [2021]

3. England pubmed.ncbi.nlm.nih.gov

Mind-body group treatment for women coping with infertility: a pilot study. [2016]

4. United States pubmed.ncbi.nlm.nih.gov

An internet-based mind/body intervention to mitigate distress in women experiencing infertility: A randomized pilot trial. [2020]

5. Netherlands pubmed.ncbi.nlm.nih.gov

Body-mind-spirit intervention for IVF women. [2022]

6. Denmark pubmed.ncbi.nlm.nih.gov

[The psychosocial consequences of infertility and fertility treatment]. [2012]

7. England pubmed.ncbi.nlm.nih.gov

Mindfulness-based program to support lifestyle modification and weight loss in infertile women: randomized controlled trial. [2022]

8. Iran pubmed.ncbi.nlm.nih.gov

What Psychiatric Interventions Are Used for Anxiety Disorders in Infertile Couples? A Systematic Review Study. [2020]

9. United States pubmed.ncbi.nlm.nih.gov

Mindfulness improves the mental health of infertile women: A systematic review. [2023]

10. Switzerland pubmed.ncbi.nlm.nih.gov

Stress of female infertility: relations to length of treatment. [2018]

11. Iran 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. [2022]