Stress Management Program for Female Infertility

(SPA Trial)

Age: 18 - 65

Sex: Female

Trial Phase: Academic

Sponsor: Courtney D.Lynch, PhD MPH

Must not be taking: DepoProvera

Disqualifiers: Currently pregnant, Infertility treatment

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

Compensation: Varies

Number of Visits: Unknown

Duration: 6 weeks

40 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

The purpose of pilot study application is to build on the investigators' previous work that established the prospective association between stress and infertility. Specifically, the investigators hope to collect the preliminary data necessary to make them competitive to submit a R01 application to NIH for funding of a full-scale randomized controlled trial of an internet-based stress management program to examine its efficacy in decreasing stress and increasing pregnancy rates among women who have tried to get pregnant for 6-12 months without success. The program called Stress Free Now (SFN) was developed at the Cleveland Clinic and has been shown to be effective in lowering stress in a variety of populations. The program introduces concepts of mindfulness and cognitive-behavioral therapy to assist individuals in managing their stress levels. The intervention includes Internet-based interaction, daily emails and recommended relaxation practice of at least four days per week. Using targeted Facebook Ads and other recruitment modalities, the investigators will randomize 40 women ages 18-34 who have been trying to conceive for 6-12 months without success. The PI has been enrolling women in a similar study using this mechanism and has found it to be an efficient and cost-effective method of identifying potentially eligible individuals. Women will be randomized to SFN or a wait list control condition and will be followed for up to three months post-randomization with weekly journals as they try to conceive. The primary outcome of this randomized controlled trial is stress level, as measured by salivary alpha-amylase, while the secondary outcome will be pregnancy rate at the end of the three-month follow-up period.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. However, if you are currently receiving infertility treatment, you would not be eligible to participate.

Is the Stress Management Program for Female Infertility safe for humans?

The studies reviewed suggest that mind-body interventions, including mindfulness-based programs, are generally safe for infertile women, with no significant safety concerns reported. These programs have been associated with reduced anxiety and depression, indicating they are well-tolerated. ^{1 2 3 4 5}

How does the Stress Free Now treatment for female infertility differ from other treatments?

The Stress Free Now treatment is unique because it focuses on managing stress through a supportive program, which has been shown to reduce perceived stress levels in women undergoing fertility treatments. Unlike traditional medical treatments, this approach emphasizes psychological support and stress reduction, which can positively impact fertility outcomes. ^{1 6 7 8 9}

What data supports the effectiveness of the treatment Stress Free Now for female infertility?

Research shows that cognitive-behavioral therapy (CBT), which is similar to stress management programs, can significantly reduce stress, anxiety, and depression in women with infertility, improving their quality of life. ^{1 10 11 12 13}

Who Is on the Research Team?

Courtney D Lynch, PhD

Principal Investigator

The Ohio State University College of Medicine

Are You a Good Fit for This Trial?

This trial is for women aged 18-34 in stable relationships, who have been trying to conceive naturally for 6-12 months without success. They must have regular internet access and show signs of stress as indicated by specific test scores. Women currently pregnant, those who've had certain contraceptive injections in the past year or are undergoing infertility treatments cannot participate.

Inclusion Criteria

I am in a stable relationship with a man.

Has regular internet access

Trying to get pregnant and last used contraception 6-12 months ago

Exclusion Criteria

Participant had a DepoProvera injection in the prior 12 months

Currently pregnant

I am currently undergoing treatment for infertility.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Online screening questionnaire

Treatment

Participants receive the Stress Free Now online stress management program or are placed in a waitlist control group

6 weeks

Weekly online interaction

Follow-up

Participants are monitored for stress levels and pregnancy rates after treatment

6 weeks

Weekly online journals

Open-label extension (optional)

Participants in the waitlist control group receive access to the Stress Free Now program

Post-study

What Are the Treatments Tested in This Trial?

Interventions

• Stress Free Now

Trial Overview The study tests an online stress management program called Stress Free Now (SFN), which uses mindfulness and cognitive-behavioral therapy techniques to reduce stress. Participants will either receive SFN or be placed on a waitlist while they attempt to get pregnant over three months, with their stress levels and pregnancy rates being monitored.

How Is the Trial Designed?

Group I: Online stress management program Experimental Treatment 1 Intervention

Participants will receive free access to Stress Free Now, which is an online stress management program developed by the Cleveland Clinic that uses mindfulness and cognitive-behavior therapy to help individuals learn to manage their stress.

Group II: Wait list control Active Control 1 Intervention

Participants in this arm will receive free access to the Stress Free Now program at the end of the study.

Who Is Running the Clinical Trial?

Courtney D.Lynch, PhD MPH

Lead Sponsor

Trials

2

Recruited

200+

University of California, Irvine

Collaborator

Trials

580

Recruited

4,943,000+

The Cleveland Clinic

Collaborator

Trials

1,072

Recruited

1,377,000+

Published Research Related to This Trial

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]

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]

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]

Citations

1. Japan pubmed.ncbi.nlm.nih.gov

Supporting stress management for women undergoing the early stages of fertility treatment: a cluster-randomized controlled trial. [2009]

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

Stress level across stages of in vitro fertilization in subsequently pregnant and nonpregnant women. [2019]

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

Psychosocial, treatment, and demographic predictors of the stress associated with infertility. [2019]

4. England pubmed.ncbi.nlm.nih.gov

Cognitive behavioural therapy for women with infertility: A systematic review and meta-analysis. [2023]

5. England pubmed.ncbi.nlm.nih.gov

Infertility-related stress and quality of life in women experiencing concurrent reproductive trauma. [2022]

6. England pubmed.ncbi.nlm.nih.gov

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

7. Austria pubmed.ncbi.nlm.nih.gov

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

8. England pubmed.ncbi.nlm.nih.gov

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

9. England pubmed.ncbi.nlm.nih.gov

Mindfulness-based program for stress reduction in infertile women: Randomized controlled trial. [2019]

10. Netherlands pubmed.ncbi.nlm.nih.gov

Does stress affect IVF outcomes? A prospective study of physiological and psychological stress in women undergoing IVF. [2020]

11. England pubmed.ncbi.nlm.nih.gov

Impact of underlying stress in infertility. [2021]

12. England pubmed.ncbi.nlm.nih.gov

Perceived stress reduction through an infertility coaching program: a randomized controlled clinical trial. [2023]

13. England pubmed.ncbi.nlm.nih.gov

The effect of the approach based on the Neuman Systems Model on stress and coping in women receiving intrauterine insemination treatment: A randomized controlled trial. [2023]