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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if an online stress management program, Stress Free Now, can assist women who have been trying to conceive for 6 to 12 months without success. Developed by the Cleveland Clinic, the program uses mindfulness and cognitive-behavioral therapy to reduce stress, potentially improving pregnancy chances. Participants will either begin the stress program immediately or join later from a waitlist. Ideal candidates are women who have attempted to conceive for 6-12 months, are in a stable relationship, and have regular internet access. The trial focuses on reducing stress levels and tracking pregnancy rates after three months. As an unphased trial, it offers a unique opportunity to explore innovative stress management techniques that could enhance conception chances.

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.

What prior data suggests that this stress management program is safe for women with infertility?

Research shows that stress management programs like Stress Free Now are generally safe for women facing infertility. Studies indicate that mind-body techniques, such as mindfulness, typically don't cause major side effects, making them easy to handle.

In previous studies, women using similar online stress management tools did not report any serious negative effects. These tools often include mindfulness exercises and a type of talk therapy that helps change thinking patterns. This approach has been linked to lower stress levels and improved overall well-being.

Overall, existing research suggests that participating in these stress management programs is safe and may help reduce stress. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Stress Free Now program because it offers a fresh approach to managing stress for women dealing with infertility. Unlike traditional treatments that might focus on medication or hormone therapy, this program uses mindfulness and cognitive-behavioral therapy to help manage stress levels. It's an online program developed by the Cleveland Clinic, making it accessible and convenient for participants to use from anywhere. This could be a game-changer by providing a holistic and non-invasive option that complements existing infertility treatments.

What evidence suggests that the Stress Free Now program is effective for managing stress in women with infertility?

Research has shown that the Stress Free Now (SFN) program effectively reduces stress in various groups. This program uses mindfulness and cognitive-behavioral therapy to help people manage stress better. In this trial, participants will either receive immediate access to the SFN program or be placed on a waitlist control, receiving access at the study's end. One study found that similar stress management techniques lowered stress levels in women struggling with infertility. Reducing stress might improve chances of pregnancy, as high stress is linked to infertility. Although more research is needed specifically for infertility, the program's success in reducing stress is promising for women trying to conceive. ^{1 2 6 7 8}

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

Currently pregnant

Participant had a DepoProvera injection in the prior 12 months

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.

withpower.com

withpower.com/trial/phase-infertility-female-4-2017-988c8

Stress Management Program for Female Infertility (SPA Trial)

The primary outcome of this randomized controlled trial is stress level, as measured by salivary alpha-amylase, while the secondary outcome will be pregnancy ...

2.

clinicaltrials.gov

clinicaltrials.gov/study/NCT03085212

Study Details | NCT03085212 | Strategies for Pregnancy ...

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 ...

3.

nature.com

nature.com/articles/s41598-023-41845-4

Perceived stress reduction through an infertility coaching ...

This present study was conducted to assess the impact of a supportive stress management program led by an infertility coach for women undergoing fertility ...

4.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC11823176/

Stress management through cognitive reconstruction and ...

This research aimed to assess the effectiveness of positive thinking counseling and cognitive reconstruction in reducing perceived stress among infertile women.

5.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC12326792/

Effect of guided imagery relaxation on stress in infertile ...

Considering the observed reduction in stress among infertile women following guided imagery relaxation, this technique may serve as a beneficial ...

6.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC12413509/

Complementary Interventions Using Technology for ...

The review indicates that complementary interventions using technology (CITs) for individuals with infertility can lead to beneficial outcomes ...

7.

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.

8.

researchprotocols.org

researchprotocols.org/2024/1/e52662/

Testing an Evidence-Based Self-Help Program for Infertility ...

The primary outcome will be fertility quality of life, while secondary outcomes will include depressive symptoms, anxious symptoms, and ...