Stress Management Program for Female Infertility

(SPA Trial)

Age: 18 - 65

Sex: Female

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Waitlist Available

Sponsor: Courtney D.Lynch, PhD MPH

No Placebo Group

Trial Summary

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.

Research Team

Courtney D Lynch, PhD

Principal Investigator

The Ohio State University College of Medicine

Eligibility Criteria

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

I am between 18 and 34 years old.

Exclusion Criteria

Participant had a DepoProvera injection in the prior 12 months

Currently pregnant

I am currently undergoing treatment for infertility.

Treatment Details

Interventions

• Stress Free Now (Behavioral Intervention)

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.

Participant Groups

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+