Strategies for Pregnancy Achievement

Summary

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.

Conditions

• Fertility Disorders
• Psychological Stress
• Infertility
• Infertility, Female

Interventions

BEHAVIORAL

Stress Free Now

Online stress management program developed by the Cleveland Clinic that uses mindfulness and cognitive-behavioral therapy to help individuals manage their stress.

Sponsors & Collaborators

• University of California, Irvine

  collaborator OTHER

• The Cleveland Clinic

  collaborator OTHER

• Courtney D.Lynch, PhD MPH

  lead OTHER

Principal Investigators

• Courtney D Lynch, PhD · The Ohio State University College of Medicine

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

34 Years

Sex

FEMALE

Healthy Volunteers

No

Timeline & Regulatory

Start

2017-05-21

Primary Completion

2019-04-03

Completion

2026-12-31

Countries

• United States

Study Locations