Strategies for Pregnancy Achievement (SPA): a Pilot Study

To allow us to address the significant data gap regarding the efficacy of interventions to reduce stress and increase fecundity, we will conduct a randomized controlled trial of a proven 6-week online stress management program called Stress Free Now (SFN). Women will be randomized to SFN or a wait list control condition (i.e., participants assigned to the control arm with be offered SFN at the end of the study, even if they are already pregnant).

Women will be followed for three months from the date of randomization as they continue to try to conceive. Women who report pursuing fertility treatment will be censored on the day they report initiating treatment.

Participants will be recruited primarily using targeted Facebook Ads, though other modalities will also be used like local ads, and ResearchMatch. The PI used Facebook for recruitment for a similar study and found it to be a very efficient method for identifying women who are currently trying to conceive. We will preferentially target women in the Midwest for this pilot study in order to keep shipping costs low.

For the proposed study, the Facebook Ad will direct participants to the study website where they can obtain more information and complete a preliminary screening questionnaire using a secure online form. The brief screening questionnaire will assess whether the potential participant meets the above-mentioned eligibility criteria and will ask individuals to complete the State-Trait Anxiety Inventory (STAI), Trait Form, the 10-item Center for Epidemiologic Studies Depression Scale Revised (CESDR-10), and the four-item Perceived Stress Scale. Women who score ≥ 34 on the STAI and/or ≥ 10 on the CESDR-10 will be contacted by study staff and offered enrollment. These two assessments were chosen because they are the two instruments shown in the PI's prior work to correlate with salivary alpha-amylase level, which the biomarker that the PI has found to be associated with reduced fecundity.

Eligible women who complete the questionnaire and are found to be eligible will be informed via email and their address will be requested so that we can mail them an informed consent and HIPAA documents. The forms will be mailed and participants will be asked to return it to study staff using the prepaid envelope. When the signed forms are received, participants will be sent an email with a link to their baseline questionnaire. Once the baseline questionnaire has been completed, women will be sent their first saliva collection kit as well as five pregnancy tests for use during the study. If a woman reports on the baseline questionnaire that she is currently receiving infertility treatment, she will be exited from the study. In addition to collecting their saliva specimen (described below), women will be asked to use one of the enclosed pregnancy tests immediately, to record the results (i.e., pregnant or not pregnant), and to return the form with the saliva specimen. Any woman who reports that she is pregnant at baseline will be thanked and exited from the study.