Strategies for Pregnancy Achievement
Status: | Active, not recruiting |
---|---|
Conditions: | Psychiatric, Women's Studies, Infertility |
Therapuetic Areas: | Psychiatry / Psychology, Reproductive |
Healthy: | No |
Age Range: | 18 - 34 |
Updated: | 3/13/2019 |
Start Date: | May 21, 2017 |
End Date: | April 1, 2019 |
Strategies for Pregnancy Achievement (SPA): a Pilot Study
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.
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.
Inclusion Criteria:
- Female
- Aged 18-34 years
- In a stable relationship with a male partner
- Has regular internet access
- Trying to get pregnant and last used contraception 6-12 months ago
- STAI-T score>=34 OR CESR-10 score >=10.
Exclusion Criteria:
- Currently pregnant
- Participant had a DepoProvera injection in the prior 12 months
- Currently receiving infertility treatment
We found this trial at
1
site
Columbus, Ohio 43210
Principal Investigator: Courtney D Lynch, PhD
Phone: 614-366-3899
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