NCT03085212

Brief 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.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
8mo left

Started May 2017

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress93%
May 2017Dec 2026

First Submitted

Initial submission to the registry

March 9, 2017

Completed
12 days until next milestone

First Posted

Study publicly available on registry

March 21, 2017

Completed
2 months until next milestone

Study Start

First participant enrolled

May 21, 2017

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 3, 2019

Completed
7.8 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2026

Expected
Last Updated

April 15, 2026

Status Verified

April 1, 2026

Enrollment Period

1.9 years

First QC Date

March 9, 2017

Last Update Submit

April 10, 2026

Conditions

Fertility DisordersPsychological StressInfertilityInfertility, Female

Outcome Measures

Primary Outcomes (1)

  • Stress level as measured by salivary alpha-amylase

    A salivary specimen will be collected to measure salivary alpha-amylase

    Six weeks post randomization

Secondary Outcomes (1)

  • Pregnancy rate

    Twelve weeks post randomization

Study Arms (2)

Online stress management program

EXPERIMENTAL

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.

Behavioral: Stress Free Now

Wait list control

ACTIVE COMPARATOR

Participants in this arm will receive free access to the Stress Free Now program at the end of the study.

Behavioral: Stress Free Now

Interventions

Stress Free NowBEHAVIORAL

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

Online stress management programWait list control

Eligibility Criteria

Age18 Years - 34 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsAs we are studying the effect of stress reduction on pregnancy rate, participants must be female.
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • Currently pregnant
  • Participant had a DepoProvera injection in the prior 12 months
  • Currently receiving infertility treatment

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Ohio State University College of Medicine

Columbus, Ohio, 43210, United States

Location

Related Links

MeSH Terms

Conditions

Stress, PsychologicalInfertilityInfertility, Female

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehaviorGenital DiseasesUrogenital DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy Complications

Study Officials

  • Courtney D Lynch, PhD

    The Ohio State University College of Medicine

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

March 9, 2017

First Posted

March 21, 2017

Study Start

May 21, 2017

Primary Completion

April 3, 2019

Study Completion (Estimated)

December 31, 2026

Last Updated

April 15, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will not share

Locations

US(1)