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Behavioral Intervention
Stress Management Program for Female Infertility (SPA Trial)
N/A
Waitlist Available
Led By Courtney D Lynch, PhD
Research Sponsored by Courtney D.Lynch, PhD MPH
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up twelve weeks post randomization
Awards & highlights
No Placebo-Only Group
Summary
This trial is testing whether an internet-based stress management program can help women who have been trying to get pregnant for 6-12 months without success.
Who is the study for?
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.
What is being tested?
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.
What are the potential side effects?
Since this intervention involves non-invasive methods like mindfulness practices and cognitive-behavioral therapy delivered via the internet, there are no direct physical side effects expected from participating in this clinical trial.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ six weeks post randomization
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~six weeks post randomization
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Stress level as measured by salivary alpha-amylase
Secondary study objectives
Pregnancy rate
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Online stress management programExperimental Treatment1 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 controlActive Control1 Intervention
Participants in this arm will receive free access to the Stress Free Now program at the end of the study.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Stress Free Now
2010
N/A
~690
Find a Location
Who is running the clinical trial?
Courtney D.Lynch, PhD MPHLead Sponsor
1 Previous Clinical Trials
161 Total Patients Enrolled
University of California, IrvineOTHER
566 Previous Clinical Trials
1,933,008 Total Patients Enrolled
The Cleveland ClinicOTHER
1,057 Previous Clinical Trials
1,371,720 Total Patients Enrolled
Courtney D Lynch, PhDPrincipal InvestigatorThe Ohio State University College of Medicine