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

This trial's timeline: 3 weeks for screening, Varies for treatment, and six weeks post randomization for reporting.

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

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