Status:
SUSPENDED
Childbirth Education Pilot Study
Lead Sponsor:
University of Wisconsin, Madison
Conditions:
Pregnancy
Anxiety
Eligibility:
FEMALE
18-40 years
Phase:
NA
Brief Summary
This study aims to investigate the effects of mindfulness training on prenatal maternal anxiety using a randomized controlled trial (RCT). An RCT of mindfulness training for prenatal anxiety has disti...
Detailed Description
Baseline (Pre-Class) Visit : Once study eligibility has been confirmed, the participant will come to the lab for an in-person visit. If they choose to continue in the study after reading and signing t...
Eligibility Criteria
Inclusion
- Maternal
- A score on the Penn State Worry Questionnaire (PSWQ) of 50 or greater
- Nulliparous and expecting a healthy (i.e., normal/low medical risk), singleton pregnancy
- No more than 28 weeks gestation at time of enrollment (to allow time to complete the intervention before 37 weeks)
- Comfortable reading, writing, and conversing in English.
- Available and able to enroll in the MBCP class
- Infant
- Born to a mother participating in the study
- Maternal
Exclusion
- Severe medical conditions that would compromise the pregnancy (e.g., pre-eclampsia, severe hyperthyroidism);
- Current or past bipolar disorder, schizophrenia, or post-traumatic stress disorder (PTSD);
- Active psychopharmacological treatment (current or in the past 6 months).
- Formal mindfulness meditation practice or long-term yoga practice
- Significant injuries, illness or surgery that may impair parent-child interaction (e.g., traumatic brain injury) or that is unstably treated.
- HIV or AIDS
- Cancer in the past year
- Major Autoimmune Disease
- Infection while pregnant such as Toxoplasmosis, Rubella, Cytomegalovirus (CMV) infection, Herpes Simplex Virus (HSV), Syphilis
- Prior childbirth
- Infant
Key Trial Info
Start Date :
July 2 2019
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
November 1 2027
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT04327557
Start Date
July 2 2019
End Date
November 1 2027
Last Update
March 11 2025
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
University of Wisconsin Madison
Madison, Wisconsin, United States, 53703-2637