Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 6:56 PM
Ignite Modification Date:
2025-12-24 @ 6:56 PM
NCT ID:
NCT04327557
Eligibility Criteria:
Maternal Inclusion Criteria:
* 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 Inclusion Criteria:
* Born to a mother participating in the study
Maternal Exclusion Criteria:
* 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 Exclusion Criteria:
* Major neurosensory impairment: legally blind or coloboma
* Isoimmunization
* Severe jaundice
* Facial cleft
* Abnormal heart rate: ECG \>180 or \<80
Healthy Volunteers:
True
Sex:
FEMALE
Minimum Age:
18 Years
Maximum Age:
40 Years
Study:
NCT04327557
Study Brief:
Protocol Section:
NCT04327557