Healthy Lifestyle Intervention for Emotional Distress During Pregnancy
(A-RCT Trial)
Trial Summary
What is the purpose of this trial?
This trial tests a program that helps pregnant minority women manage their thoughts and emotions to reduce stress. It aims to improve mental health and birth outcomes for Black and Hispanic women who are emotionally distressed.
Research Team
Bernadette Melnyk, PhD
Principal Investigator
Ohio State University
Eligibility Criteria
This trial is for Black or Hispanic pregnant women aged 18-40, under 19 weeks into an uncomplicated pregnancy. They must speak English and not have chronic conditions like hypertension or diabetes, psychiatric treatments, or obstetrical complications.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive a cognitive behavioral skills building intervention over 6 sessions spaced over 18 weeks
Follow-up
Participants are monitored for changes in self-reported healthy lifestyle beliefs, anxiety, depressive symptoms, and stress from baseline to 6 months postpartum
Postpartum Evaluation
Evaluation of birth outcomes and maternal health at 6-8 weeks postpartum
Treatment Details
Interventions
- COPE-P
Find a Clinic Near You
Who Is Running the Clinical Trial?
Ohio State University
Lead Sponsor
National Institutes of Health (NIH)
Collaborator
New York University
Collaborator
Jacobi Medical Center
Collaborator
Boston College
Collaborator
University of Arizona
Collaborator
Drexel University
Collaborator
National Institute on Minority Health and Health Disparities (NIMHD)
Collaborator
University of South Florida
Collaborator