Healthy Lifestyle Intervention for Emotional Distress During Pregnancy
(A-RCT Trial)

Recruiting in Palo Alto (17 mi)

+2 other locations

Overseen byBernadette Melnyk, PhD

Age: 18 - 65

Sex: Female

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Waitlist Available

Sponsor: Ohio State University

No Placebo Group

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.

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

Self-identified as either Black or Hispanic

Able to read and speak English

I am pregnant with one baby and less than 19 weeks along without complications.

+2 more

Exclusion Criteria

Women with chronic medical conditions (e.g., hypertension, or diabetes), are currently receiving treatment or therapy for a psychiatric diagnosis, or have participated in this study with a prior pregnancy

Women with obstetrical complications, such as preeclampsia, gestational diabetes, or fetal abnormalities.

Participant Groups

The trial tests a six-session cognitive behavioral skills building intervention called COPE-P over 18 weeks. It aims to reduce health disparities in emotionally distressed minority pregnant women at three sites in New York City and Columbus, Ohio.

2Treatment groups

Active Control

Group I: ControlActive Control1 Intervention

In addition to standard prenatal care the PregnancyPlus attention control group for 6 weeks will receive 1.5 hours of ACOG-designed patient education pamphlets. Material will include prenatal and post-partum education.. Dr. Gennaro will conduct the training of the attention control group midwives. The same protocol for assessing fidelity for COPE-P also will be used for assessing fidelity to the attention control intervention

Group II: InterventionActive Control1 Intervention

In addition to standard prenatal care the COPE-P intervention group will also receive 1.5 hours each week for 6 weeks the cognitive-behavior skills building program driven by CBT as the theoretical framework by health care providers trained in COPE-P by Dr. Melnyk. The content of the COPE program is driven by the literature review, the theoretical framework, previous studies of COPE interventions with mothers of preterm infants and prior work with pregnant minority women by our team.