Healthy Lifestyle Intervention for Emotional Distress During Pregnancy

(A-RCT Trial)

Recruiting at 2 trial locations

Overseen By Bernadette Melnyk, PhD

Age: 18 - 65

Sex: Female

Trial Phase: Academic

Sponsor: Ohio State University

Must not be taking: Psychiatric medications

Disqualifiers: Hypertension, Diabetes, Preeclampsia, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 8

Duration: 18 weeks

299 Participants Needed

What You Need to Know Before You Apply

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.

Who Is on the Research Team?

Bernadette Melnyk, PhD

Principal Investigator

Ohio State University

Are You a Good Fit for This Trial?

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

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

I am a pregnant woman aged between 18 and 40.

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.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person)

Treatment

Participants receive a cognitive behavioral skills building intervention over 6 sessions spaced over 18 weeks

18 weeks

6 visits (in-person)

Follow-up

Participants are monitored for changes in self-reported healthy lifestyle beliefs, anxiety, depressive symptoms, and stress from baseline to 6 months postpartum

6 months

Multiple visits (in-person)

Postpartum Evaluation

Evaluation of birth outcomes and maternal health at 6-8 weeks postpartum

2 weeks

1 visit (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• COPE-P

Trial Overview 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.

How Is the Trial Designed?

Group I: Control Active Control 1 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: Intervention Active Control 1 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.

Who Is Running the Clinical Trial?

Ohio State University

Lead Sponsor

Trials

891

Recruited

2,659,000+

National Institutes of Health (NIH)

Collaborator

Trials

2,896

Recruited

8,053,000+

New York University

Collaborator

Trials

249

Recruited

229,000+

Jacobi Medical Center

Collaborator

Trials

24

Recruited

4,500+

Boston College

Collaborator

Trials

40

Recruited

49,300+

University of Arizona

Collaborator

Trials

545

Recruited

161,000+

Drexel University

Collaborator

Trials

160

Recruited

48,600+

National Institute on Minority Health and Health Disparities (NIMHD)

Collaborator

Trials

473

Recruited

1,374,000+

University of South Florida

Collaborator

Trials

433

Recruited

198,000+