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Behavioral Intervention

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

N/A

Waitlist Available

Led By Bernadette Melnyk, PhD

Research Sponsored by Ohio State University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Pregnant women experiencing an uncomplicated singleton pregnancy of less than 19 weeks

Pregnant women between the ages of 18-40 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up timepoint 0 (baseline at screening), t1 = 31 gestational weeks, t2= 6-8 week postpartum visit, t3 = at 6 month well baby visit

Awards & highlights

No Placebo-Only Group

Summary

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 the study for?

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.

What is being tested?

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.

What are the potential side effects?

As COPE-P is a non-medical intervention focusing on cognitive behavioral skills, there are no direct medical side effects; however, participants may experience emotional discomfort when discussing personal issues.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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

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I am a pregnant woman aged between 18 and 40.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ timepoint 0 (baseline at screening), t1 = 31 gestational weeks, t2= 6-8 week postpartum visit, t3 = at 6 month well baby visit

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~timepoint 0 (baseline at screening), t1 = 31 gestational weeks, t2= 6-8 week postpartum visit, t3 = at 6 month well baby visit

This trial's timeline: 3 weeks for screening, Varies for treatment, and timepoint 0 (baseline at screening), t1 = 31 gestational weeks, t2= 6-8 week postpartum visit, t3 = at 6 month well baby visit for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Change is being assessed for an Increase or decrease in self-reported healthy lifestyle behaviors

Change is being assessed for an increase or decrease in self-reported Anxiety level

Change is being assessed for an increase or decrease in self-reported depressive symptoms

+2 more

Secondary study objectives

Breastfeeding initiation time

COPE-P Acceptability

Gestational age at birth

+11 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

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.

0 / 2Eligibility criteria met