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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

Summary

This trial will test a cognitive behavioral skills building intervention to help decrease health disparities in pregnant, emotionally distressed, minority women.

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 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

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.

Find a Location

Who is running the clinical trial?

Ohio State UniversityLead Sponsor
859 Previous Clinical Trials
642,466 Total Patients Enrolled
National Institutes of Health (NIH)NIH
2,765 Previous Clinical Trials
8,133,212 Total Patients Enrolled
New York UniversityOTHER
234 Previous Clinical Trials
313,596 Total Patients Enrolled

Media Library

COPE-P (Behavioral Intervention) Clinical Trial Eligibility Overview. Trial Name: NCT03416010 — N/A
Pregnancy Research Study Groups: Control, Intervention
Pregnancy Clinical Trial 2023: COPE-P Highlights & Side Effects. Trial Name: NCT03416010 — N/A
COPE-P (Behavioral Intervention) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03416010 — N/A
~40 spots leftby Sep 2025
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