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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

A-RCT Trial 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.Check my eligibility

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.See study design

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.

A-RCT Trial 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.

A-RCT Trial 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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

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 outcome measures

Breastfeeding initiation time

COPE-P Acceptability

Gestational age at birth

+11 more

A-RCT 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

Find a Location

Who is running the clinical trial?

Ohio State UniversityLead Sponsor

829 Previous Clinical Trials

505,444 Total Patients Enrolled

National Institutes of Health (NIH)NIH

2,697 Previous Clinical Trials

6,952,515 Total Patients Enrolled

New York UniversityOTHER

226 Previous Clinical Trials

313,956 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Does this research project accept participants that are at least 18 years of age?

"Patients aged 18 to 40 are eligible for this trial, while 296 studies have been conducted on those below eighteen and 1196 trials done with participants over 65."

Answered by AI

Is there still capacity for more participants in this investigation?

"This study, which was initially posted in March 2018 and recently updated on October 13th 2022, is not currently looking for participants. Despite this, there are presently 1642 other trials actively recruiting patients."

Answered by AI

Could I partake in this research project?

"This research seeks 299 individuals aged between 18 and 40, who are clinically diagnosed with depression. In addition to the age criteria, prospective participants must meet a few more conditions: be pregnant women within that same age range; have an uncomplicated singleton pregnancy of less than 19 weeks ;self-identify as either Black or Hispanic; demonstrate fluency in English; agree for their child's records to be accessed for data collection."

Answered by AI

What aims has this trial set out to accomplish?

"The primary objective of the trial, which will occur over a baseline screening visit at week 31 gestation and 6-8 weeks postpartum as well as a 6 month follow-up for babies, is to evaluate changes in self-reported stress. Secondary objectives involve ascertaining mode of delivery (C-section, forceps/vacuum, vaginal), participant height (feet & inches) and weight (in pounds) during each In Person Meeting."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Healthy Lifestyle Intervention for High-Risk Minority Pregnant Women

Bernadette Melnyk 2018. "Healthy Lifestyle Intervention for High-Risk Minority Pregnant Women". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03416010.

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