Healthy Lifestyle Intervention for Emotional Distress During Pregnancy

(A-RCT Trial)

No longer recruiting at 3 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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a program called COPE-P, a cognitive-behavioral therapy program designed to help pregnant minority women experiencing emotional stress. Over six sessions, participants learn skills to better manage stress during pregnancy. The trial compares the effectiveness of this program with standard prenatal education. Women who are early in their pregnancy, identify as Black or Hispanic, and feel emotionally distressed may be suitable candidates for the trial. As an unphased trial, it provides a unique opportunity to contribute to important research that could enhance stress management for pregnant women.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications. However, if you are receiving treatment for a psychiatric diagnosis, you would not be eligible to participate.

What prior data suggests that this intervention is safe for pregnant women?

Research has shown that the COPE-P program is generally safe for pregnant women. This program employs cognitive-behavioral therapy (CBT), a well-established method for enhancing mental health. Studies have found that COPE-P reduces depression, anxiety, and stress in pregnant women experiencing emotional distress. These studies have not reported any serious side effects, indicating that the treatment is well-tolerated.

The COPE-P program is also applied in other contexts, such as with mothers of premature babies, and has demonstrated positive results without major safety concerns. Although specific details on negative effects might not be available, the treatment is grounded in strong research and practice. This suggests that COPE-P is safe for participants in clinical trials. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the COPE-P intervention because it offers a fresh approach to tackling emotional distress during pregnancy through cognitive-behavioral therapy (CBT), which is not typically emphasized in standard prenatal care. Unlike traditional methods that primarily focus on physical health through educational materials, COPE-P incorporates skills-building sessions that aim to equip expectant mothers with practical tools to manage stress and emotions. This innovative use of CBT, led by trained healthcare providers, is anticipated to not only enhance mental well-being but also potentially improve outcomes for both mothers and their babies.

What evidence suggests that the COPE-P intervention is effective for emotional distress during pregnancy?

Research has shown that the COPE-P program, available to participants in this trial, can alleviate depression, anxiety, and stress in pregnant women experiencing emotional distress. This program imparts skills to enhance both mental and physical health. Studies involving pregnant minority women have found that COPE-P can lead to healthier births by reducing the risk of high blood pressure problems and early delivery. Additionally, the program promotes healthier habits during pregnancy. Overall, evidence suggests that COPE-P is a promising method for managing emotional distress in this group. ^{1 2 3 4 6}

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+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7686149/

Randomized Controlled Trial of the COPE-P Intervention to ... The purpose of this randomized controlled trial (RCT) is to test a manualized cognitive-behavioral skills building (CBSB) intervention entitled the Creating ...

2. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1551714420301683

Randomized controlled trial of the COPE-P intervention to ... Emotionally distressed pregnant minority women experience multiple adverse outcomes, including pre-eclampsia, preterm birth, operative deliveries and low ...

3. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/32745703/

Randomized controlled trial of the COPE-P intervention to ... If found to be efficacious, the COPE-P intervention could be a key solution to managing those with emotional distress and improving their ...

4. researchgate.net researchgate.net/publication/343342112_Randomized_controlled_trial_of_the_COPE-P_intervention_to_improve_mental_health_healthy_lifestyle_behaviors_birth_and_post-natal_outcomes_of_minority_pregnant_women_Study_protocol_with_implications

Randomized controlled trial of the COPE-P intervention to ... The COPE program is a promising intervention that can improve physical and mental health outcomes. View. Show abstract. Detection of postnatal ...

5. consensus.app consensus.app/search/how-does-the-cope-p-intervention-improve-mental-he/fn9u8fH4QuCE_OpVUGnONA/

How does the COPE-P intervention improve mental health ... COPE-P uses cognitive-behavioral skills building to improve mental health outcomes in minority pregnant women by reducing depression, anxiety, and stress ...

6. cope2thrive.com cope2thrive.com/published-papers

COPE Creating Opportunities for Personal Empowerment The brief cognitive-behavioral COPE intervention for depressed adolescents: Outcomes and feasibility of delivery in 30-minute outpatient visits. Journal of ...