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Practical Resources for Effective Postpartum (PREPP) for Postpartum Depression (PREPP Trial)

N/A

Waitlist Available

Led By Catherine Monk, PhD

Research Sponsored by New York State Psychiatric Institute

Eligibility Criteria Checklist

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

Must have

Be between 18 and 65 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up through the 4th month postpartum

Awards & highlights

PREPP Trial Summary

This trial is testing whether a coaching intervention can help reduce maternal depression and improve child development. The intervention includes 4 in-person coaching sessions and 1 phone call.

Who is the study for?

This trial is for English-speaking pregnant women aged 18-45, at risk of postpartum depression based on a specific screening score. They must be expecting one baby, in good health, and not currently receiving weekly psychotherapy or taking psychiatric medication. Women who smoke, use drugs or alcohol during pregnancy, or have certain mental disorders are excluded.Check my eligibility

What is being tested?

The PREPP study tests if coaching new moms on parenting can improve infant sleep and reduce crying to prevent maternal postpartum depression. It compares this intervention with standard care. The study also looks at mother-baby interaction quality and seeks biological markers related to the effectiveness of the intervention.See study design

What are the potential side effects?

Since this trial involves behavioral interventions rather than medications, traditional side effects are not expected; however, participants may experience varying levels of stress or emotional discomfort when discussing personal topics or changing their parenting routines.

PREPP Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ through the 4th month postpartum

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~through the 4th month postpartum

This trial's timeline: 3 weeks for screening, Varies for treatment, and through the 4th month postpartum for reporting.

Treatment Details

Study Objectives

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

Primary outcome measures

Hamilton Anxiety Scale (HRSA)

Score on HRSD-24

Score on the Edinburgh Postnatal Depression Scale (EPDS)

+3 more

Secondary outcome measures

Cry Behavior (baby)

Score on Brief Infant Sleep Questionnaire (BISQ) (baby)

Sleep Behavior (baby)

+1 more

Other outcome measures

Total Number of Sleep Hours reported on the Self-Reported Sleep Log (mother)

PREPP Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Practical Resources for Effective Postpartum (PREPP)Experimental Treatment1 Intervention

A psychotherapeutic preventive intervention that involves psychoeducation and cognitive behavioral techniques.

Group II: Enhanced Treatment as UsualActive Control1 Intervention

Psychoeducation about Postpartum Depression, referral to treatment in the community and monitoring

Do I qualify?Apply below to find out

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Who is running the clinical trial?

New York State Psychiatric InstituteLead Sponsor

475 Previous Clinical Trials

153,691 Total Patients Enrolled

2 Trials studying Postpartum Depression

114 Patients Enrolled for Postpartum Depression

Columbia UniversityLead Sponsor

1,431 Previous Clinical Trials

2,460,615 Total Patients Enrolled

1 Trials studying Postpartum Depression

214 Patients Enrolled for Postpartum Depression

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)NIH

1,963 Previous Clinical Trials

2,674,525 Total Patients Enrolled

6 Trials studying Postpartum Depression

4,286 Patients Enrolled for Postpartum Depression

Frequently Asked Questions

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

Are individuals over 70 years of age precluded from participating in this trial?

"Entry into this medical study necessitates that the patient is between 18 and 45 years old. For those outside of this range, 197 trials are available for minors while 968 studies can be found for seniors."

Answered by AI

How many participants may take part in this experiment?

"Affirmative, clinicaltrials.gov confirms that this research is recruiting participants as of March 25th 2022. It was first published on December 2nd 2018 and requires 300 subjects to be sourced from a single location."

Answered by AI

What criteria must a person meet to qualify for participation in this experiment?

"This medical research is seeking to enrol 300 individuals between 18 and 45 years of age who are suffering from depression. In order to be eligible, these potential participants must meet the following qualifications: Self-reported healthy pregnant women within the specified ages; a Predictive Index of Postnatal Depression score that surpasses 21, which indicates an elevated risk for postpartum depression; self-attested singleton pregnancy; English language proficiency; prenatal care as per usual standards."

Answered by AI

Are there vacancies for participants in this exploration?

"Affirmative. Evidence hosted on the clinicaltrials.gov website indicates that this research endeavour is actively recruiting participants, with 300 patients required from 1 site. The study was initially posted to the database on February 12th 2018 and last updated March 25th 2022."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

PREPP: Preventing Postpartum Depression

Catherine Monk 2018. "PREPP: Preventing Postpartum Depression". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03283254.