Does Enhancing Maternal Peer Interactions Decrease Rates of Postpartum Depression?

NCT ID: NCT03793569

Last Updated: 2019-08-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 33 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-08-27
• Study Completion Date: 2019-07-30

Brief Summary

The long-term goal of this study is to validate a simple and inexpensive intervention to reduce the incidence and impact of Postpartum Depression (PPD). The central hypothesis is that enhancing social support of new mothers specifically via an organized peer get-together will decrease rates of postpartum depression. The rationale for the proposed research is that even though PPD is common and risk factors for developing PPD are known, simple and inexpensive interventions to prevent PPD need to be studied. Postpartum mothers will be recruited for the study and randomized into control versus intervention group. The intervention group will be placed in a peer discussion group. Incidence of PPD will be tracked.

Detailed Description

According to a 2014 Cochrane Review, postpartum depression (PPD) is present in 13% of new mothers by twelve weeks postpartum. Infant feeding, sleep routines, growth, and socioemotional and cognitive development can be adversely affected by maternal PPD. These negative effects can last into childhood. Previous studies have shown that strong social support is protective against PPD. The 2014 Cochrane Review on this topic comments that simple, inexpensive interventions to decrease rates of PPD are needed and that interventions led by lay-people and done in groups may be helpful to decrease rates of PPD. More recent studies focus on interventions for mothers already showing symptoms of postpartum depression, not on preventing these symptoms from developing.

The proposed work is important, because it capitalizes on recommendations for future research from the 2014 Cochrane Review on Psychosocial and Psychological Interventions for Preventing Postpartum Depression. The proposed work is also innovative, because it involves a preventive intervention from lay-people in a group setting, with new moms benefiting from each other. At the completion of this project, it is our expectation that mothers in the intervention group will have sustained decreased rates of PPD.

Conditions

Postpartum Depression

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Control group

Participants will be recruited and asked to complete Edinburgh Postnatal Depression Scale (EPDS) at specific timepoints postpartum.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Intervention group

Participants will be recruited, asked to complete Edinburgh Postnatal Depression Scale at specific timepoints postpartum, and attend a peer discussion group.

Group Type: EXPERIMENTAL

Peer discussion group

Intervention Type: BEHAVIORAL

Subjects in the intervention group will be asked to attend one peer group between four and eight weeks postpartum. Peer groups will be expected to last approximately one hour. Each peer group will include 5-10 new mothers. A facilitator will be present for these groups, but the hope is to have mothers discuss with each other their postpartum experience and activities of their newborn at home.

Interventions

Peer discussion group

Subjects in the intervention group will be asked to attend one peer group between four and eight weeks postpartum. Peer groups will be expected to last approximately one hour. Each peer group will include 5-10 new mothers. A facilitator will be present for these groups, but the hope is to have mothers discuss with each other their postpartum experience and activities of their newborn at home.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

1. Women who deliver at the Hershey Medical Center

2. Postpartum women within first week after delivery

3. Women who are 18 years of age or older

Exclusion Criteria

1. Postpartum women who delivered newborn before 35 0/7 gestational age.

2. Postpartum women whose newborn required any length of stay in the newborn intensive care unit.

3. Postpartum women who do not speak English.

4. Postpartum women who are less than 18 years old.

5. Postpartum women who are unable to provide consent.

6. Postpartum women who were on antidepressant or antianxiety medication or undergoing therapy for depression or anxiety during pregnancy or during postpartum hospitalization.

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Milton S. Hershey Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Brittany Massare

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Brittany A Massare, MD

Role: PRINCIPAL_INVESTIGATOR

Milton S. Hershey Medical Center

Locations

Penn State Hershey Medical Center

Hershey, Pennsylvania, United States

Countries

United States

Other Identifiers

STUDY00007890

Identifier Type: -

Identifier Source: org_study_id