Does Enhancing Maternal Peer Interactions Decrease Rates of Postpartum Depression?

Does Enhancing Maternal Peer Interactions Decrease Rates of Postpartum Depression?

Sponsors

Lead sponsor: Milton S. Hershey Medical Center

Source Milton S. Hershey Medical Center
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.

Overall Status Completed
Start Date August 27, 2018
Completion Date July 30, 2019
Primary Completion Date July 30, 2019
Phase N/A
Study Type Interventional
Primary Outcome
Measure Time Frame
Risk of development of postpartum depression 4-8 weeks postpartum
Development of postpartum depression 12 weeks postpartum
Development of postpartum depression 6 months postpartum
Enrollment 33
Condition
Intervention

Intervention type: Behavioral

Intervention name: Peer discussion group

Description: 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.

Arm group label: Intervention group

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.

Gender: Female

Minimum age: 18 Years

Maximum age: N/A

Healthy volunteers: Accepts Healthy Volunteers

Overall Official
Last Name Role Affiliation
Brittany A Massare, MD Principal Investigator Milton S. Hershey Medical Center
Location
facility Penn State Hershey Medical Center
Location Countries

United States

Verification Date

August 2019

Responsible Party

Responsible party type: Principal Investigator

Investigator affiliation: Milton S. Hershey Medical Center

Investigator full name: Brittany Massare

Investigator title: Principal Investigator

Has Expanded Access No
Condition Browse
Number Of Arms 2
Arm Group

Arm group label: Control group

Arm group type: No Intervention

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

Arm group label: Intervention group

Arm group type: Experimental

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

Patient Data No
Study Design Info

Allocation: Randomized

Intervention model: Parallel Assignment

Intervention model description: Control group and intervention group. Intervention group will participate in peer discussion group.

Primary purpose: Prevention

Masking: None (Open Label)

Source: ClinicalTrials.gov