Clinical trial NCT03793569: Does Enhancing Maternal Peer Interactions Decrease Rates of Postpartum Depression?
Official title: Does Enhancing Maternal Peer Interactions Decrease Rates of Postpartum Depression?
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Postpartum Depression
Lead sponsor: Milton S. Hershey Medical Center
Sponsor class: OTHER
First posted: 2019-01-04
Enrollment: 33
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Control group and intervention group. Intervention group will participate in peer discussion group.
Primary purpose: PREVENTION

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.

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.

Primary outcomes:
measure: Risk of development of postpartum depression
timeFrame: 4-8 weeks postpartum
measure: Development of postpartum depression
timeFrame: 12 weeks postpartum
measure: Development of postpartum depression
timeFrame: 6 months postpartum
Secondary outcomes:
Other outcomes:
Locations:
city: Hershey
country: United States
facility: Penn State Hershey Medical Center
state: Pennsylvania
Study officials:
affiliation: Milton S. Hershey Medical Center
name: Brittany A Massare, MD
role: PRINCIPAL_INVESTIGATOR
References: