Does Enhancing Maternal Peer Interactions Decrease Rates of Postpartum Depression?

Postpartum Depression Clinical Trial

Official title:

Does Enhancing Maternal Peer Interactions Decrease Rates of Postpartum Depression?

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03793569
• Other study ID #: STUDY00007890
• Status: Completed
• Phase: N/A
• Start date: August 27, 2018
• Est. completion date: July 30, 2019

Study information

• Verified date: August 2019
• Source: Milton S. Hershey Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 33
• Est. completion date: July 30, 2019
• Est. primary completion date: July 30, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Depression
• Depression, Postpartum
• Depressive Disorder
• Postpartum Depression

Intervention

Behavioral:
• 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.

Locations

Country	Name	City	State
United States	Penn State Hershey Medical Center	Hershey	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Milton S. Hershey Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Risk of development of postpartum depression	Edinburg Postnatal Depression Scale. Score 0-30. Score > or = 10 considered greater risk of depression.	4-8 weeks postpartum
Primary	Development of postpartum depression	Edinburg Postnatal Depression Scale. Score 0-30. Score > or = 10 considered greater risk of depression.	12 weeks postpartum
Primary	Development of postpartum depression	Edinburg Postnatal Depression Scale. Score 0-30. Score > or = 10 considered greater risk of depression.	6 months postpartum