Does Enhancing Maternal Peer Interactions Decrease Rates of Postpartum Depression?
Primary Purpose
Postpartum Depression
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Peer discussion group
Sponsored by
About this trial
This is an interventional prevention trial for Postpartum Depression
Eligibility Criteria
Inclusion Criteria:
- Women who deliver at the Hershey Medical Center
- Postpartum women within first week after delivery
- Women who are 18 years of age or older
Exclusion Criteria:
- Postpartum women who delivered newborn before 35 0/7 gestational age.
- Postpartum women whose newborn required any length of stay in the newborn intensive care unit.
- Postpartum women who do not speak English.
- Postpartum women who are less than 18 years old.
- Postpartum women who are unable to provide consent.
- Postpartum women who were on antidepressant or antianxiety medication or undergoing therapy for depression or anxiety during pregnancy or during postpartum hospitalization.
Sites / Locations
- Penn State Hershey Medical Center
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Experimental
Arm Label
Control group
Intervention group
Arm Description
Participants will be recruited and asked to complete Edinburgh Postnatal Depression Scale (EPDS) at specific timepoints postpartum.
Participants will be recruited, asked to complete Edinburgh Postnatal Depression Scale at specific timepoints postpartum, and attend a peer discussion group.
Outcomes
Primary Outcome Measures
Risk of development of postpartum depression
Edinburg Postnatal Depression Scale. Score 0-30. Score > or = 10 considered greater risk of depression.
Development of postpartum depression
Edinburg Postnatal Depression Scale. Score 0-30. Score > or = 10 considered greater risk of depression.
Development of postpartum depression
Edinburg Postnatal Depression Scale. Score 0-30. Score > or = 10 considered greater risk of depression.
Secondary Outcome Measures
Full Information
NCT ID
NCT03793569
First Posted
June 5, 2018
Last Updated
August 20, 2019
Sponsor
Milton S. Hershey Medical Center
1. Study Identification
Unique Protocol Identification Number
NCT03793569
Brief Title
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
2. Study Status
Record Verification Date
August 2019
Overall Recruitment Status
Completed
Study Start Date
August 27, 2018 (Actual)
Primary Completion Date
July 30, 2019 (Actual)
Study Completion Date
July 30, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Milton S. Hershey Medical Center
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postpartum Depression
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Control group and intervention group. Intervention group will participate in peer discussion group.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
33 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Control group
Arm Type
No Intervention
Arm Description
Participants will be recruited and asked to complete Edinburgh Postnatal Depression Scale (EPDS) at specific timepoints postpartum.
Arm Title
Intervention group
Arm Type
Experimental
Arm Description
Participants will be recruited, asked to complete Edinburgh Postnatal Depression Scale at specific timepoints postpartum, and attend a peer discussion group.
Intervention Type
Behavioral
Intervention Name(s)
Peer discussion group
Intervention 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.
Primary Outcome Measure Information:
Title
Risk of development of postpartum depression
Description
Edinburg Postnatal Depression Scale. Score 0-30. Score > or = 10 considered greater risk of depression.
Time Frame
4-8 weeks postpartum
Title
Development of postpartum depression
Description
Edinburg Postnatal Depression Scale. Score 0-30. Score > or = 10 considered greater risk of depression.
Time Frame
12 weeks postpartum
Title
Development of postpartum depression
Description
Edinburg Postnatal Depression Scale. Score 0-30. Score > or = 10 considered greater risk of depression.
Time Frame
6 months postpartum
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Women who deliver at the Hershey Medical Center
Postpartum women within first week after delivery
Women who are 18 years of age or older
Exclusion Criteria:
Postpartum women who delivered newborn before 35 0/7 gestational age.
Postpartum women whose newborn required any length of stay in the newborn intensive care unit.
Postpartum women who do not speak English.
Postpartum women who are less than 18 years old.
Postpartum women who are unable to provide consent.
Postpartum women who were on antidepressant or antianxiety medication or undergoing therapy for depression or anxiety during pregnancy or during postpartum hospitalization.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Brittany A Massare, MD
Organizational Affiliation
Milton S. Hershey Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Penn State Hershey Medical Center
City
Hershey
State/Province
Pennsylvania
ZIP/Postal Code
17033
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
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Does Enhancing Maternal Peer Interactions Decrease Rates of Postpartum Depression?
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