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Does Enhancing Maternal Peer Interactions Decrease Rates of Postpartum Depression?

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ClinicalTrials.gov Identifier: NCT03793569
Recruitment Status : Active, not recruiting
First Posted : January 4, 2019
Last Update Posted : January 4, 2019
Sponsor:
Information provided by (Responsible Party):
Brittany Massare, 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.

Condition or disease Intervention/treatment Phase
Postpartum Depression Behavioral: Peer discussion group Not Applicable

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.


Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 33 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Control group and intervention group. Intervention group will participate in peer discussion group.
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Does Enhancing Maternal Peer Interactions Decrease Rates of Postpartum Depression?
Actual Study Start Date : August 27, 2018
Estimated Primary Completion Date : July 1, 2019
Estimated Study Completion Date : August 30, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
No Intervention: Control group
Participants will be recruited and asked to complete Edinburgh Postnatal Depression Scale (EPDS) at specific timepoints postpartum.
Experimental: Intervention group
Participants will be recruited, asked to complete Edinburgh Postnatal Depression Scale at specific timepoints postpartum, and attend a peer discussion group.
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.




Primary Outcome Measures :
  1. Development of postpartum depression [ Time Frame: 4-8 weeks postpartum ]
    EPDS score > or = 10

  2. Development of postpartum depression [ Time Frame: 12 weeks postpartum ]
    EPDS score > or = 10

  3. Development of postpartum depression [ Time Frame: 6 months postpartum ]
    EPDS score > or = 10



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03793569


Locations
United States, Pennsylvania
Penn State Hershey Medical Center
Hershey, Pennsylvania, United States, 17033
Sponsors and Collaborators
Milton S. Hershey Medical Center
Investigators
Principal Investigator: Brittany A Massare, MD Milton S. Hershey Medical Center

Responsible Party: Brittany Massare, Principal Investigator, Milton S. Hershey Medical Center
ClinicalTrials.gov Identifier: NCT03793569     History of Changes
Other Study ID Numbers: STUDY00007890
First Posted: January 4, 2019    Key Record Dates
Last Update Posted: January 4, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Depression
Depressive Disorder
Depression, Postpartum
Behavioral Symptoms
Mood Disorders
Mental Disorders
Puerperal Disorders
Pregnancy Complications