Does Enhancing Maternal Peer Interactions Decrease Rates of Postpartum Depression?

NCT03793569 | Completed

• 1 other identifier: STUDY00007890
• Study Type: interventional
• Target: 33
• Locations: 1 country
• Sites: 1

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.

Conditions

Postpartum Depression

Outcome Measures

Primary Outcomes (3)

• 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

• Development of postpartum depression

  Edinburg Postnatal Depression Scale. Score 0-30. Score \> or = 10 considered greater risk of depression.

  12 weeks postpartum

• Development of postpartum depression

  Edinburg Postnatal Depression Scale. Score 0-30. Score \> or = 10 considered greater risk of depression.

  6 months postpartum

Study Arms (2)

Control group

NO INTERVENTION

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

Intervention group

EXPERIMENTAL

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

Interventions

Peer discussion group BEHAVIORAL

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.

Intervention group

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Women who deliver at the Hershey Medical Center
• Postpartum women within first week after delivery
• Women who are 18 years of age or older

You may not qualify if:

• 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.

Sponsors & Collaborators

• Milton S. Hershey Medical Center: lead

Study Sites (1)

Penn State Hershey Medical Center

Hershey, Pennsylvania, 17033, United States

Location

MeSH Terms

Conditions

Depression, Postpartum

Condition Hierarchy (Ancestors)

Puerperal Disorders; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Depressive Disorder; Mood Disorders; Mental Disorders

Study Officials

• Brittany A Massare, MD

  Milton S. Hershey Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Control group and intervention group. Intervention group will participate in peer discussion group.

Study Record Dates

• First Submitted: June 5, 2018
• First Posted: January 4, 2019
• Study Start: August 27, 2018
• Primary Completion: July 30, 2019
• Study Completion: July 30, 2019
• Last Updated: August 22, 2019

Record last verified: 2019-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)