Online Intervention to Prevent Perinatal Depression and Promote Breastfeeding

Not Applicable

Completed

• Conditions: Depression; Breastfeeding
• Interventions: Behavioral: Sunnyside; Behavioral: Sunnyside Plus

• Registration Number: NCT04128202
• Lead Sponsor: University of Illinois at Chicago

Brief Summary

"SunnysidePlus" will functionally integrate a web based intervention targeting skills to promote and support breastfeeding, manage mood,and prevent depression. Sunnyside Plus will build upon the previously tested "Sunnyside" intervention which targeted skills to manage mood through an interactive website with didactic material and tools. Women in weeks 20-28 of their pregnancy will be randomized to receive either Sunnyside Plus or Sunnyside. The Sunnyside intervention will consist of 6 weeks of online lessons during pregnancy and booster sessions at 2 weeks, 4 weeks, and 6 weeks postpartum. Sunnyside Plus will include additional education and support to improve breastfeeding outcomes. Breastfeeding education and skills will be provided during the 6 weeks of online lessons during pregnancy. Breastfeeding support will continue through 6 weeks postpartum. This postpartum support will involve weekly online lessons, text support, and video support calls with a Lactation Educator provided on an as-needed basis. SunnysidePlus has the potential to provide a novel paradigm for improving breastfeeding outcomes and preventing depression; one that is accessible, highly scalable and cost-effective.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-10-02
• Study First Submitted QC: 2019-10-14
• Study First Posted: 2019-10-16
• Study Start: 2020-06-15
• Status Verified: 2021-07
• Primary Completion: 2021-07-01
• Study Completion: 2021-07-15
• Last Update Submitted: 2021-07-22
• Last Update Posted: 2021-07-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 22

Inclusion Criteria

• Female
• Black or African American
• 18 years and older
• Pregnant and between 20 and 28 weeks gestation
• Intend to breastfeed their child
• Have a score of 5-14 on the Patient Health Questionnaire-8 (PHQ-8)
• Have access to a broadband internet connection
• Are able to read and speak English

Exclusion Criteria

• Are pregnant with multiples
• Have visual, hearing, voice, or motor impairment that would prevent completion of study procedures
• Diagnosed with a major depressive episode, psychotic disorder, bipolar disorder, dissociative disorder, substance use disorder or other diagnosis for which participation in this trial is either inappropriate or dangerous based on self-report
• Are currently receiving treatment (medication or psychotherapy),have an intention to resume antidepressant medication after delivery (i.e., women who discontinued their medication during pregnancy).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Sunnyside	Sunnyside	An online intervention to better manage mood during and after pregnancy.
Sunnyside Plus	Sunnyside Plus	An online intervention to better manage mood and promote and support breastfeeding during and after pregnancy.

Primary Outcome Measures

Name	Time	Method
Patient Health Questionnaire-9 (PHQ-9)	2 weeks	The PHQ-9 is composed of 9 scored items and 1 unscored item which reflect overall functioning and impairment due to the depressive symptoms. PHQ-9 scoring interpretations are as follows: 1-4: minimal depressive symptoms; 5-9 mild depressive symptoms; 10-14: moderate depressive symptoms; 15-19: moderately severe depressive symptoms: 20-27: severe depressive symptoms.
Breastfeeding Status	Through 12 weeks postpartum	Breastfeeding initiation, exclusivity, and duration will be assessed in the postpartum period.

Trial Locations

Locations (1)

University of Illinois at Chicago; 🇺🇸 Chicago, Illinois, United States