Clinical trial NCT04128202: Online Intervention to Prevent Perinatal Depression and Promote Breastfeeding
Official title: Online Intervention to Prevent Perinatal Depression and Promote Breastfeeding
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Depression
Breastfeeding
Lead sponsor: University of Illinois at Chicago
Sponsor class: OTHER
First posted: 2019-10-16
Enrollment: 22
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


Eligibility criteria: 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).

Primary outcomes:
measure: Patient Health Questionnaire-9 (PHQ-9)
timeFrame: 2 weeks
measure: Breastfeeding Status
timeFrame: Through 12 weeks postpartum
Secondary outcomes:
Other outcomes:
Locations:
city: Chicago
country: United States
facility: University of Illinois at Chicago
state: Illinois
Study officials:
affiliation: University of Illinois at Chicago
name: Jennifer Duffecy, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Pezley L, Tussing-Humphreys L, Koenig MD, Maki P, Odoms-Young A, Freels S, DiPiazza B, Cann F, Cares K, Depa C, Klejka G, Lima Oliveira M, Prough J, Roe T, Buscemi J, Duffecy J. Feasibility of a Web-Based Intervention to Prevent Perinatal Depression and Promote Human Milk Feeding: Randomized Pilot Trial. JMIR Form Res. 2022 May 3;6(5):e32226. doi: 10.2196/32226.