Online Intervention to Prevent Perinatal Depression and Promote Breastfeeding
Primary Purpose
Depression, Breastfeeding
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Sunnyside
Sunnyside Plus
Sponsored by
About this trial
This is an interventional prevention trial for Depression
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).
Sites / Locations
- University of Illinois at Chicago
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Sunnyside
Sunnyside Plus
Arm Description
An online intervention to better manage mood during and after pregnancy.
An online intervention to better manage mood and promote and support breastfeeding during and after pregnancy.
Outcomes
Primary Outcome Measures
Patient Health Questionnaire-9 (PHQ-9)
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
Breastfeeding initiation, exclusivity, and duration will be assessed in the postpartum period.
Secondary Outcome Measures
Full Information
NCT ID
NCT04128202
First Posted
October 2, 2019
Last Updated
July 22, 2021
Sponsor
University of Illinois at Chicago
1. Study Identification
Unique Protocol Identification Number
NCT04128202
Brief Title
Online Intervention to Prevent Perinatal Depression and Promote Breastfeeding
Official Title
Online Intervention to Prevent Perinatal Depression and Promote Breastfeeding
Study Type
Interventional
2. Study Status
Record Verification Date
July 2021
Overall Recruitment Status
Completed
Study Start Date
June 15, 2020 (Actual)
Primary Completion Date
July 1, 2021 (Actual)
Study Completion Date
July 15, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Illinois at Chicago
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
"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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Depression, Breastfeeding
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
22 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Sunnyside
Arm Type
Active Comparator
Arm Description
An online intervention to better manage mood during and after pregnancy.
Arm Title
Sunnyside Plus
Arm Type
Experimental
Arm Description
An online intervention to better manage mood and promote and support breastfeeding during and after pregnancy.
Intervention Type
Behavioral
Intervention Name(s)
Sunnyside
Intervention Description
The Sunnyside intervention is an online intervention (an interactive website with didactic material and interactive tools) targeting skills to manage mood during and after pregnancy. The Sunnyside intervention will consist of 6weeks of online lessons during pregnancy and booster sessions at 2 weeks, 4 weeks, and 6 weeks postpartum. Each lesson takes approximately 10 minutes to complete.
Intervention Type
Behavioral
Intervention Name(s)
Sunnyside Plus
Intervention Description
Sunnyside Plus will build upon the Sunnyside intervention, plus include additional education and support to promote breastfeeding. Breastfeeding education and skills will be provided during the 6weeks of online lessons during pregnancy; each lesson takes approximately 10 minutes to complete. Breastfeeding support will continue through 6 weeks postpartum. This postpartum support will involve weekly online lessons(each taking approximately 10 minutes to complete), text support messages(3 sent during weeks 1 and 2, 2 sent during weeks 3 and 4, 1 sent during weeks 5 and 6), and video support calls with a Lactation Educator (LE)provided on an as-needed basis(exception: at least 1 video call is required during both week 1 postpartum and week 2 postpartum).
Primary Outcome Measure Information:
Title
Patient Health Questionnaire-9 (PHQ-9)
Description
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.
Time Frame
2 weeks
Title
Breastfeeding Status
Description
Breastfeeding initiation, exclusivity, and duration will be assessed in the postpartum period.
Time Frame
Through 12 weeks postpartum
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jennifer Duffecy, PhD
Organizational Affiliation
University of Illinois at Chicago
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Illinois at Chicago
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
35503244
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.
Results Reference
derived
Learn more about this trial
Online Intervention to Prevent Perinatal Depression and Promote Breastfeeding
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