Online Intervention to Prevent Perinatal Depression and Promote Breastfeeding

Sponsor

University of Illinois at Chicago (Other)

Overall Status

Completed

CT.gov ID

NCT04128202

Collaborator

(none)

Enrollment

Location

Arms

Actual Duration (Months)

1.7

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Depression Breastfeeding	Behavioral: Sunnyside Behavioral: Sunnyside Plus	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

22 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Prevention

Official Title:

Online Intervention to Prevent Perinatal Depression and Promote Breastfeeding

Actual Study Start Date :

Jun 15, 2020

Actual Primary Completion Date :

Jul 1, 2021

Actual Study Completion Date :

Jul 15, 2021

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Sunnyside An online intervention to better manage mood during and after pregnancy.	Behavioral: Sunnyside 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.
Experimental: Sunnyside Plus An online intervention to better manage mood and promote and support breastfeeding during and after pregnancy.	Behavioral: Sunnyside Plus 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).

Arm

Intervention/Treatment

Active Comparator: Sunnyside

An online intervention to better manage mood during and after pregnancy.

Behavioral: Sunnyside

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.

Experimental: Sunnyside Plus

An online intervention to better manage mood and promote and support breastfeeding during and after pregnancy.

Behavioral: Sunnyside Plus

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).

Outcome Measures

Primary Outcome Measures

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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Yes

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).

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Illinois at Chicago	Chicago	Illinois	United States	60612

Sponsors and Collaborators

University of Illinois at Chicago

Investigators

Principal Investigator: Jennifer Duffecy, PhD, University of Illinois at Chicago

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Jennifer Duffecy, Principal Investigator, University of Illinois at Chicago

ClinicalTrials.gov Identifier:

NCT04128202

Other Study ID Numbers:

2019-0519

First Posted:

Oct 16, 2019

Last Update Posted:

Jul 26, 2021

Last Verified:

Jul 1, 2021

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Depression

Depressive Disorder

Study Results

No Results Posted as of Jul 26, 2021