NCT02121015

Brief Summary

The overarching aim of this project is to develop and pilot an innovative online intervention (Share) that integrates an Individual Internet Intervention (III) and an Internet Support Group (ISG) in preventing Postpartum Major Depression (PPMD). To establish that supportive accountability is a critical component of the intervention, Share will be compared to an III alone, and an ISG without the III components.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
210

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started May 2016

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 17, 2014

Completed
2 months until next milestone

First Posted

Study publicly available on registry

April 23, 2014

Completed
2 years until next milestone

Study Start

First participant enrolled

May 1, 2016

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2017

Completed
Last Updated

January 18, 2020

Status Verified

January 1, 2020

Enrollment Period

1.5 years

First QC Date

February 17, 2014

Last Update Submit

January 13, 2020

Conditions

Depression, Postpartum

Keywords

Postpartum DepressionDepression PreventionSupportive AccountabilityIndividual Internet Interventions (IIIs)Internet Support Groups (ISGs)

Outcome Measures

Primary Outcomes (1)

  • Change in depression symptoms over time as measured by the Inventory of Depression and Anxiety Symptoms (IDAS)

    Week 20

Secondary Outcomes (3)

  • Usability and satisfaction based on the USE measure

    Week 20

  • Diagnosis of Major Depressive Disorder based on the Mini International Neuropsychiatric Interview (MINI)

    Week 20

  • Site usage as measured by the number of logins to the site over the course of the intervention

    Week 20

Study Arms (2)

Self-Directed

ACTIVE COMPARATOR

Access to the e-health intervention (an interactive website with didactic material and interactive tools) for participants to use at their own pace for 8 weeks (Self-Directed)

Behavioral: Self-Directed

Share

EXPERIMENTAL

Access to the same e-health intervention + an internet social networking component consisting of up to 12 other pregnant women (Share).

Behavioral: Share

Interventions

ShareBEHAVIORAL
Share
Self-DirectedBEHAVIORAL
Self-Directed

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Women who are:
  • years and older
  • Pregnant and between 20 and 28 weeks gestation and for whom there is an expectation of a full 40 week gestation at the birth of their child
  • Have a Patient Health Questionnaire (PHQ-9) score score between 5-14
  • Have access to a broadband internet connection
  • Are able to read and speak English

You may not qualify if:

  • Women who:
  • Have visual, hearing, voice, or motor impairment that would prevent completion of study procedures
  • Are diagnosed with a psychotic disorder, bipolar disorder, dissociative disorder, substance use disorder or other diagnosis using the Mini International Neuropsychiatric Interview (MINI) for which participation in this trial is either inappropriate or dangerous
  • Are currently receiving treatment (medication or psychotherapy), or have an intention to resume antidepressant medication after delivery (i.e., women who discontinued their medication during pregnancy)
  • Are suicidal (i.e., have ideation, plan, and intent)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

University of Illinois at Chicago

Chicago, Illinois, 60612, United States

Location

Northwestern University

Chicago, Illinois, United States

Location

University of Iowa

Iowa City, Iowa, United States

Location

Related Publications (2)

  • Duffecy J, Grekin R, Long JD, Mills JA, O'Hara M. Randomized controlled trial of Sunnyside: Individual versus group-based online interventions to prevent postpartum depression. J Affect Disord. 2022 Aug 15;311:538-547. doi: 10.1016/j.jad.2022.05.123. Epub 2022 May 30.

    PMID: 35654284DERIVED

  • Duffecy J, Grekin R, Hinkel H, Gallivan N, Nelson G, O'Hara MW. A Group-Based Online Intervention to Prevent Postpartum Depression (Sunnyside): Feasibility Randomized Controlled Trial. JMIR Ment Health. 2019 May 28;6(5):e10778. doi: 10.2196/10778.

    PMID: 31140443DERIVED

MeSH Terms

Conditions

Depression, Postpartum

Interventions

Reimbursement, Disproportionate Share

Condition Hierarchy (Ancestors)

Puerperal DisordersPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesDepressive DisorderMood DisordersMental Disorders

Intervention Hierarchy (Ancestors)

Reimbursement MechanismsInsurance, Health, ReimbursementFinancing, OrganizedEconomicsHealth Care Economics and Organizations

Study Officials

  • Jennifer Duffecy, PhD

    University of Illinois at Chicago

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

February 17, 2014

First Posted

April 23, 2014

Study Start

May 1, 2016

Primary Completion

November 1, 2017

Study Completion

November 1, 2017

Last Updated

January 18, 2020

Record last verified: 2020-01

Locations

US(3)