NCT00816725

Brief Summary

The original trial will evaluate the effectiveness of a Web-based program in preventing postpartum depression. The site has been modified to provide materials from both conditions.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
1,000

participants targeted

Target at P75+ for not_applicable depression

Timeline
Completed

Started Jan 2009

Longer than P75 for not_applicable depression

Geographic Reach
1 country

1 active site

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

Study Start

First participant enrolled

January 1, 2009

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

January 2, 2009

Completed
3 days until next milestone

First Posted

Study publicly available on registry

January 5, 2009

Completed
4.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2013

Completed
Last Updated

April 11, 2014

Status Verified

April 1, 2014

Enrollment Period

4.4 years

First QC Date

January 2, 2009

Last Update Submit

April 10, 2014

Conditions

DepressionPostpartum Depression

Keywords

Postnatal DepressionCognitive Behavioral TherapyMood ManagementSelf-helpInternet

Outcome Measures

Primary Outcomes (1)

  • Edinburgh Postnatal Depression Scale (EPDS)

    Measured monthly for 6 months postpartum

Secondary Outcomes (1)

  • Center for Epidemiologic Studies-Depression (CES-D) Scale

    Measured monthly for 6 months postpartum

Study Arms (1)

Self-help course and information

EXPERIMENTAL
Behavioral: Mothers and babies Internet course and PPD informational brochure

Interventions

Mothers and babies Internet course and PPD informational brochureBEHAVIORAL

An eight-lesson, self-help, Web-based program for the prevention of postpartum depression based on cognitive behavioral therapy, social-learning, and attachment theory. The PPD informational brochure is a four-page pamphlet that contains information about postpartum depression.

Self-help course and information

Eligibility Criteria

Age18 Years - 60 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Pregnant
  • Fluent in English or Spanish

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of California, San Francisco

San Francisco, California, 94110, United States

Location

Related Publications (1)

  • Barrera AZ, Kelman AR, Munoz RF. Keywords to recruit Spanish- and English-speaking participants: evidence from an online postpartum depression randomized controlled trial. J Med Internet Res. 2014 Jan 9;16(1):e6. doi: 10.2196/jmir.2999.

    PMID: 24407163DERIVED

MeSH Terms

Conditions

DepressionDepression, Postpartum

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehaviorPuerperal DisordersPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesDepressive DisorderMood DisordersMental Disorders

Study Officials

  • Alinne Z. Barrera, PhD

    University of California, San Francisco

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Staff Psychologist

Study Record Dates

First Submitted

January 2, 2009

First Posted

January 5, 2009

Study Start

January 1, 2009

Primary Completion

June 1, 2013

Study Completion

June 1, 2013

Last Updated

April 11, 2014

Record last verified: 2014-04

Locations

US(1)