Effectiveness of a Web-based Prevention Program for Postpartum Depression

April 10, 2014 updated by: Alinne Barrera, University of California, San Francisco

Using the Internet for English/Spanish Randomized Trials for Postpartum Depression

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Depression is a mental health condition in which symptoms such as sadness, inability to feel pleasure, and loss of energy interfere with a person's normal life. Postpartum depression is a type of depression experienced by women after giving birth to a child. In this study an intervention for preventing postpartum depression that has been adapted for use over the Internet will be tested. Administering a depression-prevention program over the Internet has several advantages: after the initial investment is made to develop the program, costs are lower for treating each patient; online treatment is more accessible to a greater number of people than any given clinic; and participants who may be worried about a stigma associated with mental health problems often feel more comfortable seeking information through the Internet. Previous research has shown that symptoms of depression can be reduced through Internet-based interventions, but no research has examined such interventions specifically for postpartum depression. The program tested in this study is not aimed at replacing in-person mental health care-in fact, people who have signs of serious depression will be directed to in-person mental health care. Instead, the program is aimed at providing an additional mental health service among the range of available options.

The original trial was a two-arm pilot prevention of postpartum depression trial comparing the Internet-based course called "Mothers and Babies/Mamás y Bebés" (M&B) to informational materials on postpartum depression. In the original trial, 1088 pregnant women were recruited and randomized (as anticipated) to either condition. The study Website has therefore been modified such that all participants who consent to participate will now receive materials from both conditions. We have eliminated the randomization procedure.

As in the original study, participants be allowed to enroll at any time during their pregnancies and will be followed for 6 months after the birth of their children, so the length of participation will vary between 6 and 15 months. After undergoing a screening process, participants will now have access to both the Internet-based course called "Mothers and Babies/Mamás y Bebés" (M&B) and the informational materials. The informational materials will include information about postpartum depression and depression that may occur before childbirth. All participants will be invited via email to complete monthly assessments for the duration of the study. These assessments will measure mood, depression, and satisfaction with the assigned intervention.

Study Type

Interventional

Enrollment (Anticipated)

1000

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • San Francisco, California, United States, 94110
        • University of California, San Francisco

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 60 years (ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Pregnant
  • Fluent in English or Spanish

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: PREVENTION
  • Allocation: NON_RANDOMIZED
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Self-help course and information
Behavioral: Mothers and babies Internet course and PPD informational brochure
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Edinburgh Postnatal Depression Scale (EPDS)
Time Frame: Measured monthly for 6 months postpartum
Measured monthly for 6 months postpartum

Secondary Outcome Measures

Outcome Measure
Time Frame
Center for Epidemiologic Studies-Depression (CES-D) Scale
Time Frame: Measured monthly for 6 months postpartum
Measured monthly for 6 months postpartum

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of California, San Francisco

Collaborators

National Institute of Mental Health (NIMH)

Investigators

  • Principal Investigator: Alinne Z. Barrera, PhD, University of California, San Francisco

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2009

Primary Completion (ACTUAL)

June 1, 2013

Study Completion (ACTUAL)

June 1, 2013

Study Registration Dates

First Submitted

January 2, 2009

First Submitted That Met QC Criteria

January 2, 2009

First Posted (ESTIMATE)

January 5, 2009

Study Record Updates

Last Update Posted (ESTIMATE)

April 11, 2014

Last Update Submitted That Met QC Criteria

April 10, 2014

Last Verified

April 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • F32MH077371 (NIH)
  • 5A
  • DATR AK-TAIF (OTHER_GRANT: National Institute of Mental Health)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Depression

Clinical Trials on Mothers and babies Internet course and PPD informational brochure

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