Effectiveness of a Web-based Prevention Program for Postpartum Depression

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Alinne Barrera, University of California, San Francisco
ClinicalTrials.gov Identifier:
NCT00816725
First received: January 2, 2009
Last updated: April 10, 2014
Last verified: April 2014

January 2, 2009
April 10, 2014
January 2009
June 2013   (final data collection date for primary outcome measure)
Edinburgh Postnatal Depression Scale (EPDS) [ Time Frame: Measured monthly for 6 months postpartum ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT00816725 on ClinicalTrials.gov Archive Site
Center for Epidemiologic Studies-Depression (CES-D) Scale [ Time Frame: Measured monthly for 6 months postpartum ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
Effectiveness of a Web-based Prevention Program for Postpartum Depression
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.

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.

Interventional
Not Provided
Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
  • Depression
  • Postpartum Depression
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.
Experimental: Self-help course and information
Intervention: Behavioral: Mothers and babies Internet course and PPD informational brochure
Barrera AZ, Kelman AR, Muñoz 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
1000
June 2013
June 2013   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Pregnant
  • Fluent in English or Spanish
Female
18 Years to 60 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00816725
F32 MH077371, F32MH077371, 5A, DATR AK-TAIF
No
Alinne Barrera, University of California, San Francisco
University of California, San Francisco
National Institute of Mental Health (NIMH)
Principal Investigator: Alinne Z. Barrera, PhD University of California, San Francisco
University of California, San Francisco
April 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP