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Effectiveness of a Web-Based Prevention Program for Postpartum Depression
This study is currently recruiting participants.
Verified by National Institute of Mental Health (NIMH), January 2009
Sponsored by: National Institute of Mental Health (NIMH)
Information provided by: National Institute of Mental Health (NIMH)
ClinicalTrials.gov Identifier: NCT00816725
  Purpose

This study will evaluate the effectiveness of a Web-based program in preventing postpartum depression.


Condition Intervention
Depression
Postpartum Depression
Behavioral: Mothers and babies Internet course
Other: Informational materials

MedlinePlus related topics: Depression Postpartum Depression
U.S. FDA Resources
Study Type: Interventional
Study Design: Prevention, Randomized, Open Label, Parallel Assignment, Efficacy Study
Official Title: Using the Internet for English/Spanish Randomized Trials for Postpartum Depression

Further study details as provided by National Institute of Mental Health (NIMH):

Primary Outcome Measures:
  • Edinburgh Postnatal Depression Scale (EPDS) [ Time Frame: Measured monthly for 6 months postpartum ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Center for Epidemiologic Studies-Depression (CES-D) Scale [ Time Frame: Measured monthly for 6 months postpartum ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 1000
Study Start Date: January 2009
Estimated Study Completion Date: June 2010
Estimated Primary Completion Date: June 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
1: Experimental
Participants will receive information about postpartum depression and access to an interactive mood management course online.
Behavioral: Mothers and babies Internet course
An eight-lesson, self-help, Web-based program for the prevention of postpartum depression based on cognitive behavioral therapy, social-learning, and attachment theory
Other: Informational materials
A four-page informational brochure on postpartum depression
2
Participants will receive only information about postpartum depression.
Other: Informational materials
A four-page informational brochure on postpartum depression

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.

Participants will 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 be randomly assigned to receive either the Internet-based course called "Mothers and Babies/Mamás y Bebés" (M&B) or only informational materials. The informational materials will include information about postpartum depression and depression that may occur before childbirth. Participants assigned to the M&B course will receive this same information and will have unlimited access to the M&B interactive mood management intervention online. All participants will undergo monthly assessments for the duration of the study, to be completed online. These assessments will measure mood, depression, and satisfaction with the assigned intervention.

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Pregnant
  • Fluent in English or Spanish
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00816725

Contacts
Contact: Alinne Z. Barrera, PhD 415-206-6166 alinne.barrera@ucsf.edu

Locations
United States, California
University of California, San Francisco Recruiting
San Francisco, California, United States, 94110
Contact: Alinne Z. Barrera, PhD     415-206-6166     alinne.barrera@ucsf.edu    
Principal Investigator: Alinne Z. Barrera, PhD            
Sub-Investigator: Ricardo F. Muñoz, PhD            
Sponsors and Collaborators
Investigators
Principal Investigator: Alinne Z. Barrera, PhD University of California, San Francisco
  More Information

English-speaking women interested in participating can click here to learn more.  This link exits the ClinicalTrials.gov site
Spanish-speaking women interested in participating can click here to learn more.  This link exits the ClinicalTrials.gov site

Responsible Party: University of California, San Francisco ( Alinne Z. Barrera, PhD/Postdoctoral Fellow )
Study ID Numbers: F32 MH077371, 5A, DATR AK-TAIF
Study First Received: January 2, 2009
Last Updated: January 15, 2009
ClinicalTrials.gov Identifier: NCT00816725  
Health Authority: United States: Federal Government

Keywords provided by National Institute of Mental Health (NIMH):
Postnatal Depression
Cognitive Behavioral Therapy
Mood Management
Self-help
Internet

Study placed in the following topic categories:
Pregnancy Complications
Depression
Puerperal Disorders
Depression, Postpartum
Mental Disorders
Mood Disorders
Depressive Disorder
Behavioral Symptoms

ClinicalTrials.gov processed this record on January 30, 2009