Effectiveness of a Web-based Prevention Program for Postpartum Depression
| Tracking Information | |||||
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| First Received Date ICMJE | January 2, 2009 | ||||
| Last Updated Date | June 29, 2012 | ||||
| Start Date ICMJE | January 2009 | ||||
| Estimated Primary Completion Date | June 2013 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
Edinburgh Postnatal Depression Scale (EPDS) [ Time Frame: Measured monthly for 6 months postpartum ] [ Designated as safety issue: Yes ] | ||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | Complete list of historical versions of study NCT00816725 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
Center for Epidemiologic Studies-Depression (CES-D) Scale [ Time Frame: Measured monthly for 6 months postpartum ] [ Designated as safety issue: Yes ] | ||||
| Original Secondary Outcome Measures ICMJE | Same as current | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Effectiveness of a Web-based Prevention Program for Postpartum Depression | ||||
| Official Title ICMJE | Using the Internet for English/Spanish Randomized Trials for Postpartum Depression | ||||
| 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. |
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| 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. |
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| Study Type ICMJE | Interventional | ||||
| Study Phase | Not Provided | ||||
| Study Design ICMJE | Allocation: Non-Randomized Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Prevention |
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| Condition ICMJE |
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| Intervention ICMJE | 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. |
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| Study Arm (s) | Experimental: Self-help course and information
Intervention: Behavioral: Mothers and babies Internet course and PPD informational brochure |
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| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Active, not recruiting | ||||
| Estimated Enrollment ICMJE | 1000 | ||||
| Estimated Completion Date | June 2013 | ||||
| Estimated Primary Completion Date | June 2013 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
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| Gender | Female | ||||
| Ages | 18 Years to 60 Years | ||||
| Accepts Healthy Volunteers | Yes | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | United States | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT00816725 | ||||
| Other Study ID Numbers ICMJE | F32 MH077371, F32MH077371, 5A, DATR AK-TAIF | ||||
| Has Data Monitoring Committee | No | ||||
| Responsible Party | Alinne Barrera, University of California, San Francisco | ||||
| Study Sponsor ICMJE | University of California, San Francisco | ||||
| Collaborators ICMJE | National Institute of Mental Health (NIMH) | ||||
| Investigators ICMJE |
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| Information Provided By | University of California, San Francisco | ||||
| Verification Date | June 2012 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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