Depression Clinical Trial
Official title:
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 careāin 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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Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention
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