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Dear Friend,
Thank you for your interest in our clinical
research program in depression during pregnancy
("antepartum depresion"). Before you complete our
questionnaire, we would like to tell you about our
procedures and objectives. We are offering
non-pharmacological treatment for alleviation of
symptoms that are associated with depressed mood
during pregnancy. Ours is a research program in
which you would receive home treatment under expert
clinical supervision, while allowing us to learn
more about the disorder and how it may best be
treated. We are conducting a controlled study using
specially-designed devices that replenish naturally
occurring light. During the course of the study,
you would use an apparatus to increase daily
light.
As a participant you would receive treatment and
loan of the light apparatus for use at home at no
cost to you. If you agree to participate in this
study, a review of your medical history will
confirm that you are under the care of an
obstetrician, and that you are in stable medical
health. We will provide standard blood and urine
tests at no charge. During the study, you would
also receive a series of tests designed to measure
your melatonin cycle before and after
treatment.
Pending review of your application, you would
receive an initial interview by telephone to
determine whether you would be likely to benefit by
these experimental treatments and could meet the
scheduling requirements of the study. The next step
is a personal clinical evaluation session, followed
by an orientation session. Once the symptoms are
apparent, home treatment begins on a daily basis,
and you would maintain close contact with our
staff. Assignment to the various light treatments
we are testing is made randomly, but over the
course of the study, you would be given an
opportunity to try both methods, to see which works
best for you. Over a period of about two months, we
would also schedule several visits to our clinic at
the University of Pittsburgh for evaluation of
treatment effectiveness. After participation in the
study is complete, we offer continuing treatment
throughout the remaining months of pregnancy for
those who have shown benefit.
Please note that all information you provide is
confidential, and that when we call we will not
identify ourselves to anyone but you. Completing
and returning the application does not obligate you
to participate in our study. In addition, if you
are invited to enter our program, you will have the
option of discontinuing at any time. A prompt
response will allow us to give you priority
consideration.
If you do not wish to become a research
volunteer, but instead seek a private referral in
the Pittsburgh, PA area, please complete the
application anyway, noting your request at the
top.
We look forward to hearing from you.
Sincerely yours,
Dr. Katherine L. Wisner,
Director of the Antepartum Depression Group
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