READ BELOW TO
FIND OUT:
- What is the
purpose of this study?
- Why might I
participate?
- What are the
symptoms?
- Who is eligible
to participate?
- What is the
treatment?
- More about our
program and our staff
What is the
purpose of this study?
The
Clinical Chronobiology group at Columbia-Presbyterian Medical Center
is conducting
this study to test non-drug treatment for depression during pregnancy. More
specifically, we are looking to find out if exposure to light relieves
symptoms of depression in pregnant women and to see if changes in
the timing of your body’s biological rhythm (meaning your production of
melatonin) are related to the therapeutic effects of light.
Why might I
participate?
Beyond
the expected physical discomforts of pregnancy – sleep problems,
frequent urination,
appetite changes, weight gain and bloating – pregnant mothers face
emotional challenges that can seriously affect mood, energy levels,
productivity, social life and motivation. Even if excited about the
baby, some expectant mothers develop serious depression.
Clinically,
this is called “antepartum depression” – or depression before giving
birth – and
it affects as many as 10% of pregnant women. It is also the largest
predictor of a postpartum depressive episode.
Participation
is voluntary and treatment is free. Participants receive expert diagnosis
and supervision along with loan of the treatment apparatus. Read
below to find out if this study is right for you.
What are the
symptoms?
Women with
antepartum depression feel a range of the following symptoms:
- Difficulty
falling asleep, staying asleep, or sleeping too much
- Fatigue or lack
of energy
- Loss of interest
or pleasure in activities
- Feeling down,
sad, or hopeless
- Feeling bad about
yourself or feeling you were letting yourself or family down
- Trouble
concentrating
Who
is eligible to participate?
Pregnant women from
age 18 to 40 who are currently experiencing depression, whether it began
before or after the onset of pregnancy, are eligible.
Throughout
the study, participants will continue to be monitored by their own
obstetrician.
Women will not be
eligible for the study if they have a current medical illness or if they
are using psychiatric medications, including antidepressants. Any use of
alcohol or recreational drugs is not allowed. Participants also must
be able to maintain a regular sleep schedule.
What
is the treatment?
During
the study, patients are loaned a portable, lightweight light box
to be used at home
for 60 minutes each morning while engaging in any quiet activity with eyes
open, such as reading, writing, or having breakfast. Treatment
continues daily for 5 weeks, during which we monitor progress with
a diary,
telephone contact with staff, and clinic visits every 1 to 2 weeks.
Participants are
randomly assigned (similar to the flip of a coin) to one of two different
light boxes that produce different amounts of light. Both provide
significantly more light than you would otherwise receive indoors in the
hours after you wake up. One of the boxes produces a total dose of light
that is expected to be effective for treating depression. The other
produces a different dose of light that is less likely to be effective. However,
just as individual patients may respond optimally to different doses of
a drug, individual patients might respond to either type of light
box.
You will not be
told which dose you are assigned. However, if you are given the less
active dose and do not respond, after 5 weeks you will have the option
of
continuing treatment with the alternate dose. The informed consent process
will include a discussion of the risks and benefits of participation.
About
our program:
The
Clinical Chronobiology group is a worldwide leader in developing
innovative,
effective new treatments for depression. Since 1984, we have pioneered
the concept that environmental therapies – supplementing indoor light and
air conditions – leads to an improved mood state in people with
depression. This discovery was made while treating people with winter
depression.
Our
Team:
Dr.
Michael Terman, Director, received his Ph.D. degree in physiological
psychology from Brown
University, and is a Professor in the Psychiatry Department at Columbia’s
College of Physicians & Surgeons. He collaborates in his
work with his long-time associate, Dr. Jiuan Su Terman, and their
associates, Dr. Ziad
Boulos and Dr. Mila Macchi.
FOR
MORE INFORMATION ABOUT THIS CLINICAL TRIAL,
PLEASE CALL 212-543-6118 x2
OR EMAIL US AT
NY-NJ@pregnancylight.org
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