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Therapy, Medication Combination Superior for Children with Obsessive-Compulsive Disorder

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Duke Health News 919-660-1306

DURHAM, N.C. – Children with obsessive-compulsive disorder
(OCD) fare best when treated with a combination of cognitive
behavioral therapy (CBT) and sertraline (trade name Zoloft),
researchers at Duke University Medical Center and their
colleagues at two other research institutions have determined.
The team's research findings appear in the October 27, 2004
issue of the Journal of the American Medical Association.

Despite knowing that OCD is illogical, children and
adolescents with OCD dwell or "obsess" on unwanted thoughts and
perform repetitious actions or rituals in a compulsive manner
as a way of dealing with those thoughts. Compulsive hand
washing or cleaning, counting to certain numbers or the
repetitious checking of household items or belongings are
examples of symptoms that might manifest in children and adults
with this disorder.

Until now, the researchers said, little was known about the
relative efficacy of CBT and medication, either alone or in
combination, to treat pediatric OCD. The CBT used in this study
is an OCD-specific psychotherapeutic treatment designed to
create and reinforce new thought patterns and behaviors in
children and adolescents with the disorder, said the
researchers. The drug sertraline is a selective serotonin
reuptake inhibitor (SSRI) commonly used in the treatment of
depression and OCD.

"The results are so robust decision makers at all levels of
the health care system simply have no reason not to recommend
CBT as the starting place for treatment of OCD in children and
adolescents," said John March, M.D., chief of child and
adolescent psychiatry at Duke and co-principal investigator on
the study. "Starting with medication has no clear benefit for
the patient. Our research team feels very strongly that we now
have conclusive evidence that CBT -- alone or in combination
with medication -- works exceptionally well for this patient
population."

The research team enrolled 112 patients between the ages of
7 and 17 with a primary diagnosis of OCD into a randomized,
controlled clinical trial conducted at three centers in the
U.S. Patients were randomly assigned to receive either CBT plus
sertraline, CBT alone, sertraline alone or pill placebo for a
period of 12 weeks.

Those in the active medication and placebo groups received
standard care from a child and adolescent psychiatrist who
monitored the effects of the medication (or placebo) and who
offered general support and encouragement in resisting OCD. The
participants in both groups and their care providers did not
know if they were receiving or administering the active pill or
placebo. They were seen once a week for medication adjustments
during the first six weeks of the study, and then were seen
every other week for the next six weeks. The dosage ranged from
25 to 200 milligrams over the first six weeks, depending on the
response of the individual. Over the following six weeks,
dosage was adjusted for side-effects only.

Those in the CBT groups had 14 visits with a therapist over
12 weeks – twice a week for the first two weeks and then once
weekly for the remainder of the study period. Each visit lasted
approximately one hour. Participants in the CBT-only group were
aware they were not receiving medication. Participants in the
CBT combination group were aware they were receiving active
medication, as opposed to placebo.

The team found that 53.6 percent of the participants in the
combination group (CBT plus sertraline) showed no signs of the
disorder by the end of their treatment. For the CBT-only group,
39.3 percent of participants became nearly asymptomatic for
OCD; with sertraline alone, 21.4 percent of the group became
asymptomatic, and of those receiving the placebo, only 3.6
percent responded with greatly reduced symptoms of OCD.

"The take home message from this study is that kids with OCD
should receive cognitive behavioral therapy - either alone or
in combination with an SSRI - because that is what gives
patients the best chance to overcome OCD," said March. "OCD can
be thought of as a 'brain hiccup' where an obsessive thought
gets stuck and, as a result, the child feels compelled to
perform certain actions to eliminate the thought and its
accompanying bad feelings. Patients with OCD know that their
thoughts and subsequent behaviors are irrational but they feel
powerless to do anything about it. The great thing about CBT is
it teaches a strategy called 'exposure and ritual prevention'
that has been shown to give kids and adults control over the
disease."

The team points out that all treatments were generally
well-tolerated among the study participants and there was no
evidence of harm-related events due to SSRI treatment.

OCD occurs in approximately one in 200 children, with onset
typically occurring either between the ages of 6 and 9 years
old or during the teen years. The lifetime prevalence of OCD
for the entire population is between 2 and 3 percent, according
to the researchers.

"Our study is consistent with several other studies in
showing that SSRI treatment alone is helpful for many children
and adolescents, but the vast majority remains with significant
OCD symptoms," said Edna B. Foa, Ph.D., director of the Center
for the Treatment and Study of Anxiety at the University of
Pennsylvania and co-principal investigator on the study. "This
study converges with other studies in demonstrating that many
children and adolescents with OCD really get on board with the
CBT treatment and realize that the treatment is freeing them
from a very difficult and distressing disorder. We must train
more mental health professionals in becoming proficient in
delivering CBT for pediatric OCD."

Currently, there are few providers who are well-trained in
providing CBT, said Foa. The researchers believe insurance
companies play a role in the problem by continuing to pay only
for treatment with medication and other forms of talk therapy
that are ineffective despite OCD treatment guidelines that
state medication plus CBT should be a first course of
treatment.

"People in the community often just get a prescription
because it's the easiest and cheapest course of action; yet
it's not the optimal treatment for the patient," said Henrietta
Leonard, M.D., a member of the study team, professor of
psychiatry at Brown University and director of training for
child and adolescent psychiatry at the Bradley/Hasbro
Children's Research Center. "This study argues against
medication alone as initial treatment for OCD in kids."

Research funding for "The Pediatric OCD Treatment Study" was
provided by the
National Institute for Mental Health. Sertraline and matching
placebo were provided to the study under an independent
educational grant from Pfizer, Inc. Neither the NIMH program
staff nor Pfizer participated in the design and implementation
of the study, analysis of the data, or in writing the study
findings.

March has received speaker and consultant fees, as well as
research support, from Pfizer and has served as a scientific
advisor to the company. Foa has received research support from
Pfizer and has served as a scientific advisor to the company.
Leonard has not received fees or funding from Pfizer.

Other authors on the study include Patricia Gammon, Ph.D.,
Allan Chrisman, M.D., John Curry, M.D., David Fitzgerald, Ph.D.
and Kevin Sullivan, from Duke; and, Martin Franklin, Ph.D.,
Jonathan Huppert, Ph.D., Moira Rynn, M.D., Xin Tu, Ph.D., Ning
Zhao, Ph.D., and Lori Zoellner, Ph.D., at the University of
Pennsylvania; and, Abbe Garcia, Ph.D., and Jennifer Freeman,
Ph.D., at Bradley/Hasbro Children's Research Center (Brown
University) in Providence, RI.

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