Oct. 28, 2004 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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