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Cognitive Behavioral Therapy for Pediatric Obsessive-Compulsive Disorder

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00748761
Recruitment Status : Completed
First Posted : September 9, 2008
Last Update Posted : March 25, 2020
National Institute of Mental Health (NIMH)
Information provided by (Responsible Party):
Joseph O'Neill, PhD, National Institute of Mental Health (NIMH)

Brief Summary:
This study will examine the way cognitive behavioral therapy changes the structure of the brain in patients with obsessive-compulsive disorder and will thereby determine what makes cognitive behavioral therapy an effective treatment.

Condition or disease Intervention/treatment Phase
Obsessive-Compulsive Disorder Behavioral: Cognitive Behavioral Therapy (CBT) Behavioral: Waitlist Not Applicable

Detailed Description:

Obsessive-compulsive disorder (OCD) afflicts 2% to 4% of children and adolescents, who suffer from persistent, unwanted thoughts and repetitive behaviors. One of the most effective treatments of OCD is cognitive behavioral therapy (CBT), yet researchers do not know how CBT affects the brain. In this study, brain scans will be performed to determine concentrations of several neurometabolites, which are chemicals involved in providing energy to the brain. Of particular importance are the neurometabolites glutamine and glutamate, which, in addition to providing energy to the brain, are among the most common excitatory neurotransmitters. Disruption of glutamine and glutamate is thought to be related to OCD. By examining where in the brain levels of glutamate and glutamine change, researchers will attempt to determine whether CBT modifies brain activity, whether a circuit targeted by researchers is affected by CBT, and how brain activity in people with OCD differs from that of people without the disorder in terms of the targeted circuit.

Children and adolescents ages 8 through 17 with OCD will be randomly assigned to either receive a 12-week CBT intervention or be placed on a waiting list for 8 weeks before receiving the 12-week intervention. A group of non-OCD participants in the same age group will be used as a control. All groups will undergo magnetic resonance spectroscopic imaging (MRSI), which will measure the concentrations of neurometabolites in multiple brain regions. The control group and the group initially given the CBT intervention will be scanned upon entry of the study and after 12 weeks. The group initially placed on a waiting list will be scanned three times: once upon entry, once after the 8-week waiting period, and once after the 12-week CBT intervention. To determine which participants are benefitting from the treatment, the Yale-Brown Obsessive-Compulsive Scale and other clinical and neurocognitive measures will be administered concurrently with each brain scan.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 119 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Cognitive-Behavioral Therapy & Glutamatergic Neurometabolites in Pediatric OCD
Actual Study Start Date : June 2008
Actual Primary Completion Date : December 31, 2016
Actual Study Completion Date : December 31, 2016

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: OCD Active CBT
Children with obsessive-compulsive disorder (OCD) will be treated with cognitive behavioral therapy (CBT) from the time of enrollment.
Behavioral: Cognitive Behavioral Therapy (CBT)
Nondrug psychotherapy administered weekly for 12 weeks
Other Names:
  • Behavioral therapy
  • Psychotherapy
  • Exposure and response prevention

Active Comparator: OCD Waitlist
Children with OCD will receive waitlist treatment at enrollment. Nonresponders will cross over to CBT.
Behavioral: Cognitive Behavioral Therapy (CBT)
Nondrug psychotherapy administered weekly for 12 weeks
Other Names:
  • Behavioral therapy
  • Psychotherapy
  • Exposure and response prevention

Behavioral: Waitlist
Contact waitlist weekly for 12 weeks
Other Names:
  • Waiting for treatment
  • In line for treatment

No Intervention: Healthy Controls
Healthy control children will be given no intervention.

Primary Outcome Measures :
  1. Regional concentration of glutamate and glutamine in brain, as measured by Magnetic Resonance Spectroscopic Imaging (MRSI) [ Time Frame: 14 weeks ]

Secondary Outcome Measures :
  1. Overall score on child Yale-Brown Obsessive-Compulsive Scale [ Time Frame: 14 weeks ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   6 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • Meets DSM-IV diagnostic criteria for OCD as primary diagnosis, based on the Anxiety Disorders Interview Schedule (ADIS) Clinical Severity Rating
  • Clinical Global Impressions severity score of at least 4, reflecting moderately ill or worse status
  • Children's Yale-Brown Obsessive Compulsive Scale total score of greater than or equal to 16
  • No medication for OCD or other psychiatric condition in the past 4 weeks and no use of fluoxetine for the past 6 weeks
  • Child is fluent in English
  • Parental informed consent and child or adolescent informed assent forms are signed
  • For females of childbearing potential a negative pregnancy test will be required for study entry

Exclusion Criteria:

  • IQ of less than 80 on the Wechsler Abbreviated Scales of Intelligence
  • A lifetime DSM-IV diagnosis of pervasive developmental disorder, mania, psychosis, conduct disorder, or substance dependence assessed through ADIS
  • Current DSM-IV diagnosis of major depressive disorder or attention deficit hyperactivity disorder any subtype, assessed through an ADIS rating of 4 or higher
  • Any serious psychiatric, psychosocial, or neurological condition, such as a tic disorder, non-OCD anxiety, aggression, or family discord, that requires immediate treatment other than that provided in the current study
  • One or more failed adequate trials of exposure-based CBT, defined as at least 10 sessions of therapist-assisted, exposure-based CBT with which the patient voluntarily complied
  • More than one failed selective serotonin reuptake inhibitor trial adequate in dose and duration, defined as at least 8 weeks of treatment with at least 20 mg of fluoxetine, 20 mg of paroxetine, 75 mg of sertraline or fluvoxamine, or 75mg of clomipramine
  • Any body metal (other than dental fillings), pregnancy, or other contraindications to MRSI scan

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00748761

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United States, California
UCLA Child Psychiatry
Los Angeles, California, United States, 90024
Sponsors and Collaborators
University of California, Los Angeles
National Institute of Mental Health (NIMH)
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Principal Investigator: Joseph O'Neill, PhD UCLA Child Psychiatry
Principal Investigator: John C. Piacentini, PhD UCLA Child Psychiatry
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Responsible Party: Joseph O'Neill, PhD, Associate Professor of Child Psychiatry, National Institute of Mental Health (NIMH) Identifier: NCT00748761    
Other Study ID Numbers: R01MH081864 ( U.S. NIH Grant/Contract )
R01MH081864 ( U.S. NIH Grant/Contract )
DDTR B2-NDO ( Other Identifier: UCLA )
First Posted: September 9, 2008    Key Record Dates
Last Update Posted: March 25, 2020
Last Verified: March 2020
Keywords provided by Joseph O'Neill, PhD, National Institute of Mental Health (NIMH):
Obsessive-Compulsive Disorder
Cognitive-Behavioral Therapy
Additional relevant MeSH terms:
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Compulsive Personality Disorder
Obsessive-Compulsive Disorder
Personality Disorders
Mental Disorders
Anxiety Disorders