Cognitive Behavioral Therapy for Pediatric Obsessive-Compulsive Disorder

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

119 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-06-30

Study Completion Date

2016-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Intensive Cognitive-Behavioral Therapy For Obsessive-Compulsive Disorder

NCT01368510

Obsessive-Compulsive Disorder (OCD)

COMPLETED NA

Treatment of Obsessive Compulsive Disorder in Children

NCT00074815

Obsessive-Compulsive Disorder

COMPLETED PHASE3

Attention Training for Childhood Obsessive Compulsive Disorder

NCT02114918

Obsessive Compulsive Disorder

COMPLETED NA

Overlapping Neural Circuits in Pediatric OCD

NCT02421315

Obsessive Compulsive Disorder

COMPLETED NA

Internet-based Cognitive-behavior Therapy for Children With Obsessive-compulsive Disorder

NCT02663167

Obsessive-Compulsive Disorder

COMPLETED NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Obsessive-Compulsive Disorder

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

OCD Active CBT

Children with obsessive-compulsive disorder (OCD) will be treated with cognitive behavioral therapy (CBT) from the time of enrollment.

Group Type EXPERIMENTAL

Cognitive Behavioral Therapy (CBT)

Intervention Type BEHAVIORAL

Nondrug psychotherapy administered weekly for 12 weeks

OCD Waitlist

Children with OCD will receive waitlist treatment at enrollment. Nonresponders will cross over to CBT.

Group Type ACTIVE_COMPARATOR

Cognitive Behavioral Therapy (CBT)

Intervention Type BEHAVIORAL

Nondrug psychotherapy administered weekly for 12 weeks

Waitlist

Intervention Type BEHAVIORAL

Contact waitlist weekly for 12 weeks

Healthy Controls

Healthy control children will be given no intervention.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Cognitive Behavioral Therapy (CBT)

Nondrug psychotherapy administered weekly for 12 weeks

Intervention Type BEHAVIORAL

Waitlist

Contact waitlist weekly for 12 weeks

Intervention Type BEHAVIORAL

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Behavioral therapy Psychotherapy Exposure and response prevention Waiting for treatment In line for treatment

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

6 Years

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes