NCT00748761

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
119

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jun 2008

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2008

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

September 8, 2008

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 9, 2008

Completed
8.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2016

Completed
Last Updated

March 25, 2020

Status Verified

March 1, 2020

Enrollment Period

8.6 years

First QC Date

September 8, 2008

Last Update Submit

March 23, 2020

Conditions

Obsessive-Compulsive Disorder

Keywords

Obsessive-Compulsive DisorderOCDCognitive-Behavioral TherapyCBTMRSIGlutamate

Outcome Measures

Primary Outcomes (1)

  • Regional concentration of glutamate and glutamine in brain, as measured by Magnetic Resonance Spectroscopic Imaging (MRSI)

    14 weeks

Secondary Outcomes (1)

  • Overall score on child Yale-Brown Obsessive-Compulsive Scale

    14 weeks

Study Arms (3)

OCD Active CBT

EXPERIMENTAL

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

Behavioral: Cognitive Behavioral Therapy (CBT)

OCD Waitlist

ACTIVE COMPARATOR

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

Behavioral: Cognitive Behavioral Therapy (CBT)Behavioral: Waitlist

Healthy Controls

NO INTERVENTION

Healthy control children will be given no intervention.

Interventions

Cognitive Behavioral Therapy (CBT)BEHAVIORAL

Nondrug psychotherapy administered weekly for 12 weeks

Also known as: Behavioral therapy, Psychotherapy, Exposure and response prevention
OCD Active CBTOCD Waitlist
WaitlistBEHAVIORAL

Contact waitlist weekly for 12 weeks

Also known as: Waiting for treatment, In line for treatment
OCD Waitlist

Eligibility Criteria

Age6 Years - 18 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UCLA Child Psychiatry

Los Angeles, California, 90024, United States

Location

MeSH Terms

Conditions

Obsessive-Compulsive Disorder

Interventions

Cognitive Behavioral TherapyBehavior TherapyPsychotherapyWaiting ListsTherapeutics

Condition Hierarchy (Ancestors)

Anxiety DisordersMental Disorders

Intervention Hierarchy (Ancestors)

Behavioral Disciplines and ActivitiesAppointments and SchedulesOrganization and AdministrationHealth Services Administration

Study Officials

  • Joseph O'Neill, PhD

    UCLA Child Psychiatry

    PRINCIPAL INVESTIGATOR

  • John C. Piacentini, PhD

    UCLA Child Psychiatry

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor of Child Psychiatry

Study Record Dates

First Submitted

September 8, 2008

First Posted

September 9, 2008

Study Start

June 1, 2008

Primary Completion

December 31, 2016

Study Completion

December 31, 2016

Last Updated

March 25, 2020

Record last verified: 2020-03

Locations

US(1)