Treatment of Obsessive Compulsive Disorder in Children

NCT00074815 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 124

Last updated 2014-07-29

Study results available
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Summary

This study will determine whether cognitive behavioral therapy delivered by either psychologists or psychiatrists can improve the effectiveness of serotonin reuptake inhibitor treatment in children with obsessive compulsive disorder.

Conditions

  • Obsessive-Compulsive Disorder

Interventions

DRUG

Serotonin reuptake inhibitors management

Participants are maintained on their optimized dose of SRI for OCD symptoms (see "Other Names" section for specific drugs and dosage ranges). If the participant has been treated with an SRI for at least 9 weeks AND has been at a stable dose for the past 3 weeks (e.g., the dose response curve is flat indicating no further improvement in OCD symptoms) OR the participant did not tolerate a dose increase to the next higher dose OR the participant has been at the maximum allowable dose for 3 weeks, then the participant is considered optimized and will be maintained on that dose. During trial, all participants will be maintained on their SRI dose during acute treatment at a constant dose unless side effects warrant downward adjustment of the SRI.

BEHAVIORAL

Cognitive behavioral therapy by a psychologist

CBT consists of 14 visits over 12 weeks involving: (1) psychoeducation, (2), cognitive training, (3) mapping OCD, and (4) exposure and ritual prevention (EX/RP). The intervention was adapted from March and Mulle (1998) treatment protocol for pediatric OCD.

BEHAVIORAL

Instructional cognitive behavioral therapy by a psychiatrist

The psychiatrist who manages medication will also provide instructions in the CBT procedures that have been found to help reduce OCD symptoms, namely EX/RP. MM+I-CBT was constructed as a single-doctor "best practice" treatment with three primary goals: (1) inclusion of the main psychoeducational and EX/RP components of the full CBT protocol; (2) feasibility of training psychiatrists to perform the CBT component of MM+I-CBT; (3) integration with protocol medication management visits; and (4) feasibility of implementation with the constraints of a busy practice oriented primarily toward pharmacotherapy.

Sponsors & Collaborators

  • National Institute of Mental Health (NIMH)

    collaborator NIH
  • Duke University

    lead OTHER

Principal Investigators

  • John S March, MD MPH · Duke University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
7 Years
Max Age
17 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2003-09-30
Primary Completion
2009-11-30
Completion
2009-11-30

Countries

  • United States

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00074815 on ClinicalTrials.gov