Treatment of Obsessive Compulsive Disorder in Children

Phase 3

Completed

• Conditions: Obsessive-Compulsive Disorder
• Interventions: Drug: Serotonin reuptake inhibitors management; Behavioral: Cognitive behavioral therapy by a psychologist; Behavioral: Instructional cognitive behavioral therapy by a psychiatrist

• Registration Number: NCT00074815
• Lead Sponsor: Duke University

Brief 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.

Detailed Description

The vast majority of children with obsessive compulsive disorder (OCD) are given serotonin reuptake inhibitor (SRI) drugs as initial treatment. However, recommended doses of these medications leave many children with clinically significant residual symptoms. Health care experts typically recommend augmenting SRI treatment with cognitive behavioral therapy (CBT), yet this recommendation is seldom followed. This study will contrast two CBT augmentation strategies to continued medication management alone: CBT administered by a psychologist and instructional CBT (I-CBT)administered by a psychiatrist in the context of ongoing medication management.

All patients in the trial will be eligible to receive a full course of CBT by study end. Participants in this study will be randomly assigned to receive CBT, I-CBT or continued medication management. All participants will continue their SRI treatment for 12 weeks. After the 12-week treatment period, participants who received I-CBT or medication management alone and who remain symptomatic will be given CBT as will participants who are asymptomatic but relapse within 6 months after treatment. Assessments will be conducted at Weeks 0, 4, 8, and 12. Follow-up assessments will be conducted at 3 and 6 months post-treatment.

Study Timeline

• Study Start: 2003-09
• Study First Submitted: 2003-12-19
• Study First Submitted QC: 2003-12-19
• Study First Posted: 2003-12-22
• Primary Completion: 2009-11
• Study Completion: 2009-11
• Status Verified: 2012-11
• Results First Submitted: 2012-11-15
• Results First Submitted QC: 2013-01-08
• Results First Posted: 2013-02-11
• Last Update Submitted: 2014-07-23
• Last Update Posted: 2014-07-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 124

Inclusion Criteria

• DSM-IV Diagnosis of obsessive compulsive disorder
• CYBOCS total score greater than 16

Exclusion Criteria

• Other primary or co-primary psychiatric disorder
• Pervasive developmental disorder or disorders, including Asperger's Syndrome
• Thought disorder
• Prior failed trial of cognitive-behavioral therapy
• Has pediatric autoimmune neuropsychiatric disorders associated with streptococcus (PANDAS) or maintenance antibiotic for obsessive-compulsive disorder
• Mental retardation
• Pregnancy

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
MedMgmt+CBT	Serotonin reuptake inhibitors management	Participants will receive the following interventions: 1)SRI medication management with a psychiatrist plus, 2) cognitive behavioral therapy with a psychologist.
MedMgmt+I-CBT	Serotonin reuptake inhibitors management	Participants will receive the following interventions 1)SRI medication management plus, 2) instructional cognitive behavioral therapy. Both of these will be implemented by the same psychiatrist.
MedMgmt Only	Serotonin reuptake inhibitors management	Participants will receive the intervention SRI medication management with a psychiatrist
MedMgmt+CBT	Cognitive behavioral therapy by a psychologist	Participants will receive the following interventions: 1)SRI medication management with a psychiatrist plus, 2) cognitive behavioral therapy with a psychologist.
MedMgmt+I-CBT	Instructional cognitive behavioral therapy by a psychiatrist	Participants will receive the following interventions 1)SRI medication management plus, 2) instructional cognitive behavioral therapy. Both of these will be implemented by the same psychiatrist.

Primary Outcome Measures

Name	Time	Method
Children's Yale-Brown Obsessive Compulsive Scale (CY-BOCS)	Measured at baseline and Week 12.	OCD symptom severity was measured using the CY-BOCS, an interviewer-rated instrument that assess obsessions and compulsions separately on time consumed, distress, interference, degree of resistance, and control; it yields separate severity scores for obsessions and for compulsions (0 - 20), and a composite symptom severity score (0 to 40).; Consistent with signal detection analyses examining the optimal criterion for treatment response, a CY-BOCS reduction of 30% or more from baseline to week 12 was used as the criterion for RESPONSE and was the primary dichotomous outcome measure.

Secondary Outcome Measures

Name	Time	Method
Child Obsessive -Compulsive Impact Scale (COIS)	Measured at baseline; Weeks 4, 8, and 12; and Months 3 and 6 of follow-up
Child Depression Inventory	Measured at baseline; Weeks 4, 8, and 12; and Months 3 and 6 of follow-up
Pediatric Adverse Event Rating Scale (PAERS)	Measured at baseline; Weeks 4, 8, and 12; and Months 3 and 6 of follow-up

Trial Locations

Locations (3)

University of Pennsylvania, The Center for the Treatment and Study of Anxiety; 🇺🇸 Philadelphia, Pennsylvania, United States

Duke Child and Family Study Center; 🇺🇸 Durham, North Carolina, United States

Rhode Island Hospital; 🇺🇸 Providence, Rhode Island, United States