Treatment of Obsessive Compulsive Disorder in Children

Duke University

Status and phase: Completed; Phase 3

Conditions: Obsessive-Compulsive Disorder

Treatments: Behavioral: Cognitive behavioral therapy by a psychologist; Drug: Serotonin reuptake inhibitors management; Behavioral: Instructional cognitive behavioral therapy by a psychiatrist

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT00074815

DSIR 84-CTM

Pro00008097

R01MH055121 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 124 patients

Sex: All

Ages: 7 to 17 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

124 participants in 3 patient groups

MedMgmt+CBT

Experimental group

Description:

Participants will receive the following interventions: 1)SRI medication management with a psychiatrist plus, 2) cognitive behavioral therapy with a psychologist.

Treatment:

Drug: Serotonin reuptake inhibitors management

Behavioral: Cognitive behavioral therapy by a psychologist

MedMgmt+I-CBT

Experimental group

Description:

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.

Treatment:

Drug: Serotonin reuptake inhibitors management

Behavioral: Instructional cognitive behavioral therapy by a psychiatrist

MedMgmt Only

Active Comparator group

Description:

Participants will receive the intervention SRI medication management with a psychiatrist

Treatment:

Drug: Serotonin reuptake inhibitors management