Treatment of Pediatric OCD for SRI Partial Responders
Overview
- Phase
- Phase 3
- Intervention
- Serotonin reuptake inhibitors management
- Conditions
- Obsessive-Compulsive Disorder
- Sponsor
- Duke University
- Enrollment
- 124
- Locations
- 3
- Primary Endpoint
- Children's Yale-Brown Obsessive Compulsive Scale (CY-BOCS)
- Status
- Completed
- Last Updated
- 11 years ago
Overview
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.
Investigators
Eligibility Criteria
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
Arms & Interventions
MedMgmt+CBT
Participants will receive the following interventions: 1)SRI medication management with a psychiatrist plus, 2) cognitive behavioral therapy with a psychologist.
Intervention: Serotonin reuptake inhibitors management
MedMgmt+CBT
Participants will receive the following interventions: 1)SRI medication management with a psychiatrist plus, 2) cognitive behavioral therapy with a psychologist.
Intervention: Cognitive behavioral therapy by a psychologist
MedMgmt+I-CBT
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.
Intervention: Serotonin reuptake inhibitors management
MedMgmt+I-CBT
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.
Intervention: Instructional cognitive behavioral therapy by a psychiatrist
MedMgmt Only
Participants will receive the intervention SRI medication management with a psychiatrist
Intervention: Serotonin reuptake inhibitors management
Outcomes
Primary Outcomes
Children's Yale-Brown Obsessive Compulsive Scale (CY-BOCS)
Time Frame: 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 Outcomes
- 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)