Treatment of Obsessive Compulsive Disorder in Children

Study Overview
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Brief Summary
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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
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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.

Official Title
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Treatment of Pediatric OCD for SRI Partial Responders

Conditions
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Obsessive-Compulsive Disorder

Intervention / Treatment
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* Drug: Serotonin reuptake inhibitors management
* Behavioral: Cognitive behavioral therapy by a psychologist
* Behavioral: Instructional cognitive behavioral therapy by a psychiatrist


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 7 Years
Maximum Age: 17 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: MedMgmt+CBT<br>Participants will receive the following interventions: 1)SRI medication management with a psychiatrist plus, 2) cognitive behavioral therapy with a psychologist. | Drug: Serotonin reuptake inhibitors management<br>* 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.<br>* Other names: Venlafaxine XR (Effexor)37.5-225;;Behavioral: Cognitive behavioral therapy by a psychologist<br>* 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.<br>|
| Experimental: MedMgmt+I-CBT<br>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. | Drug: Serotonin reuptake inhibitors management<br>* 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.<br>* Other names: Venlafaxine XR (Effexor)37.5-225;;Behavioral: Instructional cognitive behavioral therapy by a psychiatrist<br>* 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.<br>|
| Active Comparator: MedMgmt Only<br>Participants will receive the intervention SRI medication management with a psychiatrist | Drug: Serotonin reuptake inhibitors management<br>* 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.<br>* Other names: Venlafaxine XR (Effexor)37.5-225;;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Children's Yale-Brown Obsessive Compulsive Scale (CY-BOCS) | 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. | Measured at baseline and Week 12. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Child, Adolescent