In contrast to CBT, I-CBT did not include: (1) therapist-assisted exposure; (2) imaginal exposure; and (3) didactic parent sessions. Scale (CY-BOCS) score 16 despite ASP 2151 (Amenamevir) an adequate SRI trial. Interventions Participants were randomized to receive 12 weeks of: 1) MM (7 sessions), 2) MM+I-CBT (7 sessions) or 3) MM+CBT (7 sessions of MM plus 14 concurrent CBT sessions). Main Outcome Measures Responder status as defined as a post-treatment CY-BOCS reduction of 30% or greater compared to baseline; change in continuous CY-BOCS total score over 12 weeks. Results MM+CBT was superior to MM and to MM+I-CBT on all outcome measures. In the primary ITT analysis, 68.6% in MM+CBT (95% confidence interval [CI], 53.9%C83.3%) were considered responders, which was significantly better than the 34.0% in MM+I-CBT (95% CI, 18.0% to 50.0%), and 30.0% in MM (95% CI, 14.9% to 45.1%). Planned pairwise comparisons show that MM+CBT was superior to both MM and MM+I-CBT ( 0.01 for both). MM+I-CBT was not statistically significant from MM (= 0.72). The number needed to treat (NNT) with MM+CBT versus MM to see one additional RESPONSE at Week 12, on average, was estimated as 3; for MM+CBT versus MM+I-CBT the NNT was also estimated as 3 ;for MM+I-CBT versus MM the NNT was estimated as 25. Conclusion Among patients age 7C17 with OCD and partial response to SRI use, the addition of CBT by a psychologist to medication management compared with Rabbit Polyclonal to DCT medication management alone resulted in a significantly greater response rate, whereas, augmentation of medication management with the addition of instructions in CBT by the psychiatrist did not. Dissemination of full CBT augmentation for pediatric OCD partial responders of SRI should be an important public health objective. Obsessive compulsive disorder (OCD) affects up to 1 1 in 50 people,1 is evident across development,2 and is associated with substantial dysfunction and psychiatric comorbidity.3,4 Randomized, controlled trial findings supports the efficacy of: 1) pharmacotherapy with serotonin reuptake inhibitors (SRIs); 2) cognitive behavior therapy (CBT) involving exposure plus response prevention (ERP); and 3) combined treatment.5,6,7 However, the paucity of expertise in pediatric OCD prevents most families from accessing ERP or combined treatment. Outcome data for ASP 2151 (Amenamevir) pharmacotherapy alone, which is the most widely available treatment, indicate that partial response is the norm and that clinically significant residual symptoms typically persist even after an adequate trial.8,9 Augmenting SRI treatment with ERP was found efficacious in a randomized controlled trial of adult OCD patients,10 but this approach has yet to be examined in youth with OCD who have achieved partial response on SRIs. The observations above led us to develop a brief protocol, Instructions in CBT (I-CBT), for delivery in the context of medication management (MM) by child and adolescent psychiatrists. This integrated treatment (MM+I-CBT) was designed for implementation by physicians working in busy clinical practices that impose practical limits on session frequency and duration; our interest in generalizing study findings to such settings informed the sampling frame and treatment protocols for this pragmatic trial. We hypothesized that a full CBT protocol plus medication maintenance (MM+CBT) would be superior to both MM+I-CBT and MM, and that MM+I-CBT would be superior to MM. METHODS Design The rationale, design considerations, assessment instrument psychometrics, and research methods for POTS II have been described elsewhere.11 Briefly, POTS II was a 12-week, 3 (site: Penn, Duke, Brown) 3 (treatment conditions: MM, MM+I-CBT, & MM+CBT) 4 (repeated measures at weeks 0, 4, 8, & 12), randomized parallel group controlled trial. Although MM does not control for contact time, it does parallel treatment as typically delivered in community settings. The Institutional Review Board at each site approved the protocol. Participants Inclusion criteria were: (1) ages 7C17 years; (2) primary OCD according to DSM-IV-TR criteria; (3) clinically relevant residual OCD symptoms as defined by a 16 within the CY-BOCS total score; 4) determined by a study psychiatrist to have experienced a partial response to an adequate SRI trial; and 5) outpatient. Exclusions were: (1) main mental health analysis other than OCD; (2) pervasive developmental disorder(s); (3) failure to meet study requirements for an adequate ASP 2151 (Amenamevir) SRI trial; (4) having failed an adequate CBT trial ( 10 classes); (5) pregnancy; or (6) pediatric autoimmune neuropsychiatric disorders associated with strep illness (PANDAS). Dedication of Eligibility Eligibility was assessed via a multi-gate process designed to minimize individual burden and maximize effectiveness: 1) Gate A, a brief telephone screening with the parent/guardian; 2) Gate B, an intake that included obtaining of knowledgeable consent from your parent(s) and assent from your participant, assessment of OCD symptoms using the CY-BOCS,12,13 and a review of current medications and their effects.; 3) Gate C, a.J Panic Disord. status mainly because defined as a post-treatment CY-BOCS reduction of 30% or higher compared to baseline; switch in continuous CY-BOCS total score over 12 weeks. Results MM+CBT was superior to MM and to MM+I-CBT on all end result measures. In the primary ITT analysis, 68.6% in MM+CBT (95% confidence interval [CI], 53.9%C83.3%) were considered responders, which was significantly better than the 34.0% in MM+I-CBT (95% CI, 18.0% to 50.0%), and 30.0% in MM (95% CI, 14.9% to 45.1%). Planned pairwise comparisons display that MM+CBT was superior to both MM and MM+I-CBT ( 0.01 for both). MM+I-CBT was not statistically significant from MM (= 0.72). The number needed to treat (NNT) with MM+CBT versus MM to see one additional RESPONSE at Week 12, normally, was estimated as 3; for MM+CBT versus MM+I-CBT the NNT was also estimated as 3 ;for MM+I-CBT versus MM the NNT was estimated as 25. Summary Among patients age 7C17 with OCD and partial response to SRI use, the addition of CBT by a psychologist to medication management compared with medication management alone resulted in a significantly higher response rate, whereas, augmentation of medication management with the help of instructions in CBT from the psychiatrist did not. Dissemination of full CBT augmentation for pediatric OCD partial responders of SRI should be an important general public health objective. Obsessive compulsive disorder (OCD) affects up to 1 1 in 50 people,1 is definitely evident across development,2 and is associated with considerable dysfunction and psychiatric comorbidity.3,4 Randomized, controlled trial findings helps the effectiveness of: 1) pharmacotherapy with serotonin reuptake inhibitors (SRIs); 2) cognitive behavior therapy (CBT) including exposure plus response prevention (ERP); and 3) combined treatment.5,6,7 However, the paucity of expertise in pediatric OCD helps prevent most family members from accessing ERP or combined treatment. End result data for pharmacotherapy only, which is the most widely available treatment, show that partial response is the norm and that clinically significant residual symptoms typically persist actually after an adequate trial.8,9 Augmenting SRI treatment with ERP was found efficacious inside a randomized controlled trial of adult OCD patients,10 but this approach has yet to be examined in youth with OCD who have accomplished partial response on SRIs. The observations above led us to develop a brief protocol, Instructions in CBT (I-CBT), for delivery in the context of medication management (MM) by child and adolescent psychiatrists. This integrated treatment (MM+I-CBT) was designed for implementation by physicians working in occupied clinical methods that impose practical limits on session rate of recurrence and duration; our desire for generalizing study findings to such settings educated the sampling framework and treatment protocols for this pragmatic trial. We hypothesized that a full CBT protocol plus medication maintenance (MM+CBT) would be superior to both MM+I-CBT and MM, and that MM+I-CBT would be superior to MM. METHODS Design The rationale, design considerations, assessment instrument psychometrics, and study methods for POTS II have been described elsewhere.11 Briefly, POTS II was a 12-week, 3 (site: Penn, Duke, Brown) 3 (treatment conditions: MM, MM+I-CBT, & MM+CBT) 4 (repeated measures at weeks 0, 4, 8, & 12), randomized parallel group controlled trial. Although MM does not control for contact time, it does parallel treatment as typically delivered in community settings. The Institutional Review Table at each site authorized the protocol. Participants Inclusion criteria were: (1) age groups 7C17 years; (2) main OCD relating to DSM-IV-TR criteria; (3) clinically relevant residual OCD symptoms as defined by a 16 within the CY-BOCS total score; 4) determined by a study psychiatrist to have experienced a partial response to an adequate SRI trial; and 5) outpatient. Exclusions were: (1) main mental health analysis other than OCD; (2) pervasive developmental disorder(s); (3) failure to meet study requirements for an adequate SRI trial; (4) having failed an adequate CBT trial ( 10 classes); (5) pregnancy; or (6) pediatric autoimmune neuropsychiatric disorders associated with strep.