title: Cognitive behavior therapy augmentation of pharmacotherapy in pediatric obsessive-compulsive disorder: the Pediatric OCD Treatment Study II (POTS II) randomized controlled trial.
abstract: BACKGROUND
  The extant literature on the treatment of pediatric obsessive-compulsive disorder (OCD) indicates that partial response to serotonin reuptake inhibitors (SRIs) is the norm and that augmentation with short-term OCD-specific cognitive behavior therapy (CBT) may provide additional benefit.
  
  
  OBJECTIVE
  To examine the effects of augmenting SRIs with CBT or a brief form of CBT, instructions in CBT delivered in the context of medication management.
  
  
  METHODS
  A 12-week randomized controlled trial conducted at 3 academic medical centers between 2004 and 2009, involving 124 pediatric outpatients between the ages of 7 and 17 years with OCD as a primary diagnosis and a Children's Yale-Brown Obsessive Compulsive Scale score of 16 or higher despite an adequate SRI trial.
  
  
  METHODS
  Participants were randomly assigned to 1 of 3 treatment strategies that included 7 sessions over 12 weeks: 42 in the medication management only, 42 in the medication management plus instructions in CBT, and 42 in the medication management plus CBT; the last included 14 concurrent CBT sessions.
  
  
  METHODS
  Whether patients responded positively to treatment by improving their baseline obsessive-compulsive scale score by 30% or more and demonstrating a change in their continuous scores over 12 weeks.
  
  
  RESULTS
  The medication management plus CBT strategy was superior to the other 2 strategies on all outcome measures. In the primary intention-to-treat analysis, 68.6% (95% CI, 53.9%-83.3%) in the plus CBT group were considered responders, which was significantly better than the 34.0% (95% CI, 18.0%-50.0%) in the plus instructions in CBT group, and 30.0% (95% CI, 14.9%-45.1%) in the medication management only group. The results were similar in pairwise comparisons with the plus CBT strategy being superior to the other 2 strategies (P < .01 for both). The plus instructions in CBT strategy was not statistically superior to medication management only (P = .72). The number needed-to-treat analysis with the plus CBT vs medication management only in order to see 1 additional patient at week 12, on average, was estimated as 3; for the plus CBT vs the plus instructions in CBT strategy, the number needed to treat was also estimated as 3; for the plus instructions in CBT vs medication management only the number needed to treat was estimated as 25.
  
  
  CONCLUSIONS
  Among patients aged 7 to 17 years with OCD and partial response to SRI use, the addition of CBT to medication management compared with medication management alone resulted in a significantly greater response rate, whereas augmentation of medication management with the addition of instructions in CBT did not.
  
  
  BACKGROUND
  clinicaltrials.gov Identifier: NCT00074815.
authors.affiliation: Department of Psychiatry, University of Pennsylvania School of Medicine, Philadelphia, PA 19104, USA. marty@mail.med.upenn.edu
authors.forename: Martin E
authors.initials: ME
authors.lastname: Franklin
authors.forename: Jeffrey
authors.initials: J
authors.lastname: Sapyta
authors.forename: Jennifer B
authors.initials: JB
authors.lastname: Freeman
authors.forename: Muniya
authors.initials: M
authors.lastname: Khanna
authors.forename: Scott
authors.initials: S
authors.lastname: Compton
authors.forename: Daniel
authors.initials: D
authors.lastname: Almirall
authors.forename: Phoebe
authors.initials: P
authors.lastname: Moore
authors.forename: Molly
authors.initials: M
authors.lastname: Choate-Summers
authors.forename: Abbe
authors.initials: A
authors.lastname: Garcia
authors.forename: Aubrey L
authors.initials: AL
authors.lastname: Edson
authors.forename: Edna B
authors.initials: EB
authors.lastname: Foa
authors.forename: John S
authors.initials: JS
authors.lastname: March
mesh_terms: D000293:Adolescent; D002648:Child; D015928:Cognitive Behavioral Therapy; D003131:Combined Modality Therapy; D005260:Female; D006801:Humans; D008297:Male; D009771:Obsessive-Compulsive Disorder / Q000628:therapy*; D017367:Selective Serotonin Reuptake Inhibitors / Q000627:therapeutic use*; D012720:Severity of Illness Index; D016896:Treatment Outcome
chemical_list: D017367:Selective Serotonin Reuptake Inhibitors