Dataset Information

Predictors and moderators of treatment outcome in the Pediatric Obsessive Compulsive Treatment Study (POTS I).

ABSTRACT:

Objective

To identify predictors and moderators of outcome in the first Pediatric OCD Treatment Study (POTS I) among youth (N = 112) randomly assigned to sertraline, cognitive behavioral therapy (CBT), both sertraline and CBT (COMB), or a pill placebo.

Method

Potential baseline predictors and moderators were identified by literature review. The outcome measure was an adjusted week 12 predicted score for the Children's Yale Brown Obsessive Compulsive Scale (CY-BOCS). Main and interactive effects of treatment condition and each candidate predictor or moderator variable were examined using a general linear model on the adjusted predicted week 12 CY-BOCS scores.

Results

Youth with lower obsessive-compulsive disorder (OCD) severity, less OCD-related functional impairment, greater insight, fewer comorbid externalizing symptoms, and lower levels of family accommodation showed greater improvement across treatment conditions than their counterparts after acute POTS treatment. Those with a family history of OCD had more than a sixfold decrease in effect size in CBT monotherapy relative to their counterparts in CBT without a family history of OCD.

Conclusions

Greater attention is needed to build optimized intervention strategies for more complex youth with OCD. Youth with a family history of OCD are not likely to benefit from CBT unless offered in combination with an SSRI.

Clinical trials registration information

Treatment of Obsessive Compulsive Disorder (OCD) in Children, http://www.clinicaltrials.gov, NCT00000384.

SUBMITTER: Garcia AM

PROVIDER: S-EPMC2943932 | biostudies-literature | 2010 Oct

REPOSITORIES: biostudies-literature

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Publications

Predictors and moderators of treatment outcome in the Pediatric Obsessive Compulsive Treatment Study (POTS I).

Garcia Abbe Marrs AM Sapyta Jeffrey J JJ Moore Phoebe S PS Freeman Jennifer B JB Franklin Martin E ME March John S JS Foa Edna B EB

Journal of the American Academy of Child and Adolescent Psychiatry 20100906 10

<h4>Objective</h4>To identify predictors and moderators of outcome in the first Pediatric OCD Treatment Study (POTS I) among youth (N = 112) randomly assigned to sertraline, cognitive behavioral therapy (CBT), both sertraline and CBT (COMB), or a pill placebo.<h4>Method</h4>Potential baseline predictors and moderators were identified by literature review. The outcome measure was an adjusted week 12 predicted score for the Children's Yale Brown Obsessive Compulsive Scale (CY-BOCS). Main and inter ...[more]

PMID: 20855047

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Project description:ImportanceCognitive behavior therapy (CBT) has been established as efficacious for obsessive-compulsive disorder (OCD) among older children and adolescents, yet its effect on young children has not been evaluated sufficiently.ObjectiveTo examine the relative efficacy of family-based CBT (FB-CBT) involving exposure plus response prevention vs an FB relaxation treatment (FB-RT) control condition for children 5 to 8 years of age.Design, setting, and participantsA 14-week randomized clinical trial (Pediatric Obsessive-Compulsive Disorder Treatment Study for Young Children [POTS Jr]) conducted at 3 academic medical centers between 2006 and 2011, involving 127 pediatric outpatients 5 to 8 years of age who received a primary diagnosis of OCD and a Children's Yale-Brown Obsessive Compulsive Scale total score of 16 or higher.InterventionsParticipants were randomly assigned to 14 weeks of (1) FB-CBT, including exposure plus response prevention, or (2) FB-RT.Main outcomes and measuresResponder status defined as an independent evaluator-rated Clinical Global Impression-Improvement scale score of 1 (very much improved) or 2 (much improved) and change in independent evaluator-rated continuous Children's Yale-Brown Obsessive Compulsive Scale total score. RESULTS Family-based CBT was superior to FB-RT on both primary outcome measures. The percentages of children who were rated as 1 (very much improved) or 2 (much improved) on the Clinical Global Impression-Improvement scale at 14 weeks were 72% for FB-CBT and 41% for FB-RT. The effect size difference between FB-CBT and FB-RT on the Clinical Global Impression-Improvement scale was 0.31 (95% CI, 0.17-0.45). The number needed to treat (NNT) with FB-CBT vs FB-RT was estimated as 3.2 (95% CI, 2.2-5.8). The effect size difference between FB-CBT and FB-RT on the Children's Yale-Brown Obsessive Compulsive Scale at week 14 was 0.84 (95% CI, 0.62-1.06).Conclusions and relevanceA comprehensive FB-CBT program was superior to a relaxation program with a similar format in reducing OCD symptoms and functional impairment in young children (5-8 years of age) with OCD.Trial registrationclinicaltrials.gov Identifier: NCT00533806.

Project description:ContextThe 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.ObjectiveTo examine the effects of augmenting SRIs with CBT or a brief form of CBT, instructions in CBT delivered in the context of medication management.Design, setting, and participantsA 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.InterventionsParticipants 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.Main outcome measuresWhether 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.ResultsThe 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.ConclusionsAmong 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.Trial registrationclinicaltrials.gov Identifier: NCT00074815.

Dataset Information

Predictors and moderators of treatment outcome in the Pediatric Obsessive Compulsive Treatment Study (POTS I).

Objective

Method

Results

Conclusions

Clinical trials registration information

Publications

Predictors and moderators of treatment outcome in the Pediatric Obsessive Compulsive Treatment Study (POTS I).

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