Randomized, placebo-controlled trial of cognitive-behavioral therapy alone or combined with sertraline in the treatment of pediatric obsessive–compulsive disorder

Abstract

Background: To examine the efficacy of sequential sertraline and cognitive-behavioral therapy (CBT) treatment relative to CBT with pill placebo over 18 weeks in children and adolescents with obsessive-compulsive disorder (OCD). Methods: Forty-seven children and adolescents with OCD (Range=7-17 years) were randomized to 18-weeks of treatment in one of three arms: 1) sertraline at standard dosing + CBT (RegSert+CBT); 2) sertraline titrated slowly but achieving at least 8 weeks on the maximally tolerated daily dose + CBT (SloSert+CBT); or 3) pill placebo + CBT (PBO+CBT). Assessments were conducted at screening, baseline, weeks 1-9, 13, and 17, and post- treatment. Raters and clinicians were blinded to sertraline (but not CBT) randomization status. Primary outcomes included the Children’s Yale-Brown Obsessive-Compulsive Scale, and response and remission status. Secondary outcomes included the Child Obsessive Compulsive Impact Scale–Parent/Child, Children’s Depression Rating Scale-Revised, Multidimensional Anxiety Scale for Children, and Clinical-Global Impressions-Severity. Results: All groups exhibited large within-group effects across outcomes. There was no group by time interaction across all outcomes suggesting that group changes over time were comparable. Conclusions: Among youth with OCD, there was no evidence that sequentially provided sertraline with CBT differed from those receiving placebo with CBT.

Evidence-Based Treatments in Treatment-Naïve and Treatment-Resistant Pediatric Obsessive-Compulsive Disorder

“…Thus, the data support the European guidelines [12]. One could hypothesize that CBT alone is as good as the combined treatment when delivered by experts [20,47]. When the results of CBT are attenuated for some reason, the addition of medication may be important [20].…”

“…The pooled results of the combined treatment of CBT and SSRIs were not found to be superior to CBT alone [20,47] with no evidence of different effects based on symptom severity [28]. Thus, the data support the European guidelines [12].…”

“…Two studies have compared the combined treatment with CBT alone [20,47]. Their combined effect size does not show the superiority of the combined treatment (g=−0.13) [5].…”

Components of Cognitive Behavioral Therapy Related to Outcome in Childhood Anxiety Disorders

“…This approach also served to minimize the degree to which the authors' preconceived notions biased the selection of studies. In addition, four studies (Miller et al 2011;Simon et al 2011;Storch et al 2007Storch et al , 2013 were added from a review of the literature in order to identify additional studies that had been conducted in the past 10 years (i.e., since 2004) and met the following criteria consistent with the most inclusive source material (i.e., Reynolds et al 2012): (a) participants selected based on the presence of elevated anxiety or OCD symptoms, (b) randomization into one of at least two conditions, (c) participants age 19 or under, (d) treatment designed to reduce anxiety or OCD, and (e) outcome data provided to calculate an effect size. Together, these searches resulted in 43 RCTs published between 1994 and 2013 that compared treatment for CADs or OCD in youth age 4-19 to a control condition and included sufficient data to calculate an effect size ( Table 1).…”

“…For instance, exposure and response prevention (ERP) for pediatric OCD has been found to have very large pre-post effect sizes (e.g., ES = 1.98), to outperform medication, and to be equivalent to combined treatment Romanelli et al 2014;Storch et al 2013), although superiority to other treatments has not been found universally (e.g., POTS 2004). Similarly, CBT for adult anxiety disorders consistently leads to large pre-post effect sizes (Butler et al 2006) and outperforms placebo (e.g., between-group ESs ranging from 0.35 for panic disorder to 0.62 for social anxiety disorder; Hofmann and Smits 2008).…”