Standard of care for obsessive-compulsive disorder (OCD) is pharmacotherapy with serotonin reuptake inhibitors (SRIs), cognitive behavior therapy (CBT) involving exposure plus response prevention, and combined treatment. However, according to researchers, in the pediatric population, a lack of expertise in treating OCD “prevents most families from accessing exposure plus response prevention or combined treatment.”
Data on outcomes of pharmacotherapy demonstrate that partial response is the norm and clinically residual symptoms can persist even following an adequate trial. In a randomized controlled trial of adult patients with OCD, augmenting SRI treatment with exposure plus prevention was found to be efficacious, but there have been no studies assessing this approach in the pediatric population.
Researchers recently conducted a 12-week randomized controlled trial, POTS II (Pediatric Obsessive-Compulsive Disorder Treatment Study II), to determine the benefits of augmenting SRIs with CBT or a brief form of CBT and instructions in CBT delivered in the context of medication management. They reported results of the study in the Journal of the American Medical Association [2011;306(11):1224-1232].
The trial was conducted at 3 academic medical centers between 2004 and 2009. It involved 124 pediatric outpatients between 7 and 17 years of age with a Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition, primary diagnosis of OCD. Inclusion criteria included clinically relevant residual OCD symptoms defined by a score of ≥16 on the Children’s Yale-Brown Obsessive Compulsive Scale, being treated as an outpatient, and been determined by a study psychiatrist to have experienced partial response to an adequate trial of an SRI.
Exclusion criteria were a primary mental health diagnosis of something other than OCD, pervasive developmental disorder(s), did not meet the study definition for an adequate SRI trial, had a CBT trial of <10 sessions, pregnancy, presence of pediatric autoimmune neuropsychiatric disorders associated with strep infection, or taking >1 SRI concurrently.
The primary outcome measures were whether patients responded positively to treatment as measured by an improvement to their baseline obsessive-compulsive scale by ≥30%, and a change in their continuous scores over the 12-week study period. Patients were randomly assigned to 1 of 3 treatment strategies that included 7 sessions during the study period. The 3 treatment strategies were (1) medication management only (n=42); (2) medication management plus instructions in CBT (n=42); and (3) medication management plus CBT (n=42).
The medication management plus CBT included 14 concurrent CBT sessions. On all outcome measures, medication management plus CBT was superior to the other strategies. In the primary intention-to-treat analysis, 68.6% (95% confidence interval [CI], 53.9%-83.3%) in the plus CBT group were considered responders, a significant improvement over the other groups (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), P=.002.
Results in pairwise comparisons were similar; the medication plus CBT strategy was superior to the other 2 strategies (P<.01 for both). In summary, the researchers said, “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.” They added, “findings from POTS I and II are consistent with a growing evidence base that supports the use of exposure plus response prevention as initial or augmentative treatment for patients of all ages with OCD.”