Cognitive behavior therapy augmentation of pharmacotherapy in pediatric obsessive-compulsive disorder: the Pediatric OCD Treatment Study II (POTS II) randomized controlled trial.
This 12-week multi-center randomized controlled trial found that for children with OCD, adding CBT to medication management (with Serotonin Reuptake Inhibitors) resulted in a significantly greater response rate (68.6%) compared with medication alone (30.0%). Adding instruction in CBT to medication management was not associated with a significantly greater response rate.
- Randomized controlled trial. Evaluators of outcome measures were blinded to treatment assignment, but not patients, families, or clinicians.
- N=124 pediatric outpatients, ages 7-17, with OCD as a primary diagnosis, randomized to 12 weeks of:
- Medication management only (n=42)
- Medication management & instruction in CBT (n=40)
- Medication management & CBT (n=42)
- Medication management (with Serotonin Reuptake Inhibitors) involved 7 in-person visits over the 12 weeks.
- CBT consisted of 14 one-hour-long visits over the 12 weeks, administered by a study psychologist, and based on a treatment manual of established efficacy.
- The Instruction in CBT treatment arm involved extended sessions with the pharmacotherapist managing the patient’s medication. The usual 7 visits for medication management were extended to introduce CBT principles and plan implementation of these skills.
- Setting: 3 academic medical centers in the United States, from 2004-2009.
- Primary outcome: response to treatment, defined as improvement in Children’s Yale-Brown Obsessive-Compulsive Scale (CY-BOCS) score by ≥30% from baseline to week 12.
- Medication management plus CBT was associated with a significantly greater proportion of participants with ≥30% reduction in CY-BOCS score compared with medication management plus instruction in CBT (P=0.002) or medication management alone (P<0.001). Percentages achieving response shown below (95% CI):
- 68.6% (53.9-83.3) for Meds & CBT
- 34.0% (18.0-50.0) for Meds & instruction in CBT
- 30.0% (14.9-45.1) for Meds only
- The number needed to treat (with meds plus CBT vs the other two treatments) to see 1 additional response at week 12 was estimated at 3.
- The number needed to treat (with meds plus instruction in CBT vs meds alone) to see 1 additional response at week 12 was estimated at 25.
Franklin ME, Sapyta J, Freeman JB, et al. Cognitive behavior therapy augmentation of pharmacotherapy in pediatric obsessive-compulsive disorder: the Pediatric OCD Treatment Study II (POTS II) randomized controlled trial. JAMA. 2011;306(11):1224-1232. doi:10.1001/jama.2011.1344.