Summary

Children with anxiety disorders were treated with CBT, sertraline, their combination, or placebo for 12 weeks. Both CBT and sertraline were associated with reduced anxiety compared with placebo, and their combination had a superior response rate. Adverse effects with sertraline did not differ significantly from placebo.

Design

• N=488 children, ages 7-17, with separation anxiety disorder, generalized anxiety disorder, or social phobia, randomized (2:2:2:1) to receive 12 weeks of:
  • CBT (n=139)
  • Sertraline (n=133)
  • Combination CBT and Sertraline (n=140)
  • Placebo drug (n=76)
• CBT involved 14 hour-long sessions based on the Coping Cat program, which teaches anxiety-management skills and subsequently tests those skills in imaginary and real-life situations.
• Anxiety severity and impairment measured at baseline, and at 4, 8, and 12 weeks.
• Primary outcomes: treatment response, defined as much improved or very much improved on the Clinical Global Impression-Improvement (CGI-I) scale, at week 12. Anxiety severity was measured on the Pediatric Anxiety Rating Scale. Overall impairment was measured on the Children’s Global Assessment Scale.
• Setting: multiple centers around the United States, 2002-2007.

Results

• All treatments were superior to placebo.
• Percent of children rated very much or much improved on the CGI-I scale:
  • 80.7% for CBT plus sertraline
  • 59.7% for CBT
  • 54.9% for sertraline
  • 23.7% for placebo
• Combination CBT and sertraline was superior to either treatment as a monotherapy (P<0.001).
• Compared with CBT, sertraline was associated with more:
  • Insomnia (P=0.01)
  • Fatigue (P=0.003)
  • Sedation (P=0.01)
  • Restlessness (P=0.03)
• Compared with placebo, sertraline did not show significant difference in frequency of physical, psychiatric, or harm-related adverse events.
• There were no suicide attempts during the study.

Reference

Walkup JT, Albano AM, Piacentini J, et al. Cognitive behavioral therapy, sertraline, or a combination in childhood anxiety. N Engl J Med. 2008;359(26):2753–2766. doi:10.1056/NEJMoa0804633.