Combination of cognitive behavioral therapy and sertraline is more effective than monotherapy for pediatric anxiety disorders

Abstract

Question Among children and adolescents with anxiety disorders, what is the relative and combined efficacy of cognitive behavioral therapy and selective serotonin-reuptake inhibitors? Design Randomized, controlled trial. Setting Six mental health treatment centers in the United States. Participants A total of 488 children (age 7 to 17 years) who had a primary diagnosis of separation anxiety disorder, generalized anxiety disorder, or social phobia. Intervention Fourteen sessions of cognitive behavioral therapy (CBT), sertraline (at a dose of up to 200 mg per day), a combination of sertraline and CBT, or a placebo drug for 12 weeks in a 2:2:2:1 ratio. Outcomes Categorical and dimensional ratings of anxiety severity and impairment at baseline and at weeks 4, 8, and 12. Main Results The percentages of children who were rated as very much or much improved on the Clinician Global Impression–Improvement scale were 80.7% for combination therapy (P < .001), 59.7% for CBT (P < .001), and 54.9% for sertraline (P < .001); all therapies were superior to placebo (23.7%). Combination therapy was superior to both monotherapies (P < .001, number needed to treat [NNT] = 5 for combination therapy over CBT; NNT = 4 for combination therapy over sertraline). Results on the Pediatric Anxiety Rating Scale documented a similar magnitude and pattern of response; combination therapy had a greater response than CBT, which was equivalent to sertraline, and all therapies were superior to placebo. Adverse events, including suicidal and homicidal ideation, were no more frequent in the sertraline group than in the placebo group. No child attempted suicide. There was less insomnia, fatigue, sedation, and restlessness associated with CBT than with sertraline. Conclusions Both CBT and sertraline reduced the severity of anxiety in children with anxiety disorders; a combination of the 2 therapies had a superior response rate. Commentary Anxiety disorders are relatively prevalent disorders (6% to 20%) in the pediatric age group. However, these disorders frequently go unrecognized by medical professionals, which is a critical concern because younger age of onset leads to increased rates of later anxiety disorders, depression, substance abuse, and educational underachievement. Once identified, treatment is essential to reduce both short- and long-term impairment. Earlier randomized controlled trials have demonstrated effectiveness of the individual treatments (antidepressant medications and CBT). This study is the first direct comparison of the 2 monotherapies, and the first to examine the combination of the 2 therapies. Both monotherapies (antidepressant treatment and CBT) demonstrated similar effectiveness, although CBT takes slightly longer (8 to 12 weeks), and the medications demonstrate quick improvements, with little continued improvement after 8 weeks. Combination treatment was very effective (80%) and was superior to both monotherapies. It appears unlikely that most children with severe and persistent anxiety disorders are receiving optimal evidence-based treatments in the community. The dissemination of clinical research to clinical practice (both psychotherapy and psychopharmacology) remains a continued challenge and is a national priority.