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Cited by 1,442Anxiety, Depression, Psychometrics, Treatment, Cognitive ProcessesChild and Adolescent Psychosocial and Emotional DevelopmentPsychotherapy Techniques and Applications

Cognitive Behavioral Therapy, Sertraline, or a Combination in Childhood Anxiety

Open access
Walkup, John T., Albano, Anne Marie, Piacentini, John, Birmaher, Boris, Compton, Scott N., Sherrill, Joel T., Ginsburg, Golda S., Rynn, Moira A. +5 more·2008·New England Journal of Medicine
DOI 10.1056/nejmoa0804633PMC PMC2702984
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Abstract

BACKGROUND: Anxiety disorders are common psychiatric conditions affecting children and adolescents. Although cognitive behavioral therapy and selective serotonin-reuptake inhibitors have shown efficacy in treating these disorders, little is known about their relative or combined efficacy. METHODS: In this randomized, controlled trial, we assigned 488 children between the ages of 7 and 17 years who had a primary diagnosis of separation anxiety disorder, generalized anxiety disorder, or social phobia to receive 14 sessions of cognitive behavioral therapy, sertraline (at a dose of up to 200 mg per day), a combination of sertraline and cognitive behavioral therapy, or a placebo drug for 12 weeks in a 2:2:2:1 ratio. We administered categorical and dimensional ratings of anxiety severity and impairment at baseline and at weeks 4, 8, and 12. 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<0.001), 59.7% for cognitive behavioral therapy (P<0.001), and 54.9% for sertraline (P<0.001); all therapies were superior to placebo (23.7%). Combination therapy was superior to both monotherapies (P<0.001). Results on the Pediatric Anxiety Rating Scale documented a similar magnitude and pattern of response; combination therapy had a greater response than cognitive behavioral therapy, 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 cognitive behavioral therapy than with sertraline. CONCLUSIONS: Both cognitive behavioral therapy and sertraline reduced the severity of anxiety in children with anxiety disorders; a combination of the two therapies had a superior response rate. (ClinicalTrials.gov number, NCT00052078.)

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Crossref · 10.1056/nejmoa0804633

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  • While psychological and pharmacological interventions are mainstays of treatment for anxiety and depressive disorders in children and adolescents, alternative and adjunct treatment options are available, including exercise.

    “While psychological and pharmacological interventions are mainstays of treatment for anxiety and depressive disorders in children and adolescents (James 2020;Walkup 2008;Wang 2017), alternative and adjunct treatment options are available, including exercise.”

    From Exercise for the treatment of anxiety in children and adolescents (2022) · cites this paper as Walkup 2008

    The Background and Discussion describe cognitive behavioral therapy and medication as effective treatments for childhood anxiety disorders. They do not establish that these are mainstays for depressive disorders; the Methods excluded children with current major depressive disorder. The exercise clause follows the citations and is not attributed to this source. (LLM, conf=0.88)

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  • Randomization will be stratified by study site, age group [8-17], and baseline symptom severity, dichotomizing SCARED-41 scores as ≤33 or >33 based on the median SCARED-41 score for participants having scores ≥25 in the CAMS and LAMS studies.

    “Randomization will be stratified by study site, age group [8–17], and baseline symptom severity (dichotomizing SCARED-41 scores as ≤33 or > 33, based on the median SCARED-41 score for participants having scores ≥25 in the CAMS [49] and LAMS [163] studies).”

    From A Sequential Multiple Assignment Randomized Trial (SMART) study of medication and CBT sequencing in the treatment of pediatric anxiety disorders (2021) · cites this paper as [49]

    The Methods (Randomization and Masking; page unavailable) identify this as a randomized childhood-anxiety study, supporting its identification as the CAMS study. The paper reports stratification by age, sex, and study center, but does not report a median SCARED-41 score of 33 among participants scoring at least 25; its Outcome Assessments section instead describes the Pediatric Anxiety Rating Scale. Thus it does not substantiate the cutoff attributed to CAMS. (LLM, conf=0.84)

    Experimental — accuracy not yet measured

  • Functional gastrointestinal symptoms have been reported in 30% to 70% of children with anxiety disorders, versus 6% to 25% of children in the general population.

    “Conversely, FGID symptoms have been reported in 30% to 70% of children with anxiety disorders3,5 as compared to 6% to 25% of children from the general population.6”

    From Provider Communication Regarding Psychosocial Factors Predicts Pain Beliefs in Parent and Child (2016) · cites this paper as [6]

    The citation is attached to the reported 30%–70% rate among children with anxiety disorders, not the general-population comparison. The Methods (Study Subjects) describe children with anxiety disorders, but neither that section nor the additional passages found by searching for functional gastrointestinal and abdominal symptoms reports the claimed rate. (LLM, conf=0.77)

    Experimental — accuracy not yet measured

  • Very few studies have compared combined therapy to either treatment alone.

    “Very few studies have compared combined therapy to either treatment alone [47–49].”

    From A Sequential Multiple Assignment Randomized Trial (SMART) study of medication and CBT sequencing in the treatment of pediatric anxiety disorders (2021) · cites this paper as [49]

  • In the CAMS study, combined CBT + sertraline improved clinical response more than either modality alone, but primarily in those with severe anxiety, and not in long-term follow-up.

    “In the CAMS study, combined CBT + sertraline improved clinical response more than either modality alone [49], but primarily in those with severe anxiety [50], and not in long-term follow-up [29].”

    From A Sequential Multiple Assignment Randomized Trial (SMART) study of medication and CBT sequencing in the treatment of pediatric anxiety disorders (2021) · cites this paper as [49]

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Research works printed but not linked: 1

  1. [20]Albano AM Silverman WK The anxiety disorders interview schedule for DSM-IV, child version: clinician manual 1996 Oxford University Press New York

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Authors
Walkup, J. T., Albano, A. M., Piacentini, J., Birmaher, B., Compton, S. N., Sherrill, J. T., Ginsburg, G. S., Rynn, M. A., McCracken, J., Waslick, B., Iyengar, S., March, J. S., & Kendall, P. C.
Affiliations
  • Johns Hopkins University (US)
  • Columbia University Irving Medical Center (US)
  • University of California, Los Angeles (US)
  • University of Pittsburgh Medical Center (US)
  • Duke Medical Center (US)
  • National Institute of Mental Health (US)
  • Baystate Medical Center (US)
  • Temple University (US)
ORCID
Venue
New England Journal of Medicine
Publisher
Massachusetts Medical Society
Published
2008-12-25
Volume
359
Issue
26
Pages
2753-2766
ISSN
  • 0028-4793 (ISSN-L)
  • 1533-4406
DOI
10.1056/nejmoa0804633
PMC
PMC2702984
OpenAlex
W2131873172
Semantic Scholar
a41b3bc19195f9eba51187a6e1119eeb1b17a808
Cited by
1,442
References
30
Citations by year
2026: 46 · 2025: 46 · 2024: 64 · 2023: 63 · 2022: 92 · 2021: 97 · 2020: 85 · 2019: 91 · 2018: 93 · 2017: 89 · 2016: 85 · 2015: 109 · 2014: 88 · 2013: 100 · 2012: 82
FWCI
95.27
Type
journal article
Language
en
Open access
Locations
  • New England Journal of Medicine (publishedVersion)
  • PubMed (publishedVersion)
  • PubMed Central (acceptedVersion)
Funders
National Institute of Mental Health (U01MH64088, U01MH64107, U01MH64003, U01MH064088, U01MH064107, U01MH64092, U01MH064089, U01MH064092, U01MH63747, U01MH064003, U01MH063747, L40 MH072315, K23MH075843)
Topics
  • Social Sciences › Psychology › Experimental and Cognitive Psychology › Anxiety, Depression, Psychometrics, Treatment, Cognitive Processes
  • Social Sciences › Psychology › Clinical Psychology › Child and Adolescent Psychosocial and Emotional Development
  • Social Sciences › Psychology › Clinical Psychology › Psychotherapy Techniques and Applications
Keywords
childhood anxiety disorders, cognitive behavioral therapy, sertraline, selective serotonin reuptake inhibitors, combination therapy, separation anxiety disorder, generalized anxiety disorder, social anxiety disorder, treatment efficacy, adverse events, suicidal ideation, insomnia
MeSH terms
Adolescent, Anxiety Disorders, Child, Combined Modality Therapy, Female, Humans, Male, Cognitive Behavioral Therapy, Treatment Outcome, Selective Serotonin Reuptake Inhibitors, Sertraline

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