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Question: Is sertraline (SRT), cognitive behavioural therapy (CBT) or a combination of the two, effective at inducing remission among children and adolescents with anxiety disorders compared with placebo?
Patients: 488 children and adolescents aged between 7 and 17 years who met DSM-IV criteria for generalised anxiety disorder, social phobia and/or separation anxiety disorder.
Setting: Six sites, USA; from 2003 to 2008.
Intervention: SRT only, CBT only, SRT and CBT (COMB) or placebo pill treatment for 12 weeks.
Outcomes: Remission, defined in three different ways: (A) loss of all targeted anxiety disorders, assessed using the Anxiety Disorders Interview Schedule; (B) Clinical Global Impression Severity Scale (CGI-S) score of 1 (no symptoms) or 2 (minimal symptoms); (C) Clinical Global Impression Improvement Scale (CGI-I) score of 1 (very much improved).
Patient follow-up: 90% completed the study; 100% included in the analysis.
Design: Randomised controlled trial (the Child/Adolescent Anxiety Multimodal Study, CAMS).
Blinding: The SRT and PBO arms were double blinded while the CBT and COMB arms were single blinded (assessors only).
Follow-up period: 12 …
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