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24- and 36-Week Outcomes for the Child/Adolescent Anxiety Multimodal Study (CAMS)

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Objective

We report active treatment group differences on response and remission rates and changes in anxiety severity at weeks 24 and 36 for the Child/Adolescent Anxiety Multimodal Study (CAMS).

Method

CAMS youth (N = 488; 74% ≤12 years of age) with DSM-IV separation, generalized, or social anxiety disorder were randomized to 12 weeks of cognitive-behavioral therapy (CBT), sertraline (SRT), CBT+SRT (COMB), or medication management/pill placebo (PBO). Responders attended 6 monthly booster sessions in their assigned treatment arm; youth in COMB and SRT continued on their medication throughout this period. Efficacy of COMB, SRT, and CBT (n = 412) was assessed at 24 and 36 weeks postrandomization. Youth randomized to PBO (n = 76) were offered active CAMS treatment if nonresponsive at week 12 or over follow-up and were not included here. Independent evaluators blind to study condition assessed anxiety severity, functioning, and treatment response. Concomitant treatments were allowed but monitored over follow-up.

Results

The majority (>80%) of acute responders maintained positive response at both weeks 24 and 36. Consistent with acute outcomes, COMB maintained advantage over CBT and SRT, which did not differ, on dimensional outcomes; the 3 treatments did not differ on most categorical outcomes over follow-up. Compared to COMB and CBT, youth in SRT obtained more concomitant psychosocial treatments, whereas those in SRT and CBT obtained more concomitant combined (medication plus psychosocial) treatment.

Conclusions

COMB maintained advantage over CBT and SRT on some measures over follow-up, whereas the 2 monotherapies remained indistinguishable. The observed convergence of COMB and monotherapy may be related to greater use of concomitant treatment during follow-up among youth receiving the monotherapies, although other explanations are possible. Although outcomes were variable, most CAMS-treated youth experienced sustained treatment benefit. Clinical trial registration information—Child and Adolescent Anxiety Disorders (CAMS); URL: http://clinicaltrials.gov. Unique identifier: NCT00052078.

Section snippets

Participants

Children and adolescents (N = 488) aged 7 to 17 years (mean age, 10.7 years) years who met DSM-IV criteria for separation anxiety disorder (SAD), generalized anxiety disorder (GAD), and/or social phobia (SOP) were recruited from 6 geographically diverse sites. Exclusionary criteria included comorbid mood, psychotic, or pervasive developmental disorder, and 1 failed prior CBT trial or 2 failed SSRI trials for anxiety.4 All participants and at least 1 parent provided informed consent/assent. The

Results

The mean age of the CAMS sample at pretreatment was 10.7 ± 2.8 with 74.2% youth aged 12 or younger. Participants were predominantly white (78.9%), middle class (74.6%) youth, with a nearly equivalent number of males (50.4%) and females (49.6%). The majority of participants were diagnosed with 2 or more primary anxiety disorders (78.7%) and 1 or more secondary disorders (55.3%). Overall, 35.9% of the sample met criteria for all 3 targeted anxiety disorders, whereas the proportion of participants

Discussion

The current study examined the relative effectiveness and durability of CBT (Coping Cat), sertraline (SRT), and their combination (COMB) over 6 months of maintenance treatment after 12 weeks of acute treatment. Positive outcomes observed at the end of acute treatment (week 12) were largely maintained or enhanced across all 3 treatment conditions over the subsequent 6 months, with COMB maintaining superiority over CBT and SRT on some outcomes, whereas the monotherapies effectively caught up with

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  • Cited by (0)

    This article was reviewed under and accepted by ad hoc editor Daniel S. Pine, MD.

    This research was supported by NIMH grants U01 MH64088 (J.P.), U01 MH064003 (S.C.), U01 MH63747 (P.K.), U01 MH64003 (B.B.), U01 MH64092 (A.M.A.), U01 MH64107 (J.M.), and U01 MH064089 (J.W.). Sertraline and matching placebo were supplied free of charge by Pfizer.

    Dr. Compton served as the statistical expert for this research.

    The views expressed in this article represent those of the authors and are not intended to represent the position of NIMH, the National Institutes of Health, or the Department of Health and Human Services.

    Disclosure: Dr. Piacentini has received grant or research support from NIMH, the Tourette Syndrome Association, the Furlotti Family Foundation, and Pfizer Pharmaceuticals through the Duke University CAPTN Network. He has served on the speakers' bureau of the Tourette Syndrome Association and the International Obsessive Compulsive Disorder Foundation. He has received book royalties from Guilford Publications and Oxford University Press. He is a coauthor of the Child OCD Impact Scale–Revised (COIS-R) and the Child Anxiety Impact Scale (CAIS) assessment tools, none of which are commercially published and therefore no royalties are received. Dr. Compton has received research support from NIMH and has served as a consultant to Shire Pharmaceuticals. Dr. Kendall has received grant support from NIMH and royalties, although not from this study, from the publication of the anxiety treatment materials and books on child mental health from Guilford Press, Ericsson, Workbook Publishing, and Oxford University Press. Dr. Birmaher has received grant support from NIMH and book royalties from Random House, Inc., and Lippincott Williams and Wilkins. Dr. Albano has received grant support from NIMH, royalties from Oxford University Press for books and the NIMH Anxiety Disorders Interview Schedule for Children (ADIS), honoraria from the American Psychological Association, and consultant fees from Brackett Global. Dr. March has served as a consultant or scientific advisor to Pfizer, Eli Lilly and Co., Bristol-Myers Squibb, and Attention Therapeutics; has received study drug for an NIMH-funded study from Eli Lilly and Co., and from Pfizer; is an equity holder in MedAvante; has received royalties from Guilford Press, Oxford University Press, and MultiHealth Systems; has received research support from Pfizer, NIMH, and the National Institute on Drug Abuse (NIDA). Dr. March has not engaged in promotional work, e.g., speakers' bureau or training, for over 15 years. Dr. Sakolsky has received research support from NIMH and the National Alliance for Research on Schizophrenia and Depression (NARSAD). She has also received honoraria from the American Academy of Child and Adolescent Psychiatry for participation in the 37th Annual Review Course in Child and Adolescent Psychiatry and Training for the Oral Exams. Dr. Ginsburg has received grant support from NIMH and book royalties from Oxford University Press. Dr. Rynn has received research support from NIMH, the Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), Eli Lilly and Co., Pfizer, Merck, and Shire. She has served as a consultant to Shire. She has received royalties from American Psychiatric Publishing and a writing fee from Oxford University Press. Dr. Bergman has received grant support from NARSAD and book royalties from Oxford University Press. Dr. Gosch has received royalties from Springer Publishing Company. Dr. Waslick has received research support from the American Psychiatric Association, Pfizer Pharmaceuticals through the Duke University CAPTN Network, Novartis, and Forest Laboratories. Dr. Iyengar has received consulting fees from Stanford University and Westinghouse. Dr. McCracken has received research support from Seaside Therapeutics, Roche, and Otsuka. He has served as a consultant to BioMarin, PharmaNet, Roche, and Novartis. He has received research study drug from Shire. Dr. Walkup has received grant or research support from the Tourette Syndrome Association. He has served as a consultant to Shire. He has received free medication and placebo from Eli Lilly and Co., Pfizer, and Abbott for NIH-funded studies. He has served on the advisory board and speakers' bureau of the Tourette Syndrome Association. He has received royalties from Guilford Press and Oxford University Press. He has received honorarium and travel support for an educational meeting from the Tourette Syndrome Association. He also has received travel support unpaid activities from the Tourette Syndrome Association including an unpaid position on the Medical Advisory Board. Drs. Bennett and Sherrill report no biomedical financial interests or potential conflicts of interest.

    This article is discussed in an editorial by Dr. Neal D. Ryan on page 269.

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