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Treatment of Anxiety & Related Disorders in Children & Adolescents Martin E. Franklin, Ph.D. Associate Professor of Psychiatry & Director, Child/Adolescent OCD, Tics, Trich, & Anxiety Group (COTTAGe) University of Pennsylvania School of Medicine Anxiety Disorders in Youth • What do they have in common? » Intense anxiety resulting in distress and/or functional impairment • What are the different anxiety disorders? » Specific (Simple) Phobia » Social Anxiety Disorder (Social Phobia) & Selective Mutism » Separation Anxiety Disorder » Generalized Anxiety Disorder (GAD) » Panic Disorder » Obsessive-Compulsive Disorder (OCD) » Posttraumatic Stress Disorder (PTSD) • Why should I care? The NEW ENGLAND JOURNAL of MEDICINE EDITORIALS Pediatric Anxiety — Underrecognized and Undertreated Graham J. Emslie, M.D. Generalized anxiety disorder, separation anxiety disorder, and social phobia are relatively prevalent disorders that affect 6 to 20% of children and adolescents.1 However, these disorders frequently go unrecognized by medical professionals. This is a critical problem, since a younger age of onset and severity of illness result in poor outcomes in adolescents and adults. Furthermore, the failure to identify these disorders early in life leads to increased rates of anxiety disorders, depression, and substance abuse later in life, as well as to educational underachievement.2 In this issue of the Journal, the report by Walkup et al. on the Child-Adolescent Anxiety Multimodal Study (CAMS)3 addresses the need of early treatment for these disorders. It is important to understand that clinicians did not always consider anxiety disorders among children to be related to adult anxiety disorders. Once similar diagnostic criteria for anxiety disorders were developed for children and adults with the publication of the Diagnostic and Statistical Manual of Mental Disorders, fourth edition (DSM-IV),4 it was recognized that adult anxiety disorders often have their origins in childhood. For example, “overanxious disorder of childhood,” once considered an age-bound condition, was then understood as part of a continuum of generalized anxiety disorder that began in childhood. After generalized anxiety disorder and social phobia were labeled with DSM-IV criteria consistent across the life span, it was clear that early onset, particularly in preadolescents, was an indicator of poor prognosis. In all, the changes in diagnostic categories that stemmed from the DSM-IV criteria have led to increasing awareness of the longitudinal effect of anxiety disorders and have permitted extrapolation of treatments from research in adults to children. Anxiety disorders may go unrecognized in the pediatric population for several reasons. For one thing, fears and worries are common in healthy children. Normal, developmentally appropriate worries, fears, and shyness can be difficult to distinguish from anxiety disorders. For diagnosis, worries and fears must persist and must lead to impaired functioning. However, even distressing and dysfunctional symptoms are frequently unrecognized because children with anxiety disorders often report only physical symptoms (e.g., headache and stomachache) and are unable to verbalize their internalized symptoms of “worry” or “fear.” Furthermore, such reported symptoms are often accommodated by family or school, and the affected child may simply avoid anxietyprovoking situations (avoidant coping). Such overaccommodation strategies may minimize the immediate symptoms yet often lead to increased difficulty in coping with these anxieties later. For example, a child with marked social anxiety may well have substantial difficulties transitioning from elementary school to junior high school if the problem is not addressed. Furthermore, a child with severe social anxiety may have less opportunity to develop the necessary social skills for success later in life because of avoidant coping. Thus, recognizing anxiety disorders in children is the necessary first step in providing treatment that would facilitate learning healthier coping skills. These issues are central to the CAMS study. Although early randomized, controlled trials demonstrated the effectiveness of the individual treatments (antidepressant medications and cognitive behavioral therapy) used in this study, CAMS compares the two monotherapies, examines their combination, and reveals several interesting findings. First, the two monotherapies were equally n engl j med 359;26 www.nejm.org december 25, 2008 Downloaded from www.nejm.org at PRINCETON UNIVERSITY on January 6, 2009 . Copyright © 2008 Massachusetts Medical Society. All rights reserved. Why Pay So Much Attention to Anxiety? • Up to 20% of school age children have clinical anxiety • Negative impact in multiple domains • “Derailing” from achievement of important developmental milestones (e.g., development of dating skills) • Educational underachievement (e.g., Woodward & Fergusson, 2001) • Associated with depression & suicidal ideation • Predicts substance abuse problems & adult anxiety disorders Treatment Efficacy: Overall Effects Evidence from RCTs support the efficacy of: • Cognitive-behavioral therapy (CBT) • Pharmacological interventions (e.g., SSRIs) • Combined CBT + SSRIs CBT for Pediatric Anxiety Disorders: Theoretical & Practical Considerations Emotional Processing Theory & Treatment of Anxiety Disorders (Foa & Kozak, 1985, 1986) • Exposure is designed to activate fear network • Need to “match” exposures to the fear network • Prevention of avoidance is necessary because it disrupts the natural process of habituation and hence interferes with cognitive change • Exposure provides “corrective information” CBT Interventions for Pediatric Anxiety Typically Include: • 10 -12 + sessions delivered by trained/supervised therapists • Psychoeducation re: nature of anxiety • Identifying & dealing with anxiety-relevant cognitions • Hierarchy development & selection of treatment targets • Some form of behavioral exposure to feared thoughts & situations • Relapse prevention CBT for Pediatric Anxiety Disorders: Short Version “Blah, blah, blah…do the thing you’re afraid of… Blah, blah, blah…the more you do it, the easier it gets.” Gwen Franklin, age 6 Specific Example: March & Mulle’s (1998) CBT Protocol for Pediatric OCD • Psychoeducation • Cognitive Training • Mapping OCD: Development of Treatment Hierarchies • Exposure and Response Prevention (EX/RP) • Relapse Prevention POTS I & II: CBT Protocol Obsessive Compulsive Cycle Obsessions Distress Repetitive negative, images or impulses Anxiety, fear, disgust or shame Relief Compulsions Distress subsides temporarily Repetitive thoughts images or actions X Negative Reinforcement Pediatric OCD Treatment Study: Penn, Duke, & Brown Study Design: CBT SER n = 28 n = 28 CBT + SER n = 28 PBO n = 28 Phase l: 12 Week Acute Treatment Phase ll: 16 Week Follow-up for Treatment Responders POTS I CY-BOCS ITT Outcomes COMB > CBT = SER > PBO CY-BOCS TOTAL 30 25 20 PBO SER CBT COMB 15 10 5 0 Week 0 Pediatric OCD Study Team (2004) JAMA. Week 12 Stages of Treatment Model • Initial treatment(s) • Maintenance treatment(s) • Clinical management of partial response • Clinical management of non-response Evans D. et al., (2004). Treating and preventing adolescent mental health disorders: What we know and what we don’t know. New York: Oxford U Press. Annenberg Foundation Trust at Sunnylands’ Adolescent Mental Health Initiative POTS II Collaborative Study Group PIs: M. Franklin, J. Freeman, J. March, H. Leonard POTS II methods paper published in: Freeman J., et al. (2009). Child & Adolescent Psychiatry & Mental Health, 3:4. POTS II primary outcome paper published in: Franklin M, et al. (2011). Journal of the American Medical Association, 306, 1224-32. POTS II: Design POTS II: Penn, Duke & Brown Study Design: MM+CBT MM+I-CBT MM n = 42 n = 40 n = 42 12 Week Treatment Phase 3 & 6 month naturalistic follow-up for all participants POTS II: Demographics • Gender: 54% female • Mean age: 13.6 years (2.8) • Age range: 7-17 • % of sample < 11 yrs.: 32% • Ethnicity/race: 96% Caucasian Comorbidity • 60% had at least one comorbid disorder: - 44% had an anxiety or mood disorder - 22% had comorbid ADD/ADHD - 15% had a comorbid tic disorder CYBOCS By Visit Week Franklin et al. (2011) JAMA. Conclusions • Augmenting medication maintenance (MM) with CBT results in symptom improvement compared to MM alone • Adding a brief form of CBT as a component of routine MM offers only modest benefit • From a public health perspective, both POTS I and POTS II argue forcefully for a strong CBT dissemination effort POTS Junior: Treatment of Very Young Children w/ OCD Family Based CBT program (Freeman & Garcia, 2008) • Psychoeducation for parents and children • Child Tools • Parent Tools • Family Process Issues Family-Based Treatment of OCD in Very Young Children CBT REL N = 62 N = 62 14 Week Treatment Phase • REL participants receive open CBT • Transfer of control model for youth ages 5 - 8 Study recruitment recently completed @ Penn, Duke, & Brown Pediatric Trichotillomania (TTM) DSM IV Definition of Trichotillomania (TTM) A. Recurrent hairpulling with noticeable hair loss B. Tension before pulling or when attempting to resist C. Pleasure, gratification, or relief when pulling D. Not better accounted for by another disorder and not due to a general medical condition E. Clinically significant distress/functional impairment Franklin & Tolin’s TTM Protocol (2007): Core Elements • Psychoeducation • Self-monitoring/awareness training • Stimulus control • Competing response/habit reversal Habit Reversal Training • First increase awareness of pulling behaviors • Engage in competing behavior for 1 minute • Use competing behavior at progressively earlier stages in the pulling cycle • Formally similar to what our group and others researchers have studied in the treatment of Tourette Syndrome (Franklin et al., 2011; Piacentini et al., 2010) RCT for Pediatric TTM: Design CBT MAC N = 12 N = 12 8 Week Treatment Phase • MAC participants receive open CBT • 8 week maintenance phase for CBT participants 6 month Naturalistic Follow-up Phase RCT Sample Description (N=24) Age in years: 12.5 (2.7) Age of onset: 8.9 (3.2) % Adolescents: 67% % Female: 67% % Caucasian: 75% RCT Pulling Sites (% Endorsing) Scalp 79% Eyelashes 42% Eyebrows 25% Pubic 8% Arm/Leg 4% % Multiple sites 33% Comorbidity • 46% had at least one comorbid disorder • 33% had at least one anxiety disorder (e.g., GAD) • 13% had at least one comorbid externalizing disorder (e.g., ADD/ADHD, ODD, conduct disorder) • 13% had a comorbid mood disorder • 4% had comorbid OCD 14 BT and MAC Outcomes (LOCF on Week 40) 12 NIMH-TSS 10 8 BT (n = 12) MAC (n = 12) 6 4 2 0 Wk 0 Wk 8 Wk 16 Wk 40 Franklin et al. (2011). JAACAP. But Was Running Against MAC Really a Fair Test? BT for Pediatric TTM: Ongoing R01 CBT N = 30 SC N = 30 8 Week Treatment Phase • SC participants receive open CBT • 8 week maintenance phase for CBT participants 6 month Naturalistic Follow-up Phase Habit Reversal Training for Tics Douglas W. Woods August 4, 2006 Philadelphia, PA Common Features of Tic Disorders • Tics can be simple or complex • Tics wax & wane • Occur in bouts of bouts of bouts • Topography changes • Motor tics typically develop from head down • Frequency, intensity, severity often follow a developmental pattern • Usually preceded by premonitory urge Changing Internal Contingencies Premonitory Urge Tic X Relief Creates habituation to Premonitory Urge Negative Reinforcement Steps of CR Training • Introduce CR • Choose CR Incompatible w/ tic Mutual decision b/w patient and therapist • Therapist simulates correct implementation • Client is taught to do & practice CR in session CR Caveats • CR need not be physically incompatible to be effective, but it makes more intuitive sense to start with an incompatible response • CR should be done contingent on tic or warning sign to be maximally effective • CR is held for 1 minute or until the premonitory urge goes away (whichever is longer) • CR tends to fade as the tic fades Comprehensive Behavioral Intervention for Tics Study (CBITS) Two parallel studies comparing behavior therapy to ST Child Study: 120 children (ages 9-17) with TS/CTD Adult Study: 120 children and adults (ages 16+) with TS/CTD 8 session treatments over 10 weeks Comprehensive assessment at BL, 5 wks, 10 wks (post treatment), 3 & 6 month follow-ups Participating Sites (40 at each of 3 sites) UCLA (Child) Johns Hopkins University (Child) University of Wisconsin – Milwaukee (Child) Mass General Hospital/Harvard (Adult) Yale Child Study Center (Adult) U. of Texas Health Sciences Center (Adult) Funded by NIMH through two different mechanisms (R01 to TSA; Child study, and Collaborative R01s to Yale, Harvard, and UTHSC) Study Treatments CBIT Components • Psychoeducation Psychoed/SC Components • Phenomenology of TS • Prevalence of TS • Habit Reversal Therapy • Natural History of TS • Functional Intervention • Common Comorbidities • Reward System • Relaxation Training • Causes of TS • Psychosocial Impairments • Nonspecific Support YGTSS CBITS Results (Piacentini et al., 2010 • More children in the control group were rated as improved/ very much improved on CGI • Gains were maintained for at least 6 months Habit Reversal Training and ACT for Chronic Tic Disorders (TSA-Sponsored) • 7 participants ages 14 – 25 (3 @ Penn, 4 @ Duke) received standard HRT treatment for tics • Data from this phase used to inform HRT+ACT manual • HRT+ACT provided to 6 additional participants (3/site) • ACT did not appear to enhance HRT outcomes, perhaps because of a floor effect in HRT • Franklin et al. (2011). Journal of Developmental and Physical Disabilities Mean tic severity (YGTSS) scores over time for HRT (n = 7) versus HRT+ACT (n = 6) Treatments for Pediatric Anxiety & Related Disorders: What Do the Efficacy Data Tell Us? • CBT is efficacious, both alone and in COMB with meds • COMB might have some advantages over both monotherapies, but optimal sequencing yet to be established • CBT appears to be applicable to very young children • Treatments are neither universally nor completely effective, so there is treatment development work to be done Pediatric Anxiety & Related Disorders: What’s Next ? • Moderator analyses to examine which kids need COMB • Mediator analyses to examine mechanisms of action • Therapist effects • Transportability to community clinical settings • Novel approaches to promote dissemination (e.g., web-based training & treatments, CD-ROMs) • Protective factors: What prevents kids with behaviorally inhibited temperaments at risk for anxiety from developing anxiety disorders?