Anne Marie Albano

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

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.)

Child/Adolescent Anxiety Multimodal Study (CAMS): rationale, design, and methods

ObjectiveTo present the design, methods, and rationale of the Child/Adolescent Anxiety Multimodal Study (CAMS), a recently completed federally-funded, multi-site, randomized placebo-controlled trial that examined the relative efficacy of cognitive-behavior therapy (CBT), sertraline (SRT), and their combination (COMB) against pill placebo (PBO) for the treatment of separation anxiety disorder (SAD), generalized anxiety disorder (GAD) and social phobia (SoP) in children and adolescents.MethodsFollowing a brief review of the acute outcomes of the CAMS trial, as well as the psychosocial and pharmacologic treatment literature for pediatric anxiety disorders, the design and methods of the CAMS trial are described.ResultsCAMS was a six-year, six-site, randomized controlled trial. Four hundred eighty-eight (N = 488) children and adolescents (ages 7-17 years) with DSM-IV-TR diagnoses of SAD, GAD, or SoP were randomly assigned to one of four treatment conditions: CBT, SRT, COMB, or PBO. Assessments of anxiety symptoms, safety, and functional outcomes, as well as putative mediators and moderators of treatment response were completed in a multi-measure, multi-informant fashion. Manual-based therapies, trained clinicians and independent evaluators were used to ensure treatment and assessment fidelity. A multi-layered administrative structure with representation from all sites facilitated cross-site coordination of the entire trial, study protocols and quality assurance.ConclusionsCAMS offers a model for clinical trials methods applicable to psychosocial and psychopharmacological comparative treatment trials by using state-of-the-art methods and rigorous cross-site quality controls. CAMS also provided a large-scale examination of the relative and combined efficacy and safety of the best evidenced-based psychosocial (CBT) and pharmacologic (SSRI) treatments to date for the most commonly occurring pediatric anxiety disorders. Primary and secondary results of CAMS will hold important implications for informing practice-relevant decisions regarding the initial treatment of youth with anxiety disorders.Trial registrationClinicalTrials.gov NCT00052078.

Clinical characteristics of anxiety disordered youth.

Reports the characteristics of a large, representative sample of treatment-seeking anxious youth (N=488). Participants, aged 7-17 years (mean 10.7 years), had a principal DSM-IV diagnosis of separation anxiety disorder (SAD), generalized anxiety disorder (GAD), or social phobia (SP). Although youth with a co-primary diagnosis for which a different disorder-specific treatment would be indicated (e.g., major depressive disorder, substance abuse) were not included, there were few other exclusion criteria. Participants and their parent/guardian underwent an extensive baseline assessment using a broad array of measures capturing diagnostic status, anxiety symptoms and severity, and areas of functional impairment. Means and standard deviations of the measures of psychopathology and data on diagnostic status are provided. The sample had moderate to severe anxiety disorder and was highly comorbid, with 55.3% of participants meeting criteria for at least one non-targeted DSM-IV disorder. Anxiety disorders in youth often do not present as a single/focused disorder: such disorders in youth overlap in symptoms and are highly comorbid among themselves.

The structure of negative emotions in a clinical sample of children and adolescents.

The authors sought to define the latent factors associated with childhood anxiety and depression, using a structural equations/confirmatory factor-analytic approach involving multiple informants (i.e., parent and child report) of symptoms. A sample of 216 children and adolescents with diagnoses of an anxiety disorder or comorbid anxiety and mood disorders and their parents were administered measures of childhood fear, anxiety, and depression. Results of comparative modeling best supported 3-factor solutions (fear, anxiety, and depression) that were consistent with recent conceptual models of anxiety and depression (e.g., tripartite model). Results also suggested that 3 widely used measures of childhood negative emotion are conceptually heterogeneous (containing item sets that loaded on different latent factors). Implications for the assessment of childhood negative emotions are discussed.

Cognitive-Behavioral Group Therapy for Social Phobia in Female Adolescents: Results of a Pilot Study

OBJECTIVES To examine the efficacy of cognitive-behavioral group therapy for adolescents (CBGT-A) in females with social phobia and the effect of this treatment on the risk for major depression. METHOD Female adolescents with social phobia (N = 35) were randomly assigned to treatment (n = 12) or no treatment (n = 23) groups. Assessments were conducted at baseline, after treatment, and at a 1-year follow-up. RESULTS Eleven subjects completed treatment. Sixteen weeks of treatment produced a significant improvement in interference and reduction in symptoms of social anxiety. There was a significant reduction in the number of subjects meeting DSM-IV criteria for social phobia in the CBGT-A versus the untreated group; however, at the 1-year follow-up there were no significant differences by treatment condition. There was also suggestive evidence that treatment of social phobia lowers the risk for relapse of major depression among those with a history of major depression. Combining social phobia and major depression as the outcome produced more robust treatment effects in the 1-year follow-up. CONCLUSIONS This pilot study provides evidence for a moderate short-term effect of CBGT-A for treating female adolescents suffering from social phobia and indicates that treatment of social phobia may result in a reduction of major depression.

Screening for anxiety and depression in early adolescence.

OBJECTIVE To examine the level of diagnostic and discriminative accuracy of three dimensional rating scales for detecting anxiety and depressive disorders in a school-based survey of 9th grade youths. METHOD Classroom screening instruments, the Center for Epidemiologic Studies-Depression Scale (CES-D), the Revised Childrens Manifest Anxiety Scale (RCMAS), and the Multidimensional Anxiety Scale for Children (MASC) were administered to 632 youths from three sites in 1998. On the basis of rating scale results, samples of high-scoring and non-high-scoring youths were invited to participate in a diagnostic interview conducted within 2 months of the screening sessions. RESULTS MASC scores were most strongly associated with individual anxiety disorders, particularly among females, whereas the CES-D composite score was associated with a diagnosis of major depression, after controlling for comorbid disorders. The RCMAS was least successful in discriminating anxiety and depression. When receiver operator characteristic curves were examined, diagnostic accuracy was moderate. CONCLUSIONS The ability of the MASC and CES-D to discriminate within and between categorically defined diagnostic groups has important implications for the accurate identification of youths in need of services.

Remission after Acute Treatment in Children and Adolescents with Anxiety Disorders: Findings from the CAMS.

OBJECTIVE To report on remission rates in anxious youth who participated in the Child/Adolescent Anxiety Multimodal Study (CAMS). The CAMS, a multisite clinical trial, randomized 488 children and adolescents (ages 7-17 years; 79% Caucasian; 50% female) with separation, social, and/or generalized anxiety disorder to a 12-week treatment of sertraline (SRT), cognitive behavioral therapy (CBT), their combination (COMB), or clinical management with pill placebo (PBO). METHOD The primary definition of remission was loss of all study-entry anxiety disorder diagnoses; additional definitions of remission were used. All outcomes were rated by independent evaluators blind to treatment assignment. Predictors of remission were also examined. RESULTS Remission rates after 12 weeks of treatment ranged from 46% to 68% for COMB, 34% to 46% for SRT, 20% to 46% for CBT, and 15% to 27% for PBO. Rates of remission (i.e., achieving a nearly symptom-free state) were significantly lower than rates of response (i.e., achieving a clinically meaningful improvement relative to baseline) for the entire sample. Youth who received COMB had significantly higher rates of remission compared to all other treatment groups. Both monotherapies had higher remission rates compared to PBO, but rates were not different from each other. Predictors of remission were younger age, nonminority status, lower baseline anxiety severity, absence of other internalizing disorders (e.g., anxiety, depression), and absence of social phobia. CONCLUSIONS For the majority of children, some symptoms of anxiety persisted, even among those showing improvement after 12 weeks of treatment, suggesting a need to augment or extend current treatments for some children.

The Functional Profiles of School Refusal Behavior: Diagnostic Aspects.

School refusal behavior is a common problem seen by mental health professionals and by educators but little consensus is available as to its classification, assessment, and treatment. This study assessed 143 youth with primary school refusal behavior and their parents to examine diagnoses that are most commonly associated with proposed functions of school refusal behavior. As expected, results indicated that great heterogeneity in diagnoses marks this population. In general, anxiety-related diagnoses were associated more with negatively reinforced school refusal behavior; separation anxiety disorder was associated more with attention-seeking behavior; and oppositional defiant disorder and conduct disorder were associated more with pursuit of tangible reinforcement outside of school. These results are discussed within the context of classification, assessment, and treatment of this population.

Development of a Cognitive-Behavioral Intervention Program to Treat Anxiety and Social Deficits in Teens with High-Functioning Autism

Anxiety is a common co-occurring problem among young people with autism spectrum disorders (ASD). Characterized by deficits in social interaction, communication problems, and stereotyped behavior and restricted interests, this group of disorders is more prevalent than previously realized. When present, anxiety may compound the social deficits of young people with ASD. Given the additional disability and common co-occurrence of anxiety in ASD, we developed a manual-based cognitive-behavioral treatment program to target anxiety symptoms as well as social skill deficits in adolescents with ASD [Multimodal Anxiety and Social Skills Intervention: MASSI]. In this paper, we describe the foundation, content, and development of MASSI. We also summarize data on treatment feasibility based on a pilot study that implemented the intervention.

Cognitive-behavioral group treatment for social phobia in adolescents. A preliminary study.

The present study is a preliminary evaluation of the effectiveness of a new cognitive-behavioral group treatment protocol for social phobia in adolescents. Five adolescents with social phobia were treated in a 16-session group treatment program, with parental involvement in selected sessions. Treatment involved skills training (social skills, problem solving, assertiveness), cognitive restructuring, behavioral exposure, and homework. Self-report measures of anxiety and depression, taken throughout treatment, indicated significant improvements over a 1-year follow-up period. Behavior test measures also indicated a decrease in subjective anxiety ratings after treatment which was maintained at follow-up. Structured diagnostic interviews 1 year after treatment confirmed full remission of social phobia for four subjects, with one subjects phobia in partial remission. Overall, the present findings support the continued evaluation of this protocol for social phobic adolescents.