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      Social Effectiveness Therapy May Improve Efficacy of Fluoxetine in Children With Social Phobia: Presented at ADAA

      By Mike Fillon

      SAVANNAH, Ga -- March 11, 2008 -- Both fluoxetine and social effectiveness therapy for children (SET-C) appear superior to placebo in reducing feelings of social distress in children and adolescents with social phobia.

      In addition, SET-C appears to provide additional efficacy over fluoxetine alone, researchers reported here on March 7 at the Anxiety Disorders Association of America (ADAA) 28th Annual Conference.

      SET-C is a comprehensive behavioural approach to the treatment of social phobia that combines social skills training, peer generalisation experiences, and individualised exposure-based treatment. Fluoxetine is a selective serotonin reuptake inhibitor antidepressant.

      Social phobia is a disorder in which a person has significant anxiety and discomfort related to fear of being embarrassed, humiliated, or scorned by others in social or performance situations. The American Psychological Association (APA) estimates that as many as 5% of children suffer from this condition that, without treatment, can result in academic, social, and developmental impairment.

      While it is commonly believed that both pharmacological and psychological interventions may be efficacious for youth with social phobia, there have been few randomised controlled trials, and no comparisons of pharmacological and psychological interventions in this population.

      In a 2-site trial, researchers compared the efficacy of fluoxetine, placebo, and SET-C for 122 children and adolescents with social phobia. Participants were recruited from September 2001 through September 2004 at the Maryland Centre for Anxiety Disorders at the University of Maryland-College Park, College Park, Maryland, and at the Department of Paediatrics at Cincinnati Children's Hospital Medical Centre, Cincinnati, Ohio.

      Diagnostic interviews were conducted by psychiatrists, clinical psychologists, or doctoral students in clinical psychology using the Anxiety Disorders Interview Schedule for Children and Parents.

      In the study, fluoxetine and placebo were administered at 10 mg daily on weeks 1 and 2, 20 mg daily on weeks 3 and 4, 30 mg daily on weeks 4 and 5, and 40 mg daily on weeks 7 through 12.

      SET-C included social skills training, peer generalisation experiences, and exposure-based treatment of individual patients in situations that would bring on symptoms of social phobia. Social skills training sessions were conducted in small groups of 4 to 5 youths, whereas exposure-based treatment was conducted in sessions with individual patients. Treatment consisted of 1 individual and 1 group session per week for 12 weeks.

      Results of the study showed that both fluoxetine and SET-C were significantly superior to placebo in reducing social distress and behavioural avoidance, and in increasing general functioning (all ps < .05). When the two active interventions were compared, SET-C was superior to fluoxetine on each measure (ps < .05). It was also the only treatment superior to placebo for improving social skills, decreasing anxiety in specific social interactions, and enhancing ratings of social competence (ps < .05).

      Also, the two active treatments differed in the rate at which they achieved maximum efficacy. Whereas fluoxetine exerted maximum effect after 8 weeks of use, SET-C provided continued improvement throughout the 12 weeks of treatment.

      The results indicate that whereas both treatments appear efficacious in decreasing social distress, SET-C may have advantages over fluoxetine alone, perhaps resulting from its additive approach to enhancing social competence through social skills training, according to the researchers.

      For patients who responded positively to treatment with SET-C, effects seemed to be maintained 1 year later without additional intervention, according to lead researcher, Nina Wong, BA, Psychology Student, University of Central Florida, Oviedo, Florida, who worked on the study with Floyd R. Sallee, MD, Professor, Department of Psychiatry, University of Cincinnati, Cincinnati, Ohio. "Future studies designed to identify factors that may predict those [patients] most likely to benefit from these interventions are needed," Wong said.


      [Presentation title: SET-C Vs. Fluoxetine in the Treatment of Childhood Social Phobia. Abstract 115]



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