Generalized social phobia [GSP] is a chronic and debilitating anxiety disorder, affecting over 2% of the population and resulting in morbidity and suicide attempts. Recent studies have indicated that fluoxetine (FLU), a selective serotonin reuptake inhibitor (SSRI), cognitive behavioral therapy (CBT) and social skills training (SST) may be effective in treating GSP. No studies have compared FLU with CBT in GSP, nor examined the effectiveness of a combined treatment group. No study has yet evaluated the extent to which different treatments for GSP (e.g. medications, BT) can be transported/replicated across centers. The comparative effects of SSRIs, a widely used class of drug, alone and in a combination with BT, also have not been studied. The major goals of the proposed study are: (a) to evaluate the effectiveness of FLU, a comprehensive BT (CCBT) program including CBT and SST, and a combination of FLU, CCBT in GSP; (b)to compare relapse rates associated with the different groups after discontinuation of treatment; (c) to examine the transportability of the two treatment approaches; (d) to examine possible predictors of treatment response. Four hundred subjects (200 per site) meeting DSM-III-R criteria for GSP will be randomly assigned to one of five conditions: FLU; CCBT; FLU + CCBT; CCBT + pill placebo; and placebo alone. Treatment will be administered for 14 weeks, followed by a twenty-four week treatment-free follow up. Outcome will be assessed by independent evaluator ratings, self-report scales and behavioral measures of social skills. Assessments will be conducted before, during, and after treatment, as well as in the follow up phase. Important to this proposal is the collaboration between pharmacologically and behaviorally oriented research programs. Long range goals are to establish guidelines for the pharmacological and behavioral treatment of GSP, to understand the separate and combined effects of pharmacotherapy and CCBT in this disorder, and to integrate pharmacological and psychosocial approaches to the anxiety disorders.

National Institute of Health (NIH)
National Institute of Mental Health (NIMH)
Unknown (R10)
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Special Emphasis Panel (SRCM (01))
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Duke University
Schools of Medicine
United States
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