This competing continuation application is one-half of a jointly proposed multicenter study by Drs. Foa, Franklin, and Kozak, of the Allegheny University of Health Sciences and Drs. Davidson and Keefe of Duke University Medical Center. Who are submitting two separate but similar proposals. We request that the two proposals be reviewed together. The proposed research is a continuation of an ongoing study funded by NIMH for the period of 9/30/94 though 8/31/98. Patient recruitment in the ongoing study has been slower than anticipated, and we are seeking funds to extend the study for an additional 3 years to accrue sufficient sample size to test the original hypotheses. The major goals of the study are: (a) to evaluate the effectiveness of FLU, a comprehensive cognitive behavioral program (CCBT) that includes CT,EX and SST, and a combination of FLU and CCBT in generalized anxiety disorder (GSP); (b) to compare relapse rates associated with different groups after discontinuation of treatment; ~ to examine the transportability of the two treatment approaches; and (d) to examine possible predictors of treatment response. GSP is chronic and debilitating anxiety disorder, affecting over 2% of the population and resulting in significant morbidity and suicide attempts. Recent studies have indicated a number of promising treatments, including fluxetine (FLU), cognitive therapy (CT), exposure therapy (EX) and social skills training (SST). No studies have compared FLU ( or any other serotonergic drug) with cognitive behavior therapy in GSP or examined the effectiveness of a combined treatment group. Moreover, no study has yet evaluated the extent to which different treatments for GSP (e.g., medications, CBT) can be transported/replicated across sites. One hundred and sixty subjects (80 per site) in addition to the 200 to be accrued in the ongoing study, meeting DSM-IV criteria for GSP will be randomly assigned to one of five conditions: FLU, CCBT, FLU+CCBT, CCBT + pill placebo, and placebo alone. Treatment is administered for 14 weeks, followed by a 24 week treatment free follow-up. Outcome is assessed by independent evaluator ratings, self-report scales, and behavioral measures of social skills. Assessments are conducted before, during and after treatment as well as during an extended follow-up phase. Important to this proposal is the collaboration between pharmacologically and cognitive- behaviorally oriented research programs. Long range goals are to establish guidelines for the pharmacological and cognitive behavioral treatment of GSP, to understand the separate and combined effects of pharmacotherapy and cognitive behavioral therapy in this condition, and to integrate pharmacological and psychosocial approaches to the anxiety disorders.
