This application is one-half of a jointly proposed multicenter study by Drs. Davidson and at DUMC and AUH respectively, who are submitting two separate but similar competing continuation proposals. Generalized social phobia (GSP) a chronic and debilitating anxiety disorder affecting over 10 percent of the population and resulting in significant morbidity and suicide attempts. Recent studies have indicated that fluoxetine (FLU), a selective serotonin reuptake inhibitor (SSRI), comprehensive cognitive behavioral therapy (CCBT) may be effective in treating GSP. No studies have compared FLU vs. CCBT vs PBO in GSP, nor have they examined the effectiveness of combined FLU-CCBT. No study has yet evaluated the extent to which different treatments for GSP (e.g. medications, CCBT) can be transported/replicated across centers, nor have the comparative effects of an SSRI, a widely used class of drugs in GSP, been assessed relative to psychosocial treatments. Major goals of this ongoing study are to (1) evaluate the effectiveness of FLU, CCBT, the combination of FLU plus CCBT, vs CCBT with placebo vs placebo; (2) to compare relapse rates associated with different treatment groups following discontinuation at week 14; (3) to examine the transportability of the two treatment approaches; (4) to examine possible predictors of treatment response. This study was begun in 1994, and involves both a pharmacologically oriented site and a psychosocial treatment oriented site, thus providing state-of-the-art treatment in each mode. The collaborative study has been very successful to date, but we have proceeded at a slower speed than we had expected, and propose to extend the study for three more years in order to accumulate a sufficient sample of completed subjects to allow adequate power to test our original hypotheses. We will enroll 160 subjects at each site, to attain 120 completers (n=25 per group; n=20 for placebo). This will provide adequate statistical power to test treatment and site effects. This study serves as a model for psychotherapy-pharmacotherapy comparisons because experts in each modality are providing both forms of treatment. As a result, this protects against expert bias for either treatment and the results of this study are expected to establish guidelines for pharmacotherapy and behavioral therapy of GSP, to understand the separate and combined effects of each type of therapy in this disorder, and to integrate pharmacological and psychosocial treatments in generalized social phobia. Effective treatments can be a long way towards reducing the societal burden associated with the disorder.
| Aderka, Idan M; McLean, Carmen P; Huppert, Jonathan D et al. (2013) Fear, avoidance and physiological symptoms during cognitive-behavioral therapy for social anxiety disorder. Behav Res Ther 51:352-8 |
| Davidson, Jonathan R T; Foa, Edna B; Connor, Kathryn M et al. (2002) Hyperhidrosis in social anxiety disorder. Prog Neuropsychopharmacol Biol Psychiatry 26:1327-31 |
