Study refusal and exclusion from a randomized treatment study of generalized social phobia

Abstract

We examine treatment exclusion and refusal rates as well as reasons for non-participation in a sub-sample of phone interviews conducted to determine eligibility for a randomized study of treatments for generalized social phobia (GSP). This study compared group comprehensive cognitive behavioral therapy (CCBT) to fluoxetine (FLU), placebo (PLA), or their combination. Results suggest that the major exclusion for the study was due to comorbid depression, followed by having a different diagnosis as primary. Patient refusal to enter the study was also common, with the most frequently reported reason being not wanting to take medication. Notably, few people who refused stated an objection to entering CCBT or PLA. These results suggest that there is a need to develop and evaluate a treatment for social anxiety with comorbid depression and to systematically study reasons for reluctance to take medication among individuals with GSP.