Primary Outcome Measures:
- Liebowitz Social Anxiety Scale [ Time Frame: Measured at Months 4, 7, 10, 13, and 16 ] [ Designated as safety issue: No ]
- fMRI BOLD response [ Time Frame: Measured at Month 4 ] [ Designated as safety issue: No ]
- Behavioral assessment [ Time Frame: Measured at Months 4 and 16 ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Clinical Global Impression Improvement Scale [ Time Frame: Measured at Months 4 and 16 ] [ Designated as safety issue: No ]
- Social Interaction Anxiety Scale [ Time Frame: Measured at Months 4, 10, and 16 ] [ Designated as safety issue: No ]
- Sheehan Disability Scale [ Time Frame: Measured at Months 4, 10, and 16 ] [ Designated as safety issue: No ]
- Quality of Life Inventory [ Time Frame: Measured at Months 4, 10, and 16 ] [ Designated as safety issue: No ]
Social phobia, also known as social anxiety disorder, is a common, often debilitating condition. People with social phobia experience high levels of anxiety when they participate in social situations or perform in front of others. Approximately 80% of social phobia cases occur before the age of 18, and often precede other anxiety, mood, and substance abuse or dependence disorders. Physical symptoms typically accompany the intense anxiety caused by the disorder, and may include blushing, profuse sweating, trembling, nausea, and difficulty talking. Cognitive-behavioral therapy (CBT) has been shown to be an effective treatment method for most people with social phobia. Approximately 30% of people with the disorder, however, do not respond to CBT treatment. A better understanding of the neural mechanisms underlying social phobia and CBT's effect on these mechanisms will help physicians to better predict the best treatment for different patients. This study will evaluate the effect of CBT on how the brain processes emotional and behavioral responses to social stimuli in people with social phobia.
Participants in this open-label study will be randomly assigned to either immediate or delayed treatment with CBT. Participants who are assigned to immediate CBT will attend 16 sessions of individual CBT immediately following baseline assessments. Participants assigned to the delayed treatment condition will begin attending CBT sessions approximately 5 months following baseline assessments. Outcomes will be assessed for all participants at baseline, immediately post-treatment, and at Months 5 and 10 post-treatment. An fMRI scan will be used to measure neural responses to social stimuli, and various questionnaires and scales will be used to assess anxiety symptom severity. Participants in the delayed treatment group will be assessed on one additional occasion before they begin treatment after the 5-month waiting period.
Purpose
