Social Phobia Clinical Trial
Official title:
fMRI of Emotional Reactivity Cognitive Regulation and CBT for Social Phobia
This study will evaluate the effect of cognitive behavioral therapy on the brain during emotional and behavioral responses to social stimuli in people with social phobia.
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.
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Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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