Social Anxiety Disorder Clinical Trial
Official title:
Neural Mediators of Behavior Therapy for Anxiety
This study will compare the effects that two types of behavioral therapy have on brain function in people with social anxiety disorder.
Social anxiety disorder (SAD) is characterized by intense and debilitating anxiety in common
social situations. Cognitive behavioral therapy (CBT) is a talking treatment that aims to
reduce immediate anxiety symptoms. However, some anxiety symptoms and comorbid disorders not
directly addressed by CBT may only improve in the short term, while recurring in the long
term. Behavioral therapy based on acceptance and mindfulness is thought to have longer
lasting effects, because this approach emphasizes accepting anxiety instead of controlling
anxiety. This study will compare standard CBT to acceptance and commitment therapy (ACT),
which uses acceptance and mindfulness, to determine which is more effective on both a short-
and long-term basis. Participants with SAD will undergo brain scans to determine how the two
therapies affect brain functioning.
Participation in this study will last 12 months. Participants with SAD will be randomly
assigned to receive CBT, ACT, or a waitlist condition. Both CBT and ACT treatments will
include 12 weekly sessions that will deal with objects and situations that provoke anxiety.
All sessions will be audio- and videotaped. The waitlist group will complete weekly
self-monitoring forms to track anxiety and panic and will receive a phone call from a
research coordinator every 2 weeks to make sure symptoms have not worsened. After 12 weeks,
participants on the waitlist will be offered treatment.
All participants will attend study visits to undergo brain scanning at baseline, after 3
months, and after 12 months. Each study visit will involve MRI scanning (to evaluate brain
structure), functional MRI (fMRI) scanning (to evaluate brain function), questionnaires
about a participant's experience in the scanner, and collection of saliva samples before,
during, and after scanning. While undergoing the fMRI scan, participants will be asked to
remain at rest for a certain period of time, and then to perform tasks that will engage
certain parts of the brain. Assessments for all participants will occur at baseline and
after 3, 6, and 12 months. These assessments will include diagnostic evaluations by a
therapist, self-report questionnaires, ongoing self-monitoring, physiological measurements,
cognitive assessments, and behavioral observation.
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Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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