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| Descriptive Information Fields | |||||
| Brief Title † | Effect of Behavior Therapy on Responses to Social Stimuli in People With Social Phobia | ||||
| Official Title † | fMRI of Emotional Reactivity Cognitive Regulation and CBT for Social Phobia | ||||
| Brief Summary | 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. |
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| Detailed Description | 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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| Study Phase | |||||
| Study Type † | Interventional | ||||
| Study Design † | Treatment, Randomized, Open Label, Active Control, Single Group Assignment, Efficacy Study | ||||
| Primary Outcome Measure † | 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 ] |
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| Secondary Outcome Measure † | 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 ] |
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| Condition † | Social Phobia | ||||
| Intervention † | Behavioral: Individual Cognitive Behavioral Therapy | ||||
| MEDLINE PMIDs | |||||
| Links | Click here for the Stanford University Clinically Applied Affective Neuroscience website ![]() |
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| Recruitment Information Fields | |||||
| Recruitment Status † | Recruiting | ||||
| Enrollment † | 120 | ||||
| Start Date † | September 2006 | ||||
| Completion Date | August 2011 | ||||
| Eligibility Criteria † | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 21 Years to 55 Years | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts †† |
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| Location Countries † | United States | ||||
| Administrative Information Fields | |||||
| NCT ID † | NCT00380731 | ||||
| Organization ID | R01 MH76074 | ||||
| Secondary IDs †† | DATR A3-NSS | ||||
| Study Sponsor † | National Institute of Mental Health (NIMH) | ||||
| Collaborators †† | |||||
| Investigators † |
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| Information Provided By | National Institute of Mental Health (NIMH) | ||||
| Verification Date | August 2008 | ||||
| First Received Date † | September 22, 2006 | ||||
| Last Updated Date | August 18, 2008 | ||||