Effect of Behavior Therapy on Responses to Social Stimuli in People With Social Phobia
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First Received Date ICMJE | September 22, 2006 | ||||
Last Updated Date | November 29, 2011 | ||||
Start Date ICMJE | September 2006 | ||||
Primary Completion Date | August 2011 (final data collection date for primary outcome measure) | ||||
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Change History | Complete list of historical versions of study NCT00380731 on ClinicalTrials.gov Archive Site | ||||
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Descriptive Information | |||||
Brief Title ICMJE | Effect of Behavior Therapy on Responses to Social Stimuli in People With Social Phobia | ||||
Official Title ICMJE | 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 Type ICMJE | Interventional | ||||
Study Phase | |||||
Study Design ICMJE | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
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Condition ICMJE | Social Phobia | ||||
Intervention ICMJE | Behavioral: Individual Cognitive Behavioral Therapy
CBT includes 16 weekly 60-minute individual CBT sessions for social anxiety disorder. |
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Study Arm (s) |
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Publications * | |||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||
Recruitment Status ICMJE | Completed | ||||
Enrollment ICMJE | 124 | ||||
Completion Date | August 2011 | ||||
Primary Completion Date | August 2011 (final data collection date for primary outcome measure) | ||||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Gender | Both | ||||
Ages | 21 Years to 55 Years | ||||
Accepts Healthy Volunteers | No | ||||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
Location Countries ICMJE | United States | ||||
Administrative Information | |||||
NCT Number ICMJE | NCT00380731 | ||||
Other Study ID Numbers ICMJE | R01 MH076074, R01MH076074, DATR A3-NSS | ||||
Has Data Monitoring Committee | Yes | ||||
Responsible Party | James J. Gross, Stanford University | ||||
Study Sponsor ICMJE | Stanford University | ||||
Collaborators ICMJE | National Institute of Mental Health (NIMH) | ||||
Investigators ICMJE |
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Information Provided By | Stanford University | ||||
Verification Date | November 2011 | ||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |