Ignite Creation Date:
2024-05-05 @ 5:06 PM
Last Modification Date:
2024-10-26 @ 9:27 AM
Study NCT ID:
NCT00380731
Status:
COMPLETED
Last Update Posted:
2011-11-30
First Post:
2006-09-22
Brief Title:
Effect of Behavior Therapy on Responses to Social Stimuli in People With Social Phobia
Sponsor:
Stanford University
Organization:
Stanford University
Study Overview
Official Title:
fMRI of Emotional Reactivity Cognitive Regulation and CBT for Social Phobia
Status:
COMPLETED
Status Verified Date:
2011-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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 CBTs 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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| DATR A3-NSS | US NIH GrantContract | None | httpsreporternihgovquickSearchR01MH076074 |
| R01MH076074 | NIH | None | None |