Trials / Completed
CompletedNCT00380731
Effect of Behavior Therapy on Responses to Social Stimuli in People With Social Phobia
fMRI of Emotional Reactivity Cognitive Regulation and CBT for Social Phobia
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 124 (actual)
- Sponsor
- Stanford University · Academic / Other
- Sex
- All
- Age
- 21 Years – 55 Years
- Healthy volunteers
- Not accepted
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 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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BEHAVIORAL | Individual Cognitive Behavioral Therapy | CBT includes 16 weekly 60-minute individual CBT sessions for social anxiety disorder. |
Timeline
- Start date
- 2006-09-01
- Primary completion
- 2011-08-01
- Completion
- 2011-08-01
- First posted
- 2006-09-26
- Last updated
- 2011-11-30
Locations
1 site across 1 country: United States
Source: ClinicalTrials.gov record NCT00380731. Inclusion in this directory is not an endorsement.