Effect of Behavior Therapy on Responses to Social Stimuli in People With Social Phobia

Study Overview
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Brief Summary
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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
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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.

Official Title
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fMRI of Emotional Reactivity Cognitive Regulation and CBT for Social Phobia

Conditions
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Social Phobia

Intervention / Treatment
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* Behavioral: Individual Cognitive Behavioral Therapy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Meets DSM-IV criteria for generalized social phobia English-speaking Eligible to participate in fMRI scanning Willing to use an effective form of contraception throughout the study Exclusion Criteria: Currently undergoing any psychotherapy or pharmacotherapy (e.g, selective serotonin reuptake inhibitors, benzodiazepines, beta-blockers, anti-psychotics, blood thinners, thyroid hormone influencing agents, diabetic medications, or anticonvulsants) History of neurological or cardiovascular disorders, brain surgery, electroconvulsive or radiation treatment, brain hemorrhage or tumor, stroke, seizures or epilepsy, diabetes, hypo- or hyperthyroidism, or head trauma with loss of consciousness for more than 5 minutes Smokes cigarettes daily History of or current diagnosis of schizophrenia, schizoaffective disorder, organic mental disorder, bipolar disorder, or antisocial, schizotypal, or schizoid personality disorders Suicidal thoughts Clinically significant and/or unstable medical disease Pregnant or breastfeeding Alcohol or substance abuse or dependence within the 12 months prior to study entry History of or current seizure disorder (except febrile seizure disorder during childhood)

Ages Eligible for Study
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Minimum Age: 21 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Participants will receive immediate cognitive behavioral therapy | Behavioral: Individual Cognitive Behavioral Therapy<br>* CBT includes 16 weekly 60-minute individual CBT sessions for social anxiety disorder.<br>|
| Experimental: 2<br>Participants will receive cognitive behavioral therapy with a 16-week delayed start | Behavioral: Individual Cognitive Behavioral Therapy<br>* CBT includes 16 weekly 60-minute individual CBT sessions for social anxiety disorder.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Liebowitz Social Anxiety Scale |  | Measured at Months 4, 7, 10, 13, and 16 | 
| fMRI BOLD response |  | Measured at Month 4 | 
| Behavioral assessment |  | Measured at Months 4 and 16 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical Global Impression Improvement Scale |  | Measured at Months 4 and 16 | 
| Social Interaction Anxiety Scale |  | Measured at Months 4, 10, and 16 | 
| Sheehan Disability Scale |  | Measured at Months 4, 10, and 16 | 
| Quality of Life Inventory |  | Measured at Months 4, 10, and 16 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Social Anxiety Disorder, Magnetic Resonance Imaging, Cognitive Behavior Therapy