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

Not Applicable

Completed

• Conditions: Social Phobia
• Interventions: Behavioral: Individual Cognitive Behavioral Therapy

• Registration Number: NCT00380731
• Lead Sponsor: Stanford University

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 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.

Study Timeline

• Study Start: 2006-09
• Study First Submitted: 2006-09-22
• Study First Submitted QC: 2006-09-22
• Study First Posted: 2006-09-26
• Primary Completion: 2011-08
• Study Completion: 2011-08
• Status Verified: 2011-11
• Last Update Submitted: 2011-11-29
• Last Update Posted: 2011-11-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 124

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
1	Individual Cognitive Behavioral Therapy	Participants will receive immediate cognitive behavioral therapy
2	Individual Cognitive Behavioral Therapy	Participants will receive cognitive behavioral therapy with a 16-week delayed start

Primary Outcome Measures

Name	Time	Method
fMRI BOLD response	Measured at Month 4
Liebowitz Social Anxiety Scale	Measured at Months 4, 7, 10, 13, and 16
Behavioral assessment	Measured at Months 4 and 16

Secondary Outcome Measures

Name	Time	Method
Quality of Life Inventory	Measured at Months 4, 10, and 16
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

Trial Locations

Locations (1)

Stanford University; 🇺🇸 Stanford, California, United States