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Trial record 1 of 8 for:    social anxiety cognitive behavioral therapy Stanford
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Effect of Behavior Therapy on Responses to Social Stimuli in People With Social Phobia

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ClinicalTrials.gov Identifier: NCT00380731
Recruitment Status : Completed
First Posted : September 26, 2006
Last Update Posted : November 30, 2011
National Institute of Mental Health (NIMH)
Information provided by (Responsible Party):
James J. Gross, 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.

Condition or disease Intervention/treatment Phase
Social Phobia Behavioral: Individual Cognitive Behavioral Therapy Not Applicable

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 : Interventional  (Clinical Trial)
Actual Enrollment : 124 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: fMRI of Emotional Reactivity Cognitive Regulation and CBT for Social Phobia
Study Start Date : September 2006
Actual Primary Completion Date : August 2011
Actual Study Completion Date : August 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anxiety Phobias

Arm Intervention/treatment
Experimental: 1
Participants will receive immediate cognitive behavioral therapy
Behavioral: Individual Cognitive Behavioral Therapy
CBT includes 16 weekly 60-minute individual CBT sessions for social anxiety disorder.

Experimental: 2
Participants will receive cognitive behavioral therapy with a 16-week delayed start
Behavioral: Individual Cognitive Behavioral Therapy
CBT includes 16 weekly 60-minute individual CBT sessions for social anxiety disorder.

Primary Outcome Measures :
  1. Liebowitz Social Anxiety Scale [ Time Frame: Measured at Months 4, 7, 10, 13, and 16 ]
  2. fMRI BOLD response [ Time Frame: Measured at Month 4 ]
  3. Behavioral assessment [ Time Frame: Measured at Months 4 and 16 ]

Secondary Outcome Measures :
  1. Clinical Global Impression Improvement Scale [ Time Frame: Measured at Months 4 and 16 ]
  2. Social Interaction Anxiety Scale [ Time Frame: Measured at Months 4, 10, and 16 ]
  3. Sheehan Disability Scale [ Time Frame: Measured at Months 4, 10, and 16 ]
  4. Quality of Life Inventory [ Time Frame: Measured at Months 4, 10, and 16 ]

Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00380731

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United States, California
Stanford University
Stanford, California, United States, 94025
Sponsors and Collaborators
Stanford University
National Institute of Mental Health (NIMH)
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Principal Investigator: James J. Gross, PhD Stanford University
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: James J. Gross, professor of psychology, Stanford University
ClinicalTrials.gov Identifier: NCT00380731    
Other Study ID Numbers: R01MH076074 ( U.S. NIH Grant/Contract )
R01MH076074 ( U.S. NIH Grant/Contract )
First Posted: September 26, 2006    Key Record Dates
Last Update Posted: November 30, 2011
Last Verified: November 2011
Keywords provided by James J. Gross, Stanford University:
Social Anxiety Disorder
Magnetic Resonance Imaging
Cognitive Behavior Therapy
Additional relevant MeSH terms:
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Phobic Disorders
Phobia, Social
Anxiety Disorders
Mental Disorders