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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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00380731
Recruitment Status : Completed
First Posted : September 26, 2006
Last Update Posted : November 30, 2011
Sponsor:
Collaborator:
National Institute of Mental Health (NIMH)
Information provided by (Responsible Party):
James J. Gross, Stanford University

Tracking Information
First Submitted Date  ICMJE September 22, 2006
First Posted Date  ICMJE September 26, 2006
Last Update Posted Date November 30, 2011
Study Start Date  ICMJE September 2006
Actual Primary Completion Date August 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 17, 2007)
  • Liebowitz Social Anxiety Scale [ Time Frame: Measured at Months 4, 7, 10, 13, and 16 ]
  • fMRI BOLD response [ Time Frame: Measured at Month 4 ]
  • Behavioral assessment [ Time Frame: Measured at Months 4 and 16 ]
Original Primary Outcome Measures  ICMJE
 (submitted: September 22, 2006)
  • Measured at Months 4, 10, and 16: Liebowitz Social Anxiety Scale
  • Behavioral assessment
  • Measured at Month 4: fMRI BOLD response
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: December 17, 2007)
  • Clinical Global Impression Improvement Scale [ Time Frame: Measured at Months 4 and 16 ]
  • Social Interaction Anxiety Scale [ Time Frame: Measured at Months 4, 10, and 16 ]
  • Sheehan Disability Scale [ Time Frame: Measured at Months 4, 10, and 16 ]
  • Quality of Life Inventory [ Time Frame: Measured at Months 4, 10, and 16 ]
Original Secondary Outcome Measures  ICMJE
 (submitted: September 22, 2006)
  • Measured at Months 4, 10, and 16: Clinical Global Impression Improvement Scale
  • Social Interaction Anxiety Scale
  • Sheehan Disability Scale
  • Quality of Life Inventory
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Effect of Behavior Therapy on Responses to Social Stimuli in People With Social Phobia
Official Title  ICMJE fMRI of Emotional Reactivity Cognitive Regulation and CBT for Social Phobia
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 Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Social Phobia
Intervention  ICMJE Behavioral: Individual Cognitive Behavioral Therapy
CBT includes 16 weekly 60-minute individual CBT sessions for social anxiety disorder.
Study Arms  ICMJE
  • Experimental: 1
    Participants will receive immediate cognitive behavioral therapy
    Intervention: Behavioral: Individual Cognitive Behavioral Therapy
  • Experimental: 2
    Participants will receive cognitive behavioral therapy with a 16-week delayed start
    Intervention: Behavioral: Individual Cognitive Behavioral Therapy
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: November 29, 2011)
124
Original Enrollment  ICMJE
 (submitted: September 22, 2006)
120
Actual Study Completion Date  ICMJE August 2011
Actual Primary Completion Date August 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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)
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 21 Years to 55 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00380731
Other Study ID Numbers  ICMJE R01MH076074( U.S. NIH Grant/Contract )
R01MH076074 ( U.S. NIH Grant/Contract )
DATR A3-NSS
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party James J. Gross, Stanford University
Study Sponsor  ICMJE Stanford University
Collaborators  ICMJE National Institute of Mental Health (NIMH)
Investigators  ICMJE
Principal Investigator: James J. Gross, PhD Stanford University
PRS Account Stanford University
Verification Date November 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP