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

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
James J. Gross, Stanford University
ClinicalTrials.gov Identifier:
NCT00380731
First received: September 22, 2006
Last updated: November 29, 2011
Last verified: November 2011
  Purpose

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 Intervention
Social Phobia
Behavioral: Individual Cognitive Behavioral Therapy

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: fMRI of Emotional Reactivity Cognitive Regulation and CBT for Social Phobia

Resource links provided by NLM:


Further study details as provided by Stanford University:

Primary Outcome Measures:
  • Liebowitz Social Anxiety Scale [ Time Frame: Measured at Months 4, 7, 10, 13, and 16 ] [ Designated as safety issue: No ]
  • fMRI BOLD response [ Time Frame: Measured at Month 4 ] [ Designated as safety issue: No ]
  • Behavioral assessment [ Time Frame: Measured at Months 4 and 16 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Clinical Global Impression Improvement Scale [ Time Frame: Measured at Months 4 and 16 ] [ Designated as safety issue: No ]
  • Social Interaction Anxiety Scale [ Time Frame: Measured at Months 4, 10, and 16 ] [ Designated as safety issue: No ]
  • Sheehan Disability Scale [ Time Frame: Measured at Months 4, 10, and 16 ] [ Designated as safety issue: No ]
  • Quality of Life Inventory [ Time Frame: Measured at Months 4, 10, and 16 ] [ Designated as safety issue: No ]

Enrollment: 124
Study Start Date: September 2006
Study Completion Date: August 2011
Primary Completion Date: August 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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.

  Eligibility

Ages Eligible for Study:   21 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00380731

Locations
United States, California
Stanford University
Stanford, California, United States, 94025
Sponsors and Collaborators
Stanford University
Investigators
Principal Investigator: James J. Gross, PhD Stanford University
  More Information

Additional Information:
No publications provided by Stanford University

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: James J. Gross, professor of psychology, Stanford University
ClinicalTrials.gov Identifier: NCT00380731     History of Changes
Other Study ID Numbers: R01 MH076074, R01MH076074, DATR A3-NSS
Study First Received: September 22, 2006
Last Updated: November 29, 2011
Health Authority: United States: Federal Government

Keywords provided by Stanford University:
Social Anxiety Disorder
Magnetic Resonance Imaging
Cognitive Behavior Therapy

Additional relevant MeSH terms:
Phobic Disorders
Anxiety Disorders
Mental Disorders

ClinicalTrials.gov processed this record on August 18, 2014