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

November 29, 2011 updated by: James J. Gross, Stanford University

fMRI of Emotional Reactivity Cognitive Regulation and CBT for Social Phobia

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Interventional

Enrollment (Actual)

124

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Stanford, California, United States, 94025
        • Stanford University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years to 55 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Stanford University

Collaborators

National Institute of Mental Health (NIMH)

Investigators

  • Principal Investigator: James J. Gross, PhD, Stanford University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2006

Primary Completion (Actual)

August 1, 2011

Study Completion (Actual)

August 1, 2011

Study Registration Dates

First Submitted

September 22, 2006

First Submitted That Met QC Criteria

September 22, 2006

First Posted (Estimate)

September 26, 2006

Study Record Updates

Last Update Posted (Estimate)

November 30, 2011

Last Update Submitted That Met QC Criteria

November 29, 2011

Last Verified

November 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • R01MH076074 (U.S. NIH Grant/Contract)
  • DATR A3-NSS (Indiana University)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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