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

Social Phobia Clinical Trial

Official title:

fMRI of Emotional Reactivity Cognitive Regulation and CBT for Social Phobia

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00380731
• Other study ID #: R01MH076074
• Secondary ID: R01MH076074DATR
• Status: Completed
• Phase: N/A
• First received: September 22, 2006
• Last updated: November 29, 2011
• Start date: September 2006
• Est. completion date: August 2011

Study information

• Verified date: November 2011
• Source: Stanford University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 124
• Est. completion date: August 2011
• Est. primary completion date: August 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 21 Years to 55 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Phobic Disorders
• Social Phobia

Intervention

Behavioral:
• Individual Cognitive Behavioral Therapy
CBT includes 16 weekly 60-minute individual CBT sessions for social anxiety disorder.

Locations

Country	Name	City	State
United States	Stanford University	Stanford	California

Sponsors (2)

Lead Sponsor	Collaborator
Stanford University	National Institute of Mental Health (NIMH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Liebowitz Social Anxiety Scale		Measured at Months 4, 7, 10, 13, and 16	No
Primary	fMRI BOLD response		Measured at Month 4	No
Primary	Behavioral assessment		Measured at Months 4 and 16	No
Secondary	Clinical Global Impression Improvement Scale		Measured at Months 4 and 16	No
Secondary	Social Interaction Anxiety Scale		Measured at Months 4, 10, and 16	No
Secondary	Sheehan Disability Scale		Measured at Months 4, 10, and 16	No
Secondary	Quality of Life Inventory		Measured at Months 4, 10, and 16	No