Clinical trial NCT00380731: Effect of Behavior Therapy on Responses to Social Stimuli in People With Social Phobia
Official title: fMRI of Emotional Reactivity Cognitive Regulation and CBT for Social Phobia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Social Phobia
Keywords: Social Anxiety Disorder
Magnetic Resonance Imaging
Cognitive Behavior Therapy
Lead sponsor: Stanford University
Sponsor class: OTHER
Collaborators: name: National Institute of Mental Health (NIMH)
First posted: 2006-09-26
Enrollment: 124
Sex: ALL
Minimum age (years): 21
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility 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)

Primary outcomes:
measure: Liebowitz Social Anxiety Scale
timeFrame: Measured at Months 4, 7, 10, 13, and 16
measure: fMRI BOLD response
timeFrame: Measured at Month 4
measure: Behavioral assessment
timeFrame: Measured at Months 4 and 16
Secondary outcomes:
measure: Clinical Global Impression Improvement Scale
timeFrame: Measured at Months 4 and 16
measure: Social Interaction Anxiety Scale
timeFrame: Measured at Months 4, 10, and 16
measure: Sheehan Disability Scale
timeFrame: Measured at Months 4, 10, and 16
measure: Quality of Life Inventory
timeFrame: Measured at Months 4, 10, and 16
Other outcomes:
Locations:
city: Stanford
country: United States
facility: Stanford University
state: California
Study officials:
affiliation: Stanford University
name: James J. Gross, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Butler RM, O'Day EB, Kaplan SC, Swee MB, Horenstein A, Morrison AS, Goldin PR, Gross JJ, Heimberg RG. Do sudden gains predict treatment outcome in social anxiety disorder? Findings from two randomized controlled trials. Behav Res Ther. 2019 Oct;121:103453. doi: 10.1016/j.brat.2019.103453. Epub 2019 Aug 9.
citation: Goldin PR, Ziv M, Jazaieri H, Weeks J, Heimberg RG, Gross JJ. Impact of cognitive-behavioral therapy for social anxiety disorder on the neural bases of emotional reactivity to and regulation of social evaluation. Behav Res Ther. 2014 Nov;62:97-106. doi: 10.1016/j.brat.2014.08.005. Epub 2014 Aug 21.
citation: Goldin PR, Lee I, Ziv M, Jazaieri H, Heimberg RG, Gross JJ. Trajectories of change in emotion regulation and social anxiety during cognitive-behavioral therapy for social anxiety disorder. Behav Res Ther. 2014 May;56:7-15. doi: 10.1016/j.brat.2014.02.005. Epub 2014 Feb 28.
citation: Ziv M, Goldin PR, Jazaieri H, Hahn KS, Gross JJ. Emotion regulation in social anxiety disorder: behavioral and neural responses to three socio-emotional tasks. Biol Mood Anxiety Disord. 2013 Nov 4;3(1):20. doi: 10.1186/2045-5380-3-20.
citation: Goldin PR, Ziv M, Jazaieri H, Hahn K, Heimberg R, Gross JJ. Impact of cognitive behavioral therapy for social anxiety disorder on the neural dynamics of cognitive reappraisal of negative self-beliefs: randomized clinical trial. JAMA Psychiatry. 2013 Oct;70(10):1048-56. doi: 10.1001/jamapsychiatry.2013.234.