Effect of Behavior Therapy on Responses to Social Stimuli in People With Social Phobia
fMRI of Emotional Reactivity Cognitive Regulation and CBT for Social Phobia
2 other identifiers
interventional
124
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Sep 2006
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2006
CompletedFirst Submitted
Initial submission to the registry
September 22, 2006
CompletedFirst Posted
Study publicly available on registry
September 26, 2006
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2011
CompletedNovember 30, 2011
November 1, 2011
4.9 years
September 22, 2006
November 29, 2011
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
Liebowitz Social Anxiety Scale
Measured at Months 4, 7, 10, 13, and 16
fMRI BOLD response
Measured at Month 4
Behavioral assessment
Measured at Months 4 and 16
Secondary Outcomes (4)
Clinical Global Impression Improvement Scale
Measured at Months 4 and 16
Social Interaction Anxiety Scale
Measured at Months 4, 10, and 16
Sheehan Disability Scale
Measured at Months 4, 10, and 16
Quality of Life Inventory
Measured at Months 4, 10, and 16
Study Arms (2)
1
EXPERIMENTALParticipants will receive immediate cognitive behavioral therapy
2
EXPERIMENTALParticipants will receive cognitive behavioral therapy with a 16-week delayed start
Interventions
CBT includes 16 weekly 60-minute individual CBT sessions for social anxiety disorder.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Stanford Universitylead
- National Institute of Mental Health (NIMH)collaborator
Study Sites (1)
Stanford University
Stanford, California, 94025, United States
Related Publications (5)
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.
PMID: 31430688DERIVEDGoldin 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.
PMID: 25193002DERIVEDGoldin 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.
PMID: 24632110DERIVEDZiv 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.
PMID: 24517388DERIVEDGoldin 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.
PMID: 23945981DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
James J. Gross, PhD
Stanford University
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- professor of psychology
Study Record Dates
First Submitted
September 22, 2006
First Posted
September 26, 2006
Study Start
September 1, 2006
Primary Completion
August 1, 2011
Study Completion
August 1, 2011
Last Updated
November 30, 2011
Record last verified: 2011-11