This trial is active, not recruiting.

Condition social anxiety disorder
Treatments cognitive behavioral group therapy, mindfulness-based stress reduction
Sponsor Stanford University
Collaborator National Institute of Mental Health (NIMH)
Start date March 2011
End date August 2014
Trial size 108 participants
Trial identifier NCT02036658, CBT-MBSR 10521038


The purpose of the study is to investigate the immediate and longer-term impact of Cognitive-Behavioral Group Therapy (CBGT) versus Mindfulness-Based Stress Reduction (MBSR) for patients with Social Anxiety Disorder.

United States No locations recruiting
Other countries No locations recruiting

Study Design

Allocation randomized
Intervention model single group assignment
Masking double blind (investigator, outcomes assessor)
Primary purpose treatment
(Active Comparator)
cognitive behavioral group therapy CBGT
Cognitive Behavioral Group Therapy for social anxiety disorder is a 12-week treatment that involves psychoeducation, cognitive restructuring and exposure to social situations.
(Active Comparator)
mindfulness-based stress reduction MBSR
Mindfulness-Based Stress Reduction is completed in 12 weeks in the study and includes enhancing one's awareness non-judgmentally by focusing on the present moment through the use of mindfulness meditation.
(No Intervention)

Primary Outcomes

Changes in Liebowitz Social Anxiety Scale (LSAS)
time frame: from baseline to 1- year following treatment

Eligibility Criteria

Male or female participants from 21 years up to 55 years old.

Inclusion Criteria: - Clinically diagnosable social anxiety disorder (generalized subtype per DSM-IV-TR criteria) - aged 21-55 - working fluency in English - residence in the Bay Area. - eligible for fMRI scans (right-handed, no metal in body, etc.) Exclusion Criteria: - left-handed - Medication use in the last 3 months - Pervasive developmental disability - acute suicide potential - inability to travel to the treatment site - schizophrenia or other psychotic disorder - history of bipolar disorder - current primary Major Depression - current substance dependence - Comorbid diagnoses of Major Depressive or other mood or anxiety disorders are acceptable ONLY if clearly secondary to the diagnosis of social anxiety disorder.

Additional Information

Official title fMRI of Emotion Regulation During RCT of CBT vs. MBSR for Social Anxiety Disorder
Principal investigator James J Gross, PhD
Trial information was received from ClinicalTrials.gov and was last updated in January 2014.
Information provided to ClinicalTrials.gov by Stanford University.