Trial record 2 of 3 for:    social anxiety cognitive behavioral therapy Stanford

Emotion Regulation During RCT of CBT vs. MBSR for Social Anxiety Disorder

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Stanford University
ClinicalTrials.gov Identifier:
NCT02036658
First received: January 10, 2014
Last updated: January 14, 2014
Last verified: January 2014
  Purpose

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.


Condition Intervention
Social Anxiety Disorder
Behavioral: Cognitive Behavioral Group Therapy
Behavioral: Mindfulness-Based Stress Reduction

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double Blind (Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: fMRI of Emotion Regulation During RCT of CBT vs. MBSR for Social Anxiety Disorder

Resource links provided by NLM:


Further study details as provided by Stanford University:

Primary Outcome Measures:
  • Changes in Liebowitz Social Anxiety Scale (LSAS) [ Time Frame: from baseline to 1- year following treatment ] [ Designated as safety issue: No ]

Enrollment: 108
Study Start Date: March 2011
Estimated Primary Completion Date: August 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Cognitive Behavioral Group Therapy Behavioral: Cognitive Behavioral Group Therapy
Cognitive Behavioral Group Therapy for social anxiety disorder is a 12-week treatment that involves psychoeducation, cognitive restructuring and exposure to social situations.
Other Name: CBGT
Active Comparator: Mindfulness-Based Stress Reduction Behavioral: Mindfulness-Based Stress Reduction
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.
Other Name: MBSR
No Intervention: Waitlist Control

  Eligibility

Ages Eligible for Study:   21 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02036658

Locations
United States, California
Stanford University
Stanford, California, United States, 94305
Sponsors and Collaborators
Stanford University
Investigators
Principal Investigator: James J Gross, PhD Stanford University
Study Director: Philippe R. Goldin, PhD Stanford University
  More Information

No publications provided

Responsible Party: Stanford University
ClinicalTrials.gov Identifier: NCT02036658     History of Changes
Other Study ID Numbers: CBT-MBSR 10521038
Study First Received: January 10, 2014
Last Updated: January 14, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Stanford University:
social anxiety
treatment

Additional relevant MeSH terms:
Anxiety Disorders
Disease
Phobic Disorders
Mental Disorders
Pathologic Processes

ClinicalTrials.gov processed this record on September 18, 2014