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

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

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ClinicalTrials.gov Identifier: NCT02036658
Recruitment Status : Completed
First Posted : January 15, 2014
Last Update Posted : January 18, 2018
National Institute of Mental Health (NIMH)
Information provided by (Responsible Party):
James J. Gross, Stanford University

Brief Summary:
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 or disease Intervention/treatment
Social Anxiety Disorder Behavioral: Cognitive Behavioral Group Therapy Behavioral: Mindfulness-Based Stress Reduction

Detailed Description:

A. Aims

The overall goal of this research is to elucidate the neural bases of two specific forms of emotion regulation - cognitive regulation (CR) and attention regulation (AR). CR and AR are thought to be important mechanisms underlying therapeutic change associated with Cognitive-Behavioral Therapy (CBT) and Mindfulness-Based Stress Reduction (MBSR) for generalized Social Anxiety Disorder (SAD). We seek to test whether changes in CR and AR underlie the therapeutic effects of CBT and MBSR, which have been shown in the clinical science literature to be effective treatments for SAD. We will examine CR and AR in healthy controls (HCs) and in participants with generalized SAD at baseline, as well as in participants with SAD after they have completed a randomized controlled trial (RCT) with three treatment arms: CBT, MBSR, or Waitlist (WL). This work will address 3 aims: Aim 1 will examine the efficacy of CR and AR in individuals with SAD versus HCs; Aim 2 will investigate the immediate and longer-term impact of CBT versus MBSR for SAD; and Aim 3 will examine treatment-related changes in CR and AR and test whether these changes mediate the effects of CBT versus MBSR. The broad, long-term objective of this research is to contribute to advances in clinical interventions targeting individuals suffering from SAD, as well as a wide range of other anxiety and mood disorders.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 108 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Intervention Model Description: To investigate treatment outcome and mediators of Cognitive-Behavioral Group Therapy (CBGT) vs. Mindfulness-Based Stress Reduction (MBSR) vs. Waitlist (WL) in patients with generalized social anxiety disorder (SAD), unmedicated patients with a primary diagnosis of Social Anxiety Disorder (SAD) will be randomized to CBGT vs. MBSR vs. WL and will complete assessments at baseline, post-treatment/WL, and at 1-year follow-up, including the Liebowitz Social Anxiety Scale - Self-Report (primary outcome; Liebowitz, 1987) as well as measures of treatment-related processes.
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: fMRI of Emotion Regulation During RCT of CBT vs. MBSR for Social Anxiety Disorder
Study Start Date : March 2011
Primary Completion Date : September 1, 2015
Study Completion Date : September 1, 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anxiety
U.S. FDA Resources

Arm Intervention/treatment
Active Comparator: Cognitive Behavioral Group Therapy
Cognitive behavioral group therapy (CBGT) will be delivered by two Ph.D. clinical psychologists trained by Dr. Richard Heimberg to implement his CBGT for SAD (Heimberg & Becker, 2002). Groups of six individuals will meet for 12 sessions of 2.5 hours each. The participants will also use selected portions of the client workbook developed by (Hope, Heimberg, & Turk, 2010) to supplement relevant portions of the protocol. The treatment will be comprised of four major components: (1) psychoeducation and orientation to CBGT; (2) cognitive restructuring skills; (3) graduated exposure to feared social situations, within session and as homework; and (4) relapse prevention and termination. Further details of the treatment are available elsewhere (Heimberg & Becker, 2002).
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
MBSR will follow the standard curriculum outline compiled in 1993 by Jon Kabat-Zinn except that the one-day meditation retreat will be converted to four additional weekly group sessions between the standard class 6 and 7 so that there will be 12 weekly 2.5 hour sessions. This will be done to match the CBGT protocol in duration and time. The MBSR intervention will be delivered by a University of Massachusetts Center for Mindfulness certified MBSR instructor with more than 30 years of teaching experience. To support the practice, each participant will be given A Mindfulness-Based Stress Reduction Workbook (Stahl & Goldstein, 2010), which includes descriptions of mindfulness exercises together with pre-recorded audio files to support ongoing practice.
Behavioral: Mindfulness-Based Stress Reduction
Mindfulness-Based Stress Reduction will be 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
This will be a delayed treatment arm. Participants randomized to the waitlist control group will be re-randomized after completing the no treatment period of 12 weeks to CBGT or MBSR with equal probability.

Primary Outcome Measures :
  1. Changes in Liebowitz Social Anxiety Scale (LSAS) [ Time Frame: from baseline to 1- year following treatment ]
    The Liebowitz Social Anxiety Scale (LSAS) is a self-report questionnaire which assesses the severity of social anxiety symptoms (Fresco et al., 2001; Liebowitz, 1987). Respondents are asked to rate their level of fear and avoidance to 11 social interaction situations and 13 performance situations. A 4-point Likert-type scale is used for ratings of fear and of avoidance, with a range from 0 (none and never, respectively) to 3 (severe and usually, respectively) for each situation during the past week. Ratings are summed for a total LSAS-SR score (range 0 to 144). The LSAS-SR has demonstrated good reliability and construct validity (Rytwinski et al., 2009).

Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02036658

United States, California
Stanford University
Stanford, California, United States, 94305
Sponsors and Collaborators
Stanford University
National Institute of Mental Health (NIMH)
Principal Investigator: James J Gross, PhD Stanford University
Study Director: Philippe R. Goldin, PhD Stanford University

Heimberg RG, Becker RE. Cognitive-behavioral group therapy for social phobia: Basic mechanisms and clinical strategies. Guilford Press; 2002.
Hope DA, Heimberg RG, Turk CL. Managing social anxiety: A cognitive-behavioral therapy approach. Treatments That Work; 2010.
Kabat-Zinn J. Mindfulness meditation: Health benefits of an ancient Buddhist practice. In D. Goleman & J. Gurin (Eds.), Mind/Body Medicine (pp. 259-275). Yonkers, NY: Consumer Reports Books, 1993.
Stahl B, Goldstein E. A mindfulness-based stress reduction workbook. New Harbinger Publications; 2010 Mar 1.
American Psychiatric Association. Diagnostic and statistical manual, 4th edn, Text Revision (DSM-IV-TR). American Psychiatric Association, Washington. 2000.

Responsible Party: James J. Gross, Professor of Psychology, Stanford University
ClinicalTrials.gov Identifier: NCT02036658     History of Changes
Other Study ID Numbers: CBT-MBSR 10521038
R01MH076074 ( U.S. NIH Grant/Contract )
First Posted: January 15, 2014    Key Record Dates
Last Update Posted: January 18, 2018
Last Verified: January 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by James J. Gross, Stanford University:
social anxiety
cognitive-behavioral therapy
mindfulness-based stress reduction
emotion regulation
randomized controlled trial
functional magnetic resonance imaging

Additional relevant MeSH terms:
Anxiety Disorders
Phobia, Social
Pathologic Processes
Mental Disorders
Phobic Disorders