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

January 16, 2018 updated by: James J. Gross, Stanford University

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Enrollment (Actual)

108

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Stanford, California, United States, 94305
        • Stanford University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years to 55 years (ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: SINGLE_GROUP
  • Masking: DOUBLE

Arms and Interventions

Participant Group / 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 Names:
  • 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 Names:
  • 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
from baseline to 1- year following treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Stanford University

Collaborators

National Institute of Mental Health (NIMH)

Investigators

  • Principal Investigator: James J Gross, PhD, Stanford University
  • Study Director: Philippe R. Goldin, PhD, Stanford University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2011

Primary Completion (ACTUAL)

September 1, 2015

Study Completion (ACTUAL)

September 1, 2015

Study Registration Dates

First Submitted

January 10, 2014

First Submitted That Met QC Criteria

January 14, 2014

First Posted (ESTIMATE)

January 15, 2014

Study Record Updates

Last Update Posted (ACTUAL)

January 18, 2018

Last Update Submitted That Met QC Criteria

January 16, 2018

Last Verified

January 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CBT-MBSR 10521038
  • R01MH076074 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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