Clinical trial NCT02036658: Emotion Regulation During RCT of CBT vs. MBSR for Social Anxiety Disorder
Official title: fMRI of Emotion Regulation During RCT of CBT vs. MBSR for Social Anxiety Disorder
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Social Anxiety Disorder
Keywords: social anxiety
treatment
cognitive-behavioral therapy
mindfulness-based stress reduction
emotion regulation
randomized controlled trial
neuroimaging
functional magnetic resonance imaging
mediators
mechanisms
Lead sponsor: Stanford University
Sponsor class: OTHER
Collaborators: name: National Institute of Mental Health (NIMH)
First posted: 2014-01-15
Enrollment: 108
Sex: ALL
Minimum age (years): 21
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
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.
Primary purpose: TREATMENT

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.

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.

Eligibility 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.

Primary outcomes:
measure: Changes in Liebowitz Social Anxiety Scale (LSAS)
timeFrame: from baseline to 1- year following treatment
Secondary outcomes:
Other outcomes:
Locations:
city: Stanford
country: United States
facility: Stanford University
state: California
Study officials:
affiliation: Stanford University
name: James J Gross, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Stanford University
name: Philippe R. Goldin, PhD
role: STUDY_DIRECTOR
References:
citation: Liebowitz MR. Social phobia. Mod Probl Pharmacopsychiatry. 1987;22:141-73. doi: 10.1159/000414022. No abstract available.
citation: Heimberg RG, Becker RE. Cognitive-behavioral group therapy for social phobia: Basic mechanisms and clinical strategies. Guilford Press; 2002.
citation: Hope DA, Heimberg RG, Turk CL. Managing social anxiety: A cognitive-behavioral therapy approach. Treatments That Work; 2010.
citation: 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.
citation: Stahl B, Goldstein E. A mindfulness-based stress reduction workbook. New Harbinger Publications; 2010 Mar 1.
citation: American Psychiatric Association. Diagnostic and statistical manual, 4th edn, Text Revision (DSM-IV-TR). American Psychiatric Association, Washington. 2000.
citation: Goldin PR, Morrison A, Jazaieri H, Brozovich F, Heimberg R, Gross JJ. Group CBT versus MBSR for social anxiety disorder: A randomized controlled trial. J Consult Clin Psychol. 2016 May;84(5):427-37. doi: 10.1037/ccp0000092. Epub 2016 Mar 7.
citation: Goldin PR, Morrison AS, Jazaieri H, Heimberg RG, Gross JJ. Trajectories of social anxiety, cognitive reappraisal, and mindfulness during an RCT of CBGT versus MBSR for social anxiety disorder. Behav Res Ther. 2017 Oct;97:1-13. doi: 10.1016/j.brat.2017.06.001. Epub 2017 Jun 3.
citation: Goldin PR, Thurston M, Allende S, Moodie C, Dixon ML, Heimberg RG, Gross JJ. Evaluation of Cognitive Behavioral Therapy vs Mindfulness Meditation in Brain Changes During Reappraisal and Acceptance Among Patients With Social Anxiety Disorder: A Randomized Clinical Trial. JAMA Psychiatry. 2021 Oct 1;78(10):1134-1142. doi: 10.1001/jamapsychiatry.2021.1862.
citation: Kuo JR, Zeifman RJ, Morrison AS, Heimberg RG, Goldin PR, Gross JJ. The moderating effects of anger suppression and anger expression on cognitive behavioral group therapy and mindfulness-based stress reduction among individuals with social anxiety disorder. J Affect Disord. 2021 Apr 15;285:127-135. doi: 10.1016/j.jad.2021.02.022. Epub 2021 Feb 8.
citation: O'Day EB, Butler RM, Morrison AS, Goldin PR, Gross JJ, Heimberg RG. Reductions in social anxiety during treatment predict lower levels of loneliness during follow-up among individuals with social anxiety disorder. J Anxiety Disord. 2021 Mar;78:102362. doi: 10.1016/j.janxdis.2021.102362. Epub 2021 Jan 17.
citation: 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.
citation: Horenstein A, Morrison AS, Goldin P, Ten Brink M, Gross JJ, Heimberg RG. Sleep quality and treatment of social anxiety disorder. Anxiety Stress Coping. 2019 Jul;32(4):387-398. doi: 10.1080/10615806.2019.1617854. Epub 2019 May 13.
citation: Goldin PR, Moodie CA, Gross JJ. Acceptance versus reappraisal: Behavioral, autonomic, and neural effects. Cogn Affect Behav Neurosci. 2019 Aug;19(4):927-944. doi: 10.3758/s13415-019-00690-7.
citation: Butler RM, Boden MT, Olino TM, Morrison AS, Goldin PR, Gross JJ, Heimberg RG. Emotional clarity and attention to emotions in cognitive behavioral group therapy and mindfulness-based stress reduction for social anxiety disorder. J Anxiety Disord. 2018 Apr;55:31-38. doi: 10.1016/j.janxdis.2018.03.003. Epub 2018 Mar 9.