Emotion Regulation During RCT of CBT vs. MBSR for Social Anxiety Disorder
Condition: Social Anxiety Disorder
MeSH terms: Anxiety Disorders; Phobia, Social
Study type: Interventional

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.
    

Intervention name(s): Cognitive Behavioral Group Therapy; Mindfulness-Based Stress Reduction
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Cognitive Behavioral Group Therapy for social anxiety disorder is a 12-week treatment that involves psychoeducation, cognitive restructuring and exposure to social situations.; 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 intervention name(s): CBGT; MBSR
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
Keywords: social anxiety; treatment; cognitive-behavioral therapy; mindfulness-based stress reduction; emotion regulation; randomized controlled trial; neuroimaging; functional magnetic resonance imaging; mediators; mechanisms