fMRI of Emotion Regulation During RCT of CBT vs. MBSR for Social Anxiety Disorder
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 108
- 试验地点
- 2
- 主要终点
- Changes in Liebowitz Social Anxiety Scale (LSAS)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- Double (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 21 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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.)
排除标准
- •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.
研究组 & 干预措施
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).
干预措施: Cognitive Behavioral Group Therapy (Behavioral)
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.
干预措施: Mindfulness-Based Stress Reduction (Behavioral)
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.
结局指标
主要结局
Changes in Liebowitz Social Anxiety Scale (LSAS)
时间窗: 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).
次要结局
未报告次要终点
研究者
James J. Gross
Professor of Psychology
Stanford University