GATE: Generalized Anxiety - A Treatment Evaluation
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 226
- 试验地点
- 4
- 主要终点
- Proportion of Participants With Treatment Response
研究概览
简要总结
The purpose of this randomized study is to examine the comparative efficacy of yoga, cognitive behavioral therapy, and stress education, a previously employed control condition, for patients with Generalized Anxiety Disorder.
详细描述
We are currently conducting a treatment study to reduce stress and anxiety in people with generalized anxiety disorder (GAD). This study will not use a medication, but instead will involve weekly stress reduction classes that use different strategies to reduce anxiety. The study involves having a formal psychiatric interview, filling out questionnaires, ECGs, saliva samples, a urine test for drugs of abuse, and study visits over 12 weeks. Each study visit will take a few hours. Qualified participants will be compensated for time and travel.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female outpatients > 18 years of age with a primary psychiatric diagnosis of generalized anxiety disorder
- •Clinical Global Impression-Severity scale (CGI-S) score of 4 or higher
- •Off concurrent psychotropic medication for at least 2 weeks prior to initiation of randomized treatment, OR stable on current medication for a minimum of 6 weeks and willing to maintain a stable dose
- •Willingness and ability to perform the yoga intervention and to comply with the requirements of the study protocol.
- •For women of childbearing potential, willingness to use a reliable form of birth control
排除标准
- •Patients unable to understand study procedures and participate in the informed consent process.
- •Pregnancy as assessed by pregnancy test at screen or lack of use approved methods birth control for women of childbearing age
- •Women who are planning to become pregnant
- •Serious medical illness or instability for which hospitalization may be likely within the next year
- •Significant current suicidal ideation or suicidal behaviors within the past 6 months (assessed with the Beck Depression Inventory-II [BDI-II])
- •History of head trauma causing loss of consciousness, or seizure disorder resulting in ongoing cognitive impairment
- •Posttraumatic stress disorder, substance use disorder, eating disorder, or organic mental disorder within the past 6 months
- •Lifetime history of psychotic disorder, bipolar disorder, or developmental disorder
- •Significant personality dysfunction likely to interfere with study participation (assessed during the clinical interview)
- •Prior experience with (more than 5 Yoga classes or CBT sessions within the last 3 years) and/or current practice of mindbody techniques (e.g., yoga, meditation, Tai-Chi, etc) or cognitive behavioral therapy (CBT)
- •Concomitant therapy for generalized anxiety disorder (GAD) (any therapy)
- •Physical conditions that might cause injury from yoga (pregnancy, physical injuries and musculoskeletal problems)
- •Cognitive impairment (MOCA<21)
结局指标
主要结局
Proportion of Participants With Treatment Response
时间窗: Biweekly from weeks 0 through 12
Treatment response is a dichotomous outcome coded 0=no treatment response, 1= treatment response. This treatment response coding was derived from the Clinical Global Impression-Improvement (CGI-I) measure. The CGI-I is a clinician administered instrument that assesses level of symptom change across the course of treatment. The CGI-I ranges from 1 to 7, with lower scores indicating greater improvement. Our treatment response outcome variable was coded 0 if CGI-I was 3 or more. Treatment response was coded 1 if CGI-I was rated 1 (very much improved) or 2 (much improved).
次要结局
- Structured Interview Guide for the Hamilton Anxiety Rating Scale (SIGH-A)(Weeks 0, 6 , 12 and 6 month follow up)