Mindfulness-Based Cognitive Therapy Depression Efficacy and Effects on Inflammatory Biomarker Levels
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 43
- 试验地点
- 1
- 主要终点
- Hamilton Depression Rating Scale Change with MBCT treatment
研究概览
简要总结
This study will investigate the efficacy of an 8-week course in Mindfulness-Based Cognitive Therapy (MBCT) for adults with major depressive disorder (MDD) by ;measuring change from baseline to completion of treatment at 8 weeks in terms of depression severity using the Hamilton Depression Ratings Scale. We will measure change in C-Reactive Protein, a measure of inflammation, over the same time period.
详细描述
This study will investigate the effectiveness of MBCT as a primary treatment for MDD. Twelve unmedicated subjects with MDD were enrolled in the study. All subjects with MDD underwent depression severity assessment at baseline and after the 8-week intervention was complete to measure change. In addition, the subjects underwent blood sampling at the same time points to measure C-Reactive Protein change over the 8 weeks.
The primary goal of this pilot study is to determine the efficacy of MBCT as a primary treatment for adults with MDD. We will also measure change in the inflammatory biomarker C-Reactive Protein for an examination of the effects of depression treatment on this measure.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •English speaking
- •Able to give informed consent
- •DSM-IV (SCID) Diagnosis of Major Depression
- •HAM-D17 score ≥ 17
- •Good general medical health; no active significant uncontrolled medical illness
- •Free of antidepressant medication for a minimum of 6 weeks before study entry
- •Not "needle phobic" by self report
排除标准
- •Axis I and II disorders including: Bipolar, Obsessive Compulsive Disorder, Psychosis, or Antisocial or Borderline Personality Disorder with suicidal risk
- •Major Depression with Psychotic Features
- •Actively suicidal
- •Recent (6 month) history of substance or alcohol dependence (DSM-IV criteria)
- •Meditation practice once or more per week
- •Yoga practice more than twice per week at study entry
- •Mini Mental Status Exam score < 25or history of neurologic illness
研究组 & 干预措施
Mindfulness-Based Cognitive Therapy
Adult Participants with Major Depressive Disorder who Enroll in an open clinical trial of MBCT as Mono-therapy
干预措施: Mindfulness-Based Cognitive Therapy (Behavioral)
结局指标
主要结局
Hamilton Depression Rating Scale Change with MBCT treatment
时间窗: Week 0, 8
17-item clinician-rated measure of depression severity.
次要结局
- C-Reactive Protein (Blood) Change with MBCT treatment(Week 0-8)