NCT00999765已完成不适用
Pilot Study: Mindfulness-Based Cognitive Therapy as a Tool for Prophylactic Mood Stabilizing Therapy in Bipolar Disorder
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 36
- 试验地点
- 1
- 主要终点
- number of weeks in which criteria are meet for a mood episode evaluate with the Longitudinal Interval Follow-up Evaluation (LIFE)
研究概览
简要总结
The purpose of this study is to evaluate the feasibility and short-term efficacy of MBCT as an add-on (i.e. patients must be stable with their regular mood stabilizing medication) for the maintenance therapy of bipolar disorder.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •Males or females (>18 years old)
- •Bipolar disorder (as per the Structured Clinical Interview for DSM Disorders (SCID)(22)), euthymic state: Complete remission for at least four weeks ((Montgomery and Asberg Rating Scale (MADRS) ≤ 6 and item-1 (depressed mood) = 0 and no suicidal ideations (MADRS(item-10) < 4)
- •Must have had at least 3 depressive phases in the last 5 years
- •Cooperative and willing to complete all the aspects of the study and especially the 45 minutes of exercise per day
- •Must have completed a Secondary V (11th grade) education
排除标准
- •Other active psychiatric disorders (as per the SCID)
- •Rapid cycling
- •Bipolar disorder secondary to a medical condition or substance-induced mood disorder
- •Suicidal ideations (MADRS(item 10)>3)
- •Active i.e. unstable and/or untreated medical condition
- •Substance abuse (defined as per DSM-IV) in the last four weeks
- •CBT (No more than four sessions (ever))
- •Previous participation in a psychoeducation group within the last 6 months
- •Current other psychotherapy (more than once a month)
- •Practice of meditation (more than once a month) during the last two years
- •Practice of yoga (more than once a week) during the last year
- •Previous participation in a MBSR group
- •Electroconvulsive Therapy (ECT) within the last three months
结局指标
主要结局
number of weeks in which criteria are meet for a mood episode evaluate with the Longitudinal Interval Follow-up Evaluation (LIFE)
时间窗: 12 weeks (4 weeks post treatment)
次要结局
- Change in intensity of subsyndromal symptoms of hypomania on the YMRS scale(2, 4, 6, 8 and 12 weeks)
- Change in intensity of subsyndromal symptoms of depression on the HAM-D 29 scale(2, 4, 6, 8 and 12 weeks)
- Change in intensity of subsyndromal symptoms of depression on the MADRS scale(2, 4, 6, 8 and 12 weeks)
- Change id intensity in subsyndromal symptoms of anxiety on the HAM-A scale(2,4,6,8 and 12 weeks)
研究者
Serge Beaulieu
Serge Beaulieu
Douglas Mental Health University Institute
研究点 (1)
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