Implementation and Evaluation of "Mindfulness-Based Cognitive Therapy" in a Health Care Region in Flanders: a Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 405
- 试验地点
- 2
- 主要终点
- Feasibility to implement MBCT in a Flemish region
研究概览
简要总结
Research project regarding the possibility to implement and the efficacy of a non-drug, psychotherapeutic intervention (MBCT), in preventing relapse/recurrence of depression.
详细描述
This trial is based on the following publications:
Teasdale JD, Segal ZV, Williams JMG, Ridgeway VA, Soulsby JM, Lau MA. Prevention of relapse / recurrence in major depression by Mindfulness-Based Cognitive Therapy. Journal of Consulting and Clinical Psychology 2000; 68(4): 615-623.
Ma SH, Teasdale JD. Mindfulness-Based Cognitive Therapy for depression: replication and exploration of differential relapse prevention effects. Journal of Consulting and Clinical Psychology 2004; 72(1): 31-40.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- None
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
- •Age: 18 years and above
- •place of residence in accordance with a well-defined region (pilot study)
- •given informed consent
- •diagnosis of recurrent depression (DSM-IV-TR)
- •at least 3 depressive episodes in the anamnesis (depression: either primary or secondary diagnosis)
- •last depressive episode at least 8 weeks ago (DSM-IV-TR)
- •absence of a present depressive episode
- •history of treatment by an antidepressant medication
- •HRSD-score <14 at baseline assessment (Hamilton Rating Scale for Depression, HRSD-17)
- •absence of exclusion criteria
排除标准
- •based on DSM-IV-TR: current diagnosis of any of the following psychiatric disorders: lifetime mood disorder, chronic depression, dysthymia, current substance abuse, obsessive-compulsive disorder, bipolar disorder, acute psychosis, cognitive disorder, organic mental disorder, pervasive developmental disorder, mental retardation, primary diagnosis of axis-II-disorder, at risk for suicide
- •Extended experience with zen- or vipassana meditation (or mindfulness) in the past or
- •more than 1 hour practice of zen- or vipassana meditation (or mindfulness) per week during the last 8 weeks
- •other meditation practices except for MBCT during the training
- •more than 1 psychiatric consultation per 3-4 weeks during the training and follow-up
- •intensive psychotherapy during the training and follow-up
- •schizophrenia or schizoaffective disorder in the anamnesis
- •physical problems which make it difficult to participate in the programme
结局指标
主要结局
Feasibility to implement MBCT in a Flemish region
Relapse/recurrence of depression after approximately 12 months
次要结局
- Coping
- Health status
- Quality of life
- Fear
- Rumination