Mindfulness Based Cognitive Therapy for Patients With Recurrent Depression: a Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 220
- 试验地点
- 2
- 主要终点
- Depressive Symptoms
研究概览
简要总结
The purpose of this study is to investigate the effectiveness and possible mediating factors of Mindfulness Based Cognitive Therapy (MBCT) for recurrent depression.
详细描述
Mindfulness Based Cognitive Therapy (MBCT) is a 8 session group intervention and is well described by several authors.
Previous studies showed Mindfulness Based Cognitive Therapy (MBCT) to be effective to prevent relapse in patients with recurrent depression and 3 or more previous depressive episodes.
Study aims are:
- to replicate previous findings in The Netherlands, by a research team which did not develop the intervention
- to investigate if MBCT is applicable for patients with recurrent depression and current depressive symptoms
- to examine possible mediators of treatment effect and predictors of relapse in the year following the treatment
In this study, patients are randomly assigned to a MBCT intervention group or a waiting list control group. Patients allocated to the waiting list control condition will receive the MBCT course three months later. All patients who participated in a MBCT training will be assessed during the year following the completion of the MBCT course. We aim to include about 220 patients.
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
- 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
- •3 or more previous depressive episodes
- •if treated with medication: constant dose of at least 6 weeks
排除标准
- •Bipolar Disorder
- •Psychotic disorder
- •Neurological or somatic illness affecting depression or outcome measures
- •Current alcohol or drugs dependency
- •Acute need of psychiatric treatment
结局指标
主要结局
Depressive Symptoms
时间窗: Assessments were performed at 0, 3, 6, 9, 12, 15 months, and change between 3 and 0 months was the primary analysis.
Hamilton Depression Rating Scale. The HAMD is a standardized 17-item interview to measure number and severity of depressive symptoms on a 0-52 score. Higher values indicate a worse outcome. Specifical, HAMD scores can be interpreted as "no depression" (0-7), "mild depression" (8-16), "moderate depression" (17-23) and "severe depression" (24-52).
次要结局
- Self-report Depressive Symptoms(Assessments were performed at 0, 3, 6, 9, 12, 15 months, and change between 3 and 0 months was the primary analysis)
研究者
Anne Speckens
Anne E.M. Speckens, Prof. dr.
Radboud University Medical Center