The Clinical and Cost-effectiveness of Mindfulness Based Cognitive Therapy, Maintenance Antidepressant Medication and Its Combination in the Prevention of Relapse in Patients With Recurrent Depression
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 317
- 试验地点
- 11
- 主要终点
- Relapse/recurrence of Major Depressive Episode
研究概览
简要总结
The purpose of this study is to investigate the (cost)effectiveness of mindfulness based cognitive therapy (MBCT) compared to that of antidepressant medication, and its combination with regard to the prevention of relapse or recurrence in patients with recurrent depression.
详细描述
In the Netherlands, treatment as usual for patients with (recurrent) Major Depressive Disorder consists of maintenance antidepressant medication. Mindfulness-based cognitive therapy (MBCT) is a recently developed psychological intervention that appears to be promising in terms of preventing relapse or recurrence in patients with recurrent depression. It consists of 8 weekly group sessions in which meditation exercises are combined with cognitive therapeutic elements such as identifying negative thoughts and monitoring and scheduling activities.
In this study, the (cost)effectiveness of a) MBCT on its own, b) antidepressant medication on its own and c) the combination of MBCT and antidepressant medication will be investigated in 350 patients with recurrent depression who are currently in remission.
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
- •Recurrent Major Depressive Episode (at least 3 previous episodes)
- •Treatment with therapeutic dose of antidepressant medication during past six months
- •Currently in full or partial remission
排除标准
- •Bipolar disorder (current and previous (hypo)manic episodes)
- •Psychotic disorder (current and previous)
- •Neurological or somatic illness affecting depression or outcome measures
- •Current alcohol or drugs dependency
- •Use of high dosage benzodiazepines (> 2 mg Lorazepam equivalents daily)
- •Recent Electro Convulsive Therapy (< 3 months ago)
研究组 & 干预措施
Mindfulness Based Cognitive Therapy
Mindfulness Based Cognitive Therapy and withdrawal of antidepressant medication between the 4th and 5th session, patients being off medication until the end of study period (15 months).
干预措施: Mindfulness Based Cognitive Therapy (Behavioral)
Combination
Mindfulness Based Cognitive Therapy combined with the use of antidepressant medication during the study (15 months).
干预措施: Mindfulness Based Cognitive Therapy (Behavioral)
Combination
Mindfulness Based Cognitive Therapy combined with the use of antidepressant medication during the study (15 months).
干预措施: Optimal Medical Care (Drug)
Optimal Medical Care
Treatment with optimal medical care: therapeutic dose of antidepressant medication during at least 15 months, administered in accordance with current guidelines.
干预措施: Optimal Medical Care (Drug)
结局指标
主要结局
Relapse/recurrence of Major Depressive Episode
时间窗: 3, 6, 9, 12, 15 months
Relapse or recurrence of depression will be assessed trimonthly using the Structured Clinical Interview for DSM-V (SCID) depression module.
次要结局
- Costs made by consumption of medical care and production loss(3, 6, 9, 12, 15 months)
研究者
Anne Speckens
Prof. dr. Anne E.M. Speckens
Radboud University Medical Center