Mindfulness-based Behavioural Therapy (MIBT) Versus Psychodynamic Therapy for Patients With Major Depressive Disorder in Psychotherapeutic Day Treatment. A Randomised Clinical Pilot Trial (Mipsy)
Background:
According to the WHO, major depressive disorder is the second largest healthcare problem worldwide in terms of disability caused by illness. It afflicts an estimated 17% of individuals during their lifetimes at tremendous costs. A number of depressive patients are treated with antidepressant medication. The efficacy of antidepressant medication has been studied in a number of systematic reviews, and in recent years some of these reviews have shown that the efficacy is questionable for many patients. So are there other effective treatments for this serious illness?
Cognitive- and psychodynamic therapies are probably both significantly more effective for depression than no treatment, but only limited comparisons have been made between the two interventions. A Cochrane review shows that cognitive therapy has a preventive effect against recurrent depression, and that this effect may surpass the preventive effect of antidepressant medication. Mindfulness training may be an effective technique in preventing relapse in patients who have had at least 3 previous depressive episodes. But efficacy in treating currently depressed patients has not been studied.
Objective To perform a randomised clinical trial with blinded assessment of efficacy variables in order to study the effects of mindfulness based behavioral therapy (cognitive therapy and mindfulness) versus psychodynamic therapy in depressive patients.
Methods
A randomised clinical trial of 84 consecutive patients diagnosed with major depressive disorder, referred to the day clinic, Roskilde psychiatric services. The patients will be randomised to one of two interventions:
- MIBT (mindfulness-based behavioural therapy)
- PT (psychodynamic therapy)
研究概览
地位
研究类型
注册 (预期的)
阶段
- 不适用
联系人和位置
学习地点
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Zeeland
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Roskilde、Zeeland、丹麦、4000
- 招聘中
- The day clinic for treatment of non-psychotic disorders (Roskilde Psychiatry)
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接触：
- Erik Simonsen, Associate professor
- 电话号码：+4547327733
- 邮箱：es@regionsjaelland.dk
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接触：
- Kirsten Larsen, Medical doctor
- 电话号码：47327733
- 邮箱：kala@regionsjaelland.dk
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首席研究员：
- Janus Christian Jakobsen
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- Aged 18 to 65 years
- Major depressive disorder (SCID I).
- BDI II > 13.
- Written informed consent.
Exclusion Criteria:
- Current psychosis, diagnosis of schizophrenia or schizotypal personality disorder (DSM IV-TR).
- Alcohol or substance abuse judged to require treatment in preference to depression (assessed during patient conference).
- Commenced or changed psychopharmacological treatment less than six weeks before randomisation.
- Pregnancy.
- No written informed consent.
学习计划
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：单身的
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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实验性的：Mindfulness-based Behavioural Therapy (MIBT)
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The MIBT treatment consists of weekly individual MIBT therapy (45-50 min.), together with weekly mindfulness-skills training group (1.5 hours). The treatment is based on the cognitive model of depression, but will, based on concrete problems, draw from alternative cognitive techniques in order to treat personality-related problems and will use elements from mindfulness. |
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有源比较器：PT (psychodynamic therapy)
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The PT treatment consists of weekly individual PT therapy (45-50 min.), together with weekly PT group therapy (1.5 hours). The main elements of PT are the free-flowing, non-therapist guided dialogue, based on classic psychoanalytical free association. Basically, the role of the therapist is to set ground rules and organise the time, place and duration, to maintain a proper tone, and ultimately to ensure that a therapeutic process takes place using relevant interventions. |
研究衡量的是什么？
主要结果指标
结果测量 |
大体时间 |
|---|---|
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17 item Hamilton rating scale for depression (score at the end of 18 weeks of day- treatment)
大体时间：0 weeks, 18 weeks, and 1 year
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0 weeks, 18 weeks, and 1 year
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次要结果测量
结果测量 |
大体时间 |
|---|---|
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SCL-90-R (GSI score at the end of 18 weeks of day- treatment)
大体时间：0 weeks, 9 weeks, 18 weeks, and 1 year
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0 weeks, 9 weeks, 18 weeks, and 1 year
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The proportion of patients who achieve remission (Hamilton score < 8).
大体时间：0 weeks, 18 weeks, and 1 year
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0 weeks, 18 weeks, and 1 year
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合作者和调查者
出版物和有用的链接
一般刊物
- Jakobsen JC, Gluud C, Kongerslev M, Larsen KA, Sorensen P, Winkel P, Lange T, Sogaard U, Simonsen E. Third-wave cognitive therapy versus mentalisation-based treatment for major depressive disorder: a randomised clinical trial. BMJ Open. 2014 Aug 19;4(8):e004903. doi: 10.1136/bmjopen-2014-004903.
- Jakobsen JC, Gluud C, Kongerslev M, Larsen KA, Sorensen P, Winkel P, Lange T, Sogaard U, Simonsen E. 'Third wave' cognitive therapy versus mentalization-based therapy for major depressive disorder. A protocol for a randomised clinical trial. BMC Psychiatry. 2012 Dec 19;12:232. doi: 10.1186/1471-244X-12-232.
研究记录日期
研究主要日期
学习开始
初级完成 (预期的)
研究完成 (预期的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (估计)
上次提交的符合 QC 标准的更新
最后验证
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.
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