Mindfulness-based Behavioural Therapy (MIBT) Versus Psychodynamic Therapy for Patients With Major Depressive Disorder in Psychotherapeutic Day Treatment. A Randomised Clinical Pilot Trial
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 84
- 试验地点
- 1
- 主要终点
- 17 item Hamilton rating scale for depression (score at the end of 18 weeks of day- treatment)
研究概览
简要总结
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)
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Aged 18 to 65 years
- •Major depressive disorder (SCID I).
- •Written informed consent.
排除标准
- •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.
- •No written informed consent.
结局指标
主要结局
17 item Hamilton rating scale for depression (score at the end of 18 weeks of day- treatment)
时间窗: 0 weeks, 18 weeks, and 1 year
次要结局
- SCL-90-R (GSI score at the end of 18 weeks of day- treatment)(0 weeks, 9 weeks, 18 weeks, and 1 year)
- The proportion of patients who achieve remission (Hamilton score < 8).(0 weeks, 18 weeks, and 1 year)