跳至主要内容
临床试验/NCT01608399
NCT01608399已完成不适用

A Randomized Controlled Trial of the Effectiveness of Metacognitive Therapy (MCT) in the Treatment of Patients With Major Depressive Disorder (MDD)

Norwegian University of Science and Technology2 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2012年3月最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
40
试验地点
2
主要终点
Change in depression

研究概览

简要总结

The main aim of this study is to (1) evaluate the effectiveness of metacognitive therapy for major depressive disorder. Additional aims are to (2) investigate patterns of change and the mechanisms of action involved during treatment, and to (3) examine the impact of meta-cognitions in the treatment and relapse prevention of depression.

详细描述

Major depressive disorder is a disabling condition which adversely affects a person's family, work or school life, sleeping and eating habits, and general health.

Cognitive-behavioral therapy (CBT) is a recommended treatment for depression, with a large number of clinical trials supporting its efficacy. However, despite the success of CBT relative to other treatments, only 40-58 % of patients receiving CBT may be classified as recovered using clinical significant change assessed by the Beck Depression Inventory. Moreover, research demonstrates that only between one-third and one quarter of patients receiving CBT remain recovered at 18 months follow-up.

A new treatment approach to MDD is Meta-Cognitive Therapy. In this treatment approach, MDD is conceptualized as being maintained by rumination and meta-cognitions. Treatment seeks to challenge and change specific meta-cognitions and rumination, through behavioural experiments and verbal reattribution. No randomized controlled studies have compared the effectiveness of MCT to a waiting-list condition for MDD. Related to this, no study has examined the specific elements of therapy that are hypothesized to be of most importance for changing rumination, leading to positive treatment outcomes.

The purpose of this trial is to investigate the efficacy of Wells' MCT for Major Depressive Disorder (MDD). Another aim will be to examine the in-treatment processes associated with positive treatment outcomes.

The study will be a randomized controlled, trial comprising 50 patients with a primary diagnosis of major depressive disorder (DSM-IV; APA, 1994). Experienced diagnosticians will assess all patients by using structural interviews such as SCID-I, SCID II and the Hamilton Rating Scale for Depression.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Single Group
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

入选标准

  • Major depressive disorder
  • 18 years or older
  • Signed written informed consent prior to entry in the study

排除标准

  • Known somatic disease
  • Psychosis
  • Current suicide intent
  • Cluster A or cluster B personality disorder
  • Substance dependence
  • Not willing to accept random allocation
  • Not willing to withdraw psychotropic medication for a period of 4 weeks prior to entry to the trial

研究组 & 干预措施

Metacognitive therapy

Experimental

干预措施: Metacognitive therapy (Behavioral)

Waiting list control

No Intervention

结局指标

主要结局

Change in depression

时间窗: baseline (before treatment), week 1-11, 12 months follow-up

Hamilton Depression Rating Scale (HDRS-17; Hamilton, 1967)

Change in diagnosis

时间窗: baseline (before treatment), week 11, 12 months follow-up

SCID I and II (First et al., 1995, 1997)

次要结局

  • Change in rumination(baseline (before treatment), week 11, 6 and 12 months follow-up)
  • Change in negative beliefs(baseline (before treatment), week 11, 6 and 12 months follow-up)
  • Change in metacognitions(baseline (before treatment), week 11, 6 and 12 months follow-up)
  • Change in interpersonal problems(baseline (before treatment), week 11, 6 and 12 months follow-up)
  • Change in worry(baseline (before treatment), week 11, 6 and 12 months follow-up)
  • Change in anxiety(baseline (before treatment), week 1-11, 6 and 12 months follow-up)
  • Change in depression(baseline (before treatment), week 1-11, 6 and 12 months follow-up)
  • Change in automatic thought(baseline (before treatment), week 11, 6 and 12 months follow-up)
  • Change in resilience(baseline (before treatment), week 11, 6 and 12 months follow-up)
  • Quality of working alliance(week 3)
  • Change in positive beliefs(baseline (before treatment), week 11, 6 and 12 months follow-up)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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