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临床试验/NCT02771535
NCT02771535已完成不适用

Long-term Efficacy of Metacognitive Training for Depression (D-MCT): a 3-year Follow up

Universitätsklinikum Hamburg-Eppendorf2 个研究点 分布在 1 个国家目标入组 84 人开始时间: 2016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
84
试验地点
2
主要终点
Hamilton Depression Rating Scale

研究概览

简要总结

Aim of the current study is to investigate the long-term efficacy of Metacognitive Training for Depression (D-MCT) and to explore whether previously observed effects at the 6-month follow-up of a randomized, controlled, assessor-blind, parallel group trial are maintained at the 3-year follow-up.

详细描述

Dissemination of treatment for depression is still unsatisfying: every second patient does not receive, refuses, or is waiting for treatment. Moreover, with a drop-out rate of almost 25% in routine clinical practice, and a 54% relapse rate for treatment responders within the two years after treatment termination, improving treatment is necessary. Metacognitive Training for depression (D-MCT), a low threshold, easy to administer group intervention was designed to fill this gap. It aims at the reduction of depressive symptoms by changing cognitive biases; not only biases targeted in cognitive behavioral therapy but also those identified by basic research. It was positively evaluated with regard to feasibility and acceptance in a non-randomized pilot study. Moreover, efficacy of D-MCT was suggested in a randomized controlled trail (RCT) in comparison to an active control intervention (Jelinek et al., in press). In this trial patients with depressive disorder were completing a psychosomatic outpatient treatment program and were randomly assigned to either D-MCT or general health training. Severity of depression and cognitive biases were assessed at baseline (t0), post treatment (t1) and 6 months (t2) later by raters blind to diagnostic status. Intention-to-treat analyses demonstrated that at the end of treatment, as well as 6 months later, improvement in depression was significantly greater in the D-MCT relative to the health training group at medium effect sizes. A significantly greater number of patients in the D-MCT group were in remission at 6-month follow-up. Moreover, the decrease in cognitive biases and increase in psychological well-being/quality of life was larger in the D-MCT than the health training group over time. Aim of the current study is to investigate the long-term efficacy of D-MCT. For this purpose, an additional 3 year follow-up assessment (t3) is conducted. The Hamilton Depression Rating Scale (HDRS, 17-item version) total score serves as the primary outcome. Self-assessed depression, dysfunctional beliefs, self-esteem, quality of life, and ability to work serve as secondary outcomes.

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
Double (Investigator, 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

入选标准

  • 未提供

排除标准

  • 未提供

研究组 & 干预措施

D-MCT Group

Experimental

Metacognitive Training for Depression (D-MCT), 8 sessions (60min); twice a week over a period of 4 weeks. Metacognitive Training for depression (D-MCT) is a low-threshold, easy to administer group intervention. It aims at the reduction of depressive symptoms by changing cognitive biases; not only biases targeted in cognitive behavioral therapy but also those identified by basic research.

干预措施: D-MCT (Behavioral)

Health Training Group

Active Comparator

Health Training Group (Walking/ Psychoeducation on health); 8 sessions (60min), twice a week over a period of 4 weeks

干预措施: Health Training (Behavioral)

结局指标

主要结局

Hamilton Depression Rating Scale

时间窗: 3 years from baseline (t0) to 3-year follow up (t3)

Primary outcome is change on the Hamilton Depression Rating Scale (HDRS, 17-item version) from baseline to follow-up (t0 - t3)

次要结局

  • Quality of life(3 years from baseline (t0) to 3-year follow up (t3))
  • Work status(at 3-year follow-up (t3))
  • Dysfunctional metacognitive beliefs(3 years from baseline (t0) to 3-year follow up (t3))
  • Self-assessed depression(3 years from baseline (t0) to 3-year follow up (t3))
  • Dysfunctional beliefs(3 years from baseline (t0) to 3-year follow up (t3))
  • Self-esteem(3 years from baseline (t0) to 3-year follow up (t3))
  • Remission rate(at 3-year follow up (t3))

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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