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临床试验/NCT02538835
NCT02538835Unknown不适用

The Effect of Group Treatment for Depression: A Randomised Controlled Study of Metacognitive Therapy, Mindfulness and Support Groups

University of Southern Denmark1 个研究点 分布在 1 个国家目标入组 165 人开始时间: 2018年8月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
入组人数
165
试验地点
1
主要终点
Change from baseline on Hamilton depression scale

研究概览

简要总结

This study evaluates the effect of metacognitive group therapy on depression compared to mindfulness groups and supportive groups. The participants, all with a history of depression and with current symptoms of depression, will be randomized to one of the three group interventions.

详细描述

Metacognitive therapy (MCT) show promising results in alleviating depressive symptoms and reducing relapse of depression. However studies of MCT as a group intervention is limited and higher quality studies of the effectiveness of MCT is warranted. The present study aim to produce more conclusive evidence on the effect of MCT comparing MCT in groups with both and active control group and mindfulness based cognitive therapy (MBCT), which together with pharmacotherapy is currently one of the preferred treatment choices. Currently pharmacotherapy, cognitive therapy and MBCT seem to help 40-58% of the patients efficiently. The current studies of MCT indicate that this intervention may help a higher proportion of the patients.

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

  • •Consent to participate
  • •History of clinical depression
  • •Current depressive symptoms
  • •Verbal and cognitive abilities to complete the questionnaires during the study
  • •Stable medication - if any medication is ordinated
  • •Speaks fluently danish

排除标准

  • •If criteria for psychosis, bipolar disorder or personality disorder is matched
  • •known brain damage or mental retardation
  • •substance abuse
  • •women who are pregnant or breast feeding

研究组 & 干预措施

Metacognitive Therapy

Experimental

干预措施: Metacognitive therapy (Behavioral)

Mindfulness based cognitive therapy

Active Comparator

干预措施: Mindfulness based cognitive therapy, group (Behavioral)

Support groups

Placebo Comparator

干预措施: Support groups (Behavioral)

结局指标

主要结局

Change from baseline on Hamilton depression scale

时间窗: 32 weeks

Change from baseline on Hamilton depression scale

时间窗: 8 weeks

次要结局

  • Change from baseline on Ruminative Response Scale(32 weeks)
  • Change from baseline on Becks depression inventory(32 weeks)
  • Change from baseline on Becks Anxiety Inventory(32 weeks)
  • Change from baseline on Metacognitive questionnaire(32 weeks)
  • Change from baseline on Becks Anxiety Inventory(8 weeks)
  • Change from baseline on Becks depression inventory(8 weeks)
  • Change from baseline on Ruminative Response Scale(8 weeks)
  • Change from baseline on Metacognitive questionnaire(8 weeks)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Tonny Elmose Andersen, phd.

Associate Professor

University of Southern Denmark

研究点 (1)

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