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临床试验/NCT02437357
NCT02437357已完成不适用

A Randomized-Controlled Trial on Metacognitive Training for Depression (D-MCT) - an New Group Intervention for Depressed Patients

Universitätsklinikum Hamburg-Eppendorf2 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2015年3月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
60
试验地点
2
主要终点
Change in Hamilton Depression Rating Scale (HDRS), total score from pre to post treatment (4 weeks) and follow-up (3months)

研究概览

简要总结

The purpose of the present randomized-controlled trial is to investigate the efficacy of Metacognitive Training for Depression (D-MCT), a new low-threshold, modular group intervention.

详细描述

Despite the existence of evidence-based treatment methods, a significant treatment gap remains for major depression. While in acute psychiatric treatment of severely depressed patients a pharmacological treatment is usually applied, depression-specific psychotherapeutic (group) concepts are rarely part of the treatment, though recommended in clinical guidelines. A main reason is that present group concepts were designed primarily for outpatient settings and do not meet the structural requirements of inpatient care (i.e., short residence time, continuous admissions and dismissals).

Metacognitive Training for Depression (D-MCT) is a new low-threshold, modular group intervention which was designed to fill this treatment gap by addressing contextual and structural shortcomings of existing concepts for the use in inpatient treatment. The training targets depressive symptoms by changing (meta-) cognitive biases identified in both cognitive models of depression and basic research. D-MCT was positively evaluated with regard to feasibility and acceptance in a non-randomized pilot study.

Aim of the present randomized-controlled trial is to investigate the efficacy of D-MCT as an add-on intervention in inpatient treatment of depressed patients compared with a standard add-on group therapy (Positivity Training, PT). Based on a power analysis, the investigators target a sample size of 60 depressed patients, who will be randomized either to D-MCT or PT. Blind to diagnostic status, symptom level as well as cognitive biases will be assessed pre- and post-treatment (8 group sessions) as well as 3 months later (follow-up). Primary outcome parameter is severity of depressive symptoms measured with the HDRS total score (17-item version). Secondary outcome measures are self-assessed depression (BDI), dysfunctional beliefs (DAS), metacognitions (MCQ), self-esteem (RSE), and quality of life (WHOQOL-BREF).

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 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Diagnosis of Major Depression according to DSM-IV (MINI Interview)
  • Diagnosis of Dysthymia according to DSM-IV (MINI Interview)
  • DSM-IV = The Diagnostic and Statistical Manual of Mental Disorders- Fourth Edition, Text Revision (American Psychiatric Association, 2000)

排除标准

  • Lifetime psychotic symptoms (i.e., hallucinations, delusions, or bipolar disorder) according to DSM-IV (MINI Interview)
  • Current substance dependency according to DSM-IV (MINI Interview)

结局指标

主要结局

Change in Hamilton Depression Rating Scale (HDRS), total score from pre to post treatment (4 weeks) and follow-up (3months)

时间窗: 4 months

Clinician-rated severity of depressive symptoms, 17-item version, most commonly used interview-based measure of depression

次要结局

  • Change in Rosenberg Self-Esteem-Scale (RSE) from pre to post treatment (4 weeks) and follow-up (3months)(4 months)
  • Change in Metacognitions Questionnaire (MCQ-30) from pre to post treatment (4 weeks) and follow-up (3months)(4 months)
  • Change in Ruminative Responses Scale (RRS) from pre to post treatment (4 weeks) and follow-up (3months)(4 months)
  • Change in coping (Brief-Cope) from pre to post treatment (4 weeks) and follow-up (3months)(4 months)
  • Change in Beck Depression Inventory (BDI), total score from pre to post treatment (4 weeks) and follow-up (3months)(4 months)
  • Change in Dysfunctional Attitudes Scale (DAS) from pre to post treatment (4 weeks) and follow-up (3months)(4 months)
  • Change in quality of life (WHOQOL-BREF) from pre to post treatment (4 weeks) and follow-up (3months)(4 months)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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