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临床试验/NCT01330485
NCT01330485已完成不适用

Deficits in Emotion Regulation Skills as a Maintaining Factor in Major Depressive Disorder

Friedrich-Alexander-Universität Erlangen-Nürnberg6 个研究点 分布在 1 个国家目标入组 218 人开始时间: 2010年11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
218
试验地点
6
主要终点
Change in depressive symptoms

研究概览

简要总结

The primary aim of the study is to evaluate the efficacy of a systematic training of general affect regulation skills (ART) on the reduction of depressive symptom in individuals meeting criteria for major depressive disorder (MDD).

详细描述

Deficits in general emotion regulation skills have been shown to be associated with various mental disorders. Thus, general affect-regulation training has been proposed as promising transdiagnostic approach to the treatment of psychopathology. In the present study, we aimed to evaluate the efficacy of a general affect-regulation as a stand-alone, group-based treatment for depression. For this purpose, we randomly assigned 218 individuals who met criteria for major depressive disorder (MDD) to the Affect Regulation Training (ART), to a waitlist control condition (WLC), or to a condition controlling for common factors (CFC). The primary outcome was the course of depressive symptom severity as assessed with the Hamilton Rating Scale for Depression and the Beck Depression Inventory. Differences between groups will be analyzed with the help of multi-level analyses. To clarify mechanisms of change we will test whether changes in emotion regulation skills will mediate potential differences between conditions regarding change of depressive symptoms. As secondary goal, the study will try and clarify whether participating in ART might augment the efficacy of subsequent individual cognitive-behavioral therapy.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Factorial
主要目的
Treatment
盲法
Single (Outcomes Assessor)

盲法说明

Assessors were blinded to study conditions.

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

  • diagnosis of MDD according to DSM-IV criteria as the primary diagnosis
  • age 18 and above
  • sufficient German language skills

排除标准

  • high risk of suicide
  • indication of substantial secondary gain
  • currently in psychotherapeutic treatment with an institution/professional other than those involved in the study
  • co-occurring psychotic, bi-polar, and/or substance disorders
  • organic brain disorder(s), severe medical condition, and/or severe cognitive impairment that impedes ability to participate in the study or treatment

研究组 & 干预措施

Affect Regulation Training

Experimental

Affect Regulation Training as described in Berking & Whitley, 2014.

干预措施: Affect Regulation Training (Behavioral)

Common Factor Control Condition (CFC)

Active Comparator

Common factor based therapy control condition

干预措施: Common Factor Control Condition (Behavioral)

Waitlist Control Condition

No Intervention

Wait List Control

结局指标

主要结局

Change in depressive symptoms

时间窗: Pre to post ART, CFC or WLC; hence covering the ten week time period from the first assessment point (prior to randomization) to the assessment point 10 weeks later

Change in depressive symptoms as assessed in Beck Depression Inventory (BDI-II) and Hamilton Rating Scale for Depression (HRSD) and aggregated to a composite score is possible

次要结局

  • Emotion regulation skills(Pre to post ART, CFC or WLC; hence covering the ten week time period from the first assessment point (prior to randomization) to the assessment point 10 weeks later)

研究者

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

Matthias Berking, Ph.D.

Prof. Dr.

Friedrich-Alexander-Universität Erlangen-Nürnberg

研究点 (6)

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