跳至主要内容
临床试验/NCT04516863
NCT04516863Unknown不适用

Validation of the German Short Version of the Autobiographical Memory Interview in Patients With Depression and Healthy Controls

Rheinhessen-Fachklinik Alzey1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2020年8月15日最近更新:
适应症
干预措施

试验速览

阶段
不适用
发起方
入组人数
60
试验地点
1
主要终点
German Autobiographical Memory Interview short-form

研究概览

简要总结

Electroconvulsive therapy (ECT) is recommended for the treatment of severe depression. But, despite the high remission rates the use of ECT is strongly limited by the social stigma and treatment-emergent cognitive side effects in patients. The most relevant is retrograde amnesia (RA), because it can persists for months and years. To measure RA after ECT the short-form of the Autobiographical Memory Interview (SF-AMI) is commonly used. However, the validation of the German SF-AMI has not yet been carried out. Thus, the aim of this study is to validate the German SF-AMI in depressed patient and healthy controls.

The investigators hypothesize that the German SF-AMI is reliable and valid to quantify RA.

详细描述

To measure retrograde amnesia of autobiographical memory after ECT, various tests were used so far. Currently, the short form of the Autobiographical Memory Interview (AMI-SF) was used most frequently internationally. In Germany there is no validated translation of the AMI-SF. However, in order to be able to systematically record the cognitive side effects of ECT in clinical practice as well as in research in the German-speaking area, it is important to have validated test procedures that can be successfully used in repeated measurements. In this study, the German version of the AMI (D-AMI), i.e. the specificity of the German short version of the autobiographical memory in patients with depression will be investigated. It is also known in healthy people that autobiographical memory contents can no longer be called up over time. Therefore, the aim of this study is to investigate whether a change in autobiographical memory over the course of time in depressed patients differs from healthy control subjects. It should also be shown whether this German short version for examining autobiographical memory (D-AMI) can be carried out.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Diagnostic
盲法
None

入排标准

年龄范围
18 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者
是

入选标准

  • •HDRS > 17
  • •Age 18-80
  • •Ability to give informed consent

排除标准

  • •Drugs or drug abuse or addictions
  • •Use of benzodiazepine equivalent to lorazepam> 1.5 mg per day
  • •Cognitive impairments
  • •History of traumatic brain injury
  • •Relevant organic disease, e.g. Multiple sclerosis, Parkinson's disease
  • •Bipolar illness, dementia or schizophrenic disorder
  • •German is not the mother tongue
  • •Inability to give informed consent

研究组 & 干预措施

Patients with depression

Active Comparator
  • Major depression according to DSM-V and ICD-10 (ICD F32.1, F32.2, F32.3, F33.1, F33.2, F33.3)
  • Hamilton Depression Rating Scale > 17

干预措施: German Autobiographical Memory Interview short-form (Diagnostic Test)

Healthy controls

Active Comparator
  • Mental health

干预措施: German Autobiographical Memory Interview short-form (Diagnostic Test)

结局指标

主要结局

German Autobiographical Memory Interview short-form

时间窗: pre-post (six weeks)

Changes in autobiographical memory measured with the German Autobiographical Memory Interview short-form pre-post in depressed patients vs. a healthy control Group.

次要结局

  • Hamilton Depression Rating Scale (HAMD-17)(pre-post (six weeks))
  • Inventar Depressiver Symptome (IDS)(pre-post (six weeks))
  • Global Self-Evaluation-Memory (GSE-My)(pre-post (six weeks))
  • 36-item Health Survey (SF-36)(pre-post (six weeks))

研究者

发起方
Rheinhessen-Fachklinik Alzey
申办方类型
Other
责任方
Principal Investigator
主要研究者

Sarah Kayser

PD Dr. med. Sarah Kayser, MSc.

Rheinhessen-Fachklinik Alzey

研究点 (1)

Loading locations...

相似试验