A Validation Study of the German Autobiographical Memory Interview

Retrograde Amnesia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04516863
• Other study ID #: D-AMI 1.1
• Status: Recruiting
• Phase: N/A
• Start date: August 15, 2020
• Est. completion date: May 1, 2021

Study information

• Verified date: August 2020
• Source: Rheinhessen-Fachklinik Alzey
• Contact: Sarah PD Dr. med. MSc. Kayser, MD
• Phone: + 49 6731 50 1278
• Email: s.kayser[@]rfk.landeskrankenhaus.de
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: May 1, 2021
• Est. primary completion date: May 1, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• MDD

• HDRS > 17

• Age 18-80

• Ability to give informed consent

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Amnesia
• Retrograde Amnesia

Intervention

Diagnostic Test:
• German Autobiographical Memory Interview short-form
Diagnostic Test

Locations

Country	Name	City	State
Germany	Rheinhessen-Fachklinik Alzey	Alzey	Rheinland-Pfalz

Sponsors (2)

Lead Sponsor	Collaborator
Rheinhessen-Fachklinik Alzey	Johannes Gutenberg University Mainz

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	German Autobiographical Memory Interview short-form	Changes in autobiographical memory measured with the German Autobiographical Memory Interview short-form pre-post in depressed patients vs. a healthy control Group.	pre-post (six weeks)
Secondary	Hamilton Depression Rating Scale (HAMD-17)	Change in depression severity	pre-post (six weeks)
Secondary	Inventar Depressiver Symptome (IDS)	Change in depression severity	pre-post (six weeks)
Secondary	36-item Health Survey (SF-36)	Change in qualtiy of life	pre-post (six weeks)
Secondary	Global Self-Evaluation-Memory (GSE-My)	Change in self-evaluation of memory	pre-post (six weeks)