A Validation Study of the German Autobiographical Memory Interview

Not Applicable

• Conditions: Retrograde Amnesia
• Interventions: Diagnostic Test: German Autobiographical Memory Interview short-form

• Registration Number: NCT04516863
• Lead Sponsor: Rheinhessen-Fachklinik Alzey

Brief 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.

Detailed 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.

Study Timeline

• Status Verified: 2020-08
• Study First Submitted: 2020-08-11
• Study Start: 2020-08-15
• Study First Submitted QC: 2020-08-17
• Last Update Submitted: 2020-08-17
• Study First Posted: 2020-08-18
• Last Update Posted: 2020-08-18
• Primary Completion: 2021-05-01
• Study Completion: 2021-05-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 60

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Patients with depression	German Autobiographical Memory Interview short-form	* 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
Healthy controls	German Autobiographical Memory Interview short-form	- Mental health

Primary Outcome Measures

Name	Time	Method
German Autobiographical Memory Interview short-form	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.

Secondary Outcome Measures

Name	Time	Method
Hamilton Depression Rating Scale (HAMD-17)	pre-post (six weeks)	Change in depression severity
Inventar Depressiver Symptome (IDS)	pre-post (six weeks)	Change in depression severity
Global Self-Evaluation-Memory (GSE-My)	pre-post (six weeks)	Change in self-evaluation of memory
36-item Health Survey (SF-36)	pre-post (six weeks)	Change in qualtiy of life

Trial Locations

Locations (1)

Rheinhessen-Fachklinik Alzey; 🇩🇪 Alzey, Rheinland-Pfalz, Germany