A Validation Study of the German Autobiographical Memory Interview

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

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.

Study Overview

• Status: Unknown
• Conditions: Retrograde Amnesia
• Intervention / Treatment: Diagnostic test: German Autobiographical Memory Interview short-form

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 Type: Interventional
• Enrollment (Anticipated): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Sarah PD Dr. med. MSc. Kayser, MD; Phone Number: + 49 6731 50 1278; Email: s.kayser@rfk.landeskrankenhaus.de

Study Locations

• Germany
  • Rheinland-Pfalz
    • Alzey, Rheinland-Pfalz, Germany, 55232
      • Recruiting
      • Rheinhessen-Fachklinik Alzey
      • Contact: Sarah Kayser, MD; Phone Number: +49 6731 50 1278; Email: s.kayser@rfk.landeskrankenhaus.de

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Patients with depression; 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	Diagnostic test: German Autobiographical Memory Interview short-form; Diagnostic Test; Other Names: D-AMI
Active Comparator: Healthy controls; - Mental health	Diagnostic test: German Autobiographical Memory Interview short-form; Diagnostic Test; Other Names: D-AMI

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

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

Collaborators and Investigators

• Sponsor: Rheinhessen-Fachklinik Alzey
• Collaborators: Johannes Gutenberg University Mainz
• Investigators: Principal Investigator: Sarah PD Dr. med. MSc. Kayser, MD, Rheinhessen-Fachklinik Alzey

Study record dates

Study Major Dates

• Study Start (Actual): August 15, 2020
• Primary Completion (Anticipated): May 1, 2021
• Study Completion (Anticipated): May 1, 2021

Study Registration Dates

• First Submitted: August 11, 2020
• First Submitted That Met QC Criteria: August 17, 2020
• First Posted (Actual): August 18, 2020

Study Record Updates

• Last Update Posted (Actual): August 18, 2020
• Last Update Submitted That Met QC Criteria: August 17, 2020
• Last Verified: August 1, 2020

More Information

Terms related to this study

• Keywords: Depression; Electroconvulsive therapy; Cognitive side effects
• Additional Relevant MeSH Terms: Mental Disorders; Nervous System Diseases; Neurologic Manifestations; Neurobehavioral Manifestations; Neurocognitive Disorders; Memory Disorders; Amnesia; Amnesia, Retrograde
• Other Study ID Numbers: D-AMI 1.1

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No