Clinical trial NCT04516863: A Validation Study of the German Autobiographical Memory Interview
Official title: Validation of the German Short Version of the Autobiographical Memory Interview in Patients With Depression and Healthy Controls
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Retrograde Amnesia
Keywords: Electroconvulsive therapy
Depression
Cognitive side effects
Lead sponsor: Rheinhessen-Fachklinik Alzey
Sponsor class: OTHER
Collaborators: name: Johannes Gutenberg University Mainz
First posted: 2020-08-18
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

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.

Eligibility criteria: 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

Primary outcomes:
measure: German Autobiographical Memory Interview short-form
timeFrame: pre-post (six weeks)
Secondary outcomes:
measure: Hamilton Depression Rating Scale (HAMD-17)
timeFrame: pre-post (six weeks)
measure: Inventar Depressiver Symptome (IDS)
timeFrame: pre-post (six weeks)
measure: 36-item Health Survey (SF-36)
timeFrame: pre-post (six weeks)
measure: Global Self-Evaluation-Memory (GSE-My)
timeFrame: pre-post (six weeks)
Other outcomes:
Locations:
city: Alzey
country: Germany
facility: Rheinhessen-Fachklinik Alzey
state: Rheinland-Pfalz
Study officials:
affiliation: Rheinhessen-Fachklinik Alzey
name: Sarah PD Dr. med. MSc. Kayser, MD
role: PRINCIPAL_INVESTIGATOR
References: