A Validation Study of the German Autobiographical Memory Interview

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Retrograde Amnesia

Intervention / Treatment
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* Diagnostic Test: German Autobiographical Memory Interview short-form


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Patients with depression<br>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<br>* Diagnostic Test<br>* Other names: D-AMI;|
| Active Comparator: Healthy controls<br>- Mental health | Diagnostic Test: German Autobiographical Memory Interview short-form<br>* Diagnostic Test<br>* Other names: D-AMI;|

What is the study measuring?
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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) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Electroconvulsive therapy, Depression, Cognitive side effects