A Validation Study of the German Autobiographical Memory Interview

• Sponsor: Rheinhessen-Fachklinik Alzey (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT04516863
• Collaborator: Johannes Gutenberg University Mainz (Other)
• Enrollment: 60
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 8.5
• Patients Per Site Per Month: 7.1

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Retrograde Amnesia	Diagnostic Test: German Autobiographical Memory Interview short-form	N/A

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 Design

• Study Type: Interventional
• Anticipated Enrollment: 60 participants
• Allocation: Non-Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Diagnostic
• Official Title: Validation of the German Short Version of the Autobiographical Memory Interview in Patients With Depression and Healthy Controls
• Actual Study Start Date: Aug 15, 2020
• Anticipated Primary Completion Date: May 1, 2021
• Anticipated Study Completion Date: May 1, 2021

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. 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

1. Hamilton Depression Rating Scale (HAMD-17) [pre-post (six weeks)]

   Change in depression severity

2. Inventar Depressiver Symptome (IDS) [pre-post (six weeks)]

   Change in depression severity

3. 36-item Health Survey (SF-36) [pre-post (six weeks)]

   Change in qualtiy of life

4. Global Self-Evaluation-Memory (GSE-My) [pre-post (six weeks)]

   Change in self-evaluation of memory

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 80 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Rheinhessen-Fachklinik Alzey	Alzey	Rheinland-Pfalz	Germany	55232

Sponsors and Collaborators

• Rheinhessen-Fachklinik Alzey
• Johannes Gutenberg University Mainz

Investigators

• Principal Investigator: Sarah PD Dr. med. MSc. Kayser, MD, Rheinhessen-Fachklinik Alzey

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Sarah Kayser, PD Dr. med. Sarah Kayser, MSc., Rheinhessen-Fachklinik Alzey
• ClinicalTrials.gov Identifier: NCT04516863
• Other Study ID Numbers: D-AMI 1.1
• First Posted: Aug 18, 2020
• Last Update Posted: Aug 18, 2020
• Last Verified: Aug 1, 2020

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Sarah Kayser, PD Dr. med. Sarah Kayser, MSc., Rheinhessen-Fachklinik Alzey: Electroconvulsive therapy; Depression; Cognitive side effects
• Additional relevant MeSH terms: Amnesia; Amnesia, Retrograde

Study Results

No Results Posted as of Aug 18, 2020