Myasthenia Gravis and Psyche
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|ClinicalTrials.gov Identifier: NCT03205306|
Recruitment Status : Recruiting
First Posted : July 2, 2017
Last Update Posted : February 2, 2018
The purpose of the study is to systematically capture and characterize mental comorbidities for patients with myasthenia gravis. Anxiety disorders and depression for example, can negatively affect the quality of life and lead to e.g. unemployment and early retirement especially in young patients.
Additionally the researchers want to find out in what way certain aspects of the disease have an influence on the quality of life, and whether different concepts of coping with the disease have different effects on the quality of life for patients with myasthenia gravis.
During the study, close relatives of patients will also be asked to provide input about their current stress situation in the context of supporting their relative.
Based on the results, the investigators want to improve and supplement established treatment concepts, to ensure a more comprehensive and individual treatment.
|Condition or disease|
|Study Type :||Observational|
|Estimated Enrollment :||4300 participants|
|Official Title:||Myasthenia Gravis and Psyche|
|Actual Study Start Date :||May 8, 2017|
|Estimated Primary Completion Date :||December 2018|
|Estimated Study Completion Date :||December 2018|
- Questionnaire Survey (Patient) [ Time Frame: directly after inclusion in the study ]
- Questionnaire for self-completion by patients containing questions about general information, information on myasthenia, information on diagnosis of mental illness and psychotherapeutic care
- Hospital Anxiety and Depression Scale (HADS - questionnaire for self-completion by patients to determine the levels of anxiety and depression)
- Breslau scale PTBS-7 (questionnaire for self-completion by patients to determine the levels of Probability of posttraumatic stress disorder (PTSD))
- Mya Quality of Life 15 (Mya QoL15 - questionnaire for self-completion by patients for use as a measure of health outcome)
- Freiburg questionnaire for coping (FKV - questionnaire is used to assess disease processing modes at the levels of cognition, emotion, and behavior)
- "Häusliche Pflegeskala" (HPS) [ Time Frame: directly after inclusion in the study ]questionnaire is used to assess social work Intervention and couple's counselling
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03205306
|Contact: Andreas Meisel, Prof. Dr. med.||+49 30 450 firstname.lastname@example.org|
|Contact: Ulrike Harms, Dr. email@example.com|
|NeuroCure Clinical Research Center (NCRC), Charité||Recruiting|
|Berlin, Germany, 10117|
|Contact: Andreas Meisel, Prof. Dr. med. +49 30 450 560026 firstname.lastname@example.org|
|Contact: Ulrike Harms, Dr. med. email@example.com|
|Principal Investigator:||Andreas Meisel, Prof. Dr. med.||Charite University, Berlin, Germany|