Myasthenia Gravis and Psyche

Sponsor

Charite University, Berlin, Germany (Other)

Overall Status

Completed

CT.gov ID

NCT03205306

Collaborator

NeuroCure Clinical Research Center, Charite, Berlin (Other)

1,399

Enrollment

Location

7.2

Actual Duration (Months)

193.6

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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	Intervention/Treatment	Phase
Myasthenia Gravis

Study Design

Study Type:

Observational

Actual Enrollment :

1399 participants

Observational Model:

Cohort

Time Perspective:

Retrospective

Official Title:

Myasthenia Gravis and Psyche

Actual Study Start Date :

May 8, 2017

Actual Primary Completion Date :

Dec 14, 2017

Actual Study Completion Date :

Dec 14, 2017

Outcome Measures

Primary Outcome Measures

Questionnaire Survey (Patient) [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)

Secondary Outcome Measures

"Häusliche Pflegeskala" (HPS) [directly after inclusion in the study]
questionnaire is used to assess social work Intervention and couple's counselling