Myasthenia Gravis and Psyche

Completed

• Conditions: Myasthenia Gravis

• Registration Number: NCT03205306
• Lead Sponsor: Charite University, Berlin, Germany

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2017-05-08
• Study First Submitted: 2017-06-08
• Study First Submitted QC: 2017-06-29
• Study First Posted: 2017-07-02
• Primary Completion: 2017-12-14
• Study Completion: 2017-12-14
• Status Verified: 2023-01
• Last Update Submitted: 2023-01-06
• Last Update Posted: 2023-01-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1399

Inclusion Criteria

• Patients with Myasthenia Gravis
• Age ≥18 years

Exclusion Criteria

• N/A

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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

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

Trial Locations

Locations (1)

NeuroCure Clinical Research Center (NCRC), Charité; 🇩🇪 Berlin, Germany