Myasthenia Gravis and Psyche

NCT03205306 | Completed

• 1 other identifier: PsyMG
• Study Type: observational
• Target: 1,399
• Locations: 1 country
• Sites: 1

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.

Conditions

Myasthenia Gravis

Keywords

Myasthenia Gravis; Psyche; Depression; Anxiety Disorder; Posttraumatic Stress Disorder; Disease Processing

Outcome Measures

Primary Outcomes (1)

• Questionnaire Survey (Patient)

  * 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)

  directly after inclusion in the study

Secondary Outcomes (1)

• "Häusliche Pflegeskala" (HPS)

  directly after inclusion in the study

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients with Myasthenia Gravis and their relatives

You may qualify if:

• Patients with Myasthenia Gravis
• Age ≥18 years

You may not qualify if:

• N/A

Sponsors & Collaborators

• Charite University, Berlin, Germany: lead
• NeuroCure Clinical Research Center, Charite, Berlin: collaborator

Study Sites (1)

NeuroCure Clinical Research Center (NCRC), Charité

Berlin, 10117, Germany

Location

Related Publications (1)

• Marbin D, Piper SK, Lehnerer S, Harms U, Meisel A. Mental health in myasthenia gravis patients and its impact on caregiver burden. Sci Rep. 2022 Nov 11;12(1):19275. doi: 10.1038/s41598-022-22078-3.

  PMID: 36369246 RESULT

MeSH Terms

Conditions

Myasthenia Gravis; Depression; Anxiety Disorders; Stress Disorders, Post-Traumatic

Condition Hierarchy (Ancestors)

Paraneoplastic Syndromes, Nervous System; Nervous System Neoplasms; Neoplasms by Site; Neoplasms; Paraneoplastic Syndromes; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Neurodegenerative Diseases; Neuromuscular Junction Diseases; Neuromuscular Diseases; Autoimmune Diseases; Immune System Diseases; Behavioral Symptoms; Behavior; Mental Disorders; Stress Disorders, Traumatic; Trauma and Stressor Related Disorders

Study Officials

• Andreas Meisel, Prof. Dr. med.

  Charite University, Berlin, Germany

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof. Dr. med.

Study Record Dates

• First Submitted: June 8, 2017
• First Posted: July 2, 2017
• Study Start: May 8, 2017
• Primary Completion: December 14, 2017
• Study Completion: December 14, 2017
• Last Updated: January 10, 2023

Record last verified: 2023-01

Locations

DE (1)