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NCT Number: NCT07291713

Psychological Health and Adverse Childhood Experiences in Myasthenia Gravis: Online Mental Health BMI Learning Program

This study evaluated psychological health in patients with myasthenia gravis (MG) using an online behavioral program called the "Positive Mental Health BMI Learning Program." The program consisted of four short video units focused on interpersonal support, emotional regulation, and personal meaning. Patients receiving care in the neurology outpatient clinic were invited to complete questionnaires before and after viewing the online program. Psychological well-being, depressive symptoms, daily functioning, and quality of life were assessed to describe participants' mental health status and changes observed over the course of the program.

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Key information

Conditions

Myasthenia Gravis Activities of Daily Living Adverse Childhood Experience Autoimmune Diseases Autoimmune Diseases of the Nervous System Behavior Behavioral Symptoms Depression Depressive Symptoms Emotional Regulation Immune System Diseases Mental Health Mental Well-being Neoplasms Neoplasms by Site Nervous System Diseases Nervous System Neoplasms Neurodegenerative Diseases Neuromuscular Diseases Neuromuscular Junction Diseases Paraneoplastic Syndromes Paraneoplastic Syndromes, Nervous System Personal Satisfaction Psychological Stress Psychological Well-Being Quality of Life (QOL) Self-Control Social Behavior Stress, Psychological Well-Being, Psychological

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Shin Kong Wu Ho-Su Memorial Hospital

Taipei, 111045, Taiwan

About this study

Participants completed sociodemographic questionnaires, adverse childhood experiences (ACEs) assessments, and four psychological and disease-related measures: the Myasthenia Gravis Activities of Daily Living Scale (MG-ADL), the Myasthenia Gravis Quality of Life 15-item scale (MG-QOL15), the mental health BMI indicator (mBMI), and the Patient Health Questionnaire-9 (PHQ-9). The study collected baseline data prior to the online program and post-intervention data after completion of the four video units. Analyses examined associations between ACE exposure and psychological measures, as well as changes in clinical and psychological indicators across the intervention period.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients with a confirmed diagnosis of myasthenia gravis (MG) based on acetylcholine receptor antibody testing, single-fiber electromyography, repetitive nerve stimulation, or chest computed tomography.
  • Individuals able to clearly express their own intentions.
  • Individuals without cognitive impairment or psychiatric disorders.
  • Individuals who are able to use Facebook and who agree to participate in the study and provide written informed consent.

Exclusion criteria

  • Individuals who do not have a diagnosis of MG.
  • Patients who are unable to communicate adequately in Mandarin, Taiwanese, English, or written form.
  • Individuals with head trauma, psychiatric symptoms, or cognitive impairment that may interfere with verbal expression.

Treatment and study plan

Positive Mental Health BMI Learning Program

Behavioral

The intervention consisted of the Positive Mental Health BMI Learning Program, a four-unit online behavioral program delivered through a closed Facebook group. Each video unit was approximately 15 minutes and focused on components of positive mental health, including interpersonal support, emotional regulation, and sense of meaning and self-worth. One unit was released each month over a four-month period. Participants completed pre-test assessments before the program and post-test assessments after completing all four units.

Primary outcomes

  1. Change in the indicator of mental health BMI on well-being (mBMI) Score from baseline to post-intervention

    Time frame: Baseline to 4 months

    The indicator of mental health BMI (mBMI) is a measure of positive psychological well-being that includes three domains:

    • Befriend (B), representing interpersonal support and closeness
    • Mindfulness (M), representing emotional stability and awareness
    • Identity (I), representing self-worth and meaning.

    Scores were collected before the intervention and after completion of the four-unit online program to evaluate changes in psychological well-being.

Secondary outcomes

  1. Change in Patient Health Questionnaire-9 (PHQ-9) Score from baseline to post-intervention

    Time frame: Baseline to 4 months

    The Patient Health Questionnaire-9 (PHQ-9) is a 9-item measure used to assess the severity of depressive symptoms. Participants completed the PHQ-9 before the intervention and again after completing the four-unit online program to evaluate changes in depressive symptom severity over time.

  2. Change in Myasthenia Gravis Quality of Life 15-item (MG-QOL15) Score from baseline to post-intervention

    Time frame: Baseline to 4 months

    The Myasthenia Gravis Quality of Life 15-item scale (MG-QOL15) is a disease-specific measure used to assess the impact of myasthenia gravis on daily functioning and overall quality of life. Participants completed the MG-QOL15 before the intervention and again after completing the four-unit online program to evaluate changes in disease-related quality of life.

  3. Change in Myasthenia Gravis Activities of Daily Living (MG-ADL) Score from baseline to post-intervention

    Time frame: Baseline to 4 months

    The Myasthenia Gravis Activities of Daily Living scale (MG-ADL) is an 8-item measure used to assess symptom severity and the impact of myasthenia gravis on daily functioning. Participants completed the MG-ADL before the intervention and again after completing the four-unit online program to evaluate changes in disease-related functional status.

Sponsors and collaborators

Lead sponsor

Jiann-Horng Yeh

Other

Registry information

Official study title

Evaluating the Effects of an Online Positive Mental Health BMI Learning Program on Psychological Health in Patients With Myasthenia Gravis and Its Association With Adverse Childhood Experiences

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Dec 18, 2025
Registry last updated
Dec 18, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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