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

December 5, 2025 updated by: Jiann-Horng Yeh

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
77

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Taiwan
    • Taipei
      • Taipei, Taipei, Taiwan, 111045
        • Shin Kong Wu Ho-Su Memorial Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Intervention Group
All participants were assigned to a single intervention arm and received the Positive Mental Health BMI Learning Program. This program consisted of four pre-recorded online video units delivered over four months through a closed Facebook group. The units covered interpersonal support, emotional regulation, and self-worth and meaning. Participants completed pre-test assessments before beginning the program and post-test assessments after completing all four units.
Behavioral: Positive Mental Health BMI Learning Program
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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:

  1. Befriend (B), representing interpersonal support and closeness
  2. Mindfulness (M), representing emotional stability and awareness
  3. 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.
Baseline to 4 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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.
Baseline to 4 months
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.
Baseline to 4 months
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.
Baseline to 4 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Jiann-Horng Yeh

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Jiann-Horng Yeh, MD, Shin Kong Wu Ho-Su Memorial Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 10, 2024

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 9, 2025

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 9, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 5, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 5, 2025

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 18, 2025

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
December 18, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 5, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 20230731R

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

No plan to share individual participant data.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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