- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07291713
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
Completed
Conditions
Intervention / Treatment
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
Interventional
Enrollment (Actual)
77
Phase
- 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
-
-
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
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 |
Intervention / Treatment |
|---|---|
|
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.
|
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
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:
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
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
Investigators
- 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
- Wolfe GI, Herbelin L, Nations SP, Foster B, Bryan WW, Barohn RJ. Myasthenia gravis activities of daily living profile. Neurology. 1999 Apr 22;52(7):1487-9. doi: 10.1212/wnl.52.7.1487.
- Kroenke K, Spitzer RL, Williams JB. The PHQ-9: validity of a brief depression severity measure. J Gen Intern Med. 2001 Sep;16(9):606-13. doi: 10.1046/j.1525-1497.2001.016009606.x.
- Felitti VJ, Anda RF, Nordenberg D, Williamson DF, Spitz AM, Edwards V, Koss MP, Marks JS. Relationship of childhood abuse and household dysfunction to many of the leading causes of death in adults. The Adverse Childhood Experiences (ACE) Study. Am J Prev Med. 1998 May;14(4):245-58. doi: 10.1016/s0749-3797(98)00017-8.
- Mullins LL, Carpentier MY, Paul RH, Sanders DB; Muscle Study Group. Disease-specific measure of quality of life for myasthenia gravis. Muscle Nerve. 2008 Aug;38(2):947-56. doi: 10.1002/mus.21016.
- Liu, S. M. (2020). The Study of Cut-off Scores for Mental Health BMI Index. [master's thesis]. [Taipei (Taiwan, R.O.C.)]: National Taipei University of Nursing and Health Sciences. Available at: https://hdl.handle.net/11296/p992dy
- Li, Y. C. (2019). The Cluster Analysis of the Positive and Negative Indicators of Complete Mental Health State Model. Special Research of the Ministry of Science and Technology (MOST 108-2637-H-227-001). Available at: https://www.airitilibrary.com/Article/Detail?DocID=U0068-0309202111314000
- Li, Y. C. and Chen, Y. F. (2016). National mental health BMI. Couns. Guid. 369, 50-55. doi: 10.6251/bep.202406_55(4).0008
- Li, Y. C., Fang, C. K., Liu, C. Y., and Chang, W. H. (2024). Cluster Analysis of the Positive and Negative Indicators of Complete Mental Health State Model. Chinese Journal of Guidance and Counseling, 69, 37-75. Chin. J. Guid. Couns. 69, 37-75. doi: 10.53106/172851862024010069002
- Harris, N. B. (2018). The Deepest Well: Healing the Long-Term Effects of Childhood Adversity. New York, NY: Houghton Mifflin Harcourt. ISBN-13: 978-0544828704
- Chiu, T. Y. (2021). Effect of Promoting Positive Mental Health BMI by Group Counseling for Myasthenia Gravis. [master's thesis]. [Taipei (Taiwan, R.O.C.)]: National Taipei University of Nursing and Health Sciences. Available at: https://hdl.handle.net/11296/62vwcp
- Chung, M. Y. (2018). Building Mental Health BMI Indicator on Well-Being: A Sampling from Myasthenia Gravis Patients. [master's thesis]. [Taipei (Taiwan, R.O.C.)]: National Taipei University of Nursing and Health Sciences. Available at: https://hdl.handle.net/11296/st3u9u
- Chen, Y. J. (2023). The relationships among adverse childhood experiences, resilience, and health status in patients with ankylosing spondylitis. [master's thesis]. [Taichung (Taiwan, R.O.C.)]: Chung Shan Medical University. Available at: https://hdl.handle.net/11296/d55q94
- Liao, C. M. (2022). A Relational Research on Personality Traits, Resilience, and Career Self-Efficacy among Adults with Adverse Childhood Experiences. [master's thesis]. [Taipei (Taiwan, R.O.C.)]: National Taiwan Normal University. Available at: https://hdl.handle.net/11296/p3359x
- Huang, C. C. (2017). A Study on the Childhood Adversity Experiences and Resilience. [master's thesis]. [Kaohsiung (Taiwan, R.O.C.)]: Shu-Te University. Available at: https://hdl.handle.net/11296/d383p6
- Bellis MA, Hughes K, Ford K, Butler N, Wilson C, Quigg Z. Relative and combined contributions of adverse childhood experiences and self-reported child poverty to health and economic outcomes in adults - a retrospective study in a UK region. BMC Public Health. 2025 Oct 15;25(1):3501. doi: 10.1186/s12889-025-23938-z.
- Bunting L, Davidson G, McCartan C, Hanratty J, Bywaters P, Mason W, Steils N. The association between child maltreatment and adult poverty - A systematic review of longitudinal research. Child Abuse Negl. 2018 Mar;77:121-133. doi: 10.1016/j.chiabu.2017.12.022. Epub 2018 Jan 12.
- Liu SI, Yeh ZT, Huang HC, Sun FJ, Tjung JJ, Hwang LC, Shih YH, Yeh AW. Validation of Patient Health Questionnaire for depression screening among primary care patients in Taiwan. Compr Psychiatry. 2011 Jan-Feb;52(1):96-101. doi: 10.1016/j.comppsych.2010.04.013. Epub 2010 Jul 1.
- Burns TM, Conaway MR, Cutter GR, Sanders DB; Muscle Study Group. Less is more, or almost as much: a 15-item quality-of-life instrument for myasthenia gravis. Muscle Nerve. 2008 Aug;38(2):957-63. doi: 10.1002/mus.21053.
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)
January 10, 2024
Primary Completion (Actual)
January 9, 2025
Study Completion (Actual)
January 9, 2025
Study Registration Dates
First Submitted
December 5, 2025
First Submitted That Met QC Criteria
December 5, 2025
First Posted (Actual)
December 18, 2025
Study Record Updates
Last Update Posted (Actual)
December 18, 2025
Last Update Submitted That Met QC Criteria
December 5, 2025
Last Verified
December 1, 2025
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Nervous System Diseases
- Neoplasms by Site
- Neoplasms
- Neuromuscular Diseases
- Autoimmune Diseases
- Immune System Diseases
- Behavioral Symptoms
- Autoimmune Diseases of the Nervous System
- Neurodegenerative Diseases
- Paraneoplastic Syndromes, Nervous System
- Nervous System Neoplasms
- Paraneoplastic Syndromes
- Neuromuscular Junction Diseases
- Behavior
- Personal Satisfaction
- Social Behavior
- Self-Control
- Depression
- Myasthenia Gravis
- Stress, Psychological
- Psychological Well-Being
- Emotional Regulation
Other Study ID 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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