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Myasthenia GravisNCT07291713

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

A study testing Positive Mental Health BMI Learning Program in people with Myasthenia Gravis and Adverse Childhood Experience, run by Jiann-Horng Yeh at 1 site in Taiwan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 to 80 years
What is being tested?
Positive Mental Health BMI Learning Program
Could I receive a placebo?
No, everyone receives an active treatment
How many people
77 participants
Where
1 siteTaiwan
Study dates
10 Jan 2024to 9 Jan 2025
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

Taiwan1 site

  • Shin Kong Wu Ho-Su Memorial Hospital

    Taipei, Taipei, 111045

Other trials in Taiwan

About this study

Official 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

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.

Read the 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.

Being tested
Positive Mental Health BMI Learning Program
Keywords
myasthenia gravis, adverse childhood experience, online learning program, positive mental health BMI learning program, emotional regulation, emotional stability, psychological well-being, mental health BMI
Medical subject headings
Myasthenia Gravis, Psychological Well-Being, Depression, Stress, Psychological, Emotional Regulation

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Positive Mental Health BMI Learning ProgramBehavioural

    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.

Study groups in NCT07291713
Study groupRoleWhat they receive
Intervention GroupExperimentalAll 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.
Receives: Behavioral: Positive Mental Health BMI Learning Program

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    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.

    Measured: Baseline to 4 months

Secondary outcomes (3)

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

    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.

    Measured: Baseline to 4 months

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

    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.

    Measured: Baseline to 4 months

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

    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.

    Measured: Baseline to 4 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Dec 2025
  2. Study start10 Jan 2024
  3. Primary completion9 Jan 2025
  4. Study completion9 Jan 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Health services research
Allocation
Not applicable
Intervention model
Single group
Model description
All participants were enrolled into a single study group and received the same online behavioral intervention, the online Positive Mental Health BMI Learning Program. Pre-test and post-test assessments were completed by participants to measure psychological outcomes.
Masking
None (open label)
Enrolment
77 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07291713
Sponsor's protocol ID
20230731R
Status last verified
Dec 2025
First submitted
5 Dec 2025
Last updated
18 Dec 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: No plan to share individual participant data.

Publications

  • 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.

    PubMed 41094458

  • 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.

    PubMed 29346067

  • 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.

    PubMed 21111406

  • 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.

    PubMed 11556941

  • 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.

    PubMed 18642357

Questions about this trial

What is this clinical trial studying?

A study testing Positive Mental Health BMI Learning Program in people with Myasthenia Gravis and Adverse Childhood Experience, run by Jiann-Horng Yeh at 1 site in Taiwan.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 18 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in the indicator of mental health BMI on well-being (mBMI) Score from baseline to post-intervention (time frame: Baseline to 4 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07291713, which also lists 18 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Dec 2025.

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