NCT07291713

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
77

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2024

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 10, 2024

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 9, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 9, 2025

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

December 5, 2025

Completed
13 days until next milestone

First Posted

Study publicly available on registry

December 18, 2025

Completed
Last Updated

December 18, 2025

Status Verified

December 1, 2025

Enrollment Period

1 year

First QC Date

December 5, 2025

Last Update Submit

December 5, 2025

Conditions

Keywords

myasthenia gravisadverse childhood experienceonline learning programpositive mental health BMI learning programemotional regulationemotional stabilitypsychological well-beingmental health BMI

Outcome Measures

Primary Outcomes (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.

    Baseline to 4 months

Secondary Outcomes (3)

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

    Baseline to 4 months

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

    Baseline to 4 months

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

    Baseline to 4 months

Study Arms (1)

Intervention Group

EXPERIMENTAL

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

Interventions

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.

Intervention Group

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Shin Kong Wu Ho-Su Memorial Hospital

Taipei, Taipei, 111045, Taiwan

Location

Related Publications (18)

  • 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

    BACKGROUND
  • 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

    BACKGROUND
  • 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

    BACKGROUND
  • 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

    BACKGROUND
  • 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

    BACKGROUND
  • 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

    BACKGROUND
  • 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

    BACKGROUND
  • 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

    BACKGROUND
  • 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

    BACKGROUND
  • 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

    BACKGROUND
  • 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.

    PMID: 41094458BACKGROUND
  • 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.

    PMID: 29346067BACKGROUND
  • 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.

    PMID: 21111406BACKGROUND
  • 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.

    PMID: 11556941BACKGROUND
  • 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.

    PMID: 18642357BACKGROUND
  • 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.

    PMID: 18697209BACKGROUND
  • 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.

    PMID: 10227640BACKGROUND
  • 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.

    PMID: 9635069BACKGROUND

MeSH Terms

Conditions

Myasthenia GravisPsychological Well-BeingDepressionStress, PsychologicalEmotional Regulation

Condition Hierarchy (Ancestors)

Paraneoplastic Syndromes, Nervous SystemNervous System NeoplasmsNeoplasms by SiteNeoplasmsParaneoplastic SyndromesAutoimmune Diseases of the Nervous SystemNervous System DiseasesNeurodegenerative DiseasesNeuromuscular Junction DiseasesNeuromuscular DiseasesAutoimmune DiseasesImmune System DiseasesPersonal SatisfactionBehaviorBehavioral SymptomsSelf-ControlSocial Behavior

Study Officials

  • Jiann-Horng Yeh, MD

    Shin Kong Wu Ho-Su Memorial Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Masking Details
This was an open-label study in which no masking was used. All participants and investigators were aware of the behavioral intervention being provided.
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
SINGLE GROUP
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Vice Superintendent, Professor of Neurology, Shin Kong Wu Ho-Su Memorial Hospital

Study Record Dates

First Submitted

December 5, 2025

First Posted

December 18, 2025

Study Start

January 10, 2024

Primary Completion

January 9, 2025

Study Completion

January 9, 2025

Last Updated

December 18, 2025

Record last verified: 2025-12

Data Sharing

IPD Sharing
Will not share

No plan to share individual participant data.

Locations