Myasthenia GravisNCT07649187
Depressive Tendency and Counseling Outcomes in Thymoma-Associated MG
A study testing Psychological counseling intervention in people with Myasthenia Gravis and Depression, run by Ming-Hsing Chang at 1 site in Taiwan.
Trial summary
This study aimed to examine whether baseline depressive tendency independently predicts post-counseling clinical outcomes in patients with thymoma-associated MG. This single-group pre-post exploratory pilot study enrolled patients with thymoma-associated MG who received eight sessions of Gestalt-oriented psychological… Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Myasthenia Gravis, Depression, Thymoma
- What is being tested?
- Psychological counseling intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 19 participants
- Where
- 1 siteTaiwan
- Study dates
- 1 Jan 2024to 31 Dec 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 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- A confirmed diagnosis of MG associated with thymoma and prior completion of surgical treatment
- Age ≥ 20 years
- Ability to communicate clearly and provide reliable responses
- Absence of cognitive impairment or severe psychiatric illness that could interfere with participation
- Willingness to participate in the study with provision of written informed consent
Who cannot join
- The absence of a confirmed diagnosis of myasthenia gravis
- Failure to confirm thymoma on postoperative pathological examination
- Inability to communicate adequately in Mandarin, Taiwanese, English, or written form
- The presence of conditions that could compromise verbal communication or regular participation in counseling sessions, such as significant traumatic brain injury, severe psychiatric disorders, or cognitive impairment
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Association of Baseline Depressive Tendency With Post-Counseling Clinical Status in Patients With Thymoma-Associated Myasthenia Gravis
This study aimed to examine whether baseline depressive tendency independently predicts post-counseling clinical outcomes in patients with thymoma-associated MG. This single-group pre-post exploratory pilot study enrolled patients with thymoma-associated MG who received eight sessions of Gestalt-oriented psychological counseling. Depressive tendency was defined as a baseline Patient Health Question-naire-9 (PHQ-9) score ≥10. Clinical outcomes, including the Myasthenia Gravis Activities of Daily Living scale (MG-ADL), Myasthenia Gravis Quality of Life 15-item scale (MG-QoL15), and mental BMI (mBMI), were assessed before and after the intervention. Multivariable regression analyses were performed to evaluate whether baseline clinical severity independently predicted post-intervention outcomes after sequential adjustment for baseline scores, age, and sex.
- Conditions
- Myasthenia Gravis, Depression, Thymoma, Depression and Quality of Life, Quality of Life, Activities of Daily Living
- Being tested
- Psychological counseling intervention
- Keywords
- myasthenia gravis, thymoma, depressive tendency, psychological well-being, mental health BMI
- Medical subject headings
- Myasthenia Gravis, Depression, Thymoma, Psychological Well-Being
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Psychological counseling interventionBehavioural
The psychological counseling intervention was primarily based on Gestalt therapy, emphasizing awareness and expression of suppressed emotions and resolution of unfinished emotional experiences. It also incorporated Somatic Experiencing techniques to enhance bodily awareness, release tension, and support emotional regulation and psychological well-being. Each participant received eight individualized face-to-face sessions, delivered weekly or biweekly, with each session lasting approximately 60 minutes. Sessions were conducted by licensed counseling psychologists in a private consultation setting. No audio or video recordings were made; session records were encrypted and securely stored. The intervention followed a structured framework consisting of initial, working, and termination phases. Session content and pacing could be adjusted according to individual needs, while the overall therapeutic structure remained consistent across participants.
| Study group | Role | What they receive |
|---|---|---|
| Intervention Group | Experimental | All participants were enrolled into a single study group and received the same eight sessions of Gestalt-oriented psychological counseling. Pre-test and post-test assessments were completed by participants to measure psychological outcomes. Clinical outcomes, including the Myasthenia Gravis Activities of Daily Living scale (MG-ADL), Myasthenia Gravis Quality of Life 15-item scale (MG-QoL15), and mental BMI (mBMI), were assessed before and after the intervention. Receives: Behavioral: Psychological counseling intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
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. The scale consists of eight items covering ocular function (two items: diplopia and ptosis), bulbar function (three items: speech, chewing, and swallowing), respiratory function (one item), and limb muscle function (two items: personal hygiene and ability to rise from a chair). Each item is scored on a 4-point scale ranging from 0 (normal) to 3 (most severe). Higher scores indicate greater functional impairment. Total scores range from 0 to 24, with higher scores indicating greater disease-related impairment and therefore a worse outcome. 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
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. The MG-QoL15 consists of 15 items encompassing four domains: mobility (9 items), symptoms (3 items), emotional well-being (2 items), and general contentment (1 item). Each item is rated on a 5-point Likert scale ranging from 0 ("not at all") to 4 ("very much"). Total scores range from 0 to 60, with higher scores indicating poorer quality of life and therefore a worse outcome. 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
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:
- Befriend (B), representing interpersonal support and closeness
- Mindfulness (M), representing emotional stability and awareness
- Identity (I), representing self-worth and meaning.
Each domain is assessed using a single self-rated item scored from 0 to 10, with higher total scores indicating better psychological well-being. A total score ≥ 20.5 is considered indicative of favorable mental health status. Accordingly, the mBMI is considered a practical and concise instrument for evaluating psychological health in intervention studies.
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
Change in the indicator of mental health BMI on well-being (PHQ-9) Score from baseline to post-intervention
The PHQ-9 is a nine-item self-administered questionnaire designed to evaluate the frequency of depression-related symptoms experienced during the preceding two weeks. Total scores range from 0 to 27, with higher scores indicating greater severity of de-pressive symptoms. Depression severity can be categorized as minimal (1-4), mild (5-9), moderate (10-14), moderately severe (15-19), and severe (20-27). Higher PHQ-9 scores are associated with greater predictive value and likelihood ratios for major depressive disorder.
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.
- First posted16 Jun 2026
- Study start1 Jan 2024
- Primary completion31 Dec 2025
- Study completion31 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Myasthenia GravisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- All participants were enrolled into a single study group and received the same eight sessions of Gestalt-oriented psychological counseling. Pre-test and post-test assessments were completed by participants to measure psychological outcomes.
- Masking
- None (open label)
- Enrolment
- 19 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ming-Hsing Chang
- Sponsor type
- University, hospital or other
- Collaborators
- Shin Kong Wu Ho-Su Memorial Hospital
- Responsible party
- Sponsor-investigator, Ming-Hsing Chang, Shin Kong Wu Ho-Su Memorial Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07649187
- Sponsor's protocol ID
- 20230730R
- Other IDs
- 2024SKHCDR001
- Status last verified
- Jun 2026
- First submitted
- 4 Dec 2025
- Last updated
- 17 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared because the study involved a small patient population and sensitive psychological counseling-related data, and the informed consent did not include permission for sharing de-identified individual-level data with external researchers.
Publications
Bultz BD, Carlson LE. Emotional distress: the sixth vital sign in cancer care. J Clin Oncol. 2005 Sep 10;23(26):6440-1. doi: 10.1200/JCO.2005.02.3259. No abstract available.
PubMed 16155033Muppidi S, Silvestri NJ, Tan R, Riggs K, Leighton T, Phillips GA. Utilization of MG-ADL in myasthenia gravis clinical research and care. Muscle Nerve. 2022 Jun;65(6):630-639. doi: 10.1002/mus.27476. Epub 2022 Jan 6.
PubMed 34989427Li J, Qi G, Liu Y. Anxiety and depression in thymoma patients in China before surgery. J Cardiothorac Surg. 2022 Dec 16;17(1):313. doi: 10.1186/s13019-022-02081-5.
PubMed 36527139Marbin D, Piper SK, Lehnerer S, Harms U, Meisel A. Mental health in myasthenia gravis patients and its impact on caregiver burden. Sci Rep. 2022 Nov 11;12(1):19275. doi: 10.1038/s41598-022-22078-3.
PubMed 36369246Rodriguez RD, Anderson AEL, Gwathmey KG, Brethenoux CR, Shea LM, Govindarajan R, Souayah N, Peters WD, Jackson LA, Choudhry ZU. Mental Health Experiences and Challenges Among Individuals with Myasthenia Gravis: Insights from Patient-Centered, Qualitative Analyses. Adv Ther. 2025 Dec;42(12):6209-6233. doi: 10.1007/s12325-025-03399-x. Epub 2025 Oct 22.
PubMed 41123841Chang MH, Chang WH, Li YC, Yeh JH. Adverse Childhood Experiences and Psychological Health in Patients with Myasthenia Gravis: A Study Incorporating an Online Positive Mental Health Learning Program. Healthcare (Basel). 2026 Feb 15;14(4):502. doi: 10.3390/healthcare14040502.
PubMed 41754015
Study at a glance
From the registry record, last updated by the sponsor on 17 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Association of Baseline Depressive Tendency With Post-Counseling Clinical Status in Patients With Thymoma-Associated Myasthenia Gravis
- ClinicalTrials.gov ID
- NCT07649187
- Acronym / sponsor ID
- 20230730R
- Conditions
- Myasthenia Gravis, Depression, Thymoma, Depression and Quality of Life, Quality of Life, Activities of Daily Living
- Keywords
- myasthenia gravis, thymoma, depressive tendency, psychological well-being, mental health BMI
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 19 participants (actual)
- Lead sponsor
- Ming-Hsing ChangUniversity, hospital or other
- Collaborators
- Shin Kong Wu Ho-Su Memorial Hospital
- Study start
- 1 Jan 2024 (actual)
- Primary completion
- 31 Dec 2025 (actual)
- Study completion
- 31 Dec 2025 (actual)
- First posted
- 16 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study aimed to examine whether baseline depressive tendency independently predicts post-counseling clinical outcomes in patients with thymoma-associated MG. This single-group pre-post exploratory pilot study enrolled patients with thymoma-associated MG who received eight sessions of Gestalt-oriented psychological counseling. Depressive tendency was defined as a baseline Patient Health Question-naire-9 (PHQ-9) score ≥10. Clinical outcomes, including the Myasthenia Gravis Activities of Daily Living scale (MG-ADL), Myasthenia Gravis Quality of Life 15-item scale (MG-QoL15), and mental BMI (mBMI), were assessed before and after the intervention. Multivariable regression analyses were performed to evaluate whether baseline clinical severity independently predicted post-intervention outcomes after sequential adjustment for baseline scores, age, and sex.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- All participants were enrolled into a single study group and received the same eight sessions of Gestalt-oriented psychological counseling. Pre-test and post-test assessments were completed by participants to measure psychological outcomes.
| Arm | Type | Receives |
|---|---|---|
| Intervention Group | Experimental | Behavioral: Psychological counseling interventionAll participants were enrolled into a single study group and received the same eight sessions of Gestalt-oriented psychological counseling. Pre-test and post-test assessments were completed by participants to measure psychological outcomes. Clinical outcomes, including the Myasthenia Gravis Activities of Daily Living scale (MG-ADL), Myasthenia Gravis Quality of Life 15-item scale (MG-QoL15), and mental BMI (mBMI), were assessed before and after the intervention. |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- A confirmed diagnosis of MG associated with thymoma and prior completion of surgical treatment
- Age ≥ 20 years
- Ability to communicate clearly and provide reliable responses
- Absence of cognitive impairment or severe psychiatric illness that could interfere with participation
- Willingness to participate in the study with provision of written informed consent
Key exclusion criteria (4 listed)
- The absence of a confirmed diagnosis of myasthenia gravis
- Failure to confirm thymoma on postoperative pathological examination
- Inability to communicate adequately in Mandarin, Taiwanese, English, or written form
- The presence of conditions that could compromise verbal communication or regular participation in counseling sessions, such as significant traumatic brain injury, severe psychiatric disorders, or cognitive impairment
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Psychological counseling interventionThe psychological counseling intervention was primarily based on Gestalt therapy, emphasizing awareness and expression of suppressed emotions and resolution of unfinished emotional experiences. It also incorporated Somatic Experiencing techniques to enhance bodily awareness, release tension, and support emotional regulation and psychological well-being. Each participant received eight individualized face-to-face sessions, delivered weekly or biweekly, with each session lasting approximately 60 minutes. Sessions were conducted by licensed counseling psychologists in a private consultation setting. No audio or video recordings were made; session records were encrypted and securely stored. The intervention followed a structured framework consisting of initial, working, and termination phases. Session content and pacing could be adjusted according to individual needs, while the overall therapeutic structure remained consistent across participants. | Behavioural | Intervention Group |
Primary outcome
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. The scale consists of eight items covering ocular function (two items: diplopia and ptosis), bulbar function (three items: speech, chewing, and swallowing), respiratory function (one item), and limb muscle function (two items: personal hygiene and ability to rise from a chair). Each item is scored on a 4-point scale ranging from 0 (normal) to 3 (most severe). Higher scores indicate greater functional impairment. Total scores range from 0 to 24, with higher scores indicating greater disease-related impairment and therefore a worse outcome. 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.
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. The MG-QoL15 consists of 15 items encompassing four domains: mobility (9 items), symptoms (3 items), emotional well-being (2 items), and general contentment (1 item). Each item is rated on a 5-point Likert scale ranging from 0 ("not at all") to 4 ("very much"). Total scores range from 0 to 60, with higher scores indicating poorer quality of life and therefore a worse outcome. 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.
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. Each domain is assessed using a single self-rated item scored from 0 to 10, with higher total scores indicating better psychological well-being. A total score ≥ 20.5 is considered indicative of favorable mental health status. Accordingly, the mBMI is considered a practical and concise instrument for evaluating psychological health in intervention studies. Scores were collected before the intervention and after completion of the four-unit online program to evaluate changes in psychological well-being.
Change in the indicator of mental health BMI on well-being (PHQ-9) Score from baseline to post-intervention
Time frame: Baseline to 4 months
The PHQ-9 is a nine-item self-administered questionnaire designed to evaluate the frequency of depression-related symptoms experienced during the preceding two weeks. Total scores range from 0 to 27, with higher scores indicating greater severity of de-pressive symptoms. Depression severity can be categorized as minimal (1-4), mild (5-9), moderate (10-14), moderately severe (15-19), and severe (20-27). Higher PHQ-9 scores are associated with greater predictive value and likelihood ratios for major depressive disorder.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jun 2026.
- Background: PubMed 16155033Bultz BD, Carlson LE. Emotional distress: the sixth vital sign in cancer care. J Clin Oncol. 2005 Sep 10;23(26):6440-1. doi: 10.1200/JCO.2005.02.3259. No abstract available.
- Background: PubMed 34989427Muppidi S, Silvestri NJ, Tan R, Riggs K, Leighton T, Phillips GA. Utilization of MG-ADL in myasthenia gravis clinical research and care. Muscle Nerve. 2022 Jun;65(6):630-639. doi: 10.1002/mus.27476. Epub 2022 Jan 6.
- Background: PubMed 36527139Li J, Qi G, Liu Y. Anxiety and depression in thymoma patients in China before surgery. J Cardiothorac Surg. 2022 Dec 16;17(1):313. doi: 10.1186/s13019-022-02081-5.
- Background: PubMed 36369246Marbin D, Piper SK, Lehnerer S, Harms U, Meisel A. Mental health in myasthenia gravis patients and its impact on caregiver burden. Sci Rep. 2022 Nov 11;12(1):19275. doi: 10.1038/s41598-022-22078-3.
- Background: PubMed 41123841Rodriguez RD, Anderson AEL, Gwathmey KG, Brethenoux CR, Shea LM, Govindarajan R, Souayah N, Peters WD, Jackson LA, Choudhry ZU. Mental Health Experiences and Challenges Among Individuals with Myasthenia Gravis: Insights from Patient-Centered, Qualitative Analyses. Adv Ther. 2025 Dec;42(12):6209-6233. doi: 10.1007/s12325-025-03399-x. Epub 2025 Oct 22.
- Background: PubMed 41754015Chang MH, Chang WH, Li YC, Yeh JH. Adverse Childhood Experiences and Psychological Health in Patients with Myasthenia Gravis: A Study Incorporating an Online Positive Mental Health Learning Program. Healthcare (Basel). 2026 Feb 15;14(4):502. doi: 10.3390/healthcare14040502.
- Individual participant dataSharing planned: No. Individual participant data will not be shared because the study involved a small patient population and sensitive psychological counseling-related data, and the informed consent did not include permission for sharing de-identified individual-level data with external researchers.
Related trials for Myasthenia Gravis
Active, not recruitingPhase 3
An Extension Study Evaluating 6-week Treatment Cycles of Rozanolixizumab in Pediatric Study Participants With Generalized Myasthenia Gravis
Generalized Myasthenia Gravis
RecruitingPhase 3
A Study to Evaluate the Efficacy and Safety of Rozanolixizumab in Adult Participants With Ocular Myasthenia Gravis
Ocular Myasthenia Gravis
Active, not recruiting
Effects of Whole-body Electrical Muscle Stimulation Exercise on Adults With Neuromuscular Disease
Neuromuscular Diseases (NMD), Amyotrophic Lateral Sclerosis
RecruitingPhase 3
A Study to Evaluate The Long-Term Safety And Efficacy of Rozanolixizumab in Adult Participants With Ocular Myasthenia Gravis
Ocular Myasthenia Gravis
Recruiting
Holistic Assessment and Remote Digital MONitoring of mYasthenia Gravis Via MyoSense 360
Myasthenia Gravis, Generalized
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Psychological counseling intervention in people with Myasthenia Gravis and Depression, run by Ming-Hsing Chang 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 5 inclusion and 4 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 17 Jun 2026. 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 Myasthenia Gravis Activities of Daily Living (MG-ADL) Score from baseline to post-intervention (time frame: Baseline to 4 months). The study lists 4 primary outcomes in all. 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 NCT07649187, which also lists 6 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 17 Jun 2026.