Depressive Tendency and Counseling Outcomes in Thymoma-Associated MG

NCT07649187 | Completed

• 2 other identifiers: 20230730R2024SKHCDR001
• Study Type: interventional
• Target: 19
• Locations: 1 country
• Sites: 1

Brief 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 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

Keywords

myasthenia gravis; thymoma; depressive tendency; psychological well-being; mental health BMI

Outcome Measures

Primary Outcomes (4)

• 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.

  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.

  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: 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.

  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.

  Baseline to 4 months

Study Arms (1)

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.

Behavioral: Psychological counseling intervention

Interventions

Psychological counseling intervention BEHAVIORAL

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.

Intervention Group

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Ming-Hsing Chang: lead
• Shin Kong Wu Ho-Su Memorial Hospital: collaborator

Study Sites (1)

Shin Kong Wu Ho-Su Memorial Hospital

Taipei, Taipei, 111045, Taiwan

Location

Related Publications (6)

• 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.

  PMID: 16155033 BACKGROUND

• Muppidi 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.

  PMID: 34989427 BACKGROUND

• Li 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.

  PMID: 36527139 BACKGROUND

• Marbin 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.

  PMID: 36369246 BACKGROUND

• Rodriguez 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.

  PMID: 41123841 BACKGROUND

• Chang 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.

  PMID: 41754015 BACKGROUND

MeSH Terms

Conditions

Myasthenia Gravis; Depression; Thymoma; Psychological Well-Being

Condition Hierarchy (Ancestors)

Paraneoplastic Syndromes, Nervous System; Nervous System Neoplasms; Neoplasms by Site; Neoplasms; Paraneoplastic Syndromes; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Neurodegenerative Diseases; Neuromuscular Junction Diseases; Neuromuscular Diseases; Autoimmune Diseases; Immune System Diseases; Behavioral Symptoms; Behavior; Neoplasms, Complex and Mixed; Neoplasms by Histologic Type; Thymus Neoplasms; Thoracic Neoplasms; Lymphatic Diseases; Hemic and Lymphatic Diseases; Personal Satisfaction

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: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Attending Physician, Department of Neurology, Shin Kong Wu Ho-Su Memorial Hospital

Model Details: 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.

Study Record Dates

• First Submitted: December 4, 2025
• First Posted: June 16, 2026
• Study Start: January 1, 2024
• Primary Completion: December 31, 2025
• Study Completion: December 31, 2025
• Last Updated: June 17, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)