Depressive Tendency and Counseling Outcomes in Thymoma-Associated MG

June 15, 2026 updated by: Ming-Hsing Chang

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

19

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

  • Taiwan
    • 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:

  1. A confirmed diagnosis of MG associated with thymoma and prior completion of surgical treatment
  2. Age ≥ 20 years
  3. Ability to communicate clearly and provide reliable responses
  4. Absence of cognitive impairment or severe psychiatric illness that could interfere with participation
  5. Willingness to participate in the study with provision of written informed consent

Exclusion Criteria:

  1. The absence of a confirmed diagnosis of myasthenia gravis
  2. Failure to confirm thymoma on postoperative pathological examination
  3. Inability to communicate adequately in Mandarin, Taiwanese, English, or written form
  4. 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

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: Supportive Care
  • 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 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
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.

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 (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.
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. 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
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.
Baseline to 4 months
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.
Baseline to 4 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ming-Hsing Chang

Collaborators

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

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 1, 2024

Primary Completion (Actual)

December 31, 2025

Study Completion (Actual)

December 31, 2025

Study Registration Dates

First Submitted

December 4, 2025

First Submitted That Met QC Criteria

June 11, 2026

First Posted (Actual)

June 16, 2026

Study Record Updates

Last Update Posted (Actual)

June 17, 2026

Last Update Submitted That Met QC Criteria

June 15, 2026

Last Verified

June 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 20230730R
  • 2024SKHCDR001 (Other Grant/Funding Number: Shin Kong Wu Ho-Su Memorial Hospital)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

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.

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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