Clinical trial · Interventional
Depressive Tendency and Counseling Outcomes in Thymoma-Associated MG
Association of Baseline Depressive Tendency With Post-Counseling Clinical Status in Patients With Thymoma-Associated Myasthenia Gravis
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (6)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Activities of Daily Living | — | UNRESOLVED | — |
| Depression | — | UNRESOLVED | — |
| Depression and Quality of Life | — | UNRESOLVED | — |
| Myasthenia Gravis | — | UNRESOLVED | — |
| Quality of Life | — | UNRESOLVED | — |
| Thymoma | Thymoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Psychological counseling intervention | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Intervention Group
- 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. 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.
- interventionNames
- Behavioral: Psychological counseling intervention
Primary outcomes (4)
- measure
- Change in Myasthenia Gravis Activities of Daily Living (MG-ADL) Score from baseline to post-intervention
- timeFrame
- Baseline to 4 months
- description
- 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.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 20 Years
Show eligibility criteria text
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
References
Publications (6)
- BACKGROUNDBultz 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
- BACKGROUNDMuppidi 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
- BACKGROUNDLi 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
- BACKGROUNDMarbin 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
- BACKGROUNDRodriguez 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
- BACKGROUNDChang 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