Activities of Daily Living, Depression, Depression and Quality of Life, Myasthenia Gravis, Quality of Life, Thymoma
Conditions
Keywords
myasthenia gravis, thymoma, depressive tendency, psychological well-being, mental health BMI
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.
Interventions
BEHAVIORALPsychological 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.
Sponsors
Ming-Hsing Chang
Shin Kong Wu Ho-Su Memorial Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Masking description
This was an open-label study in which no masking was used. All participants and investigators were aware of the behavioral intervention being provided.
Intervention 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.
Eligibility
Sex/Gender
ALL
Age
20 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Myasthenia Gravis Activities of Daily Living (MG-ADL) Score from baseline to post-intervention | 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 | 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 | 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 | 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. |
Countries
Taiwan
Outcome results
None listed