Association of Baseline Depressive Tendency With Post-Counseling Clinical Status in Patients With Thymoma-Associated Myasthenia Gravis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 19
- 试验地点
- 1
- 主要终点
- Change in the indicator of mental health BMI on well-being (PHQ-9) Score from baseline to post-intervention
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 盲法
- None
盲法说明
This was an open-label study in which no masking was used. All participants and investigators were aware of the behavioral intervention being provided.
入排标准
- 年龄范围
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
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.
干预措施: Psychological counseling intervention (Behavioral)
结局指标
主要结局
Change in the indicator of mental health BMI on well-being (PHQ-9) Score from baseline to post-intervention
时间窗: 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.
Change in Myasthenia Gravis Activities of Daily Living (MG-ADL) Score from baseline to post-intervention
时间窗: 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
时间窗: 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
时间窗: 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.
次要结局
未报告次要终点
研究者
Ming-Hsing Chang
Attending Physician, Department of Neurology, Shin Kong Wu Ho-Su Memorial Hospital
Shin Kong Wu Ho-Su Memorial Hospital