Mechanism of Mindfulness-Based Online Intervention in Enhancing Cognitive Flexibility: Thoughts as Thoughts
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 595
- 试验地点
- 1
- 主要终点
- Weekly changes of 10-item Kessler Psychological Distress Scale during the intervention
研究概览
简要总结
Traditional offline interventions such as MBCT and MBSR have been implemented to treat patients with emotional disorders and obtained significantly improved clinical outcomes. However, these offline interventions require the involvement of a therapist expert in mindfulness and usually charge a high fee, which may not be accessible and cost-effective for lots of patients with psychological disorders. Fortunately, online self-help interventions can compensate for these disadvantages. Our research team has developed a self-help online mindfulness program targeting emotional distress (i.e., iMIED), which has been effective for individuals with emotional distress in a preliminary study. Since patients with emotional disorders usually suffer from emotional distress, the current study will apply this program to these patients, and investigate its auxiliary effects on patients' psychological and physical health.
The primary aim of the current study is to evaluate the effectiveness of iMIED for patients with emotional disorders. To do so, we will use a design in which patients who receive online mindfulness training (iMIED) except for treatment as usual (TAU) will be compared with patients who receive TAU alone. We expect the intervention to improve patients' psychopathological symptoms reported by the patients and the clinicians or the research team and increase their overall functioning, positive mental health, and physical health compared to TAU. In addition, previous studies have shown that mindfulness interventions improve psychological symptoms by improving cognitive flexibility. Therefore, the secondary aim of the study is to examine the mediating effect of cognitive flexibility on the relationships between mindfulness practice and improvements in outcome variables, and further explore the mechanism behind it.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects with scores greater than 21 on the Kessler Psychological Distress Scale.
排除标准
- •Subjects who could not access the Internet;
- •Subjects with insufficient Chinese ability;
- •Subjects who have participated in mindfulness based projects for more than 6 weeks before, and / or the current frequency of meditation practice is more than once a week;
- •Patients with schizophrenia or psychotic affective disorder, current organic mental disorder, substance abuse disorder and generalized developmental disorder;
- •Subjects at risk of suicide.
结局指标
主要结局
Weekly changes of 10-item Kessler Psychological Distress Scale during the intervention
时间窗: [Time Frame: pre-intervention; weekly during the 7-week intervention; immediately post-intervention]
The 10-item Kessler Psychological Distress Scale is a self-reported questionnaire measuring distress. Scores range from 10 to 50, with higher scores indicating higher levels of distress.
Weekly changes of Overall Anxiety Severity and Impairment Scale during the intervention
时间窗: [Time Frame: pre-intervention; weekly during the 7-week intervention; immediately post-intervention]
The Overall Anxiety Severity and Impairment Scale is a self-reported questionnaire measuring anxiety. Scores range from 0 to 20, with higher scores indicating higher levels of anxiety.
Weekly changes of Overall Depression Severity and Impairment Scale during the intervention
时间窗: [Time Frame: pre-intervention; weekly during the 7-week intervention; immediately post-intervention]
The Overall Depression Severity and Impairment Scale is a self-reported questionnaire measuring depression. Scores range from 0 to 20, with higher scores indicating higher levels of depression.
Weekly changes of Chinese Perceived Stress Scale during the intervention
时间窗: [Time Frame: pre-intervention; weekly during the 7-week intervention; immediately post-intervention]
The Chinese Perceived Stress Scale is a self-reported questionnaire measuring stress. Scores range from 0 to 56, with higher scores indicating higher levels of stress.
Weekly changes of Five Facet Mindfulness Questionnaire - Short Form during the intervention
时间窗: [Time Frame: pre-intervention; weekly during the 7-week intervention; immediately post-intervention]
The Five Facet Mindfulness Questionnaire - Short Form is a self-reported questionnaire measuring mindfulness levels. Scores range from 20 to 100, with higher scores indicating higher levels of mindfulness.
Weekly changes of Athens Insomnia Scale during the intervention
时间窗: [Time Frame: pre-intervention; weekly during the 7-week intervention; immediately post-intervention]
The Athens Insomnia Scale is a self-reported questionnaire measuring sleepy quality. Scores range from 0 to 24, with lower scores indicating higher levels of sleep quality.
Weekly changes of Patient Health Questionnaire during the intervention
时间窗: [Time Frame: pre-intervention; weekly during the 7-week intervention; immediately post-intervention]
The Patient Health Questionnaire is a self-reported questionnaire measuring the degree of being troubled by various common physical symptoms. Scores range from 0 to 30. 0\~4 scores: no physical symptoms; 5\~9 scores: mild physical symptoms; 10\~14 scores: moderate physical symptoms; 15\~30 scores: severe physical symptoms.
次要结局
- Change of Beck Depression Inventory-II([Time Frame: pre-intervention; 3 weeks into intervention; 5 weeks into intervention; immediately post-intervention])
- Change of Beck Anxiety Inventory([Time Frame: pre-intervention; 3 weeks into intervention; 5 weeks into intervention; immediately post-intervention])
- Change of Pittsburgh sleep quality Index([Time Frame: pre-intervention; 3 weeks into intervention; 5 weeks into intervention; immediately post-intervention])
- Change of Insomnia Severity Index([Time Frame: pre-intervention; 3 weeks into intervention; 5 weeks into intervention; immediately post-intervention])
- Change of Interpersonal Reactivity Index-C([Time Frame: pre-intervention; 3 weeks into intervention; 5 weeks into intervention; immediately post-intervention])
- Moderation effect and possible changes of the Emotion Regulation Questionnaire([Time Frame: pre-intervention; 3 weeks into intervention; 5 weeks into intervention; immediately post-intervention])
- Change of Intimacy Check and Evaluation Scale([Time Frame: pre-intervention; 3 weeks into intervention; 5 weeks into intervention; immediately post-intervention])
- Moderation effect and possible changes of the Experience Questionnaire([Time Frame: pre-intervention; 3 weeks into intervention; 5 weeks into intervention; immediately post-intervention])
- Moderation effect and possible changes of the Cognitive Flexibility Inventory([Time Frame: pre-intervention; 3 weeks into intervention; 5 weeks into intervention; immediately post-intervention])
- Moderation effect and possible changes of the Thoughts as Thoughts Scale([Time Frame: pre-intervention; 3 weeks into intervention; 5 weeks into intervention; immediately post-intervention])
- Change of Mindful Attention Awareness Scale([Time Frame: pre-intervention; 3 weeks into intervention; 5 weeks into intervention; immediately post-intervention])
- Change of Quality of Relationship Index([Time Frame: pre-intervention; 3 weeks into intervention; 5 weeks into intervention; immediately post-intervention])
- Moderation effect and possible changes of the Self-Compassion Scale([Time Frame: pre-intervention; 3 weeks into intervention; 5 weeks into intervention; immediately post-intervention])
- Moderation effect and possible changes of the Rumination- Reflection Questionnaire([Time Frame: pre-intervention; 3 weeks into intervention; 5 weeks into intervention; immediately post-intervention])
- Moderation effect and possible changes of the Scale of Life Engagement([Time Frame: pre-intervention; 3 weeks into intervention; 5 weeks into intervention; immediately post-intervention])