The Effects and Mechanisms of Mindfulness Intervention for Emotional Distress: a Multicenter Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 200
- 试验地点
- 4
- 主要终点
- Change of mindfulness
研究概览
简要总结
Traditional offline interventions such as MBCT and MBSR have been implemented in treating patients with emotional disorders and obtained significantly improved clinical outcome. However, these offline interventions require the involvement of a therapist expertized 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., MIED), which has been demonstrated to be effective for individuals with emotional distress in a preliminary study. Since patients with emotional disorders usually suffered 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 MIED for patients with emotional disorders. To do so, we will use a design in which patients who receive online mindfulness training (MIED) 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 through improving cognitive flexibility, distress tolerance, intolerance of uncertainty, and experiential avoidance. Therefore, the secondary aim of the study is to examine the mediating effect of these factors on the relationships between mindfulness practice and improvements in outcome variables.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Single (Outcomes Assessor)
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
- •Age 18-65;
- •Diagnosis of emotional disorders, including anxiety disorders (e.g., panic disorder, social anxiety disorder, generalized anxiety disorder), and unipolar depression disorders;
- •If taking medication, haven't changed for at least 4 weeks before intervention onset, and no change in medicine is expected;
- •Voluntary participation in this study and sign an informed consent form.
排除标准
- •No access to the internet;
- •Inadequate proficiency in Chinese;
- •Previous participation in mindfulness-based programs longer than 6 weeks, and/or current practice of meditation more than once per week;
- •A history of schizophrenia or schizoaffective disorder, current organic mental disorders, substance abuse disorder, and pervasive developmental disorders;
- •Manifesting with any self-injury or suicidal risks.
结局指标
主要结局
Change of mindfulness
时间窗: at baseline (T0), at week 3(T1) and at week 5 (T2), at post-intervention (T3), and at 3 (T4) months follow-ups
The 20-item Five-Facet Mindfulness Questionnaire-Short Form, self-report, score s range from 20 to 100, higher scores indicate higher levels of mindfulness
Change of other-reported anxiety
时间窗: at baseline (T0), at post-intervention (T3), and at 3 (T4) months follow-ups
Hamilton Anxiety Rating Scale, assessed by the clinicians, scores range from 0 to 56, higher scores indicate higher levels of anxiety
Change of other-reported depression
时间窗: at baseline (T0), at post-intervention (T3), and at 3 (T4) months follow-ups
Hamilton Depression Rating Scale, assessed by the clinicians, scores range from 0 to 68, higher scores indicate higher levels of depression
Change of self-reported depression
时间窗: at baseline (T0), at week 3(T1) and at week 5 (T2), at post-intervention (T3), and at 3 (T4) months follow-ups
Beck Depression Inventory-II, self-report, scores range from 0 to 63, higher scores indicate higher levels of depression
Change of sleep quality
时间窗: at baseline (T0), at week 3(T1) and at week 5 (T2), at post-intervention (T3), and at 3 (T4) months follow-ups
Pittsburgh Sleep Quality Index, self-report, scores range from 0 to 21, higher scores indicate worse sleep quality
Change of Depression Severity and Impairment
时间窗: at baseline (T0), at week 3(T1) and at week 5 (T2), at post-intervention (T3), and at 3 (T4) months follow-ups
Overall Depression Severity and Impairment Scale, self-report, scores range from 0 to 20, higher scores indicate higher levels of depression severity and impairment
Change of self-reported anxiety symptoms
时间窗: at baseline (T0), at week 3(T1) and at week 5 (T2), at post-intervention (T3), and at 3 (T4) months follow-ups
Beck Anxiety Inventory, self-report, scores range from 0 to 63, higher scores indicate higher levels of anxiety
Change of Intolerance of Uncertainty
时间窗: at baseline (T0), at week 3(T1) and at week 5 (T2), at post-intervention (T3), and at 3 (T4) months follow-ups
Intolerance of Uncertainty -Short form, self-report, scores range from 12 to 60, higher scores indicate higher levels of intolerance of uncertainty
Change of Cognitive Flexibility
时间窗: at baseline (T0), at week 3(T1) and at week 5 (T2), at post-intervention (T3), and at 3 (T4) months follow-ups
Cognitive Flexibility Inventory, self-report, scores range from 20 to 100, higher scores indicate higher levels of cognitive flexibility
Change of psychological distress
时间窗: at baseline (T0), at week 3(T1) and at week 5 (T2), at post-intervention (T3), and at 3 (T4) months follow-ups
10-item Kessler Psychological Distress Scale, self-report, scores range from 5 to 50, higher scores indicate higher levels of psychological distress
Change of distress tolerance
时间窗: at baseline (T0), at week 3(T1) and at week 5 (T2), at post-intervention (T3), and at 3 (T4) months follow-ups
The Chinese version of the Distress Tolerance Scale, self-report, scores range from 15 to 75 higher scores indicate higher levels of distress tolerance
Change of attention control
时间窗: at baseline (T0), at week 3(T1) and at week 5 (T2), at post-intervention (T3), and at 3 (T4) months follow-ups
Attention Control Scale, self-report, scores range from 16 to 64 higher scores indicate higher levels of attention control
Change of inner peace
时间窗: at baseline (T0), at week 3(T1) and at week 5 (T2), at post-intervention (T3), and at 3 (T4) months follow-ups
Inner Peace Scale, self-report, scores range from 0 to 28, higher scores indicate higher levels of inner peace
Change of perceived stress
时间窗: at baseline (T0), at week 3(T1) and at week 5 (T2), at post-intervention (T3), and at 3 (T4) months follow-ups
Chinese Perceived Stress Scales, self-report, scores range from 0 to 28, higher scores indicate higher levels of inner peace
Change of Anxiety Severity and Impairment
时间窗: at baseline (T0), at week 3(T1) and at week 5 (T2), at post-intervention (T3), and at 3 (T4) months follow-ups
Overall Anxiety Severity and Impairment Scale, self-report, scores range from 0 to 20, higher scores indicate higher levels of anxiety severity and impairment
Change of somatic symptoms
时间窗: at baseline (T0), at week 3(T1) and at week 5 (T2), at post-intervention (T3), and at 3 (T4) months follow-ups
Patient Health Questionnaire-15, self-report, scores range from 0 to 30 higher scores indicate higher levels of somatic symptoms
Change of experiential avoidance
时间窗: at baseline (T0), at week 3(T1) and at week 5 (T2), at post-intervention (T3), and at 3 (T4) months follow-ups
Brief Experience Avoidance Questionnaire, self-report, scores range from 15 to 75 higher scores indicate higher levels of experiential avoidance
Change of discomfort intolerance
时间窗: at baseline (T0), at week 3(T1) and at week 5 (T2), at post-intervention (T3), and at 3 (T4) months follow-ups
Discomfort intolerance Scale, self-report, scores range from 0 to 25 higher scores indicate higher levels of discomfort intolerance
次要结局
- Change of distress tolerance (behavioral indicator2)(at baseline (T0), at week 3(T1) and at week 5 (T2), at post-intervention (T3), and at 3 (T4) months follow-ups)
- Change of distress tolerance (behavioral indicator1)(at baseline (T0), at week 3(T1) and at week 5 (T2), at post-intervention (T3), and at 3 (T4) months follow-ups)
- Change of distress tolerance (behavioral indicator3)(at baseline (T0), at week 3(T1) and at week 5 (T2), at post-intervention (T3), and at 3 (T4) months follow-ups)
研究者
Xinghua Liu
Director
Peking University