The Effects and Mechanisms of Mindfulness Intervention for Emotional Distress
- Conditions
- Emotional Disorder
- Interventions
- Behavioral: internet-based mindfulness intervention for emotional distress
- Registration Number
- NCT05606224
- Lead Sponsor
- Peking University
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 200
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description iMIED+TAU: internet-based mindfulness intervention for emotional distress plus treatment as usual internet-based mindfulness intervention for emotional distress The internet-based self-help version of the Mindfulness Intervention for Emotional Distress (iMIED) program integrates rationales and practices from the UP and MBIs. Formal mindfulness exercises (e.g., body scan, mindful breathing, and mindful stretching) and informal mindfulness practices (e.g., mindful tooth-brushing) were retrieved from MBIs. In addition, iMIED selected several important tasks from the UP, like practicing tolerating uncomfortable feelings by interoceptive exposure practices (e.g., rapid breathing), identifying avoidant behaviors and emotion-driven behaviors and reducing them step by step, identifying common maladaptive automatic thoughts (e.g., overestimating probability and catastrophizing), and using the above strategies in daily life by completing challenging tasks.
- Primary Outcome Measures
Name Time Method Change of mindfulness 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 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
- Secondary Outcome Measures
Name Time Method 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 Emotional Image Tolerance Task, distress persistence as the behavioral indicator of emotional distress (after selecting "quit," the average time participants viewed the slide before moving on to the next slide)
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 The Paced Auditory Serial Addition Task-Computerized, task persistence as the behavioral indicator of emotional distress
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 Mirror tracing task, task persistence as the behavioral indicator of emotional distress
Trial Locations
- Locations (4)
Beijing Tiantan Hospital
🇨🇳Beijing, Beijing, China
Beijing Anding Hospital
🇨🇳Beijing, Beijing, China
Fosha Mental Health Center
🇨🇳Foshan, Guangdong, China
Nanjing Brain Hospital
🇨🇳Nanjing, Jiangsu, China