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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05606224
Other study ID # NCRC2021M01
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date February 20, 2022
Est. completion date August 30, 2023

Study information

Verified date November 2022
Source Peking University
Contact Yanjuan Li
Phone +86 15992425499
Email Lyjanice@stu.pku.edu.cn
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 200
Est. completion date August 30, 2023
Est. primary completion date August 30, 2023
Accepts healthy volunteers No
Gender All
Age group 18 Years to 65 Years
Eligibility Inclusion Criteria: - 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. Exclusion Criteria: - 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


Related Conditions & MeSH terms


Intervention

Behavioral:
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.

Locations

Country Name City State
China Beijing Anding Hospital Beijing Beijing
China Beijing Tiantan Hospital Beijing Beijing
China Fosha Mental Health Center Foshan Guangdong
China Nanjing Brain Hospital Nanjing Jiangsu

Sponsors (5)

Lead Sponsor Collaborator
Peking University Beijing Tiantan Hospital, Capital Medical University, Foshan Mental Health Center, Nanjing Brian Hospital

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary Change of mindfulness 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 at baseline (T0), at week 3(T1) and at week 5 (T2), at post-intervention (T3), and at 3 (T4) months follow-ups
Primary Change of other-reported anxiety Hamilton Anxiety Rating Scale, assessed by the clinicians, scores range from 0 to 56, higher scores indicate higher levels of anxiety at baseline (T0), at post-intervention (T3), and at 3 (T4) months follow-ups
Primary Change of other-reported depression Hamilton Depression Rating Scale, assessed by the clinicians, scores range from 0 to 68, higher scores indicate higher levels of depression at baseline (T0), at post-intervention (T3), and at 3 (T4) months follow-ups
Primary Change of self-reported depression Beck Depression Inventory-II, self-report, scores range from 0 to 63, higher scores indicate higher levels of depression at baseline (T0), at week 3(T1) and at week 5 (T2), at post-intervention (T3), and at 3 (T4) months follow-ups
Primary Change of self-reported anxiety symptoms Beck Anxiety Inventory, self-report, scores range from 0 to 63, higher scores indicate higher levels of anxiety at baseline (T0), at week 3(T1) and at week 5 (T2), at post-intervention (T3), and at 3 (T4) months follow-ups
Primary Change of psychological distress 10-item Kessler Psychological Distress Scale, self-report, scores range from 5 to 50, higher scores indicate higher levels 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
Primary Change of inner peace Inner Peace Scale, self-report, scores range from 0 to 28, higher scores indicate higher levels 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
Primary Change of perceived stress Chinese Perceived Stress Scales, self-report, scores range from 0 to 28, higher scores indicate higher levels 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
Primary Change of sleep quality Pittsburgh Sleep Quality Index, self-report, scores range from 0 to 21, higher scores indicate worse 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
Primary Change of Depression Severity and Impairment Overall Depression Severity and Impairment Scale, self-report, scores range from 0 to 20, higher scores indicate higher levels 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
Primary Change of Anxiety Severity and Impairment Overall Anxiety Severity and Impairment Scale, self-report, scores range from 0 to 20, higher scores indicate higher levels 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
Primary Change of somatic symptoms Patient Health Questionnaire-15, self-report, scores range from 0 to 30 higher scores indicate higher levels 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
Primary Change of distress tolerance The Chinese version of the Distress Tolerance Scale, self-report, scores range from 15 to 75 higher scores indicate higher levels 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
Primary Change of Intolerance of Uncertainty Intolerance of Uncertainty -Short form, self-report, scores range from 12 to 60, higher scores indicate higher levels 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
Primary Change of experiential avoidance Brief Experience Avoidance Questionnaire, self-report, scores range from 15 to 75 higher scores indicate higher levels 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
Primary Change of attention control Attention Control Scale, self-report, scores range from 16 to 64 higher scores indicate higher levels 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
Primary Change of Cognitive Flexibility Cognitive Flexibility Inventory, self-report, scores range from 20 to 100, higher scores indicate higher levels 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
Primary Change of discomfort intolerance Discomfort intolerance Scale, self-report, scores range from 0 to 25 higher scores indicate higher levels 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
Secondary Change of distress tolerance (behavioral indicator1) The Paced Auditory Serial Addition Task-Computerized, task persistence as the behavioral indicator of emotional distress at baseline (T0), at week 3(T1) and at week 5 (T2), at post-intervention (T3), and at 3 (T4) months follow-ups
Secondary Change of distress tolerance (behavioral indicator2) 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) at baseline (T0), at week 3(T1) and at week 5 (T2), at post-intervention (T3), and at 3 (T4) months follow-ups
Secondary Change of distress tolerance (behavioral indicator3) Mirror tracing task, task persistence as the behavioral indicator of emotional distress at baseline (T0), at week 3(T1) and at week 5 (T2), at post-intervention (T3), and at 3 (T4) months follow-ups
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