The Effects and Mechanisms of Mindfulness Intervention for Emotional Distress

Emotional Disorder Clinical Trial

Official title:

The Effects and Mechanisms of Mindfulness Intervention for Emotional Distress: a Multicenter Randomized Controlled Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05606224
• Other study ID #: NCRC2021M01
• Status: Recruiting
• Phase: N/A
• 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
• 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.

Related Conditions & MeSH terms

• Emotional Disorder

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