Clinical trial NCT05606224: The Effects and Mechanisms of Mindfulness Intervention for Emotional Distress
Official title: The Effects and Mechanisms of Mindfulness Intervention for Emotional Distress: a Multicenter Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Emotional Disorder
Lead sponsor: Peking University
Sponsor class: OTHER
Collaborators: name: Nanjing Brian Hospital
name: Capital Medical University
name: Beijing Tiantan Hospital
name: Foshan Mental Health Center
First posted: 2022-11-04
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Change of mindfulness
timeFrame: at baseline (T0), at week 3(T1) and at week 5 (T2), at post-intervention (T3), and at 3 (T4) months follow-ups
measure: Change of other-reported anxiety
timeFrame: at baseline (T0), at post-intervention (T3), and at 3 (T4) months follow-ups
measure: Change of other-reported depression
timeFrame: at baseline (T0), at post-intervention (T3), and at 3 (T4) months follow-ups
measure: Change of self-reported depression
timeFrame: at baseline (T0), at week 3(T1) and at week 5 (T2), at post-intervention (T3), and at 3 (T4) months follow-ups
measure: Change of self-reported anxiety symptoms
timeFrame: at baseline (T0), at week 3(T1) and at week 5 (T2), at post-intervention (T3), and at 3 (T4) months follow-ups
measure: Change of psychological distress
timeFrame: at baseline (T0), at week 3(T1) and at week 5 (T2), at post-intervention (T3), and at 3 (T4) months follow-ups
measure: Change of inner peace
timeFrame: at baseline (T0), at week 3(T1) and at week 5 (T2), at post-intervention (T3), and at 3 (T4) months follow-ups
measure: Change of perceived stress
timeFrame: at baseline (T0), at week 3(T1) and at week 5 (T2), at post-intervention (T3), and at 3 (T4) months follow-ups
measure: Change of sleep quality
timeFrame: at baseline (T0), at week 3(T1) and at week 5 (T2), at post-intervention (T3), and at 3 (T4) months follow-ups
measure: Change of Depression Severity and Impairment
timeFrame: at baseline (T0), at week 3(T1) and at week 5 (T2), at post-intervention (T3), and at 3 (T4) months follow-ups
measure: Change of Anxiety Severity and Impairment
timeFrame: at baseline (T0), at week 3(T1) and at week 5 (T2), at post-intervention (T3), and at 3 (T4) months follow-ups
measure: Change of somatic symptoms
timeFrame: at baseline (T0), at week 3(T1) and at week 5 (T2), at post-intervention (T3), and at 3 (T4) months follow-ups
measure: Change of distress tolerance
timeFrame: at baseline (T0), at week 3(T1) and at week 5 (T2), at post-intervention (T3), and at 3 (T4) months follow-ups
measure: Change of Intolerance of Uncertainty
timeFrame: at baseline (T0), at week 3(T1) and at week 5 (T2), at post-intervention (T3), and at 3 (T4) months follow-ups
measure: Change of experiential avoidance
timeFrame: at baseline (T0), at week 3(T1) and at week 5 (T2), at post-intervention (T3), and at 3 (T4) months follow-ups
measure: Change of attention control
timeFrame: at baseline (T0), at week 3(T1) and at week 5 (T2), at post-intervention (T3), and at 3 (T4) months follow-ups
measure: Change of Cognitive Flexibility
timeFrame: at baseline (T0), at week 3(T1) and at week 5 (T2), at post-intervention (T3), and at 3 (T4) months follow-ups
measure: Change of discomfort intolerance
timeFrame: at baseline (T0), at week 3(T1) and at week 5 (T2), at post-intervention (T3), and at 3 (T4) months follow-ups
Secondary outcomes:
measure: Change of distress tolerance (behavioral indicator1)
timeFrame: at baseline (T0), at week 3(T1) and at week 5 (T2), at post-intervention (T3), and at 3 (T4) months follow-ups
measure: Change of distress tolerance (behavioral indicator2)
timeFrame: at baseline (T0), at week 3(T1) and at week 5 (T2), at post-intervention (T3), and at 3 (T4) months follow-ups
measure: Change of distress tolerance (behavioral indicator3)
timeFrame: at baseline (T0), at week 3(T1) and at week 5 (T2), at post-intervention (T3), and at 3 (T4) months follow-ups
Other outcomes:
Locations:
city: Beijing
country: China
facility: Beijing Anding Hospital
state: Beijing
city: Beijing
country: China
facility: Beijing Tiantan Hospital
state: Beijing
city: Foshan
country: China
facility: Fosha Mental Health Center
state: Guangdong
city: Nanjing
country: China
facility: Nanjing Brain Hospital
state: Jiangsu
Study officials:
affiliation: School of Psychological and Cognitive Sciences, Peking University
name: Xinghua Liu
role: PRINCIPAL_INVESTIGATOR
References: