Clinical trial NCT05891015: The Mechanism of Mindfulness Intervention to Alleviate Emotional Distress in Patients With Emotional Disorders
Official title: Exploring the Mechanism of Mindfulness Intervention to Alleviate Emotional Distress in Patients With Emotional Disorders
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Emotional Distress
Emotional Disorder
Lead sponsor: Peking University
Sponsor class: OTHER
First posted: 2023-06-06
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: TREATMENT

Brief summary: This study hopes to:

1. explore whether offline and online mindfulness interventions can significantly alleviate individual emotional distress,experiential avoidance and improve cognitive flexibility,distress tolerance level.
2. explore whether cognitive flexibility, distress tolerance and experiential avoidance are the mediators in mindfulness intervention to alleviate emotional distress, and to meet the principles of mechanism.

Detailed description: Cognitive flexibility is a component of executive function, which refers to the ability to transform cognitive models to adapt to changing environmental needs.Empirical avoidance refers to an individual's resistance to experience or attempts to eliminate certain experiences (such as emotions, thoughts, physical sensations, memories, behavioral tendencies, etc.) and attempts to adopt corresponding strategies to change these experiences and the situations in which they are generated. Distress tolerance to negative emotions is considered to be one of the most important cross-diagnostic predictors of emotional distress.

Studies have shown that people with less cognitive flexibility are less effective at using cognitive restructuring techniques to alleviate emotional distress than those with better cognitive flexibility, which seems to predict the level of cognitive flexibility. Cognitive flexibility levels at the three-month follow-up period were significantly negatively correlated with depression levels and suicidal ideation, and higher levels of cognitive flexibility at baseline significantly predicted lower levels of depression and suicidal ideation in military personnel at the three-month follow-up period. Task switching task was used to measure emotional cognitive flexibility, and explored whether individual differences in cognitive flexibility predicted higher levels of trait anxiety and worry within seven weeks. The results showed that emotional cognitive flexibility in the baseline period seemed to predict anxiety and worry levels after seven weeks.

There is a significant positive correlation between mindfulness and cognitive flexibility. One study compared the changes of cognitive flexibility between the mindfulness based cognitive therapy (MBCT) intervention group and the waiting control group in a randomized controlled study of patients with mild to moderate depression. The results showed that the self-reported cognitive flexibility of the MBCT intervention group was significantly higher than that of the waiting control group, and was significantly correlated with the relief of depressive symptoms.

Some reviews suggest that empirical avoidance is one of the mechanisms for the beneficial effects of mindfulness. Some cross-sectional studies suggest that reduced empirical avoidance is an important mediating factor in the mindfulness to psychopathology pathway, a recent cross-sectional study tested the scales of mindfulness, experiential avoidance and anxiety among college students, and the results showed that experiential avoidance could significantly mediate the relationship between trait mindfulness and anxiety, while trait mindfulness could not mediate the relationship between experiential avoidance and anxiety.

Some distress tolerance related variables, such as uncertainty tolerance and experiential avoidance, were found to mediate between mindfulness or mindfulness interventions and emotional distress.

Generally speaking, exploring the mechanism of the effect of mindfulness-based intervention on emotional distress is helpful to strengthen the positive components of the intervention to optimize the therapeutic effect, distinguish the specificity of treatment from the broader non-specific effect, promote the identification of therapeutic regulators and the matching of therapeutic individuals, and provide information for theoretical development and interpretation of results. With the rapid development of online projects and online platforms, online mindfulness courses begin to receive more and more attention, and show a good application prospect. However, there are few studies on online mindfulness courses at present. In order to better understand the effectiveness of online mindfulness courses, more randomized controlled trials need to be done in the future. Therefore, this study will explore the effect of mindfulness intervention on emotional distress and the mechanism of cognitive flexibility, empirical avoidance and distress tolerance based on the basic criterion to judge the mechanism of psychological intervention.

Eligibility criteria: Inclusion Criteria:

* Subjects with scores greater than 21 on the Kessler Psychological Distress Scale.
* Subjects have been diagnosed emotional disorders in the past 6 months.

Exclusion Criteria:

* Subjects who could not access the Internet;
* Subjects with insufficient Chinese ability;
* Subjects who have participated in mindfulness based projects for more than 6 weeks before, and / or the current frequency of meditation practice is more than once a week;
* Patients with schizophrenia or psychotic affective disorder, current organic mental disorder, substance abuse disorder and generalized developmental disorder;
* Subjects at risk of suicide.

Primary outcomes:
measure: Weekly changes of Five Facet Mindfulness Questionnaire during the intervention
timeFrame: pre-intervention; weekly during the 7-week intervention; after the 7-week intervention
measure: Weekly changes of Patient Health Questionnaire during the intervention
timeFrame: pre-intervention; weekly during the 7-week intervention; after the 7-week intervention
measure: Weekly changes of Chinese Perceived Stress Scale during the intervention
timeFrame: pre-intervention; weekly during the 7-week intervention; after the 7-week intervention
measure: Weekly changes of 10-item Kessler Psychological Distress Scale during the intervention
timeFrame: pre-intervention; weekly during the 7-week intervention; after the 7-week intervention
measure: Weekly changes of Overall Anxiety Severity and Impairment Scale during the intervention
timeFrame: pre-intervention; weekly during the 7-week intervention; after the 7-week intervention
measure: Weekly changes of Overall Depression Severity and Impairment Scale during the intervention
timeFrame: pre-intervention; weekly during the 7-week intervention; after the 7-week intervention
measure: Weekly changes of Inner Peace Scale during the intervention
timeFrame: pre-intervention; weekly during the 7-week intervention; after the 7-week intervention
measure: Weekly changes of Athens Insomnia Scale during the intervention
timeFrame: pre-intervention; weekly during the 7-week intervention; after the 7-week intervention
measure: Weekly changes of 16items Chinese Version of the Attentional Control Scale during the intervention
timeFrame: pre-intervention; weekly during the 7-week intervention; after the 7-week intervention
measure: Weekly changes of Cognitive flexibility Inventory during the intervention
timeFrame: pre-intervention; weekly during the 7-week intervention; after the 7-week intervention
measure: Weekly changes of Decentralized Questionnaire during the intervention
timeFrame: pre-intervention; weekly during the 7-week intervention; after the 7-week intervention
measure: Weekly changes of Beck Depression Inventory during the intervention
timeFrame: pre-intervention; weekly during the 7-week intervention; after the 7-week intervention
measure: Weekly changes of Beck Anxiety Inventory during the intervention
timeFrame: pre-intervention; weekly during the 7-week intervention; after the 7-week intervention
measure: Weekly changes of Ruminative Responses Subscale during the intervention
timeFrame: pre-intervention; weekly during the 7-week intervention; after the 7-week intervention
measure: Weekly changes of Emotion Regulation Questionnaire during the intervention
timeFrame: pre-intervention; weekly during the 7-week intervention; after the 7-week intervention
measure: Weekly changes of Automatic thoughts questionnaire during the intervention
timeFrame: pre-intervention; weekly during the 7-week intervention; after the 7-week intervention
measure: Weekly changes of Cognitive biases questionnaire during the intervention
timeFrame: pre-intervention; weekly during the 7-week intervention; after the 7-week intervention
measure: Weekly changes of Thought suppression scale during the intervention
timeFrame: pre-intervention; weekly during the 7-week intervention; after the 7-week intervention
measure: Weekly changes of Chinese version of the Brief Experiential Avoidance Questionnaire during the intervention
timeFrame: pre-intervention; weekly during the 7-week intervention; after the 7-week intervention
measure: Weekly changes of Acceptance and Action Questionnaire-II during the intervention
timeFrame: pre-intervention; weekly during the 7-week intervention; after the 7-week intervention
measure: Weekly changes of Distress Tolerance Scale during the intervention
timeFrame: pre-intervention; weekly during the 7-week intervention; after the 7-week intervention
Secondary outcomes:
measure: Task Switching Task
timeFrame: pre-intervention; weekly during the 7-week intervention; after the 7-week intervention
measure: Image rating task
timeFrame: pre-intervention; weekly during the 7-week intervention; after the 7-week intervention
measure: The Paced Auditory Serial Addition Task-Computerized; PASAT-C
timeFrame: pre-intervention; weekly during the 7-week intervention; after the 7-week intervention
measure: Emotional Image Tolerance Task
timeFrame: pre-intervention; weekly during the 7-week intervention; after the 7-week intervention
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking University
state: Beijing
Study officials:
affiliation: School of Psychological and Cognitive Sciences, Peking University
name: Xinghua Liu
role: PRINCIPAL_INVESTIGATOR
References: