The Mechanism of Mindfulness Intervention to Alleviate Emotional Distress in Patients With Emotional Disorders

NCT ID: NCT05891015

Last Updated: 2023-06-09

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 200 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-06-20
• Study Completion Date: 2025-12-15

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.

Conditions

Emotional Distress; Emotional Disorder

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

MIED+TAU group

Mindfulness Intervention for Emotional Distress (MIED) program provide standard audio instructions for mindfulness exercises, introduce the nature and law of anxiety, depression and other emotions, the source of anxiety, depression and other emotional distress, and the strategies and methods to alleviate emotional distress. These exercises, knowledge and strategies are based on the latest progress in the field of psychological counseling and treatment, and their application in daily life can help alleviate anxiety, depression and other emotional problems.

Group Type: EXPERIMENTAL

Mindfulness Intervention for Emotional Distress(MIED)

Intervention Type: BEHAVIORAL

Mindfulness Intervention for Emotional Distress (MIED) program provide standard audio instructions for mindfulness exercises, introduce the nature and law of anxiety, depression and other emotions, the source of anxiety, depression and other emotional distress, and the strategies and methods to alleviate emotional distress. These exercises, knowledge and strategies are based on the latest progress in the field of psychological counseling and treatment, and their application in daily life can help alleviate anxiety, depression and other emotional problems.

the TAU-only group

treatment as usual (TAU) group consisted of all medicinal and psychological treatments received between baseline and follow-up (about five months). Medicinal treatments included receiving Lorazepam, Olanzapine, Paroxetine Hydrochloride, Sertraline, etc. Psychological treatments included receiving cognitive behavior therapy or psychodynamic therap

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Mindfulness Intervention for Emotional Distress(MIED)

Mindfulness Intervention for Emotional Distress (MIED) program provide standard audio instructions for mindfulness exercises, introduce the nature and law of anxiety, depression and other emotions, the source of anxiety, depression and other emotional distress, and the strategies and methods to alleviate emotional distress. These exercises, knowledge and strategies are based on the latest progress in the field of psychological counseling and treatment, and their application in daily life can help alleviate anxiety, depression and other emotional problems.

Intervention Type: BEHAVIORAL

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Peking University

OTHER

Sponsor Role: lead

Responsible Party

Xinghua Liu

Director

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Xinghua Liu

Role: PRINCIPAL_INVESTIGATOR

School of Psychological and Cognitive Sciences, Peking University

Locations

Peking University

Beijing, Beijing Municipality, China

Countries

China

Central Contacts

Zhenzhen Wang

Role: CONTACT

zhenzhenwang921@outlook.com

13236502311

Xinghua Liu

Role: CONTACT

xinghua_liu@pku.edu.cn

13371669818

Facility Contacts

Xinghua Liu

Role: primary

xinghualiu@pku.edu.cn

13371669818

Other Identifiers

E20230525

Identifier Type: -

Identifier Source: org_study_id