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Clinical Trials/NCT06051929
NCT06051929
Not yet recruiting
Not Applicable

Mechanism of Mindfulness Intervention for Emotional Distress: the Role of Cognitive Flexibility

Peking University1 site in 1 country200 target enrollmentOctober 20, 2023

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Emotional Distress
Sponsor
Peking University
Enrollment
200
Locations
1
Primary Endpoint
Weekly changes of Overall Anxiety Severity and Impairment Scale during the intervention
Status
Not yet recruiting
Last Updated
2 years ago

Overview

Brief Summary

This study hopes to:

explore whether offline and online mindfulness interventions can significantly alleviate individual emotional distress and improve cognitive flexibility level.

explore whether cognitive flexibility is a mediator 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. 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. 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 based on the basic criterion to judge the mechanism of psychological intervention.

Registry
clinicaltrials.gov
Start Date
October 20, 2023
End Date
April 24, 2024
Last Updated
2 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Peking University
Responsible Party
Principal Investigator
Principal Investigator

Xinghua Liu

Director

Peking University

Eligibility Criteria

Inclusion Criteria

  • Subjects with scores greater than 21 on the Kessler Psychological Distress Scale.

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.

Outcomes

Primary Outcomes

Weekly changes of Overall Anxiety Severity and Impairment Scale during the intervention

Time Frame: pre-intervention; weekly during the 7-week intervention; after the 7-week intervention

The Overall Anxiety Severity and Impairment Scale is a self-reported questionnaire measuring anxiety. Scores range from 0 to 20, with higher scores indicating higher levels of anxiety.

Weekly changes of 10-item Kessler Psychological Distress Scale during the intervention

Time Frame: pre-intervention; weekly during the 7-week intervention; after the 7-week intervention

The 10-item Kessler Psychological Distress Scale is a self-reported questionnaire measuring distress. Scores range from 10 to 50, with higher scores indicating higher levels of distress.

Weekly changes of experiences questionnaire during the intervention

Time Frame: pre-intervention; weekly during the 7-week intervention; after the 7-week intervention

experiences questionnaire is a self-reported questionnaire measuring decentralization ability. Scores range from 20 to 100, with higher scores indicating higher levels of Decentralized ability.

Weekly changes of Beck Depression Inventory during the intervention

Time Frame: pre-intervention; weekly during the 7-week intervention; after the 7-week intervention

Beck Depression Inventory is a self-reported questionnaire measuring depression level.Scores range from 0 to 63, with higher scores indicating higher levels of depression.

Weekly changes of Five Facet Mindfulness Questionnaire during the intervention

Time Frame: pre-intervention; weekly during the 7-week intervention; after the 7-week intervention

The Five Facet Mindfulness Questionnaire is a self-reported questionnaire measuring mindfulness levels. Scores range from 39 to 195, with higher scores indicating higher levels of mindfulness.

Weekly changes of Overall Depression Severity and Impairment Scale during the intervention

Time Frame: pre-intervention; weekly during the 7-week intervention; after the 7-week intervention

The Overall Depression Severity and Impairment Scale is a self-reported questionnaire measuring depression. Scores range from 0 to 20, with higher scores indicating higher levels of depression.

Weekly changes of Cognitive flexibility Inventory during the intervention

Time Frame: pre-intervention; weekly during the 7-week intervention; after the 7-week intervention

Cognitive flexibility Inventory is a self-reported questionnaire measuring Cognitive flexibility level.Scores range from 20 to 100, with higher scores indicating higher levels of Cognitive flexibility.

Weekly changes of Beck Anxiety Inventory during the intervention

Time Frame: pre-intervention; weekly during the 7-week intervention; after the 7-week intervention

Beck Anxiety Inventory is a self-reported questionnaire measuring Anxiety level.Scores range from 0 to 63, with higher scores indicating higher levels of Anxiety.

Weekly changes of Emotion Regulation Questionnaire during the intervention

Time Frame: pre-intervention; weekly during the 7-week intervention; after the 7-week intervention

Emotion Regulation Questionnaire is a self-reported questionnaire measuring cognitive reappraisal level.Scores range from 6 to 42, with higher scores indicating higher levels of cognitive reappraisal ability.

Weekly changes of Rumination-Reflection Questionnaire during the intervention

Time Frame: pre-intervention; weekly during the 7-week intervention; after the 7-week intervention

Rumination-Reflection Questionnaire is a self-reported questionnaire measuring Rumination level.Scores range from 12 to 60, with higher scores indicating higher levels of Rumination.

Secondary Outcomes

  • Task Switching Task(pre-intervention; weekly during the 7-week intervention; after the 7-week intervention)

Study Sites (1)

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