Clinical trial NCT06103149: The Role of Cognitive Flexibility in Mindfulness Intervention: a Functional Near-infrared Spectroscopy Study
Official title: The Role of Cognitive Flexibility in Mindfulness Intervention for Emotional Distress: a Study Based on Functional Near-infrared Spectroscopy (FNIRS)
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Emotional Distress
Lead sponsor: Peking University
Sponsor class: OTHER
First posted: 2023-10-26
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study hopes to:

explore the relationship between mindfulness mediation experiences and emotional distress and cognitive flexibility levels.

explore whether 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.

explore the brain functional characteristics and changes during the mindfulness intervention.

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 relationship between mindfulness experiences and cognitive flexibility. Then, we 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.Futher, this study hopes to explore the brain functional characteristics and changes during the mindfulness intervention.

Eligibility criteria: Inclusion Criteria:

* Subjects with scores greater than 21 on the Kessler Psychological Distress Scale(study 2).
* Subjects with mindfulness experiences (study 1,only test in baseline).

Exclusion Criteria:

study 2:

* 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.

study 1: Subjects who could not access the Internet; Subjects with insufficient Chinese ability; 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 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 Cognitive flexibility Inventory during the intervention
timeFrame: pre-intervention; weekly during the 7-week intervention; after the 7-week intervention
measure: Weekly changes of experiences 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 Emotion Regulation Questionnaire during the intervention
timeFrame: pre-intervention; weekly during the 7-week intervention; after the 7-week intervention
measure: Weekly changes of Rumination-Reflection Questionnaire 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; the third week and fifth week during the 7-week intervention; after the 7-week intervention
measure: Wisconsin card sorting task
timeFrame: pre-intervention; the third week and fifth week during the 7-week intervention; after the 7-week intervention
Other outcomes:
measure: functional Near Infrared Spectroscopy
timeFrame: pre-intervention; the third week and fifth week during the 7-week intervention; after the 7-week intervention
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: