The Role of Cognitive Flexibility in Mindfulness Intervention: a Functional Near-infrared Spectroscopy Study

Emotional Distress Clinical Trial

Official title:

The Role of Cognitive Flexibility in Mindfulness Intervention for Emotional Distress: a Study Based on Functional Near-infrared Spectroscopy (FNIRS)

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06103149
• Other study ID #: E20231021
• Status: Not yet recruiting
• Phase: N/A
• Start date: October 28, 2023
• Est. completion date: December 24, 2024

Study information

• Verified date: October 2023
• Source: Peking University
• Contact: Zhenzhen Wang
• Phone: 13236502311
• Email: zhenzhenwang921[@]outlook.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 200
• Est. completion date: December 24, 2024
• Est. primary completion date: November 20, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Emotional Distress

Intervention

Behavioral:
• Mindfulness Intervention for Emotional Distress(MIED)
The MIED program integrates the rationales and practices from the Unified Protocol for Treatment of Emotional Disorders (UP) and Mindfulness based Interventions. Formal mindfulness exercises (e.g., body scan, mindful breathing, and mindful stretching) and informal mindfulness practices (e.g., mindful tooth brushing) were adapted from Mindfulness based intervention (MBIs). The offline received the 8-week (2.5-h per week) sessions.The online MIED program was delivered by a Chat Mini Program and lasted for 49 days. Each day, participants received different materials including (a) an audio recording of mindfulness meditation guidance; (b) learning materials in text or audio; and (c) assignments (for example, informal mindfulness practice, emotion journal, and challenging tasks). In total, it took about 30 min per day to finish all the tasks.

Locations

Country	Name	City	State
China	Peking University	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Xinghua Liu

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	functional Near Infrared Spectroscopy	Functional Near Infrared Spectroscopy is a non-invasive neuroimaging technology that provides technical support for the detection and analysis of brain blood oxygen signals and can monitor changes in local oxygenated hemoglobin (?[HbO2]) and deoxygenated hemoglobin (?[HHb]) concentrations. It has been widely used in the diagnosis and efficacy evaluation of depression, anxiety, insomnia and other diseases. In the study of brain function related to emotion and cognition in psychiatric disorders, fNIRS has the following advantages: (1) non-invasive, portable and low cost; (2) Excellent temporal resolution and spatial resolution; And (3) Easy to operate, low requirements for subjects.	pre-intervention; the third week and fifth week during the 7-week intervention; after the 7-week intervention
Primary	Weekly changes of Five Facet Mindfulness Questionnaire during the 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.	pre-intervention; weekly during the 7-week intervention; after the 7-week intervention
Primary	Weekly changes of 10-item Kessler Psychological Distress Scale during the 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.	pre-intervention; weekly during the 7-week intervention; after the 7-week intervention
Primary	Weekly changes of Overall Anxiety Severity and Impairment Scale during the 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.	pre-intervention; weekly during the 7-week intervention; after the 7-week intervention
Primary	Weekly changes of Overall Depression Severity and Impairment Scale during the 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.	pre-intervention; weekly during the 7-week intervention; after the 7-week intervention
Primary	Weekly changes of Cognitive flexibility Inventory during the 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.	pre-intervention; weekly during the 7-week intervention; after the 7-week intervention
Primary	Weekly changes of experiences questionnaire during the 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.	pre-intervention; weekly during the 7-week intervention; after the 7-week intervention
Primary	Weekly changes of Beck Depression Inventory during the 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.	pre-intervention; weekly during the 7-week intervention; after the 7-week intervention
Primary	Weekly changes of Beck Anxiety Inventory during the 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.	pre-intervention; weekly during the 7-week intervention; after the 7-week intervention
Primary	Weekly changes of Emotion Regulation Questionnaire during the 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.	pre-intervention; weekly during the 7-week intervention; after the 7-week intervention
Primary	Weekly changes of Rumination-Reflection Questionnaire during the 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.	pre-intervention; weekly during the 7-week intervention; after the 7-week intervention
Secondary	Task Switching Task	The measurement of cognitive flexibility comes from the task switching paradigm, in which participants are required to classify emotional images according to "emotional task rules" or "non-emotional task rules". In emotional task rules, participants are instructed to classify images according to whether the depicted scene is positive or negative. For non-emotional task rules, participants must indicate whether the number of people in the graph is one or none (= 1), or two or more (= 2). Even if there is only a part of a person's body, it counts. The image is taken from the International emotional Image system (International Affective Picture System,IAPS). There are 40 pictures in each category: = 1 person + positive, = 2 + positive, = 1 person + negative, = 2 + negative, a total of 160 pictures. Positive and negative images differ in titer ratings, but are balanced in evocative ratings. Another 20 pictures are used for the practice module.	pre-intervention; the third week and fifth week during the 7-week intervention; after the 7-week intervention
Secondary	Wisconsin card sorting task	The WCST consists of four stimulus cards, each in red, green, blue and yellow colors, with 1 to 4 triangles, stars, crosses or circles. Four of the cards feature a red triangle, two green stars, three yellow crosses, and four blue circles, and a card similar to the one at the top will appear at the bottom of the screen. All you have to do is group the card on the bottom with one on the top, and click on the top four cards that you think are similar to each other to make a choice. After making a choice, a correct or incorrect prompt will appear on the screen, if it is wrong, it does not matter, please try to choose the right choice next time.	pre-intervention; the third week and fifth week during the 7-week intervention; after the 7-week intervention