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

NCT06103149 | Unknown

• 1 other identifier: E20231021
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

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.

Conditions

Emotional Distress

Outcome Measures

Primary Outcomes (10)

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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

• 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 Outcomes (2)

• Task Switching Task

  pre-intervention; the third week and fifth week during the 7-week intervention; after the 7-week intervention

• Wisconsin card sorting task

  pre-intervention; the third week and fifth week during the 7-week intervention; after the 7-week intervention

Other Outcomes (1)

• functional Near Infrared Spectroscopy

  pre-intervention; the third week and fifth week during the 7-week intervention; after the 7-week intervention

Study Arms (2)

MIED group

EXPERIMENTAL

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

Behavioral: Mindfulness Intervention for Emotional Distress(MIED)

Waitlist control group

NO INTERVENTION

Interventions

Mindfulness Intervention for Emotional Distress(MIED) BEHAVIORAL

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.

MIED group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Xinghua Liu: lead

Study Sites (1)

Peking University

Beijing, Beijing Municipality, 100871, China

Location

Study Officials

• Xinghua Liu

  School of Psychological and Cognitive Sciences, Peking University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Zhenzhen Wang

CONTACT

13236502311; zhenzhenwang921@outlook.com

Xinghua Liu

CONTACT

13371669818; xinghua_liu@pku.edu.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Director

Study Record Dates

• First Submitted: October 21, 2023
• First Posted: October 26, 2023
• Study Start: October 28, 2023
• Primary Completion: November 20, 2024
• Study Completion: December 24, 2024
• Last Updated: October 26, 2023

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)