Mechanisms of Mindfulness Intervention：Rumination Behavioral Experiments

NCT06722573 | Not Yet Recruiting

• 1 other identifier: E20241201
• Study Type: interventional
• Target: 160
• Locations: 0 countries
• Sites: N/A

Brief Summary

This study hopes to explore whether the changes in rumination exhibited in behavioral experiments mediates the effects of mindfulness intervention on alleviating emotional distress

Conditions

Emotional Distress

Outcome Measures

Primary Outcomes (7)

• 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; week 3; week 5; immediately after the intervention

• 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; week 3; week 5; immediately after the intervention

• 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; week 3; week 5; immediately after the intervention

• 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; week 3; week 5; immediately after the intervention

• 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; week 3; week 5; immediately after the intervention

• Changes of the Brief State Rumination Inventory during the intervention

  The Brief State Rumination Inventory comprises eight items designed to measure an individual's state rumination tendency at a given moment, encompassing aspects such as the intensity of negative emotions, repetitive thinking, loss of thought control, and the strength of negative affect. The total score, which is derived by summing up the scores of all items, indicates the overall level of the measured construct.

  pre-intervention; week 3; week 5; immediately after the intervention

• Changes of the momentary repetitive negative thinking during the intervention

  momentary repetitive negative thinking measures the "process" characteristics of rumination, which are traits that exist across diagnostic categories. The scale consists of four items (e.g., "Thoughts come to my mind that I would rather not have"). Each item focuses on a core feature of rumination - repetitiveness, intrusiveness, uncontrollability, and disruptiveness. Items are rated on a 7-point Likert scale, where 1 = not at all and 7 = extremely.

  pre-intervention; week 3; week 5; immediately after the intervention

Study Arms (2)

MIED group

EXPERIMENTAL

Mindfulness Intervention for Emotional Distress (MIED) program provides standard audio instructions for mindfulness exercises, introduces 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)-normal version

waitlist control group

NO INTERVENTION

no intervention

Interventions

Mindfulness Intervention for Emotional Distress(MIED)-normal version BEHAVIORAL

Mindfulness Intervention for Emotional Distress (MIED) program provides standard audio instructions for mindfulness exercises, introduces 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.

MIED group

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• \- Subjects with scores greater than 21 on the Kessler Psychological Distress Scale.
• \- Aged 18-55 years old.

You may not qualify if:

• \- 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;
• \- Subjects with schizophrenia or psychotic affective disorder, current organic mental disorder, substance abuse disorder and generalized developmental disorder;
• \- Subjects with high risk of suicide.

Sponsors & Collaborators

• Peking University: lead

Study Officials

• Xinghua Liu

  School of Psychological and Cognitive Sciences, Peking University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Zitong Xin

CONTACT

+86 13718720771; 2201110738@pku.edu.cn

Xinghua Liu

CONTACT

+86 13371669818; xinghua_liu@pku.edu.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director

Study Record Dates

• First Submitted: December 4, 2024
• First Posted: December 9, 2024
• Study Start: December 10, 2024
• Primary Completion: February 20, 2025
• Study Completion: June 10, 2025
• Last Updated: December 9, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share