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NCT Number: NCT06722573

Mechanisms of Mindfulness Intervention:Rumination Behavioral Experiments

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

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Key information

Conditions

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

In recent years, mindfulness-based interventions (MBIs) have seen extensive application in both clinical and non-clinical settings. Studies show that mindfulness training improves emotional regulation and processing, contributing to better emotional health. MBIs have proven effective in reducing anxiety and depression among patients with conditions like multiple sclerosis, enhancing personal well-being, and alleviating chronic pain. Given the mounting evidence supporting its benefits, MBIs have become widely adopted across various settings. Nonetheless, the precise mechanisms through which mindfulness alleviates emotional distress remain poorly understood.

Rumination, a transdiagnostic process, plays a critical role in the development and persistence of emotional distress. Empirical evidence supports the effectiveness of MBIs in reducing rumination. However, the role of rumination in mediating the effects of MBIs on emotional distress remains inconsistent across studies. Kazdin (2007, 2009) outlined criteria for evaluating mechanisms and mediators, yet existing studies lack sufficient evidence to meet these standards. This study aims to explore the mechanistic role of rumination using behavioral experiments, focusing on the consistency criterion

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

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

Treatment and study plan

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.

Primary outcomes

  1. Changes of Five Facet Mindfulness Questionnaire during the intervention

    Time frame: pre-intervention; week 3; week 5; immediately after 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.

  2. Changes of 10-item Kessler Psychological Distress Scale during the intervention

    Time frame: pre-intervention; week 3; week 5; immediately after 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.

  3. Changes of Rumination-Reflection Questionnaire during the intervention

    Time frame: pre-intervention; week 3; week 5; immediately after 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.

  4. Changes of Overall Anxiety Severity and Impairment Scale during the intervention

    Time frame: pre-intervention; week 3; week 5; immediately after 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.

  5. Changes of Overall Depression Severity and Impairment Scale during the intervention

    Time frame: pre-intervention; week 3; week 5; immediately after 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.

  6. Changes of the Brief State Rumination Inventory during the intervention

    Time frame: pre-intervention; week 3; week 5; immediately after 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.

  7. Changes of the momentary repetitive negative thinking during the intervention

    Time frame: pre-intervention; week 3; week 5; immediately after 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Xinghua Liu

CONTACT

[email protected]

+86 13371669818

Zitong Xin

CONTACT

[email protected]

+86 13718720771

Sponsors and collaborators

Lead sponsor

Peking University

Other

Registry information

Official study title

Mechanism of Rumination in the Alleviation of Emotional Distress by Mindfulness-Based Interventions: Evidence from Behavioral Experiments

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Dec 9, 2024
Registry last updated
Dec 9, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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