Clinical trial NCT06722573: Mechanisms of Mindfulness Intervention：Rumination Behavioral Experiments
Official title: Mechanism of Rumination in the Alleviation of Emotional Distress by Mindfulness-Based Interventions: Evidence from Behavioral Experiments
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Emotional Distress
Lead sponsor: Peking University
Sponsor class: OTHER
First posted: 2024-12-09
Enrollment: 160
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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

Detailed description: 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

Eligibility criteria: 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.

Primary outcomes:
measure: Changes of Five Facet Mindfulness Questionnaire during the intervention
timeFrame: pre-intervention; week 3; week 5; immediately after the intervention
measure: Changes of 10-item Kessler Psychological Distress Scale during the intervention
timeFrame: pre-intervention; week 3; week 5; immediately after the intervention
measure: Changes of Rumination-Reflection Questionnaire during the intervention
timeFrame: pre-intervention; week 3; week 5; immediately after the intervention
measure: Changes of Overall Anxiety Severity and Impairment Scale during the intervention
timeFrame: pre-intervention; week 3; week 5; immediately after the intervention
measure: Changes of Overall Depression Severity and Impairment Scale during the intervention
timeFrame: pre-intervention; week 3; week 5; immediately after the intervention
measure: Changes of the Brief State Rumination Inventory during the intervention
timeFrame: pre-intervention; week 3; week 5; immediately after the intervention
measure: Changes of the momentary repetitive negative thinking during the intervention
timeFrame: pre-intervention; week 3; week 5; immediately after the intervention
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: School of Psychological and Cognitive Sciences, Peking University
name: Xinghua Liu
role: PRINCIPAL_INVESTIGATOR
References: