Temporal Dynamics of Mindfulness Intervention for Emotional Distress: Daily Interventions and Assessments

NCT ID: NCT06919406

Last Updated: 2025-04-09

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-04-05
• Study Completion Date: 2025-09-10

Brief Summary

This research aims to adopt a complex systems perspective to thoroughly examine the impact of online mindfulness interventions on changes in emotional distress, with a particular focus on the mechanisms of action. Through a daily diary study design, the study seeks to reveal the complexity and dynamic characteristics of emotional changes and the underlying mechanisms（i.e. distress tolerance， experiential avoidance， cognition flexibility, and life engagement） throughout the intervention process. This research will enrich the theoretical framework of online mental health intervention and provide empirical evidence for optimizing online intervention strategies.

Detailed Description

Emotional distress refers to psychological discomfort related to emotions-particularly anxiety and depression-as well as the associated suffering and impairments in work and daily life. According to a Gallup survey, approximately one-third of the global population experiences emotional distress (Daly & Macchia, 2023), with depression, anxiety, and anger being the most prominent aspects. Moreover, the distress associated with worry and sadness has increased significantly from 2009 to 2021. Anxiety disorders and depressive disorders are among the most common mental illnesses worldwide (Kessler et al., 2009; World Health Organization, 2017), and depression is the leading cause of suicide (Ferrari et al., 2014). In China, the lifetime prevalence rates for anxiety disorders and depression are approximately 7.5% and 6.8%, respectively (Y. Huang et al., 2019), with only about 0.5% of patients with depression receiving adequate treatment (Lu et al., 2021). Both anxiety and depressive disorders severely restrict psychosocial functioning and adversely affect normal life. Traditional psychotherapy research has largely been limited to phenomenological descriptions, lacking in-depth exploration of the underlying mechanisms, which in turn constrains the optimization and effectiveness of interventions.

The theories and methods from the field of complex systems can help overcome these limitations by providing a deeper theoretical framework and analytical tools for studying the processes and mechanisms underlying psychotherapeutic effects. In recent years, network analysis and dynamic systems research on psychological interventions for anxiety and depressive disorders have gradually advanced. However, most current studies collect data only before and after the intervention, paying little attention to the dynamic changes during the intervention period and the long-term impact during follow-up. At the network element level, most studies focus on symptom networks, with few incorporating mechanistic variables into their models. Understanding the mechanisms of intervention effects is critical, and this requires including more mechanistic variables in the analysis framework. In conjunction with dynamic systems theory, it is possible to further explore state transitions and their early warning signals. Although early warning signals theoretically hold the potential to predict sudden changes, their practical sensitivity and specificity still need to be improved in order to provide more reliable information for clinical practice.

In summary, existing research suggests that complex network methods hold potential value in clinical practice, warranting further exploration. However, current findings are insufficient to fully and deeply reveal the specific processes underlying psychotherapeutic effects (Holmes et al., 2018). Moreover, the practical utility of complex network methods in clinical settings remains to be verified (Contreras et al., 2019; Schreuder et al., 2023). This is particularly true in the field of mindfulness interventions, where research in this area is still lacking. By adopting a complex systems perspective, incorporating intensive longitudinal measurements, and including mechanistic variables（i.e. distress tolerance， experiential avoidance， cognition flexibility, and life engagement）, this study aims to explore feedback loops with temporal dynamic characteristics. Such an approach will enable researchers to gain a more comprehensive and in-depth understanding of the complexity and dynamics involved in the alleviation of emotional distress such as anxiety and depression.

Conditions

Emotional Distress; Depression, Anxiety

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

MBIs Group

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.

Group Type: EXPERIMENTAL

Mindfulness Intervention for emotional distress(MIED）

Intervention Type: BEHAVIORAL

MIED is an eight-week program developed based on MBSR and the Unified Protocol for Transdiagnostic Treatment of Emotional Disorders. MIED consists of weekly group sessions with daily interactive materials delivered via a WeChat-based mini-program. The group sessions, conducted online, provide structured content and interactive discussions aligned with the weekly themes, for example including psychoeducation on mindfulness, emotions, and emotional distress. 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).

Interventions

Mindfulness Intervention for emotional distress(MIED）

MIED is an eight-week program developed based on MBSR and the Unified Protocol for Transdiagnostic Treatment of Emotional Disorders. MIED consists of weekly group sessions with daily interactive materials delivered via a WeChat-based mini-program. The group sessions, conducted online, provide structured content and interactive discussions aligned with the weekly themes, for example including psychoeducation on mindfulness, emotions, and emotional distress. 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).

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• Subjects with scores greater than 21 on the Kessler Psychological Distress Scale.

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Peking University

OTHER

Sponsor Role: lead

Responsible Party

Xinghua Liu

Associate Dean

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Xinghua Liu

Role: PRINCIPAL_INVESTIGATOR

School of Psychological and Cognitive Sciences, Peking University

Central Contacts

Mo Chen

Role: CONTACT

514100919@qq.com

+86 18950308693

Xinghua Liu

Role: CONTACT

xinghua_liu@pku.edu.cn

+86 13371669818

Other Identifiers

E20250325

Identifier Type: -

Identifier Source: org_study_id