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Not yet recruiting NCT06919406

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

No phase Interventional Emotional Distress Depression, Anxiety

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Mindfulness Intervention for emotional distress(MIED).
Who it may be relevant to
Registry conditions: Emotional Distress, Depression, Anxiety. Basic parameters: 18 years — 60 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Overview

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.

Interventions

  • Behavioral 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. Ea

Primary outcome measures

  • Daily changes of depression [Time frame: once per day for 63 days (1 week pre-intervention, 7 weeks during the intervention, 1 week post-intervention)]
  • Daily changes of anxiety [Time frame: once per day for 63 days (1 week pre-intervention, 7 weeks during the intervention, 1 week post-intervention)]
  • Daily changes of engaging in everyday life [Time frame: once per day for 63 days (1 week pre-intervention, 7 weeks during the intervention, 1 week post-intervention)]
  • Daily changes of distress tolerance [Time frame: once per day for 63 days (1 week pre-intervention, 7 weeks during the intervention, 1 week post-intervention)]
  • Daily changes of cognitive flexibility [Time frame: once per day for 63 days (1 week pre-intervention, 7 weeks during the intervention, 1 week post-intervention)]
  • Daily changes of treating thoughts as thoughts [Time frame: once per day for 63 days (1 week pre-intervention, 7 weeks during the intervention, 1 week post-intervention)]
  • Daily changes of Experiential Avoidance [Time frame: once per day for 63 days (1 week pre-intervention, 7 weeks during the intervention, 1 week post-intervention)]
  • Daily changes of Emotion [Time frame: once per day for 63 days (1 week pre-intervention, 7 weeks during the intervention, 1 week post-intervention)]
  • Daily changes of mindfulness [Time frame: once per day for 63 days (1 week pre-intervention, 7 weeks during the intervention, 1 week post-intervention)]
  • Daily changes of repeative negative thinking [Time frame: once per day for 63 days (1 week pre-intervention, 7 weeks during the intervention, 1 week post-intervention)]
Secondary outcome measures (12)
  • changes of trait mindfulness [Time frame: 1 week before the intervention, 1 month after the intervention,3 month after the intervention]
  • changes of Psychological Distress [Time frame: 1 week before the intervention, 1 month after the intervention,3 month after the intervention]
  • changes of depression [Time frame: 1 week before the intervention, 1 month after the intervention,3 month after the intervention]
  • changes of anxiety [Time frame: 1 week before the intervention, 1 month after the intervention,3 month after the intervention]
  • changes of Athens Insomnia Scale [Time frame: 1 week before the intervention, 1 month after the intervention,3 month after the intervention]
  • changes of engaging in everyday life [Time frame: 1 week before the intervention, 1 month after the intervention,3 month after the intervention]
  • changes of Brief Experiential Avoidance Questionnaire [Time frame: 1 week before the intervention, 1 month after the intervention,3 month after the intervention]
  • changes of Distress Tolerance Scale [Time frame: 1 week before the intervention, 1 month after the intervention,3 month after the intervention]
  • changes of Overall Anxiety Severity and Impairment Scale [Time frame: 1 week before the intervention, 1 month after the intervention,3 month after the intervention]
  • changes of Overall Depression Severity and Impairment Scale [Time frame: 1 week before the intervention, 1 month after the intervention,3 month after the intervention]
  • changes of treating thoughts as thoughts [Time frame: 1 week before the intervention, the onset of the intervention,1 week after the onset of the intervention,2 week after the onset of the intervention, 1 month after the intervention,3 month after the intervention]
  • changes of Cognitive flexibility Inventory [Time frame: 1 week before the intervention, 1 month after the intervention,3 month after the intervention]

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT06919406 · E20250325

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗