NCT06034613

The Effects and Mechanisms of Mindfulness Intervention for Emotional Distress: Daily Interventions and Daily Assessments

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 100 (estimated)
• Sponsor: Peking University · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

Summary

This clinical trial seeks to uncover the mechanisms behind the effectiveness of mindfulness-based interventions in reducing emotional distress. Using daily diaries to measure both mediating and outcome variables, the study examines whether these mechanisms precede changes in outcomes. It focuses on the Mindfulness Intervention for Emotional Distress program, which includes four strategies. The current study plans to employ a within-subjects design with daily questionnaires over 63 days, before, during and after the intervention. The aim is to gain insights into how mindfulness interventions work in alleviating emotional distress.

Detailed description

An abundance of research studies has demonstrated the potential efficacy of mindfulness-based interventions in alleviating emotional distress among individuals. However, the underlying mechanisms driving these effects have remained largely unknown. Furthermore, many of the mechanistic investigations have not taken into account the temporal precedence, where changes in mechanisms occur prior to changes in outcome variables. To address these gaps, this clinical trial aims to enhance our understanding of the mechanisms behind mindfulness-based interventions for emotional distress. By employing a daily diary approach to measure both mediating and outcome variables, investigators seek to rigorously examine whether the proposed mediating variables adhere to the criterion of temporal precedence. Additionally, utilizing daily diaries allows for the collection of extensive individual-level data. This approach also permits a network analysis perspective to explore the roles of various mechanistic variables in the context of mitigating emotional distress. The present study focuses on the Mindfulness Intervention for Emotional Distress program (liu, in press), comprising four key strategies: 1) Engaging in life to restore a sense of normalcy; 2) Enhancing distress tolerance; 3) Reducing excessive emotional reactivity; 4) Cultivating cognitive flexibility by treating thoughts as mere mental events. Through the implementation of daily diaries, investigators aim to uncover the mechanistic workings of these four strategies. The current study plans to employ a within-subjects design, with participants all receiving mindfulness intervention. They are required to complete daily measurement questionnaires during the week prior to intervention, throughout the intervention period, and for a week following the intervention. The measurement period spans a total of 63 days. Through this study design, investigators aim to gain valuable insights into the mechanisms underpinning the effectiveness of mindfulness interventions in alleviating emotional distress.

Conditions

• Emotional Distress

Interventions

Type	Name	Description
BEHAVIORAL	internet-based mindfulness intervention for emotional distress(iMIED）	The iMIED program integrates the rationales and practices from the UP and MBIs. Formal mindfulness exercises (e.g., body scan, mindful breathing, and mindful stretching) and informal mindfulness practices (e.g., mindful tooth brushing) were adapted from MBIs. In addition, the iMIED program selected several important tasks from the UP, like practicing tolerating uncomfortable feelings by interoceptive exposure practices (e.g., rapid breathing), identifying avoidant behaviors and emotion-driven behaviors and reducing them step by step, identifying common maladaptive automatic thoughts (e.g., overestimating probability and catastrophizing), and using the above strategies in daily life by completing challenging tasks. In total, it took about 30 min per day to finish all the tasks. The program lasted for 49 days.

Timeline

• Start date: 2023-09-18
• Primary completion: 2024-01-31
• Completion: 2024-01-31
• First posted: 2023-09-13
• Last updated: 2023-09-13