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

Peking University

Status: Not yet enrolling

Conditions: Emotional Distress

Treatments: Behavioral: internet-based mindfulness intervention for emotional distress(iMIED）

Study type: Interventional

Funder types: Other

Identifiers

NCT06034613

E20230830

Details and patient eligibility

About

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.

Full 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.

Enrollment: 100 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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100 participants in 1 patient group

mindfulness intervention group

Experimental group

Description:

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.

Treatment:

Behavioral: internet-based mindfulness intervention for emotional distress(iMIED）