Clinical trial NCT06034613: The Effects and Mechanisms of Mindfulness Intervention for Emotional Distress: Daily Interventions and Daily Assessments
Official title: The Effects and Mechanisms of Mindfulness Intervention for Emotional Distress: Daily Interventions and Daily Assessments
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Emotional Distress
Lead sponsor: Peking University
Sponsor class: OTHER
First posted: 2023-09-13
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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.

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.

Primary outcomes:
measure: Daily changes of mindfulness
timeFrame: once per day for 63 days (1 week pre-intervention, 7 weeks during the intervention, 1 week post-intervention)
measure: Daily changes of engaging in everyday life
timeFrame: once per day for 63 days (1 week pre-intervention, 7 weeks during the intervention, 1 week post-intervention)
measure: Daily changes of distress tolerance
timeFrame: once per day for 63 days (1 week pre-intervention, 7 weeks during the intervention, 1 week post-intervention)
measure: Daily changes of excessive emotion behaviors
timeFrame: once per day for 63 days (1 week pre-intervention, 7 weeks during the intervention, 1 week post-intervention)
measure: Daily changes of cognitive flexibility/treating thoughts as thoughts
timeFrame: once per day for 63 days (1 week pre-intervention, 7 weeks during the intervention, 1 week post-intervention)
measure: daily changes of anxiety
timeFrame: once per day for 63 days (1 week pre-intervention, 7 weeks during the intervention, 1 week post-intervention)
measure: daily changes of depression
timeFrame: once per day for 63 days (1 week pre-intervention, 7 weeks during the intervention, 1 week post-intervention)
measure: Daily changes of positive and negative affect
timeFrame: once per day for 63 days (1 week pre-intervention, 7 weeks during the intervention, 1 week post-intervention)
measure: daily stress
timeFrame: once per day for 63 days (1 week pre-intervention, 7 weeks during the intervention, 1 week post-intervention)
Secondary outcomes:
measure: daily stressors
timeFrame: once per day for 63 days (1 week pre-intervention, 7 weeks during the intervention, 1 week post-intervention)
measure: pre-post changes of Five Facet Mindfulness Questionnaire
timeFrame: 1 week before the intervention, 1week after the intervention
measure: pre-post changes of Chinese Perceived Stress Scale
timeFrame: 1 week before the intervention, 1week after the intervention
measure: pre-post changes of 10-item Kessler Psychological Distress Scale
timeFrame: 1 week before the intervention, 1week after the intervention
measure: pre-post changes of the Overall Anxiety Severity and Impairment Scale
timeFrame: 1 week before the intervention, 1week after the intervention
measure: pre-post changes of the Overall Depression Severity and Impairment Scale
timeFrame: 1 week before the intervention, 1week after the intervention
measure: pre-post changes of Patient Health Questionnaire during the intervention
timeFrame: 1 week before the intervention, 1week after the intervention
measure: pre-post changes of Distress Tolerance Scale
timeFrame: 1 week before the intervention, 1week after the intervention
measure: pre-post changes of Beck Anxiety Inventory
timeFrame: 1 week before the intervention, 1week after the intervention
measure: pre-post changes of Beck Depression Inventory
timeFrame: 1 week before the intervention, 1week after the intervention
measure: pre-post changes of Athens Insomnia Scale
timeFrame: 1 week before the intervention, 1week after the intervention
measure: pre-post changes of engaging in everyday life
timeFrame: 1 week before the intervention, 1week after the intervention
measure: pre-post changes of treating thoughts as thoughts/cognitive flexibility
timeFrame: 1 week before the intervention, 1week after the intervention
measure: pre-post changes of the Brief Experiential Avoidance Questionnaire
timeFrame: 1 week before the intervention, 1week after the intervention
measure: pre-post changes of the Rumination sub-scale
timeFrame: 1 week before the intervention, 1week after the intervention
Other outcomes:
Locations:
Study officials:
affiliation: School of Psychological and Cognitive Sciences, Peking University
name: Xinghua Liu
role: PRINCIPAL_INVESTIGATOR
References: