Mechanism of Mindfulness Based Online Intervention in Reducing Emotional Distress

NCT ID: NCT05600790

Last Updated: 2022-11-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

300 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-10-29

Study Completion Date

2023-02-28

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

This study hopes to:

1. explore whether, at the individual level, the improvement of mindfulness ability can promote peace of mind, reduce the frequency of mental wandering, weaken or cut off the cycle between negative mood and mind wandering, and improve the individual's attention monitoring ability and ability to engage in the present.
2. explore the impact of mindfulness intervention on intimate relationships in the eastern culture under the intimate relationship interaction model.
3. explore and propose the level of personality functioning could be a moderator of outcomes of MIED.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Mind Wandering is the conscious experience when an individual's attention shifts from an ongoing task or external environment to an internal thought stream unrelated to tasks and external stimuli. Mind wandering is closely related to attention and emotion. Frequent mental wandering and negative emotions, especially depression and anxiety, are positively correlated (Smallwood et al., 2009). Mindfulness and mind wandering are essentially a state of consciousness. Trait mind wandering is a general tendency of individuals, representing the overall level of individual mind wandering. Mindfulness training can improve the level of mindfulness, and individuals are more involved in the present; This study hopes to explore whether, at the individual level, the improvement of mindfulness ability can promote peace of mind, reduce the frequency of mental wandering, weaken or cut off the cycle between negative mood and mind wandering, and improve the individual's attention monitoring ability and ability to engage in the present.

Some findings suggest that higher levels of mindfulness are associated with relationship outcomes between partners (Barnes, Brown, Krusemark, Campbell \& Rogge, 2007). This paper aims to explore the impact of mindfulness intervention on intimate relationships in the eastern culture under the intimate relationship interaction model. The selected research objects were: emotionally troubled individuals who were not satisfied with the intimate relationship or marriage relationship, usually one of the parties in the intimate relationship, no matter male or female, no matter sexual orientation; The group received a 49-day Mindfulness Intervention for Emotional Distress (MIED), and the effect of detection.

Increasing evidence has demonstrated the positive effects of mindfulness-based interventions on a range of outcomes, including reducing depression and anxiety on a group level. However, rare research has identified who would most likely benefit from such interventions, especially when online mindfulness-based interventions have been popular, such as MIED in China. No consistent moderator has been found in terms of personal characteristics, including personal traits (de Vibe et al., 2015; Giluk, 2009; Hanley, 2016; Nyklíček \& Irrmischer, 2017). While the level of personality functioning has been proposed by DSM-5 AMPD and ICD-11 as a dimensional criterion crossing normal personality and personality disorders (Bender, Morey \& Skodol, 2011; Tyrer, Mulder, Kim, \& Crawford, 2019), the current study proposes that it could be a moderator of outcomes of MIED. The results could help to explore the potential mechanism underlying the beneficial effects of the MIED theoretically and guide adaptations of MIED practically.

Experiential avoidance refers to individuals resisting experiences or trying to eliminate certain experiences (such as emotions, thoughts, physical feelings, memory and behavioral tendencies, etc.), and trying to adopt corresponding strategies to change these experiences and the situations in which the experiences are generated (Hayes, Wilson, Gifford, Follette, \& Strosahl, 1996). Experiential avoidance has been proved to be a maintenance factor for many psychological disorders (Boelen \& Reijntjes, 2008), and trying to hide or suppress unpleasant thoughts, feelings and physical feelings will increase the frequency and pain of these same experiences (Gross,1998; Gross,2002; Sloan, 2004; Wegner, 1994). According to some reviews, experiential avoidance is one of the beneficial effects of mindfulness (Brown, Bravo, Roos, \& Pearson, 2015; Shapiro et al., 2006). However, at present, the measurement of experiential avoidance is limited to self-reported questionnaires, lacking objective measurement tools. Therefore, this study uses the dichotic listening task to measure experiential avoidance and explore the role of experiential avoidance as the effective mechanism of mindfulness intervention.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Emotional Distress

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

the MIED+TAU group

Intervention 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.

Group Type EXPERIMENTAL

Mindfulness Intervention for Emotional Distress

Intervention Type BEHAVIORAL

Mindfulness Intervention for Emotional Distress (MIED) program 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.

the TAU-only group

TAU consisted of all medicinal and psychological treatments received between baseline and follow-up (about five months). Medicinal treatments included receiving Lorazepam, Olanzapine, Paroxetine Hydrochloride, Sertraline, etc. Psychological treatments included receiving cognitive behavior therapy or psychodynamic therap

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Mindfulness Intervention for Emotional Distress

Mindfulness Intervention for Emotional Distress (MIED) program 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.

Intervention Type BEHAVIORAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Peking University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Xinghua Liu

Director

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Xinghua Liu

Role: PRINCIPAL_INVESTIGATOR

School of Psychological and Cognitive Sciences, Peking University

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Peking University

Beijing, Beijing Municipality, China

Site Status

Countries

Review the countries where the study has at least one active or historical site.

China

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

E20221107

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

MIndfulness for Students
NCT03669016 UNKNOWN NA