Clinical trial NCT05600790: Mechanism of Mindfulness Based Online Intervention in Reducing Emotional Distress
Official title: Mechanism of Mindfulness Based Online Intervention in Reducing Emotional Distress
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Emotional Distress
Lead sponsor: Peking University
Sponsor class: OTHER
First posted: 2022-11-01
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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: 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.

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: Weekly changes of Five Facet Mindfulness Questionnaire during the intervention
timeFrame: pre-intervention; weekly during the 7-week intervention; after the 7-week intervention
measure: Weekly changes of Patient Health Questionnaire during the intervention
timeFrame: pre-intervention; weekly during the 7-week intervention; after the 7-week intervention
measure: Weekly changes of Chinese Perceived Stress Scale during the intervention
timeFrame: pre-intervention; weekly during the 7-week intervention; after the 7-week intervention
measure: Weekly changes of 10-item Kessler Psychological Distress Scale during the intervention
timeFrame: pre-intervention; weekly during the 7-week intervention; after the 7-week intervention
measure: Weekly changes of Overall Anxiety Severity and Impairment Scale during the intervention
timeFrame: pre-intervention; weekly during the 7-week intervention; after the 7-week intervention
measure: Weekly changes of Overall Depression Severity and Impairment Scale during the intervention
timeFrame: pre-intervention; weekly during the 7-week intervention; after the 7-week intervention
measure: Weekly changes of Inner Peace Scale during the intervention
timeFrame: pre-intervention; weekly during the 7-week intervention; after the 7-week intervention
measure: Weekly changes of Athens Insomnia Scale during the intervention
timeFrame: pre-intervention; weekly during the 7-week intervention; after the 7-week intervention
Secondary outcomes:
measure: Moderation effect and possible changes of the Levels of Personality Functioning-Brief Form 2.0 during the intervention
timeFrame: pre-intervention; after the 3rd week intervention; after the 5rd week intervention; after the 7-week intervention
measure: Moderation effect and possible changes of Personality Functioning Subscale of the Chinese Personality Organization Inventory during the intervention
timeFrame: pre-intervention; after the 3rd week intervention; after the 5rd week intervention; after the 7-week intervention
measure: Weekly changes of Acceptance and Action Questionnaire-II during the first three weeks of intervention during the intervention
timeFrame: pre-intervention; after the 1st week intervention; after the 2nd week intervention; after the 3rd week intervention
measure: Weekly changes of Interpersonal Mindfulness Scale during the intervention
timeFrame: pre-intervention; after the 3rd week intervention; after the 5rd week intervention; after the 7-week intervention
measure: Weekly changes of Philadelphia Mindfulness Scale-Chinese Version during the intervention
timeFrame: pre-intervention; after the 3rd week intervention; after the 5rd week intervention; after the 7-week intervention
measure: Weekly changes of Attention-Related Cognitive Errors Scale during the intervention
timeFrame: pre-intervention; after the 3rd week intervention; after the 5rd week intervention; after the 7-week intervention
measure: Weekly changes of Mind-Wandering Questionnaire during the intervention
timeFrame: pre-intervention; after the 3rd week intervention; after the 5rd week intervention; after the 7-week intervention
measure: Weekly changes of Parter Acceptance Scale during the intervention
timeFrame: pre-intervention; after the 3rd week intervention; after the 5rd week intervention; after the 7-week intervention
measure: Weekly changes of Test of Self-Conscious Affect-3 during the intervention
timeFrame: pre-intervention; after the 3rd week intervention; after the 5rd week intervention; after the 7-week intervention
measure: Weekly changes of Brief Experiential Avoidance Questionnaire during the first three weeks of intervention
timeFrame: pre-intervention; after the 1st week intervention; after the 2nd week intervention; after the 3rd week intervention
measure: Weekly changes of Couples Satisfaction Index during the intervention
timeFrame: pre-intervention; after the 3rd week intervention; after the 5rd week intervention; after the 7-week intervention
measure: Weekly changes of the dichotic listening task during the first three weeks of intervention
timeFrame: pre-intervention; after the 1st week intervention; after the 2nd week intervention; after the 3rd week intervention
measure: Weekly changes of sustained attention response task during the intervention
timeFrame: pre-intervention; after the 3rd week intervention; after the 5rd week intervention; after the 7-week intervention
measure: Weekly changes of The Subjective well-being scale during the intervention
timeFrame: pre-intervention; after the 3rd week intervention; after the 5rd week intervention; after the 7-week intervention
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking University
state: Beijing
Study officials:
affiliation: School of Psychological and Cognitive Sciences, Peking University
name: Xinghua Liu
role: PRINCIPAL_INVESTIGATOR
References: