Clinical trial NCT05763095: Mechanism of Mindfulness Based Online Intervention in Reducing Emotional Distress: Daily Dairy Research
Official title: Mechanism of Mindfulness Based Online Intervention in Reducing Emotional Distress: Daily Dairy Research
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Emotional Distress
Lead sponsor: Peking University
Sponsor class: OTHER
First posted: 2023-03-10
Enrollment: 100
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 three weeks of MIED could promote experiential avoidance.
2. explore experiential avoidance could be a mediation of outcomes of MIED.

Detailed description: 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, no study has examined experiential avoidance as mediator in mindfulness intervention whether in the between-subject or in within-subject level . Therefore, this study uses daily diary research 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: 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 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: Daily changes of experiential avoidance
timeFrame: once a day one week before the intervention; once a day in the first three weeks of the intervention.
measure: Daily changes of anxiety
timeFrame: once a day one week before the intervention; once a day in the first three weeks of the intervention.
measure: Daily changes of depression
timeFrame: once a day one week before the intervention; once a day in the first three weeks of the 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: