Clinical trial NCT05789160: Experiential Avoidance as Mechanism of Mindfulness Based Online Intervention in Reducing Emotional Distress
Official title: Experiential Avoidance as Mechanism of Mindfulness Based Online Intervention in Reducing Emotional Distress
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Emotional Distress
Lead sponsor: Peking University
Sponsor class: OTHER
First posted: 2023-03-29
Enrollment: 158
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 explore whether experiential avoidance could be a mediator between mindfulness-based interventions and emotional distress.

Detailed description: The improvement of emotional distress by mindfulness intervention has been supported by a large number of empirical studies. For example, the meta-analysis of the effect of MBSR on people with chronic diseases shows that both anxiety (Hedges' g = 0.47) and depression (Hedges' g = 0.26) in mindfulness intervention group are reduced. Mindfulness-based interventions also have good intervention effect on anxiety (Hedges' g = 0.67) and depression (Hedges' g = 0.48) in the general population. Unfortunately, few studies have used the correct methods to test the mechanism of mindfulness-based interventions in mediation analysis or experiments.

Experiential avoidance refers to the unwillingness to keep in touch with specific personal experiences (such as physical feelings, emotions, thinking, memory, and behavioral tendencies), and to take measures to change the form or frequency of these experiences, as well as the situations that trigger these experiences. Experiential avoidance often has only a short-term effect, but it has no effect in the long run, and may even be unfavorable. The paradox of experiential avoidance is that trying to hide or suppress unpleasant thoughts, feelings and physical feelings will increase the frequency and pain of these same experiences, and will enhance the feeling that they are unreal or out of touch with themselves. In addition, long-term experiential avoidance will interfere with the fun of being completely immersed in any activity, leading to the reduction of the frequency of positive events and the suppression of positive emotions.

Some reviews believe that experiential avoidance is one of the mechanisms of beneficial effects brought by mindfulness. Some cross-sectional studies show that the reduction of empirical avoidance is an important intermediary factor in the path of mindfulness to psychopathology . However, no research has directly tested the mediating role of experiential avoidance in mindfulness-based intervention to alleviate emotional distress, which is also the problem that this study wants to explore. According to Kazdin(2007), in order to prove the timeline principle, that is, the change of experiential avoidance is before the change of emotional distress, we will measure the above variables every week during the 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;

Primary outcomes:
measure: Weekly changes of Five Facet Mindfulness Questionnaire during the intervention
timeFrame: pre-intervention; weekly during the 7-week intervention; immediately after the 7-week intervention
measure: Weekly changes of Patient Health Questionnaire during the intervention
timeFrame: pre-intervention; weekly during the 7-week intervention; immediately 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; immediately 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; immediately 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; immediately 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; immediately after the 7-week intervention
measure: Weekly changes of Inner Peace Scale during the intervention
timeFrame: pre-intervention; weekly during the 7-week intervention; immediately after the 7-week intervention
measure: Weekly changes of Athens Insomnia Scale during the intervention
timeFrame: pre-intervention; weekly during the 7-week intervention; immediately after the 7-week intervention
Secondary outcomes:
measure: Weekly changes of Brief Experiential Avoidance Questionnaire during the intervention
timeFrame: pre-intervention; weekly during the 7-week intervention; immediately after the 7-week intervention
measure: Weekly changes of Acceptance and Action Questionnaire-II during the intervention
timeFrame: pre-intervention; weekly during the 7-week intervention; immediately after the 7-week intervention
measure: Weekly changes of the Depression Anxiety Stress Scale during the intervention
timeFrame: pre-intervention; weekly during the 7-week intervention; immediately after the 7-week intervention
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking University
state: Beijing
Study officials:
affiliation: Study Principal Investigator
name: Xinghua Liu
role: PRINCIPAL_INVESTIGATOR
References: