Experiential Avoidance as Mechanism of Mindfulness Based Online Intervention in Reducing Emotional Distress

NCT05789160 | Completed

• 1 other identifier: E20220718
• Study Type: interventional
• Target: 158
• Locations: 1 country
• Sites: 1

Brief Summary

This study hopes to explore whether experiential avoidance could be a mediator between mindfulness-based interventions and emotional distress.

Conditions

Emotional Distress

Outcome Measures

Primary Outcomes (8)

• Weekly changes of Five Facet Mindfulness Questionnaire during the intervention

  The Five Facet Mindfulness Questionnaire is a self-reported questionnaire measuring mindfulness levels. Scores range from 39 to 195, with higher scores indicating higher levels of mindfulness.

  pre-intervention; weekly during the 7-week intervention; immediately after the 7-week intervention

• Weekly changes of Patient Health Questionnaire during the intervention

  The Patient Health Questionnaire is a self-reported questionnaire measuring the degree of being troubled by various common physical symptoms. Scores range from 0 to 30. 0\~4 scores: no physical symptoms; 5\~9 scores: mild physical symptoms; 10\~14 scores: moderate physical symptoms; 15\~30 scores: severe physical symptoms.

  pre-intervention; weekly during the 7-week intervention; immediately after the 7-week intervention

• Weekly changes of Chinese Perceived Stress Scale during the intervention

  The Chinese Perceived Stress Scale is a self-reported questionnaire measuring stress. Scores range from 0 to 56, with higher scores indicating higher levels of stress.

  pre-intervention; weekly during the 7-week intervention; immediately after the 7-week intervention

• Weekly changes of 10-item Kessler Psychological Distress Scale during the intervention

  The 10-item Kessler Psychological Distress Scale is a self-reported questionnaire measuring distress. Scores range from 10 to 50, with higher scores indicating higher levels of distress.

  pre-intervention; weekly during the 7-week intervention; immediately after the 7-week intervention

• Weekly changes of Overall Anxiety Severity and Impairment Scale during the intervention

  The Overall Anxiety Severity and Impairment Scale is a self-reported questionnaire measuring anxiety. Scores range from 0 to 20, with higher scores indicating higher levels of anxiety.

  pre-intervention; weekly during the 7-week intervention; immediately after the 7-week intervention

• Weekly changes of Overall Depression Severity and Impairment Scale during the intervention

  The Overall Depression Severity and Impairment Scale is a self-reported questionnaire measuring depression. Scores range from 0 to 20, with higher scores indicating higher levels of depression.

  pre-intervention; weekly during the 7-week intervention; immediately after the 7-week intervention

• Weekly changes of Inner Peace Scale during the intervention

  The Inner Peace Scale is a self-reported questionnaire measuring peace. Scores range from 0 to 28, with higher scores indicating higher levels of peace.

  pre-intervention; weekly during the 7-week intervention; immediately after the 7-week intervention

• Weekly changes of Athens Insomnia Scale during the intervention

  The Athens Insomnia Scale is a self-reported questionnaire measuring sleepy quality. Scores range from 0 to 24, with lower scores indicating higher levels of sleep quality.

  pre-intervention; weekly during the 7-week intervention; immediately after the 7-week intervention

Secondary Outcomes (3)

• Weekly changes of Brief Experiential Avoidance Questionnaire during the intervention

  pre-intervention; weekly during the 7-week intervention; immediately after the 7-week intervention

• Weekly changes of Acceptance and Action Questionnaire-II during the intervention

  pre-intervention; weekly during the 7-week intervention; immediately after the 7-week intervention

• Weekly changes of the Depression Anxiety Stress Scale during the intervention

  pre-intervention; weekly during the 7-week intervention; immediately after the 7-week intervention

Study Arms (2)

the MIED group

EXPERIMENTAL

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.

Behavioral: Mindfulness Intervention for Emotional Distress

the waiting-list group

NO INTERVENTION

no treatment.

Interventions

Mindfulness Intervention for Emotional Distress 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 MIED group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subjects with scores greater than 21 on the Kessler Psychological Distress Scale.

You may not qualify if:

• 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;

Sponsors & Collaborators

• Peking University: lead

Study Sites (1)

Peking University

Beijing, Beijing Municipality, 100871, China

Location

Study Officials

• Xinghua Liu

  Study Principal Investigator

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 10, 2023
• First Posted: March 29, 2023
• Study Start: July 11, 2022
• Primary Completion: October 30, 2022
• Study Completion: October 30, 2022
• Last Updated: March 29, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)