Mechanism of Mindfulness Based Online Intervention in Reducing Emotional Distress

NCT05600790 | Unknown

• 1 other identifier: E20221107
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 1

Brief Summary

This study hopes to:

1. 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. 2.explore the impact of mindfulness intervention on intimate relationships in the eastern culture under the intimate relationship interaction model.
3. 3.explore and propose the level of personality functioning could be a moderator of outcomes of MIED.

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; 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; 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; 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; 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; 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; 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; 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; after the 7-week intervention

Secondary Outcomes (14)

• Moderation effect and possible changes of the Levels of Personality Functioning-Brief Form 2.0 during the intervention

  pre-intervention; after the 3rd week intervention; after the 5rd week intervention; after the 7-week intervention

• Moderation effect and possible changes of Personality Functioning Subscale of the Chinese Personality Organization Inventory during the intervention

  pre-intervention; after the 3rd week intervention; after the 5rd week intervention; after the 7-week intervention

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

  pre-intervention; after the 1st week intervention; after the 2nd week intervention; after the 3rd week intervention

• Weekly changes of Interpersonal Mindfulness Scale during the intervention

  pre-intervention; after the 3rd week intervention; after the 5rd week intervention; after the 7-week intervention

• Weekly changes of Philadelphia Mindfulness Scale-Chinese Version during the intervention

  pre-intervention; after the 3rd week intervention; after the 5rd week intervention; after the 7-week intervention

Study Arms (2)

the MIED+TAU group

EXPERIMENTAL

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.

Behavioral: Mindfulness Intervention for Emotional Distress

the TAU-only group

NO INTERVENTION

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

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+TAU 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;
• Subjects at risk of suicide.

Sponsors & Collaborators

• Peking University: lead

Study Sites (1)

Peking University

Beijing, Beijing Municipality, 100871, China

Location

Study Officials

• Xinghua Liu

  School of Psychological and Cognitive Sciences, Peking University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director

Study Record Dates

• First Submitted: October 24, 2022
• First Posted: November 1, 2022
• Study Start: October 29, 2022
• Primary Completion: February 28, 2023
• Study Completion: February 28, 2023
• Last Updated: November 10, 2022

Record last verified: 2022-11

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)