The Mechanism of Mindfulness Intervention to Alleviate Emotional Distress in Patients With Emotional Disorders

NCT05891015 | Unknown

• 1 other identifier: E20230525
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

This study hopes to:

1. 1.explore whether offline and online mindfulness interventions can significantly alleviate individual emotional distress,experiential avoidance and improve cognitive flexibility,distress tolerance level.
2. 2.explore whether cognitive flexibility, distress tolerance and experiential avoidance are the mediators in mindfulness intervention to alleviate emotional distress, and to meet the principles of mechanism.

Conditions

Emotional Distress; Emotional Disorder

Outcome Measures

Primary Outcomes (21)

• 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

• Weekly changes of 16items Chinese Version of the Attentional Control Scale during the intervention

  6items Chinese Version of the Attentional Control Scale is a self-reported questionnaire measuring attentional control level.Scores range from 16 to 64, with higher scores indicating higher levels of Attentional Control.

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

• Weekly changes of Cognitive flexibility Inventory during the intervention

  Cognitive flexibility Inventory is a self-reported questionnaire measuring Cognitive flexibility level.Scores range from 20 to 100, with higher scores indicating higher levels of Cognitive flexibility.

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

• Weekly changes of Decentralized Questionnaire during the intervention

  Decentralized Questionnaire is a self-reported questionnaire measuring decentralization ability. Scores range from 20 to 100, with higher scores indicating higher levels of Decentralized ability.

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

• Weekly changes of Beck Depression Inventory during the intervention

  Beck Depression Inventory is a self-reported questionnaire measuring depression level.Scores range from 0 to 63, with higher scores indicating higher levels of depression.

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

• Weekly changes of Beck Anxiety Inventory during the intervention

  Beck Anxiety Inventory is a self-reported questionnaire measuring Anxiety level.Scores range from 0 to 63, with higher scores indicating higher levels of Anxiety.

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

• Weekly changes of Ruminative Responses Subscale during the intervention

  Ruminative Responses Subscale is a self-reported questionnaire measuring Ruminative Responses level.Scores range from 22 to 88, with higher scores indicating higher levels of Ruminative Responses.

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

• Weekly changes of Emotion Regulation Questionnaire during the intervention

  Emotion Regulation Questionnaire is a self-reported questionnaire measuring cognitive reappraisal level.Scores range from 6 to 42, with higher scores indicating higher levels of cognitive reappraisal ability.

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

• Weekly changes of Automatic thoughts questionnaire during the intervention

  Automatic thoughts questionnaire is a self-reported questionnaire measuring Automatic thoughts level.Scores range from 30 to 160, with higher scores indicating higher levels of Automatic thoughts.

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

• Weekly changes of Cognitive biases questionnaire during the intervention

  Cognitive biases questionnaire is a self-reported questionnaire measuring Cognitive biases level.The score compares the scores of four depression-distortion combinations on a scale of 0 to 23.

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

• Weekly changes of Thought suppression scale during the intervention

  Thought suppression scale is used to measure the degree of inhibition of an individual's thinking.Scores range from 15 to 75, with higher scores indicating higher levels of thought suppression.

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

• Weekly changes of Chinese version of the Brief Experiential Avoidance Questionnaire during the intervention

  Chinese version of the Brief Experiential Avoidance Questionnaire scale is used to measure Experiential Avoidance.Scores range from 15 to 90, with higher scores indicating higher levels of experiential avoidance.

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

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

  Acceptance and Action Questionnaire-II is used to measure Experiential Avoidance.Scores range from 7 to 49, with higher scores indicating higher levels of experiential avoidance.

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

• Weekly changes of Distress Tolerance Scale during the intervention

  Distress Tolerance Scale is used to measure Distress Tolerance.Scores range from 5 to 75, with higher scores indicating higher levels of Distress Tolerance.

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

Secondary Outcomes (4)

• Task Switching Task

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

• Image rating task

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

• The Paced Auditory Serial Addition Task-Computerized; PASAT-C

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

• Emotional Image Tolerance Task

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

Study Arms (2)

MIED+TAU group

EXPERIMENTAL

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.

Behavioral: Mindfulness Intervention for Emotional Distress(MIED)

the TAU-only group

NO INTERVENTION

treatment as usual (TAU) group 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(MIED) 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.

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.
• Subjects have been diagnosed emotional disorders in the past 6 months.

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

Central Study Contacts

Zhenzhen Wang

CONTACT

13236502311; zhenzhenwang921@outlook.com

Xinghua Liu

CONTACT

13371669818; xinghua_liu@pku.edu.cn

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: May 26, 2023
• First Posted: June 6, 2023
• Study Start: June 20, 2023
• Primary Completion: November 15, 2023
• Study Completion: December 15, 2025
• Last Updated: June 9, 2023

Record last verified: 2023-06

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)