Mindfulness Interventions and Emotional Distress: A Daily Study

NCT06785259 | Not Yet Recruiting

• 1 other identifier: E20250107
• Study Type: interventional
• Target: 120
• Locations: 0 countries
• Sites: N/A

Brief Summary

This study hopes to explore whether the changes in rumination exhibited in Daily Diary mediates the effects of mindfulness intervention on alleviating emotional distress

Conditions

Emotional Distress

Outcome Measures

Primary Outcomes (7)

• Daily changes of mindfulness

  The Daily Mindfulness Response Scale measures the frequency with which one returns to a nonjudgmental and unconditionally receptive present moment awareness during the day. Each item is rated on a scale ranging from 1 (rarely)to10(often). scores range from 4 to 40, with higher scores indicating higher levels of mindful responding

  once per day for 63 days (1 week pre-intervention, 7 weeks during the intervention, 1 week post-intervention)

• Daily changes of rumination

  measured by Momentary repetitive negative thinking, night items, scores range from 9 to 63, with higher scores indicating higher levels of reprtitive negative thinking.

  once per day for 63 days (1 week pre-intervention, 7 weeks during the intervention, 1 week post-intervention)

• Daily changes of positive and negative affect

  Daily positive and negative affect were measured using the 10-itemInternational Positive and Negative Affect Schedule-Short Form Scale. Scores range from 5 to 25, with higher scores indicating higher levels of positive/negative affect.

  once per day for 63 days (1 week pre-intervention, 7 weeks during the intervention, 1 week post-intervention)

• Daily changes of emotional distress

  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.

  once per day for 63 days (1 week pre-intervention, 7 weeks during the intervention, 1 week post-intervention)

• daily changes of anxiety

  Daily Anxiety Severity and Impairment Scale,5 items, scores range from 0 to 20, with higher scores indicating higher levels of anxiety.

  once per day for 63 days (1 week pre-intervention, 7 weeks during the intervention, 1 week post-intervention)

• daily changes of depression

  Daily Depression Severity and Impairment Scale,5 items, scores range from 0 to 20, with higher scores indicating higher levels of depression.

  once per day for 63 days (1 week pre-intervention, 7 weeks during the intervention, 1 week post-intervention)

• Daily changes of the Brief State Rumination Inventory

  he Brief State Rumination Inventory comprises eight items designed to measure an individual's state rumination tendency at a given moment, encompassing aspects such as the intensity of negative emotions, repetitive thinking, loss of thought control, and the strength of negative affect. The total score, which is derived by summing up the scores of all items, indicates the overall level of the measured construct.

  once per day for 63 days (1 week pre-intervention, 7 weeks during the intervention, 1 week post-intervention)

Study Arms (1)

MIED group

EXPERIMENTAL

Mindfulness Intervention for Emotional Distress (MIED) program provides standard audio instructions for mindfulness exercises, introduces 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)

Interventions

Mindfulness Intervention for Emotional Distress(MIED) BEHAVIORAL

Mindfulness Intervention for Emotional Distress (MIED) program provides standard audio instructions for mindfulness exercises, introduces 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 group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• 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 Officials

• Xinghua Liu

  School of Psychological and Cognitive Sciences, Peking University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Zitong Xin

CONTACT

+86 13718720771; 2201110738@pku.edu.cn

Xinghua Liu

CONTACT

+86 13371669818; xinghua_liu@pku.edu.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director

Study Record Dates

• First Submitted: January 7, 2025
• First Posted: January 21, 2025
• Study Start: January 18, 2025
• Primary Completion: March 20, 2025
• Study Completion: May 20, 2025
• Last Updated: January 21, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share