Mechanisms of Mindfulness Intervention: Cognitive Flexibility Dose Manipulation

NCT06622122 | Not Yet Recruiting

• 1 other identifier: E20240925
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 1

Brief Summary

This study hopes to:

1. 1.explore whether an increase in the dosage of cognitive flexibility intervention corresponds to greater effectiveness of mindfulness intervention in alleviating emotional distress.
2. 2.explore whether cognitive flexibility mediates the effects of mindfulness intervention on alleviating emotional distress.

Conditions

Emotional Distress

Outcome Measures

Primary Outcomes (10)

• 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 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 intervention

• Weekly changes of Rumination-Reflection Questionnaire during the intervention

  Rumination-Reflection Questionnaire is a self-reported questionnaire measuring Rumination level.Scores range from 12 to 60, with higher scores indicating higher levels of Rumination.

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

• Weekly changes of experiences questionnaire during the intervention

  experiences 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; immediately after the 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; immediately after the 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; immediately after the intervention

Study Arms (3)

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)-normal version

MIED+CF group

EXPERIMENTAL

The increase in cognitive flexibility dosage involves incorporating additional psychoeducational content related to cognitive flexibility and corresponding exercises to enhance cognitive flexibility within the MIED (Mindfulness Intervention for Emotional Distress) program.

Behavioral: Mindfulness Intervention for Emotional Distress(MIED)-increase cognitive flexibility

waitlist control group

NO INTERVENTION

no intervention

Interventions

Mindfulness Intervention for Emotional Distress(MIED)-normal version 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

Mindfulness Intervention for Emotional Distress(MIED)-increase cognitive flexibility BEHAVIORAL

Increase the intervention dose of cognitive flexibility in Mindfulness Intervention for Emotional Distress (MIED). For example, including more cognitive reappraisal practice, psychoeducational content and practice about regarding thoughts just as thoughts.

MIED+CF 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.
• \- Aged 18-65 years old.

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;
• \- Subjects with schizophrenia or psychotic affective disorder, current organic mental disorder, substance abuse disorder and generalized developmental disorder;
• \- Subjects with high risk of suicide.

Sponsors & Collaborators

• Peking University: lead

Study Sites (1)

Peking University

Beijing, 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: SINGLE
• Who Masked: PARTICIPANT
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director

Study Record Dates

• First Submitted: September 25, 2024
• First Posted: October 1, 2024
• Study Start: October 11, 2024
• Primary Completion: December 30, 2024
• Study Completion: May 11, 2025
• Last Updated: October 1, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)