Mechanisms of Mindfulness Intervention: Cognitive Flexibility Dose Manipulation

NCT ID: NCT06622122

Last Updated: 2024-10-01

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 300 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-10-11
• Study Completion Date: 2025-05-11

Brief Summary

This study hopes to:

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

2. explore whether cognitive flexibility mediates the effects of mindfulness intervention on alleviating emotional distress.

Detailed Description

Epidemiological findings in "The Lancet Psychiatry" indicated that anxiety disorders, including generalized anxiety disorder, panic disorder, and social anxiety disorder, are the most prevalent category of disorders in China, with a lifetime prevalence of 7.6%. Depression follows closely with a lifetime prevalence of 6.8%. With the outbreak of the COVID-19 pandemic in 2020, the prevalence of both anxiety and depressive disorders increased. However, the current availability of psychological intervention resources in China is inadequate to meet the demand. This underscores the critical importance of developing effective and efficient psychological intervention approaches, as well as investigating their effectiveness and mechanisms to optimize intervention strategies.

Epidemiological findings in "The Lancet Psychiatry" indicated that anxiety disorders, including generalized anxiety disorder, panic disorder, and social anxiety disorder, are the most prevalent category of disorders in China, with a lifetime prevalence of 7.6%. Depression follows closely with a lifetime prevalence of 6.8%. With the outbreak of the COVID-19 pandemic in 2020, the prevalence of both anxiety and depressive disorders increased. However, the current availability of psychological intervention resources in China is inadequate to meet the demand. This underscores the critical importance of developing effective and efficient psychological intervention approaches, as well as investigating their effectiveness and mechanisms to optimize intervention strategies.

In recent years, mindfulness-based interventions (MBIs) have been increasingly applied to alleviate emotional distress in both clinical and non-clinical populations, with their efficacy widely supported. Additionally, numerous researchers have explored the mechanisms underlying mindfulness and MBIs, proposing various theories. One of the mechanisms frequently suggested by researchers is cognitive flexibility. However, there has been limited direct investigation into the mechanisms of cognitive flexibility and its related processes or abilities. Cognitive flexibility (CF) is considered a common etiological factor or transdiagnostic characteristic of emotional distress, including anxiety and depression. Nevertheless, few studies have explored the mechanisms of how mindfulness interventions alleviate emotional distress from the perspective of cognitive flexibility and the transdiagnostic characteristics of anxiety and depression. This lack of research hampers our ability to obtain sufficient information to develop or enhance mindfulness-based intervention methods to assist individuals with emotional disorders or highly emotionally distressed subclinical populations.

This study is grounded in the critical role of CF in the generation and maintenance of emotional distress, as well as the mindfulness principle of approaching pain with awareness and acceptance (non-judgmental and non-reactive). It posits that cognitive flexibility might be a potential mechanism through which mindfulness interventions alleviate emotional distress. Following the criteria for establishing mechanisms, this research investigates this issue. Based on the current state of research, cognitive flexibility as a mechanism for MBIs to alleviate emotional distress meets the plausibility criterion and partially satisfies the strong association criterion and experimental manipulation criterion. However, further research is needed to assess its consistency criterion, temporal precedence criterion, and gradient criterion.

The current study primarily focuses on the experimental manipulation and gradient criteria. The aim is to examine whether the mechanism of cognitive flexibility meets the experimental manipulation and gradient criteria by adjusting the content of the mindfulness intervention for emotional distress (MIED) program, which can directly impact distress tolerance and manipulate the dosage of cognitive flexibility intervention.

Conditions

Emotional Distress

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: SINGLE

Study Groups

MIED group

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.

Group Type: EXPERIMENTAL

Mindfulness Intervention for Emotional Distress(MIED)-normal version

Intervention Type: 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+CF group

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.

Group Type: EXPERIMENTAL

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

Intervention Type: 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.

waitlist control group

no intervention

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Mindfulness Intervention for Emotional Distress(MIED)-normal version

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.

Intervention Type: BEHAVIORAL

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

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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• - Subjects with scores greater than 21 on the Kessler Psychological Distress Scale.
• - Aged 18-65 years old.

Exclusion Criteria

• - 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Peking University

OTHER

Sponsor Role: lead

Responsible Party

Xinghua Liu

Director

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Xinghua Liu

Role: PRINCIPAL_INVESTIGATOR

School of Psychological and Cognitive Sciences, Peking University

Locations

Peking University

Beijing, , China

Countries

China

Central Contacts

Zhenzhen Wang

Role: CONTACT

zhenzhenwang921@outlook.com

13236502311

Xinghua Liu

Role: CONTACT

xinghua_liu@pku.edu.cn

13371669818

Facility Contacts

Xinghua Liu

Role: primary

xinghua_liu@pku.edu.cn

13371669818

Other Identifiers

E20240925

Identifier Type: -

Identifier Source: org_study_id