Mechanism of Mindfulness-Based Online Intervention in Enhancing Cognitive Flexibility

NCT ID: NCT06035003

Last Updated: 2023-09-28

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 595 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-09-18
• Study Completion Date: 2024-02-28

Brief Summary

Traditional offline interventions such as MBCT and MBSR have been implemented to treat patients with emotional disorders and obtained significantly improved clinical outcomes. However, these offline interventions require the involvement of a therapist expert in mindfulness and usually charge a high fee, which may not be accessible and cost-effective for lots of patients with psychological disorders. Fortunately, online self-help interventions can compensate for these disadvantages. Our research team has developed a self-help online mindfulness program targeting emotional distress (i.e., iMIED), which has been effective for individuals with emotional distress in a preliminary study. Since patients with emotional disorders usually suffer from emotional distress, the current study will apply this program to these patients, and investigate its auxiliary effects on patients' psychological and physical health.

The primary aim of the current study is to evaluate the effectiveness of iMIED for patients with emotional disorders. To do so, we will use a design in which patients who receive online mindfulness training (iMIED) except for treatment as usual (TAU) will be compared with patients who receive TAU alone. We expect the intervention to improve patients' psychopathological symptoms reported by the patients and the clinicians or the research team and increase their overall functioning, positive mental health, and physical health compared to TAU. In addition, previous studies have shown that mindfulness interventions improve psychological symptoms by improving cognitive flexibility. Therefore, the secondary aim of the study is to examine the mediating effect of cognitive flexibility on the relationships between mindfulness practice and improvements in outcome variables, and further explore the mechanism behind it.

Conditions

Emotional Distress

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

iMIED+TAU group

Internet-based Mindfulness Intervention for Emotional Distress (iMIED) 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.

Group Type: EXPERIMENTAL

Internet-based Mindfulness Intervention for Emotional Distress (iMIED)

Intervention Type: BEHAVIORAL

Internet-based Mindfulness Intervention for Emotional Distress (iMIED) 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 TAU-only group

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 therapy.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Internet-based Mindfulness Intervention for Emotional Distress (iMIED)

Internet-based Mindfulness Intervention for Emotional Distress (iMIED) 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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• Subjects with scores greater than 21 on the Kessler Psychological Distress Scale.

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Peking University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Xinghua Liu

Role: PRINCIPAL_INVESTIGATOR

School of Psychological and Cognitive Sciences, Peking University

Locations

Peking University

Beijing, Beijing Municipality, China

Countries

China

References

Wang Z, Chen M, Hu A, Feng S, Hofmann SG, Liu X. Effect of cognitive flexibility in mindfulness intervention for emotional distress: Two randomized controlled trials. J Couns Psychol. 2025 Oct;72(5):581-597. doi: 10.1037/cou0000812. Epub 2025 Jul 14.

Reference Type: DERIVED

PMID: 40658552 (View on PubMed)

Other Identifiers

E20230905

Identifier Type: -

Identifier Source: org_study_id