Mechanism of Mindfulness-Based Online Intervention in Enhancing Cognitive Flexibility

NCT06035003 | Unknown

• 1 other identifier: E20230905
• Study Type: interventional
• Target: 595
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (7)

• Weekly changes of Five Facet Mindfulness Questionnaire - Short Form during the intervention

  The Five Facet Mindfulness Questionnaire - Short Form is a self-reported questionnaire measuring mindfulness levels. Scores range from 20 to 100, with higher scores indicating higher levels of mindfulness.

  [Time Frame: pre-intervention; weekly during the 7-week intervention; immediately post-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.

  [Time Frame: pre-intervention; weekly during the 7-week intervention; immediately post-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.

  [Time Frame: pre-intervention; weekly during the 7-week intervention; immediately post-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.

  [Time Frame: pre-intervention; weekly during the 7-week intervention; immediately post-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.

  [Time Frame: pre-intervention; weekly during the 7-week intervention; immediately post-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.

  [Time Frame: pre-intervention; weekly during the 7-week intervention; immediately post-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.

  [Time Frame: pre-intervention; weekly during the 7-week intervention; immediately post-intervention]

Secondary Outcomes (15)

• Change of Beck Anxiety Inventory

  [Time Frame: pre-intervention; 3 weeks into intervention; 5 weeks into intervention; immediately post-intervention]

• Change of Beck Depression Inventory-II

  [Time Frame: pre-intervention; 3 weeks into intervention; 5 weeks into intervention; immediately post-intervention]

• Change of Pittsburgh sleep quality Index

  [Time Frame: pre-intervention; 3 weeks into intervention; 5 weeks into intervention; immediately post-intervention]

• Change of Insomnia Severity Index

  [Time Frame: pre-intervention; 3 weeks into intervention; 5 weeks into intervention; immediately post-intervention]

• Change of Mindful Attention Awareness Scale

  [Time Frame: pre-intervention; 3 weeks into intervention; 5 weeks into intervention; immediately post-intervention]

Study Arms (2)

iMIED+TAU group

EXPERIMENTAL

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.

Behavioral: Internet-based Mindfulness Intervention for Emotional Distress (iMIED)

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 therapy.

Interventions

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

iMIED+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.

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

Related Publications (1)

• 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.

  PMID: 40658552 DERIVED

Study Officials

• Xinghua Liu

  School of Psychological and Cognitive Sciences, Peking University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 6, 2023
• First Posted: September 13, 2023
• Study Start: September 18, 2023
• Primary Completion: February 28, 2024
• Study Completion: February 28, 2024
• Last Updated: September 28, 2023

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)