Mechanism of Mindfulness-Based Online Intervention in Enhancing Cognitive Flexibility

Emotional Distress Clinical Trial

Official title:

Mechanism of Mindfulness-Based Online Intervention in Enhancing Cognitive Flexibility: Thoughts as Thoughts

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT06035003
• Other study ID #: E20230905
• Status: Active, not recruiting
• Phase: N/A
• Start date: September 18, 2023
• Est. completion date: February 28, 2024

Study information

• Verified date: September 2023
• Source: Peking University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 595
• Est. completion date: February 28, 2024
• Est. primary completion date: February 28, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Emotional Distress

Intervention

Behavioral:
• 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.

Locations

Country	Name	City	State
China	Peking University	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Peking University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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]
Primary	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]
Primary	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]
Primary	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]
Primary	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]
Primary	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]
Primary	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	Change of Beck Anxiety Inventory	The Beck Anxiety Inventory is a self-reported questionnaire measuring anxiety. Scores range from 0 to 63, with higher scores indicating higher levels of anxiety.	[Time Frame: pre-intervention; 3 weeks into intervention; 5 weeks into intervention; immediately post-intervention]
Secondary	Change of Beck Depression Inventory-II	The Beck Depression Inventory-II is a self-reported questionnaire measuring depression. Scores range from 0 to 63, with higher scores indicating higher levels of depression.	[Time Frame: pre-intervention; 3 weeks into intervention; 5 weeks into intervention; immediately post-intervention]
Secondary	Change of Pittsburgh sleep quality Index	The Pittsburgh sleep quality Index is a self-reported questionnaire measuring sleep quality. Scores range from 0 to 21, with higher scores indicating lower levels of sleep quality.	[Time Frame: pre-intervention; 3 weeks into intervention; 5 weeks into intervention; immediately post-intervention]
Secondary	Change of Insomnia Severity Index	The Insomnia Severity Index is a self-reported questionnaire measuring sleep quality. Scores range from 0 to 28, with higher scores indicating lower levels of sleep quality.	[Time Frame: pre-intervention; 3 weeks into intervention; 5 weeks into intervention; immediately post-intervention]
Secondary	Change of Mindful Attention Awareness Scale	The Mindful Attention Awareness Scale is a self-reported questionnaire measuring mindfulness levels. Scores range from 15 to 90, with higher scores indicating higher levels of mindfulness.	[Time Frame: pre-intervention; 3 weeks into intervention; 5 weeks into intervention; immediately post-intervention]
Secondary	Change of Quality of Relationship Index	The Quality of Relationship Index is a self-reported questionnaire measuring relationship quality. Scores range from 7 to 42, with higher scores indicating higher levels of relationship quality.	[Time Frame: pre-intervention; 3 weeks into intervention; 5 weeks into intervention; immediately post-intervention]
Secondary	Change of Interpersonal Reactivity Index-C	The Interpersonal Reactivity Index-C is a self-reported questionnaire measuring interpersonal reactivity. Scores range from 0 to 88, with higher scores indicating higher levels of interpersonal reactivity.	[Time Frame: pre-intervention; 3 weeks into intervention; 5 weeks into intervention; immediately post-intervention]
Secondary	Change of Intimacy Check and Evaluation Scale	The Intimacy Check and Evaluation Scale is a self-reported questionnaire measuring relationship intimacy. Scores range from 5 to 105, with higher scores indicating higher levels of relationship intimacy.	[Time Frame: pre-intervention; 3 weeks into intervention; 5 weeks into intervention; immediately post-intervention]
Secondary	Moderation effect and possible changes of the Experience Questionnaire	The Experience Questionnaire is a self-reported questionnaire measuring decentering ability. Scores range from 20 to 100, with higher scores indicating higher levels of decentering ability.	[Time Frame: pre-intervention; 3 weeks into intervention; 5 weeks into intervention; immediately post-intervention]
Secondary	Moderation effect and possible changes of the Emotion Regulation Questionnaire	The Experience Questionnaire is a self-reported questionnaire measuring emotion regulation ability. Scores range from 7 to 70, with higher scores indicating higher levels of emotion regulation ability.	[Time Frame: pre-intervention; 3 weeks into intervention; 5 weeks into intervention; immediately post-intervention]
Secondary	Moderation effect and possible changes of the Cognitive Flexibility Inventory	The Cognitive Flexibility Inventory is a self-reported questionnaire measuring cognitive flexibility level. Scores range from 5 to 100, with higher scores indicating higher levels of cognitive flexibility.	[Time Frame: pre-intervention; 3 weeks into intervention; 5 weeks into intervention; immediately post-intervention]
Secondary	Moderation effect and possible changes of the Thoughts as Thoughts Scale	The Thoughts as Thoughts Scale is a self-reported questionnaire measuring treating thoughts as thoughts ability. Scores range from 6 to 30, with higher scores indicating higher levels of treating thoughts as thoughts ability.	[Time Frame: pre-intervention; 3 weeks into intervention; 5 weeks into intervention; immediately post-intervention]
Secondary	Moderation effect and possible changes of the Scale of Life Engagement	The Scale of Life Engagement is a self-reported questionnaire measuring life engagement. Scores range from 0 to 56, with higher scores indicating higher levels of life engagement.	[Time Frame: pre-intervention; 3 weeks into intervention; 5 weeks into intervention; immediately post-intervention]
Secondary	Moderation effect and possible changes of the Self-Compassion Scale	The Self-Compassion Scale is a self-reported questionnaire measuring self- compassion. Scores range from 26 to 130, with higher scores indicating higher levels of self- compassion.	[Time Frame: pre-intervention; 3 weeks into intervention; 5 weeks into intervention; immediately post-intervention]
Secondary	Moderation effect and possible changes of the Rumination- Reflection Questionnaire	The Rumination- Reflection Questionnaire is a self-reported questionnaire measuring rumination- reflection level. Scores range from 5 to 60, with higher scores indicating higher levels of rumination- reflection.	[Time Frame: pre-intervention; 3 weeks into intervention; 5 weeks into intervention; immediately post-intervention]