Emotional DistressNCT06103149
The Role of Cognitive Flexibility in Mindfulness Intervention: a Functional Near-infrared Spectroscopy Study
A study testing Mindfulness Intervention for Emotional Distress(MIED) in people with Emotional Distress, run by Xinghua Liu at 1 site in China.
Trial summary
This study hopes to: explore the relationship between mindfulness mediation experiences and emotional distress and cognitive flexibility levels. explore whether mindfulness interventions can significantly alleviate individual emotional distress and improve cognitive flexibility level. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Emotional Distress
- What is being tested?
- Mindfulness Intervention for Emotional Distress(MIED)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteChina
- Study dates
- 28 Oct 2023to 24 Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Subjects with scores greater than 21 on the Kessler Psychological Distress Scale(study 2).
- Subjects with mindfulness experiences (study 1,only test in baseline).
Who cannot join
- study 2:
- 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.
- study 1: Subjects who could not access the Internet; Subjects with insufficient Chinese ability; Patients with schizophrenia or psychotic affective disorder, current organic mental disorder, substance abuse disorder and generalized developmental disorder; Subjects at risk of suicide.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Role of Cognitive Flexibility in Mindfulness Intervention for Emotional Distress: a Study Based on Functional Near-infrared Spectroscopy (FNIRS)
This study hopes to:
explore the relationship between mindfulness mediation experiences and emotional distress and cognitive flexibility levels.
explore whether mindfulness interventions can significantly alleviate individual emotional distress and improve cognitive flexibility level.
explore whether cognitive flexibility is a mediator in mindfulness intervention to alleviate emotional distress, and to meet the principles of mechanism.
explore the brain functional characteristics and changes during the mindfulness intervention.
Read the detailed description
Cognitive flexibility is a component of executive function, which refers to the ability to transform cognitive models to adapt to changing environmental needs.
Studies have shown that people with less cognitive flexibility are less effective at using cognitive restructuring techniques to alleviate emotional distress than those with better cognitive flexibility, which seems to predict the level of cognitive flexibility. Cognitive flexibility levels at the three-month follow-up period were significantly negatively correlated with depression levels and suicidal ideation, and higher levels of cognitive flexibility at baseline significantly predicted lower levels of depression and suicidal ideation in military personnel at the three-month follow-up period. Task switching task was used to measure emotional cognitive flexibility, and explored whether individual differences in cognitive flexibility predicted higher levels of trait anxiety and worry within seven weeks. The results showed that emotional cognitive flexibility in the baseline period seemed to predict anxiety and worry levels after seven weeks.
There is a significant positive correlation between mindfulness and cognitive flexibility. One study compared the changes of cognitive flexibility between the mindfulness based cognitive therapy (MBCT) intervention group and the waiting control group in a randomized controlled study of patients with mild to moderate depression. The results showed that the self-reported cognitive flexibility of the MBCT intervention group was significantly higher than that of the waiting control group, and was significantly correlated with the relief of depressive symptoms.
Generally speaking, exploring the mechanism of the effect of mindfulness-based intervention on emotional distress is helpful to strengthen the positive components of the intervention to optimize the therapeutic effect, distinguish the specificity of treatment from the broader non-specific effect, promote the identification of therapeutic regulators and the matching of therapeutic individuals, and provide information for theoretical development and interpretation of results. With the rapid development of online projects and online platforms, online mindfulness courses begin to receive more and more attention, and show a good application prospect. However, there are few studies on online mindfulness courses at present. In order to better understand the effectiveness of online mindfulness courses, more randomized controlled trials need to be done in the future.
Therefore, this study will explore the relationship between mindfulness experiences and cognitive flexibility. Then, we will explore the effect of mindfulness intervention on emotional distress and the mechanism of cognitive flexibility based on the basic criterion to judge the mechanism of psychological intervention.Futher, this study hopes to explore the brain functional characteristics and changes during the mindfulness intervention.
- Conditions
- Emotional Distress
- Being tested
- Mindfulness Intervention for Emotional Distress(MIED)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mindfulness Intervention for Emotional Distress(MIED)Behavioural
The MIED program integrates the rationales and practices from the Unified Protocol for Treatment of Emotional Disorders (UP) and Mindfulness based Interventions. Formal mindfulness exercises (e.g., body scan, mindful breathing, and mindful stretching) and informal mindfulness practices (e.g., mindful tooth brushing) were adapted from Mindfulness based intervention (MBIs). The offline received the 8-week (2.5-h per week) sessions.The online MIED program was delivered by a Chat Mini Program and lasted for 49 days. Each day, participants received different materials including (a) an audio recording of mindfulness meditation guidance; (b) learning materials in text or audio; and (c) assignments (for example, informal mindfulness practice, emotion journal, and challenging tasks). In total, it took about 30 min per day to finish all the tasks.
| Study group | Role | What they receive |
|---|---|---|
| MIED group | Experimental | 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 Receives: Behavioral: Mindfulness Intervention for Emotional Distress(MIED) |
| Waitlist control group | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: pre-intervention; weekly during the 7-week intervention; after the 7-week 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.
Measured: pre-intervention; weekly during the 7-week intervention; after the 7-week 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.
Measured: pre-intervention; weekly during the 7-week intervention; after the 7-week 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.
Measured: pre-intervention; weekly during the 7-week intervention; after the 7-week 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.
Measured: pre-intervention; weekly during the 7-week intervention; after the 7-week 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.
Measured: pre-intervention; weekly during the 7-week intervention; after the 7-week 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.
Measured: pre-intervention; weekly during the 7-week intervention; after the 7-week 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.
Measured: pre-intervention; weekly during the 7-week intervention; after the 7-week 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.
Measured: pre-intervention; weekly during the 7-week intervention; after the 7-week 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.
Measured: pre-intervention; weekly during the 7-week intervention; after the 7-week intervention
Secondary outcomes (2)
Task Switching Task
The measurement of cognitive flexibility comes from the task switching paradigm, in which participants are required to classify emotional images according to "emotional task rules" or "non-emotional task rules". In emotional task rules, participants are instructed to classify images according to whether the depicted scene is positive or negative. For non-emotional task rules, participants must indicate whether the number of people in the graph is one or none (≤ 1), or two or more (≥ 2). Even if there is only a part of a person's body, it counts. The image is taken from the International emotional Image system (International Affective Picture System,IAPS). There are 40 pictures in each category: ≤ 1 person + positive, ≥ 2 + positive, ≤ 1 person + negative, ≥ 2 + negative, a total of 160 pictures. Positive and negative images differ in titer ratings, but are balanced in evocative ratings. Another 20 pictures are used for the practice module.
Measured: pre-intervention; the third week and fifth week during the 7-week intervention; after the 7-week intervention
Wisconsin card sorting task
The WCST consists of four stimulus cards, each in red, green, blue and yellow colors, with 1 to 4 triangles, stars, crosses or circles. Four of the cards feature a red triangle, two green stars, three yellow crosses, and four blue circles, and a card similar to the one at the top will appear at the bottom of the screen. All you have to do is group the card on the bottom with one on the top, and click on the top four cards that you think are similar to each other to make a choice. After making a choice, a correct or incorrect prompt will appear on the screen, if it is wrong, it does not matter, please try to choose the right choice next time.
Measured: pre-intervention; the third week and fifth week during the 7-week intervention; after the 7-week intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Oct 2023
- Study start28 Oct 2023 (estimated)
- Primary completion20 Nov 2024 (estimated)
- Study completion24 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Emotional DistressStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Xinghua Liu
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Xinghua Liu, Peking University
- Investigators
- Xinghua Liu, Principal investigator, School of Psychological and Cognitive Sciences, Peking University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06103149
- Sponsor's protocol ID
- E20231021
- Status last verified
- Oct 2023
- First submitted
- 21 Oct 2023
- Last updated
- 26 Oct 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Role of Cognitive Flexibility in Mindfulness Intervention for Emotional Distress: a Study Based on Functional Near-infrared Spectroscopy (FNIRS)
- ClinicalTrials.gov ID
- NCT06103149
- Acronym / sponsor ID
- E20231021
- Conditions
- Emotional Distress
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Xinghua LiuUniversity, hospital or other
- Study start
- 28 Oct 2023 (estimated)
- Primary completion
- 20 Nov 2024 (estimated)
- Study completion
- 24 Dec 2024 (estimated)
- First posted
- 26 Oct 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study hopes to:
explore the relationship between mindfulness mediation experiences and emotional distress and cognitive flexibility levels.
explore whether mindfulness interventions can significantly alleviate individual emotional distress and improve cognitive flexibility level.
explore whether cognitive flexibility is a mediator in mindfulness intervention to alleviate emotional distress, and to meet the principles of mechanism.
explore the brain functional characteristics and changes during the mindfulness intervention.
Detailed description
Cognitive flexibility is a component of executive function, which refers to the ability to transform cognitive models to adapt to changing environmental needs.
Studies have shown that people with less cognitive flexibility are less effective at using cognitive restructuring techniques to alleviate emotional distress than those with better cognitive flexibility, which seems to predict the level of cognitive flexibility. Cognitive flexibility levels at the three-month follow-up period were significantly negatively correlated with depression levels and suicidal ideation, and higher levels of cognitive flexibility at baseline significantly predicted lower levels of depression and suicidal ideation in military personnel at the three-month follow-up period. Task switching task was used to measure emotional cognitive flexibility, and explored whether individual differences in cognitive flexibility predicted higher levels of trait anxiety and worry within seven weeks. The results showed that emotional cognitive flexibility in the baseline period seemed to predict anxiety and worry levels after seven weeks.
There is a significant positive correlation between mindfulness and cognitive flexibility. One study compared the changes of cognitive flexibility between the mindfulness based cognitive therapy (MBCT) intervention group and the waiting control group in a randomized controlled study of patients with mild to moderate depression. The results showed that the self-reported cognitive flexibility of the MBCT intervention group was significantly higher than that of the waiting control group, and was significantly correlated with the relief of depressive symptoms.
Generally speaking, exploring the mechanism of the effect of mindfulness-based intervention on emotional distress is helpful to strengthen the positive components of the intervention to optimize the therapeutic effect, distinguish the specificity of treatment from the broader non-specific effect, promote the identification of therapeutic regulators and the matching of therapeutic individuals, and provide information for theoretical development and interpretation of results. With the rapid development of online projects and online platforms, online mindfulness courses begin to receive more and more attention, and show a good application prospect. However, there are few studies on online mindfulness courses at present. In order to better understand the effectiveness of online mindfulness courses, more randomized controlled trials need to be done in the future.
Therefore, this study will explore the relationship between mindfulness experiences and cognitive flexibility. Then, we will explore the effect of mindfulness intervention on emotional distress and the mechanism of cognitive flexibility based on the basic criterion to judge the mechanism of psychological intervention.Futher, this study hopes to explore the brain functional characteristics and changes during the mindfulness intervention.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| MIED group | Experimental | Behavioral: Mindfulness Intervention for Emotional Distress(MIED)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 |
| Waitlist control group | No intervention | – |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Subjects with scores greater than 21 on the Kessler Psychological Distress Scale(study 2).
- Subjects with mindfulness experiences (study 1,only test in baseline).
Key exclusion criteria (3 listed)
- 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.
- study 1: Subjects who could not access the Internet; Subjects with insufficient Chinese ability; Patients with schizophrenia or psychotic affective disorder, current organic mental disorder, substance abuse disorder and generalized developmental disorder; Subjects at risk of suicide.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mindfulness Intervention for Emotional Distress(MIED)The MIED program integrates the rationales and practices from the Unified Protocol for Treatment of Emotional Disorders (UP) and Mindfulness based Interventions. Formal mindfulness exercises (e.g., body scan, mindful breathing, and mindful stretching) and informal mindfulness practices (e.g., mindful tooth brushing) were adapted from Mindfulness based intervention (MBIs). The offline received the 8-week (2.5-h per week) sessions.The online MIED program was delivered by a Chat Mini Program and lasted for 49 days. Each day, participants received different materials including (a) an audio recording of mindfulness meditation guidance; (b) learning materials in text or audio; and (c) assignments (for example, informal mindfulness practice, emotion journal, and challenging tasks). In total, it took about 30 min per day to finish all the tasks. | Behavioural | MIED group |
Primary outcome
Weekly changes of Five Facet Mindfulness Questionnaire during the intervention
Time frame: pre-intervention; weekly during the 7-week intervention; after the 7-week 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.
Weekly changes of 10-item Kessler Psychological Distress Scale during the intervention
Time frame: pre-intervention; weekly during the 7-week intervention; after the 7-week 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.
Weekly changes of Overall Anxiety Severity and Impairment Scale during the intervention
Time frame: pre-intervention; weekly during the 7-week intervention; after the 7-week 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.
Weekly changes of Overall Depression Severity and Impairment Scale during the intervention
Time frame: pre-intervention; weekly during the 7-week intervention; after the 7-week 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.
Weekly changes of Cognitive flexibility Inventory during the intervention
Time frame: pre-intervention; weekly during the 7-week intervention; after the 7-week 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.
Weekly changes of experiences questionnaire during the intervention
Time frame: pre-intervention; weekly during the 7-week intervention; after the 7-week 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.
Weekly changes of Beck Depression Inventory during the intervention
Time frame: pre-intervention; weekly during the 7-week intervention; after the 7-week 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.
Weekly changes of Beck Anxiety Inventory during the intervention
Time frame: pre-intervention; weekly during the 7-week intervention; after the 7-week 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.
Weekly changes of Emotion Regulation Questionnaire during the intervention
Time frame: pre-intervention; weekly during the 7-week intervention; after the 7-week 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.
Weekly changes of Rumination-Reflection Questionnaire during the intervention
Time frame: pre-intervention; weekly during the 7-week intervention; after the 7-week 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.
2 secondary outcomes
Task Switching Task
Time frame: pre-intervention; the third week and fifth week during the 7-week intervention; after the 7-week intervention
Wisconsin card sorting task
Time frame: pre-intervention; the third week and fifth week during the 7-week intervention; after the 7-week intervention
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Oct 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Xinghua Liu principal investigator
School of Psychological and Cognitive Sciences, Peking University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mindfulness Intervention for Emotional Distress(MIED) in people with Emotional Distress, run by Xinghua Liu at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 26 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Zhenzhen Wang (13236502311, zhenzhenwang921@outlook.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Weekly changes of Five Facet Mindfulness Questionnaire during the intervention (time frame: pre-intervention; weekly during the 7-week intervention; after the 7-week intervention). The study lists 10 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Oct 2023; AzTrials last refreshed its copy on 6 Nov 2026.