Emotional DistressNCT06035003

Mechanism of Mindfulness-Based Online Intervention in Enhancing Cognitive Flexibility

A study testing Internet-based Mindfulness Intervention for Emotional Distress (iMIED) in people with Emotional Distress, run by Peking University at 1 site in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record

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Trial summary

Who is it for?: Ages 18 to 65 years
Conditions the study is for: Emotional Distress
What is being tested?: Internet-based Mindfulness Intervention for Emotional Distress (iMIED)
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 595 participants
Where: 1 siteChina
Study dates: 18 Sep 2023to 28 Feb 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
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Who cannot join

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.

Trial locations and contacts

1 site in 1 country.

China1 site

Peking University
Beijing, Beijing Municipality, 100871

Other trials in China

About this study

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

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

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

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

Study groups in NCT06035003
Study group	Role	What they receive
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. Receives: 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.

What is being measured

The primary outcome is the main question the study is designed to answer.

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

Secondary outcomes (15)

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

18 Sep 202328 Feb 2024

First posted13 Sep 2023
Study start18 Sep 2023
Primary completion28 Feb 2024 (estimated)
Study completion28 Feb 2024 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (2)Papers the sponsor has linked to this study.
Other trials for Emotional DistressStudies of the same condition, open and under way.
More trials run by Peking UniversityThe sponsor's other registered studies.
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: 595 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06035003
Sponsor's protocol ID: E20230905
Status last verified: Sep 2023
First submitted: 6 Sep 2023
Last updated: 28 Sep 2023
Results posted: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

Jin J, Chen D, He M, Hu A, Hofmann SG, Liu X. Perceived Stress Change During a Mindfulness-Based Intervention for Emotional Distress: Integrated Evidence From Two Randomized Trials. Clin Psychol Psychother. 2026 Jul-Aug;33(4):e70304. doi: 10.1002/cpp.70304.
PubMed 42384403
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.
PubMed 40658552

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 28 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Mechanism of Mindfulness-Based Online Intervention in Enhancing Cognitive Flexibility: Thoughts as Thoughts
ClinicalTrials.gov ID: NCT06035003
Acronym / sponsor ID: E20230905
Conditions: Emotional Distress
Study type: Interventional
Recruitment status: Unknown status
Enrolment: 595 participants (actual)
Lead sponsor: Peking UniversityUniversity, hospital or other
Study start: 18 Sep 2023 (actual)
Primary completion: 28 Feb 2024 (estimated)
Study completion: 28 Feb 2024 (estimated)
First posted: 13 Sep 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.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
iMIED+TAU group	Experimental	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.
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.

Who may qualify

Ages: 18 to 65 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (1 listed)

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

Key exclusion criteria (5 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.

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
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.	Behavioural	iMIED+TAU group

Primary outcome

Weekly changes of Five Facet Mindfulness Questionnaire - Short Form during the intervention
Time frame: [Time Frame: pre-intervention; weekly during the 7-week intervention; immediately post-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.
Weekly changes of Patient Health Questionnaire during the intervention
Time frame: [Time Frame: pre-intervention; weekly during the 7-week intervention; immediately post-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.
Weekly changes of Chinese Perceived Stress Scale during the intervention
Time frame: [Time Frame: pre-intervention; weekly during the 7-week intervention; immediately post-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.
Weekly changes of 10-item Kessler Psychological Distress Scale during the intervention
Time frame: [Time Frame: pre-intervention; weekly during the 7-week intervention; immediately post-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: [Time Frame: pre-intervention; weekly during the 7-week intervention; immediately post-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: [Time Frame: pre-intervention; weekly during the 7-week intervention; immediately post-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 Athens Insomnia Scale during the intervention
Time frame: [Time Frame: pre-intervention; weekly during the 7-week intervention; immediately post-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.

15 secondary outcomes

Change of Beck Anxiety Inventory
Time frame: [Time Frame: pre-intervention; 3 weeks into intervention; 5 weeks into intervention; immediately post-intervention]
Change of Beck Depression Inventory-II
Time frame: [Time Frame: pre-intervention; 3 weeks into intervention; 5 weeks into intervention; immediately post-intervention]
Change of Pittsburgh sleep quality Index
Time frame: [Time Frame: pre-intervention; 3 weeks into intervention; 5 weeks into intervention; immediately post-intervention]
Change of Insomnia Severity Index
Time frame: [Time Frame: pre-intervention; 3 weeks into intervention; 5 weeks into intervention; immediately post-intervention]
Change of Mindful Attention Awareness Scale
Time frame: [Time Frame: pre-intervention; 3 weeks into intervention; 5 weeks into intervention; immediately post-intervention]
Change of Quality of Relationship Index
Time frame: [Time Frame: pre-intervention; 3 weeks into intervention; 5 weeks into intervention; immediately post-intervention]
Change of Interpersonal Reactivity Index-C
Time frame: [Time Frame: pre-intervention; 3 weeks into intervention; 5 weeks into intervention; immediately post-intervention]
Change of Intimacy Check and Evaluation Scale
Time frame: [Time Frame: pre-intervention; 3 weeks into intervention; 5 weeks into intervention; immediately post-intervention]
Moderation effect and possible changes of the Experience Questionnaire
Time frame: [Time Frame: pre-intervention; 3 weeks into intervention; 5 weeks into intervention; immediately post-intervention]
Moderation effect and possible changes of the Emotion Regulation Questionnaire
Time frame: [Time Frame: pre-intervention; 3 weeks into intervention; 5 weeks into intervention; immediately post-intervention]
Moderation effect and possible changes of the Cognitive Flexibility Inventory
Time frame: [Time Frame: pre-intervention; 3 weeks into intervention; 5 weeks into intervention; immediately post-intervention]
Moderation effect and possible changes of the Thoughts as Thoughts Scale
Time frame: [Time Frame: pre-intervention; 3 weeks into intervention; 5 weeks into intervention; immediately post-intervention]
Moderation effect and possible changes of the Scale of Life Engagement
Time frame: [Time Frame: pre-intervention; 3 weeks into intervention; 5 weeks into intervention; immediately post-intervention]
Moderation effect and possible changes of the Self-Compassion Scale
Time frame: [Time Frame: pre-intervention; 3 weeks into intervention; 5 weeks into intervention; immediately post-intervention]
Moderation effect and possible changes of the Rumination- Reflection Questionnaire
Time frame: [Time Frame: pre-intervention; 3 weeks into intervention; 5 weeks into intervention; immediately post-intervention]

Results and safety

Results are not available in the source record.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 28 Sep 2023.
Derived from this study: PubMed 42384403Jin J, Chen D, He M, Hu A, Hofmann SG, Liu X. Perceived Stress Change During a Mindfulness-Based Intervention for Emotional Distress: Integrated Evidence From Two Randomized Trials. Clin Psychol Psychother. 2026 Jul-Aug;33(4):e70304. doi: 10.1002/cpp.70304.
Derived from this study: PubMed 40658552Wang 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.
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 Internet-based Mindfulness Intervention for Emotional Distress (iMIED) in people with Emotional Distress, run by Peking University 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 1 inclusion and 5 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 28 Sep 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?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Weekly changes of Five Facet Mindfulness Questionnaire - Short Form during the intervention (time frame: [Time Frame: pre-intervention; weekly during the 7-week intervention; immediately post-intervention]). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06035003, which also lists 2 linked publications.

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 28 Sep 2023.