Emotional DisorderNCT05606224
The Effects and Mechanisms of Mindfulness Intervention for Emotional Distress
A study testing internet-based mindfulness intervention for emotional distress in people with Emotional Disorder, run by Peking University at 4 sites in China.
Trial summary
Traditional offline interventions such as MBCT and MBSR have been implemented in treating patients with emotional disorders and obtained significantly improved clinical outcome. However, these offline interventions require the involvement of a therapist expertized in mindfulness and usually charge a high fee, which… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Emotional Disorder
- What is being tested?
- internet-based mindfulness intervention for emotional distress
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 4 sitesChina
- Study dates
- 20 Feb 2022to 30 Aug 2023
- 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
- Age 18-65;
- Diagnosis of emotional disorders, including anxiety disorders (e.g., panic disorder, social anxiety disorder, generalized anxiety disorder), and unipolar depression disorders;
- If taking medication, haven't changed for at least 4 weeks before intervention onset, and no change in medicine is expected;
- Voluntary participation in this study and sign an informed consent form.
Who cannot join
- No access to the internet;
- Inadequate proficiency in Chinese;
- Previous participation in mindfulness-based programs longer than 6 weeks, and/or current practice of meditation more than once per week;
- A history of schizophrenia or schizoaffective disorder, current organic mental disorders, substance abuse disorder, and pervasive developmental disorders;
- Manifesting with any self-injury or suicidal risks.
Trial locations and contacts
4 sites in 1 country.
China4 sites, 4 recruiting
- Recruiting
Beijing Anding Hospital
Beijing, Beijing Municipality
Jia Luo, 17744510103, luojia_210@163.com
- Recruiting
Beijing Tiantan Hospital
Beijing, Beijing Municipality
Boyuan Zhang, 13071108806, 331814129@qq.com
- Recruiting
Fosha Mental Health Center
Foshan, Guangdong
Yang Yu, 13929902386, psyyuyang@163.com
Yang Yu
- Recruiting
Nanjing Brain Hospital
Nanjing, Jiangsu
Chun Wang, 15850566376, chun_wang@njmu.edu.cn
About this study
Official title: The Effects and Mechanisms of Mindfulness Intervention for Emotional Distress: a Multicenter Randomized Controlled Trial
Traditional offline interventions such as MBCT and MBSR have been implemented in treating patients with emotional disorders and obtained significantly improved clinical outcome. However, these offline interventions require the involvement of a therapist expertized 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., MIED), which has been demonstrated to be effective for individuals with emotional distress in a preliminary study. Since patients with emotional disorders usually suffered 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 MIED for patients with emotional disorders. To do so, we will use a design in which patients who receive online mindfulness training (MIED) 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 through improving cognitive flexibility, distress tolerance, intolerance of uncertainty, and experiential avoidance. Therefore, the secondary aim of the study is to examine the mediating effect of these factors on the relationships between mindfulness practice and improvements in outcome variables.
- Conditions
- Emotional Disorder
- Being tested
- internet-based mindfulness intervention for emotional distress
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 distressBehavioural
The internet-based self-help version of the Mindfulness Intervention for Emotional Distress (iMIED) program integrates rationales and practices from the UP and MBIs. Formal mindfulness exercises (e.g., body scan, mindful breathing, and mindful stretching) and informal mindfulness practices (e.g., mindful tooth-brushing) were retrieved from MBIs. In addition, iMIED selected several important tasks from the UP, like practicing tolerating uncomfortable feelings by interoceptive exposure practices (e.g., rapid breathing), identifying avoidant behaviors and emotion-driven behaviors and reducing them step by step, identifying common maladaptive automatic thoughts (e.g., overestimating probability and catastrophizing), and using the above strategies in daily life by completing challenging tasks.
| Study group | Role | What they receive |
|---|---|---|
| iMIED+TAU: internet-based mindfulness intervention for emotional distress plus treatment as usual | Experimental | The internet-based self-help version of the Mindfulness Intervention for Emotional Distress (iMIED) program integrates rationales and practices from the UP and MBIs. Formal mindfulness exercises (e.g., body scan, mindful breathing, and mindful stretching) and informal mindfulness practices (e.g., mindful tooth-brushing) were retrieved from MBIs. In addition, iMIED selected several important tasks from the UP, like practicing tolerating uncomfortable feelings by interoceptive exposure practices (e.g., rapid breathing), identifying avoidant behaviors and emotion-driven behaviors and reducing them step by step, identifying common maladaptive automatic thoughts (e.g., overestimating probability and catastrophizing), and using the above strategies in daily life by completing challenging tasks. Receives: Behavioral: internet-based mindfulness intervention for emotional distress |
| TAU-only: treatment as usual | No intervention | In the current study, TAU 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.
Change of mindfulness
The 20-item Five-Facet Mindfulness Questionnaire-Short Form, self-report, score s range from 20 to 100, higher scores indicate higher levels of mindfulness
Measured: at baseline (T0), at week 3(T1) and at week 5 (T2), at post-intervention (T3), and at 3 (T4) months follow-ups
Change of other-reported anxiety
Hamilton Anxiety Rating Scale, assessed by the clinicians, scores range from 0 to 56, higher scores indicate higher levels of anxiety
Measured: at baseline (T0), at post-intervention (T3), and at 3 (T4) months follow-ups
Change of other-reported depression
Hamilton Depression Rating Scale, assessed by the clinicians, scores range from 0 to 68, higher scores indicate higher levels of depression
Measured: at baseline (T0), at post-intervention (T3), and at 3 (T4) months follow-ups
Change of self-reported depression
Beck Depression Inventory-II, self-report, scores range from 0 to 63, higher scores indicate higher levels of depression
Measured: at baseline (T0), at week 3(T1) and at week 5 (T2), at post-intervention (T3), and at 3 (T4) months follow-ups
Change of self-reported anxiety symptoms
Beck Anxiety Inventory, self-report, scores range from 0 to 63, higher scores indicate higher levels of anxiety
Measured: at baseline (T0), at week 3(T1) and at week 5 (T2), at post-intervention (T3), and at 3 (T4) months follow-ups
Change of psychological distress
10-item Kessler Psychological Distress Scale, self-report, scores range from 5 to 50, higher scores indicate higher levels of psychological distress
Measured: at baseline (T0), at week 3(T1) and at week 5 (T2), at post-intervention (T3), and at 3 (T4) months follow-ups
Change of inner peace
Inner Peace Scale, self-report, scores range from 0 to 28, higher scores indicate higher levels of inner peace
Measured: at baseline (T0), at week 3(T1) and at week 5 (T2), at post-intervention (T3), and at 3 (T4) months follow-ups
Change of perceived stress
Chinese Perceived Stress Scales, self-report, scores range from 0 to 28, higher scores indicate higher levels of inner peace
Measured: at baseline (T0), at week 3(T1) and at week 5 (T2), at post-intervention (T3), and at 3 (T4) months follow-ups
Change of sleep quality
Pittsburgh Sleep Quality Index, self-report, scores range from 0 to 21, higher scores indicate worse sleep quality
Measured: at baseline (T0), at week 3(T1) and at week 5 (T2), at post-intervention (T3), and at 3 (T4) months follow-ups
Change of Depression Severity and Impairment
Overall Depression Severity and Impairment Scale, self-report, scores range from 0 to 20, higher scores indicate higher levels of depression severity and impairment
Measured: at baseline (T0), at week 3(T1) and at week 5 (T2), at post-intervention (T3), and at 3 (T4) months follow-ups
Change of Anxiety Severity and Impairment
Overall Anxiety Severity and Impairment Scale, self-report, scores range from 0 to 20, higher scores indicate higher levels of anxiety severity and impairment
Measured: at baseline (T0), at week 3(T1) and at week 5 (T2), at post-intervention (T3), and at 3 (T4) months follow-ups
Change of somatic symptoms
Patient Health Questionnaire-15, self-report, scores range from 0 to 30 higher scores indicate higher levels of somatic symptoms
Measured: at baseline (T0), at week 3(T1) and at week 5 (T2), at post-intervention (T3), and at 3 (T4) months follow-ups
Change of distress tolerance
The Chinese version of the Distress Tolerance Scale, self-report, scores range from 15 to 75 higher scores indicate higher levels of distress tolerance
Measured: at baseline (T0), at week 3(T1) and at week 5 (T2), at post-intervention (T3), and at 3 (T4) months follow-ups
Change of Intolerance of Uncertainty
Intolerance of Uncertainty -Short form, self-report, scores range from 12 to 60, higher scores indicate higher levels of intolerance of uncertainty
Measured: at baseline (T0), at week 3(T1) and at week 5 (T2), at post-intervention (T3), and at 3 (T4) months follow-ups
Change of experiential avoidance
Brief Experience Avoidance Questionnaire, self-report, scores range from 15 to 75 higher scores indicate higher levels of experiential avoidance
Measured: at baseline (T0), at week 3(T1) and at week 5 (T2), at post-intervention (T3), and at 3 (T4) months follow-ups
Change of attention control
Attention Control Scale, self-report, scores range from 16 to 64 higher scores indicate higher levels of attention control
Measured: at baseline (T0), at week 3(T1) and at week 5 (T2), at post-intervention (T3), and at 3 (T4) months follow-ups
Change of Cognitive Flexibility
Cognitive Flexibility Inventory, self-report, scores range from 20 to 100, higher scores indicate higher levels of cognitive flexibility
Measured: at baseline (T0), at week 3(T1) and at week 5 (T2), at post-intervention (T3), and at 3 (T4) months follow-ups
Change of discomfort intolerance
Discomfort intolerance Scale, self-report, scores range from 0 to 25 higher scores indicate higher levels of discomfort intolerance
Measured: at baseline (T0), at week 3(T1) and at week 5 (T2), at post-intervention (T3), and at 3 (T4) months follow-ups
Secondary outcomes (3)
Change of distress tolerance (behavioral indicator1)
The Paced Auditory Serial Addition Task-Computerized, task persistence as the behavioral indicator of emotional distress
Measured: at baseline (T0), at week 3(T1) and at week 5 (T2), at post-intervention (T3), and at 3 (T4) months follow-ups
Change of distress tolerance (behavioral indicator2)
Emotional Image Tolerance Task, distress persistence as the behavioral indicator of emotional distress (after selecting "quit," the average time participants viewed the slide before moving on to the next slide)
Measured: at baseline (T0), at week 3(T1) and at week 5 (T2), at post-intervention (T3), and at 3 (T4) months follow-ups
Change of distress tolerance (behavioral indicator3)
Mirror tracing task, task persistence as the behavioral indicator of emotional distress
Measured: at baseline (T0), at week 3(T1) and at week 5 (T2), at post-intervention (T3), and at 3 (T4) months follow-ups
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Nov 2022
- Study start20 Feb 2022
- Primary completion30 Aug 2023 (estimated)
- Study completion30 Aug 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Emotional DisorderStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking University
- Sponsor type
- University, hospital or other
- Collaborators
- Nanjing Brain Hospital, Capital Medical University, Beijing Tiantan Hospital, Foshan Mental Health Center
- Responsible party
- Principal 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
- NCT05606224
- Sponsor's protocol ID
- NCRC2021M01
- Status last verified
- Nov 2022
- First submitted
- 20 Oct 2022
- Last updated
- 10 Nov 2022
- Results posted
- 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 10 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects and Mechanisms of Mindfulness Intervention for Emotional Distress: a Multicenter Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05606224
- Acronym / sponsor ID
- NCRC2021M01
- Conditions
- Emotional Disorder
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Peking UniversityUniversity, hospital or other
- Collaborators
- Nanjing Brain Hospital, Capital Medical University, Beijing Tiantan Hospital, Foshan Mental Health Center
- Study start
- 20 Feb 2022 (actual)
- Primary completion
- 30 Aug 2023 (estimated)
- Study completion
- 30 Aug 2023 (estimated)
- First posted
- 4 Nov 2022 (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.
Traditional offline interventions such as MBCT and MBSR have been implemented in treating patients with emotional disorders and obtained significantly improved clinical outcome. However, these offline interventions require the involvement of a therapist expertized 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., MIED), which has been demonstrated to be effective for individuals with emotional distress in a preliminary study. Since patients with emotional disorders usually suffered 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 MIED for patients with emotional disorders. To do so, we will use a design in which patients who receive online mindfulness training (MIED) 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 through improving cognitive flexibility, distress tolerance, intolerance of uncertainty, and experiential avoidance. Therefore, the secondary aim of the study is to examine the mediating effect of these factors on the relationships between mindfulness practice and improvements in outcome variables.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| iMIED+TAU: internet-based mindfulness intervention for emotional distress plus treatment as usual | Experimental | Behavioral: internet-based mindfulness intervention for emotional distressThe internet-based self-help version of the Mindfulness Intervention for Emotional Distress (iMIED) program integrates rationales and practices from the UP and MBIs. Formal mindfulness exercises (e.g., body scan, mindful breathing, and mindful stretching) and informal mindfulness practices (e.g., mindful tooth-brushing) were retrieved from MBIs. In addition, iMIED selected several important tasks from the UP, like practicing tolerating uncomfortable feelings by interoceptive exposure practices (e.g., rapid breathing), identifying avoidant behaviors and emotion-driven behaviors and reducing them step by step, identifying common maladaptive automatic thoughts (e.g., overestimating probability and catastrophizing), and using the above strategies in daily life by completing challenging tasks. |
| TAU-only: treatment as usual | No intervention | –In the current study, TAU 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 (4 listed)
- Age 18-65;
- Diagnosis of emotional disorders, including anxiety disorders (e.g., panic disorder, social anxiety disorder, generalized anxiety disorder), and unipolar depression disorders;
- If taking medication, haven't changed for at least 4 weeks before intervention onset, and no change in medicine is expected;
- Voluntary participation in this study and sign an informed consent form.
Key exclusion criteria (5 listed)
- No access to the internet;
- Inadequate proficiency in Chinese;
- Previous participation in mindfulness-based programs longer than 6 weeks, and/or current practice of meditation more than once per week;
- A history of schizophrenia or schizoaffective disorder, current organic mental disorders, substance abuse disorder, and pervasive developmental disorders;
- Manifesting with any self-injury or suicidal risks.
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 distressThe internet-based self-help version of the Mindfulness Intervention for Emotional Distress (iMIED) program integrates rationales and practices from the UP and MBIs. Formal mindfulness exercises (e.g., body scan, mindful breathing, and mindful stretching) and informal mindfulness practices (e.g., mindful tooth-brushing) were retrieved from MBIs. In addition, iMIED selected several important tasks from the UP, like practicing tolerating uncomfortable feelings by interoceptive exposure practices (e.g., rapid breathing), identifying avoidant behaviors and emotion-driven behaviors and reducing them step by step, identifying common maladaptive automatic thoughts (e.g., overestimating probability and catastrophizing), and using the above strategies in daily life by completing challenging tasks. | Behavioural | iMIED+TAU: internet-based mindfulness intervention for emotional distress plus treatment as usual |
Primary outcome
Change of mindfulness
Time frame: at baseline (T0), at week 3(T1) and at week 5 (T2), at post-intervention (T3), and at 3 (T4) months follow-ups
The 20-item Five-Facet Mindfulness Questionnaire-Short Form, self-report, score s range from 20 to 100, higher scores indicate higher levels of mindfulness
Change of other-reported anxiety
Time frame: at baseline (T0), at post-intervention (T3), and at 3 (T4) months follow-ups
Hamilton Anxiety Rating Scale, assessed by the clinicians, scores range from 0 to 56, higher scores indicate higher levels of anxiety
Change of other-reported depression
Time frame: at baseline (T0), at post-intervention (T3), and at 3 (T4) months follow-ups
Hamilton Depression Rating Scale, assessed by the clinicians, scores range from 0 to 68, higher scores indicate higher levels of depression
Change of self-reported depression
Time frame: at baseline (T0), at week 3(T1) and at week 5 (T2), at post-intervention (T3), and at 3 (T4) months follow-ups
Beck Depression Inventory-II, self-report, scores range from 0 to 63, higher scores indicate higher levels of depression
Change of self-reported anxiety symptoms
Time frame: at baseline (T0), at week 3(T1) and at week 5 (T2), at post-intervention (T3), and at 3 (T4) months follow-ups
Beck Anxiety Inventory, self-report, scores range from 0 to 63, higher scores indicate higher levels of anxiety
Change of psychological distress
Time frame: at baseline (T0), at week 3(T1) and at week 5 (T2), at post-intervention (T3), and at 3 (T4) months follow-ups
10-item Kessler Psychological Distress Scale, self-report, scores range from 5 to 50, higher scores indicate higher levels of psychological distress
Change of inner peace
Time frame: at baseline (T0), at week 3(T1) and at week 5 (T2), at post-intervention (T3), and at 3 (T4) months follow-ups
Inner Peace Scale, self-report, scores range from 0 to 28, higher scores indicate higher levels of inner peace
Change of perceived stress
Time frame: at baseline (T0), at week 3(T1) and at week 5 (T2), at post-intervention (T3), and at 3 (T4) months follow-ups
Chinese Perceived Stress Scales, self-report, scores range from 0 to 28, higher scores indicate higher levels of inner peace
Change of sleep quality
Time frame: at baseline (T0), at week 3(T1) and at week 5 (T2), at post-intervention (T3), and at 3 (T4) months follow-ups
Pittsburgh Sleep Quality Index, self-report, scores range from 0 to 21, higher scores indicate worse sleep quality
Change of Depression Severity and Impairment
Time frame: at baseline (T0), at week 3(T1) and at week 5 (T2), at post-intervention (T3), and at 3 (T4) months follow-ups
Overall Depression Severity and Impairment Scale, self-report, scores range from 0 to 20, higher scores indicate higher levels of depression severity and impairment
Change of Anxiety Severity and Impairment
Time frame: at baseline (T0), at week 3(T1) and at week 5 (T2), at post-intervention (T3), and at 3 (T4) months follow-ups
Overall Anxiety Severity and Impairment Scale, self-report, scores range from 0 to 20, higher scores indicate higher levels of anxiety severity and impairment
Change of somatic symptoms
Time frame: at baseline (T0), at week 3(T1) and at week 5 (T2), at post-intervention (T3), and at 3 (T4) months follow-ups
Patient Health Questionnaire-15, self-report, scores range from 0 to 30 higher scores indicate higher levels of somatic symptoms
Change of distress tolerance
Time frame: at baseline (T0), at week 3(T1) and at week 5 (T2), at post-intervention (T3), and at 3 (T4) months follow-ups
The Chinese version of the Distress Tolerance Scale, self-report, scores range from 15 to 75 higher scores indicate higher levels of distress tolerance
Change of Intolerance of Uncertainty
Time frame: at baseline (T0), at week 3(T1) and at week 5 (T2), at post-intervention (T3), and at 3 (T4) months follow-ups
Intolerance of Uncertainty -Short form, self-report, scores range from 12 to 60, higher scores indicate higher levels of intolerance of uncertainty
Change of experiential avoidance
Time frame: at baseline (T0), at week 3(T1) and at week 5 (T2), at post-intervention (T3), and at 3 (T4) months follow-ups
Brief Experience Avoidance Questionnaire, self-report, scores range from 15 to 75 higher scores indicate higher levels of experiential avoidance
Change of attention control
Time frame: at baseline (T0), at week 3(T1) and at week 5 (T2), at post-intervention (T3), and at 3 (T4) months follow-ups
Attention Control Scale, self-report, scores range from 16 to 64 higher scores indicate higher levels of attention control
Change of Cognitive Flexibility
Time frame: at baseline (T0), at week 3(T1) and at week 5 (T2), at post-intervention (T3), and at 3 (T4) months follow-ups
Cognitive Flexibility Inventory, self-report, scores range from 20 to 100, higher scores indicate higher levels of cognitive flexibility
Change of discomfort intolerance
Time frame: at baseline (T0), at week 3(T1) and at week 5 (T2), at post-intervention (T3), and at 3 (T4) months follow-ups
Discomfort intolerance Scale, self-report, scores range from 0 to 25 higher scores indicate higher levels of discomfort intolerance
3 secondary outcomes
Change of distress tolerance (behavioral indicator1)
Time frame: at baseline (T0), at week 3(T1) and at week 5 (T2), at post-intervention (T3), and at 3 (T4) months follow-ups
Change of distress tolerance (behavioral indicator2)
Time frame: at baseline (T0), at week 3(T1) and at week 5 (T2), at post-intervention (T3), and at 3 (T4) months follow-ups
Change of distress tolerance (behavioral indicator3)
Time frame: at baseline (T0), at week 3(T1) and at week 5 (T2), at post-intervention (T3), and at 3 (T4) months follow-ups
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Nov 2022.
- 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
4 sites 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 in people with Emotional Disorder, run by Peking University at 4 sites 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 4 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 10 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites 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 Yanjuan Li (+86 15992425499, Lyjanice@stu.pku.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change of mindfulness (time frame: at baseline (T0), at week 3(T1) and at week 5 (T2), at post-intervention (T3), and at 3 (T4) months follow-ups). The study lists 18 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 10 Nov 2022; AzTrials last refreshed its copy on 8 Nov 2026.