Emotional DistressNCT05600790
Mechanism of Mindfulness Based Online Intervention in Reducing Emotional Distress
A study testing Mindfulness Intervention for Emotional Distress in people with Emotional Distress, run by Peking University at 1 site in China.
Trial summary
This study hopes to: 1. explore whether, at the individual level, the improvement of mindfulness ability can promote peace of mind, reduce the frequency of mental wandering, weaken or cut off the cycle between negative mood and mind wandering, and improve the individual's attention monitoring ability and ability to… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Emotional Distress
- What is being tested?
- 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
- 300 participants
- Where
- 1 siteChina
- Study dates
- 29 Oct 2022to 28 Feb 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
- 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.
About this study
This study hopes to:
- explore whether, at the individual level, the improvement of mindfulness ability can promote peace of mind, reduce the frequency of mental wandering, weaken or cut off the cycle between negative mood and mind wandering, and improve the individual's attention monitoring ability and ability to engage in the present.
- explore the impact of mindfulness intervention on intimate relationships in the eastern culture under the intimate relationship interaction model.
- explore and propose the level of personality functioning could be a moderator of outcomes of MIED.
Read the detailed description
Mind Wandering is the conscious experience when an individual's attention shifts from an ongoing task or external environment to an internal thought stream unrelated to tasks and external stimuli. Mind wandering is closely related to attention and emotion. Frequent mental wandering and negative emotions, especially depression and anxiety, are positively correlated (Smallwood et al., 2009). Mindfulness and mind wandering are essentially a state of consciousness. Trait mind wandering is a general tendency of individuals, representing the overall level of individual mind wandering. Mindfulness training can improve the level of mindfulness, and individuals are more involved in the present; This study hopes to explore whether, at the individual level, the improvement of mindfulness ability can promote peace of mind, reduce the frequency of mental wandering, weaken or cut off the cycle between negative mood and mind wandering, and improve the individual's attention monitoring ability and ability to engage in the present.
Some findings suggest that higher levels of mindfulness are associated with relationship outcomes between partners (Barnes, Brown, Krusemark, Campbell \& Rogge, 2007). This paper aims to explore the impact of mindfulness intervention on intimate relationships in the eastern culture under the intimate relationship interaction model. The selected research objects were: emotionally troubled individuals who were not satisfied with the intimate relationship or marriage relationship, usually one of the parties in the intimate relationship, no matter male or female, no matter sexual orientation; The group received a 49-day Mindfulness Intervention for Emotional Distress (MIED), and the effect of detection.
Increasing evidence has demonstrated the positive effects of mindfulness-based interventions on a range of outcomes, including reducing depression and anxiety on a group level. However, rare research has identified who would most likely benefit from such interventions, especially when online mindfulness-based interventions have been popular, such as MIED in China. No consistent moderator has been found in terms of personal characteristics, including personal traits (de Vibe et al., 2015; Giluk, 2009; Hanley, 2016; Nyklíček \& Irrmischer, 2017). While the level of personality functioning has been proposed by DSM-5 AMPD and ICD-11 as a dimensional criterion crossing normal personality and personality disorders (Bender, Morey \& Skodol, 2011; Tyrer, Mulder, Kim, \& Crawford, 2019), the current study proposes that it could be a moderator of outcomes of MIED. The results could help to explore the potential mechanism underlying the beneficial effects of the MIED theoretically and guide adaptations of MIED practically.
Experiential avoidance refers to individuals resisting experiences or trying to eliminate certain experiences (such as emotions, thoughts, physical feelings, memory and behavioral tendencies, etc.), and trying to adopt corresponding strategies to change these experiences and the situations in which the experiences are generated (Hayes, Wilson, Gifford, Follette, \& Strosahl, 1996). Experiential avoidance has been proved to be a maintenance factor for many psychological disorders (Boelen \& Reijntjes, 2008), and trying to hide or suppress unpleasant thoughts, feelings and physical feelings will increase the frequency and pain of these same experiences (Gross,1998; Gross,2002; Sloan, 2004; Wegner, 1994). According to some reviews, experiential avoidance is one of the beneficial effects of mindfulness (Brown, Bravo, Roos, \& Pearson, 2015; Shapiro et al., 2006). However, at present, the measurement of experiential avoidance is limited to self-reported questionnaires, lacking objective measurement tools. Therefore, this study uses the dichotic listening task to measure experiential avoidance and explore the role of experiential avoidance as the effective mechanism of mindfulness intervention.
- Conditions
- Emotional Distress
- Being tested
- Mindfulness Intervention for Emotional Distress
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mindfulness Intervention for Emotional DistressBehavioural
Mindfulness Intervention for Emotional Distress (MIED) 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 group | Role | What they receive |
|---|---|---|
| the MIED+TAU group | Experimental | Intervention description: 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 |
| the TAU-only group | No intervention | 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 therap |
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 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: pre-intervention; weekly during the 7-week intervention; after the 7-week 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: 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 Inner Peace Scale during the intervention
The Inner Peace Scale is a self-reported questionnaire measuring peace. Scores range from 0 to 28, with higher scores indicating higher levels of peace.
Measured: pre-intervention; weekly during the 7-week intervention; after the 7-week 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: pre-intervention; weekly during the 7-week intervention; after the 7-week intervention
Secondary outcomes (14)
Moderation effect and possible changes of the Levels of Personality Functioning-Brief Form 2.0 during the intervention
The Levels of Personality Functioning-Brief Form 2.0 is a self-reported questionnaire measuring personality functioning. Scores range from 12 to 48, with higher scores indicating worse levels of personality functioning.
Measured: pre-intervention; after the 3rd week intervention; after the 5rd week intervention; after the 7-week intervention
Moderation effect and possible changes of Personality Functioning Subscale of the Chinese Personality Organization Inventory during the intervention
Personality Functioning Subscale of the Chinese Personality Organization Inventory is a self-reported questionnaire measuring personality functioning. Scores range from 0 to 20, with higher scores indicating worse levels of personality functioning.
Measured: pre-intervention; after the 3rd week intervention; after the 5rd week intervention; after the 7-week intervention
Weekly changes of Acceptance and Action Questionnaire-II during the first three weeks of intervention during the intervention
The Acceptance and Action Questionnaire-II is a self-reported questionnaire measuring experiential avoidance. Scores range from 7 to 49, with higher scores indicating higher levels of experiential avoidance.
Measured: pre-intervention; after the 1st week intervention; after the 2nd week intervention; after the 3rd week intervention
Weekly changes of Interpersonal Mindfulness Scale during the intervention
The Interpersonal Mindfulness Questionnaire is a self-reported questionnaire measuring mindfulness level within interpersonal events, such as communication and emotion exchange. The 27-item scale contains four dimensions: focus on the present, awareness of self and others, non-judgmental acceptance, and non-reaction. Scores range from 0 to 135, with higher scores indicating higher levels of interpersonal mindfulness.
Measured: pre-intervention; after the 3rd week intervention; after the 5rd week intervention; after the 7-week intervention
Weekly changes of Philadelphia Mindfulness Scale-Chinese Version during the intervention
Philadelphia Mindfulness Scale-Chinese Version is a self-reported questionnaire measuring awareness and acceptance levels. Scores range from 16 to 80, with higher scores indicating higher levels of awareness and acceptance.
Measured: pre-intervention; after the 3rd week intervention; after the 5rd week intervention; after the 7-week intervention
Weekly changes of Attention-Related Cognitive Errors Scale during the intervention
Attention-Related Cognitive Errors Scale is a questionnaire for individuals to report the frequency of attention related cognitive errors. Scores range from 11 to 55, with higher scores indicating higher levels of the more mistakes occur without awareness.
Measured: pre-intervention; after the 3rd week intervention; after the 5rd week intervention; after the 7-week intervention
Weekly changes of Mind-Wandering Questionnaire during the intervention
The Frequency of Mind Wandering Questionnaire is a self-reported scale for individual to evaluate the frequency of wandering. Scores range from 21 to 105, with higher scores indicating higher levels of mind wandering.
Measured: pre-intervention; after the 3rd week intervention; after the 5rd week intervention; after the 7-week intervention
Weekly changes of Parter Acceptance Scale during the intervention
The Partner Acceptance Scale (PAS) is a self-reported questionnaire measuring one's acceptance level towards the other partner. Scores range from 0 to 35, with higher scores indicating higher levels of acceptancy.
Measured: pre-intervention; after the 3rd week intervention; after the 5rd week intervention; after the 7-week intervention
Weekly changes of Test of Self-Conscious Affect-3 during the intervention
Test of Self-Conscious Affect-3 is a self-reported questionnaire measuring behavioral tendency of shame, guilt and etc. Scores range from 64 to 320, with higher scores indicating higher tendency of feeling certain self-conscious emotion.
Measured: pre-intervention; after the 3rd week intervention; after the 5rd week intervention; after the 7-week intervention
Weekly changes of Brief Experiential Avoidance Questionnaire during the first three weeks of intervention
The Brief Experiential Avoidance Questionnaire is a self-reported questionnaire measuring experiential avoidance. Scores range from 15 to 90, with higher scores indicating higher levels of experiential avoidance.
Measured: pre-intervention; after the 1st week intervention; after the 2nd week intervention; after the 3rd week intervention
Weekly changes of Couples Satisfaction Index during the intervention
The Couples Satisfaction Index (CSI) is a self-reported questionnaire measuring individual's subjective satisfaction towards couple. Scores range from 0 to 36, with higher scores indicating higher levels of satisfaction.
Measured: pre-intervention; after the 3rd week intervention; after the 5rd week intervention; after the 7-week intervention
Weekly changes of the dichotic listening task during the first three weeks of intervention
The dichotic listening task is a computer-based behavioral task to measure experiential avoidance. The task involved presenting words into an unattending ear while worry or neutral scenarios were presented into the attending ear. Participants were given a surprise word recognition test of the words. Greater percentage of words recognition indicates higher levels of experiential avoidance.
Measured: pre-intervention; after the 1st week intervention; after the 2nd week intervention; after the 3rd week intervention
Weekly changes of sustained attention response task during the intervention
The SART is a Go/No-Go task. In the SART, each digit is presented for 500 ms, followed by a mask presented for 900 ms (for a total trial duration of 5900 ms),260 trials in total. If no response was made to a go stimulus (the digits 1-2 and 4-9), this was coded as an omission. Responses to the no-go stimulus (3) were coded as errors. The question of randomly inserting 13 probes is to examine the current attention state of the subjects.
Measured: pre-intervention; after the 3rd week intervention; after the 5rd week intervention; after the 7-week intervention
Weekly changes of The Subjective well-being scale during the intervention
The Subjective Well-being Scale is a self-reported questionnaire measuring individual's well-being level. Scores range from 0 to 35, with higher scores indicating higher levels of satisfaction.
Measured: pre-intervention; after the 3rd week intervention; after the 5rd 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 posted1 Nov 2022
- Study start29 Oct 2022
- Primary completion28 Feb 2023 (estimated)
- Study completion28 Feb 2023 (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.
- 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
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking University
- Sponsor type
- University, hospital or other
- 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
- NCT05600790
- Sponsor's protocol ID
- E20221107
- Status last verified
- Nov 2022
- First submitted
- 24 Oct 2022
- Last updated
- 10 Nov 2022
- 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 10 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mechanism of Mindfulness Based Online Intervention in Reducing Emotional Distress
- ClinicalTrials.gov ID
- NCT05600790
- Acronym / sponsor ID
- E20221107
- Conditions
- Emotional Distress
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Peking UniversityUniversity, hospital or other
- Study start
- 29 Oct 2022 (actual)
- Primary completion
- 28 Feb 2023 (estimated)
- Study completion
- 28 Feb 2023 (estimated)
- First posted
- 1 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.
This study hopes to:
- explore whether, at the individual level, the improvement of mindfulness ability can promote peace of mind, reduce the frequency of mental wandering, weaken or cut off the cycle between negative mood and mind wandering, and improve the individual's attention monitoring ability and ability to engage in the present.
- explore the impact of mindfulness intervention on intimate relationships in the eastern culture under the intimate relationship interaction model.
- explore and propose the level of personality functioning could be a moderator of outcomes of MIED.
Detailed description
Mind Wandering is the conscious experience when an individual's attention shifts from an ongoing task or external environment to an internal thought stream unrelated to tasks and external stimuli. Mind wandering is closely related to attention and emotion. Frequent mental wandering and negative emotions, especially depression and anxiety, are positively correlated (Smallwood et al., 2009). Mindfulness and mind wandering are essentially a state of consciousness. Trait mind wandering is a general tendency of individuals, representing the overall level of individual mind wandering. Mindfulness training can improve the level of mindfulness, and individuals are more involved in the present; This study hopes to explore whether, at the individual level, the improvement of mindfulness ability can promote peace of mind, reduce the frequency of mental wandering, weaken or cut off the cycle between negative mood and mind wandering, and improve the individual's attention monitoring ability and ability to engage in the present.
Some findings suggest that higher levels of mindfulness are associated with relationship outcomes between partners (Barnes, Brown, Krusemark, Campbell \& Rogge, 2007). This paper aims to explore the impact of mindfulness intervention on intimate relationships in the eastern culture under the intimate relationship interaction model. The selected research objects were: emotionally troubled individuals who were not satisfied with the intimate relationship or marriage relationship, usually one of the parties in the intimate relationship, no matter male or female, no matter sexual orientation; The group received a 49-day Mindfulness Intervention for Emotional Distress (MIED), and the effect of detection.
Increasing evidence has demonstrated the positive effects of mindfulness-based interventions on a range of outcomes, including reducing depression and anxiety on a group level. However, rare research has identified who would most likely benefit from such interventions, especially when online mindfulness-based interventions have been popular, such as MIED in China. No consistent moderator has been found in terms of personal characteristics, including personal traits (de Vibe et al., 2015; Giluk, 2009; Hanley, 2016; Nyklíček \& Irrmischer, 2017). While the level of personality functioning has been proposed by DSM-5 AMPD and ICD-11 as a dimensional criterion crossing normal personality and personality disorders (Bender, Morey \& Skodol, 2011; Tyrer, Mulder, Kim, \& Crawford, 2019), the current study proposes that it could be a moderator of outcomes of MIED. The results could help to explore the potential mechanism underlying the beneficial effects of the MIED theoretically and guide adaptations of MIED practically.
Experiential avoidance refers to individuals resisting experiences or trying to eliminate certain experiences (such as emotions, thoughts, physical feelings, memory and behavioral tendencies, etc.), and trying to adopt corresponding strategies to change these experiences and the situations in which the experiences are generated (Hayes, Wilson, Gifford, Follette, \& Strosahl, 1996). Experiential avoidance has been proved to be a maintenance factor for many psychological disorders (Boelen \& Reijntjes, 2008), and trying to hide or suppress unpleasant thoughts, feelings and physical feelings will increase the frequency and pain of these same experiences (Gross,1998; Gross,2002; Sloan, 2004; Wegner, 1994). According to some reviews, experiential avoidance is one of the beneficial effects of mindfulness (Brown, Bravo, Roos, \& Pearson, 2015; Shapiro et al., 2006). However, at present, the measurement of experiential avoidance is limited to self-reported questionnaires, lacking objective measurement tools. Therefore, this study uses the dichotic listening task to measure experiential avoidance and explore the role of experiential avoidance as the effective mechanism of mindfulness intervention.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| the MIED+TAU group | Experimental | Behavioral: Mindfulness Intervention for Emotional DistressIntervention description: 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 | –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 therap |
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 |
|---|---|---|
| Mindfulness Intervention for Emotional DistressMindfulness Intervention for Emotional Distress (MIED) 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 | the MIED+TAU 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 Patient Health Questionnaire during the intervention
Time frame: pre-intervention; weekly during the 7-week intervention; after the 7-week 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: pre-intervention; weekly during the 7-week intervention; after the 7-week 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: 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 Inner Peace Scale during the intervention
Time frame: pre-intervention; weekly during the 7-week intervention; after the 7-week intervention
The Inner Peace Scale is a self-reported questionnaire measuring peace. Scores range from 0 to 28, with higher scores indicating higher levels of peace.
Weekly changes of Athens Insomnia Scale during the intervention
Time frame: pre-intervention; weekly during the 7-week intervention; after the 7-week 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.
14 secondary outcomes
Moderation effect and possible changes of the Levels of Personality Functioning-Brief Form 2.0 during the intervention
Time frame: pre-intervention; after the 3rd week intervention; after the 5rd week intervention; after the 7-week intervention
Moderation effect and possible changes of Personality Functioning Subscale of the Chinese Personality Organization Inventory during the intervention
Time frame: pre-intervention; after the 3rd week intervention; after the 5rd week intervention; after the 7-week intervention
Weekly changes of Acceptance and Action Questionnaire-II during the first three weeks of intervention during the intervention
Time frame: pre-intervention; after the 1st week intervention; after the 2nd week intervention; after the 3rd week intervention
Weekly changes of Interpersonal Mindfulness Scale during the intervention
Time frame: pre-intervention; after the 3rd week intervention; after the 5rd week intervention; after the 7-week intervention
Weekly changes of Philadelphia Mindfulness Scale-Chinese Version during the intervention
Time frame: pre-intervention; after the 3rd week intervention; after the 5rd week intervention; after the 7-week intervention
Weekly changes of Attention-Related Cognitive Errors Scale during the intervention
Time frame: pre-intervention; after the 3rd week intervention; after the 5rd week intervention; after the 7-week intervention
Weekly changes of Mind-Wandering Questionnaire during the intervention
Time frame: pre-intervention; after the 3rd week intervention; after the 5rd week intervention; after the 7-week intervention
Weekly changes of Parter Acceptance Scale during the intervention
Time frame: pre-intervention; after the 3rd week intervention; after the 5rd week intervention; after the 7-week intervention
Weekly changes of Test of Self-Conscious Affect-3 during the intervention
Time frame: pre-intervention; after the 3rd week intervention; after the 5rd week intervention; after the 7-week intervention
Weekly changes of Brief Experiential Avoidance Questionnaire during the first three weeks of intervention
Time frame: pre-intervention; after the 1st week intervention; after the 2nd week intervention; after the 3rd week intervention
Weekly changes of Couples Satisfaction Index during the intervention
Time frame: pre-intervention; after the 3rd week intervention; after the 5rd week intervention; after the 7-week intervention
Weekly changes of the dichotic listening task during the first three weeks of intervention
Time frame: pre-intervention; after the 1st week intervention; after the 2nd week intervention; after the 3rd week intervention
Weekly changes of sustained attention response task during the intervention
Time frame: pre-intervention; after the 3rd week intervention; after the 5rd week intervention; after the 7-week intervention
Weekly changes of The Subjective well-being scale during the intervention
Time frame: pre-intervention; after the 3rd week intervention; after the 5rd 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 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
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 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 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 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 during the intervention (time frame: pre-intervention; weekly during the 7-week intervention; after the 7-week intervention). The study lists 8 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.