Emotional DistressNCT06056232
Mechanisms of Mindfulness Intervention: Distress Tolerance Dose Manipulation
A study testing Mindfulness Intervention for Emotional Distress(MIED)-normal version, Mindfulness Intervention for Emotional Distress(MIED)-increase distress tolerance and Mindfulness Intervention for Emotional Distress(MIED)-decrease distress tolerance in people with Emotional Distress and Emotional Disorder, run by Peking University at 1 site in China.
Trial summary
This study hopes to: 1. explore whether an increase in the dosage of distress tolerance intervention corresponds to greater effectiveness of mindfulness intervention in alleviating emotional distress. 2. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Emotional Distress, Emotional Disorder
- What is being tested?
- Mindfulness Intervention for Emotional Distress(MIED)-normal version, Mindfulness Intervention for Emotional Distress(MIED)-increase distress tolerance and Mindfulness Intervention for Emotional Distress(MIED)-decrease distress tolerance
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteChina
- Study dates
- 5 Oct 2023to 10 Mar 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
- Age 18-65;
- Subjects with scores greater than 21 on the Kessler Psychological Distress Scale.
- 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
- Subjects who have participated in mindfulness-based projects (especially MIED), 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
Official title: Exploring the Mechanism of Mindfulness Intervention: Manipulating Distress the Dose of Tolerance Intervention Dose
This study hopes to:
- explore whether an increase in the dosage of distress tolerance intervention corresponds to greater effectiveness of mindfulness intervention in alleviating emotional distress.
- explore whether distress tolerance mediates the effects of mindfulness intervention on alleviating emotional distress.
Read the detailed description
Epidemiological findings in "The Lancet Psychiatry" indicated that anxiety disorders, including generalized anxiety disorder, panic disorder, and social anxiety disorder, are the most prevalent category of disorders in China, with a lifetime prevalence of 7.6%. Depression follows closely with a lifetime prevalence of 6.8%. With the outbreak of the COVID-19 pandemic in 2020, the prevalence of both anxiety and depressive disorders increased. However, the current availability of psychological intervention resources in China is inadequate to meet the demand. This underscores the critical importance of developing effective and efficient psychological intervention approaches, as well as investigating their effectiveness and mechanisms to optimize intervention strategies.
In recent years, mindfulness-based interventions (MBIs) have been increasingly applied to alleviate emotional distress in both clinical and non-clinical populations, with their efficacy widely supported. Additionally, numerous researchers have explored the mechanisms underlying mindfulness and MBIs, proposing various theories. One of the mechanisms frequently suggested by researchers is exposure. However, there has been limited direct investigation into the mechanisms of exposure and its related processes or abilities. Distress tolerance (DT) is closely associated with exposure and is considered a common etiological factor or transdiagnostic characteristic of emotional distress, including anxiety and depression. Nevertheless, few studies have explored the mechanisms of how mindfulness interventions alleviate emotional distress from the perspective of exposure and the transdiagnostic characteristics of anxiety and depression. This lack of research hampers our ability to obtain sufficient information to develop or enhance mindfulness-based intervention methods to assist individuals with emotional disorders or highly emotionally distressed subclinical populations.
This study is grounded in the critical role of DT in the generation and maintenance of emotional distress, as well as the mindfulness principle of approaching pain with awareness and acceptance (non-judgmental and non-reactive). It posits that DT might be a potential mechanism through which mindfulness interventions alleviate emotional distress. Following the criteria for establishing mechanisms, this research investigates this issue. Based on the current state of research, DT as a mechanism for MBIs to alleviate emotional distress meets the plausibility criterion and partially satisfies the strong association criterion and experimental manipulation criterion. However, further research is needed to assess its consistency criterion, temporal precedence criterion, and gradient criterion.
The current study primarily focuses on the experimental manipulation and gradient criteria. The aim is to examine whether the mechanism of DT meets the experimental manipulation and gradient criteria by adjusting the content of the mindfulness intervention for emotional distress (MIED) program, which can directly impact distress tolerance and manipulate the dosage of distress tolerance intervention.
- Conditions
- Emotional Distress, Emotional Disorder
- Being tested
- Mindfulness Intervention for Emotional Distress(MIED)-normal version, Mindfulness Intervention for Emotional Distress(MIED)-increase distress tolerance, Mindfulness Intervention for Emotional Distress(MIED)-decrease distress tolerance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mindfulness Intervention for Emotional Distress(MIED)-normal versionBehavioural
Mindfulness Intervention for Emotional Distress (MIED) program provides standard audio instructions for mindfulness exercises, introduces 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.
Mindfulness Intervention for Emotional Distress(MIED)-increase distress toleranceBehavioural
Increase the intervention dose of distress tolerance in Mindfulness Intervention for Emotional Distress (MIED). For example, including more emotion exposure tasks, materials from Facing Your Feelings.
Mindfulness Intervention for Emotional Distress(MIED)-decrease distress toleranceBehavioural
Decrease the intervention dose of distress tolerance in Mindfulness Intervention for Emotional Distress (MIED). For example, including less emotion exposure tasks and interoceptive exposure tasks.
| Study group | Role | What they receive |
|---|---|---|
| MIED group | Experimental | Mindfulness Intervention for Emotional Distress (MIED) program provides standard audio instructions for mindfulness exercises, introduces the nature and law of anxiety, depression, and other emotions, the source of anxiety, depression, and other emotional distress, and the strategies and methods to alleviate emotional distress. These exercises, knowledge, and strategies are based on the latest progress in the field of psychological counseling and treatment, and their application in daily life can help alleviate anxiety, depression, and other emotional problems. Receives: Behavioral: Mindfulness Intervention for Emotional Distress(MIED)-normal version |
| MIED+DT group | Experimental | The increase in distress tolerance dosage involves incorporating additional psychoeducational content related to distress tolerance and corresponding exercises to enhance distress tolerance within the MIED (Mindfulness Intervention for Emotional Distress) program. Receives: Behavioral: Mindfulness Intervention for Emotional Distress(MIED)-increase distress tolerance |
| MIED-DT group | Experimental | The decrease in distress tolerance dosage entails reducing exercises related to distress tolerance within the MIED, such as interoceptive exposure exercises and challenging tasks. Receives: Behavioral: Mindfulness Intervention for Emotional Distress(MIED)-decrease distress tolerance |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes of Five Facet Mindfulness Questionnaire-short form 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: at baseline (T0), at week 3(T1) and at week 5 (T2), at post-intervention (T3), and at 3 (T4) months follow-ups
Changes of Distress Tolerance Scale during the intervention
Distress Tolerance Scale is used to measure Distress Tolerance. Scores range from 5 to 75, with higher scores indicating 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
Changes of Discomfort Intolerance Scale during the intervention
Discomfort Intolerance Scale is used to measure Discomfort Intolerance. Scores range from 0 to 25, with higher scores indicating 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
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: at baseline (T0), at week 3(T1) and at week 5 (T2), at post-intervention (T3), and at 3 (T4) months follow-ups
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: at baseline (T0), at week 3(T1) and at week 5 (T2), at post-intervention (T3), and at 3 (T4) months follow-ups
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: at baseline (T0), at week 3(T1) and at week 5 (T2), at post-intervention (T3), and at 3 (T4) months follow-ups
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: at baseline (T0), at week 3(T1) and at week 5 (T2), at post-intervention (T3), and at 3 (T4) months follow-ups
Changes of Beck Depression Inventory during the intervention
Beck Depression Inventory is a self-reported questionnaire measuring depression level.Scores range from 0 to 63, with higher scores indicating higher levels of depression.
Measured: at baseline (T0), at week 3(T1) and at week 5 (T2), at post-intervention (T3), and at 3 (T4) months follow-ups
Changes of Beck Anxiety Inventory during the intervention
Beck Anxiety Inventory is a self-reported questionnaire measuring Anxiety level.Scores range from 0 to 63, with higher scores indicating higher levels of Anxiety.
Measured: at baseline (T0), at week 3(T1) and at week 5 (T2), at post-intervention (T3), and at 3 (T4) months follow-ups
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: at baseline (T0), at week 3(T1) and at week 5 (T2), at post-intervention (T3), and at 3 (T4) months follow-ups
Changes of Rumination during the intervention
the Rumination subscale, extracted from the Rumination-Reflection Questionnaire, contains 12 items. Scores range from 5 to 60, with higher scores indicating higher levels of rumination.
Measured: at baseline (T0), at week 3(T1) and at week 5 (T2), at post-intervention (T3), and at 3 (T4) months follow-ups
Changes of Chinese version of the Brief Experiential Avoidance Questionnaire during the intervention
Chinese version of the Brief Experiential Avoidance Questionnaire scale is used to measure experiential avoidance. Scores range from 15 to 90, with higher scores indicating 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
Changes of Patient Health Questionnaire during the intervention
he Patient Health Questionnaire is a self-reported questionnaire consisting of 18 items designed to measure 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: at baseline (T0), at week 3(T1) and at week 5 (T2), at post-intervention (T3), and at 3 (T4) months follow-ups
Changes of behavioral inhibition system/behavioral activation system (BIS/BAS) scale during the intervention
The BIS/BAS scale is a self-report questionnaire consisting of 18 items designed to assess the intensity of two motivational systems, namely the Behavioral Inhibition System (BIS) and the Behavioral Activation System (BAS). Scores on this scale can vary between 18 and 72, with elevated scores indicative of a greater tendency to avoid aversive outcomes and pursue goal-oriented outcomes.
Measured: at baseline (T0), at week 3(T1) and at week 5 (T2), at post-intervention (T3), and at 3 (T4) months follow-ups
Changes of Multidimensional Assessment of Interoceptive Awareness-2 (MAIA-2) scale during the intervention
The Multidimensional Assessment of Interoceptive Awareness-2 (MAIA-2) is a self-report questionnaire that aims to measure Interoceptive Awareness. Scores range from 0 to 165. Higher scores indicate higher ability or tendency in several domains including Noticing, Not-Distracting, Not-Worrying, Attention Regulation, Emotional Awareness, Self-regulation, Body Listening, and Trusting.
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 (1)
The Paced Auditory Serial Addition Task-Computerized (PASAT-C)
PASAT-C In this task, participants were presented with a series of numbers and were given the task of adding the last two numbers. They were given points for correct answers and unpleasant vocal feedback for incorrect answers. The task consists of four stages: (1) simple stage, which is the control condition of cognitive and motor function; (2) Latency test stage to determine the level of completion of the addition test; (3) distress induced stage, used to induce emotional pain; (4) distress tolerance stage, used to measure distress tolerance (i.e., the time before task termination).
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 posted28 Sep 2023
- Study start5 Oct 2023 (estimated)
- Primary completion8 Dec 2023 (estimated)
- Study completion10 Mar 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Emotional DistressStudies of the same condition, open and under way.
- 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
- Participant
- Enrolment
- 200 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
- NCT06056232
- Sponsor's protocol ID
- E20230919
- Status last verified
- Sep 2023
- First submitted
- 20 Sep 2023
- Last updated
- 3 Oct 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exploring the Mechanism of Mindfulness Intervention: Manipulating Distress the Dose of Tolerance Intervention Dose
- ClinicalTrials.gov ID
- NCT06056232
- Acronym / sponsor ID
- E20230919
- Conditions
- Emotional Distress, Emotional Disorder
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Peking UniversityUniversity, hospital or other
- Study start
- 5 Oct 2023 (estimated)
- Primary completion
- 8 Dec 2023 (estimated)
- Study completion
- 10 Mar 2024 (estimated)
- First posted
- 28 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.
This study hopes to:
- explore whether an increase in the dosage of distress tolerance intervention corresponds to greater effectiveness of mindfulness intervention in alleviating emotional distress.
- explore whether distress tolerance mediates the effects of mindfulness intervention on alleviating emotional distress.
Detailed description
Epidemiological findings in "The Lancet Psychiatry" indicated that anxiety disorders, including generalized anxiety disorder, panic disorder, and social anxiety disorder, are the most prevalent category of disorders in China, with a lifetime prevalence of 7.6%. Depression follows closely with a lifetime prevalence of 6.8%. With the outbreak of the COVID-19 pandemic in 2020, the prevalence of both anxiety and depressive disorders increased. However, the current availability of psychological intervention resources in China is inadequate to meet the demand. This underscores the critical importance of developing effective and efficient psychological intervention approaches, as well as investigating their effectiveness and mechanisms to optimize intervention strategies.
In recent years, mindfulness-based interventions (MBIs) have been increasingly applied to alleviate emotional distress in both clinical and non-clinical populations, with their efficacy widely supported. Additionally, numerous researchers have explored the mechanisms underlying mindfulness and MBIs, proposing various theories. One of the mechanisms frequently suggested by researchers is exposure. However, there has been limited direct investigation into the mechanisms of exposure and its related processes or abilities. Distress tolerance (DT) is closely associated with exposure and is considered a common etiological factor or transdiagnostic characteristic of emotional distress, including anxiety and depression. Nevertheless, few studies have explored the mechanisms of how mindfulness interventions alleviate emotional distress from the perspective of exposure and the transdiagnostic characteristics of anxiety and depression. This lack of research hampers our ability to obtain sufficient information to develop or enhance mindfulness-based intervention methods to assist individuals with emotional disorders or highly emotionally distressed subclinical populations.
This study is grounded in the critical role of DT in the generation and maintenance of emotional distress, as well as the mindfulness principle of approaching pain with awareness and acceptance (non-judgmental and non-reactive). It posits that DT might be a potential mechanism through which mindfulness interventions alleviate emotional distress. Following the criteria for establishing mechanisms, this research investigates this issue. Based on the current state of research, DT as a mechanism for MBIs to alleviate emotional distress meets the plausibility criterion and partially satisfies the strong association criterion and experimental manipulation criterion. However, further research is needed to assess its consistency criterion, temporal precedence criterion, and gradient criterion.
The current study primarily focuses on the experimental manipulation and gradient criteria. The aim is to examine whether the mechanism of DT meets the experimental manipulation and gradient criteria by adjusting the content of the mindfulness intervention for emotional distress (MIED) program, which can directly impact distress tolerance and manipulate the dosage of distress tolerance intervention.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| MIED group | Experimental | Behavioral: Mindfulness Intervention for Emotional Distress(MIED)-normal versionMindfulness Intervention for Emotional Distress (MIED) program provides standard audio instructions for mindfulness exercises, introduces 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. |
| MIED+DT group | Experimental | Behavioral: Mindfulness Intervention for Emotional Distress(MIED)-increase distress toleranceThe increase in distress tolerance dosage involves incorporating additional psychoeducational content related to distress tolerance and corresponding exercises to enhance distress tolerance within the MIED (Mindfulness Intervention for Emotional Distress) program. |
| MIED-DT group | Experimental | Behavioral: Mindfulness Intervention for Emotional Distress(MIED)-decrease distress toleranceThe decrease in distress tolerance dosage entails reducing exercises related to distress tolerance within the MIED, such as interoceptive exposure exercises and challenging tasks. |
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;
- Subjects with scores greater than 21 on the Kessler Psychological Distress Scale.
- 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 (3 listed)
- Subjects who have participated in mindfulness-based projects (especially MIED), 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 Distress(MIED)-normal versionMindfulness Intervention for Emotional Distress (MIED) program provides standard audio instructions for mindfulness exercises, introduces 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 | MIED group |
| Mindfulness Intervention for Emotional Distress(MIED)-increase distress toleranceIncrease the intervention dose of distress tolerance in Mindfulness Intervention for Emotional Distress (MIED). For example, including more emotion exposure tasks, materials from Facing Your Feelings. | Behavioural | MIED+DT group |
| Mindfulness Intervention for Emotional Distress(MIED)-decrease distress toleranceDecrease the intervention dose of distress tolerance in Mindfulness Intervention for Emotional Distress (MIED). For example, including less emotion exposure tasks and interoceptive exposure tasks. | Behavioural | MIED-DT group |
Primary outcome
Changes of Five Facet Mindfulness Questionnaire-short form during the intervention
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 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.
Changes of Distress Tolerance Scale during the intervention
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
Distress Tolerance Scale is used to measure Distress Tolerance. Scores range from 5 to 75, with higher scores indicating higher levels of Distress Tolerance.
Changes of Discomfort Intolerance Scale during the intervention
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 is used to measure Discomfort Intolerance. Scores range from 0 to 25, with higher scores indicating higher levels of discomfort intolerance.
Changes of Chinese Perceived Stress Scale during the intervention
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 Perceived Stress Scale is a self-reported questionnaire measuring stress. Scores range from 0 to 56, with higher scores indicating higher levels of stress.
Changes of 10-item Kessler Psychological Distress Scale during the intervention
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 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.
Changes of Overall Anxiety Severity and Impairment Scale during the intervention
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 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.
Changes of Overall Depression Severity and Impairment Scale during the intervention
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 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.
Changes of Beck Depression Inventory during the intervention
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 is a self-reported questionnaire measuring depression level.Scores range from 0 to 63, with higher scores indicating higher levels of depression.
Changes of Beck Anxiety Inventory during the intervention
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 is a self-reported questionnaire measuring Anxiety level.Scores range from 0 to 63, with higher scores indicating higher levels of Anxiety.
Changes of Athens Insomnia Scale during the intervention
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 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.
Changes of Rumination during the intervention
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 Rumination subscale, extracted from the Rumination-Reflection Questionnaire, contains 12 items. Scores range from 5 to 60, with higher scores indicating higher levels of rumination.
Changes of Chinese version of the Brief Experiential Avoidance Questionnaire during the intervention
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 version of the Brief Experiential Avoidance Questionnaire scale is used to measure experiential avoidance. Scores range from 15 to 90, with higher scores indicating higher levels of experiential avoidance.
Changes of Patient Health Questionnaire during the intervention
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
he Patient Health Questionnaire is a self-reported questionnaire consisting of 18 items designed to measure 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.
Changes of behavioral inhibition system/behavioral activation system (BIS/BAS) scale during the intervention
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 BIS/BAS scale is a self-report questionnaire consisting of 18 items designed to assess the intensity of two motivational systems, namely the Behavioral Inhibition System (BIS) and the Behavioral Activation System (BAS). Scores on this scale can vary between 18 and 72, with elevated scores indicative of a greater tendency to avoid aversive outcomes and pursue goal-oriented outcomes.
Changes of Multidimensional Assessment of Interoceptive Awareness-2 (MAIA-2) scale during the intervention
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 Multidimensional Assessment of Interoceptive Awareness-2 (MAIA-2) is a self-report questionnaire that aims to measure Interoceptive Awareness. Scores range from 0 to 165. Higher scores indicate higher ability or tendency in several domains including Noticing, Not-Distracting, Not-Worrying, Attention Regulation, Emotional Awareness, Self-regulation, Body Listening, and Trusting.
1 secondary outcome
The Paced Auditory Serial Addition Task-Computerized (PASAT-C)
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 3 Oct 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Xinghua Liu principal investigator
School of Psychological and Cognitive Sciences, Peking University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mindfulness Intervention for Emotional Distress(MIED)-normal version, Mindfulness Intervention for Emotional Distress(MIED)-increase distress tolerance and Mindfulness Intervention for Emotional Distress(MIED)-decrease distress tolerance in people with Emotional Distress and Emotional Disorder, 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 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 3 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact 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?
Changes of Five Facet Mindfulness Questionnaire-short form during the intervention (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 15 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 3 Oct 2023.