Emotional Distress Clinical Trial
Official title:
Mechanism of Mindfulness Intervention for Emotional Distress: the Role of Cognitive Flexibility
This study hopes to: explore whether offline and online mindfulness interventions can significantly alleviate individual emotional distress and improve cognitive flexibility level. explore whether cognitive flexibility is a mediator in mindfulness intervention to alleviate emotional distress, and to meet the principles of mechanism.
Status | Not yet recruiting |
Enrollment | 200 |
Est. completion date | April 24, 2024 |
Est. primary completion date | April 20, 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 65 Years |
Eligibility | Inclusion Criteria: - Subjects with scores greater than 21 on the Kessler Psychological Distress Scale. Exclusion Criteria: - 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. |
Country | Name | City | State |
---|---|---|---|
China | Peking University | Beijing | Beijing |
Lead Sponsor | Collaborator |
---|---|
Peking University |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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. | pre-intervention; weekly during the 7-week intervention; after the 7-week intervention | |
Primary | 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. | pre-intervention; weekly during the 7-week intervention; after the 7-week intervention | |
Primary | 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. | pre-intervention; weekly during the 7-week intervention; after the 7-week intervention | |
Primary | 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. | pre-intervention; weekly during the 7-week intervention; after the 7-week intervention | |
Primary | Weekly changes of Cognitive flexibility Inventory during the intervention | Cognitive flexibility Inventory is a self-reported questionnaire measuring Cognitive flexibility level.Scores range from 20 to 100, with higher scores indicating higher levels of Cognitive flexibility. | pre-intervention; weekly during the 7-week intervention; after the 7-week intervention | |
Primary | Weekly changes of experiences questionnaire during the intervention | experiences questionnaire is a self-reported questionnaire measuring decentralization ability. Scores range from 20 to 100, with higher scores indicating higher levels of Decentralized ability. | pre-intervention; weekly during the 7-week intervention; after the 7-week intervention | |
Primary | Weekly changes of Beck Depression Inventory during the intervention | Beck Depression Inventory is a self-reported questionnaire measuring depression level.Scores range from 0 to 63, with higher scores indicating higher levels of depression. | pre-intervention; weekly during the 7-week intervention; after the 7-week intervention | |
Primary | Weekly changes of Beck Anxiety Inventory during the intervention | Beck Anxiety Inventory is a self-reported questionnaire measuring Anxiety level.Scores range from 0 to 63, with higher scores indicating higher levels of Anxiety. | pre-intervention; weekly during the 7-week intervention; after the 7-week intervention | |
Primary | Weekly changes of Emotion Regulation Questionnaire during the intervention | Emotion Regulation Questionnaire is a self-reported questionnaire measuring cognitive reappraisal level.Scores range from 6 to 42, with higher scores indicating higher levels of cognitive reappraisal ability. | pre-intervention; weekly during the 7-week intervention; after the 7-week intervention | |
Primary | Weekly changes of Rumination-Reflection Questionnaire during the intervention | Rumination-Reflection Questionnaire is a self-reported questionnaire measuring Rumination level.Scores range from 12 to 60, with higher scores indicating higher levels of Rumination. | pre-intervention; weekly during the 7-week intervention; after the 7-week intervention | |
Secondary | Task Switching Task | The measurement of cognitive flexibility comes from the task switching paradigm, in which participants are required to classify emotional images according to "emotional task rules" or "non-emotional task rules". In emotional task rules, participants are instructed to classify images according to whether the depicted scene is positive or negative. For non-emotional task rules, participants must indicate whether the number of people in the graph is one or none (= 1), or two or more (= 2). Even if there is only a part of a person's body, it counts. The image is taken from the International emotional Image system (International Affective Picture System,IAPS). There are 40 pictures in each category: = 1 person + positive, = 2 + positive, = 1 person + negative, = 2 + negative, a total of 160 pictures. Positive and negative images differ in titer ratings, but are balanced in evocative ratings. Another 20 pictures are used for the practice module. | pre-intervention; weekly during the 7-week intervention; after the 7-week intervention |
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