Temporal Dynamics of Mindfulness Intervention for Emotional Distress: Daily Interventions and Assessments
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-60
SponsorPeking University
About this trial
This research aims to adopt a complex systems perspective to thoroughly examine the impact of online mindfulness interventions on changes in emotional distress, with a particular focus on the mechanisms of action. Through a daily diary study design, the study seeks to reveal the complexity and dynamic characteristics of emotional changes and the underlying mechanisms（i.e. distress tolerance， experiential avoidance， cognition flexibility, and life engagement） throughout the intervention process. This research will enrich the theoretical framework of online mental health intervention and provide empirical evidence for optimizing online intervention strategies.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Subjects with scores greater than 21 on the Kessler Psychological Distress Scale.
Disqualifiers
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.
Trial design
Design model
Single group
Treatments tested in this trial
Mindfulness Intervention for emotional distress(MIED）
BehavioralMIED is an eight-week program developed based on MBSR and the Unified Protocol for Transdiagnostic Treatment of Emotional Disorders. MIED consists of weekly group sessions with daily interactive materials delivered via a WeChat-based mini-program. The group sessions, conducted online, provide structured content and interactive discussions aligned with the weekly themes, for example including psychoeducation on mindfulness, emotions, and emotional distress. Mini Program and lasted for 49 days. Each day, participants received different materials including (a) an audio recording of mindfulness meditation guidance; (b) learning materials in text or audio; and (c) assignments (for example, informal mindfulness practice, emotion journal, and challenging tasks).
Treatment groups
100 Participants
are divided into 1 treatment groupGroup A: MBIs GroupExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Daily changes of depression
Daily Depression Severity and Impairment Scale,5 items, scores range from 0 to 20, with higher scores indicating higher levels of depression.
Time frame
once per day for 63 days (1 week pre-intervention, 7 weeks during the intervention, 1 week post-intervention)2
Daily changes of anxiety
Daily Anxiety Severity and Impairment Scale,5 items, scores range from 0 to 20, with higher scores indicating higher levels of anxiety.
Time frame
once per day for 63 days (1 week pre-intervention, 7 weeks during the intervention, 1 week post-intervention)3
Daily changes of engaging in everyday life
Self-developed scale assessing the extent to which individuals' daily engagement in life domains (such as work, social interactions, and leisure activities) is affected by physical and psychological discomfort, 4 items, scores range from 0 to 16, with higher scores indicating higher levels of engaging in everyday life.
Time frame
once per day for 63 days (1 week pre-intervention, 7 weeks during the intervention, 1 week post-intervention)4
Daily changes of distress tolerance
Based on a preliminary study, the items with the highest factor loading from each subscale of the DTS (Simon \& Gaher, 2005) were chosen to form the Daily Distress Tolerance Scale (DDTS). The DDTS consists of four items. Each item is rated on a scale ranging from 1 (strongly agree) to 5 (strongly disagree). Scores range from 4 to 20, with higher scores indicating greater distress tolerance.
Time frame
once per day for 63 days (1 week pre-intervention, 7 weeks during the intervention, 1 week post-intervention)Secondary outcomes
1
changes of trait mindfulness
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.
Time frame
1 week before the intervention, 1 month after the intervention，3 month after the intervention2
changes of Psychological Distress
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.
Time frame
1 week before the intervention, 1 month after the intervention，3 month after the intervention3
changes of depression
The Patient Health Questionnaire-9 (PHQ-9) measures the severity of depressive symptoms over the past two weeks. Each item is rated on a scale ranging from 0 (not at all) to 3 (nearly every day). Scores range from 0 to 27, with higher scores indicating greater severity of depressive symptoms.
Time frame
1 week before the intervention, 1 month after the intervention，3 month after the intervention4
changes of anxiety
The Generalized Anxiety Disorder-7 (GAD-7) measures the severity of generalized anxiety symptoms over the past two weeks. Each item is rated on a scale ranging from 0 (not at all) to 3 (nearly every day). Scores range from 0 to 21, with higher scores indicating greater severity of anxiety symptoms.
Time frame
1 week before the intervention, 1 month after the intervention，3 month after the interventionLocations
Sponsors and contacts
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Source ClinicalTrials.gov
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