Clinical trial NCT06035003: Mechanism of Mindfulness-Based Online Intervention in Enhancing Cognitive Flexibility
Official title: Mechanism of Mindfulness-Based Online Intervention in Enhancing Cognitive Flexibility: Thoughts as Thoughts
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Emotional Distress
Lead sponsor: Peking University
Sponsor class: OTHER
First posted: 2023-09-13
Enrollment: 595
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Traditional offline interventions such as MBCT and MBSR have been implemented to treat patients with emotional disorders and obtained significantly improved clinical outcomes. However, these offline interventions require the involvement of a therapist expert 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., iMIED), which has been effective for individuals with emotional distress in a preliminary study. Since patients with emotional disorders usually suffer 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 iMIED for patients with emotional disorders. To do so, we will use a design in which patients who receive online mindfulness training (iMIED) 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 by improving cognitive flexibility. Therefore, the secondary aim of the study is to examine the mediating effect of cognitive flexibility on the relationships between mindfulness practice and improvements in outcome variables, and further explore the mechanism behind it.


Eligibility criteria: 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.

Primary outcomes:
measure: Weekly changes of Five Facet Mindfulness Questionnaire - Short Form during the intervention
timeFrame: [Time Frame: pre-intervention; weekly during the 7-week intervention; immediately post-intervention]
measure: Weekly changes of Patient Health Questionnaire during the intervention
timeFrame: [Time Frame: pre-intervention; weekly during the 7-week intervention; immediately post-intervention]
measure: Weekly changes of Chinese Perceived Stress Scale during the intervention
timeFrame: [Time Frame: pre-intervention; weekly during the 7-week intervention; immediately post-intervention]
measure: Weekly changes of 10-item Kessler Psychological Distress Scale during the intervention
timeFrame: [Time Frame: pre-intervention; weekly during the 7-week intervention; immediately post-intervention]
measure: Weekly changes of Overall Anxiety Severity and Impairment Scale during the intervention
timeFrame: [Time Frame: pre-intervention; weekly during the 7-week intervention; immediately post-intervention]
measure: Weekly changes of Overall Depression Severity and Impairment Scale during the intervention
timeFrame: [Time Frame: pre-intervention; weekly during the 7-week intervention; immediately post-intervention]
measure: Weekly changes of Athens Insomnia Scale during the intervention
timeFrame: [Time Frame: pre-intervention; weekly during the 7-week intervention; immediately post-intervention]
Secondary outcomes:
measure: Change of Beck Anxiety Inventory
timeFrame: [Time Frame: pre-intervention; 3 weeks into intervention; 5 weeks into intervention; immediately post-intervention]
measure: Change of Beck Depression Inventory-II
timeFrame: [Time Frame: pre-intervention; 3 weeks into intervention; 5 weeks into intervention; immediately post-intervention]
measure: Change of Pittsburgh sleep quality Index
timeFrame: [Time Frame: pre-intervention; 3 weeks into intervention; 5 weeks into intervention; immediately post-intervention]
measure: Change of Insomnia Severity Index
timeFrame: [Time Frame: pre-intervention; 3 weeks into intervention; 5 weeks into intervention; immediately post-intervention]
measure: Change of Mindful Attention Awareness Scale
timeFrame: [Time Frame: pre-intervention; 3 weeks into intervention; 5 weeks into intervention; immediately post-intervention]
measure: Change of Quality of Relationship Index
timeFrame: [Time Frame: pre-intervention; 3 weeks into intervention; 5 weeks into intervention; immediately post-intervention]
measure: Change of Interpersonal Reactivity Index-C
timeFrame: [Time Frame: pre-intervention; 3 weeks into intervention; 5 weeks into intervention; immediately post-intervention]
measure: Change of Intimacy Check and Evaluation Scale
timeFrame: [Time Frame: pre-intervention; 3 weeks into intervention; 5 weeks into intervention; immediately post-intervention]
measure: Moderation effect and possible changes of the Experience Questionnaire
timeFrame: [Time Frame: pre-intervention; 3 weeks into intervention; 5 weeks into intervention; immediately post-intervention]
measure: Moderation effect and possible changes of the Emotion Regulation Questionnaire
timeFrame: [Time Frame: pre-intervention; 3 weeks into intervention; 5 weeks into intervention; immediately post-intervention]
measure: Moderation effect and possible changes of the Cognitive Flexibility Inventory
timeFrame: [Time Frame: pre-intervention; 3 weeks into intervention; 5 weeks into intervention; immediately post-intervention]
measure: Moderation effect and possible changes of the Thoughts as Thoughts Scale
timeFrame: [Time Frame: pre-intervention; 3 weeks into intervention; 5 weeks into intervention; immediately post-intervention]
measure: Moderation effect and possible changes of the Scale of Life Engagement
timeFrame: [Time Frame: pre-intervention; 3 weeks into intervention; 5 weeks into intervention; immediately post-intervention]
measure: Moderation effect and possible changes of the Self-Compassion Scale
timeFrame: [Time Frame: pre-intervention; 3 weeks into intervention; 5 weeks into intervention; immediately post-intervention]
measure: Moderation effect and possible changes of the Rumination- Reflection Questionnaire
timeFrame: [Time Frame: pre-intervention; 3 weeks into intervention; 5 weeks into intervention; immediately post-intervention]
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking University
state: Beijing
Study officials:
affiliation: School of Psychological and Cognitive Sciences, Peking University
name: Xinghua Liu
role: PRINCIPAL_INVESTIGATOR
References: