NCT05606224

The Effects and Mechanisms of Mindfulness Intervention for Emotional Distress

The Effects and Mechanisms of Mindfulness Intervention for Emotional Distress: a Multicenter Randomized Controlled Trial

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 200 (estimated)
• Sponsor: Peking University · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

Traditional offline interventions such as MBCT and MBSR have been implemented in treating patients with emotional disorders and obtained significantly improved clinical outcome. However, these offline interventions require the involvement of a therapist expertized 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., MIED), which has been demonstrated to be effective for individuals with emotional distress in a preliminary study. Since patients with emotional disorders usually suffered 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 MIED for patients with emotional disorders. To do so, we will use a design in which patients who receive online mindfulness training (MIED) 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 through improving cognitive flexibility, distress tolerance, intolerance of uncertainty, and experiential avoidance. Therefore, the secondary aim of the study is to examine the mediating effect of these factors on the relationships between mindfulness practice and improvements in outcome variables.

Conditions

• Emotional Disorder

Interventions

Type	Name	Description
BEHAVIORAL	internet-based mindfulness intervention for emotional distress	The internet-based self-help version of the Mindfulness Intervention for Emotional Distress (iMIED) program integrates rationales and practices from the UP and MBIs. Formal mindfulness exercises (e.g., body scan, mindful breathing, and mindful stretching) and informal mindfulness practices (e.g., mindful tooth-brushing) were retrieved from MBIs. In addition, iMIED selected several important tasks from the UP, like practicing tolerating uncomfortable feelings by interoceptive exposure practices (e.g., rapid breathing), identifying avoidant behaviors and emotion-driven behaviors and reducing them step by step, identifying common maladaptive automatic thoughts (e.g., overestimating probability and catastrophizing), and using the above strategies in daily life by completing challenging tasks.

Timeline

• Start date: 2022-02-20
• Primary completion: 2023-08-30
• Completion: 2023-08-30
• First posted: 2022-11-04
• Last updated: 2022-11-10

Locations

4 sites across 1 country: China