NCT05606224

The Effects and Mechanisms of Mindfulness Intervention for Emotional Distress

Status unknown NA Last updated 10 November 2022

What this trial tests

NA trial testing internet-based mindfulness intervention for emotional distress in Emotional Disorder in 200 participants. Status unknown.

Timeline

20 February 2022

Primary endpoint
30 August 2023

30 August 2023

Quick facts

Lead sponsor	Peking University
Phase	NA
Status	Status unknown
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	single
Primary purpose	supportive care
Enrollment	200
Start date	20 February 2022
Primary completion	30 August 2023
Estimated completion	30 August 2023
Sites	4 locations across China

Drugs / interventions tested

• internet-based mindfulness intervention for emotional distress

Conditions studied

• Emotional Disorder — all drugs for Emotional Disorder →

Sponsor

Peking University

Who can join

Adults 18 to 65, any sex, with Emotional Disorder. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.