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NCT05606224
The Effects and Mechanisms of Mindfulness Intervention for Emotional Distress
Conditions: Emotional Disorder
Sex: All
Ages: 18 Years – 65 Years
Phase: NA
Enrollment: 200
Sponsor: Peking University
Location: China
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.
Eligibility Criteria
Inclusion Criteria:Age 18-65;Diagnosis of emotional disorders, including anxiety disorders (e.g., panic disorder, social anxiety disorder, generalized anxiety disorder), and unipolar depression disorders;If taking medication, haven't changed for at least 4 weeks before intervention onset, and no change in medicine is expected;Voluntary participation in this study and sign an informed consent form.Exclusion Criteria:No access to the internet;Inadequate proficiency in Chinese;Previous participation in mindfulness-based programs longer than 6 weeks, and/or current practice of meditation more than once per week;A history of schizophrenia or schizoaffective disorder, current organic mental disorders, substance abuse disorder, and pervasive developmental disorders;Manifesting with any self-injury or suicidal risks.
Source: ClinicalTrials.gov (NCT05606224). StuddyBuddy aggregates publicly available trial information.