---
title: The Effects and Mechanisms of Mindfulness Intervention for Emotional Distress
nct_id: NCT05606224
overall_status: UNKNOWN
phase: NA
sponsor: Peking University
study_type: INTERVENTIONAL
primary_condition: Emotional Disorder
countries: China
canonical_url: "https://parkinsonspathways.com/agent/trials/NCT05606224.md"
clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT05606224"
ct_last_update_post_date: 2022-11-10
last_seen_at: "2026-05-12T06:11:11.585Z"
source: ClinicalTrials.gov (mirrored, no enrichment)
---
# The Effects and Mechanisms of Mindfulness Intervention for Emotional Distress

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

**NCT ID:** [NCT05606224](https://clinicaltrials.gov/study/NCT05606224)

## Key Facts

- **Status:** UNKNOWN
- **Phase:** NA
- **Study Type:** INTERVENTIONAL
- **Target Enrollment:** 200
- **Lead Sponsor:** Peking University
- **Collaborators:** Nanjing Brian Hospital, Capital Medical University, Beijing Tiantan Hospital, Foshan Mental Health Center
- **Conditions:** Emotional Disorder
- **Start Date:** 2022-02-20
- **Completion Date:** 2023-08-30
- **CT.gov Last Update:** 2022-11-10

## Brief 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

- **Minimum age:** 18 Years
- **Maximum age:** 65 Years
- **Sex:** ALL
- **Healthy Volunteers:** No

```
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.
```

## Arms

- **iMIED+TAU: internet-based mindfulness intervention for emotional distress plus treatment as usual** (EXPERIMENTAL) — 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.
- **TAU-only: treatment as usual** (NO_INTERVENTION) — In the current study, TAU consisted of all medicinal and psychological treatments received between baseline and follow-up (about five months). Medicinal treatments included receiving Lorazepam, Olanzapine, Paroxetine Hydrochloride, Sertraline, etc. Psychological treatments included receiving cognitive behavior therapy or psychodynamic therapy.

## Interventions

- **internet-based mindfulness intervention for emotional distress** (BEHAVIORAL) — 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.

## Primary Outcomes

- **Change of mindfulness** _(time frame: at baseline (T0), at week 3(T1) and at week 5 (T2), at post-intervention (T3), and at 3 (T4) months follow-ups)_ — The 20-item Five-Facet Mindfulness Questionnaire-Short Form, self-report, score s range from 20 to 100, higher scores indicate higher levels of mindfulness
- **Change of other-reported anxiety** _(time frame: at baseline (T0), at post-intervention (T3), and at 3 (T4) months follow-ups)_ — Hamilton Anxiety Rating Scale, assessed by the clinicians, scores range from 0 to 56, higher scores indicate higher levels of anxiety
- **Change of other-reported depression** _(time frame: at baseline (T0), at post-intervention (T3), and at 3 (T4) months follow-ups)_ — Hamilton Depression Rating Scale, assessed by the clinicians, scores range from 0 to 68, higher scores indicate higher levels of depression
- **Change of self-reported depression** _(time frame: at baseline (T0), at week 3(T1) and at week 5 (T2), at post-intervention (T3), and at 3 (T4) months follow-ups)_ — Beck Depression Inventory-II, self-report, scores range from 0 to 63, higher scores indicate higher levels of depression
- **Change of self-reported anxiety symptoms** _(time frame: at baseline (T0), at week 3(T1) and at week 5 (T2), at post-intervention (T3), and at 3 (T4) months follow-ups)_ — Beck Anxiety Inventory, self-report, scores range from 0 to 63, higher scores indicate higher levels of anxiety
- **Change of psychological distress** _(time frame: at baseline (T0), at week 3(T1) and at week 5 (T2), at post-intervention (T3), and at 3 (T4) months follow-ups)_ — 10-item Kessler Psychological Distress Scale, self-report, scores range from 5 to 50, higher scores indicate higher levels of psychological distress
- **Change of inner peace** _(time frame: at baseline (T0), at week 3(T1) and at week 5 (T2), at post-intervention (T3), and at 3 (T4) months follow-ups)_ — Inner Peace Scale, self-report, scores range from 0 to 28, higher scores indicate higher levels of inner peace
- **Change of perceived stress** _(time frame: at baseline (T0), at week 3(T1) and at week 5 (T2), at post-intervention (T3), and at 3 (T4) months follow-ups)_ — Chinese Perceived Stress Scales, self-report, scores range from 0 to 28, higher scores indicate higher levels of inner peace
- **Change of sleep quality** _(time frame: at baseline (T0), at week 3(T1) and at week 5 (T2), at post-intervention (T3), and at 3 (T4) months follow-ups)_ — Pittsburgh Sleep Quality Index, self-report, scores range from 0 to 21, higher scores indicate worse sleep quality
- **Change of Depression Severity and Impairment** _(time frame: at baseline (T0), at week 3(T1) and at week 5 (T2), at post-intervention (T3), and at 3 (T4) months follow-ups)_ — Overall Depression Severity and Impairment Scale, self-report, scores range from 0 to 20, higher scores indicate higher levels of depression severity and impairment
- **Change of Anxiety Severity and Impairment** _(time frame: at baseline (T0), at week 3(T1) and at week 5 (T2), at post-intervention (T3), and at 3 (T4) months follow-ups)_ — Overall Anxiety Severity and Impairment Scale, self-report, scores range from 0 to 20, higher scores indicate higher levels of anxiety severity and impairment
- **Change of somatic symptoms** _(time frame: at baseline (T0), at week 3(T1) and at week 5 (T2), at post-intervention (T3), and at 3 (T4) months follow-ups)_ — Patient Health Questionnaire-15, self-report, scores range from 0 to 30 higher scores indicate higher levels of somatic symptoms
- **Change of distress tolerance** _(time frame: at baseline (T0), at week 3(T1) and at week 5 (T2), at post-intervention (T3), and at 3 (T4) months follow-ups)_ — The Chinese version of the Distress Tolerance Scale, self-report, scores range from 15 to 75 higher scores indicate higher levels of distress tolerance
- **Change of Intolerance of Uncertainty** _(time frame: at baseline (T0), at week 3(T1) and at week 5 (T2), at post-intervention (T3), and at 3 (T4) months follow-ups)_ — Intolerance of Uncertainty -Short form, self-report, scores range from 12 to 60, higher scores indicate higher levels of intolerance of uncertainty
- **Change of experiential avoidance** _(time frame: at baseline (T0), at week 3(T1) and at week 5 (T2), at post-intervention (T3), and at 3 (T4) months follow-ups)_ — Brief Experience Avoidance Questionnaire, self-report, scores range from 15 to 75 higher scores indicate higher levels of experiential avoidance
- **Change of attention control** _(time frame: at baseline (T0), at week 3(T1) and at week 5 (T2), at post-intervention (T3), and at 3 (T4) months follow-ups)_ — Attention Control Scale, self-report, scores range from 16 to 64 higher scores indicate higher levels of attention control
- **Change of Cognitive Flexibility** _(time frame: at baseline (T0), at week 3(T1) and at week 5 (T2), at post-intervention (T3), and at 3 (T4) months follow-ups)_ — Cognitive Flexibility Inventory, self-report, scores range from 20 to 100, higher scores indicate higher levels of cognitive flexibility
- **Change of discomfort intolerance** _(time frame: at baseline (T0), at week 3(T1) and at week 5 (T2), at post-intervention (T3), and at 3 (T4) months follow-ups)_ — Discomfort intolerance Scale, self-report, scores range from 0 to 25 higher scores indicate higher levels of discomfort intolerance

## Secondary Outcomes

- **Change of distress tolerance (behavioral indicator1)** _(time frame: at baseline (T0), at week 3(T1) and at week 5 (T2), at post-intervention (T3), and at 3 (T4) months follow-ups)_
- **Change of distress tolerance (behavioral indicator2)** _(time frame: at baseline (T0), at week 3(T1) and at week 5 (T2), at post-intervention (T3), and at 3 (T4) months follow-ups)_
- **Change of distress tolerance (behavioral indicator3)** _(time frame: at baseline (T0), at week 3(T1) and at week 5 (T2), at post-intervention (T3), and at 3 (T4) months follow-ups)_

## Locations (4)

- Beijing Anding Hospital, Beijing, Beijing Municipality, China — _RECRUITING_
- Beijing Tiantan Hospital, Beijing, Beijing Municipality, China — _RECRUITING_
- Fosha Mental Health Center, Foshan, Guangdong, China — _RECRUITING_
- Nanjing Brain Hospital, Nanjing, Jiangsu, China — _RECRUITING_

## Recent Field Changes (last 30 days)

- `status.overallStatus` — added _(2026-05-12)_
- `status.primaryCompletionDate` — added _(2026-05-12)_
- `status.completionDate` — added _(2026-05-12)_
- `status.lastUpdatePostDate` — added _(2026-05-12)_
- `design.phases` — added _(2026-05-12)_
- `design.enrollmentCount` — added _(2026-05-12)_
- `eligibility.criteria` — added _(2026-05-12)_
- `eligibility.minAge` — added _(2026-05-12)_
- `eligibility.maxAge` — added _(2026-05-12)_
- `eligibility.sex` — added _(2026-05-12)_
- `locations.nanjing brain hospital|nanjing|jiangsu|china` — added _(2026-05-12)_
- `outcomes.primary` — added _(2026-05-12)_
- `outcomes.secondary` — added _(2026-05-12)_
- `armsInterventions.arms` — added _(2026-05-12)_
- `armsInterventions.interventions` — added _(2026-05-12)_
- `sponsor.lead` — added _(2026-05-12)_
- `sponsor.collaborators` — added _(2026-05-12)_
- `results.hasResults` — added _(2026-05-12)_
- `locations.beijing anding hospital|beijing|beijing municipality|china` — added _(2026-05-12)_
- `locations.beijing tiantan hospital|beijing|beijing municipality|china` — added _(2026-05-12)_
- `locations.fosha mental health center|foshan|guangdong|china` — added _(2026-05-12)_

---

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