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AI-Assisted Mindfulness Intervention in Emotional Distress

NCT07542561 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 550

Last updated 2026-04-21

No results posted yet for this study

Summary

The goal of this clinical trial is to learn whether an artificial intelligence-assisted internet-based mindfulness intervention for emotional distress (iMIED) can prevent or reduce anxiety and depressive symptoms in adults with subclinical emotional distress. The main questions it aims to answer are:

Can iMIED reduce anxiety symptoms, as measured by the Generalized Anxiety Disorder-7 (GAD-7)? Can iMIED reduce depressive symptoms, as measured by the Patient Health Questionnaire-9 (PHQ-9)?

Researchers will compare participants receiving iMIED plus access to usual mental health resources with participants receiving usual mental health resources alone to see whether iMIED leads to greater improvement in emotional distress over time.

Participants will:

complete online screening and baseline assessments; be randomly assigned to either the iMIED intervention group or the control group; if assigned to the intervention group, complete a 49-day AI-assisted online mindfulness self-help program using a WeChat mini-program and AI support tool; complete follow-up online questionnaires during the intervention and at 3, 6, 12, 18, and 24 months after the intervention; report information on mental health symptoms, quality of life, healthcare use, sleep, stress, resilience, and life satisfaction.

Conditions

  • Subclinical Depression
  • Subclinical Anxious Adults
  • Subclinical Emotional Distress

Interventions

COMBINATION_PRODUCT

Artificial Intelligence-Assisted Internet-Based Mindfulness Intervention

Delivered via the internet, the intervention is grounded in the Psychopathology Diamond Model proposed by Liu Xinghua's team. It integrates four core strategies: increasing engagement in life, enhancing distress tolerance, reducing excessive emotional behavior, and improving cognitive flexibility (Liu, 2024). Based on advanced large language models, including Tencent Hunyuan and DeepSeek R1, and supported by an official MIED knowledge base comprising the "Mindfulness Practice" WeChat public account, supervision Q\&A records, and other official materials produced by Liu Xinghua and colleagues, the team developed an AI assistant called the "MIED Mindfulness Assistant," along with a WeChat self-help mini-program. Together, these tools support participants' learning and practice over a 49-day continuous training period (Liu, 2024).

Sponsors & Collaborators

  • Xinghua Liu

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-04-15
Primary Completion
2029-04-15
Completion
2029-05-15

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07542561 on ClinicalTrials.gov