AI-Assisted Mindfulness Intervention in Emotional Distress

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.

NCT Number	NCT07542561
Lead Sponsor	Xinghua Liu
Conditions	Subclinical Depression, Subclinical Anxious Adults, Subclinical Emotional Distress
Enrollment	550 participants
Start Date	2026-04-15
Primary Completion	2029-04-15 (estimated)
Study Completion	2029-05-15 (estimated)
Updated on ClinicalTrials.gov	2026-06-25